Biosimilar Testing Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F

The Biosimilar Testing Services Market was valued at USD 1.53 Billion in 2024, and is expected to reach USD 3.03 Billion by 2030, rising at a CAGR of 12.04%. This growth is driven by rising demand for cost-effective alternatives to biologic drugs, particularly as patents for many high-revenue biologics expire. Pharmaceutical companies are increasingly investing in biosimilar development to gain competitive advantage and offer more affordable treatment options. This surge in biosimilar development has amplified the need for specialized testing services to ensure regulatory compliance, safety, and efficacy. Regulatory authorities such as the U.S. FDA and EMA require extensive analytical, non-clinical, and clinical testing for biosimilar approval. As a result, contract research organizations (CROs) and biopharmaceutical service providers play a pivotal role in supporting biosimilar manufacturers with services such as characterization studies, bioanalytical testing, and pharmacokinetic/pharmacodynamic analysis.

Key Market Drivers

Rising Prevalence of Chronic and Autoimmune Diseases

The increasing incidence of chronic and autoimmune diseases is a key factor driving growth in the Global Biosimilar Testing Services Market, as it boosts demand for affordable biologic therapies. Chronic noncommunicable diseases (NCDs) continue to be a major global health concern. According to the World Health Organization (WHO), NCDs were responsible for approximately 43 million deaths in 2021 - about 75% of all non-pandemic-related fatalities. Cardiovascular diseases led with 19 million deaths, followed by cancers (10 million), chronic respiratory illnesses (4 million), and diabetes-related complications (over 2 million). The high burden of these diseases has intensified the need for biosimilars as cost-effective alternatives, thereby increasing the demand for comprehensive testing services to ensure therapeutic equivalence and safety.

Key Market Challenges

High Complexity and Cost of Biosimilar Development and Testing

The intricate nature and high cost of biosimilar development and testing remain major challenges in the Global Biosimilar Testing Services Market. Unlike small-molecule generics, biosimilars are complex biologics produced using living systems, requiring advanced analytical and functional characterization to establish similarity with reference products.

Technologies such as mass spectrometry, chromatography, capillary electrophoresis, and NMR spectroscopy are essential for detailed analysis, significantly raising development expenses. Biosimilar developers must also conduct robust comparability assessments, potency tests, immunogenicity evaluations, pharmacokinetic/pharmacodynamic studies, and clinical trials to comply with rigorous regulations set by bodies like the U.S. FDA, EMA, and PMDA. These multifaceted regulatory demands lead to prolonged development timelines and substantial financial investment, posing barriers especially for small and mid-sized firms.

Key Market Trends

Increasing Adoption of Advanced Analytical Techniques for Biosimilar Characterization

A prominent trend in the Global Biosimilar Testing Services Market is the growing reliance on advanced analytical tools for biosimilar characterization. To meet regulatory expectations set by agencies such as the U.S. FDA, EMA, and PMDA, biosimilar developers must demonstrate structural and functional equivalence to originator biologics. Traditional methods often lack the sensitivity to detect subtle molecular differences, prompting increased use of high-resolution mass spectrometry (HRMS), nuclear magnetic resonance (NMR) spectroscopy, capillary electrophoresis (CE), and surface plasmon resonance (SPR). These technologies enable comprehensive assessments of purity, potency, and immunogenicity.

With biologics like monoclonal antibodies, fusion proteins, and recombinant hormones growing more complex, the need for precise testing of attributes such as glycosylation patterns, post-translational modifications, and aggregation is intensifying. Complementary techniques like high-performance liquid chromatography (HPLC) and size-exclusion chromatography (SEC) are widely employed to analyze stability and degradation pathways. The integration of automation and high-throughput screening platforms is also enhancing reproducibility and reducing testing variability, ultimately improving testing efficiency and quality.

Key Market Players

Thermo Fisher Scientific Inc.
Charles River Laboratories, Inc.
SGS S.A.
Eurofins Scientific Limited
Intertek Group plc
Element Materials Technology
Pacific BioLabs, Inc.
Sartorius AG
WuXi AppTec
Syngene International Ltd.

