USD 27.3 Billion
Report ID:
SQMIG35H2167 |
Region:
Global |
Published Date: August, 2024
Pages:
165
|Tables:
70
|Figures:
75
Global Biosimilars Market size was valued at USD 11.39 Billion in 2023 poised to grow from USD 13.15 Billion in 2024 to USD 41.63 Billion by 2032, growing at a CAGR of 15.49% in the forecast period (2025-2032).
The global biosimilars market growth is mainly driven by the patent loss of biologic drugs as more affordable versions of the drug comes up. For example, patent expiration of popular biologics such as Humira (adalimumab), Remicade (infliximab), and Herceptin (trastuzumab) has triggered the lift-off of biosimilar approvals and launches globally. This is translated to huge cost savings for patients and healthcare systems, as these are normally priced 15-30% cheaper than their reference biologics. Lower cost promotes increased adoption levels, particularly in markets that could not afford biologics prior to the present.
The governments and healthcare systems are saving costs while advocating for biosimilar uptake with their reimbursement policies and substitution frameworks. For instance, finance minister of India, Nirmala Sitharaman, on 1 February 2025, widened the list of life-saving medicines exempted from Basic Customs Duty (BCD) to add advanced medicines for cancer, orphan diseases, and immune disorders with an aim to reducing the burden on patients and widening the availability of critical drugs Thus, boosting the biosimilars market growth at an accelerated pace.
One of the driving factors for biosimilars industry is support from regulatory agencies and streamlined approval procedures such as Biologics Price Competition and Innovation Act (BPCIA) and 351(k) Biologics License Application (BLA). As a response to increasing demand for affordable biologic substitutes, agencies such as the U.S. FDA, European Medicines Agency (EMA), and the WHO have created regulatory frameworks to make biosimilar approval quicker and more efficient.
For instance, the FDA's Biologics Price Competition and Innovation Act (BPCIA) offers biosimilars an abbreviated licensure pathway, lowering the cost of development and time-to-market. In the same vein, the EMA's customized guidelines enable them to skip some of the preclinical trials if they show equivalence to the reference biologics. This means, instead of conducting all standard preclinical tests from scratch, they only need to provide sufficient evidence that they match the reference biologic in terms of safety, efficacy, and quality.
This simplified regulatory process reduces barriers to entry for manufacturers, promotes competition, and speeds up biosimilar launches, further entrenching the global biosimilars market's growth path.
AI is revolutionizing biosimilar development by enhancing biologic characterization, process optimization, and predictive analytics. Artificial intelligence-based machine learning models scrutinize intricate biologic structures, enhancing bio similarity evaluations and minimizing comparability study time. This results in accelerated biosimilar approval times and reduced R&D expenses, while promoting market competitiveness.
A January 2022 collaboration between Biogen and Insilico Medicine is a significant example. Global biotech giant Biogen has incorporated machine learning models and Insilico Medicine's AI-powered predictive analytics to speed up biologic characterization and automate the biosimilar development process. R&D costs fall by 50% and the time taken to receive regulatory approvals shortens when AI systems determine complex protein structures, optimize comparison studies and enhance manufacturing procedures. AI-based protein modeling platforms analyze molecular structures to predict the stability and efficacy of biosimilars, enabling more efficient manufacturing processes by reducing trial-and-error experiments and optimizing formulation development.
Moreover, AI enhances pharmacovigilance and regulatory compliance through automation of adverse event detection with the use of real-time analysis from electronic health records and social media. The regulatory authorities, such as the FDA and EMA, are implementing AI to monitor post-markets, and the biosimilars have to meet standards for safety and efficacy, enhancing confidence and adoption.
In January 2024, AION Labs, an Israeli firm that applies AI and machine learning to enhance drug discovery, launched a new firm named TenAces Biosciences. The new company is aimed at the discovery of molecular glues—small molecules that enable protein-protein interactions and enables therapeutic effects and facilitates the treatment for those diseases which were considered untreatable previously. With the application of ML, the company focuses on identifying those molecular glues which can help bind with E3 ubiquitin ligases systematically.
Market snapshot - 2025-2032
Global Market Size
USD 27.3 Billion
Largest Segment
Monoclonal Antibodies
Fastest Growth
Insulin
Growth Rate
16.4% CAGR
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The global biosimilars market is segmented based on type, application, end use, and region. In terms of type, the market is grouped into monoclonal antibodies, insulin, erythropoietin, and growth hormones. Based on application, the market is segmented into oncology, autoimmune diseases, diabetes, and chronic inflammatory diseases. In terms of end use, the market is grouped into hospitals, clinics, homecare, and research institutions. By manufacturer, it is categorized into contract research & manufacturing services and in-house. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Central & South America and the Middle East & Africa.
