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Globe and Mail
10 hours ago
- Business
- Globe and Mail
Ovarian Cancer Market Forecast to 2034: Advancing Treatment Frontiers and Epidemiological Shifts
Ovarian cancer remains a significant global health challenge, often diagnosed at an advanced stage due to non-specific symptoms and a lack of effective early screening. It encompasses a spectrum of histological subtypes, including high-grade serous (HGSOC), low-grade serous (LGSOC), and epithelial tumors, each with unique biological and clinical features. High recurrence rates and poor long-term survival continue to drive the urgent need for improved treatment options and earlier detection. DelveInsight's latest report, ' Ovarian Cancer – Market Insight, Epidemiology, and Market Forecast – 2034,' provides a comprehensive overview of the disease's burden across the US, EU4 (Germany, France, Italy, Spain), the UK, and Japan. It offers in-depth segmentation by subtype, stage, age group, and biomarker status, alongside historical and projected epidemiological trends. The analysis highlights rising incidence rates, shifting subtype proportions—particularly serous carcinomas—and the evolving landscape of diagnostic and therapeutic innovation. The ovarian cancer market has transformed in recent years, driven by the expanding use of PARP inhibitors, antiangiogenic agents, and emerging targeted therapies. These options have shifted the treatment paradigm, particularly for BRCA-mutated, HRD-positive, and platinum-sensitive disease. Nonetheless, persistent issues such as chemoresistance, limited options in late-line settings, and variability in biomarker testing are hindering further progress. Looking ahead, the market is anticipated to grow steadily through 2034, propelled by innovations in epigenetic modulators, antibody-drug conjugates (ADCs), immune-oncology combinations, and advanced diagnostics like liquid biopsies. Enhanced biomarker testing and personalized treatment strategies will support optimized patient care. DelveInsight's full report explores pipeline highlights, market drivers and barriers, and strategic recommendations for stakeholders aiming to transform the outlook for ovarian cancer patients. Request a sample and uncover the latest breakthroughs shaping the Ovarian Cancer market landscape and future outlook Some of the key insights of the Ovarian Cancer Market Report: • In 2024, the ovarian cancer market in the 7MM was valued at USD 2.7 billion. • Market size is expected to grow with the launch of new ovarian cancer therapies. • The U.S. held the largest share, reaching USD 1.92 billion in 2024. • Total incident ovarian cancer cases in the 7MM were 61K in 2024. • The U.S. reported the highest number of high and low-grade serous ovarian cancer cases. • There were approximately 37.6K serous ovarian cancer cases in the 7MM in 2024. • In January 2025, IPS HEART received Orphan Drug Designation (ODD) from the FDA for GIVI-MPCs, recognizing their potential to create new muscle with full-length dystrophin in Becker Muscular Dystrophy (BMD). The therapy has shown promising results in generating human muscle with full-length dystrophin in dystrophic pigs, young and aged Duchenne Muscular Dystrophy (DMD) mice, and an Ovarian Cancer mouse model. • In April 2025, Biocon Biologics received FDA approval for JOBEVNE (bevacizumab-nwgd), a biosimilar to Avastin®, for intravenous use. JOBEVNE is approved for multiple cancers, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, and ovarian, fallopian tube, or primary peritoneal cancer. • In February 2025, the FDA granted fast-track designation to CUSP06, a CDH6-directed antibody-drug conjugate (ADC), for the treatment of patients with platinum-resistant ovarian cancer. • Emerging therapies for ovarian cancer include Avutometinib + defactinib, Relacorilant, IMFINZI, Rinatabart sesutecan, Olvimulogene nanivacirepvec, Nemvaleukin alfa, Catequentinib, Raludotatug deruxtecan, Luveltamab Tazevibulin, Sacituzumab tirumotecan, Azenosertib (ZN-c3) + Niraparib, TORL-1-23, and others. • Key companies involved in the treatment of ovarian cancer include Genmab, AstraZeneca, On Target Laboratories, Chipscreen Biosciences, Aravive, Inc., Allarity Therapeutics, Merck KGaA, GlaxoSmithKline, Aprea Therapeutics, Verastem, Inc., Ellipses Pharma, Impact Therapeutics, Inc., BeiGene, Apexigen, Novartis Oncology, VBL Therapeutics, Cristal Therapeutics, Bayer, Regeneron Pharmaceuticals, DCPrime BV, AIM ImmunoTech Inc., Pharmicell Co., Ltd., Shattuck Labs, Inc., Laekna Limited, Celsion, and others. Curious to see the graphical version of these numbers? The ovarian cancer infographic is ready for you. Check it out here! Ovarian Cancer Overview Ovarian cancer is a complex and often late-diagnosed malignancy arising from the epithelial cells, stromal cells, or germ cells of the ovary. Among these, epithelial ovarian cancer is the most prevalent, accounting for over 90% of malignant ovarian tumors. Due to its subtle early symptoms and lack of reliable screening methods, the disease is frequently diagnosed at advanced stages, contributing to its high mortality rate among gynecological cancers. The most common and aggressive subtype is High-Grade Serous Ovarian Cancer (HGSOC), which often presents with widespread peritoneal metastases. In contrast, Low-Grade Serous Ovarian Cancer (LGSOC) tends to follow a more indolent course but shows resistance to standard chemotherapy, highlighting a critical unmet need for targeted therapies. Genetic mutations such as BRCA1/2 and alterations in the MAPK pathway (BRAF/KRAS/NRAS/NF1) and homologous recombination deficiency (HRD) status play a pivotal role in disease stratification and therapy selection. Over the past decade, the ovarian cancer treatment landscape has evolved with the introduction of PARP inhibitors, anti-angiogenic agents, and targeted therapies that have significantly improved outcomes in biomarker-driven subpopulations. Despite these advancements, resistance development, limited options for certain subtypes like LGSOC, and high relapse rates continue to challenge long-term disease control. As research progresses, efforts are focused on improving early diagnosis, personalizing treatment based on molecular profiling, and expanding therapeutic options through clinical trials and novel drug development. Get a free sample for the Ovarian Cancer market forecast, size & share analysis report: Ovarian Cancer Epidemiology The epidemiology section offers an overview of historical, current, and projected trends in the seven major countries (7MM) from 2020 to 2034. It helps identify the factors influencing these trends by examining various studies and perspectives from key opinion leaders. Additionally, the section provides an in-depth analysis of the diagnosed patient population and future trends. Ovarian Cancer Epidemiology Segmentation: The Ovarian Cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: • Total incident cases of Ovarian Cancer • Age-specific cases of Ovarian Cancer • Type-Specific Cases of Ovarian Cancer • Stage-specific Cases of high and Low-Grade Serous Ovarian Cancer • Biomarker-specific Cases of high and Low-Grade Serous Ovarian Cancer Ovarian Cancer Drugs Uptake and Pipeline Development Activities The Drug Uptake section offers a detailed analysis of the adoption trends of newly launched and upcoming therapies for Ovarian Cancer throughout the study period. It evaluates patient adoption rates, market penetration, and the commercial performance of each therapy, providing a clear understanding of the factors driving or hindering the market acceptance of these treatments. The Therapeutics Assessment further highlights the Ovarian Cancer drugs, demonstrating the most rapid uptake. It examines the underlying drivers contributing to their swift adoption and compares the market share of these therapies to identify those gaining significant traction. Additionally, the report provides an in-depth overview of the current therapeutic pipeline for Ovarian Cancer, covering investigational drugs at various stages of development. It profiles the key pharmaceutical and biotech companies actively involved in advancing targeted treatments and presents the latest updates on partnerships, mergers and acquisitions, licensing deals, and other strategic developments shaping the future of Ovarian Cancer therapeutics. Ovarian Cancer Market Outlook The ovarian cancer treatment landscape is undergoing a significant transformation, with the integration of targeted therapies, personalized medicine, and ongoing clinical research aimed at improving long-term outcomes. High-grade serous ovarian cancer (HGSOC), the most prevalent subtype, continues to be treated with a combination of surgery and platinum-based chemotherapy. However, the emergence of maintenance therapies—especially PARP inhibitors—has reshaped post-treatment strategies for patients with BRCA or HRD mutations, helping reduce recurrence rates and extend progression-free survival. The future of ovarian cancer care is increasingly personalized, with clinical trials exploring novel options like immunotherapy, vaccine-based approaches, and radiation strategies for advanced or recurrent disease. These innovations reflect a broader trend toward therapies tailored to molecular profiles and disease stage, moving away from one-size-fits-all treatment. However, disparities in access to care remain a major challenge. Socioeconomic, racial, and geographic barriers often limit timely diagnosis and appropriate treatment, particularly in underserved populations. As awareness of BRCA testing and biomarker-driven treatment grows, expanding access to genetic screening and oncology expertise will be crucial. The ovarian cancer market is expected to expand steadily through 2034, driven by rising disease burden, evolving therapeutic options, and a growing emphasis on precision medicine. Addressing current gaps in care delivery, especially among high-risk and underserved groups, will be essential to unlocking the full potential of these medical advancements. Ovarian Cancer Market Drivers • The introduction of PARP inhibitors (e.g., olaparib, niraparib) and other targeted agents based on BRCA and HRD status has revolutionized ovarian cancer treatment, improving survival and reducing recurrence in select patient groups. • Increasing adoption of genetic and molecular testing for BRCA mutations, HRD status, and other biomarkers is enabling personalized treatment strategies, driving demand for advanced therapeutic options. Ovarian Cancer Market Barriers • The absence of reliable early screening methods and vague initial symptoms often lead to diagnosis at advanced stages, limiting curative treatment options and affecting patient outcomes. • Limited access to specialized oncology care, especially in rural and low-income regions, along with underutilization of genetic testing among minority populations, continues to hinder