The overall HER2+ gastric cancer market is projected to grow, driven by increasing biomarker testing, better patient selection, and continued advancements in HER2-targeted ADCs, bispecific antibodies, and novel immune-based approaches. Additionally, the launch of therapies such as Zanidatamab (Jazz Pharmaceuticals), Rilvegostomig (AstraZeneca), Evorpacept (ALX Oncology), and others in the future is expected to bring a positive shift in the treatment landscape of HER2+ gastric cancer.
DelveInsight's HER2+ Gastric Cancer (including GEJ) Marketreport includes a comprehensive understanding of current treatment practices, emerging HER2+ gastric cancer therapies, market share of individual therapies, and current and forecasted HER2+ gastric cancermarket size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
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Key Takeaways from the HER2+ Gastric Cancer Market Report
— As per DelveInsight's analysis, the total market size of HER2+ gastric cancer (including GEJ) in the 7MM is approximately USD 700 million in 2024 and is projected to increase during the forecast period (2025-2034).
— In 2024, among the current therapies for HER2+ gastric cancer, the largest revenue was generated by Trastuzumab ± Chemotherapy, i.e., USD 140 million in the United States.
— The total number of incident cases of HER2+ gastric cancer in the 7MM accounted for approximately. 45,000 in 2024. These cases are expected to increase by 2034.
— Leading HER2+ gastric cancercompanies, such as AstraZeneca/Daiichi Sankyo, Merck, Jazz Pharmaceuticals, BeiGene, Zymeworks, Shanghai Henlius Biotech, AbClon, ALX Oncology, Artiva Biotherapeutics, GC Cell, KLUS Pharma, Shanghai Miracogen, Pfizer, Bayer, Enliven Therapeutics, Ambrx, NovoCodex, Mersana Therapeutics, GSK, SystImmune, and others, are developing novel HER2+ Gastric cancer therapies that can be available in the HER2+ gastric cancer market in the coming years.
— Daiichi Sankyo and AstraZeneca's ENHERTU(trastuzumab deruxtecan), is the only approved therapy for the treatment of advanced or metastatic HER2+ gastric cancer for 2L therapy. The drug received accelerated approval in January 2021. Along with ENHERTU (trastuzumab deruxtecan), KEYTRUDA (pembrolizumab), and HERCEPTIN (trastuzumab) are approved for HER2+ gastric cancer for 1L therapy.
— Daiichi Sankyo and AstraZeneca's ENHERTU is also expanding into the first-line treatment setting, which is expected to increase its patient share and, consequently, drive growth in the market size.
— Some of the key HER2+ gastric cancer emerging therapiesin the pipeline include ZIIHERA (zanidatamab), Rilvegostomig, HLX22 (AC101), Evorpacept (ALX148), TUKYSA (tucatinib), BAY2927088, AB-201 (GCC2003, HER2 CAR-NK), A166 (Trastuzumab botidotin), MRG002, AIDIXI (disitamab vedotin), BAY2701439, ELVN-002, ARX788, XMT-2056, BL-M07D1, and others.
— Data presented during the recent ASCO 2025 meeting showed that ENHERTU extended overall survival for more than 3 months in patients with advanced HER2-positive gastric or GEJA following progression on first-line therapy, based on the Phase III DESTINY-Gastric04 trial.
— In February 2025, AstraZeneca anticipated a data readout from the Phase Ib/II (NCT04379596, DESTINY-Gastric03) trial, which was focused on treating metastatic or unresectable HER2+ gastric cancer, GEJ, and GEA, in 2026.
— In February 2025, AstraZeneca expected the first patient dosing of ENHERTU (NCT06731478, DESTINY-Gastric05) for HER2+ first-line locally advanced or metastatic gastric cancer or GEJ adenocarcinoma to begin in Q1 2025, with data anticipated to be available after 2026.
— In the January 2025 presentation, Jazz Pharmaceuticals anticipated the potential approval and launch of zanidatamab as a first-line treatment for GEA in 2026. Additionally, the company is also looking forward to expanding its market strategy for zanidatamab in 2026.
— In January 2025, ALX Oncology presented positive updated data from the ASPEN-06 Phase II clinical trial at the 2025 ASCO Gastrointestinal Cancers Symposium, demonstrating that the company's investigational CD47-blocker, evorpacept, produces a durable clinical response and exhibits a well-tolerated safety profile in patients with previously treated HER2+ advanced gastric cancer or GEJ cancer.
