Trastuzumab Biosimilar Market Outlook:
Trastuzumab Biosimilar Market size was over USD 3.4 Billion in 2024 and is likely to exceed USD 15.8 Billion by the end of 2037, growing at over 18.9% CAGR during the forecast period i.e., between 2025-2037. In 2025, the industry size of trastuzumab biosimilar is assessed at USD 3.9 billion.
A growing number of patients in the trastuzumab biosimilar market are experiencing an increased number of positive breast and gastric cancer cases. As per the study of the World Health Organization, over 2 million new cases of breast cancer are diagnosed every year. Approximately 18% of the breast cancer cases are HER2-positive, which requires an intervention through trastuzumab biosimilars therapies. Betterment in the health care and improved diagnosis process resulted in an increase in the number of incidences of breast and gastric cancers. For instance, the emerging economy is the reason behind the rising incidence of breast and gastric cancer in Asia and Latin America, with the development diagnosis process in the advanced health infrastructure.
Furthermore, active pharmaceutical ingredients (APIs) are the most important raw material that is necessary for the production of trastuzumab biosimilars. India and China are the leading markets in supplying API in the global market. According to the 2023 USITC data report, more than 45% of the API is imported by the U.S. and Europe, and the finished products are regulated by the addressed trastuzumab biosimilar market. As per the information of the U.S. Bureau of Labor Statistics, the producer price index decreased by 12.5% for trastuzumab biosimilars, and the consumer price index rose by 5.5% for cancer biologics, which reflects the inflated supply chain cost. Besides, government investment for improved research and development is ensured through the allocation of approximately USD 651 million in 2023.
Trastuzumab Biosimilar Market - Growth Drivers and Challenges
Growth Drivers
-
Improved healthcare quality: Advancement, improved research, and development in trastuzumab biosimilars resulted in higher patient outcomes. As per the findings of the Agency for Healthcare Research and Quality study, it was identified that hospitalization cases are reduced by over 20% through intervention with trastuzumab biosimilars, leading to saving USD 951 million in two years within the U.S. market. The National Health Service of the UK identified that over 28% of the lower advanced events are intervened with the biosimilars in comparison to the originators due to the strict pharmacovigilance. The adoption rate of the trastuzumab biosimilars is higher in the healthcare system and advocating the value care models that lead to a cost-effective oncology pathway.
- Expansion in patient pool: Rising awareness and early diagnosis are the leading factors behind the rise in breast and gastric incidence numbers. Advancement of the health infrastructure results in fast screening and quick intervention that leads to higher patient inflow within the trastuzumab biosimilar market of trastuzumab biosimilars. For instance, North America is expected to have over 287,000 breast cancer patients in 2025, of which over 18% are HER2-positive. The growing cases of HER2+ gastric cancer are leading in Germany, and as per the study of the Centers for Disease Control and Prevention, it has been identified a 12.4% of growth since 2018, with over 8,000 patients annually. The growing number of patients leads to a rise in the market of trastuzumab biosimilars in the global platform.
Manufacturing Strategies to Ensure Trastuzumab Biosimilar Market Expansion
The leading manufacturers in the global trastuzumab biosimilar market focused on expansion to gain scalability in manufacturing capacity and revenue growth. Three core pillars that strengthen the global market positions are price leadership, product innovation, and emerging market focus. For instance, Biocon followed the price-leading strategy and delivered over 58% of price discount in comparison to the originators, which led to a boost in the market of biosimilars by 24.5%. Pfizer followed the product innovation strategy to expand its market. The launch of its subcutaneous Trazimera helped the company generate an additional revenue of USD 321 million in 2023. Celltrion, on the other hand, focused on the emerging market and collaborated with Brazil’s Ministry of Health. This resulted in better market penetration and elevated revenue generation by over 35% following the tiered pricing strategy.