equitable treatment and diagnosis. Scope of the Ovarian Cancer Market Report • Study Period: 2020–2034 • Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]. • Key Ovarian Cancer Companies: Genmab, AstraZeneca, On Target Laboratories, Chipscreen Biosciences, Aravive, Inc., Allarity Therapeutics, Merck KGaA, GlaxoSmithKline, Aprea Therapeutics, Verastem, Inc., Ellipses Pharma, Impact Therapeutics, Inc., BeiGene, Apexigen, Novartis Oncology, VBL Therapeutics, Cristal Therapeutics, Bayer, Regeneron Pharmaceuticals, DCPrime BV, AIM ImmunoTech Inc., Pharmicell Co., Ltd., Shattuck Labs, Inc., Laekna Limited, Celsion, and others. • Key Ovarian Cancer Therapies: Avutometinib + defactinib, Relacorilant, IMFINZI, Rinatabart sesutecan, Olvimulogene nanivacirepvec, Nemvaleukin alfa, Catequentinib, Raludotatug deruxtecan, Luveltamab Tazevibulin, Sacituzumab tirumotecan, Azenosertib (ZN-c3) + Niraparib, TORL-1-23, and others. • Ovarian Cancer Therapeutic Assessment: Ovarian Cancer currently marketed, and Ovarian Cancer emerging therapies. • Ovarian Cancer Market Dynamics: Ovarian Cancer market drivers and Ovarian Cancer market barriers. • Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies. • Ovarian Cancer Unmet Needs, KOL's views, Analyst's views, Ovarian Cancer Market Access and Reimbursement. Table of Contents 1. Ovarian Cancer Market Report Introduction 2. Executive Summary for Ovarian Cancer 3. SWOT analysis of Ovarian Cancer 4. Ovarian Cancer Patient Share (%) Overview at a Glance 5. Ovarian Cancer Market Overview at a Glance 6. Ovarian Cancer Disease Background and Overview 7. Ovarian Cancer Epidemiology and Patient Population 8. Country-Specific Patient Population of Ovarian Cancer 9. Ovarian Cancer Current Treatment and Medical Practices 10. Ovarian Cancer Unmet Needs 11. Ovarian Cancer Emerging Therapies 12. Ovarian Cancer Market Outlook 13. Country-Wise Ovarian Cancer Market Analysis (2020–2034) 14. Ovarian Cancer Market Access and Reimbursement of Therapies 15. Ovarian Cancer Market Drivers 16. Ovarian Cancer Market Barriers 17. Ovarian Cancer Appendix 18. Ovarian Cancer Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve. Media Contact Company Name: DelveInsight Contact Person: Jatin Vimal Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
Malaysian Reserve
a day ago
- Business
- Malaysian Reserve
Delta-like Ligand 3 Targeted Therapies Market is Predicted to Heat Up During the Forecast Period (2025-2034) Across 7MM Owing to a Robust Pipeline
The delta-like ligand 3 targeted therapies market is witnessing significant growth, driven by the rising incidence of small cell lung cancer (SCLC) and neuroendocrine tumors. Advancements in antibody-drug conjugate (ADC) technology and increasing clinical trial activity are propelling the development of DLL3-targeted candidates. Growing interest from biopharma companies and strategic collaborations are also accelerating the DLL3-targeted therapies market expansion. LAS VEGAS, June 19, 2025 /PRNewswire/ — DelveInsight's Delta-like Ligand 3 Targeted Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, emerging delta-like ligand 3 targeted therapies, market share of individual therapies, and current and forecasted delta-like ligand 3 targeted therapies market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Delta-like Ligand 3 Targeted Therapies Market Report As per DelveInsight's analysis, the total market size of delta-like ligand 3 targeted therapies in the 7MM is expected to surge significantly by 2034. The approval of the first DLL3-targeted Bispecific T-cell Engager therapy, IMDELLTRA, by the US Food and Drug Administration (FDA) in May 2024 marked a pivotal moment for patients battling Extensive-stage small-cell lung Cancer (ES-SCLC). Leading delta-like ligand 3 targeted therapies companies, such as Phanes Therapeutics, Merck, Daiichi Sankyo, Legend Biotech, Novartis, Abdera Therapeutics, Boehringer Ingelheim, Chugai Pharmaceutical, Roche, Molecular Partners, Orano Med, Zai Lab, Allogene Therapeutics, and others, are developing novel delta-like ligand 3 targeted therapies that can be available in the delta-like ligand 3 targeted therapies market in the coming years. Some of the key delta-like ligand 3 targeted therapies in the pipeline include Peluntamig (PT217), MK-6070/DS3280, LB2102/ DLL3-targeted CAR Ts, 225Ac-ABD147, Obrixtamig (BI 764532), ALPS12/RG6524, MP0712, ZL-1310, ALL-213, and others. In February 2025, Phanes Therapeutics announced that the first patient was dosed in the clinical study of peluntamig (PT217) in combination with chemotherapy. In September 2024, Abdera Therapeutics announced that the US FDA granted ODD to ABD-147 for the treatment of NEC. In August 2024, Daiichi Sankyo and Merck expanded their existing global co-development and co-commercialization agreement for Merck's MK-6070 for the treatment of SCLC. Discover which indication is expected to grab the major delta-like ligand 3 targeted therapies market share @ Delta-like Ligand 3 Targeted Therapies Market Report Delta-like Ligand 3 Targeted Therapies Market Dynamics The delta-like ligand 3 targeted therapies market is emerging as a dynamic and promising area in oncology, particularly for hard-to-treat cancers like SCLC and other neuroendocrine tumors. With a growing understanding of its role in tumorigenesis, drug developers have shifted focus toward exploiting this target through various modalities, including ADCs, BiTEs, and CAR-T cell therapies. The FDA approval of tarlatamab (IMDELLTRA), a DLL3-targeted BiTE, has catalyzed commercial and clinical interest in this space. The competitive landscape is rapidly evolving, driven by both established pharmaceutical players and biotech innovators. Several companies are advancing DLL3-targeted assets through clinical pipelines, highlighting the growing investment and belief in the target's therapeutic value. Tarlatamab, in particular, has set a precedent by demonstrating durable responses in patients with extensive-stage SCLC who have limited treatment options after frontline chemotherapy. Its clinical success has validated DLL3 as a viable target and opened the door for additional programs in earlier lines of therapy and combination regimens. However, the DLL3-targeted therapy market faces challenges that could shape its trajectory. The heterogeneity of DLL3 expression among patient populations, potential for resistance mechanisms, and safety concerns, especially cytokine release syndrome (CRS) in immune-engaging therapies, are critical issues under active investigation. Additionally, biomarker-based patient selection strategies are essential to optimize efficacy, which may limit the addressable population unless companion diagnostics evolve in parallel. Market dynamics are also influenced by the broader shift toward personalized and immune-based treatments. The rise of bispecific and cell-based platforms enhances the flexibility in targeting DLL3, but also introduces manufacturing and logistical hurdles. As such, scalability, cost-effectiveness, and global accessibility will be important considerations in the commercial rollout. Reimbursement strategies and payer acceptance will further impact uptake, especially given the premium pricing associated with novel biologics. Looking ahead, the DLL3-targeted therapies market is poised for expansion beyond SCLC. Preliminary studies are exploring DLL3 expression in other neuroendocrine carcinomas, prostate cancer, and some pediatric tumors. This potential for label expansion, coupled with advancing drug formats and supportive regulatory pathways, indicates a robust growth trajectory. As the clinical pipeline matures and real-world data accumulate, DLL3-targeted approaches are expected to play an increasingly integral role in the precision oncology landscape. Delta-like Ligand 3 Targeted Therapies Treatment Market DLL3-targeted therapies are emerging as a promising new approach in the treatment of small-cell lung cancer and neuroendocrine carcinomas, bringing renewed optimism for patients with these aggressive cancers. A major breakthrough came in May 2024, when the US FDA approved IMDELLTRA, the first bispecific T-cell engager therapy targeting DLL3. Developed by Amgen, this first-in-class immunotherapy is designed to bind DLL3 on tumor cells and CD3 on T cells, triggering a T-cell–mediated attack on DLL3-expressing cancer cells through the formation of a cytolytic synapse. The approval and subsequent launch of IMDELLTRA have been widely recognized as a significant advancement in DLL3-focused treatments, generating approximately USD 115 million in US sales in 2024. This therapy offers a game-changing option for patients with previously treated Extensive-stage SCLC, showing durable responses. As the second FDA-approved BiTE molecule from Amgen, IMDELLTRA underscores the company's commitment to tackling hard-to-treat cancers. For patients urgently needing new therapeutic solutions, this approval delivers a much-needed and long-awaited source of hope. Learn more about the FDA-approved delta-like ligand 3 targeted therapies @ Approved Delta-like Ligand 3 Targeted Therapies Key Emerging Delta-like Ligand 3 Targeted Therapies and Companies The current pipeline is dominated with early-stage DLL-3 targeted therapies like peluntamig (Phanes Therapeutics), MK-6070/ HPN328-4001/ DS3280 (Merck / Daiichi Sankyo), LB2102/ DLL3-targeted CAR-Ts (Legend Biotech and Novartis), 225Ac-ABD147 (Abdera Therapeutics), BI 764532 (Boehringer Ingelheim), ALPS12/ RG6524 (Chugai Pharmaceutical and Roche), ZL-1310 (Zai Lab), and others. Peluntamig (PT217) is a first-in-class, native IgG-like bispecific antibody designed to target both DLL3 and CD47. It is being developed for the treatment of SCLC and neuroendocrine carcinomas, including neuroendocrine prostate cancer (NEPC). The FDA has awarded peluntamig two Orphan Drug Designations (ODDs) for SCLC and NEC, along with two Fast Track Designations (FTDs): one for extensive-stage SCLC that has progressed following platinum-based chemotherapy (with or without checkpoint inhibitors), and another for metastatic de novo or treatment-emergent NEPC. The therapy is currently undergoing evaluation in the Phase I/II SKYBRIDGE trial (NCT05652686) for SCLC and NEC. MK-6070 is an experimental tri-specific T-cell engager targeting DLL3, under Phase I/II clinical investigation. It is being tested as a standalone therapy in patients with advanced DLL3-expressing tumors and in combination with atezolizumab for certain cases of SCLC. The FDA granted MK-6070 Orphan Drug Designation for SCLC in March 2022. In March 2024, Merck finalized its acquisition of Harpoon Therapeutics, the original developer. In August 2024, Daiichi Sankyo and Merck expanded their global partnership to include MK-6070 under their co-development and co-commercialization agreement for DXd antibody-drug conjugates. Merck retains exclusive rights in Japan and will handle all manufacturing and supply responsibilities