4 Emerging Graft versus Host Disease Therapies That Could Change the Treatment Landscape
Key companies, such as CSL Behring, Equillium, Biocon, and medac, are advancing their assets through late-stage graft versus host disease clinical trials, driving innovation in the graft versus host disease market and creating significant growth opportunities.
LAS VEGAS, June 12, 2025 /PRNewswire/ -- Graft versus host disease (GvHD) is an immune-driven disorder caused by a complex interplay between the donor's and recipient's adaptive immune systems. It typically manifests in two main forms: acute (aGvHD) and chronic (cGvHD).
As per DelveInsight's analysis, approximately 60,000 allogeneic transplants and around 55,000 GvHD cases occurred in the 7MM in 2024. These numbers are projected to grow at a notable CAGR over the forecast period from 2025 to 2034.
Corticosteroids like prednisone and methylprednisolone are the primary first-line treatments, often combined with other immunosuppressants. Mild GcHD is managed with topical steroids, while systemic cases require stronger immunosuppressive therapy.
Several treatments for GvHD have received FDA approval in the US, including ORENCIA (abatacept), JAKAFI/JAKAVI (ruxolitinib), IMBRUVICA (ibrutinib), and REZUROCK (belumosudil), among others. In the upcoming GvHD treatment market landscape, there are a plethora of companies investigating agents in various stages of development.
To know more about the graft versus host disease clinical trials market, visit @ Graft versus Host Disease Market
DelveInsight estimates that the market size for GvHD is expected to grow from USD 1.4 billion in 2024 with a significant CAGR of 8.2% by 2034. This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies.
The current pipeline for graft versus host disease includes a range of drugs with diverse mechanisms of action (MoA). CSL964 (Alpha 1 Antitrypsin), EQ001 (Itolizumab; Bmab600), MaaT013, and MC0518 are the most promising drugs that are in the late-stage of development for GvHD treatment. Ongoing research and current trials have the potential to change the GvHD market.
Keen to know how the GvHD market will evolve by 2034? Find out @ Graft versus Host Disease (GvHD) Market Forecast
Apart from this, several GvHD drugs currently in the early stages of development include RLS-0071 by ReAlta Life Sciences, Vimseltinib by Deciphera Pharmaceuticals, ASC-930 by ASC Therapeutics, RGI-2001 by REGiMMUNE, CYP-001 by Cynata Therapeutics, arsenic trioxide (As2O3) by BioSenic (Medsenic), TRX103 (Tregs) by Tr1X, TCD601 (Siplizumab) by ITB-MED, F-652 by Evive Biotech, RHPRG4 by Lubris BioPharma, XBI302 by Xbiome, RG6287 by Genentech, ALTB-168 by AltruBio, and SER-155 by Seres Therapeutics.
Now, let's examine the late-stage pipeline therapies under investigation for GvHD treatment
CSL Behring's ZEMAIRA
CSL964 Alpha-1 Antitrypsin, an Alpha1-Proteinase Inhibitor (A1-PI) developed by CSL Behring, is being studied for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD) and for the prevention of aGvHD in high-risk patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It is currently in Phase III clinical trials for the treatment of steroid-refractory aGvHD and is also being evaluated in Phase II/III trials for its potential in preventing aGvHD.
Equillium/Biocon's EQ001
EQ001 (Itolizumab; Bmab600) is a first-in-class immune-modulating antibody that targets CD6 to suppress the activation and migration of harmful T cells responsible for releasing pro-inflammatory cytokines in autoimmune and inflammatory conditions such as GvHD, moderate-to-severe uncontrolled asthma, and lupus nephritis. By acting on the CD6-ALCAM signaling pathway, Itolizumab selectively inhibits pathogenic effector T cells (Teffs) while preserving regulatory T cells (Tregs), which are essential for immune system balance.
Currently, EQ001 is undergoing a Phase III clinical trial in combination with corticosteroids as a first-line therapy for GvHD.In March 2025, Equillium reported topline Phase III EQUATOR trial results for itolizumab in first-line aGVHD. While the study did not show a meaningful difference in CR or ORR at Day 29 versus placebo, itolizumab demonstrated statistically significant and clinically meaningful improvements in longer-term outcomes, including CR at Day 99, duration of response, and failure-free survival. In April 2025, the FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for itolizumab, citing limitations in the EQUATOR study data.