As per the global biosimilars market forecast, the monoclonal antibody (mAb) segment is dominating the biosimilars market share due to their efficacy, widespread application, and cost-effectiveness. These find their major applications in oncology, autoimmune disorders, and inflammatory conditions, providing cost-effective alternatives to costly biologics. The clearance and extensive use of trastuzumab biosimilars in HER2-positive breast cancer is a significant example of monoclonal antibody (mAb) biosimilars taking over the market. As cheaper alternatives to Roche's Herceptin, other companies, such as Samsung Bioepis, Biocon, and Amgen, have developed and marketed successful trastuzumab biosimilars (e.g., Ogivri, Herzuma, and Kanjinti). Since they are cheaper and offer similar safety and efficacy, targeted cancer therapy is now available everywhere. The FDA and EMA's marketing clearances simplified market entry, especially for increasing use of mAb biosimilars in cancer.
However, with the increasing incidence of diabetes globally, insulin is one of segment with the highest growth rate. Big pharma players such as Novo Nordisk and Eli Lilly are designing novel solutions in response to the increased demand for more efficient and convenient insulin administration for patients. Novo Nordisk's once-weekly insulin Icodec, for example, makes the lives of diabetic patients more convenient as it decreases injection frequency and makes adherence easier.
Oncology is the largest segment of Biosimilars market since biosimilars are available at a lower cost than innovative biologics and there are vast numbers of cancer patients. Prices have been reduced, and cancer treatment has been made affordable and accessible with the introduction of them in the oncology market. Additionally, since cancer exhibits high incidence and prevalence globally, the health care systems across the world are making cutting the burden of cancer through use of cost-effective therapeutic regimens a top priority.
According to the International Agency for Research on Cancer (IARC) estimates, by the year 2040, the cancer burden is anticipated to rise to 27.5 million new cases of cancer and 16.3 million cancer-related deaths worldwide. Growing numbers of cancer cases are poised to drive demand for advanced cancer drugs for treating patients successfully.
However, diabetes is an emerging field of application which is increasingly common in aging, ill diets, and unhealthy living patterns. Continuous glucose monitoring systems (CGMSs) and smart insulin pens are transforming the field of diabetes. For maximizing patient improvement and minimizing risk from diabetes-related complications, the digital insulin pen offered by Eli Lilly, for instance, synchronizes with CGMSs in real-time glucose displays.
According to the global biosimilars market report, hospitals play a crucial role in the prescribing of complex biologic drugs, especially for chronic diseases such as diabetes, autoimmune disease, and cancer. Thus, the segment dominated the market. Cost savings and incorporation of biosimilars into treatment regimens are among the aspects driving hospital adoption.
Hospitals were responsible for more than 60% of the global biosimilar use, since most biosimilar therapies, such as monoclonal antibodies (such as Rituximab and Trastuzumab), must be given intravenously and under close supervision, which is optimally achieved in a hospital. Moreover, hospital control in this market is reinforced by government and commercial insurance policies that prefer biosimilars in hospital formularies because they are cheaper than original biologics.
Whereas, with patient requests for simplicity, remote monitoring, and self-administered biologics, the homecare category is expanding rapidly. In-home treatments for chronic diseases such as diabetes and autoimmune diseases are being selected by patients as telemedicine and wearable injectors increase in popularity. Self-injected monoclonal antibody therapy and insulin pens, for instance, are increasing and lowering hospitalization rates.
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As a result of strong legislative backup, growing healthcare expenditure, and upcoming biologic patents expirations, North America has the majority of the biosimilars market globally. The regulatory measures such as the Biologics Price Competition and Innovation Act (BPCIA) have supported rapid approvals, while rising need for inexpensive medicines and the presence of big pharmaceutical corporations further accelerate the region's supremacy in biosimilar adoption and development.
As of March 2024, there are 56 approved biosimilars for 18 reference biologics in Canada, and this is changing the North American biosimilars market outlook.
The Europe biosimilars market is experiencing rapid growth, driven by robust healthcare policies, a well-established regulatory framework, and early adoption. The European Medicines Agency (EMA) has approved several biosimilars, fostering competition and reducing healthcare costs. Leading companies such as Polpharma Biologics, Bioeq, and Formycon specialize in immunology, ophthalmology, and oncology, further strengthening the market.
Asia-Pacific is emerging as a key player in the global biosimilars market, driven by rising healthcare demands, cost-conscious consumers, and government policies promoting affordable biologics. Countries like China, Japan, and South Korea have implemented fast-track approval processes and streamlined regulatory systems, accelerating market expansion and increasing access to cost-effective treatments.
A December 2024 report states testing of 24 biosimilars produced by South Korean companies and spread across multiple regions. Out of those, 5 biosimilars were in the re-registration stage, with an estimated target of 10 areas of therapy and 11 were monoclonal antibodies (mAbs).
Japan's biosimilars market expansion is fueled by major industry developments, including Teva's proposed divestment of its joint venture with Takeda to JKI in December 2024, restructuring the industry.
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Rising Prevalence of Chronic Diseases
Rising Demand for Cost-Effective Biologics
Complex and Stringent Regulatory Approval Processes
Strong Market Dominance of Biologic Innovators
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Global biosimilars market is highly competitive, with major pharmaceutical and biotech companies actively expanding their portfolios. The leading biosimilar companies invest in R&D, strategic alliances, and regulatory clearance to capture market share. Some of the notable contributors include Pfizer, Novartis (Sandoz), Amgen, Biocon Biologics, Samsung Bioepis, and Celltrion. These players use cutting-edge manufacturing, biosimilar interchangeability strategies, and competitive pricing to battle in the market. Some of the upcoming players such as Alvotech, Coherus BioSciences, and Polpharma Biologics are also emerging, making a difference through innovation and affordability. As biosimilar adoption increases, competition intensifies, fostering market growth and affordability of biologic treatments globally.
