Biosimilars Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Biosimilars Market Report Segments the Industry Into by Product Class (Monoclonal Antibodies, Recombinant Hormones, Immunomodulators, Anti-Inflammatory Agents, Other Product Classes), by Application (Blood Disorders, Growth Hormonal Deficiency, Chronic and Autoimmune Disorders, Oncology, Other Applications), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America).

Global Biosimilars Market Size and Share

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Global Biosimilars Market Analysis by Mordor Intelligence

The biosimilar market size is valued at USD 41.97 billion in 2025 and is forecast to reach USD 97.32 billion by 2030, expanding at an 18.32 % CAGR. This sharp growth curve reflects the biosimilar industry’s passage from cautious pilot programs to routine clinical use, and it signals that payers see follow-on biologics as a structural lever for long-term cost containment. A fresh inference that emerges from the current numbers is that global spending on reference biologics is unlikely to plateau even as biosimilars accelerate because many new originator molecules are simultaneously entering the market. Europe’s 37% biosimilar market share highlights how an early, clear regulatory framework can translate into commercial scale, yet it also illustrates that leadership positions are not immutable—Asia-Pacific now records the highest regional CAGR at 24 %. This regional shift implies that supply chain decisions made in Seoul, Shanghai, and Hyderabad will increasingly shape global price points.

The five-year outlook set out anticipates that more than USD 170 billion worth of biologic revenues will lose exclusivity by 2030, widening the revenue pool accessible to biosimilar entrants. That single datapoint means the biosimilar market size could grow faster than even the high CAGR suggests, as payer-driven substitution policies intensify. A second inference is that while monoclonal antibodies hold a 48% share, their relative dominance may decline because low-molecular-weight heparins and novel fusion proteins are posting steeper growth curves. Furthermore, recent U.S. Food and Drug Administration (FDA) policy revisions that streamline interchangeability designations are likely to compress launch timelines, tilting competitive advantage toward firms with scale manufacturing capacity.

Key Report Takeaways

  • The biosimilar market is forecast to nearly double from USD 41.97 billion in 2025 to USD 97.32 billion by 2030, advancing at an 18.32 % CAGR.
  • Europe retains the largest regional share at 37 %, while Asia-Pacific posts the fastest growth with a 24 % CAGR through 2030.
  • Monoclonal antibodies dominate product class revenue with a 48 % share in 2024; low-molecular-weight heparins represent the fastest-growing class at a 21 % CAGR.
  • Oncology applications lead with 55 % of 2024 revenue, whereas autoimmune and chronic inflammatory indications grow the quickest at a 23 % CAGR.
  • Contract development and manufacturing organizations are on track to control more than 54 % of global biologics capacity by 2028, reshaping make-or-buy strategies.

Segment Analysis

Product Class: Monoclonal Antibodies Lead Market Transformation

The biosimilar market size for monoclonal antibodies stands at 48 % of total revenue in 2024, and while their aggregate CAGR moderates to the mid-teens, absolute sales continue to rise. One inference is that share leadership masks underlying fragmentation, as dozens of mAb targets now split manufacturer focus. Low-molecular-weight heparins are growing at 21% CAGR, signaling that anticoagulation may become the next competitive battleground. FDA approval of five ustekinumab biosimilars in 2024 underscores how clustering of launches compresses price points and may shorten product life cycles for each successive entrant. Developers are prioritizing mAbs such as rituximab and bevacizumab because clinical endpoints are well established, reducing comparative study scope. Yet, emerging bispecific antibodies could complicate future equivalence work, nudging regulators to refine guidelines yet again.

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Note: Segment shares of all individual segments available upon report purchase

Indication: Oncology Dominates While Autoimmune Surges

The oncology segment accounts for 55% biosimilar market share in 2024, commanding the largest slice of reimbursement budgets. An immediate inference is that oncology payers possess the greatest leverage to enforce switching, thereby accelerating penetration. Autoimmune and inflammatory diseases post a 23% forecast CAGR, which implies that by 2030 the revenue gap between the two indications could narrow considerably. Upcoming biosimilar launches targeting checkpoint inhibitors like Yervoy hint at a second-order effect: if expensive immuno-oncology drugs see biosimilar erosion, the savings could fund broader use of precision therapies. In turn, that dynamic may push innovators toward even more complex biologic constructs, renewing the innovation cycle.

End-user: Hospitals Dominate While Retail Channels Expand

Hospitals hold a 68% biosimilar market share in 2024 because intravenous (IV) administration and high-cost oncology regimens anchor spending in infusion centers. Inference: hospital group-purchasing power shapes early price negotiations, but once subcutaneous formulations dominate, retail pharmacy chains will wield more influence. The retail and mail-order channel already shows a 22% forecast CAGR through 2030, driven by self-injectable biosimilars that bypass infusion chairs. Fresenius Kabi’s Tyenne (tocilizumab-aazg) provides both IV and subcutaneous options, evidencing a strategic pivot toward patient-convenience models[3]Michael Brown, “Tyenne Biosimilar Receives FDA Approval,” Fresenius Kabi, fresenius-kabi.com. This shift also introduces inventory-management challenges, as pharmacies must stock multiple vial sizes and devices, increasing logistical complexity.

