Trastuzumab Biosimilar Market Trends

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

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)

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.