Revenue Opportunities for Manufacturers
|
Company |
Strategy Implemented |
Projected Revenue Impact (USD) |
Implementation Year |
|
Biocon |
Introducing Price Discounting |
+4.3 billion |
2023 |
|
Pfizer |
Innovation with SC Formulations |
+1.9 billion |
2023 |
|
Celltrion |
Focusing on Emerging Market Contracts |
+2.6 billion |
2024 |
|
Dr. Reddy’s |
Investment in the India API plant |
+1.3 billion |
2025 |
Key Market Dynamics for Historical Patient Growth
A significant growth in the international trastuzumab biosimilar market is addressed in the time period of 2014 to 2024. The advancement in the infrastructure and the growth of the biopharmaceutical demand in the healthcare system led to a robust growth of patient inflow in the U.S. and Germany. Focusing on the local manufacturing and fulfilling the unmet need of the market through advancement of the health infrastructure and affordable trastuzumab biosimilars therapies led to a fundamental growth in the Asia Pacific market. Key opportunities that are identified for the manufacturers with the patient growth include localized manufacturing of API in the Asia Pacific market, subcutaneous formulation for the market of EU and U.S. markets, and partnership or collaboration with government-led initiatives.
Historical Patient Growth (2014–2024)
|
Country |
2014 Procedures (Thousands) |
2024 Procedures (Thousands) |
CAGR (%) |
|
U.S. |
45.5 |
220.2 |
17.3% |
|
Germany |
32.3 |
150.5 |
16.8% |
|
France |
18.3 |
120.6 |
21.3% |
|
Spain |
12.4 |
35.3 |
90.4% |
|
Australia |
5.3 |
40.2 |
23.3 |
|
Japan |
8.6 |
70.5 |
24.4% |
|
India |
10.2 |
180.7 |
33.8% |
|
China |
15.4 |
250.6 |
32.7% |
Challenges
-
Cold chain logistics and supply chain vulnerability: Cold-chain logistics is extremely important for trastuzumab biosimilar, which helps to maintain the product integrity. Developing countries often face the issue of cold chain logistics and a lack of advanced infrastructure, which creates complexity within the supply chain management. According to the study of the World Health Organization, over 12% of clinics in sub-Sahara Africa need a temperature of an average of 4°C for cold storage. This is one of the major issues that is faced while transporting the trastuzumab biosimilar in Africa or the Latin American market, and poses a risk of low product integrity.
Trastuzumab Biosimilar Market Size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
18.9% |
|
Base Year Market Size (2024) |
USD 3.4 billion |
|
Forecast Year Market Size (2037) |
USD 15.8 billion |
|
Regional Scope |
|
Trastuzumab Biosimilar Market Segmentation:
Application Segment Analysis
Breast cancer is the dominating sub-segment that is projected to hold a global trastuzumab biosimilar market share of 72.4% by the end of the forecast period. The global assessment as per the World Health Organization, projected that the incidence of HER2+ breast cancer is poised to grow up to 3 million each year by 2037. The growth of breast cancer cases is expected to expand the demand for intervention through trastuzumab biosimilar and result in market growth. Meanwhile, the expansion of the medical coverage is the growth factor that advocates the application scope through higher accessibility for patients.
Product Type Segment Analysis
Injectable segment in trastuzumab biosimilar market is leading and is anticipated to hold a share of 68.4% by the end of 2037. Injectable biosimilars are cost-saving in nature and provide a higher safety and efficacy rate during the intervention stage. According to the study of the National Health Institute, more than 88% of the U.S. oncologists rely on the injectable product type for dosing control. As per the analysis of the Food and Drug Administration, injectable products are approximately 31% cheaper in comparison to the lyophilized powders. This results in higher market accessibility and robust growth for the address subsegment of the trastuzumab biosimilar market.
