Biosimilars Market by Drug Class (mAbs, GCSF, Insulin, Anticoagulant, rhGH, Teriparatide, GLP-1), Indication, Competitive Landscape, Region - Global Forecast to 2035
The global biosimilars market is projected to reach USD 72.29 billion by 2035 from USD 35.04 billion in 2025, at a CAGR of 7.5% during the forecast period. The expansion of the biosimilars market has been predominantly fueled by heightened awareness and education regarding the safety, efficacy, and interchangeability of biosimilar products. Additionally, favorable insurance coverage and reimbursement structures implemented by both public and private payers have played a crucial role in this growth, alongside an increasing demand for cost-effective biologic therapies. Nonetheless, the market faces challenges from escalating complexities in the manufacturing processes and intensifying competition, leading to significant pricing pressures that may hinder further growth.
Scope of the Report
Years Considered for the Study
2024-2032
Base Year
2024
Forecast Period
2024-2035
Units Considered
Value (USD billion)
Segments
Drug Class, Indication, Region
Regions covered
North America, Europe, Asia Pacific, Latin America, Middle East, and Africa
The monoclonal antibodies segment is expected to grow at the highest CAGR during the study period.
Monoclonal antibodies (mAbs) such as infliximab, rituximab, adalimumab, trastuzumab, pembrolizumab, dupilumab, Ustekinumab, Risankizumab, and others are primarily utilized for the treatment of autoimmune disorders, various cancers, chronic illnesses, and select infectious diseases. The anticipated rise in patient demographics, coupled with increasing adoption rates and the impending patent expirations of several key biologics, is projected to drive demand in the mAb sector. These therapeutics are extensively employed in managing chronic and life-threatening conditions, notably cancer, rheumatoid arthritis, psoriasis, and inflammatory bowel disease, which are experiencing heightened global prevalence due to an aging populace and lifestyle-related risk factors. The emergence of biosimilars for these mAbs offers an opportunity to mitigate healthcare expenditures and improve access to essential therapies. With over 10-15 leading mAbs facing patent expirations within the next decade, competition is poised to intensify, piquing the interest of pharmaceutical companies in the mAb market. The affordability and extensive applicability of mAb biosimilars, particularly in oncology and autoimmune therapies, are likely to significantly contribute to future market growth.
The US is expected to grow at the highest CAGR in the global biosimilars market from 2025 to 2035.
The United States is projected to experience the highest compound annual growth rate (CAGR) in the global biosimilars market between 2025 and 2035. This rapid growth is largely driven by the expiration of patents on several blockbuster biologics and the increasingly favorable regulatory environment established by the Biologics Price Competition and Innovation Act (BPCIA). Over the next decade, the US is expected to see biosimilar entries for major biologics such as Keytruda (pembrolizumab), Stelara (ustekinumab), and Eylea (aflibercept), which are all multi-billion-dollar products. These launches will significantly expand the addressable market for biosimilars, particularly in oncology, immunology, and ophthalmology. Additionally, the growing payer and provider acceptance of biosimilars in the US healthcare system is accelerating uptake. For instance, biosimilars of adalimumab (Humira), the highest-selling biologic in the US for over a decade, began launching in 2023 with multiple entrants such as Amgen, Boehringer Ingelheim, and Sandoz. Early signs show that competitive pricing is starting to drive formulary access and payer adoption. Moreover, legislative and policy efforts, including Medicare reforms and price transparency regulations, are expected to further incentivize biosimilar use, leading to cost savings and greater market penetration. As more biosimilars gain interchangeable status, market dynamics are likely to mirror those seen in generics, thus supporting sustained growth in the US biosimilars sector over the next decade.
The primary interviews conducted for this report can be categorized as follows:
By Respondent: Supply Side-70% and Demand Side-30%
By Designation: Managers-45%, CXO and Directors-30%, and Executives-25%
By Region: North America-40%, Europe-25%, the Asia Pacific-25%, Latin America-5%, and the Middle East & Africa-5%
List of Key Companies Profiled in the Report:
Sandoz Group AG (Switzerland), Pfizer Inc. (US), Amgen Inc. (US), Celltrion, Inc. (South Korea), Biocon (India), Dr. Reddy's Laboratories Ltd. (India), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd. (Israel), Fresenius Kabi AG (Germany), STADA Arzneimittel AG (Germany), Boehringer Ingelheim International GmbH (Germany), Samsung Biologics Co., Ltd. (South Korea), Amneal Pharmaceuticals LLC (US), Coherus BioSciences, Inc. (US), Bio-Thera Solutions, Ltd. (China), Aprogen Inc. (South Korea), Shanghai Henlius Biopharmaceuticals, Inc. (China).
