Biosimilars Market Research Report – Segmented by Product Type (Monoclonal Antibodies, Recombinant Hormones, Immunomodulators, Anti-Inflammatory Agents, and Others); By Therapeutic Application (Oncology, Autoimmune Diseases, Hematology Disorders, Infectious Diseases, Endocrine Disorders, and Others); By Distribution Channels ( Hospital Pharmacies, Speciality Clinics and Centers, Retail Pharmacies, Online Pharmacies, and Others); and Region - Size, Share, Growth Analysis | Forecast (2023 – 2030)

Biosimilars Market Size (2023-2030)

The Global Biosimilars Market was valued at USD 33.37 billion and is projected to reach a market size of USD 70.69 billion by the end of 2030. Over the forecast period of 2024-2030, the market is projected to grow at a CAGR of 11.32%. 


Biosimilars are highly similar to approved reference biological products, but not identical, as they are complex, large molecules produced using living organisms. Extensive scientific and regulatory processes are followed to establish their similarity, safety, and efficacy. Biosimilars offer increased access to affordable biological therapies, promote competition, and undergo strict regulatory evaluation. They are not interchangeable with the reference product and require the involvement of healthcare professionals for prescribing. Biosimilars play a vital role in expanding treatment options while maintaining high standards of safety and efficacy. Biosimilars offer several benefits to healthcare systems and patients. They provide increased access to biological therapies at potentially lower costs, promoting affordability and improving patient access to essential treatments. Biosimilars foster competition in the market, driving down prices and potentially reducing healthcare expenditure.

Global Biosimilars Market Drivers:

The aging population and the increase in chronic diseases are boosting market demand

The global increase in the aging population and the prevalence of chronic diseases, including cancer, has created a higher demand for biological therapies. Biosimilars can expand access to these life-saving treatments, providing more options for patients. The availability of biosimilars for cancer treatment not only expands access but also fosters competition within the biologics market. Increased competition can drive down prices, leading to more cost-effective options for patients and healthcare systems. This competition promotes innovation and investment in the development of new biosimilars, enhancing treatment options for cancer patients. Moreover, biosimilars can also contribute to the sustainability of healthcare systems. The cost savings associated with biosimilars can free up resources that can be directed toward other healthcare priorities, such as research, early detection, and supportive care for cancer patients.

Increasing demand for cost-effective healthcare is fuelling the market for biosimilars

Biosimilars have the potential to offer substantial cost savings compared to originator biologics. The development and production of biosimilars typically require less investment and resources compared to developing an entirely new biologic. By offering cost-effective alternatives, biosimilars help address the rising demand for more affordable healthcare solutions. The high cost of originator biologics can place a significant financial burden on patients, especially those with chronic or complex diseases who require long-term treatment. Biosimilars provide an opportunity to reduce this financial burden and improve patient access to essential treatment. By incorporating biosimilars into treatment options, payers can allocate resources more efficiently and effectively. For instance, European Commission estimated potential cost savings of €11.8 to €33.4 billion in European Union healthcare systems from 2007 to 2020 due to the use of biosimilars. The American Journal of Managed Care published a study that concluded that the use of biosimilar infliximab led to cost savings of $6.4 million over 1 year.

Increasing government investments, initiatives, and policies are together contributing to the growth of biosimilars

Governments worldwide are implementing policies to drive the adoption of biosimilars and achieve cost savings in healthcare systems. These include reimbursement policies, tendering processes, educational campaigns, and robust regulatory frameworks. These initiatives promote the use of biosimilars, increase market demand, and ensure affordable and sustainable healthcare. Increased funding from the federal government and the growth of the healthcare industry, driven by both public and private players, particularly in developing economies, are key factors driving the growth of the personal health devices market. Other factors include a rise in personal disposable income, technological advancements in hospitals, increased investment in advanced healthcare, and a growing focus on women's healthcare and hormonal imbalance treatment. These factors collectively contribute to the positive growth rate of the market.

Global Biosimilars Market Challenges:

Regulatory Complexity and Intellectual Property and Market Exclusivity are some of the reasons leading to the slowdown of the biosimilars market

The regulatory pathway for biosimilars can be complex and time-consuming. The rigorous regulatory requirements and lengthy approval processes are in place to ensure patient safety and maintain the high quality and efficacy standards of biological therapies. However, these processes can lead to increased development costs for biosimilar manufacturers, as they require significant investments in clinical trials, manufacturing, and regulatory compliance. Additionally, originator biologics often hold patents and market exclusivity rights, limiting the entry of biosimilars into the market. Legal battles and patent disputes between biosimilar manufacturers and originator biologic companies can create uncertainties and delays. Patent litigation can impact the launch and availability of biosimilars, affecting market competition.