for MK-6070. The two companies also plan to explore the use of MK-6070 in combination with ifinatamab deruxtecan (I-DXd) for SCLC, along with other potential combination strategies. The anticipated launch of these emerging therapies is poised to transform the delta-like ligand 3 targeted therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the delta-like ligand 3 targeted therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about delta-like ligand 3 targeted therapies clinical trials, visit @ Delta-like Ligand 3 Targeted Therapies Treatment Delta-like Ligand 3 Targeted Therapies Overview Delta-like ligand 3 (DLL3) targeted therapies is an unconventional ligand within the Notch signaling pathway that, when overexpressed, supports the growth, migration, and invasiveness of small cell lung cancer (SCLC) cells. It also contributes to the development of metastatic and therapy-resistant traits in neuroendocrine carcinomas (NECs), enhancing both tumor cell proliferation and resistance to platinum-based chemotherapy. In normal cells, DLL3 expression is minimal and confined to the Golgi apparatus and cytoplasmic vesicles. This specific intracellular localization is regulated by its transmembrane domain and nearby protein sequences, which serve as retention signals. In contrast, SCLC cells exhibit high levels of DLL3 that are abnormally localized to the cell surface, a characteristic observed in up to 85% of human SCLC cases. While the mechanisms behind this overexpression and altered trafficking are not fully understood, DLL3's distinct expression pattern positions it as a promising biomarker and therapeutic target in SCLC. Beyond SCLC, DLL3 is also widely expressed in various NECs, including certain molecular subtypes of pulmonary large cell NEC (LCNEC) and NECs originating from the gastroenteropancreatic tract, bladder, prostate, and cervix. In these tumors, elevated DLL3 expression correlates with more advanced disease and poorer overall survival, suggesting a strong association between high DLL3 levels and unfavorable clinical outcomes. Delta-like Ligand 3 Targeted Therapies Epidemiology Segmentation The delta-like ligand 3 targeted therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases in Selected Indications for DLL3-targeted Therapies Total Eligible Patient Pool in Selected Indications for DLL3-targeted Therapies Total Treated Cases in Selected Indications for DLL3-targeted Therapies Delta-like Ligand 3 Targeted Therapies Report Metrics Details Study Period 2020–2034 Delta-like Ligand 3 Targeted Therapies Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Delta-like Ligand 3 Targeted Therapies Companies Phanes Therapeutics, Merck, Daiichi Sankyo, Legend Biotech, Novartis, Abdera Therapeutics, Boehringer Ingelheim, Chugai Pharmaceutical, Roche, Molecular Partners, Orano Med, Zai Lab, Allogene Therapeutics, Amgen, and others Key Delta-like Ligand 3 Targeted Therapies Peluntamig (PT217), MK-6070/DS3280, LB2102/ DLL3-targeted CAR Ts, 225Ac-ABD147, Obrixtamig (BI 764532), ALPS12/RG6524, MP0712, ZL-1310, ALL-213, IMDELLTRA, and others Scope of the Delta-like Ligand 3 Targeted Therapies Market Report Delta-like Ligand 3 Targeted Therapies Therapeutic Assessment: Delta-like Ligand 3 Targeted Therapies current marketed and emerging therapies Delta-like Ligand 3 Targeted Therapies Market Dynamics: Conjoint Analysis of Emerging Delta-like Ligand 3 Targeted Therapies Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Delta-like Ligand 3 Targeted Therapies Market Access and Reimbursement Discover more about delta-like ligand 3 targeted therapies in development @ Delta-like Ligand 3 Targeted Therapies Clinical Trials Table of Contents 1. Key Insights 2. Report Introduction 3. Executive Summary 4. Key Events 5. Market Forecast Methodology 6. Delta-like Ligand 3 Targeted Therapies Market Overview at a Glance in the 7MM 6.1. Market Share (%) Distribution by Therapies in 2025 6.2. Market Share (%) Distribution by Therapies in 2034 6.3. Market Share (%) Distribution by Indications in 2025 6.4. Market Share (%) Distribution by Indications in 2034 7. Delta-like Ligand 3 (DLL3)-targeted Therapies: Background and Overview 7.1. Introduction 7.2. The Potential of Delta-like Ligand 3 (DLL3)-targeted Therapies in Different Indications 7.3. Clinical Applications of Delta-like Ligand 3 (DLL3)-targeted Therapies 8. Target Patient Pool of Delta-like Ligand 3 (DLL3)-targeted Therapies 8.1. Assumptions and Rationale 8.2. Key Findings 8.3. Total Cases of Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 8.4. Total Eligible Patient Pool of Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 8.5. Total Treatable Cases in Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 9. Marketed Therapies 9.1. Key Competitors 9.2. IMDELLTRA (tarlatamab-dlle): Amgen 9.2.1. Product Description 9.2.2. Regulatory milestones 9.2.3. Other developmental activities 9.2.4. Clinical development 9.2.5. Safety and efficacy List to be continued in the report 10. Emerging Therapies 10.1. Key Competitors 10.2. Peluntamig (PT217): Phanes Therapeutics 10.2.1. Product Description 10.2.2. Other developmental activities 10.2.3. Clinical development 10.2.4. Safety and efficacy 10.3. MK-6070/ HPN328-4001/ DS3280: Merck/ Daiichi Sankyo 10.3.1. Product Description 10.3.2. Other developmental activities 10.3.3. Clinical development 10.3.4. Safety and efficacy List to be continued in the report 11. Delta-like Ligand 3 Targeted Therapies: Seven Major Market Analysis 11.1. Key Findings 11.2. Market Outlook 11.3. Conjoint Analysis 11.4. Key Market Forecast Assumptions 11.4.1. Cost Assumptions and Rebates 11.4.2. Pricing Trends 11.4.3. Analogue Assessment 11.4.4. Launch Year and Therapy Uptakes 11.5. Total Market Sizes of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in the 7MM 11.6. The United States Market Size 11.6.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies in the United States 11.6.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indication in the United States 11.6.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in the United States 11.7. EU4 and the UK 11.7.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies in EU4 and the UK 11.7.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in EU4 and the UK 11.7.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in EU4 and the UK 11.8. Japan 11.8.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies Inhibitors in Japan 11.8.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in Japan 11.8.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in Japan 12. SWOT Analysis 13. KOL Views 14. Unmet Needs 15. Market Access and Reimbursement 16. Appendix 16.1. Bibliography 16.2. Report Methodology 17. DelveInsight Capabilities 18. Disclaimer 19. About DelveInsight Related Reports Small Cell Lung Cancer Market Small Cell Lung Cancer Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SCLC companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, GlaxoSmithKline, Advanced Accelerator Applications, Trillium Therapeutics, Vernalis, Oncoceutics, NewBio Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, Xencor, Jiangsu HengRui Medicine, Aileron Therapeutics, Roche, Ipsen, Celgene, Lee's Pharmaceutical Limited, AbbVie, G1 Therapeutics, Chipscreen Biosciences, Luye Pharma Group, Shanghai Henlius Biotech, CSPC ZhongQi Pharmaceutical Technology, Impact Therapeutics, among others. Extensive-Stage Small Cell Lung Cancer Market Extensive-Stage Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ES-SCLC companies, including Shanghai Henlius Biotech, MacroGenics, Inc., RayzeBio, Inc., Genentech, Eli Lilly and Company, Amgen, Hutchison Medipharma Limited, Biocity Biopharmaceutics Co., Ltd., Biotheus Inc., GSK, InxMed (Shanghai) Co., Ltd., Daiichi Sankyo, Merck Sharp & Dohme LLC, among others. Neuroendocrine Carcinoma Market Neuroendocrine Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NEC companies, including Novartis AG, Boehringer Ingelheim International GmbH, Pfizer, Inc., Ipsen Pharma, AVEO Oncology, Hutchison MediPharma Limited, Progenics Pharmaceuticals, among others. Neuroendocrine Prostate Cancer Market Neuroendocrine Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key neuroendocrine prostate cancer companies, including Pfizer, Novartis, Bristol-Myers Squibb, Exelixis, Ipsen, Takeda, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content:
Yahoo
2 days ago
- Business
- Yahoo
HER2-low Cancers Market Set to Register Immense Growth at a CAGR of 9.4% During the Study Period (2020-2034)
The future of the HER2-low cancer treatment market is poised for significant transformation, driven by the approval of ENHERTU and the advancement of other innovative antibody-drug conjugates (ADCs) like DATROWAY, TRODELVY, ifinatamab deruxtecan, BB-1701, and Disitamab vedotin. These ADCs are designed to target HER2-low-expressing cancer cells, with major development ongoing in Breast Cancer. LAS VEGAS, June 19, 2025 /PRNewswire/ -- DelveInsight's HER2-low Cancers Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, emerging HER2-low cancer therapies, market share of individual therapies, and current and forecasted HER2-low cancers market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the HER2-low Cancers Market Report HER2-low cancer refers to tumors with low HER2 protein expression that do not meet the criteria for HER2-positive classification. The prevalence of HER2-low expression varies across cancers, occurring in approximately 63% of breast cancers, 42% of biliary tract cancers, 38% of urothelial carcinomas, and 35% of gastric cancers. As per DelveInsight's analysis, the total market size of HER2-low cancers in the 7MM was USD 3.2 billion in 2024 and is projected to grow during the forecast period (2025-2034), driven by ENHERTU's usage and strong uptake in this cancer type. Of the target indications, breast cancer and gastric cancer are anticipated to generate the most revenue by 2034 due to the highest level of clinical development and authorization of HER2-low cancer therapies. Among all therapies, ENHERTU is expected to capture the highest market share, due to its proven clinical efficacy, strong safety, and first-mover advantage in treating HER2-low cancers. Based on Delveinsight's assessment in 2024, the 7MM had approximately 360,000 target pool cases of HER2-low cancers. These cases are projected to increase during the forecast period (2025–2034) due to recent clinical advances recognizing HER2-low as a distinct category, thereby expanding the treatable patient population There are no HER2-targeting therapies currently in the pipeline for first-line treatment; all available options are focused on the relapsed or refractory setting. The HER2-low breast cancer pipeline is becoming increasingly competitive, as ENHERTU has dramatically shifted market dynamics. Its approval for HER2-low breast cancer has significantly transformed the market trajectory, leading to a doubling of