Global Biosimilar Hormones Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

The global biosimilar hormones market is growing rapidly due to increasing demand for affordable alternatives to branded biologics. This market is segmented by type, with key categories including teriparatide biosimilars, follitropin alfa biosimilars, insulin biosimilars, somatropin biosimilars, and others. Among these, insulin biosimilars dominate the market due to the widespread use of insulin for diabetes management. However, somatropin and teriparatide biosimilars are also gaining traction due to their applications in growth disorders and osteoporosis, respectively, contributing to the overall growth of the biosimilar market.

The market is further segmented by drug class, with prominent segments including filgrastim & peg-filgrastim biosimilars, monoclonal antibodies, and others. Filgrastim and peg-filgrastim biosimilars are particularly significant for cancer patients undergoing chemotherapy, as they help stimulate white blood cell production to combat infections. Monoclonal antibodies are also an important segment due to their broad application in treating autoimmune diseases, cancers, and other chronic conditions. The "others" category includes various other biosimilar drugs that cater to a wide range of therapeutic areas, contributing to the market's diversification.

Applications of biosimilar hormones are diverse, with primary segments being diagnostics, biocatalysts, therapeutics, and others. The therapeutics segment is the largest and fastest-growing due to the increasing prevalence of chronic diseases such as diabetes, osteoporosis, and growth hormone deficiencies. Biosimilars are widely used in therapeutic treatments, providing a more cost-effective solution compared to their reference biologics. Diagnostics and biocatalysts applications are also growing, driven by the demand for more precise and cost-efficient testing methods and enzyme-based solutions in various industrial processes.

Geographically, North America, Europe, Asia Pacific, the Middle East and Africa, and Latin America exhibit varying growth patterns. North America holds a significant share due to high healthcare expenditure and the increasing adoption of biosimilars in countries like the U.S. and Canada. Europe is also a major market, with several biosimilar approvals and a strong regulatory framework. Asia Pacific is expected to witness rapid growth, driven by expanding healthcare infrastructure and rising demand for affordable biologics in countries such as India and China. The Middle East, Africa, and Latin America are emerging markets, with growing healthcare needs and increasing acceptance of biosimilar treatments.

Global Biosimilar Hormones Segment Analysis

In this report, the Global Biosimilar Hormones Market has been segmented by Type, Drug Class, Application, Distribution Channel and Geography.

Global Biosimilar Hormones Market, Segmentation by Type

The Global Biosimilar Hormones Market has been segmented by Type into Teriparatide Biosimilars, Follitropin Alfa Biosimilars, Insulin Biosimilars, Somatropin Biosimilars and Others.

The global biosimilar hormones market is segmented by type into several key categories, each representing a distinct class of biologic hormones that have been developed as biosimilar products. These include Teriparatide biosimilars, which mimic the function of the parathyroid hormone and are primarily used to treat osteoporosis by stimulating bone formation and increasing bone mineral density. Follitropin Alfa biosimilars emulate the follicle-stimulating hormone (FSH) and are employed in reproductive medicine to induce ovulation in women undergoing assisted reproductive technologies like in vitro fertilization (IVF).

Insulin biosimilars replicate the function of human insulin, playing a crucial role in managing diabetes by regulating blood glucose levels. These biosimilars are available in various forms such as rapid-acting, short-acting, intermediate-acting, and long-acting formulations, offering patients more affordable alternatives to branded insulin products.

Somatropin biosimilars emulate human growth hormone (hGH) and are essential in treating growth disorders in children and adults, including growth hormone deficiency and Turner syndrome. These biosimilars stimulate skeletal growth, enhance muscle mass development, and regulate metabolism, supporting overall growth and development in individuals with hormone deficiencies.

Other types of biosimilar hormones encompass a range of biologic products that mimic hormones involved in various physiological processes. These may include biosimilar versions of hormones used in hormone replacement therapy, oncology treatments, and other specialized medical applications where biologic therapies are crucial.

Global Biosimilar Hormones Market, Segmentation by Drug Class

The Global Biosimilar Hormones Market has been segmented by Drug Class into Filgrastim & Peg-filgrastim, Monoclonal Antibodies, and Others.

The global biosimilar hormones market has been segmented by drug class into Filgrastim & Peg-filgrastim, Monoclonal Antibodies, and Others. Filgrastim and Peg-filgrastim are among the most commonly used biosimilar hormones, primarily used in the treatment of neutropenia and other immune system disorders. These biosimilars are gaining significant traction due to their cost-effectiveness compared to their reference biologics, providing an affordable treatment option for patients requiring granulocyte-stimulating factors.

Monoclonal antibodies represent another key segment in the biosimilar hormones market. These biologics are used in various therapeutic areas, including oncology, autoimmune diseases, and chronic conditions like rheumatoid arthritis. The approval and availability of biosimilar monoclonal antibodies have led to increased treatment access, offering patients effective and lower-cost alternatives to original biologic therapies. The demand for monoclonal antibodies is particularly high in oncology, where these therapies are integral to treating cancer.

