North Carolina Headlines

DelveInsight, a leading market research and consulting company, announces the release of its latest report, “Claudin 18.2 Directed Therapies Market Size, Target Population, Competitive Landscape & Market Forecast – 2036.” The report provides an in-depth understanding of Claudin 18.2 directed therapies, including target patient population analysis, competitive landscape, emerging therapies, market trends, market size, market share, technology assessment, pricing dynamics, and future opportunities across the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan.

Key Takeaways from the Claudin 18.2 Directed Therapies Market

• The Claudin 18.2 Directed Therapies market is expected to witness significant growth throughout the forecast period 2022–2036.

• Claudin 18.2 has emerged as one of the most promising therapeutic targets in oncology due to its highly restricted expression in normal tissues and broad expression across several gastrointestinal malignancies.

• VYLOY (zolbetuximab) from Astellas became the first and only approved Claudin 18.2-directed therapy, receiving approvals in Japan (March 2024), Europe (September 2024), the United Kingdom (August 2024), and the United States (October 2024).

• In 2025, the United States reported approximately 50,000 incident gastric cancer cases and more than 67,000 incident pancreatic cancer cases, representing key addressable patient populations for Claudin 18.2 targeted therapies.

• Claudin 18.2 expression is retained in the majority of gastric and gastroesophageal junction adenocarcinomas and is reported in approximately 60–90% of pancreatic ductal adenocarcinoma cases, supporting broad therapeutic potential.

• The United States represented the largest Claudin 18.2 Directed Therapies market, valued at approximately USD 495 million in 2025, and is projected to exceed USD 1.26 billion by 2036.

• Japan remains a major market opportunity due to early adoption of Claudin 18.2 testing and targeted therapies, with the market projected to reach approximately USD 283 million by 2036.

• Leading Claudin 18.2 directed therapy companies include Astellas Pharma, Innovent Biologics, Takeda, AstraZeneca, Phanes Therapeutics, Merck, Antegene, and Kelun, among others.

• Key emerging Claudin 18.2 therapies include IBI-343, Sonesitatug Vedotin (AZD0901), Spevatamig (PT886), ATG-022, and SKB315.

Keen to know more about the market? Request our sample page at https://www.delveinsight.com/sample-request/claudin-182-directed-therapies-market-forecast

Key Factors Driving the Claudin 18.2 Directed Therapies Market

Growing Adoption of Precision Oncology

The increasing use of biomarker-guided treatment approaches and companion diagnostic testing is expanding the identification of patients eligible for Claudin 18.2-directed therapies, supporting market growth.

Expanding Burden of Gastric and Pancreatic Cancers

The rising incidence of gastric cancer, gastroesophageal junction adenocarcinoma, and pancreatic cancer continues to create substantial demand for innovative targeted therapies capable of improving survival outcomes.

Success of VYLOY and First-Mover Advantage

The approval of VYLOY has validated Claudin 18.2 as a clinically actionable target and established a commercial foundation for future entrants into the market.

Rapidly Advancing Pipeline

The emergence of antibody-drug conjugates (ADCs), bispecific antibodies, and novel combination approaches targeting Claudin 18.2 is expected to expand therapeutic applications and improve patient outcomes.

Claudin 18.2 Directed Therapies Competitive Landscape

Several Claudin 18.2-directed therapies are currently being developed across gastric cancer, gastroesophageal junction adenocarcinoma, pancreatic cancer, and other solid tumors. VYLOY (zolbetuximab) remains the only approved therapy and currently leads the market owing to its first-mover advantage and strong clinical data.

The emerging Claudin 18.2 pipeline includes promising therapies such as IBI-343 (Innovent and Takeda), Sonesitatug Vedotin/AZD0901 (AstraZeneca), Spevatamig/PT886 (Phanes Therapeutics and Merck), ATG-022 (Antegene), and SKB315 (Kelun). These therapies leverage diverse mechanisms including monoclonal antibodies, antibody-drug conjugates, and bispecific antibodies targeting Claudin 18.2-positive tumors.

Advanced-stage candidates such as AZD0901, IBI-343, and Spevatamig are expected to intensify competition and capture significant market share over the forecast period, particularly as biomarker testing becomes more widely adopted.

Discover more about therapies set to grab major Claudin 18.2 Directed Therapies market share @ Claudin 18.2 Directed Therapies Clinical Trials and Therapeutic Assessment.