overall sales in 2023. Leading HER2-low cancer companies, such as AstraZeneca, Daiichi Sankyo, RemeGen, Pfizer (Seagen), Gilead Sciences, Merck, Bliss Biopharmaceutical (Hangzhou), Zymeworks, Jazz Pharmaceuticals, ALX Oncology, Dragonfly Therapeutics, Mersana Therapeutics, and others, are developing novel HER2-low cancer therapies that can be available in the HER2-low cancer market in the coming years. Some of the key HER2-low cancer therapies in the pipeline include DATROWAY (datopotamab deruxtecan/Dato-DXd), AIDIXI (disitamab vedotin), TRODELVY (sacituzumab govitecan), Ifinatamab deruxtecan (I-DXd)/MK-2400, BB-1701, ZIIHERA (zanidatamab), DF1001, Emiltatug ledadotin (XMT-1660), and others. Discover which therapies are expected to grab the HER2-low cancers market share @ HER2-low Cancers Market Report HER2-low Cancers Market Dynamics The HER2-low cancer market has recently garnered significant attention, primarily due to the advancements in targeted therapies for cancers with low expression of the HER2 protein. While HER2-positive cancers, such as breast and gastric cancers, have long been the focus of targeted treatments like trastuzumab (HERCEPTIN), HER2-low cancers represent a distinct subset that requires different therapeutic strategies. These cancers exhibit a lower level of HER2 expression, making them more challenging to treat with traditional HER2-targeted therapies. However, recent breakthroughs in ADCs and novel monoclonal antibodies are starting to offer new avenues for patients with this subgroup. As researchers continue to explore HER2-low cancers, one of the key dynamics driving the market is the recognition that these tumors can benefit from a broader range of treatments. In particular, ADCs are showing promise as they allow for more precise delivery of chemotherapy agents directly to tumor cells. This approach offers hope for patients whose cancers were previously thought to be less amenable to targeted therapies. The approval of drugs like ENHERTU for HER2-low breast cancer has created a significant shift in the oncology treatment landscape, leading to a surge of interest from pharmaceutical companies developing similar therapies. The growing understanding of HER2-low cancers has also influenced diagnostic practices, with an emphasis on accurate biomarker testing. Companies are now focusing on developing more sensitive and specific assays to detect low levels of HER2 expression, ensuring that patients are correctly identified for targeted treatment options. This has led to the rise of precision medicine in oncology, where treatments are tailored not only to the type of cancer but also to the molecular characteristics of the tumor. The better the diagnostics, the more likely it is that patients will receive appropriate therapies, boosting market potential. Additionally, market dynamics are shaped by the competitive landscape, with several big pharmaceutical companies investing heavily in the development of new agents for HER2-low cancers. The approval of HER2-targeted treatments for low-expressing cancers is expected to trigger a surge in demand, especially in indications such as breast and gastric cancers. However, challenges remain, including the cost of these novel therapies, their accessibility in different healthcare settings, and the need for continued clinical validation. As these therapies advance through the pipeline, the future market for HER2-low cancer treatments looks promising, but it will require a combination of scientific innovation, regulatory support, and healthcare infrastructure to realize its full potential. HER2-low Cancers Treatment Market HER2-low cancers, which are marked by low levels of the HER2 protein, pose distinct treatment challenges. Recent research has focused on targeted therapies for such cancers, especially breast cancers. Treatment options for HER2-low cancers, including gastric, endometrial, and other cancers, are evolving as research continues to explore the role of HER2 in these diseases. Traditional therapies, such as monoclonal antibodies and small molecular Tyrosine Kinase Inhibitors (TKIs), have shown limited effectiveness in breast cancers with HER2-low expression. For years, HER2-low breast cancer has been treated similarly to HER2-negative breast cancer, including HR+/HER2− and TNBC cases. For gastric cancer, particularly adenocarcinoma of the stomach and gastroesophageal junction, recent research has highlighted the potential of ENHERTU, an antibody-drug conjugate. ENHERTU has shown promising results in patients with HER2-low expression (IHC 1+ or 2+/ISH−). In January 2025, ENHERTU was approved by the US FDA for treating adult patients with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow (IHC 0 with membrane staining) breast cancer, who have progressed on one or more endocrine therapies in the metastatic setting, based on an FDA-approved test. For HR-negative/HER2-low breast cancer, treatment usually begins with first-line chemotherapy, potentially combined with immunotherapy for PD-L1-positive patients, followed by sequential chemotherapy treatments. For HR-positive breast cancer, due to its progression-free survival advantage over chemotherapy, PARP inhibitors (PARPi) are considered for patients with a germline BRCA mutation. Learn more about the FDA-approved HER2-low cancer therapies @ HER2-low Cancer Treatment Drugs HER2-low Cancers Pipeline Therapies and Key Companies Currently, the clinical development landscape includes late and mid-stage assets. Consequently, our forecast considers the potential impact of Pfizer's Disitamab vedotin, Immutep's Eftilagimod alpha (IMP321), AstraZeneca and Daiichi Sankyo's DATROWAY, Gilead Sciences' TRODELVY, Duality Biologics and BioNTech's DB-1303/BNT323, Daiichi Sankyo and Merck's Ifinatamab deruxtecan, Bliss Biopharmaceutical's BB-1701, and Dragonfly Therapeutics' DF1001. Dato-DXd is an experimental TROP2-targeted ADC, developed using Daiichi Sankyo's proprietary DXd ADC Technology. It is one of six DXd ADCs in their oncology pipeline and a key program in AstraZeneca's ADC scientific platform. In collaboration with Sapporo Medical University, Dato-DXd is designed with topoisomerase I inhibitor payloads linked via tetrapeptide-based cleavable linkers. The drug is currently in Phase III trials for inoperable or metastatic HR-positive, HER2-low or negative breast cancer (IHC 0, IHC 1+, or IHC 2+/ISH-) that has previously been treated with endocrine therapy and at least one systemic therapy. AstraZeneca expects Phase I results from the TROPION-PanTumor01 trial (NCT03401385) to be available in the latter half of 2025, as reported in their 2024 clinical trial appendix. In February 2025, Daiichi Sankyo presented data from the Phase III TROPION-Breast01 DATROWAY trial for HR+/HER2-low breast cancer at the ESMO Virtual Meeting. While overall survival did not reach statistical significance, Dato-DXd showed a manageable safety profile and continued to favor the investigator's choice of chemotherapy on secondary efficacy endpoints. TRODELVY is a first-in-class TROP-2-targeting ADC designed with a proprietary hydrolyzable linker and SN-38, a topoisomerase I inhibitor payload. This combination delivers potent activity to TROP-2-expressing cells and the surrounding microenvironment. It is currently undergoing Phase III trials for HR-positive/HER-negative (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH–]) inoperable, locally advanced, or metastatic breast cancer after endocrine therapy. Its patent is set to expire in the US by 2028 and in Europe by 2029. BNT323/DB-1303 is a third-generation ADC targeting HER2, built on DualityBio's proprietary Duality Immune Toxin Antibody Conjugates (DITAC) platform. This candidate has shown antitumor activity in HER2-positive and HER2-low tumor models, as well as in multiple solid tumors, including breast, gastric, endometrial, biliary tract cancers, and other advanced solid tumors. BNT323/DB-1303 is currently being evaluated in a Phase I/II study (NCT05150691) for advanced/metastatic solid tumors and in a pivotal Phase III study (NCT06018337) for HR-positive and HER2-low, metastatic breast cancer that has progressed on hormone and/or CDK4/6 therapy. The anticipated launch of these emerging therapies are poised to transform the HER2-low cancers market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the HER2-low cancers market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about HER2-low cancer drug clinical trials, visit @ HER2-low Cancer Drugs Recent Developments in the HER2-low Cancer Market In January 2025, the US FDA approved ENHERTU for adults with unresectable or metastatic HR+, HER2-low or HER2-ultralow breast cancer, based on DESTINY-Breast06 Phase III results following progression on one or more endocrine therapies. In January 2025, the US FDA granted FTD to emiltatug ledadotin, B7-H4 ADC, for advanced or metastatic HER2-low or HER2-negative breast cancer, including triple-negative cases previously treated with a topoisomerase-1 inhibitor ADC, based on promising results from a Phase I trial. As per BioNTech's Q4 2024 annual presentation, published in March 2025, the company plans to prioritize the advancement of DB-1303 for BLA submission in 2025 as a second-line or subsequent therapy in HER2-expressing advanced endometrial cancer. According to Pfizer's presentation, the launch of disitamab vedotin for second-line HER2+/low metastatic urothelial carcinoma is expected in 2026. HER2-low Cancers Overview HER2 is a transmembrane tyrosine kinase receptor encoded by the ERBB2 gene, playing a crucial role in cell growth, differentiation, and survival. It is part of the epidermal growth factor receptor family and is typically analyzed using molecular techniques. HER2 protein overexpression is assessed through immunohistochemistry (IHC), while gene amplification is determined using fluorescence in situ hybridization (FISH). A HER2-low status is defined as an IHC score of 1+ or 2+, with no gene amplification detected by FISH. HER2/neu primarily activates the MAPK and PI3K pathways, contributing to malignant transformation when overexpressed or amplified. This receptor is found in several cancers, including breast, colorectal, ovarian, endometrial, bladder, gastric, and biliary tract cancers, with breast cancer being the most prevalent. HER2-low Cancers Epidemiology Segmentation In the 7MM, in 2024, among all the HER2-low cancer indications, breast cancer accounted for the highest number of incident cases, while ovarian cancer occupied the bottom of the ladder. The HER2-low cancers market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Targeted Patient Pool of Selected Indications for HER2-low Cancers Treatment Eligible Pool of Selected Indications for HER2-low Cancers Total Incident Cases of HER2-low Breast Cancers Age-specific Cases of HER2-low Breast Cancers Stage-specific Cases of HER2-low Breast Cancers HER2-low Cancers Report Metrics Details Study