Trastuzumab Biosimilars Market Report 2026

The trastuzumab biosimilars market size has grown exponentially in recent years. It will grow from $6.9 billion in 2025 to $8.86 billion in 2026 at a compound annual growth rate (CAGR) of 28.5%. The growth in the historic period can be attributed to high incidence of HER2 positive breast cancer, loss of trastuzumab patent exclusivity, rising oncology drug costs, regulatory biosimilar pathways, hospital oncology adoption.

The trastuzumab biosimilars market size is expected to see exponential growth in the next few years. It will grow to $24.48 billion in 2030 at a compound annual growth rate (CAGR) of 28.9%. The growth in the forecast period can be attributed to increasing cancer prevalence, expansion into gastric cancer indications, favorable reimbursement for biosimilars, growing physician confidence, rising healthcare cost containment efforts. Major trends in the forecast period include rapid uptake of oncology biosimilars, improved access to HER2 targeted therapies, price competition in breast cancer treatment, expansion of hospital oncology use, growing acceptance of biosimilar switching.

The increasing prevalence of breast and gastric cancer has contributed to the growth of the trastuzumab biosimilars market. Trastuzumab biosimilars are used in the treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer and metastatic gastric cancer. For example, in September 2023, according to the American Cancer Society, a US-based voluntary health organization focused on eliminating cancer, approximately 297,790 new cases of invasive breast cancer were expected to be diagnosed in women in 2023, with about 43,700 deaths occurring in the same year. Additionally, according to Cancer India, breast cancer is the most common cancer among women in India and accounts for around 14% of all cancers in women. As a result, the rising incidence of breast and gastric cancers is increasing demand for trastuzumab biosimilars, which offer cost savings compared with high-priced branded therapies, thereby driving the growth of the trastuzumab biosimilars market.

Key players in the market are increasingly concentrating on launching new products in untapped regions, which is shaping the development of the trastuzumab biosimilars market. Companies operating in this space are adopting various strategic initiatives, including new product development, partnerships, and geographic as well as product portfolio expansion, to maintain their competitive position and better meet customer needs. For instance, in April 2024, Accord BioPharma Inc., a US-based pharmaceutical company, announced that the U.S. Food and Drug Administration had approved HERCESSI (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), for the treatment of multiple forms of HER2-overexpressing cancer. HERCESSI is indicated for the adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma. HER2-positive cancers are typically aggressive but respond well to targeted therapies. HERCESSI acts by binding to the HER2 receptor, blocking its activity and slowing the growth and replication of cancer cells.

In June 2025, Alvotech, an Iceland-based biotechnology company, acquired Xbrane Biopharma AB for $28.9 million. Through this acquisition, Alvotech aims to strengthen its research and development capabilities and establish a stronger presence within the Swedish life sciences ecosystem. Xbrane Biopharma AB is a Sweden-based biopharmaceutical company specializing in the development of biosimilars and long-acting injectable therapies.

Major companies operating in the trastuzumab biosimilars market are Pfizer Inc., 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 2025. 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, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the trastuzumab biosimilars market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Tariffs have affected the trastuzumab biosimilars market by increasing costs for imported monoclonal antibody inputs and sterile manufacturing supplies. These pressures are most pronounced in hospital pharmacies across Asia Pacific and Europe where biosimilars are widely adopted. Distribution costs have risen due to tariffs on cold chain components. On the positive side, tariffs are encouraging regional biologics manufacturing and supporting local biosimilar production capacity expansion.

The trastuzumab biosimilars market research report is one of a series of new reports that provides trastuzumab biosimilars market statistics, including trastuzumab biosimilars industry global market size, regional shares, competitors with a trastuzumab biosimilars market share, detailed trastuzumab biosimilars market segments, market trends and opportunities, and any further data you may need to thrive in the trastuzumab biosimilars industry. This trastuzumab biosimilars market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Trastuzumab biosimilar is a HER2-targeted therapeutic drug developed to treat early-stage and metastatic HER2-positive breast cancers. It is a monoclonal antibody that binds to the human epidermal growth factor receptor 2 (HER2/neu) on cancer cells, thereby inactivating the receptor.

The main products in the trastuzumab biosimilars category include Ogivri, Herzuma, Ontruzant, Trazimera, and others. The various indications include adjuvant breast cancer, metastatic breast cancer, metastatic gastric cancer, and others, and these products are distributed through hospital pharmacies and online pharmacies.

The trastuzumab biosimilars market consists of sales of herceptin, avastin, and Kanjinti. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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