Manufacturing Type: In-house Dominance Facing CDMO Challenge

In-house manufacturing retains 60 % biosimilar market share in 2024, yet outsourced capacity grows at a 20% CAGR. The inference here is that cost differentials alone cannot explain the surge in outsourcing; instead, speed-to-market and regulatory familiarity drive the trend. CDMOs offer ready-to-use process platforms and validated analytical suites, making them attractive to both start-ups and large pharma units seeking flexibility. Proprietary process knowledge remains a reason for some firms to keep critical steps internal, but tech-transfer innovations are reducing the risk of knowledge leakage. Vertical integration strategies now weigh the trade-off between fixed-cost absorption and supply-chain agility.

Global Biosimilars Market: Market Share by Manufacturing Type
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Route of Administration: Evolving Preferences Reshaping Market

Intravenous infusions remain dominant today, but subcutaneous biosimilars are climbing in uptake, aided by device innovations that reduce injection time. The fresh inference is that dual-route approvals enhance market share because they let clinicians match patient preferences without switching products. Tyenne’s approval in both formulations exemplifies this flexibility. Subcutaneous uptake also correlates with telemedicine adoption, as self-administration enables remote patient monitoring. Patents for subcutaneous delivery systems like rituximab SC expire within the decade, suggesting that more multi-format launches will arrive and could tilt market share toward retail pharmacies.

Geography Analysis

Europe continues to lead with 37 % biosimilar market share, reflecting its pioneering 2006 regulatory path and coordinated procurement policies. Many EU member states have instituted gain-sharing schemes, channeling savings back to hospital budgets, which encourages prescriber engagement. The inference is that Europe’s mature infrastructure now operates as a test-bed for advanced contracting models, such as multi-winner tenders that preserve supplier diversity. Infliximab case studies show that originator prices fell sharply when biosimilars arrived, proving competition works even in specialty therapeutics. The region faces a triple set of loss-of-exclusivity events that will accelerate biosimilar penetration but could also intensify price erosion beyond comfortable thresholds for smaller manufacturers.

Asia-Pacific is the fastest-growing territory at a projected 24 % CAGR, catalyzed by South Korean giants Samsung Bioepis and Celltrion and by China’s regulatory reforms. An inference drawn from capacity figures is that Asia is evolving from a contract-manufacturing hub into a design-and-development powerhouse, evident in the localization of clinical trial infrastructure. India leverages its generics heritage to fast-track biosimilar filings, while Australia and Japan are investing in domestic bioproduction for supply-chain resilience. The pandemic accelerated government incentives for biologics self-sufficiency, suggesting that Asia’s share of global approvals will rise faster than global demand growth alone would indicate.

North America—dominated by the United States—lags Europe in penetration yet offers the largest absolute revenue potential, supported by 56 FDA approvals and 41 launches as of July 2024. A notable inference is that Medicare payment reforms embedded in the Inflation Reduction Act (IRA) may realign incentives toward rapid biosimilar switching in public programs. Projected U.S. savings of USD 181 billion over five years underscore the economic stakes. Canadian provincial formularies are also mandating non-medical switches, a policy choice that could harmonize adoption across the continent. Collectively, these factors point to North America overtaking Europe in market size by the early 2030s if current growth differentials persist.

Global Biosimilars Market CAGR (%), Growth Rate by Region
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Competitive Landscape

The top 10 firms control roughly 70% of biosimilar market share, yet that concentration masks divergent strategies. Samsung Bioepis has surpassed KRW 1 trillion in sales with 12 commercialized molecules, underscoring how scale manufacturing and focused portfolios can outflank diversified Big Pharma. The inference here is that specialized players gain agility by limiting internal competition for capital with high-margin innovative drugs. White-space opportunities also exist in ophthalmology, where biosimilar penetration is minimal but reference drug prices remain high.

Technological differentiation is growing in importance; Samsung Biologics’ proprietary S-AfuCHO and S-HiCon platforms aim to shorten development cycles and improve yields. AI-assisted molecule screening and trial design increase first-time-right success probabilities, suggesting that digital capabilities could widen performance gaps. Some analysts predict Big Pharma may retreat from biosimilars because of price pressure, but statements from Amgen and Pfizer indicate continued commitment, implying that competitive exits, if they occur, will be selective. The inference is that capital markets may reward firms that either dominate innovation or specialize in efficiency, penalizing hybrid models.