Period 2020–2034 HER2-low Cancers Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] HER2-low Cancer Market CAGR 9.4 % HER2-low Cancer Market Size in 2024 USD 3.2 billion Key HER2-low Cancer Companies AstraZeneca, Daiichi Sankyo, RemeGen, Pfizer (Seagen), Gilead Sciences, Merck, Bliss Biopharmaceutical (Hangzhou), Zymeworks, Jazz Pharmaceuticals, ALX Oncology, Dragonfly Therapeutics, Mersana Therapeutics, and others Key HER2-low Cancer Therapies ENHERTU, DATROWAY (datopotamab deruxtecan/Dato-DXd), AIDIXI (disitamab vedotin), TRODELVY (sacituzumab govitecan), Ifinatamab deruxtecan (I-DXd)/MK-2400, BB-1701, ZIIHERA (zanidatamab), DF1001, Emiltatug ledadotin (XMT-1660), and others Scope of the HER2-low Cancers Market Report HER2-low Cancers Therapeutic Assessment: HER2-low Cancers current marketed and emerging therapies HER2-low Cancers Market Dynamics: Conjoint analysis of approved and emerging HER2-low Cancers Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Cost assumptions, HER2-low Cancers Market Access and Reimbursement Discover more about HER2-low cancer drugs in development @ HER2-low Cancers Clinical Trials Table of Contents 1 KEY INSIGHTS 2 REPORT INTRODUCTION 3 EXECUTIVE SUMMARY 4 KEY EVENTS 5 EPIDEMIOLOGY AND MARKET FORECAST METHODOLOGY 6 HER2-LOW CANCERS MARKET OVERVIEW AT A GLANCE 6.1 MARKET SHARE (%) DISTRIBUTION BY THERAPIES OF HER2-LOW CANCERS IN 2024 IN THE 7MM 6.2 MARKET SHARE (%) DISTRIBUTION BY THERAPIES OF HER2-LOW CANCERS IN 2034 IN THE 7MM 6.3 MARKET SHARE (%) DISTRIBUTION BY INDICATIONS IN 2024 IN THE 7MM 6.4 MARKET SHARE (%) DISTRIBUTION BY INDICATIONS IN 2034 IN THE 7MM 7 DISEASE BACKGROUND AND OVERVIEW 7.1 INTRODUCTION 7.2 SYMPTOMS 7.3 RISK FACTORS 7.4 PATHOPHYSIOLOGY OF HER2-LOW CANCERS 7.5 PROGNOSIS 7.6 DIAGNOSIS 7.7 TREATMENT 7.8 GUIDELINES 7.8.1 Diagnostic Guidelines and Recommendations for HER2-low Cancers 7.8.1.1 ASCO Diagnostic Recommendations for HER2 Testing 7.8.1.2 The ASCO-College of American Pathologists (CAP) Recommendations for HER2 Testing 7.8.1.3 ESCO Guidelines for HER2-low Cancers 7.8.1.4 Interpretation by the ASCO/CAP 2018 Guidelines and by the 2023 ESMO Consensus on HER2-low Breast Cancer Regarding Each Pattern of HER2 Staining 7.8.1.5 Pan-Asian Adapted ESMO Guidelines for HER2-low Cancers 7.8.1.6 Japanese Breast Cancer Society Clinical Practice Guidelines for Pathological Diagnosis of Breast Cancer, 2022 Edition 7.8.2 Treatment Guidelines and Recommendations for HER2-low Cancers 7.8.2.1 ESMO Guidelines for HER2-low Cancers 7.8.2.2 Pan-Asian Adapted ESMO Guidelines for HER2-low Cancers 8 EPIDEMIOLOGY AND PATIENT POPULATION 8.1 KEY FINDINGS 8.2 ASSUMPTION AND RATIONALE OF HER2-LOW CANCERS: THE 7MM 8.3 TOTAL TARGETED PATIENT POOL OF SELECTED INDICATIONS FOR HER2-LOW CANCERS IN THE 7MM 8.4 TREATMENT ELIGIBLE POOL OF SELECTED INDICATIONS FOR HER2-LOW CANCERS IN THE 7MM 8.5 THE UNITED STATES 8.5.1 Total Incident Cases of HER2-low Breast Cancers in the United States 8.5.2 Age-specific Cases of HER2-low Breast Cancers in the United States 8.5.3 Stage-specific Cases of HER2-low Breast Cancers in the United States 8.6 EU4 AND THE UK 8.6.1 Total Incident Cases of HER2-low Breast Cancers in EU4 and the UK 8.6.2 Age-specific Cases of HER2-low Breast Cancers in EU4 and the UK 8.6.3 Stage-specific Cases of HER2-low Breast Cancers in EU4 and the UK 8.7 JAPAN 8.7.1 Total Incident Cases of HER2-low Breast Cancers in Japan (2020-2034) 8.7.2 Age specific Cases of HER2-low Breast Cancers in Japan 8.7.3 Stage-specific Cases of HER2-low Breast Cancers in Japan 9 PATIENT JOURNEY 10 MARKETED DRUG 10.1 KEY COMPETITOR 10.2 ENHERTU (TRASTUZUMAB DERUXTECAN): DAIICHI SANKYO AND ASTRAZENECA 10.2.1 Product Description 10.2.2 Regulatory Milestones 10.2.3 Other Developmental Activities 10.2.4 Clinical Development 10.2.4.1 Clinical Trial Information 10.2.5 Safety and Efficacy 11 EMERGING THERAPIES 11.1 KEY CROSS COMPETITION 11.2 DATROWAY (DATOPOTAMAB DERUXTECAN/DATO-DXD): ASTRAZENECA AND DAIICHI SANKYO 11.2.1 Product Description 11.2.2 Other Developmental Activities 11.2.3 Clinical Development 11.2.3.1 Clinical Trials Information 11.2.4 Safety and Efficacy 11.2.5 Analyst Views 11.3 TRODELVY (SACITUZUMAB GOVITECAN): GILEAD SCIENCES 11.3.1 Product Description 11.3.2 Other Developmental Activities 11.3.3 Clinical Development 11.3.3.1 Clinical Trials Information 11.3.4 Safety and Efficacy 11.3.5 Analyst Views 11.4 DB-1303/BNT323 (TRASTUZUMAB PAMIRTECAN): DUALITY BIOLOGICS AND BIONTECH 11.4.1 Product Description 11.4.2 Other Developmental Activities 11.4.3 Clinical Development 11.4.3.1 Clinical Trials Information 11.4.4 Safety and Efficacy 11.4.5 Analyst Views 11.5 AIDIXI (DISITAMAB VEDOTIN): REMEGEN AND PFIZER (SEAGEN) 11.5.1 Product Description 11.5.2 Other Developmental Activities 11.5.3 Clinical Development 11.5.4 Safety and Efficacy 11.5.5 Analyst Views 11.6 EFTILAGIMOD ALPHA (IMP321): IMMUTEP 11.6.1 Product Description 11.6.2 Other Developmental Activities 11.6.3 Clinical Development 11.6.3.1 Clinical Trials Information 11.6.4 Safety and Efficacy 11.6.5 Analyst Views 11.7 IFINATAMAB DERUXTECAN (I-DXD)/MK-2400: DAIICHI SANKYO AND MERCK 11.7.1 Product Description 11.7.2 Other Developmental Activities 11.7.3 Clinical Development 11.7.3.1 Clinical Trials Information 11.7.4 Analyst Views 11.8 BB-1701: BLISS BIOPHARMACEUTICAL (HANGZHOU) 11.8.1 Product Description 11.8.2 Other Developmental Activities 11.8.3 Clinical Development 11.8.3.1 Clinical Trials Information 11.8.4 Safety and Efficacy 11.8.5 Analyst Views 11.9 DF1001: DRAGONFLY THERAPEUTICS 11.9.1 Product Description 11.9.2 Other Developmental Activities 11.9.3 Clinical Development 11.9.3.1 Clinical Trials Information 11.9.4 Safety and Efficacy 11.9.5 Analyst Views 11.1 ZIIHERA (ZANIDATAMAB): ZYMEWORKS/JAZZ PHARMACEUTICALS/ALX ONCOLOGY 11.10.1 Product Description 11.10.2 Other Developmental Activities 11.10.3 Clinical Development 11.10.4 Safety and Efficacy 11.10.5 Analyst Views 11.11 HF158K1/HF-K1: HIGHFIELD BIOPHARMACEUTICALS 11.11.1 Product Description 11.11.2 Other Developmental Activities 11.11.3 Clinical Development 11.11.3.1 Clinical Trials Information 11.11.4 Safety and Efficacy 11.11.5 Analyst Views 11.12 EMILTATUG LEDADOTIN (XMT-1660): MERSANA THERAPEUTICS 11.12.1 Product Description 11.12.2 Other Developmental Activities 11.12.3 Clinical Development 11.12.3.1 Clinical Trials Information 11.12.4 Safety and Efficacy 11.12.5 Analyst Views 12 HER2-LOW CANCERS: SEVEN MAJOR MARKET ANALYSIS 12.1 KEY FINDINGS 12.2 MARKET OUTLOOK 12.3 CONJOINT ANALYSIS 12.4 KEY MARKET FORECAST ASSUMPTIONS 12.4.1 Cost Assumptions 12.4.2 Pricing Trends 12.4.3 Analogue Assessment 12.4.4 Launch Year and Therapy Uptakes 12.5 TOTAL MARKET SIZE OF HER2-LOW CANCERS BY COUNTRY IN THE 7MM 12.6 TOTAL MARKET SIZE OF HER2-LOW CANCERS BY INDICATIONS IN THE 7MM 12.7 MARKET SIZE OF HER2-LOW CANCERS BY THERAPIES IN 7MM 12.8 UNITED STATES MARKET SIZE 12.8.1 Total Market Size of HER2-low Cancers in the United States 12.8.2 Market Size of HER2-low Cancers by Therapies in the United States 12.9 EU4 AND THE UK MARKET SIZE 12.9.1 Total Market Size of HER2-low Cancers in EU4 and the UK 12.9.2 Market Size of HER2-low Cancers by Therapies in EU4 and the UK 12.1 JAPAN 12.10.1 Total Market Size of HER2-low Cancers in Japan 12.10.2 Market Size of HER2-low Cancers by Therapies in Japan 13 UNMET NEEDS 14 SWOT ANALYSIS 15 KOL VIEWS 16 MARKET ACCESS AND REIMBURSEMENT 16.1 UNITED STATES 16.1.1 Centre for Medicare and Medicaid Services (CMS) 16.2 EU4 AND THE UK 16.2.1 Germany 16.2.2 France 16.2.3 Italy 16.2.4 Spain 16.2.5 United Kingdom 16.3 JAPAN 16.3.1 MHLW 16.4 MARKET ACCESS AND REIMBURSEMENT OF HER2-LOW CANCERS 17 APPENDIX 17.1 BIBLIOGRAPHY 17.2 REPORT METHODOLOGY 18 DELVEINSIGHT CAPABILITIES 19 DISCLAIMER 20 ABOUT DELVEINSIGHT Related Reports HER2+ Market HER2+ Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of HER2+, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key HER2+ companies, including Zymeworks, Jazz Pharmaceuticals, Ambrx, AnBogen Therapeutics, Enliven Therapeutics, Roche, among others. 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Triple Negative Breast Cancer Market Triple Negative Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key TNBC companies including AstraZeneca, Daiichi Sankyo, OBI Pharma, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. 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Delta-like Ligand 3 Targeted Therapies Market is Predicted to Heat Up During the Forecast Period (2025-2034) Across 7MM Owing to a Robust Pipeline
The delta-like ligand 3 targeted therapies market is witnessing significant growth, driven by the rising incidence of small cell lung cancer (SCLC) and neuroendocrine tumors. Advancements in antibody-drug conjugate (ADC) technology and increasing clinical trial activity are propelling the development of DLL3-targeted candidates. Growing interest from biopharma companies and strategic collaborations are also accelerating the DLL3-targeted therapies market expansion. LAS VEGAS, June 19, 2025 /PRNewswire/ -- DelveInsight's Delta-like Ligand 3 Targeted Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, emerging delta-like ligand 3 targeted therapies, market share of individual therapies, and current and forecasted delta-like ligand 3 targeted therapies market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Delta-like Ligand 3 Targeted Therapies Market Report As per DelveInsight's analysis, the total market size of delta-like ligand 3 targeted therapies in the 7MM is expected to surge significantly by 2034. The approval of the first DLL3-targeted Bispecific T-cell Engager therapy, IMDELLTRA, by the US Food and Drug Administration (FDA) in May 2024 marked a pivotal moment for patients battling Extensive-stage small-cell lung Cancer (ES-SCLC). Leading delta-like ligand 3 targeted therapies companies, such as Phanes Therapeutics, Merck, Daiichi Sankyo, Legend Biotech, Novartis, Abdera Therapeutics, Boehringer Ingelheim, Chugai Pharmaceutical, Roche, Molecular Partners, Orano Med, Zai Lab, Allogene Therapeutics, and others, are developing novel delta-like ligand 3 targeted therapies that can be available in the delta-like ligand 3 targeted therapies market in the coming years. Some of the key delta-like ligand 3 targeted therapies in the pipeline include Peluntamig (PT217), MK-6070/DS3280, LB2102/ DLL3-targeted CAR Ts, 225Ac-ABD147, Obrixtamig (BI 764532), ALPS12/RG6524, MP0712, ZL-1310, ALL-213, and others. In February 2025, Phanes Therapeutics announced that the first patient was dosed in the clinical study of peluntamig (PT217) in combination with chemotherapy. In September 2024, Abdera Therapeutics announced that the US FDA granted ODD to ABD-147 for the treatment of NEC. In August 2024, Daiichi Sankyo and Merck expanded their existing global co-development and co-commercialization agreement for Merck's MK-6070 for the treatment of SCLC. Discover which indication is expected to grab the major delta-like