Global Biosimilar Testing and Development Services
Market Report
2025
Global Biosimilar Testing and Development Service Market size is USD 2651.00 million in 2024. The increasing demand for cost-effective therapies is expected to boost the sales to USD 6046.13 Million by 2031 with a Compound Annual Growth Rate (CAGR) of 12.50% from 2024 to 2031.
The base year for the calculation is 2024. The historical will be 2021 to 2024. The year 2025 will be estimated one while the forecasted data will be from year 2025 to 2033. When we deliver the report that time we updated report data till the purchase date.
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According to Cognitive Market Research, the global Biosimilar Testing and Development Service market size is USD 2651.00 million in 2024. It will expand at a compound annual growth rate (CAGR) of 12.50% from 2024 to 2031.
2024 | 2025 | 2032 | 2033 | CAGR | |
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Global Biosimilar Testing and Development Services Market Sales Revenue | $ 2651 Million | 121212 | 121212 | 121212 | 12.5% |
North America Biosimilar Testing and Development Services Market Sales Revenue | $ 1060.4 Million | 121212 | 121212 | 121212 | 10.7% |
United States Biosimilar Testing and Development Services Market Sales Revenue | $ 836.66 Million | 121212 | 121212 | 121212 | 10.5% |
Mexico Biosimilar Testing and Development Services Market Sales Revenue | $ 96.5 Million | 121212 | 121212 | 121212 | 11.2% |
Canada Biosimilar Testing and Development Services Market Sales Revenue | $ 127.25 Million | 121212 | 121212 | 121212 | 11.5% |
Europe Biosimilar Testing and Development Services Market Sales Revenue | $ 795.3 Million | 121212 | 121212 | 121212 | 11% |
Spain Biosimilar Testing and Development Services Market Sales Revenue | $ 65.21 Million | 121212 | 121212 | 121212 | 10.1% |
United Kingdom Biosimilar Testing and Development Services Market Sales Revenue | $ 133.61 Million | 121212 | 121212 | 121212 | 11.8% |
Russia Biosimilar Testing and Development Services Market Sales Revenue | $ 123.27 Million | 121212 | 121212 | 121212 | 10% |
Italy Biosimilar Testing and Development Services Market Sales Revenue | $ 68.4 Million | 121212 | 121212 | 121212 | 10.4% |
Germany Biosimilar Testing and Development Services Market Sales Revenue | $ 157.47 Million | 121212 | 121212 | 121212 | 11.2% |
France Biosimilar Testing and Development Services Market Sales Revenue | $ 73.17 Million | 121212 | 121212 | 121212 | 10.2% |
Rest of Europe Biosimilar Testing and Development Services Market Sales Revenue | $ 123.27 Million | 121212 | 121212 | 121212 | 9.7% |
Asia Pacific Biosimilar Testing and Development Services Market Sales Revenue | $ 609.73 Million | 121212 | 121212 | 121212 | 14.5% |
Korea Biosimilar Testing and Development Services Market Sales Revenue | $ 60.97 Million | 121212 | 121212 | 121212 | 13.6% |
Japan Biosimilar Testing and Development Services Market Sales Revenue | $ 84.14 Million | 121212 | 121212 | 121212 | 13% |
China Biosimilar Testing and Development Services Market Sales Revenue | $ 274.38 Million | 121212 | 121212 | 121212 | 14% |
Australia Biosimilar Testing and Development Services Market Sales Revenue | $ 31.71 Million | 121212 | 121212 | 121212 | 14.2% |
India Biosimilar Testing and Development Services Market Sales Revenue | $ 73.17 Million | 121212 | 121212 | 121212 | 16.3% |
Rest of APAC Biosimilar Testing and Development Services Market Sales Revenue | $ 43.29 Million | 121212 | 121212 | 121212 | 14.3% |
South America Biosimilar Testing and Development Services Market Sales Revenue | $ 132.55 Million | 121212 | 121212 | 121212 | 11.9% |
Brazil Biosimilar Testing and Development Services Market Sales Revenue | $ 56.73 Million | 121212 | 121212 | 121212 | 12.5% |
Chile Biosimilar Testing and Development Services Market Sales Revenue | $ 9.54 Million | 121212 | 121212 | 121212 | 12.2% |
Peru Biosimilar Testing and Development Services Market Sales Revenue | $ 10.87 Million | 121212 | 121212 | 121212 | 12.1% |
Colombia Biosimilar Testing and Development Services Market Sales Revenue | $ 11.8 Million | 121212 | 121212 | 121212 | 11.7% |
Argentina Biosimilar Testing and Development Services Market Sales Revenue | $ 22.27 Million | 121212 | 121212 | 121212 | 12.8% |
Rest of South America Biosimilar Testing and Development Services Market Sales Revenue | $ 21.34 Million | 121212 | 121212 | 121212 | 11% |
Middle East and Africa Biosimilar Testing and Development Services Market Sales Revenue | $ 53.02 Million | 121212 | 121212 | 121212 | 12.2% |
Egypt Biosimilar Testing and Development Services Market Sales Revenue | $ 5.57 Million | 121212 | 121212 | 121212 | 12.5% |
