Biosimilars Market to Reach US$ 171.79 Billion by 2033 at 25.5% CAGR; North America Leads with 35% Share, Key Players: Amgen, Pfizer, Sandoz, Biocon Biologics, Samsung Bioepis, Teva.

Market Overview

The Global Biosimilars Market reached US$ 22.58 billion in 2024 and is projected to grow to US$ 171.79 billion by 2033, at a CAGR of 25.5% during the forecast period 2025-2033. Biosimilars are biological medical products highly similar to an already approved reference biologic drug, with no clinically meaningful differences in safety, purity, and potency. Produced using living organisms via complex methods such as recombinant DNA technology, biosimilars must undergo rigorous analytical, preclinical, and clinical studies to demonstrate similarity to their reference products.

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A key advantage of biosimilars is their cost-effectiveness. Since manufacturers do not bear the substantial research and marketing costs of the original biologic, biosimilars are typically priced lower. This reduces overall healthcare costs, improves accessibility to critical biologic therapies, and supports the sustainability of healthcare systems worldwide.

FDA Approved Biosimilar Products:

Biosimilar Name Approval Date Reference Product
Omlyclo (omalizumab-igec) March 2025 Xolair (omalizumab)
Osenvelt (denosumab-bmwo) February 2025 Prolia (denosumab)
Stoboclo (denosumab-bmwo) February 2025 Prolia (denosumab)
Merilog (insulin aspart-szjj) February 2025 Novolog (insulin aspart)
Ospomyvtm & Xbryktm (denosumab-dssb) February 2025 Prolia & Xgeva (denosumab)
Avtozma (tocilizumab-anoh) January 2025 Actemra (tocilizumab)

Recent Developments:

✅ January 2026 - United States: The FDA approved new denosumab biosimilars, expanding treatment options for osteoporosis and bone metastases and increasing competition in the biologics space.

✅ Late 2025 - Global: Alvotech reported strong commercial performance and revenue growth, driven by high sales of adalimumab and ustekinumab biosimilars, highlighting the increasing commercial viability of biosimilar products.

✅ October 2025 - Europe: Bio‐Thera and STADA expanded their alliance to include a tocilizumab biosimilar, granting exclusive commercialization rights across Europe and broadening access to immunology biosimilars.

✅ Late 2025 - EU & U.S.: Regulatory momentum continued with significant biosimilar approvals and strategic launches, enhancing competition in therapeutic areas including immunology, bone health, and oncology.

✅ 2025 - Global: Multiple denosumab and aflibercept biosimilars received approvals, expanding treatment choices and improving market access for affordable biologics.

Mergers & Acquisitions:

✅ January 2026 - United States: A leading biosimilar manufacturer acquired a denosumab biosimilar developer to expand its biologics portfolio and strengthen market presence.

✅ October 2025 - Europe: Bio‐Thera and STADA partnership expanded via acquisition of exclusive commercialization rights for tocilizumab biosimilars across multiple European countries.

✅ 2025 - Global: Major biosimilar companies merged with strategic biotech startups to enhance their product pipeline, manufacturing capabilities, and global distribution networks.

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Key Players:
Amgen | Pfizer | Sandoz | Biocon Biologics | Samsung Bioepis | Teva | Biogen | Dr. Reddy's

Key Highlights:

• Amgen - Holds an estimated 18% share, offering a broad portfolio of biosimilars across oncology, immunology, and hematology, with strong global distribution and regulatory expertise.

• Pfizer - Holds an estimated 16% share, providing multiple approved biosimilars including infliximab and etanercept, leveraging its global manufacturing and commercialization network.

• Sandoz - Holds an estimated 14% share, pioneering biosimilars development and commercialization with focus on immunology and oncology products.

• Biocon Biologics - Holds an estimated 12% share, a key player in insulin, oncology, and immunology biosimilars, with strong presence in emerging markets.

• Samsung Bioepis - Holds an estimated 10% share, delivering high-quality biosimilars across multiple therapeutic areas including oncology and autoimmune disorders, with partnerships for global distribution.

• Teva - Holds an estimated 8% share, focusing on biosimilars for immunology and specialty care, complementing its generics portfolio.

• Biogen - Holds an estimated 11% share, expanding into biosimilars for neurology and rare disease indications.

• Dr. Reddy's - Holds an estimated 11% share, offering a diverse range of biosimilars in oncology, immunology, and other therapeutic areas, with strong presence in India and emerging markets.