Report Scope:

In this report, the Global Biosimilar Testing Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Biosimilar Testing Services Market, By Service Type:

Analytical Testing
Clinical Testing

Biosimilar Testing Services Market, By Molecule Type:

Monoclonal Antibodies
Recombinant Hormones
Insulin
Interferons
Enzymes
Others

Biosimilar Testing Services Market, By Therapeutic Area:

Oncology
Autoimmune Diseases
Diabetes
Infectious Diseases
Neurology
Others

Biosimilar Testing Services Market, By End User:

Pharmaceutical & Biotechnology Companies
Contract Research Organizations
Academic & Research Institutes
Others

Biosimilar Testing Services Market, By Region:

North America
United States
Canada
Mexico
Europe
France
United Kingdom
Italy
Germany
Spain
Asia-Pacific
China
India
Japan
Australia
South Korea
South America
Brazil
Argentina
Colombia
Middle East & Africa
South Africa
Saudi Arabia
UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Biosimilar Testing Services Market.

Available Customizations:

With the given market data, the publisher offers customizations according to a company's specific needs. The following customization options are available for the report.

Company Information

Detailed analysis and profiling of additional market players (up to five).

This product will be delivered within 1-3 business days.

1. Product Overview

1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations

2. Research Methodology

2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations

3. Executive Summary

3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, and Trends

4. Voice of Customer

5. Global Biosimilar Testing Services Market Outlook

5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Service Type (Analytical Testing, Clinical Testing)
5.2.2. By Molecule Type (Monoclonal Antibodies, Recombinant Hormones, Insulin, Interferons, Enzymes, Others)
5.2.3. By Therapeutic Area (Oncology, Autoimmune Diseases, Diabetes, Infectious Diseases, Neurology, Others)
5.2.4. By End User (Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic & Research Institutes, Others)
5.2.5. By Company (2024)
5.2.6. By Region
5.3. Market Map

6. North America Biosimilar Testing Services Market Outlook

6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Service Type
6.2.2. By Molecule Type
6.2.3. By Therapeutic Area
6.2.4. By End User
6.2.5. By Country
6.3. North America: Country Analysis
6.3.1. United States Biosimilar Testing Services Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Service Type
6.3.1.2.2. By Molecule Type
6.3.1.2.3. By Therapeutic Area
6.3.1.2.4. By End User
6.3.2. Mexico Biosimilar Testing Services Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Service Type
6.3.2.2.2. By Molecule Type
6.3.2.2.3. By Therapeutic Area
6.3.2.2.4. By End User
6.3.3. Canada Biosimilar Testing Services Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Service Type
6.3.3.2.2. By Molecule Type
6.3.3.2.3. By Therapeutic Area
6.3.3.2.4. By End User

7. Europe Biosimilar Testing Services Market Outlook

7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Service Type
7.2.2. By Molecule Type
7.2.3. By Therapeutic Area
7.2.4. By End User
7.2.5. By Country
7.3. Europe: Country Analysis
7.3.1. France Biosimilar Testing Services Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Service Type
7.3.1.2.2. By Molecule Type
7.3.1.2.3. By Therapeutic Area
7.3.1.2.4. By End User
7.3.2. Germany Biosimilar Testing Services Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Service Type
7.3.2.2.2. By Molecule Type
7.3.2.2.3. By Therapeutic Area
7.3.2.2.4. By End User
7.3.3. United Kingdom Biosimilar Testing Services Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Service Type
7.3.3.2.2. By Molecule Type
7.3.3.2.3. By Therapeutic Area
7.3.3.2.4. By End User
7.3.4. Italy Biosimilar Testing Services Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Service Type
7.3.4.2.2. By Molecule Type
7.3.4.2.3. By Therapeutic Area
7.3.4.2.4. By End User
7.3.5. Spain Biosimilar Testing Services Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Service Type
7.3.5.2.2. By Molecule Type
7.3.5.2.3. By Therapeutic Area
7.3.5.2.4. By End User

8. Asia-Pacific Biosimilar Testing Services Market Outlook

8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Service Type
8.2.2. By Molecule Type
8.2.3. By Therapeutic Area
8.2.4. By End User
8.2.5. By Country
8.3. Asia-Pacific: Country Analysis
8.3.1. China Biosimilar Testing Services Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Service Type
8.3.1.2.2. By Molecule Type
8.3.1.2.3. By Therapeutic Area
8.3.1.2.4. By End User
8.3.2. India Biosimilar Testing Services Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Service Type
8.3.2.2.2. By Molecule Type
8.3.2.2.3. By Therapeutic Area
8.3.2.2.4. By End User
8.3.3. South Korea Biosimilar Testing Services Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Service Type
8.3.3.2.2. By Molecule Type
8.3.3.2.3. By Therapeutic Area
8.3.3.2.4. By End User
8.3.4. Japan Biosimilar Testing Services Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Service Type
8.3.4.2.2. By Molecule Type
8.3.4.2.3. By Therapeutic Area
8.3.4.2.4. By End User
8.3.5. Australia Biosimilar Testing Services Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Service Type
8.3.5.2.2. By Molecule Type
8.3.5.2.3. By Therapeutic Area
8.3.5.2.4. By End User