Discover which therapies are expected to grab the HER2+ gastric cancermarket share @ HER2+ Gastric Cancer Market Report
HER2+ Gastric Cancer Overview
Gastric cancer is the fifth most common type of cancer and the fourth leading cause of cancer-related deaths worldwide. HER2, also known as HER2/neu or ERBB2, is found in approximately 15-30% of gastric cancers, including those at the Gastroesophageal Junction (GEJ). It is located on chromosome 17q21 and is part of the EGFR family, which includes EGFR/HER1, HER3, and HER4. The ligand for the HER2 tyrosine kinase receptor remains unidentified. HER2 can form both homodimers and heterodimers with other EGFR family receptors, and overexpression of HER2 can result in ligand-independent activation. In gastric cancer, ERBB2 mutations are most commonly found in the CIN subtype, primarily consisting of missense mutations (74%), with smaller proportions of insertions (22%) and fusions (0.7%). HER2 expression is more frequently observed in the intestinal subtype (according to Lauren's classification), as well as in proximal gastric cancer, GEJ cancer, metastatic disease (particularly liver metastasis), and lymph node involvement.
HER2+ Gastric Cancer Epidemiology Segmentation
In the 7MM, in 2024, among all the HER2+ Gastric cancer indications, breast cancer accounted for the highest number of incident cases, while ovarian cancer occupied the bottom of the ladder. The HER2+ gastric cancer market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
— Total Incident Cases of Gastric Cancer (including GEJ)
— Gender-Specific Cases of Gastric Cancer (including GEJ)
— Stage-Specific Cases of Gastric Cancer (including GEJ)
— Total Incident Cases of HER2+ Gastric Cancer (including GEJ)
— Total Incident Cases of Advanced HER2+ Gastric Cancer (including GEJ)
HER2+ Gastric Cancer Treatment Market
HER2, which is overexpressed or amplified in 6-36% of gastric cancer patients, represents a key target in the development of novel treatment strategies for metastatic gastric cancer. While surgical resection remains the primary treatment and can cure patients with early-stage cancer, the survival rates for those with advanced resectable gastric or gastroesophageal junction cancers remain low, despite the introduction of new treatments like perioperative chemotherapy or adjuvant chemoradiation. For patients diagnosed with early-stage disease, gastrectomy is the standard treatment. However, survival rates for those with advanced resectable cancers are still poor, even with the addition of new therapies such as perioperative chemotherapy or adjuvant chemoradiation.
Treatment for HER2-positive gastric cancer depends on factors such as tumor size, location, and the patient's overall health. The humanized monoclonal antibody HERCEPTIN (trastuzumab) targets HER2, inhibiting the growth and survival of HER2-dependent tumors. Alongside HERCEPTIN, KEYTRUDA (Merck), one of the first therapies approved for gastric cancer, works by binding to the Programmed Cell Death-1 (PD-1) receptor, blocking its interaction with PD-L1 and PD-L2, and reversing PD-1 pathway-mediated immune suppression, including the antitumor immune response. Most recent approvals for targeted therapies, such as ENHERTU (Daiichi Sankyo) and AIDIXI (Remegen Biosciences), are used in second- and third-line treatments for gastric cancer.
Learn more about the FDA-approved HER2+ gastric cancer therapies @ HER2+ Gastric Cancer Treatment Drugs
Key Emerging HER2+ Gastric Cancer and Companies
Various new therapies are in development with a focus on the mentioned limitations of the currently approved drugs. Some of the most prominent ones include Evorpacept (ALX Oncology), Zanidatamab (Jazz Pharmaceuticals), IAM1363 (Iambic Therapeutics), ELVN-002 (Enliven Therapeutics), ARX788 (Ambrx), Rilvegostomig (AstraZeneca), and others. These emerging drugs play a vital part in fulfilling the unmet need for the treatment approach of HER2+ gastric cancer.
Although the space is quite active and various trials are underway to treat patients with HER2+ gastric cancer, continuous efforts are further needed to develop novel drugs that would be more effective and less toxic.
ZIIHERA is a bispecific antibody targeting HER2, binding to two extracellular sites on the HER2 protein. In November 2024, the FDA granted accelerated approval for ZIIHERA for adult patients with previously treated, unresectable, or metastatic HER2+ (immunohistochemistry 3+) biliary tract cancer (BTC), identified through an FDA-approved test.