Global Biosimilars Market Opportunities:

Biosimilars are being developed across a range of therapeutic areas, including oncology, autoimmune diseases, and chronic conditions. As more therapeutic areas are explored, it opens up opportunities for biosimilar manufacturers to address unmet medical needs and provide affordable treatment options. Developing economies with growing healthcare infrastructure and increasing access to healthcare present significant opportunities for biosimilar manufacturers. These markets have a rising demand for affordable biologics and offer the potential for market expansion.

COVID-19 Impact on the Global Biosimilars Market:

The COVID-19 pandemic has had both positive and negative impacts on the biosimilars market. The pandemic resulted in disruptions to global supply chains, impacting the production and distribution of biosimilars. Manufacturing facilities faced challenges such as workforce shortages, transportation disruptions, and raw material shortages, which affected the availability of biosimilar products. Many clinical trials for biosimilars were temporarily halted or delayed due to the pandemic. Restrictions on patient enrollment, limited access to healthcare facilities, and prioritization of COVID-19 research affected the progress of clinical studies, potentially delaying the approval and market entry of biosimilars.

COVID-19 saw some positive inclination as well towards biosimilars. The pandemic highlighted the importance of biological therapies, particularly in the context of COVID-19 treatments and vaccines. This increased focus on biologics has created opportunities for biosimilars as they offer more cost-effective alternatives to originator biologics. The economic impact of the pandemic has placed greater emphasis on cost management in healthcare systems. This has created opportunities for biosimilars as they can offer significant cost savings compared to originator biologics. Some governments implemented policies and initiatives to support the use of biosimilars during the pandemic. These include regulatory flexibility, accelerated approval processes, and incentives to promote the adoption of biosimilars, aiming to increase access to affordable treatments and manage healthcare costs.




Market Size Available

2022 - 2030

Base Year


Forecast Period

2023 - 2030



Segments Covered

By Product Type, Therapeutic Application, Distribution Channel, and Region

Various Analyses Covered

Global, Regional & Country Level Analysis, Segment-Level Analysis, DROC, PESTLE Analysis, Porter’s Five Forces Analysis, Competitive Landscape, Analyst Overview on Investment Opportunities

Regional Scope

North America, Europe, APAC, Latin America, Middle East & Africa

Key Companies Profiled

Pfizer Inc., Novartis International AG (Sandoz), Amgen Inc., Celltrion Inc., Biocon Ltd., Teva Pharmaceutical Industries Ltd., Samsung Bioepis Co., Ltd., Mylan N.V., Fresenius Kabi AG

Global Biosimilars Market Segmentation: By Product Type

Based on the product type, the largest segment in terms of market size and adoption is typically the biosimilars targeting monoclonal antibodies. Monoclonal antibodies have a broad range of applications in treating various diseases, including cancer, autoimmune disorders, and inflammatory conditions. The demand for biosimilars in this segment is driven by the high prevalence of these diseases and the need for more cost-effective treatment options. Biosimilar monoclonal antibodies have gained significant traction in the market due to their potential for cost savings and expanded patient access to these critical therapies.

Global Biosimilars Market Segmentation: By Therapeutic Application

  • Oncology

  • Autoimmune Diseases

  • Hematology Disorders

  • Infectious Diseases

  • Endocrine Disorders

  • Others

Among the segments in the biosimilars market based on application, the largest segment is typically the oncology segment. The demand for biosimilars in oncology is driven by the high prevalence of cancer and the need for more affordable and accessible treatment options. Biosimilar products in this segment aim to provide cost-effective alternatives to originator biologics for various types of cancer, such as breast cancer, lung cancer, colorectal cancer, and others. The oncology segment has witnessed significant adoption and market size due to the increasing acceptance and utilization of biosimilars in cancer therapy. The autoimmune diseases segment is often projected to be one of the fastest-growing segments. The prevalence of autoimmune diseases is increasing, driving the demand for effective and affordable treatment options.

Global Biosimilars Market Segmentation: By Distribution Channel

  • Hospital Pharmacies

  • Speciality Clinics and Centers

  • Retail Pharmacies

  • Online Pharmacies

  • Others

Based on the distribution channel, the largest segment is typically hospital pharmacies. Hospital pharmacies are responsible for dispensing biosimilars to healthcare professionals for patient treatment. Given the significant patient volume and the diverse range of diseases and conditions treated in hospitals, the utilization of biosimilars through hospital pharmacies tends to be the largest segment in terms of distribution.

Online pharmacies and retail pharmacies are often anticipated to be the fastest-growing segments. The rise of e-commerce and the increasing acceptance of online transactions have contributed to the growth of online pharmacies as a distribution channel for biosimilars. Retail pharmacies are easily accessible to the general public and provide face-to-face interaction with pharmacists.

