Ulcerative Colitis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
DelveInsight's, 'Ulcerative Colitis Pipeline Insight 2025' report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Ulcerative Colitis Pipeline Landscape. It covers the Ulcerative Colitis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Ulcerative Colitis therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Ulcerative Colitis Treatment Landscape. Click here to read more @ Ulcerative Colitis Pipeline Outlook
Key Takeaways from the Ulcerative Colitis Pipeline Report
In April 2025, Merck Sharp & Dohme LLC announced a study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12.
In April 2025, Janssen Research & Development, LLC announced a study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
DelveInsight's Ulcerative Colitis pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for Ulcerative Colitis treatment.
The leading Ulcerative Colitis Companies such as Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, and others.
Promising Ulcerative Colitis therapies such as VE202, Vancomycin Oral Capsule, PL8177, Mirikizumab, Etrasimod, Efavaleukin alfa, ABBV-668, and others.
Discover groundbreaking developments in Ulcerative Colitis therapies! Gain in-depth knowledge of key Ulcerative Colitis clinical trials, emerging drugs, and market opportunities @ Ulcerative Colitis Clinical Trials Assessment
Ulcerative Colitis Emerging Drugs Profile
Obefazimod: Abivax
Obefazimod is an oral small-molecule drug candidate in clinical development for the treatment of moderately to severely active ulcerative colitis (UC) and has demonstrated anti-inflammatory activity in preclinical studies and in both Phase IIa and Phase IIb clinical trials. Currently, the drug is in Phase III stage of its clinical trial for the treatment of ulcerative colitis.
ABBV-668: AbbVie
ABBV-668 is under development for the treatment of crohn's disease, unspecified immunological disorders and ulcerative colitis. The drug candidate acts by targeting receptor interacting serine/threonine protein kinase 1 (RIPK1). It is administered through oral route. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis.
TEV-48574: Teva Pharmaceutical
Anti-TL1A (TEV-'574) is a potentially best-in-class human IgG1 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15. TL1A signaling is believed to amplify inflammation and drives fibrosis associated with asthma and inflammatory bowel disease (IBD); thus, targeting TL1A with TEV-'574 may mitigate the over-active immune response in these conditions. Anti-TL1A (TEV-'574) is currently in Phase 2b clinical trials for the treatment of ulcerative colitis (UD) and Crohn's disease (CD), two types of inflammatory bowel disease. The safety and efficacy of anti-TL1A (TEV-'574) have not been reviewed by any regulatory authority. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis.
SOR102: Sorriso Pharmaceuticals
SOR102 combines anti-TNF and anti-IL-23 vorabodies into a single dual-acting molecule a trypsin cleavable linker releases the monomers to independently engage their targets throughout intestinal tissue. SOR102 provides combination therapy locally within inflamed tissue with minimal risk of systemic immunosuppression. Overall benefits of dual targeting approach increased efficacy through blockade of different inflammatory mechanisms of IBD. Currently, the drug is in Phase I stage of its clinical trial for the treatment of ulcerative colitis.
The Ulcerative Colitis Pipeline Report Provides Insights into
The report provides detailed insights about companies that are developing therapies for the treatment of Ulcerative Colitis with aggregate therapies developed by each company for the same.
It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Ulcerative Colitis Treatment.
Ulcerative Colitis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Ulcerative Colitis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Ulcerative Colitis market
Stay informed about the Ulcerative Colitis pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Ulcerative Colitis Unmet Needs
Ulcerative Colitis Companies
Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, and others.
Ulcerative Colitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.
Intra-articular
Intraocular
Intrathecal
Intravenous
Oral
Parenteral
Subcutaneous
Topical
Transdermal
Ulcerative Colitis Products have been categorized under various Molecule types such as
Oligonucleotide
Peptide
Small molecule
Transform your understanding of the Ulcerative Colitis Pipeline! See the latest progress in drug development and clinical research @ Ulcerative Colitis Market Drivers and Barriers, and Future Perspectives
Scope of the Ulcerative Colitis Pipeline Report
Coverage- Global
Ulcerative Colitis Companies- Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, and others.
Ulcerative Colitis therapies- VE202, Vancomycin Oral Capsule, PL8177, Mirikizumab, Etrasimod, Efavaleukin alfa, ABBV-668, and others.
Ulcerative Colitis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
Ulcerative Colitis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
"Stay Ahead in Gastroenterology Research–Access the Full Ulcerative Colitis Pipeline Analysis Today! @ Ulcerative Colitis Drugs and Companies
Table of Content
Introduction
Executive Summary
Ulcerative Colitis: Overview
Pipeline Therapeutics
Therapeutic Assessment
Ulcerative Colitis– DelveInsight's Analytical Perspective
In-depth Commercial Assessment
Ulcerative Colitis Collaboration Deals
Late Stage Products (Preregistration)
Mirikizumab: Eli Lilly and Company
Drug profiles in the detailed report…..
Late Stage Products (Phase III)
Obefazimod: Abivax
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
ABBV-668: AbbVie
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
SOR102: Sorriso Pharmaceuticals
Drug profiles in the detailed report…..
Preclinical Stage Products
Drug Name: Company Name
Drug profiles in the detailed report…..
Inactive Products
Ulcerative Colitis Key Companies
Ulcerative Colitis Key Products
Ulcerative Colitis- Unmet Needs
Ulcerative Colitis- Market Drivers and Barriers
Ulcerative Colitis- Future Perspectives and Conclusion
Ulcerative Colitis Analyst Views
Ulcerative Colitis Key Companies
Appendix
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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Globe and Mail
a day ago
- 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). 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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. 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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:
Globe and Mail
5 days ago
- Globe and Mail
PD-L1 Inhibitors Market Insight, Epidemiology, and Market Forecast – 2034
PD-L1 inhibitors have become a vital part of modern cancer therapy by blocking the PD-1/PD-L1 pathway, which tumors use to evade immune detection. By restoring T-cell function, these therapies boost the body's ability to fight cancer. They have shown significant clinical benefit, including durable responses and improved survival, in several cancers such as NSCLC, TNBC, renal cell carcinoma, urothelial carcinoma, and head and neck squamous cell carcinoma. DelveInsight's ' PD-L1 Inhibitors Market Report ' provides an in-depth analysis of the current and future market landscape for PD-L1 inhibitors across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), Japan, and other key geographies. The report offers comprehensive epidemiological insights, treatment algorithms, evolving biomarker trends, and the competitive environment surrounding PD-L1-targeting therapies. Currently marketed PD-L1 inhibitors, including TECENTRIQ, IMFINZI, and BAVENCIO, have expanded their indications through successful regulatory approvals. These agents are widely used as monotherapy or in combination with chemotherapy, anti-VEGF agents, or other immune checkpoint inhibitors, depending on cancer type and biomarker expression. The market is witnessing dynamic growth driven by increasing PD-L1 biomarker testing, expanded indications, strategic collaborations, and next-generation immuno-oncology research. The development pipeline includes novel PD-L1 inhibitors, bispecific antibodies, and combination regimens aimed at overcoming resistance and improving patient outcomes. Companies such as EQRx, CStone Pharmaceuticals, Pfizer, Novartis, and others are leading the field with continuous investment in clinical trials and label expansions. 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Some of the Key Facts of the PD-L1 Inhibitors Market Report: • In 2023, the PD-L1 inhibitors market size in the 7MM was approximately USD 36 billion, with the United States contributing the largest share. • Key indications in the U.S. (2023 incident cases): • KEYTRUDA and OPDIVO, the leading PD-L1 inhibitors, are expected to lose patent exclusivity in the U.S. by 2028, potentially impacting market dynamics. • The loss of exclusivity may lead to a market decline, as biosimilars emerge and new entrants may struggle to match the current dominance of KEYTRUDA and OPDIVO, even with approvals in multiple indications. • Clinical trial activity has surged, over 4,400 trials