ligand 3 targeted therapies market share @ Delta-like Ligand 3 Targeted Therapies Market Report Delta-like Ligand 3 Targeted Therapies Market Dynamics The delta-like ligand 3 targeted therapies market is emerging as a dynamic and promising area in oncology, particularly for hard-to-treat cancers like SCLC and other neuroendocrine tumors. With a growing understanding of its role in tumorigenesis, drug developers have shifted focus toward exploiting this target through various modalities, including ADCs, BiTEs, and CAR-T cell therapies. The FDA approval of tarlatamab (IMDELLTRA), a DLL3-targeted BiTE, has catalyzed commercial and clinical interest in this space. The competitive landscape is rapidly evolving, driven by both established pharmaceutical players and biotech innovators. Several companies are advancing DLL3-targeted assets through clinical pipelines, highlighting the growing investment and belief in the target's therapeutic value. Tarlatamab, in particular, has set a precedent by demonstrating durable responses in patients with extensive-stage SCLC who have limited treatment options after frontline chemotherapy. Its clinical success has validated DLL3 as a viable target and opened the door for additional programs in earlier lines of therapy and combination regimens. However, the DLL3-targeted therapy market faces challenges that could shape its trajectory. The heterogeneity of DLL3 expression among patient populations, potential for resistance mechanisms, and safety concerns, especially cytokine release syndrome (CRS) in immune-engaging therapies, are critical issues under active investigation. Additionally, biomarker-based patient selection strategies are essential to optimize efficacy, which may limit the addressable population unless companion diagnostics evolve in parallel. Market dynamics are also influenced by the broader shift toward personalized and immune-based treatments. The rise of bispecific and cell-based platforms enhances the flexibility in targeting DLL3, but also introduces manufacturing and logistical hurdles. As such, scalability, cost-effectiveness, and global accessibility will be important considerations in the commercial rollout. Reimbursement strategies and payer acceptance will further impact uptake, especially given the premium pricing associated with novel biologics. Looking ahead, the DLL3-targeted therapies market is poised for expansion beyond SCLC. Preliminary studies are exploring DLL3 expression in other neuroendocrine carcinomas, prostate cancer, and some pediatric tumors. This potential for label expansion, coupled with advancing drug formats and supportive regulatory pathways, indicates a robust growth trajectory. As the clinical pipeline matures and real-world data accumulate, DLL3-targeted approaches are expected to play an increasingly integral role in the precision oncology landscape. Delta-like Ligand 3 Targeted Therapies Treatment Market DLL3-targeted therapies are emerging as a promising new approach in the treatment of small-cell lung cancer and neuroendocrine carcinomas, bringing renewed optimism for patients with these aggressive cancers. A major breakthrough came in May 2024, when the US FDA approved IMDELLTRA, the first bispecific T-cell engager therapy targeting DLL3. Developed by Amgen, this first-in-class immunotherapy is designed to bind DLL3 on tumor cells and CD3 on T cells, triggering a T-cell–mediated attack on DLL3-expressing cancer cells through the formation of a cytolytic synapse. The approval and subsequent launch of IMDELLTRA have been widely recognized as a significant advancement in DLL3-focused treatments, generating approximately USD 115 million in US sales in 2024. This therapy offers a game-changing option for patients with previously treated Extensive-stage SCLC, showing durable responses. As the second FDA-approved BiTE molecule from Amgen, IMDELLTRA underscores the company's commitment to tackling hard-to-treat cancers. For patients urgently needing new therapeutic solutions, this approval delivers a much-needed and long-awaited source of hope. Learn more about the FDA-approved delta-like ligand 3 targeted therapies @ Approved Delta-like Ligand 3 Targeted Therapies Key Emerging Delta-like Ligand 3 Targeted Therapies and Companies The current pipeline is dominated with early-stage DLL-3 targeted therapies like peluntamig (Phanes Therapeutics), MK-6070/ HPN328-4001/ DS3280 (Merck / Daiichi Sankyo), LB2102/ DLL3-targeted CAR-Ts (Legend Biotech and Novartis), 225Ac-ABD147 (Abdera Therapeutics), BI 764532 (Boehringer Ingelheim), ALPS12/ RG6524 (Chugai Pharmaceutical and Roche), ZL-1310 (Zai Lab), and others. Peluntamig (PT217) is a first-in-class, native IgG-like bispecific antibody designed to target both DLL3 and CD47. It is being developed for the treatment of SCLC and neuroendocrine carcinomas, including neuroendocrine prostate cancer (NEPC). The FDA has awarded peluntamig two Orphan Drug Designations (ODDs) for SCLC and NEC, along with two Fast Track Designations (FTDs): one for extensive-stage SCLC that has progressed following platinum-based chemotherapy (with or without checkpoint inhibitors), and another for metastatic de novo or treatment-emergent NEPC. The therapy is currently undergoing evaluation in the Phase I/II SKYBRIDGE trial (NCT05652686) for SCLC and NEC. MK-6070 is an experimental tri-specific T-cell engager targeting DLL3, under Phase I/II clinical investigation. It is being tested as a standalone therapy in patients with advanced DLL3-expressing tumors and in combination with atezolizumab for certain cases of SCLC. The FDA granted MK-6070 Orphan Drug Designation for SCLC in March 2022. In March 2024, Merck finalized its acquisition of Harpoon Therapeutics, the original developer. In August 2024, Daiichi Sankyo and Merck expanded their global partnership to include MK-6070 under their co-development and co-commercialization agreement for DXd antibody-drug conjugates. Merck retains exclusive rights in Japan and will handle all manufacturing and supply responsibilities for MK-6070. The two companies also plan to explore the use of MK-6070 in combination with ifinatamab deruxtecan (I-DXd) for SCLC, along with other potential combination strategies. The anticipated launch of these emerging therapies is poised to transform the delta-like ligand 3 targeted therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the delta-like ligand 3 targeted therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about delta-like ligand 3 targeted therapies clinical trials, visit @ Delta-like Ligand 3 Targeted Therapies Treatment Delta-like Ligand 3 Targeted Therapies Overview Delta-like ligand 3 (DLL3) targeted therapies is an unconventional ligand within the Notch signaling pathway that, when overexpressed, supports the growth, migration, and invasiveness of small cell lung cancer (SCLC) cells. It also contributes to the development of metastatic and therapy-resistant traits in neuroendocrine carcinomas (NECs), enhancing both tumor cell proliferation and resistance to platinum-based chemotherapy. In normal cells, DLL3 expression is minimal and confined to the Golgi apparatus and cytoplasmic vesicles. This specific intracellular localization is regulated by its transmembrane domain and nearby protein sequences, which serve as retention signals. In contrast, SCLC cells exhibit high levels of DLL3 that are abnormally localized to the cell surface, a characteristic observed in up to 85% of human SCLC cases. While the mechanisms behind this overexpression and altered trafficking are not fully understood, DLL3's distinct expression pattern positions it as a promising biomarker and therapeutic target in SCLC. Beyond SCLC, DLL3 is also widely expressed in various NECs, including certain molecular subtypes of pulmonary large cell NEC (LCNEC) and NECs originating from the gastroenteropancreatic tract, bladder, prostate, and cervix. In these tumors, elevated DLL3 expression correlates with more advanced disease and poorer overall survival, suggesting a strong association between high DLL3 levels and unfavorable clinical outcomes. Delta-like Ligand 3 Targeted Therapies Epidemiology Segmentation The delta-like ligand 3 targeted therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases in Selected Indications for DLL3-targeted Therapies Total Eligible Patient Pool in Selected Indications for DLL3-targeted Therapies Total Treated Cases in Selected Indications for DLL3-targeted Therapies Delta-like Ligand 3 Targeted Therapies Report Metrics Details Study Period 2020–2034 Delta-like Ligand 3 Targeted Therapies Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Delta-like Ligand 3 Targeted Therapies Companies Phanes Therapeutics, Merck, Daiichi Sankyo, Legend Biotech, Novartis, Abdera Therapeutics, Boehringer Ingelheim, Chugai Pharmaceutical, Roche, Molecular Partners, Orano Med, Zai Lab, Allogene Therapeutics, Amgen, and others Key Delta-like Ligand 3 Targeted Therapies Peluntamig (PT217), MK-6070/DS3280, LB2102/ DLL3-targeted CAR Ts, 225Ac-ABD147, Obrixtamig (BI 764532), ALPS12/RG6524, MP0712, ZL-1310, ALL-213, IMDELLTRA, and others Scope of the Delta-like Ligand 3 Targeted Therapies Market Report Delta-like Ligand 3 Targeted Therapies Therapeutic Assessment: Delta-like Ligand 3 Targeted Therapies current marketed and emerging therapies Delta-like Ligand 3 Targeted Therapies Market Dynamics: Conjoint Analysis of Emerging Delta-like Ligand 3 Targeted Therapies Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Delta-like Ligand 3 Targeted Therapies Market Access and Reimbursement Discover more about delta-like ligand 3 targeted therapies in development @ Delta-like Ligand 3 Targeted Therapies Clinical Trials Table of Contents 1. Key Insights 2. Report Introduction 3. Executive Summary 4. Key Events 5. Market Forecast Methodology 6. Delta-like Ligand 3 Targeted Therapies Market Overview at a Glance in the 7MM 6.1. Market Share (%) Distribution by Therapies in 2025 6.2. Market Share (%) Distribution by Therapies in 2034 6.3. Market Share (%) Distribution by Indications in 2025 6.4. Market Share (%) Distribution by Indications in 2034 7. Delta-like Ligand 3 (DLL3)-targeted Therapies: Background and Overview 7.1. Introduction 7.2. The Potential of Delta-like Ligand 3 (DLL3)-targeted Therapies in Different Indications 7.3. Clinical Applications of Delta-like Ligand 3 (DLL3)-targeted Therapies 8. Target Patient Pool of Delta-like Ligand 3 (DLL3)-targeted Therapies 8.1. Assumptions and Rationale 8.2. Key Findings 8.3. Total Cases of Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 8.4. Total Eligible Patient Pool of Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 8.5. Total Treatable Cases in Selected Indication for Delta-like Ligand 3 (DLL3)-targeted Therapies in the 7MM 9. Marketed Therapies 9.1. Key Competitors 9.2. IMDELLTRA (tarlatamab-dlle): Amgen 9.2.1. Product Description 9.2.2. Regulatory milestones 9.2.3. Other developmental activities 9.2.4. Clinical development 9.2.5. Safety and efficacy List to be continued in the report 10. Emerging Therapies 10.1. Key Competitors 10.2. Peluntamig (PT217): Phanes Therapeutics 10.2.1. Product Description 10.2.2. Other developmental activities 10.2.3. Clinical development 10.2.4. Safety and efficacy 10.3. MK-6070/ HPN328-4001/ DS3280: Merck/ Daiichi Sankyo 10.3.1. Product Description 10.3.2. Other developmental activities 10.3.3. Clinical development 10.3.4. Safety and efficacy List to be continued in the report 11. Delta-like Ligand 3 Targeted Therapies: Seven Major Market Analysis 11.1. Key Findings 11.2. Market Outlook 11.3. Conjoint Analysis 11.4. Key Market Forecast Assumptions 11.4.1. Cost Assumptions and Rebates 11.4.2. Pricing Trends 11.4.3. Analogue Assessment 11.4.4. Launch Year and Therapy Uptakes 11.5. Total Market Sizes of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in the 7MM 11.6. The United States Market Size 11.6.