The global biosimilar testing and development services market was valued at $ 2486.9 million in 2022 and is projected to reach $ 7807.7 million by 2032, registering a CAGR of 12.1% from 2023 to 2032. Biosimilar testing and development services are specialized services provided by companies, contract research organizations (CROs), or research institutions to support the development, approval, and commercialization of biosimilar products. Biosimilars are biologic drugs that are highly similar to an already approved biological product (reference product) in terms of quality, safety, and efficacy. Biologic drugs, unlike conventional pharmaceuticals, are manufactured using living cells and are typically more complex molecules, making them difficult to replicate exactly. However, biosimilars are developed to be as close as possible to the reference product and are intended to have no clinically meaningful differences in terms of safety and effectiveness.
The biosimilar testing and development services market is driven by rise in outsourcing of preclinical, clinical and laboratory testing services by pharma and biotech companies, and rise in need of biosimilar testing services to meet the growing demand for biosimilars for the treatment of chronic diseases. The biosimilar testing and development services market is expected to experience a significant surge due to the notable rise in outsourcing by pharmaceutical and biotech companies for preclinical, clinical, and laboratory testing services. Increasing pressure to bring cost-effective drugs to market has driven pharmaceutical and biotech firms to explore alternative strategies for biosimilar development. Outsourcing preclinical and clinical testing services to specialized providers offers a cost-efficient approach as compared to maintaining in-house facilities and capabilities. By doing so, companies can redirect their resources towards core R&D activities, enhancing their overall competitiveness in the industry. In addition, the complexity and stringent regulatory requirements associated with biosimilar development have necessitated the engagement of expert organizations that possess the necessary knowledge and experience. Outsourcing to established testing service providers allows pharmaceutical and biotech companies to tap into a vast pool of expertise, ensuring compliance with the strict regulatory guidelines governing biosimilar approval processes. The strategic approach has allowed these companies to streamline their operations, access specialized expertise and cutting-edge technologies, navigate complex regulatory requirements, and capitalize on the market for biosimilars. In conclusion, the rise in outsourcing of preclinical, clinical, and laboratory testing services by pharmaceutical and biotech companies has emerged as a pivotal driver for the biosimilar testing and development services market. Moreover, the rise in demand for biosimilars is expected to drive the growth of the biosimilar testing and development services market. The rise in demand for biosimilars is attributed to the cost-effectivity of the biosimilar as compared to its reference drug and the surge in prevalence of chronic diseases.
One of the key factors fueling the demand for biosimilars is the escalating burden of chronic diseases, such as cancer, autoimmune disorders, diabetes, and others. According to a study conducted by researchers at Oxford University, as of 2023, one in ten people has autoimmune disorders. As these conditions continue to afflict a large segment of the global population, there is a pressing need for affordable and accessible treatment options. Biosimilars have emerged as a compelling solution, presenting the same therapeutic effects as their originator counterparts but at reduced costs. This affordability aspect significantly expands patient access to crucial treatments, particularly in emerging economies where healthcare budgets may be constrained. According to U.S. Food and Drug Administration, as of May 2023, 41 biosimilars drugs are approved. These biosimilars are approved for the treatment of chronic disease such as rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PA), ankylosing spondylitis (AS), plaque psoriasis (PsO), inflammatory bowel disease (IBD), adult Crohn disease (CD), ulcerative colitis (UC), granulomatosis with polyangiitis (GPA) (Wegener granulomatosis), microscopic polyangiitis (MPA), type 1 diabetes mellitus (DM), non-squamous non-small cell lung cancer, metastatic colorectal cancer, metastatic renal cell carcinoma, glioblastoma, recurrent or metastatic cervical cancer, HER2 (human epidermal growth factor receptor 2) associated breast cancer, HER2 associated gastric (metastatic) or gastroesophageal junction adenocarcinoma, chronic lymphocytic leukemia (CLL), and non-Hodgkin lymphoma (NHL).
In addition, biologics drugs, which are highly effective in treating various chronic and life-threatening diseases, often come with high price tags, making them inaccessible to a large segment of the population. However, biosimilars, which are comparable versions of reference biologics, present a promising solution to this problem. Biosimilar drugs undergo a rigorous development process to demonstrate dissimilarity to the reference product in terms of quality, safety, and efficacy. Once approved, biosimilars can offer significant cost savings as compared to the original biologic drugs. According to Association for Accessible Medicines (U.S.), in 2021, biosimilars generated $7 billion in savings for patients and the healthcare system. This cost advantage has the potential to drive healthcare expenditure, making essential treatments more accessible to patients while also reducing the financial burden on healthcare systems. Rise in demand for biosimilar product results in demand for services that facilitate the testing and development of biosimilars.