The "Others" segment includes a wide range of biosimilar hormones not falling into the Filgrastim & Peg-filgrastim or Monoclonal Antibodies categories. This includes biosimilars for hormone therapies used in endocrinology, such as insulin, growth hormones, and thyroid hormones. The increasing use of biosimilars in this category is driven by their cost advantages and the growing demand for treatments in both developed and emerging markets. This segment is expected to experience substantial growth as more biosimilars enter the market and are approved for various therapeutic indications.

Global Biosimilar Hormones Market, Segmentation by Application

The Global Biosimilar Hormones Market has been segmented by Application into Diagnostics, Biocatalysts, Therapeutics and Others.

Therapeutics constitute a significant segment within the biosimilar hormones market, encompassing applications such as hormone replacement therapy (HRT), diabetes management, growth disorders, and reproductive health. Biosimilar hormones in therapeutics replicate the functions of endogenous hormones to treat conditions like growth hormone deficiencies, osteoporosis, infertility, and hormonal imbalances. These biosimilars offer cost-effective alternatives to branded biologics, enhancing accessibility and affordability of essential therapies worldwide.

Diagnostics represent another crucial application area for biosimilar hormones, where these products are utilized in laboratory testing kits and assays to detect specific biomarkers and hormone levels accurately. Diagnostic biosimilar hormones play a vital role in diagnosing endocrine disorders, assessing hormonal imbalances, and monitoring treatment responses in patients. Their reliability and consistency contribute to accurate disease detection and management, supporting clinical decision-making and patient care.

Biocatalysts form a specialized segment within the biosimilar hormones market, involving the use of biosimilar products as catalysts in biochemical reactions. These biocatalysts facilitate industrial processes in pharmaceutical manufacturing, agriculture, and environmental remediation. Biosimilar hormones used as biocatalysts contribute to sustainable production practices, enhancing efficiency and reducing environmental impact in various industrial applications.

Global Biosimilar Hormones Market, Segmentation by Distribution Channel

The Global Biosimilar Hormones Market has been segmented by Type into Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies.

The global biosimilar hormones market is divided into various distribution channels, with hospital pharmacies, retail pharmacies, and online pharmacies being the primary segments. Hospital pharmacies play a crucial role in the distribution of biosimilar hormones. These pharmacies cater to the needs of patients within hospital settings, ensuring timely access to medications that are typically prescribed for specialized treatments. Hospital pharmacies often have direct relationships with healthcare providers, making them a trusted source for biosimilars, especially for patients with critical health conditions requiring hormone treatments.

Retail pharmacies also serve a significant portion of the market, offering biosimilar hormones to a broad consumer base. These pharmacies are easily accessible and cater to individuals seeking medications on a more routine basis. Retail pharmacies tend to provide a wider range of pharmaceutical products, including biosimilars, at convenient locations. Patients prefer retail pharmacies for their convenience, allowing them to obtain prescribed biosimilars without the need for hospitalization, which is particularly important for ongoing, chronic hormone treatments.

Online pharmacies are becoming increasingly prominent in the global biosimilar hormones market, offering an alternative for patients who may not have easy access to physical pharmacies. These platforms provide the advantage of convenience and privacy, allowing patients to order biosimilars from the comfort of their homes. With the growing trend of e-commerce in healthcare, online pharmacies are likely to witness further growth, especially in regions with a high penetration of internet users. Online pharmacies may offer competitive pricing and home delivery, attracting a segment of the population seeking cost-effective and efficient access to biosimilars.

Global Biosimilar Hormones Market, Segmentation by Geography

In this report, the Global Biosimilar Hormones Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Biosimilar Hormones Market Share (%), by Geographical Region, 2024

North America represents a significant market segment for biosimilar hormones, driven by advanced healthcare systems, substantial investments in biotechnology research, and supportive regulatory environments. The United States and Canada lead in market size, with robust initiatives to promote biosimilar adoption and address healthcare cost containment through affordable biologic alternatives.

Europe is another prominent region in the biosimilar hormones market, characterized by stringent regulatory standards, favorable reimbursement policies, and increasing acceptance of biosimilar therapies among healthcare providers and patients. Countries such as Germany, the United Kingdom, and France are key contributors, fostering market growth through policies that encourage biosimilar competition and enhance patient access to cost-effective hormone treatments.

Asia-Pacific emerges as a rapidly growing market for biosimilar hormones, fueled by expanding healthcare expenditures, rising prevalence of chronic diseases, and initiatives to improve healthcare accessibility. Countries like China, India, and Japan are pivotal in market expansion, supported by governmental efforts to accelerate biosimilar approvals, enhance healthcare infrastructure, and address unmet medical needs in hormone therapy.

The geographic segmentation of the biosimilar hormones market underscores diverse regional opportunities and challenges shaped by healthcare policies, economic factors, and demographic trends. As biosimilar technologies evolve and regulatory harmonization progresses globally, the market is poised for continued expansion, offering healthcare stakeholders innovative solutions to address healthcare disparities, enhance patient care, and support sustainable healthcare delivery on a global scale.

