Dublin, May 22, 2025 (GLOBE NEWSWIRE) -- The "Claudin 18.2 Targeted Therapy Market Forecast & Clinical Trials Insight 2029" has been added to ResearchAndMarkets.com's offering.
Claudin18.2 (CLDN18.2) is a promising biomarker in oncology, showing abnormal expression in various primary malignancies, notably gastric cancer, gastroesophageal junction cancer, and other solid tumors. This discovery has fueled the development of targeted therapies aimed at inhibiting Claudin18.2, primarily benefiting gastric cancers.
By November 2024, one such therapy, Vyloy (zolbetuximab), has received approval, with additional treatments in advanced development stages. Pharmaceutical companies worldwide are heavily investing in Claudin18.2-targeted therapies, underscoring their transformative potential in gastric cancer treatment. This area of research is rapidly gaining attention.
Market Forecast & Clinical Trials Insights 2029:
- Global and regional market trend insights.
- Vyloy (zolbetuximab) is currently the only approved Claudin18.2 targeted drug.
- Details on approved drug dosage, pricing, and sales.
- Claudin 18.2 therapy clinical trends and innovations by indication.
- Over 60 drugs in clinical trials targeting Claudin18.2.
- Insights on technical and clinical platforms for advanced therapy development.
The approval of Vyloy in March 2024 marked a crucial advancement, being the first Claudin18.2-targeted medication. Developed by Ganymed Pharmaceuticals and later acquired by Astellas Pharma, Vyloy has approval in the US, EU, and Japan for first-line treatment in combination with chemotherapy for HER2-negative G/GEJ adenocarcinoma with Claudin18.2 expression. An expected approval in China by the end of 2024 signals its global therapy expansion.
Sales for Vyloy reached over US$ 7 Million by Q3 2024, indicating strong market adoption. These numbers highlight the significant unmet need for effective treatments and Claudin18.2's therapeutic potential. Zolbetuximab is undergoing clinical trials examining combinations with various regimens and potential applications in tumors beyond G/GEJ adenocarcinoma, like pancreatic carcinoma, potentially broadening the impact of Claudin18.2-targeted medications.
Apart from Vyloy, numerous Claudin18.2-targeting treatments are under development, including monoclonal antibodies, bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates (ADCs). Five candidates are in phase 3 clinical trials, primarily for G/GEJ malignancies, with promising research in other cancer types, such as ovarian and lung cancers, reflecting the growing interest and potential for targeting Claudin18.2 in oncology.
The competitive landscape is becoming more dynamic, with major companies investing in research and development. Notably, China has become a hub for innovation, with companies like Innovent, MabWorks, and Biotheus leading in developing Claudin18.2-targeting medicines.
Companion diagnostic tests play a vital role in this industry. Roche Diagnostics introduced the Ventana CLDN18 (43-14A) RxDx Assay, the first immunohistochemistry-based test approved to detect Claudin18.2 expression in G/GEJ adenocarcinoma patients. This test helps identify patients likely to benefit from Vyloy treatment, enabling more precise and successful therapy selection. As the market expands, developing companion diagnostics will be crucial in enhancing treatment outcomes.
Looking ahead, the Claudin18.2-targeting therapy market is projected to grow due to promising results and an expanding pipeline. While G/GEJ cancers remain the primary focus, research into other indications may broaden therapy applications. The market's global reach, with strong representation from Western and Asian enterprises, fosters a competitive and collaborative environment likely to drive further innovation. As more therapies are developed and approved, and companion diagnostics become more accessible, Claudin18.2-targeted therapies are expected to significantly impact cancer treatment, offering new hope for patients with challenging-to-treat cancers.
Key Topics Covered:
1. Introduction To Claudin 18.2 Therapy
2. Research Advancement Targeting Claudin 18.2 For Cancer Immunotherapy
3. Approved Claudin 18.2 Targeting Therapies
4. Vyloy - 1st Approved Claudin 18.2 Targeted Therapy
5. Global Claudin 18.2 Market Scenario
6. Claudin 18.2 Therapy Trend Analysis By Region
7. Claudin 18.2 Therapy Clinical Trends & Innovations by Indication
8. Technical & Clinical Platforms For Developing Advanced Claudin 18.2 Therapy
9. Global Claudin 18.2 Drugs Clinical Trials Overview
10. Global Claudin 18.2 Drugs Clinical Trials By Company, Indication & Phase
11. Marketed Claudin 18.2 Drugs Clinical Insight
12. Competitive Landscape
- Abpro Therapeutics
- Antengene Corporation
- Arovella Therapeutics
- Astellas Pharma
- AstraZeneca
- Beijing Mabworks Biotech
- Biotheus
- CARsgen
- Dragonboat Biopharmaceutical
- Gracell Biotechnology
- Harbour BioMed
- Innovent Biologics
- Klus Pharma
- L and L Biopharma
- LaNova Medicines Limited
- Leap Therapeutics
- Luye Pharma Group
- Nanjing Bioheng Biotech
- Nanjing KAEDI Biotech
- OriCell Therapeutics
- Shanghai Junshi Biosciences
- SparX Biopharmaceutical
- TORL Biotherapeutics
- Transcenta Holding
For more information about this report visit https://www.researchandmarkets.com/r/cgov0x
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