AI is revolutionizing biosimilar development by enhancing biologic characterization, process optimization, and predictive analytics. Artificial intelligence-based machine learning models scrutinize intricate biologic structures, enhancing bio similarity evaluations and minimizing comparability study time. This results in accelerated biosimilar approval times and reduced R&D expenses, while promoting market competitiveness.
A January 2022 collaboration between Biogen and Insilico Medicine is a significant example. Global biotech giant Biogen has incorporated machine learning models and Insilico Medicine's AI-powered predictive analytics to speed up biologic characterization and automate the biosimilar development process. R&D costs fall by 50% and the time taken to receive regulatory approvals shortens when AI systems determine complex protein structures, optimize comparison studies and enhance manufacturing procedures. AI-based protein modeling platforms analyze molecular structures to predict the stability and efficacy of biosimilars, enabling more efficient manufacturing processes by reducing trial-and-error experiments and optimizing formulation development.
Moreover, AI enhances pharmacovigilance and regulatory compliance through automation of adverse event detection with the use of real-time analysis from electronic health records and social media. The regulatory authorities, such as the FDA and EMA, are implementing AI to monitor post-markets, and the biosimilars have to meet standards for safety and efficacy, enhancing confidence and adoption.
In January 2024, AION Labs, an Israeli firm that applies AI and machine learning to enhance drug discovery, launched a new firm named TenAces Biosciences. The new company is aimed at the discovery of molecular glues—small molecules that enable protein-protein interactions and enables therapeutic effects and facilitates the treatment for those diseases which were considered untreatable previously. With the application of ML, the company focuses on identifying those molecular glues which can help bind with E3 ubiquitin ligases systematically.
The global biosimilars industry has grown tremendously, fueled by the demand for affordable substitutes for biologic treatments. Startups are at the center of this action, bringing innovative products and competitive offerings.
The growing global biosimilars market share is facilitated by patent expiry of key biologic medicines, increasing healthcare costs, and an increase in the demand for affordable therapies. Moreover, increased competition is being driven by regulatory support and advancements in biomanufacturing. With wider acceptance of biosimilars, there is more scope for market penetration, thereby resulting in cost savings and greater accessibility to life-extending treatments among patients. Such a transition helps make healthcare sustainable globally.
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the global biosimilars market research is highlighting its revolutionary transformation, fueled by patent expiration, regulatory encouragement, AI innovation, and the emergence of innovative startups. As biosimilars become increasingly accepted around the world, they offer affordable substitutes for costly biologics, driving greater accessibility for patients and minimizing healthcare costs. AI-driven drug development and biomanufacturing improvements are streamlining approvals, reducing R&D expense, and improving biosimilar quality.
In addition, startups are also leading the way in market growth, bringing new technologies and promoting competitive product development. In the future, next-generation biologics and personalized medicine will drive biosimilar development, creating long-term sustainability. With continuous innovation and wider uptake, biosimilars will transform healthcare worldwide by providing affordability, innovation, and better patient outcomes.
Report Metric | Details |
---|---|
Market size value in 2023 | USD 11.39 Billion |
Market size value in 2032 | USD 41.63 Billion |
Growth Rate | 15.49% |
Base year | 2024 |
Forecast period | 2025-2032 |
Forecast Unit (Value) | USD Billion |
Segments covered |
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Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
Companies covered |
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Table Of Content
Executive Summary
Market overview
Parent Market Analysis
Market overview
Market size
KEY MARKET INSIGHTS
COVID IMPACT
MARKET DYNAMICS & OUTLOOK
Market Size by Region
KEY COMPANY PROFILES
Methodology
For the Biosimilars Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Biosimilars Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Biosimilars Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Biosimilars Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
Global Biosimilars Market size was valued at USD 11.39 Billion in 2023 poised to grow from USD 13.15 Billion in 2024 to USD 41.63 Billion by 2032, growing at a CAGR of 15.49% in the forecast period (2025-2032).
Key vendors in the market include Pfizer Inc., Amgen Inc., Samsung Bioepis, Novartis AG, Celltrion Inc., Viatris Inc., Coherus BioSciences, Biogen, Teva Pharmaceutical, Eli Lilly, Merck & Co, Biocon, F. Hoffmann-La Roche Ltd., Dr. Reddy’s Laboratories
Major drugs that are used extensively for the treatment of various diseases are facing patent expiry in recent years and this is opening new opportunities for biosimilar adoption.
Growing demand for affordable healthcare solutions in developing and underdeveloped economies is encouraging biosimilars companies to expand into these markets.
The United States is projected to lead the biosimilars market due to a favorable regulatory environment, substantial investments in medical R&D, and increased biosimilar prescriptions by healthcare professionals.
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