Market Segmentation:

By Product Type:

Monoclonal Antibodies (mAbs) lead the market with an estimated 28% share, driven by high adoption in oncology, autoimmune diseases, and inflammatory disorders due to their efficacy and cost-effectiveness compared to reference biologics.

Recombinant Human Growth Hormone (rhGH) holds around 10%, used to treat growth hormone deficiencies in children and adults, with biosimilars improving affordability and accessibility.

Insulin accounts for approximately 12%, as biosimilar insulin products address rising diabetes prevalence worldwide and provide cost-effective alternatives to branded biologics.

Anti-coagulants represent 8%, helping manage thrombosis and cardiovascular disorders with growing uptake of biosimilar options.

Erythropoietin (EPO) holds 9%, used in anemia treatment, particularly for chronic kidney disease and chemotherapy-induced anemia.

Granulocyte Colony Stimulating Factor (G-CSF) accounts for 7%, supporting neutropenia management in oncology patients, with biosimilars expanding patient access.

Follitropin represents 5%, applied in fertility treatments, where biosimilar products improve affordability of assisted reproductive therapies.

Interferons hold 6%, used in autoimmune and viral diseases, with biosimilar alternatives reducing treatment costs.

By Application:

Oncology leads with 30% share, driven by the high demand for biosimilar monoclonal antibodies, growth factors, and supportive care biologics to manage cancers.

Chronic Diseases hold around 20%, including diabetes, cardiovascular disorders, and renal diseases, where insulin, erythropoietin, and other biosimilars are widely adopted.

Autoimmune Diseases account for 18%, supported by monoclonal antibody biosimilars targeting rheumatoid arthritis, psoriasis, and inflammatory bowel disease.

Infectious Diseases represent 8%, with biosimilar interferons and other immunomodulators being used for hepatitis and viral infections.

Growth Hormone Deficiency holds 10%, driven by recombinant human growth hormone (rhGH) biosimilars improving patient access.

Hematology represents 14%, covering conditions like neutropenia, anemia, and thrombocytopenia, where biosimilars such as G-CSF and EPO are in high demand.

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Regional Insights:

North America dominates the biosimilars market with an estimated 35% share, driven by early adoption of biosimilars, strong regulatory support from the FDA, and increasing demand for cost-effective biologic therapies in oncology, autoimmune, and chronic disease treatment. The U.S. leads this growth due to a well-established healthcare infrastructure and favorable reimbursement policies.

Europe holds around 30% of the market, supported by the European Medicines Agency (EMA) biosimilar framework, high awareness among healthcare providers, and growing adoption in countries such as Germany, France, the UK, and Italy. The region benefits from government initiatives to reduce healthcare expenditure by encouraging biosimilar use.

Asia-Pacific accounts for approximately 20%, led by countries like China, India, Japan, and South Korea. Growth is driven by rising incidence of chronic and autoimmune diseases, expanding healthcare infrastructure, increasing affordability of biosimilars, and government initiatives to improve access to biologic therapies.

Latin America represents 10%, with countries like Brazil and Mexico showing increasing adoption of biosimilars in oncology and chronic disease management due to growing healthcare expenditure and emerging regulatory frameworks.

Market Dynamics:

Driver:
The global biosimilars market is being significantly driven by the increasing number of biosimilar approvals across multiple therapeutic areas. As regulatory agencies expedite the approval process, more biosimilars are entering the market, targeting oncology, autoimmune disorders, chronic diseases, diabetes, and hematology, thereby expanding treatment options and increasing patient access to affordable biologic therapies.

For example, in March 2025, Celltrion announced that the FDA approved OMLYCLO (omalizumab-igec) as the first and only biosimilar designated interchangeable with XOLAIR (omalizumab). This approval enables treatment for moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy, and chronic spontaneous urticaria (CSU), demonstrating how biosimilar approvals are broadening therapeutic reach and improving affordability in complex disease management.

Restraint:
Despite market growth, high development costs, complex manufacturing processes, and stringent regulatory requirements pose challenges. Developing biosimilars requires extensive analytical, preclinical, and clinical studies to demonstrate similarity to the reference biologic. The lengthy and costly approval process can delay product launch, limit competition, and restrict adoption in price-sensitive markets.

Opportunity:
Biosimilars offer substantial cost savings compared to reference biologics, creating opportunities for healthcare systems to reduce expenditures and increase patient access to essential therapies. Growing awareness among healthcare providers, favorable reimbursement policies, and government initiatives promoting biosimilar adoption further support market expansion, particularly in emerging economies.

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