Biosimilar Testing and Development Service Market Overview:
As per MRFR analysis, the Biosimilar Testing and Development Service Market Size was estimated at 3.43 (USD Billion) in 2022. The Biosimilar Testing and Development Service Market is expected to grow from 3.9 (USD Billion) in 2023 to 12.3 (USD Billion) by 2032. The Biosimilar Testing and Development Service Market CAGR (growth rate) is expected to be around 13.62% during the forecast period (2024 - 2032).
Key Biosimilar Testing and Development Service Market Trends Highlighted
Key market drivers include the rising demand for cost-effective treatments, increasing incidence of chronic diseases, and technological advancements. Opportunities lie in the development of novel biosimilars and the expansion into emerging markets.
Recent trends include the adoption of analytical techniques to enhance biosimilarity assessment, the increasing utilization of in vitro and in vivo models for preclinical safety and efficacy evaluation, and the use of high-throughput screening technologies for rapid and efficient biosimilar characterization.
These trends are driven by the need for comprehensive evaluation and cost-effective development of biosimilar products. By leveraging these trends and addressing the unmet needs in the market, players can position themselves for success in the Biosimilar Testing and Development Service Market.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
Biosimilar Testing and Development Service Market Drivers
Rising Demand for Biosimilars
The increasing prevalence of chronic diseases, such as cancer, diabetes, and autoimmune disorders, has led to a surge in demand for biologics, including biosimilars. Biosimilars are highly similar to their reference biologics in terms of safety, efficacy, and quality, but they are typically more affordable, making them an attractive option for patients and healthcare providers.
The growing demand for biosimilars is expected to drive the growth of the Biosimilar Testing and Development Service Market.
Technological Advancements
The rapid advancements in biotechnology and analytical techniques have enabled the development of more sophisticated and efficient methods for testing and developing biosimilars.
These advancements have reduced the time and cost associated with biosimilar development, making it more feasible for companies to enter the market.
The increasing availability of advanced testing and development services is expected to further fuel the growth of the Biosimilar Testing and Development Service Market.
Supportive Regulatory Environment
Regulatory agencies around the world have implemented supportive policies to encourage the development and approval of biosimilars. These policies include clear regulatory pathways, streamlined approval processes, and data exclusivity protection.
The supportive regulatory environment has created a favorable landscape for companies to invest in biosimilar development and has contributed to the growth of the Biosimilar Testing and Development Service Market.
Biosimilar Testing and Development Service Market Segment Insights:
Biosimilar Testing and Development Service Market Testing Type Insights
Analytical Testing segment held the largest share in the Biosimilar Testing and Development Service Market in 2023 and is anticipated to maintain its dominance throughout the forecast period. Analytical Testing is crucial for ensuring the quality and safety of biosimilars, as it involves evaluating their physicochemical and biological properties to compare them with the reference product.
Functional Testing evaluates the biological activity of biosimilars to ensure that they exhibit similar functionality to the reference product. This segment is expected to witness significant growth due to the increasing demand for biosimilars in various therapeutic areas.
Immunogenicity Testing assesses the immune response elicited by biosimilars, which is critical for determining their safety and efficacy. The growing awareness of immunogenicity concerns is driving the growth of this segment.
Stability Testing evaluates the stability of biosimilars over time to ensure their shelf life and storage conditions. The increasing focus on maintaining the integrity and potency of biosimilars is fueling the growth of this segment.
Other Testing Types include various specialized tests, such as cell-based assays and potency assays, which are gaining prominence due to their ability to provide comprehensive characterization of biosimilars. The growing adoption of advanced testing technologies is expected to drive the growth of this segment.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
Biosimilar Testing and Development Service Market Development Phase Insights
The Biosimilar Testing and Development Service Market segmentation by Development Phase includes Preclinical Development, Clinical Development, Regulatory Approval, and Post-Approval Development.
The Preclinical Development segment accounted for the largest share of the Biosimilar Testing and Development Service Market revenue in 2023, and it is expected to continue to dominate the market over the forecast period. This is due to the increasing demand for preclinical testing services to evaluate the safety and efficacy of biosimilar products before they enter clinical trials.
The Clinical Development segment is expected to grow at a significant CAGR during the forecast period, owing to the increasing number of biosimilar products entering clinical development. The Regulatory Approval segment is expected to grow steadily over the forecast period, as biosimilar products gain regulatory approval in various countries.
The Post-Approval Development segment is expected to grow at a moderate CAGR during the forecast period, as biosimilar products are monitored for safety and efficacy after they are approved for marketing.