Turkey Biosimilar Testing and Development Services Market Sales Revenue | $ 4.56 Million | 121212 | 121212 | 121212 | 11.7% |
Rest of MEA Biosimilar Testing and Development Services Market Sales Revenue | $ 6.26 Million | 121212 | 121212 | 121212 | 11.2% |
Base Year | 2024 |
Historical Data Time Period | 2021-2024 |
Forecast Period | 2025-2033 |
Market Split by Type |
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Market Split by End User |
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List of Competitors |
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Regional Analysis |
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Country Analysis |
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Biosimilar Testing and Development Services Market is Segmented as below. Particular segment of your interest can be provided without any additional cost. Download the Sample Pages!
The Biosimilar Testing and Development Service Market is vital in producing affordable alternatives to costly biologic drugs. Key drivers include the increasing demand for cost-effective therapies, rising chronic disease prevalence, and supportive regulatory frameworks. Patent expirations of major biologics further propel biosimilar development, expanding the market. Notable trends involve advancements in testing and analytical technologies, improving development precision and efficiency. Strategic collaborations and partnerships are on the rise, pooling resources and expertise to expedite development timelines. Additionally, growing acceptance of biosimilars among healthcare providers and patients boosts demand. Overall, the market is set for significant growth, fueled by the need for affordable healthcare solutions and continuous innovations in biosimilar testing and development processes.
For instance, in May 2022, Amneal Pharmaceuticals, Inc. has obtained approval from the United States Food and Drug Administration ("FDA") for a Biologics License Application ("BLA") concerning pegfilgrastim-pbbk, a biosimilar referencing Neulasta. This product is slated for marketing under the name FYLNETRA.
(Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10099086/ )
The increasing demand for cost-effective therapies is a major driver of the Biosimilar Testing and Development Service Market. Biosimilars offer a more affordable alternative to expensive biologic drugs, making them attractive to healthcare providers and patients, particularly in cost-sensitive markets. As healthcare costs continue to rise, there is a growing need for cheaper therapeutic options to ensure broader patient access and sustainability of healthcare systems. This demand fuels the development and rigorous testing of biosimilars to ensure they meet safety and efficacy standards comparable to original biologics. Consequently, the market for testing and development services expands, driven by the necessity to provide high-quality, cost-effective treatment options.
Increasing acceptance among physicians is significantly driving the Biosimilar Testing and Development Service Market. As physicians become more familiar with the safety, efficacy, and cost benefits of biosimilars, their willingness to prescribe these alternatives grows. This acceptance reduces the barriers to adoption, leading to a higher demand for biosimilars. To meet this demand, rigorous testing and development processes are essential to ensure biosimilars meet stringent regulatory standards and gain physician trust. Consequently, the need for comprehensive biosimilar testing and development services escalates. As more physicians advocate for and prescribe biosimilars, the market for these services expands, driven by the necessity to maintain high-quality standards and to support the growing biosimilar market.
High development costs significantly restrain the Biosimilar Testing and Development Service Market. Developing biosimilars involves extensive research, advanced technology, and rigorous clinical trials to ensure they match the safety and efficacy of original biologics. These processes are both time-consuming and expensive, often requiring substantial financial investment. Small and medium-sized enterprises, in particular, may find it challenging to bear these costs, limiting their ability to enter the market. Additionally, the high costs can deter investors, slowing down innovation and the development of new biosimilars. The financial burden associated with biosimilar development thus acts as a significant barrier, restricting market growth and limiting the availability of affordable biosimilar therapies.