This report provides an in depth analysis of various factors that impact the dynamics of Global Biosimilar Hormones Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers:

• Rising healthcare costs
• Patent expirations
• Regulatory support for biosimilars

• Increasing prevalence of hormone-related disorders - The increasing prevalence of hormone-related disorders represents a significant health challenge globally, driving the demand for effective therapies such as biosimilar hormones. Hormones play crucial roles in regulating various physiological processes, including growth, metabolism, reproduction, and immune function. As populations age and lifestyles evolve, the incidence of hormone-related disorders has been on the rise, contributing to a growing burden on healthcare systems worldwide.

  One notable example is diabetes mellitus, a chronic metabolic disorder characterized by inadequate insulin production or impaired insulin function. With the global prevalence of diabetes increasing steadily, particularly type 2 diabetes linked to obesity and sedentary lifestyles, there is a heightened need for insulin therapies to manage blood glucose levels effectively. Biosimilar insulin products offer cost-effective alternatives to branded biologics, making essential diabetes treatments more accessible to a broader population.

  In reproductive health, infertility affects a significant number of couples globally, often requiring hormone-based interventions to stimulate ovulation or manage hormonal imbalances. Biosimilar hormones such as Follitropin Alfa, which mimic the follicle-stimulating hormone (FSH), play a vital role in assisted reproductive technologies like in vitro fertilization (IVF). These biosimilars provide affordable options for fertility treatments, addressing a critical healthcare need among couples seeking to conceive.

Restraints:

• Complex manufacturing processes
• Regulatory challenges and approval timelines
• High development costs

• Market competition from branded biologics - Market competition from branded biologics represents a significant factor influencing the biosimilar market landscape, particularly in the context of hormone therapies and other biologic treatments. Branded biologics, developed by pharmaceutical companies through extensive research and clinical trials, typically enjoy patent protection for a limited period, during which they hold exclusive rights to market their products. This exclusivity allows branded biologics to establish strong market positions based on proven efficacy, safety, and brand recognition.

  As patents on branded biologics approach expiration, it opens opportunities for biosimilar manufacturers to develop and market comparable versions of these biologics. Biosimilars are designed to be highly similar to the reference biologic in terms of structure, function, and clinical performance, but they may be offered at lower prices due to reduced development costs and competition among biosimilar manufacturers.

  Despite the introduction of biosimilars into the market, branded biologics continue to exert competitive pressures. Pharmaceutical companies often employ strategies such as lifecycle management, including patent extensions, formulation improvements, and marketing tactics to maintain market share and delay biosimilar competition. Additionally, brand loyalty among healthcare providers and patients, coupled with perceptions of superior quality and reliability associated with branded products, can present challenges for biosimilar adoption.

  Regulatory frameworks also influence market competition. Regulatory agencies require rigorous comparability studies to demonstrate biosimilarity, ensuring that biosimilar products meet stringent safety and efficacy standards. While this regulatory scrutiny ensures patient safety, it can also prolong the approval process and delay biosimilar market entry, giving branded biologics an extended period of exclusivity.

Opportunities:

• Expanding healthcare infrastructure in emerging markets
• Growing demand for affordable healthcare solutions
• Increasing investments in biotechnology research and development

• Patent expirations of biologic drugs - Patent expirations of biologic drugs play a crucial role in shaping the pharmaceutical landscape by opening opportunities for the development and commercialization of biosimilars. Biologic drugs are complex molecules derived from living organisms, such as proteins, antibodies, and hormones, used to treat various diseases ranging from cancer to autoimmune disorders. These biologics typically enjoy patent protection for a limited period, which grants their manufacturers exclusive rights to produce and market them.

  When patents on biologic drugs expire, it allows other pharmaceutical companies to develop biosimilars—products that are highly similar to the original biologic in terms of quality, safety, and efficacy. Unlike generic drugs, which are chemical copies of small-molecule drugs and can be easily replicated, biosimilars are more complex to develop due to the inherent variability of biological materials and manufacturing processes.

  The expiration of patents on biologic drugs creates opportunities for biosimilar manufacturers to enter the market with more affordable alternatives. Biosimilars aim to offer similar therapeutic benefits as the reference biologic but at potentially lower costs, promoting competition and driving down prices. This increased competition benefits healthcare systems, insurers, and patients by improving access to essential treatments and potentially reducing overall healthcare expenditures.

  Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established specific pathways for the approval of biosimilars. These pathways require rigorous comparability studies to demonstrate that biosimilars are highly similar to the reference biologic in terms of structure, function, pharmacokinetics, pharmacodynamics, and immunogenicity. This regulatory scrutiny ensures that biosimilars meet stringent standards for safety and efficacy before they can be approved for commercialization.

Key players in Global Biosimilar Hormones Market include:

• Teva Pharmaceutical
• Gedeon Richter
• Intas Pharmaceuticals
• Biocon
• Mylan

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis