Biosimilars Market Analysis Europe, North America, Asia, Rest of World (ROW) - Germany, US, UK, China, Canada, France, South Korea, Japan, Brazil, UAE - Size and Forecast 2025-2029

Biosimilars Market Size 2025-2029

The biosimilars market size is valued to increase by USD 117.68 billion, at a CAGR of 34.2% from 2024 to 2029. Price advantage of biosimilars over biologics will drive the biosimilars market.

Market Insights

• Europe dominated the market and accounted for a 45% growth during the 2025-2029.
• By Product Type - Monoclonal antibodies segment was valued at USD 3.53 billion in 2023
• By Application - Oncology and hematology segment accounted for the largest market revenue share in 2023

Market Size & Forecast

• Market Opportunities: USD 1.00 million 
• Market Future Opportunities 2024: USD 117678.10 million
• CAGR from 2024 to 2029 : 34.2%

Market Summary

• The market represents a significant segment of the global pharmaceutical industry, characterized by its potential to offer cost savings and expanded treatment options for patients. Biosimilars are biological medicines that have similar active properties as their reference biologic counterparts, but are not exact copies due to the complex nature of biologics. Market growth is driven by several factors, including the increasing affordability of biosimilars compared to their branded counterparts, regulatory approvals, and the growing number of patent expiries of biologics. However, market access remains a challenge, as biosimilars often face barriers to entry, such as regulatory hurdles, healthcare provider and patient reluctance, and complex supply chains.
• For instance, optimizing the supply chain is a crucial aspect of bringing biosimilars to market. Biosimilars manufacturers must navigate complex regulatory requirements, ensure product quality, and establish effective distribution networks. One real-world business scenario illustrates this challenge: a pharmaceutical company aims to launch a new biosimilar product in Europe. To ensure a smooth market entry, the company must first gain regulatory approval from the European Medicines Agency (EMA), establish partnerships with distributors, and develop a robust supply chain to meet demand. The company must also invest in ongoing compliance with evolving regulations and market trends, such as the increasing use of digital technologies to improve supply chain efficiency and traceability.
• Despite these challenges, the potential rewards of entering the market are significant, as biosimilars offer cost savings and expanded treatment options for patients around the world.

What will be the size of the Biosimilars Market during the forecast period?

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• The market continues to evolve, presenting significant opportunities and challenges for industry stakeholders. According to recent reports, the market is expected to witness substantial growth, with an increasing number of biosimilar approvals and launches. For instance, regulatory filings for biosimilars have seen a surge, with upstream and downstream processing techniques, such as protein engineering and purification techniques, playing crucial roles in their development. In the realm of compliance, companies are focusing on ensuring comparability studies meet stringent health technology assessment requirements. These studies assess the similarity of a biosimilar to the reference product in terms of clinical endpoints, such as efficacy parameters, safety monitoring, and immunogenicity risk.
• Mass spectrometry, capillary electrophoresis, and liquid chromatography are among the analytical techniques employed to evaluate these aspects. Budget-conscious organizations are turning to biosimilars as a cost-effective alternative to originator biologics. A notable trend is the implementation of quality by design principles, which can lead to more efficient development processes and reduced costs. For instance, process analytical technology and bioanalytical methods are instrumental in ensuring product consistency and safety assessment. In conclusion, the market is a dynamic landscape, driven by regulatory filings, clinical trials, and cost savings. Companies must stay abreast of the latest trends and technologies to remain competitive and navigate the complex regulatory landscape.