Our in-depth analysis of the global trastuzumab biosimilar market includes the following segments:
|
Segment |
Subsegment |
|
Product Type |
|
|
Application |
|
|
Distribution Channel |
|
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Trastuzumab Biosimilar Market - Regional Analysis
North America Market Insights
North America is the dominating region in the global trastuzumab biosimilar market and is anticipated to hold a market share of 32.4% by 2037. The adoption rate of early and aggressive biosimilars is high in the global healthcare market. For instance, the first trastuzumab biosimilar, Ogivri, approved by the FDA adopted by the market at a first rate, accelerated the scope of market entry. An expansion of Medicare and Medicaid coverage raised the accessibility rate and created high demand for trastuzumab biosimilar in North America. The availability of strong cold chain logistics enhanced the product integrity of approximately 94% in North America in comparison to Africa. Lastly, the government mandate is a significant growth factor that pushed the adoption rate and expanded the market growth of trastuzumab biosimilar.
The U.S. market for trastuzumab biosimilar is dominating in the North America region. According to the report of the Centres for Disease Control and Prevention, an allocation of federal funding amounted to approximately USD 4.8 billion in 2023, expanding the scope of better R&D and efficiency growth for the concerned market. More than 285,000 new incidences of breast cancer are addressed in the U.S., and over 88% of the patients are treated with the trastuzumab biosimilar, thus suitable for the market growth in the country.
Asia Pacific Insights
The trastuzumab biosimilar market in Asia Pacific is emerging in the global market and is anticipated to uplift with a market share accumulation of 30.7% by 2037. According to the study of the World Health Organization, over 1.6 million new cases of breast cancer are diagnosed each year in the region. This results in explosive patient pool capacity in the region and indicates emerging market demand for trastuzumab biosimilar. Asia Pacific is the dominant region in API manufacturing within the global market, which enables the region to produce affordable products and leverage the market growth. Government spending on elevation healthcare infrastructure and expansion of medical insurance leads to high market accessibility in the overall region.
China is the dominating country in the Asia Pacific region that is anticipated to grow with a market share of 42.2% by 2037 in the trastuzumab biosimilar market. The country has been identified as having more than 50% of the HER2+ patients in the global market. This is one of the leading factors of market growth of trastuzumab biosimilar due to the high demand for medical intervention in oncology. Volume-based procurement is followed in China, which resulted in a discount up to 72% for the trastuzumab biosimilar products and upscale market adoption. The Dual Circulation policy of China led to the fulfillment of local demand for global export, which advocated the growth of the concerned market. As per the report of the National Healthcare Security Administration, the healthcare budget is expanded to approximately USD 220 billion, within which USD 4.6 billion is allocated for the development of biosimilars.
Government Investment & Policy Table for 2025- trastuzumab biosimilar
|
Country |
Investment (USD) |
Key policies |
Target |
|
India |
2.1 billion |
Production-Linked Incentive (PLI) Scheme |
Boost local API production |
|
Japan |
3.2 billion |
Biosimilar Acceleration Plan |
Increased biosimilar penetration to 50% |
|
South Korea |
1.3 billion |
Tax incentives for SCD drug manufacturers and subsidies in Pediatric SCD treatment |
Capturing the significant market share of the EU |
|
Australia |
800.5 million |
PBS Listing for Biosimilars |
92% patient coverage for trastuzumab biosimilars |
Europe Market Insights
A significant growth is addressed in the trastuzumab biosimilar market of Europe and is anticipated to accumulate a market share of 28.7% by 2037. The rising incidence of breast cancer is the key factor that has accelerated the demand for trastuzumab biosimilar. Government mandates such as incentives for biosimilar adoption and cost-containment policies led to the expansion of the market in Europe. Over 14 new trastuzumab products have been introduced in the European market of Europe through the approval of the European Medicines Agency (EMA). Reimbursement policies are expanded, that led to higher accessibility of patients in the concerned market and directed towards growth. The allocation of over €3.1 billion in funds is considered by the Pharmaceutical Strategy of the EU, which helped to penetrate the market. Growth of HER2+ incidence is evaluated at a rate of 4.2% annually in Europe, which expands the market growth of trastuzumab biosimilar.