Biosimilar Testing and Development Service Market Target Indication Insights
The Biosimilar Testing and Development Service Market is segmented by Target Indication into Oncology, Autoimmune Diseases, Infectious Diseases, Rare Diseases, and Other Target Indications. Oncology held the largest share of the market in 2023, accounting for over 50% of the Biosimilar Testing and Development Service Market revenue.
The high prevalence of cancer and the increasing demand for biosimilar therapies for cancer treatment are driving the growth of this segment. Autoimmune Diseases is another major segment, accounting for over 20% of the market share.
The rising incidence of autoimmune diseases and the need for effective and affordable treatments are fueling the growth of this segment. Infectious Diseases and Rare Diseases are also significant segments, with growing demand for biosimilar therapies for the treatment of infectious diseases and rare diseases, respectively.
Other Target Indications include cardiovascular diseases, respiratory diseases, and metabolic disorders, which are also expected to contribute to the growth of the Biosimilar Testing and Development Service Market.
Biosimilar Testing and Development Service Market Biosimilar Type Insights
The Biosimilar Type segment plays a crucial role in the Biosimilar Testing and Development Service Market. Monoclonal Antibodies hold a significant market share, driven by the presence of various approved biosimilars, such as rituximab, trastuzumab, and bevacizumab.
Growth Factors, particularly erythropoietin biosimilars, are also gaining traction due to their increasing usage in treating anemia associated with chronic kidney disease. Enzymes, such as hyaluronidase, are witnessing growing demand in biopharmaceutical manufacturing processes.
Hormones, including insulin biosimilars, are expected to contribute to market growth as they offer cost-effective alternatives to branded products. Other Biosimilar Types, such as interferons and interleukins, are also expected to gain prominence in specific therapeutic areas.
The Biosimilar Testing and Development Service Market revenue for Biosimilar Type is projected to reach USD 5.2 billion by 2024, exhibiting a steady growth rate.
Biosimilar Testing and Development Service Market Regional Insights
The Biosimilar Testing and Development Service Market is segmented into North America, Europe, APAC, South America, and MEA. Among these regions, North America held the largest market share in 2023, owing to the presence of a large number of biopharmaceutical companies and favorable regulatory policies.
The European market is also expected to grow significantly, driven by increasing demand for biosimilars and government initiatives to promote their adoption.
The APAC region is expected to witness the fastest growth over the forecast period, due to the rising prevalence of chronic diseases and increasing healthcare expenditure.
South America and MEA are expected to account for a smaller share of the global market, but are expected to grow at a steady pace over the forecast period.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
Biosimilar Testing and Development Service Market Key Players and Competitive Insights:
Major players in the Biosimilar Testing and Development Service Market are constantly striving to gain competitive advantage by investing in research and development, expanding their service offerings, and forming strategic partnerships.
Leading Biosimilar Testing and Development Service Market players are focusing on providing comprehensive solutions that encompass the entire biosimilar development lifecycle, from early-stage concept development to regulatory approval and commercialization.
The Biosimilar Testing and Development Service Market is highly competitive, with a number of established players and emerging companies vying for market share. Key players in the Biosimilar Testing and Development Service Market include Charles River Laboratories, Eurofins Scientific, SGS, Wuxi AppTec, and Thermo Fisher Scientific.
These companies offer a range of services, including bioanalytical testing, cell-based assays, and immunogenicity testing.
A leading player in the Biosimilar Testing and Development Service Market, Charles River Laboratories, provides a comprehensive suite of services to support biosimilar development, including bioanalytical testing, cell-based assays, and immunogenicity testing.
The company has a global network of laboratories and a team of experienced scientists who are dedicated to providing high-quality data and timely results. Charles River Laboratories is committed to working closely with its clients to develop and execute customized testing plans that meet their specific needs.
A major competitor in the Biosimilar Testing and Development Service Market, Eurofins Scientific, offers a wide range of biosimilar testing services, including bioanalytical testing, cell-based assays, and immunogenicity testing. The company has a global network of laboratories and a team of experienced scientists who are dedicated to providing high-quality data and timely results.
Eurofins Scientific is committed to working closely with its clients to develop and execute customized testing plans that meet their specific needs. The company's strong track record and commitment to quality make it a trusted partner for biosimilar developers around the world.
Key Companies in the Biosimilar Testing and Development Service Market Include:
- Alcami
- PPD, Inc.
- Charles River Laboratories International, Inc.
