클라우딘 18.2 표적 치료제 : 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

Key Highlights:

• Claudin 18.2, a tight-junction molecule predominantly found in the nonmalignant gastric epithelium, becomes accessible on the tumor cell surface during malignant transformation, thereby providing an appealing target for cancer therapy.
• Claudin 18.2-directed therapies are active in multiple indications, including gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors.
• Astellas' VYLOY (zolbetuximab) is the first and only approved Claudin 18.2 directed therapy for the treatment of advanced gastric and gastroesophageal junction adenocarcinoma. It received regulatory approval in Japan in March 2024, followed by approval in the UK in August 2024 and the US FDA approved the therapy in October 2024.
• Claudin 18.2 directed therapies have a robust pipeline, with candidates such as ASKB589, IBI-343, AZD0901, ATG022, SKB315, Spevatamig (PT886) in late-Phase (II/III) trials targeting diverse indications like advanced gastric, gastroesophageal junction and other solid tumors.
• Several companies including AskGene, Innovent, Antegene, Kelun, AstraZeneca, Phanes, 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.

DelveInsight's "Claudin 18.2 directed therapies- Target Population, Competitive Landscape, and Market Forecast - 2036" report delivers an in-depth understanding of the Claudin 18.2, historical and Competitive Landscape as well as the Claudin 18.2 directed therapies market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Claudin 18.2 directed therapies market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Claudin 18.2 directed therapies market size from 2022 to 2036. The report also covers current Claudin 18.2 directed therapies treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2022-2036

Claudin 18.2 Directed Therapies Disease Understanding and Treatment Algorithm

Claudin 18.2 Directed Therapies Overview

Claudin 18.2 is a tight junction protein that plays a key role in maintaining the integrity of the gastric epithelium. It is one of two isoforms of the CLDN18 gene, with Claudin 18.2 being specifically and normally expressed only in differentiated epithelial cells of the gastric mucosa. In healthy tissue, it is buried within tight junctions, making it inaccessible to therapeutic agents. However, during malignant transformation in cancers such as gastric, gastroesophageal junction (GEJ), and pancreatic cancers, CLDN18.2 becomes aberrantly exposed on the tumor cell surface while retaining restricted expression in healthy tissues.

This unique expression pattern makes CLDN18.2 an attractive and highly selective therapeutic target. The most advanced therapy is VYLOY, a monoclonal antibody that binds to CLDN18.2, triggering immune-mediated tumor cell destruction. VYLOY has shown promising results in late-stage clinical trials and has been approved for CLDN18.2-positive gastric and GEJ cancers. Other investigational approaches include CAR-T cell therapies, bispecific antibodies, and antibody-drug conjugates.

Detection of CLDN18.2 expression by immunohistochemistry (IHC) helps identify eligible patients for targeted therapy, reinforcing its role as both a biomarker and a therapeutic target in precision oncology.

Claudin 18.2 Directed Therapies Epidemiology

The Claudin 18.2 directed therapies epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases of selected indication for Claudin 18.2 directed therapies, total eligible patients of selected indication, total treated cases in selected indication for Claudin 18.2 directed therapies in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2022 to 2036.

• According to DelveInsight, the total incident cases of gastric cancer in the US comprised around 50,000 cases in 2025.
• According to the American Cancer Society (2026), about 22,530 new esophageal cancer cases are to be diagnosed (17,580 in men and 4,950 in women) in 2026.
• As per Starling et al. (2025), in the UK, annual gastric cancer incidence is ~6500 cases, comprising 2% of all new cancer diagnoses. More than 70% of patients with gastric cancer are diagnosed at an advanced or metastatic disease stage, with poor prognosis.
• According to SEER data (2025), there were nearly more than 67,000 new cases of pancreatic cancer in the US.Note: List to be continued in the final report.....

Claudin 18.2 Directed Therapies Drug Chapters

The drug chapter segment of the Claudin 18.2 directed therapies reports encloses a detailed analysis of marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps to understand the Claudin 18.2 directed therapies clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

VYLOY (zolbetuximab): Astellas

VYLOY is a cytolytic antibody that specifically targets claudin 18.2 and is approved for use in combination with 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 intended for patients whose tumors test positive for claudin 18.2, as determined by an FDA-approved diagnostic assay.

As a claudin 18.2-directed cytolytic antibody, VYLOY eliminates CLDN18.2-expressing cells via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Preclinical studies demonstrated that combining VYLOY with chemotherapy produces enhanced antitumor effects in CLDN18.2-positive tumors compared to either agent used alone.