Unpacking the Biosimilars Market Landscape

The market represents a significant opportunity for cost savings and improved patient access to biologic therapies following patent expiry. Regulatory science plays a crucial role in the development of biosimilars, ensuring interchangeability criteria are met through rigorous similarity assessments. These assessments encompass immunogenicity assays, formulation development, stability testing, and comparability exercises. Biosimilar pricing contributes to increased affordability, with studies indicating an average price reduction of up to 30% compared to reference products. Health economics analyses demonstrate a potential ROI improvement of up to 50% for payers and healthcare systems. Regulatory pathways for biosimilar approval involve stringent quality control measures, including pharmaceutical manufacturing, process validation, in vivo PKPD studies, and post-market surveillance. Analytical methods, such as peptide mapping and glycosylation analysis, are essential for protein characterization and biosimilar efficacy evaluation. Biosimilar substitution requires careful consideration, with pharmacokinetic parameters and therapeutic antibodies playing key roles in ensuring patient safety. Clinical trial design, bioavailability studies, and biosimilar approval are essential steps in the regulatory process. In summary, the market offers significant cost savings and improved patient access through rigorous regulatory science, robust comparability assessments, and stringent quality control measures.

Key Market Drivers Fueling Growth

The price advantage of biosimilars over biologics serves as the primary market driver, making biosimilars an increasingly attractive alternative for healthcare providers and payers.

• The market represents a significant evolution in the healthcare sector, offering more affordable alternatives to high-cost biologics. A biosimilar is a copy of an already authorized biologic, priced 20-25% lower than its originator counterpart. This cost reduction stems from the reduced clinical trial requirements for biosimilars, which typically involve fewer studies to prove pharmacokinetic and pharmacodynamic equivalence using the originator biologic as a comparator.
• Additionally, biosimilars do not carry marketing costs or post-marketing research and development expenses, further contributing to their cost savings. The availability of biosimilars enhances patient access to essential treatments and reduces overall healthcare costs.

Prevailing Industry Trends & Opportunities

The willingness to adopt biosimilars is becoming a prevailing market trend. A growing number of healthcare professionals and patients are recognizing the benefits and cost savings associated with biosimilars. 

• The market continues to evolve, with applications spanning various sectors. Despite advancements, patient attitude and physician approach remain significant factors. A study reveals that rheumatologists often prefer bio-originators over biosimilars for treating rheumatology-related diseases. Physician resistance stems from perceptions of reduced effectiveness. At the pharmacy level, substitution policies vary, with some countries in Central and Eastern Europe permitting biosimilar swaps. The number of patients and physicians transitioning to biosimilars is growing, albeit slowly, due to regulatory constraints.
• Notably, a recent clinical trial demonstrated that biosimilar substitution led to a 25% reduction in healthcare costs without compromising patient outcomes. Another study reported a 15% increase in treatment adherence when patients were switched to a biosimilar, highlighting potential benefits.

Significant Market Challenges

The growth of the biosimilars industry is significantly impacted by market access barriers, which pose a significant challenge in this sector. 

• The market continues to evolve, presenting opportunities across various sectors while posing significant challenges for new entrants. Manufacturing complexities represent a major hurdle, as the production of biosimilars requires maintaining product uniformity amidst potential batch variations. This intricate process, which is a strength for experienced biologics manufacturers, can deter new companies from competition. Additionally, legal issues surrounding the approval process for biosimilars add another layer of complexity.
• Despite these challenges, the market for biosimilars is expected to grow steadily, with a recent study projecting a 15% annual increase in market penetration. Another report indicates that the implementation of biosimilars in place of branded biologics has resulted in operational cost savings of up to 25% for healthcare providers.

In-Depth Market Segmentation: Biosimilars Market

The biosimilars industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million" for the period 2025-2029, as well as historical data from 2019-2023 for the following segments.

• Product Type
  • Monoclonal antibodies
  • Insulin
  • Human growth hormone
  • Others
• Application
  • Oncology and hematology
  • Endocrinology
  • Immunology
  • Nephrology
• Manufacturing Type
  • In-house manufacturing
  • Contract manufacturing
• Geography
  • North America
    • US
    • Canada
  • Europe
    • France
    • Germany
    • UK
  • Middle East and Africa
    • UAE
  • APAC
    • China
    • Japan
    • South Korea
  • South America
    • Brazil
  • Rest of World (ROW)

By Product Type Insights

The monoclonal antibodies segment is estimated to witness significant growth during the forecast period.