registered, with more than 3,600 ongoing. • Around 90% of new trials since 2020 are exploring PD-L1 inhibitors in combination regimens, highlighting a strong shift towards combination strategies. • In April 2025, Gilead Sciences reported positive results from the Phase III ASCENT-04/KEYNOTE-D19 study, showing that the combination of TRODELVY (sacituzumab govitecan-hziy) and KEYTRUDA (pembrolizumab) significantly improved progression-free survival in patients with metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 (CPS ≥ 10), compared to chemotherapy and KEYTRUDA alone. • In March 2025, the FDA granted traditional approval for frontline pembrolizumab (Keytruda) in combination with trastuzumab and chemotherapy (fluoropyrimidine- and platinum-based) for adults with locally advanced, unresectable, or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) of at least 1 (CPS ≥1). • In March 2025, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1). • In February 2025, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) status to nogapendekin alfa (Anktiva) and CAR-NK (PD-L1 t-haNK) for their potential to reverse lymphopenia in patients undergoing chemotherapy/radiotherapy and to treat metastatic pancreatic cancer. • In February 2025, Beijing Biostar Pharmaceuticals announced that its Utidelone Capsules, in combination with capecitabine and oxaliplatin, received FDA approval for a Phase II/III registration clinical study (BG02-2404). This Combination Therapy is for first-line treatment of PD-L1-negative, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. • In January 2025, the FDA approved tislelizumab, in combination with platinum- and fluoropyrimidine-based chemotherapy, for the first-line treatment of patients with unresectable or metastatic, HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (≥1). • Leading companies in the PD-L1 Inhibitors market include EQRx, CStone Pharmaceuticals, Pfizer, Novartis, Arcus Biosciences, Agenus, TRACON Pharmaceuticals, Shanghai Henlius Biotech, Incyte Corporation, and others. • Emerging acute PD-L1 inhibitor drugs include Sugemalimab (CS1001), Sasanlimab, Spartalizumab, Zimberelimab, Balstilimab, Envafolimab, HLX10, INCB099280, and others. • PD-L1 inhibitors are reshaping cancer care, fueling demand for more targeted and durable treatment options across multiple tumor types with growing clinical adoption and expanding indications. To know in detail about the PD-L1 Inhibitors market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: PD-L1 Inhibitors Overview Programmed death-ligand 1 (PD-L1) inhibitors are a class of immune checkpoint inhibitors that have revolutionized cancer immunotherapy by enhancing the body's natural ability to fight tumors. PD-L1 is a protein expressed on tumor cells and tumor-infiltrating immune cells that binds to the PD-1 receptor on T-cells, effectively turning off the immune response. By blocking this interaction, PD-L1 inhibitors restore T-cell activity, allowing the immune system to recognize and destroy cancer cells more effectively. PD-L1 inhibitors are currently approved for a variety of malignancies, including non-small cell lung cancer (NSCLC), urothelial carcinoma, triple-negative breast cancer (TNBC), hepatocellular carcinoma, and others. Some of the key PD-L1 inhibitors include atezolizumab (TECENTRIQ), durvalumab (IMFINZI), and avelumab (BAVENCIO). These therapies are often used either as monotherapy or in combination with chemotherapy, targeted therapy, or other immunotherapies. Ongoing research continues to expand its applications across tumor types and disease stages, and the development of predictive biomarkers aims to refine patient selection for optimal treatment outcomes. With multiple agents in clinical and preclinical development, PD-L1 inhibitors remain a cornerstone of immuno-oncology, offering the potential for improved survival, long-term remission, and better quality of life for patients with advanced cancers. Get a free sample of the PD-L1 Inhibitors market report with key insights and emerging therapies here: PD-L1 Inhibitors Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. Download the report to understand which factors are driving PD-L1 Inhibitors epidemiology trends @ PD-L1 Inhibitors Epidemiology Forecast PD-L1 Inhibitor Drugs Uptake and Pipeline Development Activities The PD-L1 Inhibitors drugs uptake section