Biosimilars Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Indication (Oncology, Inflammatory and Autoimmune Diseases, Chronic Diseases, Blood Disorders, Growth Hormone Deficiency, Infectious Diseases, and Others), By Product (Monoclonal Antibodies, Insulin, Granulocyte Colony-Stimulating Factor, Erythropoietin, Recombinant Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Interferons, Anticoagulants, Others), By Region and Competition, 2020-2030F

Market Overview

The Global Biosimilars Market will grow from USD 31.07 Billion in 2024 to USD 42.36 Billion by 2030 at a 5.30% CAGR. Biosimilars are biological medical products highly similar to an already approved original biologic, known as the reference product, demonstrating no clinically meaningful differences in safety, purity, and effectiveness. The global biosimilars market's growth is primarily driven by the imminent patent expiry of numerous blockbuster biologics, compelling the demand for more affordable therapeutic alternatives, alongside the increasing prevalence of chronic diseases globally. Furthermore, supportive regulatory frameworks across various regions contribute significantly to market expansion by streamlining approval pathways.

In the United States, according to the Association for Accessible Medicines, generic and biosimilar medicines together generated $467 billion in savings for the healthcare system in 2024, highlighting their critical role in cost containment. Despite these benefits, a significant challenge impeding global market expansion remains the inherent manufacturing complexities and high associated costs required to develop and produce biosimilar products, due to their intricate biological nature.

Key Market Drivers

The global biosimilars market expansion is fundamentally propelled by the imminent patent expiration of numerous high-value biologic drugs, creating substantial opportunities for more affordable alternatives. The pharmaceutical industry is currently navigating a significant $236 billion patent cliff projected between 2025 and 2030, with nearly 70 blockbuster products set to lose exclusivity and open their therapeutic areas to biosimilar competition. This widespread loss of exclusivity acts as a primary catalyst, enabling biosimilar manufacturers to develop and launch products that directly compete with established biologics. Concurrently, the enhanced cost-effectiveness and affordability offered by biosimilars represent a critical market driver, addressing increasing pressures on healthcare budgets globally. These products provide clinically equivalent treatment options at a reduced cost, significantly contributing to healthcare system savings. According to the Association for Accessible Medicines (AAM)'s September 2025 report "Biosimilars Drive Savings and Access, Yet Looming Development Gap Threatens Future", biosimilars generated $20.2 billion in savings in 2024 alone, underscoring their crucial role in mitigating rising drug expenditures. This economic advantage fosters greater patient access and broader adoption among payers and healthcare providers.

The increasing approval rate for biosimilar products also significantly shapes the global market, signaling maturing conditions and reinforcing stakeholder confidence. As of July 2025, the U.S. Food and Drug Administration had approved 84 biosimilars for 21 reference products, according to the Association for Accessible Medicines (AAM)'s September 2025 report "Biosimilars Drive Savings and Access, Yet Looming Development Gap Threatens Future." This steady increase broadens the scope of treatable conditions with more economical options, fostering a competitive landscape that encourages further innovation and investment in the biosimilar development pipeline.

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Key Market Challenges

The inherent manufacturing complexities and high associated costs represent a significant impediment to the global biosimilars market's expansion. Developing and producing biosimilar products requires extensive investment in research, highly specialized manufacturing facilities, and stringent purification processes due to their intricate biological nature. These factors directly contribute to extended development timelines and elevated capital expenditure for biosimilar manufacturers, creating substantial financial outlay and technical hurdles.

This situation can deter new market entrants and limit the capacity for existing players to scale production efficiently, directly impacting the competitive landscape. According to the Association for Accessible Medicines' 2025 U.S. Generic & Biosimilar Medicines Savings Report, out of 118 biologics projected to lose patent exclusivity over the next decade, only 12 molecules currently have biosimilars in development, highlighting a "biosimilar void". This lack of pipeline activity underscores how the inherent high costs and complexities in development translate into reduced market competition and slower expansion of affordable therapeutic alternatives.

Key Market Trends

The global biosimilars market is significantly influenced by the expansion into GLP-1 agonist biosimilars, marking a strategic pivot towards high-demand therapeutic areas. This trend addresses the substantial patient populations grappling with chronic conditions such as type 2 diabetes and obesity, promising to broaden access and alleviate healthcare costs. The entry of biosimilar versions of these highly effective drugs is poised to intensify competition and foster innovation within this lucrative segment. According to Teva Pharmaceuticals, in the third quarter of 2025, the company launched its liraglutide injection, a generic version of Saxenda, representing the first generic GLP-1 treatment specifically for weight loss, which strengthens its complex generics portfolio. This development highlights the market's trajectory towards offering more affordable options in areas previously dominated by expensive branded biologics.

Another key trend shaping the market is the increasing prevalence of strategic alliances and commercial partnerships. Companies are actively forging collaborations to share the substantial costs and risks associated with biosimilar development and commercialization, while also leveraging complementary expertise in manufacturing, regulatory navigation, and market penetration. These partnerships are instrumental in accelerating product pipelines and ensuring wider geographical reach, particularly for complex biologic molecules. For instance, on September 19, 2025, Alvotech's Japanese partner, Fuji Pharma, secured marketing approval for three biosimilars—AVT03, AVT05, and AVT06—from the Japanese Ministry of Health, Labor and Welfare, demonstrating the critical role of such alliances in achieving global market access and regulatory milestones. This collaborative approach enables efficient resource allocation and capitalizes on localized market insights.

Segmental Insights

The oncology segment stands out as the fastest-growing area within the global biosimilars market, driven by a confluence of factors. The increasing worldwide prevalence of various cancer types creates an urgent and substantial demand for effective therapeutic solutions. This demand is increasingly met by biosimilars as patent expirations for numerous blockbuster biologic cancer drugs open avenues for more affordable alternatives. Consequently, healthcare systems globally are actively seeking cost-effective treatment options, and biosimilars significantly reduce expenditures, enhancing patient access to essential therapies. Furthermore, well-defined regulatory pathways established by authoritative bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) facilitate timely approvals and foster confidence in the safety and efficacy of oncology biosimilars.

Regional Insights

North America leads the global biosimilars market, primarily driven by a robust regulatory environment. The U.S. Food and Drug Administration, through legislation like the Biologics Price Competition and Innovation Act, has established clear pathways for biosimilar approval, facilitating market entry and competition. This supportive framework, coupled with the impending patent expiration of numerous high-value blockbuster biologics, creates substantial opportunities for biosimilar manufacturers. Furthermore, increasing prevalence of chronic diseases and the imperative for cost-effective treatment options among patients and healthcare systems are accelerating the adoption of biosimilars across the region. Advanced healthcare infrastructure and growing awareness among healthcare professionals also contribute to North America's market dominance.

Recent Developments

• In June 2025, Sandoz commenced the US launch of Wyost® and Jubbonti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab). These products were the first and only interchangeable denosumab biosimilars to achieve approval (in March 2024) and subsequent market introduction in the United States. They offered the same indications, dosage forms, and routes of administration as Amgen's reference products. The market entry followed a settlement agreement between Sandoz and Amgen in April 2024, which resolved patent infringement litigation and allowed for the US launch starting May 31, 2025. This development contributed new, cost-effective alternatives to the global biosimilars market for bone health.

• In January 2025, Sandoz outlined its strategic roadmap, reporting strong financial performance in the biosimilars sector. The company had achieved over 30% sales growth during the first nine months of 2024, primarily driven by its biosimilar portfolio. Sandoz also announced an expansion of its biosimilar pipeline to include 28 molecules, with plans for five mid-term launches such as Pyzchiva®, Tyruko®, Wyost®/Jubbonti®, and Afqlir®. This strategy aimed to leverage significant market opportunities presented by reference medicines valued at over $400 billion, whose exclusivities were set to expire between 2029 and 2034, reinforcing Sandoz's position in the global biosimilars market.

• In May 2024, Teva and Alvotech announced the availability of their interchangeable adalimumab biosimilar, Simlandi® (adalimumab-ryvk, AVT02), in the United States. Simlandi® had received FDA approval in February 2024, becoming the first interchangeable, high-concentration, citrate-free biosimilar to Humira. This launch was particularly significant because the high-concentration formulation accounted for nearly 88% of adalimumab prescriptions in the US. The collaboration between Teva, responsible for US commercialization, and Alvotech, handling development and manufacturing, aimed to increase access to affordable treatment options within the global biosimilars market, addressing various autoimmune conditions.

• In February 2024, Alvotech disclosed its intentions to launch AVT04, a biosimilar referencing Johnson & Johnson’s Stelara, across several key international markets. Following successful settlements with Johnson & Johnson, Alvotech prepared for market entry in Canada, Japan, and the European Economic Area. Regulatory approvals had been secured in these regions. The company anticipated that its biosimilar would first become available in Canada during the first quarter of 2024, followed by Japan after national reimbursement listings in May. Introduction into European markets was planned as soon as possible, subsequent to Stelara’s European supplementary protection certificate expiration in late July. This initiative significantly expanded the global biosimilars market.

Key Market Players

• Dr. Reddy's Laboratories Ltd.
• Sandoz Group AG
• Coherus Biosciences
• Viatris Inc.
• Bio-Thera Solutions
• Pfizer Inc.
• Apobiologix
• Teva Pharmaceuticals
• Biocon Ltd
• Reliance Life Sciences

Report Scope:

In this report, the Global Biosimilars Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Biosimilars Market, By Indication:

o   Oncology

o   Inflammatory and autoimmune diseases

o   Chronic diseases

o   Blood disorders

o   Growth hormone deficiency

o   Infectious diseases

o   Others

• Biosimilars Market, By Product:

o   Monoclonal antibodies

o   Insulin

o   Granulocyte colony-stimulating factor

o   Erythropoietin

o   Recombinant human growth hormone

o   Etanercept

o   follitropin

o   Teriparatide

o   Interferons

o   Anticoagulants

o   Others

• Biosimilars Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Biosimilars Market.

Available Customizations:

Global Biosimilars Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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