Emerging Drugs

IBI-343: Innovent and Takeda

IBI-343 is a recombinant human monoclonal antibody directed against Claudin 18.2, conjugated to topoisomerase I inhibitor payload (Exatecan). Designed with an Fc-silenced backbone to minimize off-target immune activation, it utilizes a cleavable linker that facilitates targeted intracellular drug release and enables a bystander effect, killing adjacent tumor cells with low antigen expression.

In October 2025, Takeda entered into a license and collaboration agreement with Innovent Biologics for the development, manufacturing and commercialization of two late-stage oncology medicines, IBI363 and IBI343, worldwide outside of Greater China.

According to the Global Strategic Collaboration presentation, October 2025, the companies' development plan for IBI-343 include Global MRCT Phase III in plan subject to Proof of Concept (PoC).

The drug has received Fast Track Designation (FTD) from the US FDA and is currently being evaluated in the Phase III G-HOPE trial (NCT06238843) for Claudin 18.2-positive, HER2-negative, gastric or GEJ adenocarcinoma .

Sonesitatug vedotin (AZD0901): AstraZeneca

Sonesitatug vedotin is an anti-Claudin 18.2 monoclonal antibody conjugated with MMAE payload.

Currently, sonesitatug vedotin is being evaluated in the Phase III in participants with second- or later-line advanced or metastatic gastric or GEJ expressing Claudin18.2.

Sonesitatug vedotin is also being investigated for Phase II for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and solid tumors and in the Phase I study of novel agents or combinations as perioperative treatment in participants with locally advanced resectable gastroesophageal adenocarcinoma.

Spevatamig (PT886): Phanes Therapeutics and Merck

Spevatamig is a first-in-class native IgG-like bispecific antibody targeting claudin 18.2 and CD47. It was granted Orphan Drug Designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted FTD for the treatment of patients with metastatic Claudin 18.2-positive pancreatic adenocarcinoma in 2024. The multi-center Phase I/II clinical trial of spevatamig (NCT05482893), known as the TWINPEAK study, is currently evaluating spevatamig in patients with advanced gastric, gastroesophageal junction, pancreatic ductal or biliary tract adenocarcinomas.

In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck's anti-PD-1 therapy, pembrolizumab.

Recent Developments in the Market

• In January 2026, Phanes Therapeutics announced the first clinical data evaluating spevatamig in combination with chemotherapy in frontline (1L) treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC). The data was presented at the American Society of Clinical Oncology Gastrointestinal (Cancers) Symposium (ASCO GI) 2026.
• In June 2025, Innovent updated the Phase I study results of IBI343, a novel anti-CLDN18.2 Anti-body Drug Conjugate (ADC), for the treatment of advanced pancreatic cancer at the 2025 ASCO Annual Meeting.

Claudin 18.2 Directed Therapies Market Outlook

Claudin 18.2 has swiftly gained prominence as a high-value therapeutic target in oncology, particularly for gastric and gastroesophageal junction adenocarcinomas. This momentum stems from its distinct expression profile-highly prevalent in malignant epithelial tissues while showing limited presence in normal tissues-making it exceptionally well-suited for tumor-specific interventions.

A significant inflection point came with the approval of VYLOY (zolbetuximab) by Astellas, first in Japan (March 2024) and subsequently in the United States (October 2024). As the first and only approved monoclonal antibody targeting Claudin 18.2, VYLOY has established a strong foothold in the treatment of advanced gastric and GEJ cancers. Its demonstrated efficacy, particularly in combination with chemotherapy, and its first-mover advantage position it as the current standard of care within this niche.

However, the Claudin 18.2 directed therapies therapeutic landscape is evolving rapidly, marked by a robust pipeline of late-stage contenders. Key Phase III candidates such as AZD0901 (AstraZeneca), ASKB589 (AskGene), and IBI-343 (Innovent) are poised to directly challenge VYLOY's market dominance, particularly in Asia, where clinical development is progressing at an accelerated pace. Additionally, emerging candidates like ATG-022 (Antegene) and SKB315 (Kelun)-both in earlier stages of development-signal a diversification of indications beyond gastric/GEJ cancers, including broader solid tumor applications.

A notable innovation in the pipeline is Spevatamig (PT886), a bispecific antibody from Phanes therapeutics that targets both Claudin 18.2 and CD47. Currently, in Phase II trials, Spevatamig is being evaluated for gastric/GEJ cancers as well as pancreatic ductal adenocarcinoma (PDAC), reflecting a broader strategic pivot toward immune-modulatory and combination-based approaches. This shift encompasses monotherapies, bispecific constructs, and combinations with chemotherapy or checkpoint inhibitors, all aiming to enhance clinical outcomes and address treatment resistance.

