HER2 Positive Gastric Cancer Market By Therapy Type (Monoclonal Antibodies, Antibody-Drug Conjugates, Tyrosine Kinase Inhibitors, Immunotherapies); By Line of Treatment (First-Line, Second-Line, Third-Line & Beyond); By Diagnostic Modality (IHC, FISH, NGS); By Distribution Channel (Hospital Pharmacies, Specialty Pharmacies, Infusion Centers); By Geography, Segment Revenue Estimation, Forecast, 2024–2030.

Introduction And Strategic Context

The Global HER2 Positive Gastric Cancer Market will witness a steady CAGR of 6.8% , valued at USD 3.7 billion in 2024 , and projected to reach nearly USD 5.5 billion by 2030 , according to Strategic Market Research .

 

HER2 positive gastric cancer is a biologically distinct subtype of gastric cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2). While HER2 positivity is more commonly associated with breast cancer, it has emerged as a crucial biomarker in gastric and gastroesophageal junction (GEJ) adenocarcinomas. This biomarker now defines treatment eligibility for targeted therapies such as trastuzumab, trastuzumab deruxtecan , and newer agents under investigation.

 

What makes this market strategically relevant is the confluence of precision oncology, growing biomarker testing, and unmet clinical needs in advanced gastric cancer care. Gastric cancer remains the fifth most common cancer globally and the third leading cause of cancer death. Yet, only around 15–20% of gastric tumors express HER2 — creating a highly defined but clinically urgent niche.

 

As diagnostics improve, HER2 testing is increasingly standardized at diagnosis, particularly in major markets like the U.S., Japan, China, and South Korea. That standardization is enabling earlier initiation of HER2-targeted therapies — a shift from the traditional chemotherapy-first model.

 

The treatment landscape is also moving beyond trastuzumab. Antibody-drug conjugates (ADCs), bispecific antibodies, and HER2-directed immunotherapies are being tested in first-line and refractory settings. These pipeline developments reflect a broader industry shift: from broad-spectrum cytotoxic agents to precision-targeted combinations.

 

Stakeholders across the board are positioning around this shift. Pharmaceutical companies are competing to introduce next-generation HER2 inhibitors. Diagnostic firms are partnering with oncology networks to expand HER2 IHC and FISH testing access. Healthcare systems are adjusting reimbursement structures to include high-cost biologics, while clinical oncologists are reshaping protocols around biomarker-first treatment planning.

 

Market Segmentation And Forecast Scope

The HER2 positive gastric cancer market is structured around several critical dimensions — each reflecting a unique lever in how therapy is delivered, monitored, and optimized. These segmentations are not just clinical—they're shaping how drugs are commercialized, how trials are designed, and how access decisions are made globally.

By Therapy Type

The market is primarily segmented into targeted monoclonal antibodies, antibody-drug conjugates (ADCs), tyrosine kinase inhibitors (TKIs), and immunotherapy-based combinations. Among these, targeted monoclonal antibodies — driven by the use of trastuzumab in first-line treatment — represent the largest share in 2024, accounting for an estimated 48% of total revenue. However, ADCs are gaining momentum rapidly due to the entry of agents like trastuzumab deruxtecan (T- DXd ), which is showing strong results in later-line settings.

Many oncologists are now positioning ADCs as the go-to option in trastuzumab-resistant cases, particularly due to their favorable toxicity profiles and deeper tumor penetration.

 

By Line of Treatment

Segmenting by treatment line offers a more nuanced view. First-line treatments still dominate, driven by trastuzumab-based regimens combined with chemotherapy. However, second-line and beyond are seeing a spike in demand due to the rise of trastuzumab failures and the need for novel agents. Clinical data suggest that HER2 expression may evolve over time, making dynamic re-biopsy and line-specific drugs an emerging segment.

 

By Diagnostic Modality

HER2 status in gastric cancer is determined primarily by immunohistochemistry (IHC) and confirmed via fluorescence in situ hybridization (FISH). While IHC is more cost-effective and widely adopted, FISH remains the gold standard for borderline or equivocal cases. In some advanced centers , next-generation sequencing (NGS) is being used to identify co-mutations that could affect HER2 expression or drug resistance. Diagnostic vendors are beginning to bundle HER2 testing kits for gastric and breast cancer — a move aimed at scaling access in community oncology settings.