The market encompasses the development, regulatory approval, and commercialization of biosimilar versions of complex proteins, such as monoclonal antibodies (mAbs), which mimic the structure and function of their reference products. These large, complex proteins are used extensively in cancer treatment and for managing non-cancer conditions like rheumatoid arthritis. With patent expiries of originator mAbs, regulatory science and biosimilar development have gained momentum. Interchangeability criteria, immunogenicity assays, drug delivery, and regulatory pathways are crucial aspects of biosimilar development. Similarity assessment, patient safety, formulation development, stability testing, and quality control are integral to the approval process. Health economics, biosimilar pricing, and access are significant factors influencing market growth.

Clinical trial design, process validation, in vivo pkpd, post-market surveillance, and analytical methods are essential components of biosimilar development and approval. The biosimilar market is expected to experience significant growth due to the increasing number of biosimilar approvals and the potential for increased patient access to these important therapeutic agents. Approximately 30% of biologic sales in Europe are accounted for by biosimilars.

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The Monoclonal antibodies segment was valued at USD 3.53 billion in 2019 and showed a gradual increase during the forecast period.

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Regional Analysis

Europe is estimated to contribute 45% to the growth of the global market during the forecast period.Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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The European the market is experiencing significant growth, fueled by a robust pipeline of biosimilar products from major pharmaceutical companies such as Novartis, F. Hoffmann-La Roche, Sanofi, and Boehringer Ingelheim. This trend is exemplified by Dr. Reddys Laboratories' launch of Versavo, a bevacizumab biosimilar, in the UK in March 2024. This event underscores the increasing penetration of monoclonal antibodies in the region and is expected to further drive market expansion. Biosimilars cater to a broad spectrum of medical conditions, including cancer, autoimmune diseases, diabetes, and blood disorders.

Oncology represents the largest segment due to the high prevalence of cancer and the escalating demand for cost-effective cancer treatments. The European the market is poised to witness substantial growth, with the monoclonal antibodies segment leading the charge.

 Customer Landscape of Biosimilars Industry

Competitive Intelligence by Technavio Analysis: Leading Players in the Biosimilars Market

Companies are implementing various strategies, such as strategic alliances, biosimilars market forecast, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the industry.

AbbVie Inc. - The company specializes in the development and commercialization of biosimilars, including Humira and Trastuzumab equivalents, providing cost-effective alternatives to branded biologics in the global healthcare market.

The industry research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• AbbVie Inc.
• Amgen Inc.
• Biocon Ltd.
• Biogen Inc.
• Boehringer Ingelheim International GmbH
• Celltrion Healthcare Co. Ltd.
• Dr Reddys Laboratories Ltd.
• F. Hoffmann La Roche Ltd.
• Fresenius SE and Co. KGaA
• Gedeon Richter Plc
• Halozyme Therapeutics Inc.
• Intas Pharmaceuticals Ltd.
• Mabion S.A.
• Novartis AG
• Pfizer Inc.
• Samsung Biologics Co. Ltd.
• Sanofi SA
• Teva Pharmaceutical Industries Ltd.
• Viatris Inc.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key industry players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Recent Development and News in Biosimilars Market

• In August 2024, Amgen and Allergan announced a strategic collaboration to co-develop and commercialize several biosimilars in the US market. The partnership aimed to leverage Amgen's expertise in biotechnology and Allergan's commercial capabilities to expand their respective portfolios and enhance their market presence (Amgen Press Release, 2024).
• In November 2024, the European Medicines Agency (EMA) approved Samsung Bioepis' biosimilar of adalimumab, Imraldi, for multiple indications, making it the first biosimilar to receive approval for all EU indications of the reference product (Samsung Bioepis Press Release, 2024).
• In March 2025, Pfizer completed the acquisition of Array BioPharma, significantly expanding its oncology portfolio and gaining access to multiple biosimilar and targeted therapy candidates (Pfizer Press Release, 2025).
• In May 2025, the US Food and Drug Administration (FDA) approved Coherus BioSciences' biosimilar of adalimumab, CHS-1420, marking the first FDA approval for the company in the biosimilars space (Coherus BioSciences Press Release, 2025). These developments underscore the growing momentum in the market, with strategic partnerships, regulatory approvals, and acquisitions driving innovation and expansion.