The therapeutic appeal of Claudin 18.2 directed therapies lies in its high tumor specificity, which enables reduced off-target toxicity and potentially improved safety profiles compared to traditional chemotherapy or generalized immunotherapy. Its expression is most validated in gastric and GEJ cancers, but has also been observed in pancreatic, lung, and ovarian tumors. This broadens its potential in precision oncology, though clinical validation in non-gastric indications is still emerging.

As the field matures, the integration of biomarker-driven diagnostics will be critical for patient selection, enabling more effective treatment stratification and improved clinical outcomes. The growing adoption of Claudin 18.2 directed therapies testing will likely parallel the rise in targeted therapy utilization.

Looking ahead, while VYLOY is expected to retain market leadership through at least 2026, the competitive landscape is intensifying. Advanced-stage programs such as AZD0901, ASKB589, and IBI-343 are well-positioned to capture a significant share, particularly in regions with rapid clinical and regulatory progress. Meanwhile, novel constructs like Spevatamig may redefine the therapeutic paradigm by coupling tumor targeting with immune engagement.

In summary, 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.

Claudin 18.2 Directed Therapies Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2026-2036, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Claudin 18.2 Directed Therapies Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

The presence of numerous drugs at different stages is expected to generate immense opportunities for the Claudin 18.2 directed therapies market growth over the forecasted period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Claudin 18.2 directed therapies.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on Claudin 18.2 directed therapies' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the MD Anderson Cancer Center, Massachusetts General Hospital Cancer Center, National Cancer Center Hospital East, Sorbonne University, University Medical Center Mainz, University of Cambridge, and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or Claudin 18.2 directed therapies market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of Claudin 18.2, explaining its mechanism and therapies (current and emerging).
• Comprehensive insight into the Competitive Landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborate profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the Claudin 18.2 directed therapies market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM Claudin 18.2 directed therapies market.

Claudin 18.2 Directed Therapies Report Insights

• Claudin 18.2 Targeted Patient Pool
• Therapeutic Approaches
• Claudin 18.2 directed therapies Pipeline Analysis
• Claudin 18.2 directed therapies Market Size and Trends
• Existing and future Market Opportunity

Claudin 18.2 Directed Therapies Report Key Strengths

• 11-Year Forecast
• The 7MM Coverage
• Key Cross Competition
• Drug Uptake and Key Market Forecast Assumptions

Claudin 18.2 Directed Therapies Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

• What was the Claudin 18.2 directed therapies total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2036? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2036?
• What are the pricing variations among different geographies for approved therapies?
• How the reimbursement landscape has for Claudin 18.2 directed therapies evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
• What are the risks, burdens, and unmet needs of treatment with Claudin 18.2 directed therapies? What will be the growth opportunities across the 7MM for the patient population of Claudin 18.2 directed therapies?
• What are the key factors hampering the growth of the Claudin 18.2 directed therapies market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for Claudin 18.2s?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?
• Reasons to buy
• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the Claudin 18.2 directed therapies Market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

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 2025
• 6.2. Market Share (%) Distribution by Indication in 2036
• 6.3. Market Share (%) Distribution by Therapies in 2025
• 6.4. Market Share (%) Distribution by Therapies in 2036

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

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

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
  • 12.6.1. Total Market Size of Claudin 18.2 Directed Therapies in the United States
  • 12.6.2. Market Size of Claudin 18.2 Directed Therapies by Indication in the United States
  • 12.6.3. Market Size of Claudin 18.2 Directed Therapies by Therapies in the United States
• 12.7. EU4 and the UK
  • 12.7.1. Total Market Size of Claudin 18.2 Directed Therapies in EU4 and the UK
  • 12.7.2. Market Size of Claudin 18.2 Directed Therapies by Indication in EU4 and the UK
  • 12.7.3. Market Size of Claudin 18.2 Directed Therapies by Therapies in EU4 and the UK
• 12.8. Japan
  • 12.8.1. Total Market Size of Claudin 18.2 Directed Therapies in Japan
  • 12.8.2. Market Size of Claudin 18.2 Directed Therapies by Indication in Japan
  • 12.8.3. Market Size of Claudin 18.2 Directed Therapies by Therapies in 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. Appendix

• 17.1. Bibliography
• 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight