Claudin 18.2-Directed Oncology Therapeutics--A Fast-Growing Market with Blockbuster Potential | DelveInsight
Claudin 18.2-directed therapies are on track to become foundational in the treatment of gastrointestinal and select solid tumors. Fueled by innovation in antibody engineering, combination strategies, and biomarker testing, this therapeutic class is set to play a transformative role in the next generation of precision oncology.
LAS VEGAS, July 23, 2025 /PRNewswire/ -- DelveInsight's Claudin 18.2 Directed Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging Claudin 18.2-directed therapies, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM.
Key Takeaways from the Claudin 18.2 Directed Therapies Market Report
- As per DelveInsight's analysis, the total market size of Claudin 18.2-directed therapies in the 7MM is expected to surge significantly by 2034.
- The report provides the total potential number of patients in the indications, such as Gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors
- Leading Claudin 18.2-directed therapies companies, such as AskGene, Innovent, AstraZeneca, Antegene, Antennova, Kelun, Phanes, and others, are developing novel Claudin 18.2-directed therapies that can be available in the Claudin 18.2-directed therapies market in the coming years.
- Some of the key Claudin 18.2-directed therapies in the pipeline include ASKB589, IBI-343, AZD0901, ATG022/ATN022, SKB315, Spevatamig (PT886), and others.
- In May 2025, Astellas entered an exclusive license agreement with Evopoint Biosciences for XNW27011, a novel clinical-stage antibody-drug conjugate targeting CLDN18.2.
Discover which indication is expected to grab the major Claudin 18.2-directed therapies market share @ Claudin 18.2 Directed Therapies Market Report
Claudin 18.2 Directed Therapies Market Dynamics
The Claudin 18.2-directed therapies market has been witnessing significant momentum driven by advancements in targeted oncology therapies. Claudin 18.2 is a tight junction protein selectively expressed in certain cancers, such as gastric cancer, gastroesophageal junction adenocarcinoma, and pancreatic cancer, making it an attractive therapeutic target. The approval of zolbetuximab (VYLOY) by Astellas has validated the clinical potential of Claudin 18.2-targeting monoclonal antibodies, positioning the pathway as a critical frontier in precision oncology. Other players, including domestic and international pharmaceutical companies, are actively developing monoclonal antibodies, antibody-drug conjugates (ADCs), and bispecific antibodies directed against Claudin 18.2, further intensifying the competitive dynamics.
The market is characterized by a robust pipeline across various modalities. Monoclonal antibodies such as zolbetuximab lead the segment, but the pipeline also features novel ADCs and bispecifics, aiming to improve efficacy and overcome resistance mechanisms. Several companies are exploring combination regimens with checkpoint inhibitors and chemotherapy to enhance treatment outcomes. Additionally, there is a growing interest in expanding the therapeutic scope beyond gastric and gastroesophageal junction cancers to include pancreatic, lung, and other solid tumors where Claudin 18.2 expression is evident, potentially broadening the patient pool.
Despite the growth prospects, the Claudin 18.2-directed therapies market faces several challenges. These include the need for reliable diagnostic tools to identify Claudin 18.2 expression, patient heterogeneity in expression levels, and potential off-target effects leading to safety concerns. Moreover, market penetration may be impacted by the high cost of biologics and the evolving reimbursement landscape, particularly in emerging markets. Nonetheless, the strong clinical efficacy signals, favorable regulatory momentum, and increasing physician awareness position Claudin 18.2 therapies for substantial growth over the next decade.
Looking ahead, the Claudin 18.2-directed therapy landscape is expected to diversify with the introduction of next-generation modalities such as CAR-T therapies and vaccines targeting the protein. The competitive intensity is likely to increase as additional players enter late-stage development and as combination regimens redefine the treatment paradigm. Continued biomarker-driven patient selection and companion diagnostic development will be critical to optimizing outcomes and driving adoption. Overall, the Claudin 18.2 market represents a dynamic and evolving segment of the oncology therapeutics space, poised for continued innovation and expansion.
Claudin 18.2 Directed Therapies Treatment Market
Therapies targeting Claudin 18.2 have shown activity across several cancers, such as gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors. Astellas' VYLOY (zolbetuximab) is currently the first and only approved therapy directed against Claudin 18.2 for advanced gastric and gastroesophageal junction adenocarcinoma. It was first approved in Japan in March 2024, followed by regulatory clearance in the UK in August 2024, and later by the US FDA in October 2024.
VYLOY is a cytolytic monoclonal antibody that targets claudin 18.2 and is approved for use alongside fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. This treatment is specifically intended for patients whose tumors express claudin 18.2, as confirmed by an FDA-approved diagnostic test.
As a claudin 18.2-targeting cytolytic antibody, VYLOY destroys CLDN18.2-positive cells through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Preclinical models have shown that combining VYLOY with chemotherapy enhances antitumor activity in CLDN18.2-positive tumors compared to the use of either treatment alone.
Learn more about the Claudin 18.2-directed therapies @ Claudin 18.2 Directed Therapies Analysis
Key Emerging Claudin 18.2 Directed Therapies and Companies
Several companies, including AskGene (ASKB589), Innovent (IBI-343), Antegene (ATG022/ATN022), Kelun (SKB315), AstraZeneca (AZD0901), Phanes (Spevatamig), and others, are currently engaged in the development and production of CLDN 18.2 therapies, which have the potential to significantly impact and enhance the MCR therapies market.
ASKB589 is a humanized IgG1 monoclonal antibody targeting CLDN1, specifically designed to enhance antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). In combination with CAPOX chemotherapy and a PD-1 inhibitor as a first-line therapy for patients with gastric/gastroesophageal junction (G/GEJ) cancer, ASKB589 showed a favorable safety and tolerability profile. The addition of a PD-1 inhibitor to the ASKB589 plus CAPOX regimen in patients expressing moderate to high levels of CLDN18.2 led to promising anti-tumor effects, characterized by strong and lasting responses.
IBI-343 is a recombinant human monoclonal antibody targeting Claudin 18.2, linked to a topoisomerase I inhibitor payload (Exatecan). Engineered with an Fc-silenced backbone to reduce unwanted immune activation, it features a cleavable linker for targeted drug release within tumor cells, enabling a bystander killing effect that affects neighboring tumor cells with low antigen expression. IBI-343 has been granted Fast Track Designation by the U.S. FDA and is currently being investigated in the Phase III G-HOPE trial (NCT06238843).
The anticipated launch of these emerging therapies are poised to transform the Claudin 18.2-directed 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 Claudin 18.2-directed therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about Claudin 18.2-directed therapies clinical trials, visit @ Claudin 18.2 Directed Therapies Treatment
Claudin 18.2 Directed Therapies Overview
Claudin 18.2 is a tight junction protein essential for preserving the integrity of the stomach lining. It is one of the two isoforms produced by the CLDN18 gene and is normally found only in differentiated epithelial cells of the gastric mucosa. In healthy tissues, Claudin 18.2 is hidden within tight junctions, making it inaccessible to drugs. However, during the development of cancers like gastric, gastroesophageal junction (GEJ), and pancreatic cancer, Claudin 18.2 becomes abnormally exposed on the surface of tumor cells, while its expression in normal tissues remains limited.
This distinct expression profile makes Claudin 18.2 a promising and highly specific therapeutic target. The most advanced treatment targeting this protein is VYLOY, a monoclonal antibody that binds to Claudin 18.2 and induces immune-mediated killing of tumor cells. VYLOY has demonstrated encouraging results in late-stage clinical trials and is now approved for treating CLDN18.2-positive gastric and GEJ cancers. Additional therapies under investigation include CAR-T cell therapies, bispecific antibodies, and antibody-drug conjugates.
Testing for CLDN18.2 expression using immunohistochemistry (IHC) helps identify patients who may benefit from these targeted treatments, highlighting the dual role of CLDN18.2 as both a biomarker and a therapeutic target in precision cancer therapy.
Claudin 18.2 Directed Therapies Epidemiology Segmentation
The Claudin 18.2-directed therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
- Total Cases of Selected Indications for Claudin 18.2-directed Therapies
- Total Eligible Patients of the Selected Indications of Claudin 18.2-directed Therapies
- Total Treated Cases in Selected Indications for Claudin 18.2-directed Therapies
Claudin 18.2 Directed Therapies Report Metrics | Details |
Study Period | 2020–2034 |
Claudin 18.2 Directed Therapies Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Key Indications Covered in the Report | Gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors |
Key Claudin 18.2 Directed Therapies Companies | AskGene, Innovent, AstraZeneca, Antegene, Antennova, Kelun, Phanes, Astellas, and others |
Key Claudin 18.2 Directed Therapies | ASKB589, IBI-343, AZD0901, ATG022/ATN022, SKB315, Spevatamig (PT886), VYLOY, and others |
Scope of the Claudin 18.2 Directed Therapies Market Report
- Claudin 18.2 Directed Therapies Therapeutic Assessment: Claudin 18.2 Directed Therapies current marketed and emerging therapies
- Claudin 18.2 Directed Therapies Market Dynamics: Conjoint Analysis of Emerging Claudin 18.2 Directed Therapies Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Claudin 18.2 Directed Therapies Market Access and Reimbursement