Jazz Pharmaceuticalsexpects to release top-line data in the second quarter of 2025 from the Phase III HERIZON-GEA-01 trial (NCT05152147), which is assessing zanidatamab combined with chemotherapy, with or without tislelizumab, as a first-line treatment for HER2-positive metastatic gastric and esophageal adenocarcinoma (GEA). According to the presentation, Jazz Pharmaceuticals aims to potentially approve and launch zanidatamab as a first-line treatment for gastric cancer in 2026. The company is also planning to expand its market strategy for zanidatamab in 2026.
HLX22 (AC101), a novel anti-HER2 monoclonal antibody developed by AbClon and further advanced by Henlius, is currently under investigation. In November 2024, Henlius Biotech announced that the first patient was dosed in the Phase III international multicenter clinical trial (HLX22-GC-301) for HLX22. In October 2024, Henlius received approval from Japan's PMDA for the Clinical Trial Notification (CTN) of a Phase III international multicenter study of HLX22, in combination with trastuzumab and chemotherapy, as a first-line treatment for HER2-positive advanced gastric cancer.
The other therapies in the HER2+ gastric cancer pipeline include
— TUKYSA (tucatinib): Pfizer
— BAY2927088: Bayer
— AB-201 (GCC2003, HER2 CAR-NK): Artiva Biotherapeutics and GC Cell
— A166 (Trastuzumab botidotin): KLUS Pharma
— MRG002: Shanghai Miracogen
— AIDIXI (disitamab vedotin): Pfizer
— BAY2701439: Bayer
— XMT-2056: Mersana Therapeutics and GSK
— BL-M07D1: SystImmune
— and others
The anticipated launch of these emerging therapies are poised to transform the HER2+ gastric cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the HER2+ gastric cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about HER2+ gastric cancer drug clinical trials, visit @ HER2+ Gastric Cancer Drugs
HER2+ Gastric Cancer Market Dynamics
The HER2+ gastric cancer market dynamics are expected to change in the coming years. HER2-targeted therapies, such as HERCEPTIN, ENHERTU, and anti-PD1 therapy KEYTRUDA, offer more precise treatment by improving efficacy and minimizing side effects compared to traditional chemotherapy. Daiichi Sankyo and AstraZeneca's ENHERTU is expanding into the first-line treatment setting, which is expected to increase its patient share and drive market growth.
There is growing research interest in combining next-generation HER2 inhibitors or bispecific antibodies with Immune Checkpoint Inhibitors (ICIs), presenting significant opportunities to enhance treatment efficacy and improve patient survival. Additionally, the HER2+ gastric cancer market is projected to grow due to increased incidence rates, an aging population, and advancements in treatment methodologies, potentially leading to more investment in research and development.
Furthermore, potential therapies are being investigated for the treatment of HER2+ gastric cancer, and it is safe to predict that the treatment space will significantly impact the HER2+ gastric cancermarket during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the HER2+ gastric cancermarket in the 7MM.
However, several factors may impede the growth of the HER2+ gastric cancermarket. HER2+ gastric cancer is an aggressive form of the disease with a significantly high mortality rate, poor survival rates, and a poor prognosis due to factors such as low screening rates, high rates of refractory/relapsed tumors, and the advanced age of patients. The complexity of tumor biology, including intratumoral heterogeneity, poses challenges to effective treatment strategies and limits the efficacy of current therapies. Additionally, HER2+ gastric cancer is prone to developing resistance to targeted therapies, highlighting the need for the continuous development of next-generation agents, which further increases R&D costs.
Moreover, HER2+ gastric cancertreatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the HER2+ gastric cancermarket growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the HER2+ gastric cancer market growth.
Scope of the HER2+ Gastric CancerMarket Report
— HER2+ Gastric Cancer Therapeutic Assessment: HER2+ Gastric Cancercurrent marketed and emerging therapies
— HER2+ Gastric CancerMarket Dynamics: Conjoint Analysis of Emerging HER2+ Gastric Cancer Drugs
— Competitive Intelligence Analysis:SWOT analysis and Market entry strategies
— Unmet Needs, KOL's views, Analyst's views, HER2+ Gastric Cancer Market Access and Reimbursement
Discover more about HER2+ gastric cancer drugsin development @ HER2+ Gastric Cancer Clinical Trials
Table of Contents
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