 

By Distribution Channel

Hospital pharmacies account for the majority of HER2-targeted therapy distribution, given the complexity and reimbursement tracking tied to biologics. That said, specialty pharmacies are making inroads, particularly in countries like the U.S. and Japan where outpatient cancer care is expanding. Infusion centers with HER2 protocols are also becoming key touchpoints for drug delivery, especially for ADCs requiring monitored administration.

 

By Region

North America and Asia Pacific are the two dominant regions, with Japan, China, and South Korea contributing significantly to patient volume due to high gastric cancer incidence and structured HER2 testing programs. Europe is a steady market, though with variability in access across Western and Eastern countries. Latin America and parts of the Middle East remain underpenetrated — but offer growth potential as diagnostics infrastructure improves.

 

Market Trends And Innovation Landscape

The HER2 positive gastric cancer market is no longer riding on trastuzumab alone. In fact, the innovation wave here is starting to mirror the complexity seen in breast cancer — with multiple drug classes, biomarker-guided regimens, and combination strategies competing for dominance.

Antibody-Drug Conjugates Are Reshaping the Post-Trastuzumab Landscape

The most disruptive trend right now is the clinical success of antibody-drug conjugates (ADCs) like trastuzumab deruxtecan (T- DXd ). Unlike traditional HER2 inhibitors, these drugs deliver potent cytotoxics directly to tumor cells via HER2 targeting, minimizing collateral damage. Phase II and III studies have shown T- DXd improving progression-free survival (PFS) and overall survival (OS) in patients who’ve already failed trastuzumab.

One oncologist in Singapore described ADCs as “the first real breakthrough we’ve had for HER2 positive gastric cancer beyond first-line.”

These drugs are also being tested in combination with immune checkpoint inhibitors, opening up new dual-targeting frontiers.

 

Next-Generation HER2 Inhibitors Are Targeting Resistance Pathways

Several newer HER2 inhibitors, including reversible TKIs and bispecific antibodies, are in clinical trials aimed at overcoming acquired resistance. Resistance mechanisms in gastric cancer are different from breast cancer — often involving heterogeneity in HER2 expression or activation of bypass pathways like MET and EGFR.

Developers are now testing combination regimens that include HER2 inhibition plus co-pathway blockade, hoping to increase durability of response. Agents like zanidatamab (a bispecific HER2 antibody) are showing promise in early-phase trials.

 

Companion Diagnostics Are Becoming More Integrated — and More Digital

Another important shift is happening at the diagnostic level. HER2 testing is becoming more streamlined, with digital pathology tools enabling automated scoring and remote interpretation of IHC slides. Some vendors are also integrating HER2 testing into broader NGS panels, allowing oncologists to capture HER2 status along with microsatellite instability (MSI), PD-L1, and tumor mutational burden (TMB) — all of which may influence treatment planning.

In emerging markets, point-of-care HER2 assays are being piloted in regional cancer centers , especially in high-incidence geographies like China and South Korea. That decentralization could radically accelerate time-to-treatment.

 

Immunotherapy Combinations Are Gaining Ground

While checkpoint inhibitors alone haven’t shown strong efficacy in HER2 positive patients, combinations with HER2-targeted agents are being studied intensively. Trials like KEYNOTE-811 have already incorporated pembrolizumab into first-line trastuzumab-based regimens. The hypothesis is that HER2-targeting may boost antigen presentation, making tumors more responsive to immunotherapy.

The next wave of approvals could involve multi-agent regimens — HER2 inhibition plus PD-1 blockade — setting a new treatment standard for newly diagnosed patients.

 

Real-World Evidence Is Influencing Access Pathways

Payers and health technology assessment (HTA) bodies are increasingly relying on real-world data (RWD) to make coverage decisions for high-cost therapies. Several registry-based studies in Japan and Europe are tracking long-term outcomes for patients on T- DXd or HER2-immunotherapy combinations. This is influencing reimbursement timelines and shaping national formulary updates — particularly in publicly funded systems.