Discover more about Claudin 18.2-directed therapies in development @ Claudin 18.2 Directed Therapies Clinical Trials
Table of Contents
1 | Key Insights |
2 | Report Introduction |
3 | Executive Summary of Claudin 18.2 Directed Therapies |
4 | Key Events |
5 | Epidemiology and Market Forecast Methodology |
6 | Claudin 18.2 Directed Therapies Market Overview at a Glance in the 7MM |
6.1 | Market Share (%) Distribution by Indication in 2024 |
6.2 | Market Share (%) Distribution by Indication in 2034 |
6.3 | Market Share (%) Distribution by Therapies in 2024 |
6.4 | Market Share (%) Distribution by Therapies in 2034 |
7 | Claudin 18.2 Directed Therapies: Background and Overview |
8 | Treatment and Management |
9 | Target Patient Pool |
9.1 | Key Findings |
9.2 | Assumptions and Rationale: 7MM |
9.3 | Epidemiology Scenario in the 7MM |
9.3.1 | Total Cases of Selected Indication for Claudin 18.2 Directed Therapies in the 7MM |
9.3.2 | Total Eligible Patient Pool for Claudin 18.2 Directed Therapies in Selected Indication in the 7MM |
9.3.3 | Total Treatable Cases in Selected Indications for Claudin 18.2 Directed Therapies in the 7MM |
10 | Marketed Therapies |
10.1 | Key Competitors |
10.2 | VYLOY (zolbetuximab): Astellas |
10.2.1 | Product Description |
10.2.2 | Regulatory milestones |
10.2.3 | Other developmental activities |
10.2.4 | Clinical development |
10.2.5 | Safety and efficacy |
List to be continued in the report… | |
11 | Emerging Therapies |
11.1 | Key Competitors |
11.2 | ASKB589: AskGene |
11.2.1 | Product Description |
11.2.2 | Other developmental activities |
11.2.3 | Clinical development |
11.2.4 | Safety and efficacy |
11.2.5 | Analyst Views |
11.3 | IBI-343: Innovent |
11.3.1 | Product Description |
11.3.2 | Other developmental activities |
11.3.3 | Clinical development |
11.3.4 | Safety and efficacy |
11.3.5 | Analyst Views |
List to be continued in the report… | |
12 | Claudin 18.2 Directed Therapies: 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 and Rebates |
12.4.2 | Pricing Trends |
12.4.3 | Analogue Assessment |
12.4.4 | Launch Year and Therapy Uptakes |
12.5 | Total Market Size of Claudin 18.2 Directed Therapies in the 7MM |
12.6 | The United States |
12.7 | EU4 and the UK |
12.8 | Japan |
13 | SWOT Analysis of Claudin 18.2 Directed Therapies |
14 | KOL Views of Claudin 18.2 Directed Therapies |
15 | Unmet Needs of Claudin 18.2 Directed Therapies |
16 | Market Access and Reimbursement |
17 | Bibliography |
18 | Report Methodology |
Related Reports
Gastric 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 gastric cancer companies, including BeiGene, Linton Pharm Co. Ltd., RAPT Therapeutics, Leap Therapeutics, Idience, Bolt Biotherapeutics, Hubro Therapeutics, Immunocore, Ambrx, Hangzhou DAC Biotech, Beijing Immunoah Pharma Tech, Nanjing KAEDI Biotech, HiberCell, Transcenta Holding, Suzhou Zelgen Biopharmaceuticals, Daiichi Sankyo, Ipsen, Alligator Bioscience, Bristol Myers Squibb, Jiangsu Hengrui Medicine, Shanghai Junshi Biosciences, ImmunoACT, among others.
Pancreatic 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 pancreatic cancer companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, Celgene, Bristol Myers Squibb, BioLineRx, Alligator Bioscience, Bellicum Pharmaceuticals, OSE Immunotherapeutics, Actuate Therapeutics, FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, Merus, Mirati Therapeutics, Rexahn Pharmaceuticals, Ocuphire Pharma, Processa Pharmaceuticals, ImmunityBio, Berg, Panbela Therapeutics, GlaxoSmithKline, Eleison Pharmaceuticals, Molecular Templates, Lokon Pharma AB, Cantargia AB, Bristol-Myers Squibb, among others.
Gastroesophageal Junction Adenocarcinoma Market
Gastroesophageal Junction Adenocarcinoma 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 gastroesophageal junction adenocarcinoma companies, including Astellas Pharmaceuticals, AstraZeneca, Bayer, Beigene, Bristol-Myers Squibb, Daichii Sankyo, Elevar Therapeutics, Eli Lilly, FivePrime Therapeutics, Incyte Corporation, Macrogenics, Merck Co., Ono Pharmaceuticals, Roche, Taiho Pharmaceuticals, Zai Labs, ZymeWorks, among others.
Pancreatic Ductal Adenocarcinoma Market
Pancreatic Ductal Adenocarcinoma 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 PDAC companies, including Cardiff Oncology, Cantargia, RenovoRx, Jeil Pharmaceutical, 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 Us
Shruti Thakur
info@delveinsight.com
+14699457679
Logo: https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/claudin-18-2-directed-oncology-therapeuticsa-fast-growing-market-with-blockbuster-potential--delveinsight-302511749.html