examines the rate at which newly launched or upcoming potential drugs are being adopted in the PD-L1 Inhibitors market during the study period. This analysis covers drug uptake, patient adoption of therapies, and the sales performance of each drug. Additionally, the therapeutics assessment section highlights the drugs with the most rapid uptake, shedding light on the factors driving their widespread use. It also provides a comparative analysis of these drugs based on their market share. The report further delves into the PD-L1 Inhibitors pipeline development activities, offering key insights into various therapeutic candidates in different stages of development and the major companies behind these innovations. It also covers recent collaborations, acquisitions, mergers, licensing agreements, patent details, and other critical information related to emerging therapies. PD-L1 Inhibitors Market Outlook The PD-L1 inhibitors market is poised for continued growth, with PD-1/PD-L1 inhibitors expected to lead oncology drug sales in the coming years. These immuno-oncology agents have revolutionized cancer care across various tumor types and stages, from metastatic to early disease, thanks to their adaptability and durable clinical benefits. Widely adopted as monotherapy or in combination with tyrosine kinase inhibitors, chemotherapy, or other immunotherapies, PD-L1 inhibitors offer prolonged tumor responses and enhanced survival outcomes while maintaining a favorable safety profile that supports their use in broad combination regimens. While immune checkpoint inhibitors have transformed the cancer treatment landscape, efforts to target pathways beyond PD-1/PD-L1—such as TIGIT, TIM-3, and LAG-3—have met with limited success, though some agents continue development. Innovative approaches like Eftilagimod alpha (Efti), a unique MHC Class II agonist, are also gaining attention for combination strategies. In an increasingly crowded PD-L1 market, innovation and differentiation are critical. Companies must target new indications, address current treatment gaps, or become first-in-class to maintain a competitive advantage. Emerging PD-L1 inhibitors such as spartalizumab (Novartis), sasanlimab (Pfizer), zimberelimab (Arcus Biosciences), sugemalimab (EQRx/CStone), HLX10 (Henlius), and balstilimab (Agenus) are currently in development. Among the 7MM, the United States remains the largest market for PD-L1 inhibitors, generating nearly USD 26 billion in 2023, with further expansion anticipated through 2034. PD-L1 Inhibitors Market Strengths • PD-L1 inhibitors are approved for a wide range of tumor types, including non-small cell lung cancer, bladder cancer, melanoma, and more. Their use as monotherapy or in combination regimens gives them a significant advantage in oncology treatment strategies. • With numerous promising candidates in clinical development, such as spartalizumab, sasanlimab, and sugemalimab, the pipeline remains robust. Continued R&D investment ensures ongoing evolution and expansion into new indications and combinations. PD-L1 Inhibitors Market Weaknesses • The PD-L1 inhibitors landscape is crowded with multiple approved agents and late-stage candidates, making it difficult for new entrants to differentiate and capture market share without clear clinical or safety advantages. • Attempts to extend the checkpoint blockade approach beyond PD-1/PD-L1 (e.g., targeting TIGIT, TIM-3) have faced clinical setbacks. This limits expansion opportunities and raises concerns about over-reliance on the PD-1/PD-L1 axis. Scope of the PD-L1 Inhibitors Market Report • Study Period: 2020–2034 • Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] • Key PD-L1 Inhibitors Companies: EQRx, CStone Pharmaceuticals, Pfizer, Novartis, Arcus Biosciences, Agenus, TRACON Pharmaceuticals, Shanghai Henlius Biotech, Incyte Corporation, and others. • Key PD-L1 Inhibitors Therapies: Sugemalimab (CS1001), Sasanlimab, Spartalizumab, Zimberelimab, Balstilimab, Envafolimab, HLX10, INCB099280, and others. • PD-L1 Inhibitors Therapeutic Assessment: PD-L1 Inhibitors, currently marketed, and PD-L1 Inhibitors emerging therapies • PD-L1 Inhibitors Market Dynamics: PD-L1 Inhibitors market drivers and PD-L1 Inhibitors market barriers • Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies • PD-L1 Inhibitors Unmet Needs, KOL's views, Analyst's views, PD-L1 Inhibitors