Research Coverage:
This research report categorizes the biosimilars market by biosimilars market, by drug class [monoclonal antibodies (rituximab, infliximab, adalimumab, trastuzumab, Pembrolizumab, Dupilumab, Ustekinumab, Risankizumab, and other monoclonal antibodies), granulocyte colony-stimulating factor, insulin, erythropoietin, recombinant human growth hormone, etanercept, follitropin, teriparatide, interferons, anticoagulants, Aflibercept, GLP-1 antagonist, and other products), By indication (oncology, inflammatory and autoimmune diseases, chronic diseases, blood disorders, growth hormone deficiency, infectious diseases, type II diabetes, obesity, and other indications) and by region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa).
The scope of the report covers detailed information regarding the major factors, such as drivers, restraints, challenges, and opportunities, influencing the growth of the biosimilars market. A detailed analysis of the key industry players has been done to provide insights into their business overview, products, solutions, key strategies, collaborations, partnerships, and agreements. New approvals/launches, collaborations, acquisitions, and recent developments associated with the biosimilars market.
Key Benefits of Buying the Report:
The report will help market leaders and new entrants by providing them with the closest approximations of the revenue numbers for the overall biosimilars market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to better position their businesses and make suitable go-to-market strategies. This report will enable stakeholders to understand the market's pulse and provide them with information on the key market drivers, restraints, opportunities, and challenges.
The report provides insights on the following pointers:
Analysis of key drivers (rising global demand for affordable alternatives to expensive biologic therapies, increasing number of biosimilar launches and approvals, Impending and ongoing patent expiry of blockbuster biologics, entry of emerging players with cost-efficient manufacturing capabilities), restraints (manufacturing complexities and high cost of biosimilars, intense competition, and pricing pressure among market players), opportunities (launch of GLP-1 biosimilars, increasing strategic partnerships and collaborations among biosimilar manufacturers, and growing focus on advanced R&D operating models), and Challenges (increased market competition between biosimilar manufacturers and originator biologic companies).
Product Development/Innovation: Detailed insights on upcoming products, research and development activities, and new product approvals/launches in the biosimilars market.
Market Development: Comprehensive information about lucrative markets; the report analyses the market across varied regions.
Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the biosimilars market.
Competitive Assessment: In-depth assessment of market shares, growth strategies, and product offerings of leading players. A detailed analysis of the key industry players has been done to provide insights into their key strategies, product launches/ approvals, pipeline analysis, acquisitions, partnerships, agreements, collaborations, other recent developments, investment and funding activities, brand/product comparative analysis, and vendor valuation and financial metrics of the biosimilars market.
TABLE OF CONTENTS
1 INTRODUCTION
1.1 STUDY OBJECTIVES
1.2 MARKET DEFINITION
1.3 STUDY SCOPE
1.3.1 MARKET SEGMENTATION & REGIONAL SCOPE
1.3.2 INCLUSIONS & EXCLUSIONS
1.3.3 YEARS CONSIDERED
1.3.4 CURRENCY CONSIDERED
1.4 STAKEHOLDERS
1.5 SUMMARY OF CHANGES
2 RESEARCH METHODOLOGY
2.1 RESEARCH DATA
2.1.1 SECONDARY DATA
2.1.1.1 Objectives of secondary research
2.1.1.2 Key data from secondary sources
2.1.2 PRIMARY DATA
2.1.2.1 Breakdown of primaries
2.1.2.2 Key objective of primary research
2.2 MARKET ESTIMATION
2.2.1 GLOBAL MARKET ESTIMATION
2.2.1.1 Company revenue analysis (bottom-up approach)
2.2.1.1.1 Revenue share analysis of Sandoz Group AG