Biosimilars Market Analysis & Forecast: 2025-2032

Biosimilars Market Size and Trends Forecast: 2025 - 2032

The biosimilars market is estimated to be valued at USD 42.53 Bn in 2025 and is expected to reach USD 136.37 Bn by 2032, exhibiting a compound annual growth rate (CAGR) of 18.1% from 2025 to 2032.

Key Takeaways of the Biosimilars Market

• The recombinant human growth hormone segment is expected to lead the market, holding an estimated share of 20. 5% in 2025.
• Based on therapy type, the oncology segment is projected to dominate holding a share of 25. 12 in 2025.
• The hospital pharmacies segment is estimated to lead the market, holding a share of 30. 5% in 2025.
• North America is projected to dominate the market with a share of 40. 7% in 2025.

Market Overview

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Growing demand for affordable biological drugs along with patent expiries of major biologics drugs can drive the market growth. Increasing investments by market players for research & development and production of biosimilars coupled with supportive regulatory framework can also boost demand for biosimilars. Moreover, biosimilars provide similar therapeutic efficacy in comparison to reference biologics with significant cost savings, which makes them an attractive alternative.

However, manufacturing challenges associated with biosimilars can hinder the market growth over the forecast period.

Market Concentration and Competitive Landscape

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Current Events and Their Impact on the Biosimilars Market

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Segmental Insights

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Biosimilars Market Insights By Drug Class: Versatility and Wide Range of Applications Drive Recombinant Human Growth Hormone Segment Growth

In terms of drug class, recombinant human growth hormone segment is estimated to contribute the highest market share of 20.5% in 2025, owing to its versatility and wide range of applications.

Recombinant human growth hormone is used to treat a variety of conditions related to growth hormone deficiency in both pediatric and adult patients. Some of the major conditions treated with recombinant human growth hormone include turner syndrome, Prader-Willi syndrome, chronic renal insufficiency, and AIDS-related wasting. Its ability to stimulate growth in both children and adults through different growth-promoting effects makes it a favorable treatment option for doctors and patients.

Biosimilars Market Insights By Therapy Type: High Disease Prevalence and Efficacy Drive Oncology Segment Growth

In terms of therapy type, oncology segment is estimated to contribute the highest market share of 25.12 % in 2025, owing to the high prevalence of cancer and efficacy of biosimilars in oncological treatment.

The continually growing cancer patient pool boosts demand for cost-effective oncology biosimilars. Many blockbusters biologic drugs have lost exclusivity in recent years, providing opportunities for oncology biosimilars. Areas such as non-Hodgkin's lymphoma, breast cancer, and colorectal cancer with large biologic drug consuming patient bases are prime market targets. Biosimilars of widely prescribed biologics like bevacizumab, trastuzumab, rituximab and cetuximab witness huge uptake due to demonstrated similar clinical outcomes.

Biosimilars Market Insights By Distribution Channel: Cost Savings and Procurement Advantages Drive Hospital Pharmacies Segment

In terms of distribution channel, hospital pharmacies segment is estimated to contribute the highest market share of 30.5% in 2025, owing to the potential for cost savings and bulk procurement advantages.

Hospital pharmacies treat a large volume of patients on a daily basis requiring immense drug budgets. Biosimilars enable substantial drug expenditure reductions for cash strapped hospitals. Their lower prices compared to reference biologics result in significant budgetary relief without compromising treatment quality. Furthermore, hospitals can leverage their bulk purchasing power to negotiate additional discounts on biosimilar prices from manufacturers.

Emerging Innovations in the Biosimilars Market

• The Enhanced Analytical Capabilities and Process Controls
  • The enhanced analytical capabilities and process controls increase confidence among regulators, healthcare providers, and patients regarding the safety and efficacy of biosimilars. This trust is crucial for market penetration given lingering concerns in some regions about biosimilar interchangeability and immunogenicity. Stronger regulatory frameworks bolstered by science-based technological advances are leading to shortened approval times and streamlined pathways, encouraging more companies to enter the biosimilars arena.
• Technological Progress Facilitates the Expansion of Biosimilar Applications
  • Research into novel biosimilars targeting emerging therapeutic areas such as rare diseases, multiple sclerosis, and other chronic conditions is underway, supported by advances in molecular engineering and protein expression systems. This broadens the pipeline and diversifies therapeutic options, complementing existing treatment standards.

Impacts of Artificial Intelligence (AI) on the Biosimilars Market

Artificial Intelligence (AI) is playing an instrumental role in transforming this sector by enhancing drug development processes, optimizing manufacturing, and improving market strategies. The integration of AI within the biosimilars industry is not only accelerating time-to-market but also ensuring higher precision and cost-efficiency.

• Pfizer’s AI-driven analytics platform integrates real-world evidence and patient data to continuously monitor biosimilar performance and safety post-launch. This approach allows for real-time adjustments to treatment protocols and personalized patient support programs. As a result, healthcare providers and patients experience improved therapeutic outcomes with increased confidence in biosimilar medicines.
• Samsung Bioepis has utilized AI-based predictive models to accelerate stability testing and enhance quality control of biosimilar drugs. By employing AI to analyze protein structures and predict physicochemical behaviors, Samsung Bioepis improved efficiency in the formulation process, reducing development cycles and manufacturing costs.

Regional Insights

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North America Biosimilars Market Analysis and Trends

North America currently dominates the global biosimilars market, accounting for an estimated 40.7% of the global market share in 2025. With biosimilars expected to drive down healthcare costs in the U.S., the U.S. Food and Drug Administration (FDA) has approved over 20 biosimilars to date in an effort to increase competition. Major players in the U.S. market include Pfizer, Novartis, and Merck who are well positioned to leverage their pharmaceutical expertise and capture market share as familiar biosimilars continue to go off-patent.

For instance, April 2025, the U.S. Food and Drugs Administration (FDA) approved 10 biosimilars, including: Celltrion’s Avtozma, Osenvelt and Stoboclo, and Omlyclo; Samsung Bioepis’ Ospomyv and Xbryk; Sanofi-Aventis’ Merilog; Fresenius Kabi’s Bomyntra and Conexxence; and Biocon’s Jobevne.

Europe Biosimilars Market Analysis and Trends

Europe is expected to be the fastest-growing region for the market over the forecast period. Countries like Germany, France, and the U.K. have particularly strong biosimilar markets and industry presence. Germany in particular has emerged as a biosimilars manufacturing powerhouse with several local companies, attracting global biosimilar developers through its strategically strong position in the value chain.

For instance, in April 2025, the European Commission (EC) approved the denosumab (Xgeva) biosimilar Denbrayce for the prevention of skeletal-related events in adult patients with advanced malignancies involving the bone and in adult and skeletally mature adolescent patients with giant cell tumor of the bone.

Biosimilars Market Outlook for Key Countries

U.S. Biosimilars Market Analysis and Trends

In the U.S., biosimilars are gaining traction as health systems and insurers push for lower-cost alternatives to expensive biologic therapies. Intermediaries such as pharmacy benefit managers and insurer plans exert strong influence over formulary placement, driving adoption when incentives align. Regulatory clarity on interchangeable designation has begun to boost prescriber confidence, though uptake remains influenced by pricing strategies and rebate structures.

Germany Biosimilars Market Analysis and Trends

Germany stands out in Europe for its comprehensive approach to encouraging biosimilar use. Regional physician associations set annual prescribing targets backed by financial incentives or penalties, and doctors who exceed quotas may share savings with insurers. Meanwhile, legislation empowers pharmacists to substitute interchangeable biosimilars unless explicitly prohibited—reinforcing uptake through streamlined policies and proactive education among clinicians.

India Biosimilars Market Analysis and Trends

India’s biosimilars sector is driven by cost-sensitive health systems and global manufacturing capacity. With numerous domestic producers and high-quality production standards, Indian companies have become major exporters while maintaining affordable pricing for domestic use. Regulatory evolution and growing emphasis on biologic access support continued expansion both at home and in global markets.

China Biosimilars Market Analysis and Trends

China is a major driver in the biosimilars market due to its rapidly expanding biopharmaceutical sector, supportive government policies, and increasing demand for affordable biologic therapies. The Chinese government has implemented regulatory reforms to accelerate biosimilar approvals, including guidelines that align more closely with international standards.

Pricing Analysis of the Biosimilars Market

• Western Europe:
  • Countries like Germany, France, U.K., Italy, and Spain have considerable biosimilar availability
  • Pricing competition is aggressive, especially in tendered hospital markets
  • Typical discounts at launch range from 20% to 40% depending on product and country
• Nordic Countries (Sweden, Norway, Finland, Denmark):
  • Very competitive markets with centralized procurement tenders
  • Biosimilar prices can show discounts reaching 50%-70% relative to originators
  • High uptake makes biosimilars preferred first-line agents
• Eastern Europe (Poland, Hungary, Czech Republic, Romania):
  • Market penetration of biosimilars is growing but uneven
  • Discounts tend to be higher nominally but originator prices are lower compared to Western Europe
  • Tender systems dominate pricing, leading to significant variability between countries

Market Report Scope

Biosimilars Market Industry News

• In July 2025, Sandoz, announced the beginning of construction for a new, state-of-the-art biosimilars production center for sterile product manufacturing in Brnik, Slovenia. This USD 440 million project will bring the company’s total planned and ongoing investment in Slovenia to more than USD 1.1 billion by 2029.
• In February 2025, Celltrion expanded its biosimilar portfolio in the European Union following European Commission approval of two biosimilars, Eydenzelt (aflibercept), Stoboclo and Osenvelt (denosumab) in the EU market.
• In July 2025, Biocon biologics expanded its diabetes portfolio with FDA approval of Kirsty, the first and only interchangeable rapid-acting insulin aspart in the U.S.
• In June 2025, Alvotech and Dr. Reddy’s entered into a collaboration to co-develop biosimilar candidate to Keytruda (pembrolizumab). The collaboration will combine Dr. Reddy’s and Alvotech’s proven capabilities in biosimilars, thereby, speeding up the development process and extending the global reach for this biosimilar candidate.

Analyst View

• The biosimilars market is gaining significant traction globally due to the increasing demand for affordable therapeutic alternatives to expensive biologics. One of the primary drivers propelling this market is the rising prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes, which necessitate long-term treatment.
• Additionally, patent expirations of several blockbuster biologics have opened opportunities for biosimilar manufacturers, fostering competitive pricing and increased accessibility. However, stringent regulatory frameworks and high development costs remain notable restraints, limiting rapid market penetration, especially in developing regions.
• From a geographical standpoint, North America continues to dominate the biosimilars market, supported by well-established healthcare infrastructure, favorable regulatory policies, and growing acceptance among healthcare professionals. Europe is also a key player, largely due to early adoption facilitated by supportive reimbursement policies and rising awareness. Meanwhile, the Asia Pacific region is emerging as the fastest-growing market, driven by increasing healthcare expenditure, expanding patient population, and growing investments in biopharmaceutical Research & Development (R&D).
• Opportunities in the market are abundant, particularly in expanding therapeutic indications beyond oncology and autoimmune diseases and improving biosimilar manufacturing processes to enhance cost-efficiency.

Market Segmentation

•  Drug Class Insights (Revenue, USD Bn, 2020 - 2032)
• Recombinant Human Growth Hormone
• Granulocyte Colony-Stimulating Factor
• Insulin
• Anticoagulants
• Fusion Proteins Erythropoietin
• Monoclonal Antibodies
• Follitropin
• Others
•  Therapy Type Insights (Revenue, USD Bn, 2020 - 2032)
• Oncology
• Immunology
• Hematology
• Hormone Therapy
• Metabolic Disorders
• Others
•  Distribution Channel Insights (Revenue, USD Bn, 2020 - 2032)
• Hospital Pharmacies
• Retail Pharmacies
• Specialty Pharmacies
• Regional Insights (Revenue, USD Bn, 2020 - 2032)
• North America
• U.S.
• Canada
• Latin America
• Brazil
• Argentina
• Mexico
• Rest of Latin America
• Europe
• Germany
• U.K.
• Spain
• France
• Italy
• Russia
• Rest of Europe
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• ASEAN
• Rest of Asia Pacific
• Middle East
• GCC Countries
• Israel
• Rest of Middle East
• Africa
• South Africa
• North Africa
• Central Africa

Sources

Primary Research Interviews

• Biosimilar Manufacturers
• Contract Research Organizations (CROs)
• Healthcare Providers/Oncologists
• Regulatory Authorities
• Others

Magazines

• BioPharm International
• Generics and Biosimilars Initiative Journal (GaBI Journal)
• Pharmaceutical Technology
• Others

Journals

• Journal of Bioscience and Bioengineering
• mAbs
• Expert Opinion on Biological Therapy
• Others

Newspapers

• The Economic Times - Healthcare Section
• The Financial Times - Pharmaceuticals
• Business Standard - Healthcare News
• Others

Associations

• The Biosimilar Council (part of the Generic Pharmaceutical Association)
• International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
• Biotechnology Innovation Organization (BIO)
• Others

Public Domain Sources

• World Health Organization (WHO)
• U.S. Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• ClinicalTrials.gov
• Others

Proprietary Elements

• CMI Data Analytics Tool – Biosimilars Market
• CMI Existing Repository of Information for the Last 8 Years

*Definition: The global biosimilars market refers to the market for biological medicinal products that are similar to already approved original branded biologic medicines. Biosimilar medicines compete with innovator biologic medicines after the patent and exclusivity period ends. The global biosimilars market has seen significant growth in recent years as patents of large biologics expire and more biosimilars are approved. Various factors such as rising healthcare costs, patent expiries of major biologics, and regulatory support for biosimilars are driving the demand in this market across regions.