The trastuzumab biosimilars market has seen considerable growth due to a variety of factors.
• The market size for trastuzumab biosimilars has experienced significant growth recently, ballooning from $4.27 billion in 2024 to an expected $5.43 billion in 2025 with a CAGR of 27.1%.
This historic growth can be credited to an assortment of factors such as market broadening and globalization, expiration of patents, and the arrival of new market participants, swift progression of biosimilars, validation of clinical effectiveness, and competitive cost strategies.
The trastuzumab biosimilars market is expected to maintain its strong growth trajectory in upcoming years.
• Predictions show that the trastuzumab biosimilars market is set to undergo significant expansion in the coming years, rising to a value of $14.69 billion by 2029, a surge that points to a compound annual growth rate (CAGR) of 28.3%.
This robust growth during the forecast period can be linked to increased market competition, growth in the biosimilar pipeline, regulatory approvals and standardizations, global market penetration, as well as trends in physician adoption and prescribing habits. Other key trends expected during the forecast period include improved access, strategies in market segmentation, educational initiatives, a shift towards biosimilar patient preference, and physician acceptance.
The escalating instances of breast and gastric cancer have spurred the expansion of the trastuzumab biosimilars market. Trastuzumab biosimilar, a medication utilized for combating human epidermal growth factor receptor 2 (HER2) over-expressing breast cancer and metastatic gastric cancer, is in increasing demand. For instance, projections by the American Cancer Society, a volunteer health organization committed to eradicating cancer, suggest that around 297,790 new invasive breast cancer cases will be identified in women in 2023, and about 43,700 women could succumb to the disease within the same year. Cancer India suggests that breast cancer is the most prevalent type of cancer among Indian women, constituting 14% of all cancers in women. Hence, the increasing instances of breast and gastric cancer boost demand for cost-effective solutions like trastuzumab biosimilar as compared to higher-priced medicines, thus propelling the trastuzumab biosimilars market.
The trastuzumab biosimilars market covered in this report is segmented –
1) By Product: Ogivri, Herzuma, Ontruzant, Trazimera, Other Products
2) By Indication: Adjuvant Breast Cancer, Metastatic Breast Cancer, Metastatic Gastric Cancer, Other Indications
3) By Distribution Channel: Hospital Pharmacy, Online Pharmacy
The key market players are relentlessly focusing on introducing new products in previously unexplored regions, which is influencing the trastuzumab biosimilars market. To maintain their competitive edge in the market and cater better to customer needs, corporations within the trastuzumab biosimilars market are implementing various strategic measures like new product development, collaborations, and expanding their geographical reach and product portfolio. A case in point is the approval granted by the U.S. Food and Drug Administration (FDA) to Accord BioPharma Inc., a US-based pharmaceutical company, for HERCESSI (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), in April 2024 for treating several types of HER2-Overexpressing Cancer. This drug is commonly used for adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma. Despite HER2-positive cancers being aggressive, they respond well to targeted treatments. HERCESSI functions by attaching to the HER2 receptor, thereby restraining its activity, which in turn slows down the multiplication of cancer cells.
Major companies operating in the trastuzumab biosimilars market include:
• Pfizer Inc.
• Merck & Co.
• Amgen Inc.
• Teva Pharmaceutical Industries Ltd.
• Mylan NV
• Fujifilm Kyowa Kirin Biologics Co. Ltd.
• Innovent Biologics Inc.
• STADA Arzneimittel AG
• Apotex Inc.
• Samsung Bioepis Co. Ltd.
• Celltrion Inc.
• Zydus Lifesciences Limited
• BIOCAD
• Shanghai Henlius Biotech Inc.
• Biocon Limited
• Alvotech Holdings S.A.
• Polpharma Biologics S.A
• EirGenix Inc.
• Hetero Biopharma Limited
• Mabion SA
• ALTEOGEN Inc.
• Prestige BioPharma Limited
• AryoGen Pharmed Co. Ltd.
• Intas Pharmaceuticals Limited
• Glenmark Pharmaceuticals Ltd.
• Dr. Reddy's Laboratories Limited
• Torrent Pharmaceuticals Limited
North America was the largest region in the trastuzumab biosimilars market in 2024. Middle East is expected to be the fastest growing region in the trastuzumab biosimilars market report during the forecast period. The regions covered in the trastuzumab biosimilars market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.