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.