However, stringent regulatory requirements might act as a restraint for the growth of the market. However, patent expiration of biological drugs is expected to serve as a growth opportunity in the market.
The biosimilar testing and development services market is segmented on the basis of type and end user, and region. By type, the market is categorized into pharmacokinetics, immunogenicity, and others. The others include, ligand binding assay, biomarker, and stability testing. By end user, the market is categorized into pharmaceutical and biopharmaceutical companies, contract research organizations, and others. Others include contract development and manufacturing organization, independent lab, and regulatory bodies. Region-wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and rest of LAMEA). Major key players that operate in the global biosimilar testing and development services market are Charles River Laboratories, Element Materials Technology, Intertek Group plc, Pacific biolabs, Inc, Profacgen Technologies Inc, Sartorius AG, SGS, BioPharmaSpec Ltd., Veeda Clinical Research Pvt. Ltd, and Eurofins Scientific SE.
The biosimilar testing and development services market is driven by rise in outsourcing of preclinical, clinical and laboratory testing services by pharma and biotech companies, and rise in need of biosimilar testing services to meet the growing demand for biosimilars for the treatment of chronic diseases. The biosimilar testing and development services market is expected to experience a significant surge due to the notable rise in outsourcing by pharmaceutical and biotech companies for preclinical, clinical, and laboratory testing services. Increasing pressure to bring cost-effective drugs to market has driven pharmaceutical and biotech firms to explore alternative strategies for biosimilar development. Outsourcing preclinical and clinical testing services to specialized providers offers a cost-efficient approach as compared to maintaining in-house facilities and capabilities. By doing so, companies can redirect their resources towards core R&D activities, enhancing their overall competitiveness in the industry. In addition, the complexity and stringent regulatory requirements associated with biosimilar development have necessitated the engagement of expert organizations that possess the necessary knowledge and experience. Outsourcing to established testing service providers allows pharmaceutical and biotech companies to tap into a vast pool of expertise, ensuring compliance with the strict regulatory guidelines governing biosimilar approval processes. The strategic approach has allowed these companies to streamline their operations, access specialized expertise and cutting-edge technologies, navigate complex regulatory requirements, and capitalize on the market for biosimilars. In conclusion, the rise in outsourcing of preclinical, clinical, and laboratory testing services by pharmaceutical and biotech companies has emerged as a pivotal driver for the biosimilar testing and development services market. Moreover, the rise in demand for biosimilars is expected to drive the growth of the biosimilar testing and development services market. The rise in demand for biosimilars is attributed to the cost-effectivity of the biosimilar as compared to its reference drug and the surge in prevalence of chronic diseases.
One of the key factors fueling the demand for biosimilars is the escalating burden of chronic diseases, such as cancer, autoimmune disorders, diabetes, and others. According to a study conducted by researchers at Oxford University, as of 2023, one in ten people has autoimmune disorders. As these conditions continue to afflict a large segment of the global population, there is a pressing need for affordable and accessible treatment options. Biosimilars have emerged as a compelling solution, presenting the same therapeutic effects as their originator counterparts but at reduced costs. This affordability aspect significantly expands patient access to crucial treatments, particularly in emerging economies where healthcare budgets may be constrained. According to U.S. Food and Drug Administration, as of May 2023, 41 biosimilars drugs are approved. These biosimilars are approved for the treatment of chronic disease such as rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PA), ankylosing spondylitis (AS), plaque psoriasis (PsO), inflammatory bowel disease (IBD), adult Crohn disease (CD), ulcerative colitis (UC), granulomatosis with polyangiitis (GPA) (Wegener granulomatosis), microscopic polyangiitis (MPA), type 1 diabetes mellitus (DM), non-squamous non-small cell lung cancer, metastatic colorectal cancer, metastatic renal cell carcinoma, glioblastoma, recurrent or metastatic cervical cancer, HER2 (human epidermal growth factor receptor 2) associated breast cancer, HER2 associated gastric (metastatic) or gastroesophageal junction adenocarcinoma, chronic lymphocytic leukemia (CLL), and non-Hodgkin lymphoma (NHL).