The COVID-19 pandemic impacted the Biosimilar Testing and Development Service Market by disrupting global supply chains and causing delays in clinical trials, which increased development costs and created bottlenecks. Healthcare resources were redirected to address the pandemic, leading to reduced focus on biosimilar projects. However, the crisis also underscored the need for cost-effective therapies, heightening interest in biosimilars as affordable alternatives to expensive biologics. This surge in demand has driven renewed investment in biosimilar research and development. Additionally, the accelerated adoption of digital technologies and remote monitoring improved the efficiency of some testing processes. Despite initial challenges, the pandemic highlighted the importance of biosimilars in ensuring healthcare affordability, potentially driving long-term growth in the market.
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The competitive landscape of the Biosimilar Testing and Development Service Market is characterized by several key players offering comprehensive testing and development services for biosimilar products. Major companies such as SGS SA, Eurofins Scientific, and Charles River Laboratories International, Inc. dominate the market, leveraging their expertise and global presence. Additionally, smaller players like BioOutsource Ltd. and WuXi AppTec contribute to the competitive landscape, offering specialized services and innovative solutions. Overall, intense competition drives innovation and quality assurance in the market.
September 2021: Samsung Bioepis and Biogen have jointly declared that the Food and Drug Administration (FDA) has granted approval for BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS (ranibizumab), designated for treating neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. BYOOVIZ stands as the inaugural ophthalmology biosimilar to receive FDA approval in the United States.
Top Companies Market Share in Biosimilar Testing and Development Services Industry: (In no particular order of Rank)
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According to Cognitive Market Research, North America commands the largest market share in the Biosimilar Testing and Development Service Market due to several factors. The region boasts a robust regulatory framework and favorable reimbursement policies, facilitating biosimilar development. Additionally, high healthcare expenditure and a large patient pool drive demand for cost-effective therapies, stimulating market growth. Moreover, the presence of key market players, advanced healthcare infrastructure, and extensive research and development activities further contribute to North America's dominance in the biosimilar testing and development services sector.
The Asia Pacific region is experiencing the fastest Compound Annual Growth Rate (CAGR) in the Biosimilar Testing and Development Service Market due to several reasons. This growth is propelled by increasing healthcare expenditure, rising prevalence of chronic diseases, and expanding access to healthcare across the region. Moreover, favorable government initiatives, supportive regulatory frameworks, and a large pool of skilled workforce contribute to the rapid expansion of biosimilar testing and development services in Asia Pacific, making it a key growth market in the industry.
The current report Scope analyzes Biosimilar Testing and Development Services Market on 5 major region Split (In case you wish to acquire a specific region edition (more granular data) or any country Edition data then please write us on info@cognitivemarketresearch.com
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According to Cognitive Market Research, the global Biosimilar Testing and Development Service market size was estimated at USD 2651.00 Million, out of which North America held the major market of more than 40% of the global revenue with a market size of USD 1060.40 million in 2024 and will grow at a compound annual growth rate (CAGR) of 10.7% from 2024 to 2031.
According to Cognitive Market Research, the global Biosimilar Testing and Development Service market size was estimated at USD 2651.00 Million out of which Europe held the market of more than 30% of the global revenue with a market size of USD 795.30 million in 2024 and will grow at a compound annual growth rate (CAGR) of 11.0% from 2024 to 2031.
According to Cognitive Market Research, the global Biosimilar Testing and Development Service market size was estimated at USD 2651.00 Million, out of which Asia Pacific held the market of around 23% of the global revenue with a market size of USD 609.73 million in 2024 and will grow at a compound annual growth rate (CAGR) of 14.5% from 2024 to 2031.
According to Cognitive Market Research, the global Biosimilar Testing and Development Service market size was estimated at USD 2651.00 Million out of which Latin America market of more than 5% of the global revenue with a market size of USD 132.55 million in 2024 and will grow at a compound annual growth rate (CAGR) of 11.9% from 2024 to 2031.
According to Cognitive Market Research, the global Biosimilar Testing and Development Service market size was estimated at USD 2651.00 Million, out of which the Middle East and Africa held the major market of around 2% of the global revenue with a market size of USD 53.02 million in 2024 and will grow at a compound annual growth rate (CAGR) of 12.2% from 2024 to 2031.