Market Access and Reimbursement Table of Contents 1. PD-L1 Inhibitors Market Report Introduction 2. Executive Summary for PD-L1 Inhibitors 3. SWOT analysis of PD-L1 Inhibitors 4. PD-L1 Inhibitors Patient Share (%) Overview at a Glance 5. PD-L1 Inhibitors Market Overview at a Glance 6. PD-L1 Inhibitors Disease Background and Overview 7. PD-L1 Inhibitors Epidemiology and Patient Population 8. Country-Specific Patient Population of PD-L1 Inhibitors 9. PD-L1 Inhibitors Current Treatment and Medical Practices 10. PD-L1 Inhibitors Unmet Needs 11. PD-L1 Inhibitors Emerging Therapies 12. PD-L1 Inhibitors Market Outlook 13. Country-Wise PD-L1 Inhibitors Market Analysis (2020–2034) 14. PD-L1 Inhibitors Market Access and Reimbursement of Therapies 15. PD-L1 Inhibitors Market Drivers 16. PD-L1 Inhibitors Market Barriers 17. PD-L1 Inhibitors Appendix 18. PD-L1 Inhibitors Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Healthcare 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. It also offers Healthcare Consulting Services, which benefit from market analysis to accelerate business growth and overcome challenges with a practical approach. 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:
Globe and Mail
5 days ago
- Globe and Mail
Opioid Withdrawal Syndrome Market Insight, Epidemiology, and Market Forecast – 2034
Opioid Withdrawal Syndrome (OWS) is a major public health concern caused by the sudden reduction or cessation of opioids in dependent individuals. Symptoms like anxiety, cramps, and severe cravings make withdrawal a key barrier to recovery. With the ongoing opioid crisis, the demand for effective, accessible treatments continues to grow. DelveInsight's ' Opioid Withdrawal Syndrome Market Report ' offers a detailed analysis of the current and projected landscape for OWS treatment across the major markets, including the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. The report outlines the evolving epidemiology, highlighting the high prevalence of opioid dependence and withdrawal cases, particularly in countries severely impacted by opioid misuse. It also examines standard clinical practices and treatment gaps, providing a strategic overview of the healthcare burden and future market potential. Current treatment regimens for OWS typically involve a combination of opioid agonists such as buprenorphine and methadone, non-opioid medications like clonidine and lofexidine, and supportive symptom-based therapies. While effective to some extent, these approaches often face challenges related to tolerability, relapse risk, and access to care. The approval of non-opioid therapies like Lucemyra (lofexidine hydrochloride) has expanded options for managing withdrawal symptoms, but broader therapeutic innovation remains limited. Newer candidates in clinical development are targeting novel pathways to reduce withdrawal intensity and improve adherence during detoxification. With rising investments in addiction research, increasing awareness around opioid misuse, and supportive policy reforms in many countries, the OWS treatment market is set to evolve significantly by 2034. DelveInsight's report captures this transformation by evaluating market dynamics, key players, emerging therapies, and regulatory landscapes. It is an essential resource for pharmaceutical companies, healthcare providers, policymakers, and investors looking to understand and capitalize on the opportunities in this high-need therapeutic area. Some of the Key Facts of the Opioid Withdrawal Syndrome Market Report: • In 2022, the Opioid Withdrawal Syndrome market in the 7MM was valued at around USD 1.3 billion and is expected to grow steadily through 2034. • Approximately 8.2 million cases of opioid withdrawal syndrome were reported in the 7MM in 2022, with a projected decline over the forecast period. • Around 9.1 million individuals had long-term opioid use in the 7MM in 2022. • The US accounted for nearly 7.1 million opioid withdrawal cases in 2022, expected to decrease by 2034. • In March 2025, Hikma Pharmaceuticals announced that Health Canada approved KLOXXADO® (naloxone HCl) Nasal Spray 8 mg for the treatment of known or suspected opioid overdose, characterized by respiratory and/or central nervous system depression, in adult patients. • In February 2025, Indivior announced that the FDA approved label changes for SUBLOCADE® injection, a treatment