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies in the United States 11.6.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indication in the United States 11.6.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in the United States 11.7. EU4 and the UK 11.7.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies in EU4 and the UK 11.7.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in EU4 and the UK 11.7.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in EU4 and the UK 11.8. Japan 11.8.1. Total Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies Inhibitors in Japan 11.8.2. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Indications in Japan 11.8.3. Market Size of Delta-like Ligand 3 (DLL3)-targeted Therapies by Therapies in Japan 12. SWOT Analysis 13. KOL Views 14. Unmet Needs 15. Market Access and Reimbursement 16. Appendix 16.1. Bibliography 16.2. Report Methodology 17. DelveInsight Capabilities 18. Disclaimer 19. About DelveInsight Related Reports Small Cell Lung Cancer Market Small Cell Lung Cancer Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SCLC companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, GlaxoSmithKline, Advanced Accelerator Applications, Trillium Therapeutics, Vernalis, Oncoceutics, NewBio Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, Xencor, Jiangsu HengRui Medicine, Aileron Therapeutics, Roche, Ipsen, Celgene, Lee's Pharmaceutical Limited, AbbVie, G1 Therapeutics, Chipscreen Biosciences, Luye Pharma Group, Shanghai Henlius Biotech, CSPC ZhongQi Pharmaceutical Technology, Impact Therapeutics, among others. 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About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Oligonucleotides Clinical Trial Pipeline Analysis Demonstrates 280+ Key Companies at the Horizon Expected to Transform the Treatment Paradigm, Assesses DelveInsight
Oligonucleotides are short chains of nucleic acid molecules that can be used to treat or manage a variety of diseases. Oligonucleotides are being increasingly explored for a variety of therapeutic areas, such as rare diseases, cancer, infectious diseases, and genetic disorders. Technologies like antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), and aptamers are at the forefront of innovation. New York, USA, June 17, 2025 (GLOBE NEWSWIRE) -- Oligonucleotides Clinical Trial Pipeline Analysis Demonstrates 280+ Key Companies at the Horizon Expected to Transform the Treatment Paradigm, Assesses DelveInsight Oligonucleotides are short chains of nucleic acid molecules that can be used to treat or manage a variety of diseases. Oligonucleotides are being increasingly explored for a variety of therapeutic areas, such as rare diseases, cancer, infectious diseases, and genetic disorders. Technologies like antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), and aptamers are at the forefront of innovation. DelveInsight's 'Oligonucleotides Competitive Landscape 2025' report provides comprehensive global coverage of pipeline oligonucleotides in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the oligonucleotides pipeline domain. Key Takeaways from the Oligonucleotides Pipeline Report DelveInsight's oligonucleotides competitive report presents a robust market with over 280 active players developing more than 320 pipeline oligonucleotides. Key oligonucleotide companies such as Novartis, Astellas, Alnylam Pharmaceuticals, Ionis Pharmaceuticals, 4D Molecular Therapeutics, Avidity Biosciences, Suzhou Ribo Life Science, Amgen, ProQR Therapeutics, Stoke Therapeutics, MiNA Therapeutics, Sylentis, GSK, Silexion Therapeutics, Novo Nordisk A/S, Bio-Path Holdings, Sunhawk Vision Biotech, Isarna Therapeutics, Sirnaomics, Laboratoire Thea, Dyne Therapeutics, Vertex Pharmaceuticals, Korro Bio, Praxis-Precision-Medicines, Vico Therapeutics, BioMarin Pharmaceutical, TransCode Therapeutics, TME Therapeutics, ARTHEx Biotech, aptaTargets, CSPC Zhongnuo Pharmaceutical, ExoRNA Bioscience, Visirna Therapeutics, AiCuris, Comanche Biopharma, Tallac Therapeutics, and others are evaluating new oligonucleotides to improve the treatment landscape. Promising pipeline oligonucleotides such as Pelacarsen, Izervay, Nucresiran, ALN-6400, Zilganersen, 4D-150, Delpacibart Etedesiran, RBD1007, Olpasiran, GSK3228836, Sepofarsen, STK-001, MTL-CEBPA, SYL-1801, Loder, CDR132L, BP1001, SHJ002, ISTH0036, STP705, Ultevursen, DYNE-101, VX-670, KRRO 110, PRAX-222, VO659, BMN 351, TTX-MC138, TME151, ATX-01, ApTOLL, SYH2062, ER2001, VSA012, AIC468, CBP-4888, ALTA-002, and others are under different phases of oligonucleotide clinical trials. Request a sample and discover the recent advances in oligonucleotide drugs @ Oligonucleotides Competitive Report Oligonucleotides Overview Oligonucleotides are short chains of nucleotides, composed of repeating units that include a ribose or deoxyribose sugar, nitrogenous bases, and a phosphate backbone. Their ability to selectively bind to complementary DNA or RNA strands allows them to form duplexes or, less commonly, more complex structures. This property makes oligonucleotides valuable tools for detecting specific nucleic acid sequences. Typically ranging from 13 to 25 nucleotides in length, oligonucleotides can hybridize with target DNA or RNA. They are classified into several types, including antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), microRNAs (miRNAs), and aptamers. These molecules are being actively explored for their therapeutic potential in treating conditions such as neurodegenerative diseases, cancer, and rare diseases. Clinical trials are also evaluating their use in dermatological, gastrointestinal, and endocrine disorders. Oligonucleotides influence gene expression through various mechanisms, such as RNA interference (RNAi), RNase H-mediated degradation, splicing modulation, inhibition of non-coding RNAs, gene activation, and programmable gene editing. As a result, oligonucleotide therapeutics, including ASOs, siRNAs, and splice-modulating oligonucleotides, are emerging as a powerful new class of drugs capable of targeting a broad range of genetic and non-genetic diseases. However, their clinical success depends heavily on overcoming significant delivery challenges. Due to their high molecular weight, hydrophilicity, and negative charge, oligonucleotides face difficulty crossing cell membranes. They are also prone to degradation by nucleases, have limited tissue penetration, are quickly cleared by the kidneys, and often require targeted delivery to specific tissues. Despite these hurdles, oligonucleotides have transformed both diagnostics and therapeutics thanks to their high specificity, programmable nature, and ease of synthesis. In diagnostics, they serve key roles as primers in PCR/qPCR, probes in assays like FISH, and functional elements in technologies such as microarrays and CRISPR-based platforms. Aptamers enhance imaging by targeting specific biomarkers, and chemical modifications can significantly improve their stability in biological environments. Therapeutically, oligonucleotides include drugs like pegaptanib (aptamer), nusinersen (ASO), and patisiran (siRNA), which work by silencing or modulating gene expression. They also play a foundational role in mRNA and DNA vaccines, miRNA inhibitors, and gene editing tools like CRISPR. While challenges such as off-target effects and rapid systemic clearance remain, innovations like GalNAc conjugation and AI-driven design are advancing the field, enhancing specificity, delivery efficiency, and clinical effectiveness, and propelling the era of precision medicine Market Dynamics The oligonucleotides market is experiencing significant growth, driven by advances in genomic research, increased prevalence of genetic disorders, and rising interest in personalized medicine. Key therapeutic modalities, including antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), and aptamers, are gaining traction due to their ability to target diseases at the genetic level. The success of RNA-based drugs like SPINRAZA (nusinersen) and ONPATTRO (patisiran) has validated the commercial potential of oligonucleotide therapeutics, spurring further investment and innovation in the space. The market dynamics are shaped by several influential trends. Technological advancements in oligonucleotide synthesis and chemical modifications have improved stability, bioavailability, and target specificity, thereby expanding clinical applications. Concurrently, the adoption of automated synthesis platforms and solid-phase synthesis technologies has increased manufacturing efficiency and scalability. However, production remains complex and cost-intensive, especially for therapeutic-grade oligonucleotides, creating opportunities for specialized CDMOs that can meet stringent regulatory and quality standards. Pharmaceutical and biotech companies are aggressively expanding their oligonucleotide-based therapeutic pipelines, targeting a broad spectrum of indications including rare genetic diseases, cancer, neurodegenerative disorders, and infectious diseases. The oncology segment, in particular, is attracting attention for oligonucleotide therapies due to their ability to silence oncogenes or modulate gene expression with high precision. Moreover, the regulatory environment is becoming more supportive, with agencies like the FDA and EMA providing clear guidance for oligonucleotide drug development, fast-track designations, and orphan drug incentives. Despite its promise, the oligonucleotides market faces several challenges. These include delivery barriers, especially for intracellular targets, off-target effects, and immunogenicity concerns. Lipid nanoparticles (LNPs), conjugation strategies (e.g., GalNAc), and novel carrier systems are under active investigation to address these issues. Furthermore, intellectual property landscapes are becoming increasingly complex as more players enter the field, potentially leading to patent disputes and licensing complexities. In conclusion, the