Global Biosimilar Testing and Development Services Market Report 2025 Edition talks about crucial market insights with the help of segments and sub-segments analysis. In this section, we reveal an in-depth analysis of the key factors influencing Biosimilar Testing and Development Services Industry growth. Biosimilar Testing and Development Services market has been segmented with the help of its Type, End User , and others. Biosimilar Testing and Development Services market analysis helps to understand key industry segments, and their global, regional, and country-level insights. Furthermore, this analysis also provides information pertaining to segments that are going to be most lucrative in the near future and their expected growth rate and future market opportunities. The report also provides detailed insights into factors responsible for the positive or negative growth of each industry segment.
How are Segments Performing in the Global Biosimilar Testing and Development Service Market?
According to Cognitive Market Research, Pharmacokinetics Assay stands out as the dominating category. Pharmacokinetics assays have captured the largest market share in the Biosimilar Testing and Development Service Market due to their critical role in assessing the similarity between biosimilars and reference biologics. These assays provide valuable data on the absorption, distribution, metabolism, and excretion of drugs, helping to establish bioequivalence. With regulatory agencies placing a strong emphasis on pharmacokinetic studies for biosimilar approval, the demand for pharmacokinetics assay services has surged, driving their dominance in the biosimilar testing and development services market.
Immunogenicity testing is experiencing the highest Compound Annual Growth Rate (CAGR) in the Biosimilar Testing and Development Service Market due to its crucial role in assessing the immune response to biosimilar products. With regulatory agencies increasingly emphasizing the importance of immunogenicity assessment for biosimilar approval, the demand for these tests has surged. Additionally, as biosimilar development progresses, ensuring minimal immunogenicity and comparable safety to reference biologics becomes paramount, further driving the growth of immunogenicity testing services in the market.
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According to Cognitive Market Research, the dominating category is Pharmaceutical and Biopharmaceutical Companies. Pharmaceutical and biopharmaceutical companies are the largest end users in the Biosimilar Testing and Development Service Market due to several factors. These companies are at the forefront of biosimilar development, investing heavily in research and development to bring new biologic products to market. They require comprehensive testing and development services to ensure the safety, efficacy, and compliance of biosimilars with regulatory standards. Consequently, they represent the primary clientele for biosimilar testing and development service providers, capturing the largest market share.
Contract Research Organizations (CROs) are witnessing the highest Compound Annual Growth Rate (CAGR) in the Biosimilar Testing and Development Service Market due to several factors. As pharmaceutical companies increasingly outsource their research and development activities to specialized service providers, CROs are experiencing a surge in demand for biosimilar testing and development services. Moreover, the flexibility, cost-effectiveness, and expertise offered by CROs appeal to companies seeking to streamline their operations and accelerate biosimilar development, driving their rapid growth in the market.
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Senior Research Associate at Cognitive Market Research
Manjiri Kanhere is an experienced market researcher focused on the Pharma & Healthcare industry. With over 3+ years of experience, She has worked with major pharmaceutical companies and healthcare providers, helping them to understand market trends, identify new business opportunities, and develop effective sales & marketing strategies. Her expertise lies in the ability to analyze complex data sets and deliver insights that drive business decisions. At Cognitive Market Research, she handles the market research related to Pharma and healthcare industry.
Manjiri Kanhere is an experienced market researcher focused on the Pharma & Healthcare industry. With over three years of experience, She has worked with major pharmaceutical companies and healthcare providers, helping them to understand market trends, identify new business opportunities, and develop effective sales & marketing strategies.
In her current role, Manjiri handles the market research related to Pharma and healthcare industry. Her passion lies in utilizing innovative approaches to distill complex information into strategic insights that empower organizations to make informed decisions.Manjiri remains an invaluable asset in the dynamic landscape of market research.
Conclusion
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The Biosimilar Testing and Development Service Market plays a crucial role in creating cost-effective alternatives to expensive biologic drugs.