- FUJIFILM Holdings Corporation
- Abcam plc
- Eurofins Scientific
- Patheon N.V.
- Lonza Group Ltd
- Merck KGaA
- Laboratory Corporation of America Holdings
- Parexel International Corporation
- SGS SA
- Accenture plc
- General Electric Company
- ICON plc
Biosimilar Testing and Development Service Market Developments
The rising prevalence of chronic diseases, increasing demand for affordable biologics, and technological advancements in biosimilar development drive market growth. Key recent developments include:
In January 2023, Merck entered a strategic partnership with Samsung Biologics to enhance its biosimilar development and manufacturing capabilities.
In February 2024, Lonza announced the expansion of its biosimilar manufacturing facility in Singapore to meet the growing demand for biosimilars in the Asia-Pacific region.
The US Food and Drug Administration (FDA) has issued several guidance documents to streamline the biosimilar approval process, further propelling market growth.
Biosimilar Testing and Development Service Market Segmentation Insights
- Biosimilar Testing and Development Service Market Testing Type Outlook
- Analytical Testing
- Functional Testing
- Immunogenicity Testing
- Stability Testing
- Other Testing Types
- Biosimilar Testing and Development Service Market Development Phase Outlook
- Preclinical Development
- Clinical Development
- Regulatory Approval
- Post-Approval Development
- Biosimilar Testing and Development Service Market Target Indication Outlook
- Oncology
- Autoimmune Diseases
- Infectious Diseases
- Rare Diseases
- Other Target Indications
- Biosimilar Testing and Development Service Market Biosimilar Type Outlook
- Monoclonal Antibodies
- Growth Factors
- Enzymes
- Hormones
- Other Biosimilar Types
- Biosimilar Testing and Development Service Market Regional Outlook
- North America
- Europe
- South America
- Asia Pacific
- Middle East and Africa
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Report Attribute/Metric
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Details
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Market Size 2022
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3.43(USD Billion)
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Market Size 2023
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3.9(USD Billion)
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Market Size 2032
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12.3(USD Billion)
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Compound Annual Growth Rate (CAGR)
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13.62% (2024 - 2032)
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Report Coverage
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Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
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Base Year
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2023
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Market Forecast Period
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2024 - 2032
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Historical Data
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2019 - 2023
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Market Forecast Units
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USD Billion
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Key Companies Profiled
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Alcami, PPD, Inc., Charles River Laboratories International, Inc., FUJIFILM Holdings Corporation, Abcam plc, Eurofins Scientific, Patheon N.V., Lonza Group Ltd, Merck KGaA, Laboratory Corporation of America Holdings, Parexel International Corporation, SGS SA, Accenture plc, General Electric Company, ICON plc
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Segments Covered
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Testing Type, Development Phase, Target Indication, Biosimilar Type, Regional
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Key Market Opportunities
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Growing demand for biosimilar drug development
Increasing government support for biosimilar development
Technological advancements in biosimilar testing
Rising prevalence of chronic diseases
Expanding healthcare infrastructure in emerging markets-
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Key Market Dynamics
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Rising adoption of biosimilars, increasing demand for cost-effective alternatives, technological advancements, patent expiry of biologics, and growing incidence of chronic diseases.
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Countries Covered
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North America, Europe, APAC, South America, MEA
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Frequently Asked Questions (FAQ) :
The Biosimilar Testing and Development Service Market reached a valuation of approximately 3.9 billion USD in 2023.
The Biosimilar Testing and Development Service Market is estimated to grow at a CAGR of 13.62% from 2024 to 2032.
The Biosimilar Testing and Development Service Market is expected to reach a valuation of around 12.3 billion USD by the end of 2032.
North America is anticipated to dominate the Biosimilar Testing and Development Service Market throughout the forecast period.
Rising prevalence of chronic diseases, increasing demand for cost-effective healthcare solutions, and technological advancements are major growth drivers for the Biosimilar Testing and Development Service Market.
Key players in the Biosimilar Testing and Development Service Market include Charles River Laboratories, SGS SA, Eurofins Scientific, and Intertek Group plc.
Biosimilar Testing and Development Services are primarily used for preclinical and clinical testing of biosimilar products to ensure their safety and efficacy.
The competitive landscape of the Biosimilar Testing and Development Service Market is anticipated to remain competitive, with established players and emerging companies vying for market share.
Technological advancements, such as automation and digitalization, are expected to shape the future of the Biosimilar Testing and Development Service Market.
Regulatory complexities and reimbursement issues pose potential challenges to the growth of the Biosimilar Testing and Development Service Market.