oligonucleotides market is poised for sustained growth, driven by technological innovation, clinical success stories, and expanding therapeutic frontiers. As barriers to delivery and cost are gradually overcome, oligonucleotide therapeutics are expected to become a mainstay in precision medicine, especially in areas with unmet medical needs. Strategic partnerships, regulatory clarity, and continued investment in R&D will be crucial to fully unlocking the potential of this transformative modality. To know more about oligonucleotides, visit @ Oligonucleotides Market Insights Approved Oligonucleotides Drug Profile Analysis LEQVIO: Novartis LEQVIO (inclisiran) is a first-of-its-kind small interfering RNA (siRNA) therapy developed by Novartis that targets the mRNA of PCSK9 (proprotein convertase subtilisin/kexin type 9). Unlike traditional treatments, LEQVIO reduces the production of the PCSK9 protein in the liver, enhancing the liver's ability to absorb and eliminate LDL-C from the bloodstream. In 2023, Japan's Ministry of Health, Labour and Welfare (MHLW) approved LEQVIO for both familial and non-familial hypercholesterolemia, as well as for individuals at high risk of cardiovascular events. The treatment regimen involves an initial dose, a second injection after three months, and subsequent maintenance doses every six months. Clinical trials have shown that when used alongside statins, LEQVIO can lower LDL-C levels by around 50%. IZERVAY: Astellas Pharma Avacincaptad pegol, sold under the brand name IZERVAY, is an approved treatment specifically developed for geographic atrophy. It is an RNA aptamer chemically linked to a branched polyethylene glycol (PEG) molecule. The drug works by targeting and inhibiting complement factor C5, a critical element of the complement system involved in inflammation related to age-related macular degeneration (AMD). By preventing the conversion of C5 into its active forms (C5a and C5b), avacincaptad pegol helps reduce inflammation and slow GA progression. The FDA approved IZERVAY on August 4, 2023, for GA secondary to AMD. It is currently under evaluation by the European Medicines Agency and is also being studied for potential use in treating Stargardt disease. Find out more about oligonucleotide drugs @ Oligonucleotide Analysis A snapshot of the Pipeline Oligonucleotides mentioned in the report: Drugs Company Phase Indication Pelacarsen Novartis Pharmaceuticals III Hyperlipoproteinaemia Trabedersen Oncotelic III Glioblastoma 4D-150 4D Molecular Therapeutics III Wet age-related macular degeneration Delpacibart Etedesiran Avidity Biosciences III Myotonic dystrophy GSK3228836 GSK III Chronic hepatitis B virus infection WVE-N531 Wave Life Sciences II Duchenne muscular dystrophy ATX-01 ARTHEx Biotech II Myotonic dystrophy Type I & II TAC001 Tallac Therapeutics I/II Solid tumors ATB 301 Autotelic Bio I Pancreatic cancer Learn more about the emerging oligonucleotides @ Oligonucleotides Clinical Trials Key Developments in the Oligonucleotides Treatment Space In May 2025, Cure Rare Disease (CRD), announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational anti-sense Oligonucleotide therapeutic for the treatment of Spinocerebellar Ataxia (SCA), including Spinocerebellar Ataxia Type 3 (SCA3), a progressive and currently untreatable neurodegenerative disorder. In April 2025, Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer's disease. In March 2025, Korro Bio, Inc., a clinical-stage biopharmaceutical company focused on developing a new class of genetic medicines based on editing RNA for both rare and highly prevalent diseases, announced that the FDA had granted orphan drug designation to the investigational medicine KRRO-110 for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). In February 2025, AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (together AusperBio), a clinical-stage biotechnology company, announced recent progress in the ongoing clinical development of its lead candidate AHB-137, an antisense oligonucleotide (ASO) therapeutic for functional cure of chronic Hepatitis B (CHB). In January 2025, Arrowhead Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) had accepted the New Drug Application (NDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome (FCS), a severe and rare genetic disease. In December 2024, Vir Biotechnology, Inc. announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD). In December 2024, the FDA granted breakthrough therapy designation to Stoke Therapeutics' investigational antisense agent STK-001 for the treatment of genetically confirmed Dravet syndrome (DS), a rare epilepsy disorder. In November 2024, Ionis Pharmaceuticals announced that the US Food and Drug Administration (FDA) had accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. The FDA has set an action date of August 21, 2025, under the Prescription Drug User Fee Act (PDUFA). In October 2024, Ribocure Pharmaceuticals AB and Suzhou Ribo Life Science Ltd received authorization from the Swedish Medicinal Product Agency (MPA) to initiate a Phase II clinical trial in Sweden with the lipid-lowering siRNA drug RBD5044 that targets APOC3. The trial will evaluate efficacy and safety in patients with mixed dyslipidemia In September 2024, WVE-N531, an exon-skipping oligonucleotide developed by Wave Life Sciences for the treatment of Duchenne muscular dystrophy (DMD) in patients amenable to exon 53 skipping, received Orphan Drug Designation from the US Food and Drug Administration (FDA). In September 2024, NS Pharma, Inc., a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced that the Food and Drug Administration (FDA) had granted rare pediatric disease designation to NS050/NCNP-03, which is being developed for the treatment of Duchenne muscular dystrophy (Duchenne). In May 2024, Sunhawk Vision Biotech announced that it had received authorization from the US FDA to commence a Phase II clinical trial for myopia control in children. In May 2024, Imvax, Inc., announced the completion of enrollment in its randomized, multicenter, double-blind, placebo-controlled Phase IIb clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM). Scope of the Oligonucleotides Pipeline Report Coverage: Global Key Oligonucleotides Companies: Novartis, Astellas, Alnylam Pharmaceuticals, Ionis Pharmaceuticals, 4D Molecular Therapeutics, Avidity Biosciences, Suzhou Ribo Life Science, Amgen, ProQR Therapeutics, Stoke Therapeutics, MiNA Therapeutics, Sylentis, GSK, Silexion Therapeutics, Novo Nordisk A/S, Bio-Path Holdings, Sunhawk Vision Biotech, Isarna Therapeutics, Sirnaomics, Laboratoire Thea, Dyne Therapeutics, Vertex Pharmaceuticals, Korro Bio, Praxis-Precision-Medicines, Vico Therapeutics, BioMarin Pharmaceutical, TransCode Therapeutics, TME Therapeutics, ARTHEx Biotech, aptaTargets, CSPC Zhongnuo Pharmaceutical, ExoRNA Bioscience, Visirna Therapeutics, AiCuris, Comanche Biopharma, Tallac Therapeutics and others. Key Oligonucleotides in Pipeline: Pelacarsen, Izervay, Nucresiran, ALN-6400, Zilganersen, 4D-150, Delpacibart Etedesiran, RBD1007, Olpasiran, GSK3228836, Sepofarsen, STK-001, MTL-CEBPA, SYL-1801, Loder, CDR132L, BP1001, SHJ002, ISTH0036, STP705, Ultevursen, DYNE-101, VX-670, KRRO 110, PRAX-222, VO659, BMN 351, TTX-MC138, TME151, ATX-01, ApTOLL, SYH2062, ER2001, VSA012, AIC468, CBP-4888, ALTA-002 and others are under different phases of oligonucleotide clinical trials. Dive deep into rich insights for new oligonucleotide treatments, visit @ Oligonucleotides Drugs Table of Contents 1. Oligonucleotides Pipeline Report Introduction 2. Oligonucleotides Pipeline Report Executive Summary 3. Oligonucleotides Pipeline: Overview 4. Oligonucleotides Marketed Drugs 4.1. LEQVIO: Novartis Pharmaceuticals 5. Oligonucleotides Clinical Trial Therapeutics 6. Oligonucleotides Pipeline: Late-Stage Products (Pre-registration) 7. Oligonucleotides Pipeline: Late-Stage Products (Phase III) 7.1. Pelacarsen: Novartis Pharmaceuticals 8. Oligonucleotides Pipeline: Mid-Stage Products (Phase II) 8.1. Trabedersen: Oncotelic 9. Oligonucleotides Pipeline: Early-Stage Products (Phase I) 9.1. ATB 301: Autotelic Bio 10. Oligonucleotides Pipeline: Preclinical and Discovery Stage Products 11. Oligonucleotides Pipeline Therapeutics Assessment 12. Inactive Products in the Oligonucleotides Pipeline 13. Company-University Collaborations (Licensing/Partnering) Analysis 14. Unmet Needs 15. Oligonucleotides Market Drivers and Barriers 16. Appendix For further information on the oligonucleotides pipeline therapeutics, reach out @ Oligonucleotides Therapeutics Related Reports Antisense Oligonucleotide Therapeutics Pipeline Antisense Oligonucleotide Therapeutics Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key antisense oligonucleotide therapeutics companies, including Ionis Pharmaceuticals, Secarna Pharmaceuticals, Aro Biotherapeutics, NeuBase Therapeutics, Bio-Path Holdings, Inc., Scopus Biopharma, Dyne Therapeutics, CAMP4 Therapeutics, Pulmotect, GeneTx Biotherapeutics, Aligos Therapeutics, WaVe Life Sciences, among others. Oligonucleotide Synthesis Market Oligonucleotide Synthesis Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key oligonucleotide synthesis companies, including Thermo Fisher Scientific Inc., Agilent Technologies, Merck KGaA, Bio-Synthesis Inc., Ajinomoto Bio-Pharma Services, CordenPharma, Creative Biolabs, Ella Biotech, Eurofins Genomics, Future Synthesis, Integrated DNA Technologies, Kaneka Eurogentec, LGC Biosearch Technologies, Microsynth, Nitto Avecia, Ribo Biotechnology, STA Pharmaceutical, Sumitomo Chemical, TriLink Biotechnologies, Sarepta Therapeutics, among others. RNA Interference Pipeline RNA Interference Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RNA interference companies, including Silence Therapeutics, Janssen Research & Development, Eli Lilly and Company, Arrowhead Pharmaceuticals, Sylentis, Sirnaomics, Dicerna Pharmaceuticals, Suzhou Ribo Life Science, Alnylam Pharmaceuticals, Suzhou Ribo Life Science, Vir Biotechnology, Arbutus Biopharma, Silenseed, OliX Pharmaceuticals, Bio-Path Holdings, among others. Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key global messenger RNA -based vaccines and therapeutics companies, including Moderna, Inc., BioNTech SE, CureVac N.V., Arcturus Therapeutics, Translate Bio, Inc., GSK, among others. mRNA Vaccines and Therapeutics Market mRNA Vaccines and Therapeutics Market Insights, Competitive Landscape, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key mRNA vaccines and therapeutics companies, including Pfizer Inc., BioNTech SE, Moderna, Inc., Gennova Biopharmaceuticals Limited, GSK plc., Daiichi Sankyo, Arcturus, Boehringer Ingelheim International GmbH, Ethris GmbH, CureVac SE, AIM Vaccine Corporation, Charoen Pokphand Group, Argos Therapeutics Inc., Sanofi, Kernal Biologics Inc, among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn CONTACT: Contact Us Shruti Thakur info@ +14699457679 in to access your portfolio