Disclaimer:
Type | Pharmacokinetics Assay, Immunogenicity Testing, Others |
End User | Pharmaceutical and Biopharmaceutical Companies, Contract Research Organizations, Others |
List of Competitors | SGS SA (Switzerland), Eurofins Scientific (Luxembourg), Charles River Laboratories International, Inc. (United States), Sartorius AG (Germany), Intertek Group plc (United Kingdom), PPD, Inc. (United States), ICON plc (Ireland), WuXi AppTec (China), BioOutsource Ltd. (United Kingdom), Syneos Health, Inc. (United States) |
This chapter will help you gain GLOBAL Market Analysis of Biosimilar Testing and Development Services. Further deep in this chapter, you will be able to review Global Biosimilar Testing and Development Services Market Split by various segments and Geographical Split.
Chapter 1 Global Market Analysis
Global Market has been segmented on the basis 5 major regions such as North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America.
You can purchase only the Executive Summary of Global Market (2019 vs 2024 vs 2031)
Global Market Dynamics, Trends, Drivers, Restraints, Opportunities, Only Pointers will be deliverable
This chapter will help you gain North America Market Analysis of Biosimilar Testing and Development Services. Further deep in this chapter, you will be able to review North America Biosimilar Testing and Development Services Market Split by various segments and Country Split.
Chapter 2 North America Market Analysis
This chapter will help you gain Europe Market Analysis of Biosimilar Testing and Development Services. Further deep in this chapter, you will be able to review Europe Biosimilar Testing and Development Services Market Split by various segments and Country Split.
Chapter 3 Europe Market Analysis
This chapter will help you gain Asia Pacific Market Analysis of Biosimilar Testing and Development Services. Further deep in this chapter, you will be able to review Asia Pacific Biosimilar Testing and Development Services Market Split by various segments and Country Split.
Chapter 4 Asia Pacific Market Analysis
This chapter will help you gain South America Market Analysis of Biosimilar Testing and Development Services. Further deep in this chapter, you will be able to review South America Biosimilar Testing and Development Services Market Split by various segments and Country Split.
Chapter 5 South America Market Analysis
This chapter will help you gain Middle East and Africa Market Analysis of Biosimilar Testing and Development Services. Further deep in this chapter, you will be able to review Middle East and Africa Biosimilar Testing and Development Services Market Split by various segments and Country Split.
Chapter 6 Middle East and Africa Market Analysis
This chapter provides an in-depth analysis of the market share among key competitors of Biosimilar Testing and Development Services. The analysis highlights each competitor's position in the market, growth trends, and financial performance, offering insights into competitive dynamics, and emerging players.
Chapter 7 Competitor Analysis (Subject to Data Availability (Private Players))
(Subject to Data Availability (Private Players))
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
This chapter would comprehensively cover market drivers, trends, restraints, opportunities, and various in-depth analyses like industrial chain, PESTEL, Porter’s Five Forces, and ESG, among others. It would also include product life cycle, technological advancements, and patent insights.
Chapter 8 Qualitative Analysis (Subject to Data Availability)
Segmentation Type Analysis 2019 -2031, will provide market size split by Type. This Information is provided at Global Level, Regional Level and Top Countries Level The report with the segmentation perspective mentioned under this chapters will be delivered to you On Demand. So please let us know if you would like to receive this additional data as well. No additional cost will be applicable for the same.
Chapter 9 Market Split by Type Analysis 2021 - 2033
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Chapter 10 Market Split by End User Analysis 2021 - 2033
This chapter helps you understand the Key Takeaways and Analyst Point of View of the global Biosimilar Testing and Development Services market
Chapter 11 Research Findings
Here the analyst will summarize the content of entire report and will share his view point on the current industry scenario and how the market is expected to perform in the near future. The points shared by the analyst are based on his/her detailed in-depth understanding of the market during the course of this report study. You will be provided exclusive rights to interact with the concerned analyst for unlimited time pre purchase as well as post purchase of the report.
Chapter 12 Research Methodology and Sources
Why Pharmacokinetics Assay have a significant impact on Biosimilar Testing and Development Services market? |
What are the key factors affecting the Pharmacokinetics Assay and Immunogenicity Testing of Biosimilar Testing and Development Services Market? |
What is the CAGR/Growth Rate of Pharmaceutical and Biopharmaceutical Companies during the forecast period? |
By type, which segment accounted for largest share of the global Biosimilar Testing and Development Services Market? |
Which region is expected to dominate the global Biosimilar Testing and Development Services Market within the forecast period? |
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