Global Biosimilars Market Segmentation: By Region

  • North America

  • Europe

  • Asia Pacific

  • Middle East and Africa

  • South America

Based on region, the largest segment is typically Europe. Europe has been a frontrunner in the adoption and development of biosimilars and holds the largest share of this market, with countries like Germany, France, and the United Kingdom leading the way. Europe has a well-established biosimilars market supported by favorable regulatory policies, robust healthcare systems, and extensive experience in the approval and utilization of biosimilars.

Asia-Pacific region is often projected to be the fastest-growing segment, including countries such as China, India, and Japan, which have witnessed significant growth in the biosimilars market. Factors such as rising healthcare expenditure, increasing demand for affordable treatments, supportive government initiatives, the region's large population, rising prevalence of chronic diseases, and the need to address healthcare access and affordability issues contribute to the strong growth potential for biosimilars in this region.

Global Biosimilars Market Key Players:

  1. Pfizer Inc.

  2. Novartis International AG (Sandoz)

  3. Amgen Inc.

  4. Celltrion Inc.

  5. Biocon Ltd.

  6. Teva Pharmaceutical Industries Ltd.

  7. Samsung Bioepis Co., Ltd.

  8. Mylan N.V.

  9. Fresenius Kabi AG

Chapter 1. Biosimilars Market - Scope & Methodology
1.1    Market Segmentation
1.2    Assumptions
1.3    Research Methodology
1.4    Primary Sources
1.5    Secondary Sources
Chapter 2. Biosimilars Market - Executive Summary
2.1    Market Size & Forecast – (2023 – 2030) ($M/$Bn)
2.2    Key Trends & Insights
2.3    COVID-19 Impact Analysis
           2.3.1    Impact during 2023 – 2030
           2.3.2    Impact on Supply – Demand
Chapter 3. Biosimilars Market - Competition Scenario
3.1    Market Share Analysis
3.2    Product Benchmarking
3.3    Competitive Strategy & Development Scenario
3.4    Competitive Pricing Analysis
3.5    Supplier - Distributor Analysis
Chapter 4. Biosimilars Market - Entry Scenario
4.1     Case Studies – Start-up/Thriving Companies
4.2     Regulatory Scenario - By Region
4.3    Customer Analysis
4.4     Porter's Five Force Model
           4.4.1     Bargaining Power of Suppliers
           4.4.2     Bargaining Powers of Customers
           4.4.3    Threat of New Entrants
           4.4.4     Rivalry among Existing Players
           4.4.5    Threat of Substitutes
Chapter 5. Biosimilars Market - Landscape
5.1     Value Chain Analysis – Key Stakeholders Impact Analysis
5.2    Market Drivers
5.3    Market Restraints/Challenges
5.4    Market Opportunities 
Chapter 6. Biosimilars Market - By Product Type
6.1    Monoclonal Antibodies
6.2    Recombinant Hormones
6.3    Immunomodulators
6.4    Anti-Inflammatory Agents
6.5    Others
Chapter 7. Biosimilars Market - By Therapeutic Application
7.1    Oncology
7.2    Autoimmune Diseases
7.3    Hematology Disorders
7.4    Infectious Diseases
7.5    Endocrine Disorders
7.6    Others
Chapter 8. Biosimilars Market - By Distribution Channel
8.1    Hospital Pharmacies
8.2    Speciality Clinics and Centers
8.3    Retail Pharmacies
8.4    Online Pharmacies
8.5    Others
Chapter 9. Biosimilars Market – By Region
9.1    North America
9.2    Europe
9.3    Asia-Pacific
9.4    Latin America
9.5    The Middle East
9.6    Africa
Chapter 10. Biosimilars Market – Key players
10.1    Pfizer Inc.
10.2    Novartis International AG (Sandoz)
10.3    Amgen Inc.
10.4    Celltrion Inc.
10.5    Biocon Ltd.
10.6    Teva Pharmaceutical Industries Ltd.
10.7    Samsung Bioepis Co., Ltd.
10.8    Mylan N.V.
10.9    Fresenius Kabi AG


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Frequently Asked Questions

The Global Biosimilars Market was estimated to be worth USD 29.98 Billion in 2023 and is anticipated to reach a value of USD 70.70 Billion by 2030, growing at a fast CAGR of 11.32% during the forecast period 2023-2030.

The global Biosimilars market is driven by factors such as cost savings, increasing demand for biologics, rising prevalence of chronic diseases and cancer, and supportive government initiatives.

Monoclonal Antibodies, Insulin, Growth Factors, Interferons, and Erythropoietin are segments under the Global Biosimilars Market by product type.

Europe dominates the market in Global Biosimilars Market.

Asia-Pacific is the fastest-growing region in the Global Biosimilars Market.

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