Vertical integration by pharmacy benefit managers (PBMs) into biosimilar manufacturing—through entities such as CVS Health’s Cordavis—could reset distribution economics. PBM entry might tighten formulary control, reinforcing their negotiating leverage. The inference is that biosimilar developers who lack PBM partnerships may face restricted market access despite regulatory approval. Consequently, future competitive advantage may hinge on downstream integration rather than solely on manufacturing scale.

Global Biosimilars Industry Leaders

  1. Pfizer Inc

  2. Novartis AG

  3. Samsung Bioepies Co., Ltd

  4. Coherus Biosciences, Inc.

  5. Amgen Inc

  6. *Disclaimer: Major Players sorted in no particular order
Global Biosimilars Market
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Recent Industry Developments

  • March 2025: The FDA approved Celltrion USA's Omlyclo (omalizumab-igec) as the first biosimilar to reference Xolair (omalizumab). The biosimilar, granted interchangeability status, is the first respiratory biosimilar in the US. Omlyclo is approved for managing moderate to severe asthma in adults and children aged 6 and older with allergies unresponsive to inhaled steroids. It is also approved for adults with chronic sinus inflammation and nasal polyps unresponsive to nasal corticosteroids.
  • January 2025: Amgen launched Wezlana (ustekinumab-auub), the first interchangeable Stelara biosimilar, via Optum’s Nuvaila platform, broadening autoimmune treatment access.
  • October 2024: The FDA cleared Imuldosa (ustekinumab-srlf), the fifth U.S. ustekinumab biosimilar, with commercialization rights assigned to Intas Pharmaceuticals.
  • October 2024: Teva’s denosumab biosimilar TVB-009P entered FDA and EMA review, with decisions expected in 2H 2025.

Table of Contents for Global Biosimilars Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Imminent Patent Expiry Of Multiple Blockbuster Biologics
    • 4.2.2 Escalating Prevalence Of Chronic And Autoimmune Diseases
    • 4.2.3 Global Cost-Containment Mandates And Tender-Based Procurement Models
    • 4.2.4 Growing Clinician And Patient Confidence Driven By Real-World Evidence
    • 4.2.5 Rising Capital Investment, Strategic Alliances, And Cmo/Cdmo Capacity Expansions
    • 4.2.6 Increasing Demand Due To Cost-Effectiveness
  • 4.3 Market Restraints
    • 4.3.1 Intrinsic Manufacturing And Analytical Complexity
    • 4.3.2 Ongoing Interchangeability And Substitution Skepticism In Certain Healthcare Systems
    • 4.3.3 Originator Defensive Tactics—Patent Litigation, Rebate Walls, And Brand-Loyalty Programs
    • 4.3.4 Severe Price Erosion And Narrow Margins
  • 4.4 Value-Chain Analysis
  • 4.5 Regulatory Outlook
  • 4.6 Porter’s Five Forces Analysis
    • 4.6.1 Threat of New Entrants
    • 4.6.2 Bargaining Power of Buyers
    • 4.6.3 Bargaining Power of Suppliers
    • 4.6.4 Threat of Substitutes
    • 4.6.5 Competitive Rivalry

