Biosimilar Hormones Market Report 2025

This Biosimilar Hormones 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 biosimilar hormones market size has grown exponentially in recent years. It will grow from $3.9 billion in 2024 to $4.98 billion in 2025 at a compound annual growth rate (CAGR) of 27.5%. The growth in the historic period can be attributed to the rising prevalence of chronic diseases, increasing aging population, growing awareness of biosimilar hormones, and expanded access to healthcare.

The biosimilar hormones market size is expected to see exponential growth in the next few years. It will grow to $11.77 billion in 2029 at a compound annual growth rate (CAGR) of 24%. The growth in the forecast period can be attributed to expanding hormone targets, growing patient acceptance, advances in manufacturing, government support, growing clinical trial data, and expanded access to healthcare. Major trends in the forecast period include personalized hormone replacement, product launches, pricing and access, and patient-centric care.

The biosimilar hormones market is seeing growth due to the prevalence of deficiencies in growth and metabolic hormones. Advancements in treatments for hormone-related conditions have led to increased demand for biosimilar hormones, fueled by the estimated global prevalence of growth hormone deficiency (GHD) in children ranging from 1 in 3500 to 1 in 10000, as reported by the British Medical Journal in January 2022. Additionally, approximately 6,000 adults in the USA are projected to be diagnosed with growth hormone deficiency, underlining the escalating need to address hormonal deficiencies, which drives the market growth for biosimilar hormones.

The rising prevalence of diabetes is expected to drive the expansion of the biosimilar hormones market. Diabetes is a chronic condition that affects the body’s ability to process food into energy. Biosimilar hormones, such as insulin, provide safe and effective alternatives for diabetes management, potentially lowering costs and enhancing accessibility for patients. Additionally, biosimilar growth hormone can aid in diabetes treatment by improving blood sugar control in adults with type 1 and type 2 diabetes. For example, in June 2023, the International Diabetes Federation (IDF), a Germany-based organization representing over 240 national diabetes associations, reported a significant increase in diabetes cases, estimating that 783 million adults aged 20-79 will have diabetes by 2045. Therefore, the rising prevalence of diabetes is set to further boost the growth of the biosimilar hormones market in the coming years.

Key players in the biosimilar hormones market are actively implementing strategic initiatives, such as expanding into untapped regions through new product launches, aiming to increase accessibility and capture wider market segments. Notably, Alvotech Holdings S.A., in February 2022, announced a strategic partnership with Fuji Pharma Co. Ltd., intending to develop biosimilar drug candidates specifically targeted for the Japanese market. This alliance represents a focused effort to create and market biosimilar medicines in Japan, demonstrating a strategic move to enhance market presence and generate higher revenues.

Major companies operating in the biosimilar hormones sector are innovating with new product launches to augment their market profitability. Novo Nordisk's FDA approval in April 2023 for Sogroya (somapacitan-beco) injection marks a significant milestone. Sogroya, designed as a once-weekly growth hormone therapy for children and adults, gained a new indication for treating children aged 2.5 years and older with growth failure due to insufficient endogenous growth hormone secretion. Supported by findings from the phase 3 REAL4 trial, this approval validates Sogroya's efficacy in addressing growth hormone deficiency in pediatric patients, representing a strategic move to strengthen their market position and profitability.

Major companies operating in the biosimilar hormones market include Teva Pharmaceutical Industries Ltd., Gedeon Richter Plc., Intas Pharmaceuticals Ltd., Biocon Limited, Mylan, Sanofi, Sandoz Group AG, LG Life Sciences, Ferring Pharmaceuticals, GC Pharma, Pfizer Inc., Dr. Reddy's Laboratories, Amgen Inc., Eli Lilly and Company, Celltrion Inc., Samsungbioepis Co.Ltd, Merck & Co., Biogen Inc., Boehringer Ingelheim, Alvotech, BioXpress Therapeutics, Cipla Limited, Lupin Ltd., Stada Arzneimittel AG, Torrent Pharmaceuticals, Zydus Cadila, Accord Healthcare, Hetero Drugs, Wockhardt.

Biosimilar hormones refer to hormone products that mirror the chemical structure of the hormones naturally produced by the human body. In many cases, these hormones in bioidentical drugs closely resemble those utilized in traditional hormone therapy. They are employed to address imbalances or deficiencies in hormone levels within individuals.

The primary categories of biosimilar hormones encompass teriparatide biosimilars, follitropin alfa biosimilars, insulin biosimilars, somatropin biosimilars, among others. Teriparatide, for instance, is a recombinant form of parathyroid hormone (PTH). It functions similarly to a component of human PTH and, when administered regularly, stimulates osteoblasts more than osteoclasts, thereby enhancing bone mass. These hormones find diverse applications in research and biotechnology, diagnostics, biocatalysts, therapeutics, and various other fields. They are made available through multiple distribution channels, including hospital and retail pharmacies, online pharmacies or e-pharmacy platforms, as well as specialty clinics, catering to different healthcare needs and preferences.

The biosimilar hormones market research report is one of a series of new reports that provides biosimilar hormones market statistics, including biosimilar hormones industry global market size, regional shares, competitors with a biosimilar hormones market share, detailed biosimilar hormones market segments, market trends and opportunities, and any further data you may need to thrive in the biosimilar hormones industry. The biosimilar hormones 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.

North America was the largest region in the biosimilar hormones market in 2024. The regions covered in the biosimilar hormones market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the biosimilar hormones market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Spain, Canada.

The biosimilar hormones market consists of sales of estrace, estradil, and estring. 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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