Press release
HER2 therapy market is expected to grow to $33.7 billion by 2034. Crucial Participants: AstraZeneca and Roche
HER2 therapy
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From monoclonal antibodies like trastuzumab and pertuzumab to tyrosine kinase inhibitors (TKIs) and antibody-drug conjugates (ADCs) such as trastuzumab deruxtecan, HER2-targeted drugs have revolutionized treatment outcomes. With rising cancer incidence, strong clinical pipelines, and expanding indications, the HER2 therapy market is positioned for robust growth in the coming decade.
Market Overview
• Market Size 2024: USD 13.8 billion
• Forecast 2034: USD 33.7 billion
• CAGR (2024-2034): 9.4%
Key Highlights:
• Monoclonal antibodies remain the gold standard but ADCs are gaining rapid adoption due to enhanced efficacy.
• Expanding HER2-targeted indications into gastric, colorectal, and non-small cell lung cancers is widening the patient pool.
• Strong clinical pipeline with multiple late-stage trials from leading pharma companies.
• North America and Europe dominate current adoption, while Asia-Pacific is emerging as a high-growth market.
Challenges include therapy resistance, high treatment costs, and access limitations in low-income regions, but innovation continues to drive optimism.
Market Segmentation
By Therapy Type
• Monoclonal Antibodies (Trastuzumab, Pertuzumab, Others)
• Tyrosine Kinase Inhibitors (Lapatinib, Neratinib, Tucatinib)
• Antibody-Drug Conjugates (Trastuzumab Emtansine, Trastuzumab Deruxtecan, Others)
• Combination Therapies
By Indication
• Breast Cancer
• Gastric Cancer
• Colorectal Cancer
• Non-Small Cell Lung Cancer (NSCLC)
• Others
By Route of Administration
• Intravenous (IV)
• Oral
By End User
• Hospitals
• Specialty Oncology Clinics
• Academic & Research Institutes
Segmentation Summary:
Breast cancer remains the dominant indication, but gastric and colorectal cancers are emerging as strong growth drivers. ADCs represent the fastest-growing therapy type, given their improved efficacy and potential to overcome resistance. Hospitals and oncology clinics account for the majority of usage due to specialized treatment requirements.
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Regional Analysis
North America
• Largest market with ~45% share in 2024.
• Driven by high cancer prevalence, early adoption of novel HER2 therapies, and strong reimbursement frameworks.
• The U.S. dominates, with widespread use of trastuzumab, pertuzumab, and trastuzumab deruxtecan.
Europe
• Accounts for nearly 30% of the market.
• EMA approvals and strong adoption in Germany, France, and the UK support growth.
• Increasing use of biosimilars is improving affordability.
Asia-Pacific
• Fastest-growing region, CAGR above 11%.
• Rising breast and gastric cancer cases in China, India, and Japan driving demand.
• Expanding healthcare infrastructure and biosimilar adoption fuel accessibility.
Middle East & Africa
• Early-stage adoption with growing oncology infrastructure.
• Limited access to expensive therapies remains a challenge.
Latin America
• Brazil and Mexico lead regional adoption.
• Government initiatives and partnerships improving patient access to targeted therapies.
Regional Summary:
While North America and Europe dominate adoption today, Asia-Pacific is set to be the fastest-growing market by 2034, reshaping the global HER2 therapy landscape.
Market Dynamics
Growth Drivers
• Rising Cancer Prevalence: Increasing incidence of HER2-positive breast and gastric cancers.
• Pipeline Expansion: Ongoing trials expanding HER2 therapies into new cancer types.
• ADC Innovation: New antibody-drug conjugates improving efficacy and overcoming resistance.
• Government & Insurance Support: Reimbursement policies driving accessibility in developed markets.
Key Challenges
• Drug Resistance: Patients often develop resistance to first-line HER2 therapies.
• High Cost: Advanced HER2 therapies, particularly ADCs, remain expensive.
• Access Gaps: Limited adoption in low- and middle-income regions due to affordability issues.
Latest Trends
• Combination Therapies: HER2-targeted drugs increasingly combined with immunotherapies and chemotherapies.
• Biosimilars: Entry of trastuzumab and pertuzumab biosimilars reducing costs.
• Personalized Medicine: Genomic profiling enabling precise treatment selection.
• Expanded Indications: HER2 therapies being tested for rare cancers and earlier lines of therapy.
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Competitive Landscape
Key Players
• F. Hoffmann-La Roche Ltd. (Herceptin, Perjeta, Kadcyla)
• AstraZeneca (Enhertu - Trastuzumab Deruxtecan, jointly with Daiichi Sankyo)
• Daiichi Sankyo Co., Ltd.
• Novartis AG
• Pfizer Inc.
• Seagen Inc. (Tucatinib)
• Samsung Bioepis (Biosimilars)
• Amgen Inc.
• Mylan N.V. (Viatris)
• Biocon Biologics Ltd.
• Eli Lilly and Company
• Apotex Inc.
• Celltrion Healthcare
• Merck & Co., Inc.
• Bristol Myers Squibb
Competitive Summary:
The HER2 therapy market is moderately consolidated, with Roche, AstraZeneca/Daiichi Sankyo, and Seagen leading. Roche's legacy portfolio (Herceptin, Perjeta, Kadcyla) still holds significant share, but new entrants like Enhertu (AstraZeneca/Daiichi Sankyo) and Tucatinib (Seagen) are reshaping competition. Biosimilar manufacturers such as Biocon, Samsung Bioepis, and Mylan are expanding access through affordable alternatives.
Conclusion
The HER2 Therapy Market is expected to grow from USD 13.8 billion in 2024 to USD 33.7 billion by 2034, at a strong CAGR of 9.4%. Innovation in ADCs, expansion into gastric and lung cancers, and wider biosimilar adoption will drive future growth.
North America and Europe currently lead, but Asia-Pacific will emerge as the fastest-growing market, reshaping the competitive dynamics.
With newer drug classes, personalized medicine, and strong biosimilar competition, HER2 therapy will remain a cornerstone of oncology care. For pharmaceutical companies, biotech firms, and investors, this market presents a high-value opportunity in the evolving global cancer treatment landscape.
This report is also available in the following languages : Japanese (HER2治療市場), Korean (HER2 치료 시장), Chinese (HER2治疗市场), French (Marché de la thérapie HER2), German (Markt für HER2-Therapien), and Italian (Mercato della terapia HER2), etc.
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