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市場調查報告書
商品編碼
1770829

生物相似藥測試服務市場－全球產業規模、佔有率、趨勢、機會和預測，按服務類型、分子類型、治療領域、最終用戶、地區和競爭細分，2020 年至 2030 年

Biosimilar Testing Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service Type, By Molecule Type, By Therapeutic Area, By End User, By Region and Competition, 2020-2030F
出版日期: | 出版商: TechSci Research | 英文 181 Pages | 商品交期: 2-3個工作天內

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簡介目錄

2024 年全球生物相似藥測試服務市值為 15.3 億美元，預計到 2030 年將達到 30.3 億美元，複合年成長率為 12.04%。這一成長是由對生物藥物具有成本效益的替代品的需求不斷成長所驅動，特別是隨著許多高收入生物製劑的專利到期。製藥公司正在增加對生物相似藥開發的投資，以獲得競爭優勢並提供更多負擔得起的治療選擇。生物相似藥開發的激增增加了對專門測試服務的需求，以確保法規遵循、安全和有效性。美國 FDA 和 EMA 等監管機構要求對生物相似藥進行廣泛的分析、非臨床和臨床測試。因此，合約研究組織 (CRO) 和生物製藥服務提供者在支持生物相似藥製造商方面發揮關鍵作用，為他們提供特性研究、生物分析測試和藥物動力學/藥效學分析等服務。

市場概覽
預測期 2026-2030
2024年市場規模 15.3億美元
2030年市場規模 30.3億美元
2025-2030 年複合年成長率 12.04%
成長最快的領域 自體免疫疾病
最大的市場 北美洲

關鍵市場促進因素

慢性病和自體免疫疾病盛行率上升

主要市場挑戰

生物相似藥開發和測試的複雜性和成本高

主要市場趨勢

擴大採用先進的分析技術進行生物相似藥表徵

目錄

第 1 章：產品概述

第2章：研究方法

第3章：執行摘要

第4章：顧客之聲

第5章：全球生物相似藥測試服務市場展望

  • 市場規模和預測
    • 按價值
  • 市場佔有率和預測
    • 按服務類型（分析測試、臨床測試）
    • 依分子類型（單株抗體、重組激素、胰島素、干擾素、酵素、其他）
    • 依治療領域（腫瘤學、自體免疫疾病、糖尿病、傳染病、神經病學、其他）
    • 按最終用戶（製藥和生物技術公司、合約研究組織、學術和研究機構等）
    • 按公司分類（2024）
    • 按地區
  • 市場地圖

第6章：北美生物相似藥測試服務市場展望

  • 市場規模和預測
  • 市場佔有率和預測
  • 北美：國家分析
    • 美國
    • 墨西哥
    • 加拿大

第7章：歐洲生物相似藥測試服務市場展望

  • 市場規模和預測
  • 市場佔有率和預測
  • 歐洲：國家分析
    • 法國
    • 德國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太生物相似藥測試服務市場展望

  • 市場規模和預測
  • 市場佔有率和預測
  • 亞太地區：國家分析
    • 中國
    • 印度
    • 韓國
    • 日本
    • 澳洲

第9章：南美洲生物相似藥測試服務市場展望

  • 市場規模和預測
  • 市場佔有率和預測
  • 南美洲：國家分析
    • 巴西
    • 阿根廷
    • 哥倫比亞

第10章：中東和非洲生物相似藥測試服務市場展望

  • 市場規模和預測
  • 市場佔有率和預測
  • MEA：國家分析
    • 南非
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國

第 11 章：市場動態

  • 驅動程式
  • 挑戰

第 12 章：市場趨勢與發展

  • 合併與收購（如有）
  • 產品發布（如有）
  • 最新動態

第13章：干擾：衝突、流行病與貿易壁壘

第 14 章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的力量
  • 顧客的力量
  • 替代產品的威脅

第 15 章：競爭格局

  • 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：策略建議

第17章調查會社について,免責事項

簡介目錄
Product Code: 29985

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.

Market Overview
Forecast Period2026-2030
Market Size 2024USD 1.53 Billion
Market Size 2030USD 3.03 Billion
CAGR 2025-203012.04%
Fastest Growing SegmentAutoimmune Diseases
Largest MarketNorth America

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