In addition, biologics drugs, which are highly effective in treating various chronic and life-threatening diseases, often come with high price tags, making them inaccessible to a large segment of the population. However, biosimilars, which are comparable versions of reference biologics, present a promising solution to this problem. Biosimilar drugs undergo a rigorous development process to demonstrate dissimilarity to the reference product in terms of quality, safety, and efficacy. Once approved, biosimilars can offer significant cost savings as compared to the original biologic drugs. According to Association for Accessible Medicines (U.S.), in 2021, biosimilars generated $7 billion in savings for patients and the healthcare system. This cost advantage has the potential to drive healthcare expenditure, making essential treatments more accessible to patients while also reducing the financial burden on healthcare systems. Rise in demand for biosimilar product results in demand for services that facilitate the testing and development of biosimilars.
However, stringent regulatory requirements might act as a restraint for the growth of the market. However, patent expiration of biological drugs is expected to serve as a growth opportunity in the market.
The biosimilar testing and development services market is segmented on the basis of type and end user, and region. By type, the market is categorized into pharmacokinetics, immunogenicity, and others. The others include, ligand binding assay, biomarker, and stability testing. By end user, the market is categorized into pharmaceutical and biopharmaceutical companies, contract research organizations, and others. Others include contract development and manufacturing organization, independent lab, and regulatory bodies. Region-wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and rest of LAMEA). Major key players that operate in the global biosimilar testing and development services market are Charles River Laboratories, Element Materials Technology, Intertek Group plc, Pacific biolabs, Inc, Profacgen Technologies Inc, Sartorius AG, SGS, BioPharmaSpec Ltd., Veeda Clinical Research Pvt. Ltd, and Eurofins Scientific SE.
Key Benefits For Stakeholders
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the biosimilar testing and development services market analysis from 2022 to 2032 to identify the prevailing biosimilar testing and development services market opportunities.
- The market research is offered along with information related to key drivers, restraints, and opportunities.
- Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the biosimilar testing and development services market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report includes the analysis of the regional as well as global biosimilar testing and development services market trends, key players, market segments, application areas, and market growth strategies.
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Key Market Segments
By Type
- Pharmacokinetics Assay
- Immunogenicity Testing
- Others
By End User
- Pharmaceutical and Biopharmaceutical Companies
- Contract Research Organizations
- Others
By Region
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- Japan
- China
- India
- Australia
- South Korea
- Rest of Asia-Pacific
- LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest of LAMEA
- Sartorius AG
- Pacific Biolabs, Inc.
- BioPharmaSpec Ltd.
- Charles River Laboratories
- Intertek Group plc
- SGS
- Veeda Clinical Research Pvt. Ltd.
- Eurofins Scientific SE
- Profacgen Technologies Inc.
- Element Materials Technology
Table of Contents
CHAPTER 1: INTRODUCTION
CHAPTER 2: EXECUTIVE SUMMARY
CHAPTER 3: MARKET OVERVIEW
CHAPTER 4: BIOSIMILAR TESTING AND DEVELOPMENT SERVICES MARKET, BY TYPE
CHAPTER 5: BIOSIMILAR TESTING AND DEVELOPMENT SERVICES MARKET, BY END USER
CHAPTER 6: BIOSIMILAR TESTING AND DEVELOPMENT SERVICES MARKET, BY REGION
CHAPTER 7: COMPETITIVE LANDSCAPE
CHAPTER 8: COMPANY PROFILES
List of Tables
List of Figures
Companies Mentioned
- Sartorius AG
- Pacific Biolabs, Inc.
- BioPharmaSpec Ltd.
- Charles River Laboratories
- Intertek Group plc
- SGS
- Veeda Clinical Research Pvt. Ltd.
- Eurofins Scientific SE
- Profacgen Technologies Inc.
- Element Materials Technology
Methodology
The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.
They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.
They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic news articles and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast
Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 302 |
| Published | December 2023 |
| Forecast Period | 2022 - 2032 |
| Estimated Market Value ( USD | $ 2486.9 million |
| Forecasted Market Value ( USD | $ 7807.7 million |
| Compound Annual Growth Rate | 12.1% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