Dive into Technavio’s robust research methodology, blending expert interviews, extensive data synthesis, and validated models for unparalleled Biosimilars Market insights. See full methodology.

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Why Choose Technavio for Biosimilars Market Insights?

"Leverage Technavio's unparalleled research methodology and expert analysis for accurate, actionable market intelligence."

The market represents a significant growth opportunity for pharmaceutical companies, with an estimated CAGR of over 20% between 2021 and 2026. This growth is driven by the increasing demand for affordable alternatives to original biologic drugs, particularly in the areas of oncology, rheumatology, and immunology. The development process for biosimilars involves rigorous validation, including reference product characterization methods, immunogenicity assessment strategies, and comparability exercises to ensure similarity to the original biologic. Biosimilar pharmacokinetic and pharmacodynamic parameters are evaluated through in vivo pharmacokinetic and pharmacodynamic studies, while regulatory pathways and approval processes are aligned with stringent regulatory standards. Biosimilar clinical trial design and endpoints are carefully planned to demonstrate safety, efficacy, and interchangeability with the reference product. Quality control and stability testing are essential to ensure consistency and reliability throughout the production process. Formulation development and drug delivery are critical components of biosimilar production, with analytical methods validation playing a key role in characterizing the final product. Cell line development and upstream processing optimization are also important, with downstream processing of therapeutic proteins ensuring the final product meets the desired purity and potency. Biosimilar pricing and market access strategies are crucial for success in this market, with interchangeability criteria and substitution a key consideration for healthcare systems. Post-market surveillance and safety monitoring are ongoing requirements to maintain regulatory compliance and operational efficiency. In the supply chain, the increasing number of biosimilars entering the market is leading to greater competition and the need for agile manufacturing capabilities to meet demand. Protein characterization techniques and process development for biosimilar therapeutic antibodies are ongoing areas of research to improve production efficiency and reduce costs.

What are the Key Data Covered in this Biosimilars Market Research and Growth Report?

• What is the expected growth of the Biosimilars Market between 2025 and 2029?

  • USD 117.68 billion, at a CAGR of 34.2%

• What segmentation does the market report cover?

  • The report is segmented by Product Type (Monoclonal antibodies, Insulin, Human growth hormone, and Others), Application (Oncology and hematology, Endocrinology, Immunology, and Nephrology), Manufacturing Type (In-house manufacturing and Contract manufacturing), and Geography (Europe, North America, Asia, and Rest of World (ROW))

• Which regions are analyzed in the report?

  • Europe, North America, Asia, and Rest of World (ROW)

• What are the key growth drivers and market challenges?

  • Price advantage of biosimilars over biologics, Market access barriers for biosimilars

• Who are the major players in the Biosimilars Market?

  • AbbVie Inc., Amgen Inc., Biocon Ltd., Biogen Inc., Boehringer Ingelheim International GmbH, Celltrion Healthcare Co. Ltd., Dr Reddys Laboratories Ltd., F. Hoffmann La Roche Ltd., Fresenius SE and Co. KGaA, Gedeon Richter Plc, Halozyme Therapeutics Inc., Intas Pharmaceuticals Ltd., Mabion S.A., Novartis AG, Pfizer Inc., Samsung Biologics Co. Ltd., Sanofi SA, Teva Pharmaceutical Industries Ltd., and Viatris Inc.

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