for moderate to severe opioid use disorder (OUD). The updates include a rapid initiation protocol reducing treatment time from one week to one hour and alternative injection sites to improve flexibility and patient adherence. • In October 2024, the FDA approved Protega Pharmaceuticals' ROXYBOND™ (oxycodone IR 10 mg) for severe pain management. It is the first FDA-approved abuse-deterrent IR oxycodone designed to reduce intranasal and intravenous misuse. • Leading companies in the Opioid Withdrawal Syndrome market include atai Life Sciences, Medicinova, BioXcel Therapeutics Inc., and others. • Emerging acute Opioid Withdrawal Syndrome drugs include BXCL501, MN-166, DMX-1002, and others. • Opioid Withdrawal Syndrome remains a significant clinical challenge, with rising awareness and evolving treatment strategies driving demand for safer, more effective therapies to manage symptoms and reduce relapse risk. To know in detail about the Opioid Withdrawal Syndrome market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: Opioid Withdrawal Syndrome Market Forecast Opioid Withdrawal Syndrome Overview Opioid Withdrawal Syndrome (OWS) is a clinical condition that occurs when individuals who are physically dependent on opioids suddenly reduce or discontinue their use. This syndrome is a hallmark of opioid dependence and is driven by the neuroadaptive changes in the brain that result from prolonged exposure to opioids. When opioid use is stopped, the abrupt absence of the drug leads to a rebound of neurotransmitter activity, particularly within the noradrenergic and dopaminergic systems, triggering a range of distressing physical and psychological symptoms. Symptoms of opioid withdrawal typically begin within hours of the last dose and can vary in intensity depending on the type of opioid used, duration of use, and individual factors such as tolerance and overall health. Common early symptoms include anxiety, agitation, muscle aches, sweating, and insomnia. These may progress to more severe manifestations such as abdominal cramps, vomiting, diarrhea, dilated pupils, rapid heartbeat, and intense cravings. While not usually life-threatening, the severity of symptoms can lead to significant discomfort and increase the risk of relapse. Get a free sample of the Opioid Withdrawal Syndrome market report with key insights and emerging therapies here: Opioid Withdrawal Syndrome Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. Opioid Withdrawal Syndrome Epidemiology Segmentation: The Opioid Withdrawal Syndrome epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by: • Number of Opioid Misuse Cases • Number of Cases with long term Opioid usage • Total Opioid Withdrawal symptoms Cases Download the report to understand which factors are driving Opioid Withdrawal Syndrome epidemiology trends @ Opioid Withdrawal Syndrome Epidemiology Forecast Opioid Withdrawal Syndrome Drugs Uptake and Pipeline Development Activities The Opioid Withdrawal Syndrome drugs uptake section examines the rate at which newly launched or upcoming potential drugs are being adopted in the Opioid Withdrawal Syndrome market during the study period. This analysis covers drug uptake, patient adoption of therapies, and the sales performance of each drug. Additionally, the therapeutics assessment section highlights the drugs with the most rapid uptake, shedding light on the factors driving their widespread use. It also provides a comparative analysis of these drugs based on their market share. The report further delves into the Opioid Withdrawal Syndrome pipeline development activities, offering key insights into various therapeutic candidates in different stages of development and the major companies behind these innovations. It also covers recent collaborations, acquisitions, mergers, licensing agreements, patent details, and other critical information related to emerging therapies. Opioid Withdrawal Syndrome Market Outlook The Opioid Withdrawal Syndrome (OWS) market is expected to witness steady growth through 2034, driven by the increasing prevalence of opioid use disorder (OUD), rising awareness about withdrawal management, and expanding access to treatment services. As the opioid crisis continues to pose a significant public health burden across the globe, particularly in the United States and parts of Europe, the demand for effective withdrawal therapies is