9. South America Biosimilar Testing Services Market Outlook

9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Service Type
9.2.2. By Molecule Type
9.2.3. By Therapeutic Area
9.2.4. By End User
9.2.5. By Country
9.3. South America: Country Analysis
9.3.1. Brazil Biosimilar Testing Services Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Service Type
9.3.1.2.2. By Molecule Type
9.3.1.2.3. By Therapeutic Area
9.3.1.2.4. By End User
9.3.2. Argentina Biosimilar Testing Services Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Service Type
9.3.2.2.2. By Molecule Type
9.3.2.2.3. By Therapeutic Area
9.3.2.2.4. By End User
9.3.3. Colombia Biosimilar Testing Services Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Service Type
9.3.3.2.2. By Molecule Type
9.3.3.2.3. By Therapeutic Area
9.3.3.2.4. By End User

10. Middle East and Africa Biosimilar Testing Services Market Outlook

10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Service Type
10.2.2. By Molecule Type
10.2.3. By Therapeutic Area
10.2.4. By End User
10.2.5. By Country
10.3. MEA: Country Analysis
10.3.1. South Africa Biosimilar Testing Services Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Service Type
10.3.1.2.2. By Molecule Type
10.3.1.2.3. By Therapeutic Area
10.3.1.2.4. By End User
10.3.2. Saudi Arabia Biosimilar Testing Services Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Service Type
10.3.2.2.2. By Molecule Type
10.3.2.2.3. By Therapeutic Area
10.3.2.2.4. By End User
10.3.3. UAE Biosimilar Testing Services Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Service Type
10.3.3.2.2. By Molecule Type
10.3.3.2.3. By Therapeutic Area
10.3.3.2.4. By End User

11. Market Dynamics

11.1. Drivers
11.2. Challenges

12. Market Trends & Developments

12.1. Merger & Acquisition (If Any)
12.2. Product Launches (If Any)
12.3. Recent Developments

13. Disruptions: Conflicts, Pandemics and Trade Barriers

14. Porters Five Forces Analysis

14.1. Competition in the Industry
14.2. Potential of New Entrants
14.3. Power of Suppliers
14.4. Power of Customers
14.5. Threat of Substitute Products

15. Competitive Landscape

15.1. Thermo Fisher Scientific Inc.
15.1.1. Business Overview
15.1.2. Company Snapshot
15.1.3. Products & Services
15.1.4. Financials (As Reported)
15.1.5. Recent Developments
15.1.6. Key Personnel Details
15.1.7. SWOT Analysis
15.2. Charles River Laboratories, Inc.
15.3. SGS S.A.
15.4. Eurofins Scientific Limited
15.5. Intertek Group plc
15.6. Element Materials Technology
15.7. Pacific BioLabs, Inc.
15.8. Sartorius AG
15.9. WuXi AppTec
15.10. Syngene International Ltd.

16. Strategic Recommendations17. About the Publisher & Disclaimer

Companies Mentioned

Thermo Fisher Scientific Inc.
Charles River Laboratories, Inc.
SGS S.A.
Eurofins Scientific Limited
Intertek Group plc
Element Materials Technology
Pacific BioLabs, Inc.
Sartorius AG
WuXi AppTec
Syngene International Ltd.

Table Information

Report Attribute	Details
No. of Pages	181
Published	July 2025
Forecast Period	2024 - 2030
Estimated Market Value ( USD ) in 2024	$ 1.53 Billion
Forecasted Market Value ( USD ) by 2030	$ 3.03 Billion
Compound Annual Growth Rate	12.0%
Regions Covered	Global
No. of Companies Mentioned	10

License	Format	Properties	Price
SINGLE USER LICENSE PDF	The product is a PDF.	This is a single user license, allowing one user access to the product.	€4010EUR$4,500USD£3,479GBP
ENTERPRISE LICENSE PDF	The product is a PDF.	This is an enterprise license, allowing all employees within your organization access to the product.	€4901EUR$5,500USD£4,252GBP