Discover which therapies are expected to grab major GvHD market share @ Graft versus Host Disease Treatment Market
MaaT Pharma's MaaT013
MaaT013 is a standardized, donor-derived microbiome ecosystem therapy characterized by high richness and diversity. It includes BUTYCORE, a consortium of bacterial species known for producing anti-inflammatory short-chain fatty acids. The therapy is designed to reestablish the balance between the patient's gut microbiome and immune system, aiming to enhance immune tolerance and responsiveness, thereby addressing steroid-resistant, gastrointestinal-dominant aGvHD. MaaT013 has been granted Orphan Drug Designation (ODD) by both the US FDA and the EMA.
In December 2024, MaaT Pharma shared encouraging updated results from its Early Access Program at the ASH 2024 Annual Meeting. Subsequently, in January 2025, the company announced promising topline findings from the Phase III ARES trial, where MaaT013 achieved a 62% overall gastrointestinal response rate by Day 28, marking a significant advancement as a third-line treatment for GI-aGvHD.
medac's MC0518
MC0518 is an investigational mesenchymal stromal cell (MSC) therapy developed by Medac GmbH, currently undergoing clinical trials for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) following allogeneic hematopoietic stem cell transplantation. This therapy leverages the immunomodulatory properties of MSCs to mitigate the severe inflammatory responses characteristic of SR-aGvHD, a condition where the donor's immune cells attack the recipient's tissues despite steroid treatment.
The IDUNN trial, a pivotal Phase III study, is evaluating the efficacy and safety of MC0518 compared to the best available therapy (BAT) in pediatric and adolescent patients. The primary endpoint is the overall response rate (ORR) at Day 28, with secondary objectives including overall survival (OS) up to 24 months and freedom from treatment failure (FFTF) within six months. Preclinical assessments have demonstrated that MC0518 is well-tolerated, with no evidence of tumorigenicity or significant adverse effects in animal models.
Discover more about drugs for GvHD in development @ Graft versus Host Disease Clinical Trials
The anticipated launch of these emerging therapies for GvHD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the GvHD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight's latest published market report, titled as Graft versus Host Disease Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the GvHD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The GvHD market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
Total allogenic transplant cases
Total Graft Versus Host Disease Cases
Type-specific Cases of Graft Versus Host Disease
Acute Graft Versus Host Disease Cases by Grading
Acute Graft Versus Host Disease Cases by Organ Involvement
Chronic Graft Versus Host Disease Cases by Grading
Chronic Graft Versus Host Disease Cases by Organ Involvement
Total Treated Cases of Graft Versus Host Disease
Mortality Adjusted Treated Cases of Graft Versus Host Disease
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM GvHD market. Highlights include:
10-year Forecast
7MM Analysis
Epidemiology-based Market Forecasting
Historical and Forecasted Market Analysis upto 2034
Emerging Drug Market Uptake
Peak Sales Analysis
Key Cross Competition Analysis
Industry Expert's Opinion
Access and Reimbursement
Download this GvHD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the GvHD market. Also, stay abreast of the mitigating factors to improve your market position in the GvHD therapeutic space.
Related Reports
Graft versus Host Disease Epidemiology Forecast
Graft versus Host Disease Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted GvHD epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy, France) and the United Kingdom, and Japan.
Graft versus Host Disease Pipeline
Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key GvHD companies, including Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical, CTI BioPharma, ViGenCell, Lipella Pharmaceuticals, Cellestia Biotech, Seres Therapeutics, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK, Amgen, among others.
Acute Graft versus Host Disease Pipeline
Acute Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute GvHD companies, including MaaT Pharma, Medac, CSL Behring, Humanigen, Ironwood Pharmaceuticals, ReAlta Life Sciences, Roche, Incyte Corporation, among others.
Ocular Graft versus Host Disease Pipeline
Ocular Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ocular GvHD companies, including Cambium Medical Technologies, Glia LLC., Ocular Discovery, Selagine, 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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HER2-low Cancers Market Set to Register Immense Growth at a CAGR of 9.4% During the Study Period (2020-2034)
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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. 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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. 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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. Metastatic HER2-Positive Breast Cancer Market Metastatic HER2-Positive Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic HER2-positive breast cancer companies, including Byondis, Roche, Ambrx, Zymeworks, Jazz Pharmaceuticals, Pfizer, among others. Metastatic HR+/HER2-negativeBreast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic HR+/HER2-negative breast cancer companies including Merck, Arvinas, Olema Pharmaceuticals, Celcuity, Roche, AstraZeneca, Daiichi Sankyo, Eli Lilly, Sermonix Pharmaceuticals, Genentech, Veru Pharma, DualityBio, BioNtech, Evgen Pharma, Carrick Therapeutics, EQRx, G1 Therapeutics, Immutep, among others. 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. 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: 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. 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