Trastuzumab Biosimilars Global Market Report 2024

The trastuzumab biosimilars market size has grown exponentially in recent years. It will grow from $4.27 billion in 2023 to $5.43 billion in 2024 at a compound annual growth rate (CAGR) of 27.1%. The growth observed in the historical period can be attributed to factors such as the expansion of the market and its global reach, the expiration of patents leading to market entry, swift development of biosimilars, validation of clinical efficacy, and 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 2028 at a compound annual growth rate (CAGR) of 28.3%. The forecasted growth in the upcoming period can be attributed to the intensification of market competition, development of biosimilar pipelines, regulatory approvals, standardizations, global market penetration, and patterns of physician adoption and prescribing. Major trends expected in the forecast period include enhanced access, strategies for market segmentation, educational campaigns, patient preference for biosimilars, and increased acceptance among physicians.

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 anticipated growth of the trastuzumab biosimilars market is expected to be driven by increasing healthcare expenditure. Healthcare expenditure refers to the funds allocated to healthcare goods and services, encompassing personal health care, public health activities, and health administration. The pivotal role of healthcare expenditure lies in fostering the development of trastuzumab biosimilars by providing cost-effective alternatives to biologics, enhancing adoption and development. Notably, the UK witnessed a 9.4% increase in nominal terms and 9.7% in real terms in healthcare spending between 2020 and 2021. Spending on preventive care doubled to $45.72 billion in 2021. Consequently, the surge in healthcare expenditure is a driving force behind the growth of the trastuzumab biosimilars market.

The potential side effects associated with trastuzumab biosimilars are anticipated to hinder the market's growth. Side effects of Herceptin (Trastuzumab) include diarrhea, nausea, fever, heart problems, infection, cough, and rashes. Studies on breast cancer have revealed an increased rate of asymptomatic cardiac dysfunction during a two-year trastuzumab treatment period. The rate of Grade-3 or higher adverse events is higher for a two-year treatment with trastuzumab compared to one year. These side effects pose challenges to the trastuzumab biosimilars market.

Prominent players are consistently concentrating on introducing novel products in untapped regions, influencing the trastuzumab biosimilars market. Companies engaged in the trastuzumab biosimilars market are implementing various strategic initiatives, including new product development, partnerships, and geographical and product portfolio expansion, to uphold their competitive stance and better cater to customer needs. For instance, in May 2021, Zydus Cadila, an India-based pharmaceutical company, unveiled the world's first biosimilar form of trastuzumab emtansine, an antibody drug compound (trastuzumab) that not only retards cancer cell growth but also administers a cytotoxic substance to aid in its destruction. It is utilized for treating aggressive breast cancer that is human epidermal growth factor receptor 2 (HER2) positive, accounting for 20% to 25% of all breast cancers.

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.

Major companies operating in the trastuzumab biosimilars market report are Pfizer Inc., Outlook Therapeutics lnc., Merck & Co., Amgen Inc., BioXpress Therapeutics SA, Teva Pharmaceutical Industries Ltd., Mylan NV, Fujifilm Kyowa Kirin Biologics Co.Ltd., Innovent Biologics lnc., STADA Arzneimittel AG, Apotex Inc., Samsungbioepis Co. Ltd., Celltrion Inc., Zydus Lifesciences Limited, BIOCAD, Shanghai Henlius Biotech lnc., Biocon Limited, Sunshine Guojian Pharmaceutical Co. Ltd., Shanghai CP Guojian Pharmaceutical Co.Ltd., Alvotech Holdings S.A, Polpharma Biologics S.A, EirGenix Inc., Hetero Biopharma Limited, Mabion SA, ALTEOGEN Inc., PlantForm Corporation, STC Biologics Ltd., Prestige BioPharma Limited, Protheragen Inc., AryoGen Pharmed Co. Ltd., Intas Pharmaceuticals Limited, Glenmark Pharmaceuticals Ltd., Dr. Reddy's Laboratories Limited, Torrent Pharmaceuticals Limited, Reliance Life Sciences Pvt. Ltd. North America was the largest region in the trastuzumab biosimilars market in 2023. 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 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.

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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