Germany is the leading country in the Europe region of the trastuzumab biosimilar market. Government mandate declared by the Federal Ministry of Health (BMG) led to market expansion by approximately 78% through biosimilars usage. Government spending is one of the key factors that led to better research and development and advancement of the infrastructure to elevate the performance of trastuzumab biosimilar. According to the report of BMG, approximately € 2.5 billion was invested in biosimilars in 2024, which ensured better market penetration.
Key Trastuzumab Biosimilar Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The trastuzumab biosimilar market experienced a highly competitive environment and leading key players such as Celltrion, Biocon, and many more incorporated different competitive strategies to gain a strong hold in the market. Price aggression is followed by Biocon in the market of India that offers the market over USD 98 per dose, which is comparatively quite cheaper than the originator. Collaboration is one of the efficient competitive strategies followed by Celltrion to collaborate with Teva to boost the U.S. distribution, overcoming the PBM rebate obstacles. Reliance of India and Henlius of China followed the localized production strategy through the API self-sufficiency that helped to control the cost of production and offer an affordable range of products.
Here are some leading players in the global trastuzumab biosimilar market:
|
Company Name |
Industry Focus |
Market Share (2024) |
|
Celltrion (South Korea) |
Leading biosimilar developer |
18.4% |
|
Biocon/Mylan (India) |
Supplies Ogivri |
15.6% |
|
Pfizer (U.S.) |
Markets Trazimer: strong EU/U.S. presence. |
12.3% |
|
Amgen (U.S.) |
Kanjinti is approved in 40+ countries. |
10.4% |
|
Samsung Bioepis (South Korea) |
Ontruzant dominates EU/Asian markets. |
9.5% |
|
Dr. Reddy’s (India) |
CIPLA-Trastuzumab for low-cost markets. |
xx% |
|
Novartis/Sandoz (Switzerland) |
Ziextenz (biosimilar portfolio expansion). |
xx% |
|
Henlius (China) |
HLX02 approved in China/EU; targets APAC. |
xx% |
|
Teva (Israel) |
Partners with Celltrion for U.S. distribution. |
xx% |
|
Apotex (Canada) |
Supplies BFL-Trastuzumab in Canada/Latin America. |
xx% |
|
Stada Arzneimittel (Germany) |
Developing Lupin-Trastuzumab for India/Africa. |
xx% |
|
Lupin (India) |
Exploring anti-inflammatory SCD drugs. |
xx% |
|
Intas Pharma (India) |
Supplies Elizuma™ in emerging markets. |
xx% |
|
Shanghai CP Guojian (China) |
State-backed SCT200 biosimilar for China. |
xx% |
|
Reliance Life Sciences (India) |
ReliMAb targets cost-sensitive regions. |
xx% |
|
Hetero Drugs (India) |
Hertraz approved in 15+ countries. |
xx% |
|
Aurobindo Pharma (India) |
Developing Auro-Trastuzumab for Latin America. |
xx% |
|
JHL Biotech (Taiwan) |
Focus on APAC biosimilars; partnered with Genor Biopharma. |
xx% |
|
Probiomed (Mexico) |
Supplies ProbiHer in Latin America. |
xx% |
|
BioXpress Therapeutics (Malaysia) |
Emerging ASEAN-focused manufacturer. |
xx% |
Below are the areas covered for each company in the trastuzumab biosimilar market:
Recent Developments
- In March 2024, Henlius launched HLXo2 after receiving approval for metastatic breast cancer treatment from the EMA. The product is offered at over 35% discounted price, that resulted in a higher adoption rate in the cost-sensitive markets.
- In May 2024, Biocon introduced CANMAb in Brazil through collaborating with the Ministry of Health to supply a dosage of over 145,000 each year. The reduction of trastuzumab cost by 58% and accessibility of additional patients over 49000 is experienced in Brazil.
- Report ID: 3011
- Published Date: Jun 19, 2025
- Report Format: PDF, PPT
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