Recent Developments in the Claudin 18.2 Directed Therapies Market

• In January 2026, Phanes Therapeutics presented the first clinical data evaluating Spevatamig in combination with chemotherapy for first-line metastatic pancreatic ductal adenocarcinoma at ASCO GI 2026.

• In June 2025, Innovent presented updated Phase I clinical data for IBI-343 in advanced pancreatic cancer at the ASCO Annual Meeting 2025.

• In October 2025, Takeda and Innovent entered into a global licensing and collaboration agreement for the development and commercialization of IBI-343 outside Greater China.

• In 2024, Astellas secured multiple approvals for VYLOY, including approvals in Japan, Europe, the UK, and the United States.

• Spevatamig received FDA Orphan Drug Designation in pancreatic cancer and Fast Track Designation for metastatic Claudin 18.2-positive pancreatic adenocarcinoma.

What are Claudin 18.2 Directed Therapies?

Claudin 18.2 Directed Therapies are targeted cancer treatments designed to recognize and attack tumor cells expressing the Claudin 18.2 protein. Claudin 18.2 is a tight-junction protein normally restricted to gastric mucosal cells but becomes highly accessible during malignant transformation. This unique expression pattern makes it an attractive therapeutic target in gastric cancer, gastroesophageal junction adenocarcinoma, pancreatic cancer, and several other solid tumors. These therapies include monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, and other innovative targeted approaches.

Claudin 18.2 Directed Therapies Epidemiology and Target Population Segmentation

The Claudin 18.2 Directed Therapies market assessment includes:

• Total Incident Cases of Gastric Cancer

• Total Incident Cases of Pancreatic Cancer

• Total Eligible Claudin 18.2 Positive Patient Population

• Total Treated Cases in Selected Indications

• Gastric Cancer Patient Population

• Gastroesophageal Junction Adenocarcinoma Patient Population

• Pancreatic Cancer Patient Population

• Other Solid Tumor Patient Populations

• Country-Specific Addressable Patient Pool

Scope of the Claudin 18.2 Directed Therapies Market Report

• Therapeutic Assessment: Marketed and Emerging Claudin 18.2 Directed Therapies

• Claudin 18.2 Directed Therapies Market Dynamics: Drivers, Barriers, Opportunities, and Future Trends

• Key Companies: Astellas Pharma, Innovent Biologics, Takeda, AstraZeneca, Phanes Therapeutics, Merck, Antegene, Kelun, and others

• Key Therapies: VYLOY, IBI-343, Sonesitatug Vedotin (AZD0901), Spevatamig (PT886), ATG-022, SKB315, and others

• Competitive Intelligence Analysis: SWOT Analysis and Market Entry Strategies

• Claudin 18.2 Directed Therapies Market Size, Market Share, Industry Trends, and Forecast Analysis

• Technology Assessment and Biomarker Landscape

• Pricing Trends and Analogue Analysis

• KOL Perspectives, Analyst Views, Market Access, and Reimbursement Assessment

To know more about Claudin 18.2 Directed Therapies companies working in the treatment market, visit @ Claudin 18.2 Directed Therapies Clinical Trials and Therapeutic AssessmentTable of Contents

• Claudin 18.2 Directed Therapies Market Report Introduction

• Executive Summary for Claudin 18.2 Directed Therapies

• Claudin 18.2 Directed Therapies Market Overview at a Glance

• Background and Disease Overview

• Epidemiology and Patient Population

• Target Patient Pool Analysis

• Current Treatment Landscape

• VYLOY (Zolbetuximab): Marketed Therapy Assessment

• Emerging Therapies

• IBI-343: Innovent and Takeda

• Sonesitatug Vedotin (AZD0901): AstraZeneca

• Spevatamig (PT886): Phanes Therapeutics and Merck

• Competitive Landscape

• Clinical Trial Analysis

• Conjoint Analysis

• Market Outlook

• Country-wise Market Analysis (2022–2036)

• Market Size by Indication

• Market Size by Therapy

• Pricing Trends and Analogue Assessment

• Market Access and Reimbursement

• SWOT Analysis

• KOL Perspectives

• Unmet Needs

• Report Methodology

• DelveInsight Capabilities

• Disclaimer

• 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 its subscription-based platform PharmDelve.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Kirti Sharma
Email: Send Email
Phone: 09650213330
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/