5. Market Size & Growth Forecasts (Value)

  • 5.1 By Product Class
    • 5.1.1 Monoclonal Antibodies
    • 5.1.2 Recombinant Hormones (EPO, G-CSF)
    • 5.1.3 Insulins
    • 5.1.4 Low-Molecular-Weight Heparins
    • 5.1.5 Fusion Proteins & Others
  • 5.2 By Indication
    • 5.2.1 Oncology
    • 5.2.2 Autoimmune & Chronic Inflammatory
    • 5.2.3 Metabolic Disorders
    • 5.2.4 Blood & Coagulation Disorders
    • 5.2.5 Others
  • 5.3 By End-user
    • 5.3.1 Hospitals
    • 5.3.2 Specialty Clinics
    • 5.3.3 Retail & Mail-Order Pharmacies
  • 5.4 By Manufacturing Type
    • 5.4.1 In-house
    • 5.4.2 Contract/Outsourced (CMO/CDMO)
  • 5.5 By Expression System
    • 5.5.1 Mammalian Cell (CHO, SP2/0)
    • 5.5.2 Microbial (E. coli, Yeast)
  • 5.6 By Route of Administration
    • 5.6.1 Intravenous
    • 5.6.2 Sub-cutaneous
  • 5.7 By Geography
    • 5.7.1 North America
    • 5.7.1.1 United States
    • 5.7.1.2 Canada
    • 5.7.1.3 Mexico
    • 5.7.2 Europe
    • 5.7.2.1 Germany
    • 5.7.2.2 United Kingdom
    • 5.7.2.3 France
    • 5.7.2.4 Italy
    • 5.7.2.5 Spain
    • 5.7.2.6 Rest of Europe
    • 5.7.3 Asia-Pacific
    • 5.7.3.1 China
    • 5.7.3.2 Japan
    • 5.7.3.3 India
    • 5.7.3.4 South Korea
    • 5.7.3.5 Australia
    • 5.7.3.6 Rest of Asia-Pacific
    • 5.7.4 Middle East
    • 5.7.4.1 GCC
    • 5.7.4.2 South Africa
    • 5.7.4.3 Rest of Middle East
    • 5.7.5 South America
    • 5.7.5.1 Brazil
    • 5.7.5.2 Argentina
    • 5.7.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Strategic Moves
  • 6.3 Market Share Analysis
  • 6.4 Company Profiles (includes Global-level Overview, Market-level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
    • 6.4.1 Pfizer Inc.
    • 6.4.2 Sandoz
    • 6.4.3 Amgen Inc.
    • 6.4.4 Viatris Inc.
    • 6.4.5 Samsung Bioepis Co. Ltd
    • 6.4.6 Celltrion Healthcare
    • 6.4.7 Eli Lilly and Company
    • 6.4.8 Biocon Ltd
    • 6.4.9 Teva Pharmaceutical Industries Ltd
    • 6.4.10 Stada Arzneimittel AG
    • 6.4.11 Dr Reddy’s Laboratories
    • 6.4.12 Coherus Biosciences Inc.
    • 6.4.13 LG Chem (LG Life Sciences)
    • 6.4.14 Intas Pharmaceuticals Ltd
    • 6.4.15 Fresenius Kabi
    • 6.4.16 Alvotech
    • 6.4.17 Bio-Thera Solutions
    • 6.4.18 Shanghai Henlius Biotech
    • 6.4.19 Lupin Ltd
    • 6.4.20 Hikma Pharmaceuticals PLC

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-Need Assessment
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Global Biosimilars Market Report Scope

As per the scope of the report, a biosimilar is a biologic that is "similar" to another biologic medicine (known as a reference product) that is already licensed by the regulatory bodies. Biosimilars are highly similar to the reference product in terms of safety, purity, and potency but may have minor differences in clinically inactive components. In approving biosimilars, the regulatory body may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity, or potency in one or more uses for which the reference product is licensed, and the biosimilar seeks licensure.

The biosimilars market is segmented by product class (monoclonal antibodies, recombinant hormones, immunomodulators, anti-inflammatory agents, and other product classes), application (blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, oncology, and other applications), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated global biosimilar market sizes and trends for 17 countries across various regions. The report offers the value (USD million) for the above-mentioned segments.

By Product Class Monoclonal Antibodies
Recombinant Hormones (EPO, G-CSF)
Insulins
Low-Molecular-Weight Heparins
Fusion Proteins & Others
By Indication Oncology
Autoimmune & Chronic Inflammatory
Metabolic Disorders
Blood & Coagulation Disorders
Others
By End-user Hospitals
Specialty Clinics
Retail & Mail-Order Pharmacies
By Manufacturing Type In-house
Contract/Outsourced (CMO/CDMO)
By Expression System Mammalian Cell (CHO, SP2/0)
Microbial (E. coli, Yeast)
By Route of Administration Intravenous
Sub-cutaneous
By Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
South Korea
Australia
Rest of Asia-Pacific
Middle East GCC
South Africa
Rest of Middle East
South America Brazil
Argentina
Rest of South America
By Product Class
Monoclonal Antibodies
Recombinant Hormones (EPO, G-CSF)
Insulins
Low-Molecular-Weight Heparins
Fusion Proteins & Others
By Indication
Oncology
Autoimmune & Chronic Inflammatory
Metabolic Disorders
Blood & Coagulation Disorders
Others
By End-user
Hospitals
Specialty Clinics
Retail & Mail-Order Pharmacies
By Manufacturing Type
In-house
Contract/Outsourced (CMO/CDMO)
By Expression System
Mammalian Cell (CHO, SP2/0)
Microbial (E. coli, Yeast)
By Route of Administration
Intravenous
Sub-cutaneous
By Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
South Korea
Australia
Rest of Asia-Pacific
Middle East GCC
South Africa
Rest of Middle East
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

How big is the Global Biosimilars Market?

The Global Biosimilars Market size is expected to reach USD 41.97 billion in 2025 and grow at a CAGR of 18.32% to reach USD 97.32 billion by 2030.

Which region holds the largest biosimilar market share?

Europe leads with a 37 % market share, supported by its early regulatory framework and high adoption rates.

Which is the fastest growing region in Global Biosimilars Market?

Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).

Why are monoclonal antibody biosimilars so important?

Monoclonal antibodies command 48 % of biosimilar revenue because their reference products are high-cost therapies in oncology and autoimmune diseases, creating strong economic incentives for follow-on versions.

Page last updated on: July 2, 2025