Trastuzumab Biosimilars Market Report 2025

This Trastuzumab Biosimilars market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The trastuzumab biosimilars market size has grown exponentially in recent years. It will grow from $4.27 billion in 2024 to $5.43 billion in 2025 at a compound annual growth rate (CAGR) of 27.1%. The growth in the historic period can be attributed to market expansion and global reach, patent expiry and market entry, rapid biosimilar development, clinical efficacy validation, competitive pricing.

The trastuzumab biosimilars market size is expected to see exponential growth in the next few years. It will grow to $14.69 billion in 2029 at a compound annual growth rate (CAGR) of 28.3%. The growth in the forecast period can be attributed to market competition intensification, biosimilar pipeline development, regulatory approvals and standardizations, global market penetration, physician adoption and prescribing patterns. Major trends in the forecast period include improved access, market segmentation strategies, educational campaigns, patient preference for biosimilars, physician acceptance.

The growth of the trastuzumab biosimilars market has been influenced by the increasing prevalence of breast and gastric cancer. Trastuzumab biosimilar is employed in treating breast cancer and metastatic gastric cancer with human epidermal growth factor receptor 2 (HER2) overexpression. For instance, in September 2023, the American Cancer Society reported that approximately 297,790 new cases of invasive breast cancer would be diagnosed in women, leading to about 43,700 women succumbing to breast cancer in the same year. Breast cancer is a prevalent type of cancer in India, constituting 14% of cancers in women. This rising prevalence of breast and gastric cancer enhances the demand for trastuzumab biosimilars due to cost-effectiveness compared to expensive medicines, thereby propelling the trastuzumab biosimilars market.

The growth of the trastuzumab biosimilars market is expected to be significantly influenced by rising healthcare expenditure. Healthcare expenditure encompasses the total amount spent on healthcare goods and services, which includes personal health care, public health activities, and health administration. This expenditure is crucial for the development of trastuzumab biosimilars as it facilitates the provision of these products at reduced costs, thereby promoting their adoption and development. As investments in the healthcare sector increase, biosimilars can enhance patient access to care by offering a more affordable alternative to biologics. For instance, in May 2024, a report from the Office for National Statistics, a UK-based government department, indicated that total healthcare expenditure rose by 5.6% in nominal terms between 2022 and 2023, compared to a growth rate of just 0.9% in 2022. Consequently, the rise in healthcare expenditure is driving the growth of the trastuzumab biosimilars market.

Key players in the trastuzumab biosimilars market are actively focused on launching new products in previously untapped regions, significantly influencing market dynamics. Companies within this sector are engaging in various strategic initiatives, including new product development, partnerships, and expansion of both geographic and product portfolios, to enhance their competitive edge and better meet customer needs. For example, in April 2024, Accord BioPharma Inc., a US-based pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved HERCESSI (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), for treating several 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 functions by binding to the HER2 receptor, inhibiting its activity and thereby slowing the replication of cancer cells.

Major companies operating in the trastuzumab biosimilars market are intensifying efforts to introduce novel products and secure approvals from government bodies to gain a competitive advantage. The drug launch signifies the introduction of a new pharmaceutical product, typically medication, into the commercial market for distribution and use. The drug approval process involves multiple stages, encompassing preclinical testing and clinical trials to assess the drug's effects. For instance, in February 2022, Samsung Bioepis Co. Ltd., a South Korea-based biopharmaceutical company, announced the approval of ONTRUZANT (also known as SB3) by Health Canada, a Canada-based government department. ONTRUZANT is a biosimilar referencing Herceptin (Trastuzumab) and is developed for treating adults with early breast cancer (EBC), metastatic breast cancer (MBC), and metastatic gastric cancer (MGC).

In March 2022, Biocon Biologics, a fully integrated biopharmaceutical company based in India, acquired Viatris Inc for $3.3 billion. This acquisition aims to establish a unique, fully integrated, global biosimilars enterprise. The strategic alliance combines the strengths and complementary skills of both entities, positioning Biocon Biologics for a decade of value creation for all stakeholders. Viatris Inc is a US-based pharmaceutical company and a developer of biosimilar trastuzumab.

Trastuzumab biosimilars are therapeutic drugs targeting HER2 and specifically developed to treat both early and metastatic HER2-positive breast cancers. As a monoclonal antibody, trastuzumab biosimilar binds to the human epidermal growth factor receptor 2 (HER2)/neu receptor, thereby deactivating it.

The primary products in the trastuzumab biosimilars category include Ogivri, Herzuma, Ontruzant, Trazimera, and others. These biosimilars cater to various indications such as adjuvant breast cancer, metastatic breast cancer, metastatic gastric cancer, among others. They are made available through distribution channels such as hospital pharmacies and online pharmacies.

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 scenarios of the industry.

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. The countries covered in the trastuzumab biosimilars market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

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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