 

Competitive Intelligence And Benchmarking

The HER2 positive gastric cancer market is shaped by a focused but aggressive group of biopharmaceutical companies — many of which originally built their HER2 portfolios around breast cancer. What sets them apart today isn’t just who entered the space first, but how they're adapting to the unique biology and treatment challenges of gastric tumors .

Roche / Genentech
Still seen as the foundational player in HER2 targeting, Roche’s trastuzumab remains the first-line standard across most markets. The company was quick to translate its breast cancer success into gastric indications, and continues to lead in terms of installed clinical use. That said, their innovation pace has slowed relative to newer entrants, and biosimilar competition is starting to erode margins in regions like Asia and Eastern Europe.

Roche is banking on lifecycle management through fixed-dose combinations and subcutaneous formulations — but its dominance is no longer uncontested.

 

AstraZeneca and Daiichi Sankyo
This alliance has emerged as the most disruptive force in the market. Their antibody-drug conjugate, trastuzumab deruxtecan (T- DXd ) , has demonstrated strong efficacy in patients previously treated with trastuzumab, driving rapid uptake as a second-line therapy. AstraZeneca brings global commercialization muscle, while Daiichi provides deep ADC expertise — a rare pairing that is raising the bar for next-gen HER2 therapy.

They’re also investing heavily in combination trials, targeting expansion into first-line settings and even HER2-low subtypes.

 

Zymeworks
A rising biotech contender, Zymeworks is pushing the envelope with zanidatamab , a bispecific antibody that binds to two different domains on HER2. Early data suggests potential activity in both high and heterogeneous HER2-expressing tumors , which are common in gastric cancer. The company is carving out a clear differentiation path through structural biology and is seen as a partner of interest for larger firms seeking access to gastric trials.

 

Seagen (now part of Pfizer)
Seagen , known for its ADC portfolio, is expanding its HER2 pipeline through internal candidates and licensing deals. With Pfizer now in control, the company may accelerate its push into HER2 positive GI cancers as part of a broader strategic pivot into oncology. Seagen’s modular linker-payload technology may also enable more tumor -specific delivery — an area where gastric cancer poses challenges due to tissue heterogeneity.

 

Jiangsu Hengrui / Innovent Biologics
In China, local pharmaceutical firms like Hengrui and Innovent are rapidly developing biosimilars and homegrown HER2 inhibitors tailored to regional clinical guidelines. They offer more affordable alternatives to Western therapies, and in some cases are developing novel combinations targeting HER2 plus EGFR or PD-1. These players are especially influential in Tier 2 and Tier 3 Chinese cities where pricing pressure dominates procurement decisions.

 

Benchmark Dynamics at a Glance:

• First-mover advantage still benefits Roche, but its single-agent approach is aging fast.

• AstraZeneca/Daiichi are setting the innovation pace with ADCs and global expansion.

• Mid-tier biotechs like Zymeworks are innovating around HER2 heterogeneity and resistance.

• Local players in Asia are gaining traction through affordability and biosimilar launches.

• Global strategy is shifting from monotherapy to carefully layered regimens — often involving diagnostics, immune agents, and patient stratification.

 

Regional Landscape And Adoption Outlook

HER2 positive gastric cancer is a global concern — but how it’s diagnosed, treated, and reimbursed varies widely from one region to another. Incidence rates, health system maturity, access to biologics, and even patient referral patterns all play a role in shaping regional dynamics. Here's how adoption is playing out across key geographies.

North America

The U.S. remains a stronghold for HER2-targeted innovation, especially in clinical trial activity and early drug adoption. HER2 testing is now routine for newly diagnosed gastric and gastroesophageal junction (GEJ) adenocarcinomas in academic and community settings. Trastuzumab-based regimens dominate first-line use, while newer entrants like trastuzumab deruxtecan are rapidly gaining formulary status through expedited FDA reviews.

Reimbursement frameworks under Medicare and commercial payers have largely aligned with NCCN guidelines, which endorse HER2 testing and HER2-directed therapy. However, disparities remain: access is smoother in major cancer centers , but rural patients often face delays in both diagnostics and infusion services.

The U.S. is also a key R&D hub, with most HER2 gastric trials anchored at leading oncology centers like MD Anderson and Memorial Sloan Kettering.