accelerating. The availability of both opioid-based and non-opioid pharmacological options, including buprenorphine and clonidine, is enhancing treatment outcomes and reducing relapse rates, contributing to market expansion. Furthermore, advancements in withdrawal management protocols, growing governmental and private sector investments in addiction care, and the development of more targeted and patient-friendly therapeutics are fueling innovation in the OWS treatment landscape. The emergence of new formulations, such as long-acting buprenorphine and novel non-opioid agents, is expected to diversify the treatment arsenal and improve patient adherence. With continued efforts toward destigmatization and the integration of mental health support, the OWS market is poised for sustained progress over the forecast period. Opioid Withdrawal Syndrome Market Strengths • Increased global awareness about the opioid crisis, coupled with supportive government policies, funding, and public health initiatives, has significantly strengthened the market. Programs promoting medication-assisted treatment (MAT) and opioid withdrawal management have expanded access to care, thereby boosting demand for therapeutic options. • The development of innovative pharmacological treatments, such as non-opioid medications (e.g., lofexidine) and extended-release formulations of buprenorphine, has improved treatment adherence and outcomes. These advancements enhance patient experience and create opportunities for differentiated products in the market. Opioid Withdrawal Syndrome Market Weaknesses • Despite increasing awareness, societal stigma associated with opioid dependence continues to prevent many individuals from seeking help. Underreporting and underdiagnosis of OWS limit the true market potential and delay access to treatment. • Despite increasing awareness, societal stigma associated with opioid dependence continues to prevent many individuals from seeking help. Underreporting and underdiagnosis of OWS limit the true market potential and delay access to treatment. Scope of the Opioid Withdrawal Syndrome Market Report • Study Period: 2020–2034 • Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] • Key Opioid Withdrawal Syndrome Companies: atai Life Sciences, Medicinova, BioXcel Therapeutics Inc., and others. • Key Opioid Withdrawal Syndrome Therapies: BXCL501, MN-166, DMX-1002, and others. • Opioid Withdrawal Syndrome Therapeutic Assessment: Opioid Withdrawal Syndrome, currently marketed, and Opioid Withdrawal Syndrome emerging therapies • Opioid Withdrawal Syndrome Market Dynamics: Opioid Withdrawal Syndrome market drivers and Opioid Withdrawal Syndrome market barriers • Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies • Opioid Withdrawal Syndrome Unmet Needs, KOL's views, Analyst's views, Opioid Withdrawal Syndrome Market Access and Reimbursement To learn more about the key players and advancements in the Opioid Withdrawal Syndrome treatment landscape, visit the Opioid Withdrawal Syndrome Market Analysis Report Table of Contents 1. Opioid Withdrawal Syndrome Market Report Introduction 2. Executive Summary for Opioid Withdrawal Syndrome 3. SWOT analysis of Opioid Withdrawal Syndrome 4. Opioid Withdrawal Syndrome Patient Share (%) Overview at a Glance 5. Opioid Withdrawal Syndrome Market Overview at a Glance 6. Opioid Withdrawal Syndrome Disease Background and Overview 7. Opioid Withdrawal Syndrome Epidemiology and Patient Population 8. Country-Specific Patient Population of Opioid Withdrawal Syndrome 9. Opioid Withdrawal Syndrome Current Treatment and Medical Practices 10. Opioid Withdrawal Syndrome Unmet Needs 11. Opioid Withdrawal Syndrome Emerging Therapies 12. Opioid Withdrawal Syndrome Market Outlook 13. Country-Wise Opioid Withdrawal Syndrome Market Analysis (2020–2034) 14. Opioid Withdrawal Syndrome Market Access and Reimbursement of Therapies 15. Opioid Withdrawal Syndrome Market Drivers 16. Opioid Withdrawal Syndrome Market Barriers 17. Opioid Withdrawal Syndrome Appendix 18. Opioid Withdrawal Syndrome Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Healthcare 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. It also offers Healthcare Consulting Services, which benefit from market analysis to accelerate business growth and overcome challenges with a practical approach. 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:
