生物相似药测试服务市场－全球产业规模、份额、趋势、机会和预测，按服务类型、分子类型、治疗领域、最终用户、地区和竞争细分，2020 年至 2030 年

2024 年全球生物相似药测试服务市值为 15.3 亿美元，预计到 2030 年将达到 30.3 亿美元，复合年增长率为 12.04%。这一增长是由对生物药物具有成本效益的替代品的需求不断增长所驱动，特别是随着许多高收入生物製剂的专利到期。製药公司正在增加对生物相似药开发的投资，以获得竞争优势并提供更多负担得起的治疗选择。生物相似药开发的激增增加了对专门测试服务的需求，以确保法规遵循、安全和有效性。美国 FDA 和 EMA 等监管机构要求对生物相似药进行广泛的分析、非临床和临床测试。因此，合约研究组织 (CRO) 和生物製药服务提供者在支持生物相似药製造商方面发挥关键作用，为他们提供特性研究、生物分析测试和药物动力学/药效学分析等服务。

关键市场驱动因素

慢性病和自体免疫疾病盛行率上升

主要市场挑战

生物相似药开发和测试的复杂性和成本高

主要市场趋势

越来越多地采用先进的分析技术进行生物相似药表征

目录

第 1 章：产品概述

第二章：研究方法

第三章：执行摘要

第四章：顾客之声

第五章：全球生物相似药测试服务市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按服务类型（分析测试、临床测试）
  • 依分子类型（单株抗体、重组激素、胰岛素、干扰素、酵素、其他）
  • 依治疗领域（肿瘤学、自体免疫疾病、糖尿病、传染病、神经病学、其他）
  • 按最终用户（製药和生物技术公司、合约研究组织、学术和研究机构等）
  • 按公司分类（2024）
  • 按地区
• 市场地图

第六章：北美生物相似药测试服务市场展望

• 市场规模和预测
• 市场占有率和预测
• 北美：国家分析
  • 美国
  • 墨西哥
  • 加拿大

第七章：欧洲生物相似药测试服务市场展望

• 市场规模和预测
• 市场占有率和预测
• 欧洲：国家分析
  • 法国
  • 德国
  • 英国
  • 义大利
  • 西班牙

第八章：亚太生物相似药测试服务市场展望

• 市场规模和预测
• 市场占有率和预测
• 亚太地区：国家分析
  • 中国
  • 印度
  • 韩国
  • 日本
  • 澳洲

第九章：南美洲生物相似药测试服务市场展望

• 市场规模和预测
• 市场占有率和预测
• 南美洲：国家分析
  • 巴西
  • 阿根廷
  • 哥伦比亚

第十章：中东和非洲生物相似药测试服务市场展望

• 市场规模和预测
• 市场占有率和预测
• MEA：国家分析
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第 11 章：市场动态

• 驱动程式
• 挑战

第 12 章：市场趋势与发展

• 合併与收购（如有）
• 产品发布（如有）
• 最新动态

第十三章：干扰：衝突、流行病与贸易壁垒

第 14 章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的力量
• 顾客的力量
• 替代产品的威胁

第 15 章：竞争格局

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

第 16 章：策略建议

第17章调查会社について・免责事项

The Global Biosimilar Testing Services Market was valued at USD 1.53 Billion in 2024 and is projected to reach USD 3.03 Billion by 2030, growing 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:

Global Biosimilar Testing Services Market report with the given market data, TechSci Research 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).

Table of Contents

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 Recommendations

17. About Us & Disclaimer