 

Europe

In Europe, uptake is strong in countries with centralized cancer care systems — particularly Germany, France, and the UK. HER2 testing is part of national gastric cancer protocols, and trastuzumab has been integrated into treatment pathways since EMA approval. That said, newer agents like ADCs face variable adoption due to country-specific cost-effectiveness thresholds.

Health technology assessment (HTA) agencies, such as NICE in the UK, are cautious about approving high-cost biologics without long-term real-world data. Some Eastern European countries lag behind in both testing infrastructure and biologic drug access, which creates a two-speed market even within the EU.

Multinational pharma companies are now tailoring market access strategies country by country, often using real-world evidence to justify pricing.

 

Asia Pacific

This is the most dynamic region for HER2 positive gastric cancer, largely because it has the highest gastric cancer incidence in the world. Japan, South Korea, and China collectively account for a significant share of global HER2 gastric cases — and they’re also leading innovation in this space.

Japan was one of the earliest adopters of HER2 testing for gastric cancer and continues to be a high-uptake market for both trastuzumab and ADCs. South Korea’s reimbursement system supports biomarker-driven therapy, and clinical trial participation is high.

China, while still fragmented, is evolving fast. The country has scaled HER2 testing in urban tertiary centers and is moving toward broader biologics access through provincial reimbursement lists. Domestic pharma players are also launching biosimilars and co-developing HER2 candidates, accelerating affordability.

Asia’s big opportunity lies in expanding HER2 access beyond tier-1 cities — and many global and local companies are racing to build distribution and diagnostic networks accordingly.

 

Latin America, Middle East, and Africa (LAMEA)

This region remains the most underpenetrated — not due to lack of need, but due to infrastructure and cost barriers. In countries like Brazil and Mexico, HER2 testing is available in urban cancer hospitals, but access to trastuzumab or newer biologics is inconsistent. Out-of-pocket costs are a major barrier, and public insurance systems are slow to incorporate expensive targeted therapies.

The Middle East shows a bifurcated picture. The UAE and Saudi Arabia are building specialized oncology centers and increasingly funding HER2-directed therapy. However, access remains limited in North and Sub-Saharan Africa, where basic pathology services are still uneven.

NGOs and global cancer alliances are beginning to fund HER2 testing and treatment programs in low-resource settings, but coverage remains patchy.

 

Regional Summary

• North America leads in early adoption and innovation

• Europe is mature but price-sensitive, especially for next- gen therapies

• Asia Pacific is the high-volume growth engine with strong public-private momentum

• LAMEA is the white space — and the long-term opportunity for scalable, affordable HER2 solutions

 

End-User Dynamics And Use Case

In the HER2 positive gastric cancer market, end users aren’t just healthcare providers — they are key decision-makers who determine how and when targeted therapies are initiated. From large academic hospitals to mid-tier oncology clinics, treatment workflows differ significantly based on institutional infrastructure, diagnostic access, and reimbursement environment.

Tertiary Cancer Centers

These institutions represent the primary point of care for most HER2 positive gastric cancer patients. They typically have in-house pathology labs, streamlined HER2 IHC and FISH testing capabilities, and multidisciplinary tumor boards that can make quick treatment decisions. These centers are also the first to adopt emerging agents like antibody-drug conjugates (ADCs) and participate in combination trials.

In many cases, patients are referred here only after diagnosis — which places added pressure on these centers to revalidate HER2 status and start treatment within narrow therapeutic windows. Integration with clinical research units allows them to offer newer drugs before full market availability.

These hospitals also serve as data generators — their real-world outcomes often influence national guidelines and payer decisions.

 

Community Oncology Clinics

In the U.S., Japan, and parts of Europe, community oncology practices are beginning to offer HER2-targeted treatments, especially as more agents become standard of care. However, most of these clinics rely on external labs for HER2 testing, which can introduce delays. They typically administer trastuzumab and chemotherapy but may refer patients to larger centers for second-line options like T- DXd .

Pharmaceutical companies often support these clinics through patient access programs, dosing protocols, and educational resources to ensure adherence to guidelines.

For these centers , simplicity and predictability in therapy administration are key. That’s why subcutaneous formulations and shorter infusion times are gaining favor .

 

Diagnostic Laboratories

While not administering therapy, diagnostic labs are crucial end users in their own right — especially those performing centralized HER2 testing. Their turnaround time, reporting quality, and interpretive accuracy directly influence treatment selection. Some labs are now bundling HER2 testing with broader NGS panels to capture co-mutations and predict resistance, enabling oncologists to personalize treatment early.

 

Pharmacy and Infusion Networks

Hospital pharmacies and infusion centers handle the backend of drug logistics — including acquisition, reimbursement processing, and administration of HER2-targeted agents. ADCs like T- DXd require cold-chain handling and trained infusion staff, which makes integration with pharmacy services critical. In several regions, dedicated infusion slots are now allocated for HER2 positive gastric patients due to the growing complexity of regimens.

 

Use Case Highlight

A major cancer institute in South Korea faced a recurring problem: delayed HER2 test results were pushing treatment initiation beyond the recommended 14-day window. To solve this, the hospital partnered with a local diagnostic firm to install an on-site digital pathology scanner with AI-based HER2 scoring. Results were available within 36 hours.

This allowed the tumor board to initiate HER2-targeted therapy significantly faster. Over a 12-month pilot, average time-to-treatment dropped by 42%, and treatment adherence rose by nearly 30%. The hospital also reduced the number of patients requiring bridge chemotherapy while waiting for test results.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

• Trastuzumab deruxtecan (T- DXd ) received expanded FDA approval in 2024 for second-line HER2 positive gastric cancer based on updated survival data from DESTINY-Gastric02 trial.

• Zanidatamab , a bispecific HER2 antibody from Zymeworks , entered Phase III trials in early 2025 targeting HER2-positive gastroesophageal junction adenocarcinoma patients.

• China’s NMPA approved a locally developed HER2 biosimilar (HLX02 by Henlius ) for use in gastric cancer in late 2023, expanding regional access.

• MSKCC and GE Healthcare launched a digital pathology AI pilot for HER2 scoring in gastric biopsy slides, aiming to cut diagnostic delays by 50%.

• Combination regimens involving trastuzumab, nivolumab, and chemotherapy are being piloted in Europe under EORTC-supported umbrella trials targeting HER2 and PD-1 co-expression.

 

Opportunities

• First-Line Combination Expansion
  As evidence grows for HER2 plus PD-1 inhibitors, next-generation regimens could redefine the treatment paradigm from the start — opening the door for dual approvals.

• HER2 Testing Penetration in Asia and LAMEA
  Expanding IHC and FISH access in India, Brazil, and sub-Saharan Africa presents a significant growth lever — especially as diagnostic kits become more affordable.

• Digital Diagnostics and AI-Scoring
  Adoption of AI-based HER2 interpretation tools could reduce variability and bring HER2 testing to under-resourced hospitals, improving access to precision therapy globally.

 

Restraints

• Biologic Therapy Cost Burden
  HER2-targeted drugs, especially ADCs, remain among the most expensive oncology therapies. In many middle-income countries, this limits both adoption and reimbursement.

• Tumor Heterogeneity and Testing Accuracy
  HER2 expression in gastric cancer is often heterogeneous, leading to testing challenges and inconsistent treatment response — especially in community settings with limited pathology expertise.
   

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 3.7 Billion
Revenue Forecast in 2030	USD 5.5 Billion
Overall Growth Rate	CAGR of 6.8% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Therapy Type, Line of Treatment, Diagnostic Modality, Distribution Channel, Geography
By Therapy Type	Monoclonal Antibodies, ADCs, TKIs, Immunotherapies
By Line of Treatment	First-Line, Second-Line, Third-Line & Beyond
By Diagnostic Modality	IHC, FISH, NGS
By Distribution Channel	Hospital Pharmacies, Specialty Pharmacies, Infusion Centers
By Region	North America, Europe, Asia Pacific, Latin America, Middle East & Africa
Country Scope	U.S., Canada, Germany, UK, France, China, Japan, South Korea, India, Brazil, Saudi Arabia
Market Drivers	- Growing adoption of HER2 testing in gastric cancers - Expansion of ADC and combination therapy pipelines - Rising gastric cancer burden in Asia-Pacific
Customization Option	Available upon request