バイオシミラー検査サービス市場- 世界の産業規模、シェア、動向、機会、予測、サービスタイプ別、分子タイプ別、治療領域別、エンドユーザー別、地域別、競合別、2020-2030年

バイオシミラー検査サービスの世界市場は、2024年に15億3,000万米ドルと評価され、2030年には30億3,000万米ドルに達し、CAGR 12.04％で成長すると予測されています。

この成長は、特に多くの高収益生物製剤の特許が切れる中、生物製剤に代わる費用対効果の高い代替品への需要が高まっていることが背景にあります。製薬会社は競争上の優位性を獲得し、より安価な治療選択肢を提供するため、バイオシミラー開発への投資を増やしています。このようなバイオシミラー開発の急増により、規制への適合性、安全性、有効性を確保するための専門的な検査サービスの必要性が高まっています。米国FDAや欧州医薬品庁（EMA）などの規制当局は、バイオシミラー医薬品の承認取得のために、広範な分析試験、非臨床試験、臨床試験を要求しています。その結果、医薬品開発業務受託機関（CRO）やバイオ医薬品サービスプロバイダーは、特性試験、生物学的分析試験、薬物動態学的／薬力学的分析などのサービスでバイオシミラーメーカーをサポートする上で極めて重要な役割を果たしています。

市場促進要因

慢性疾患および自己免疫疾患の有病率の上昇

主な市場課題

バイオシミラー開発と試験の複雑さとコストの高さ

主要市場動向

バイオシミラーの特性解析における高度な分析技術の採用の増加

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界のバイオシミラー検査サービス市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • サービスタイプ別（分析試験、臨床検査）
  • 分子タイプ別（モノクローナル抗体、組み換えホルモン、インスリン、インターフェロン、酵素、その他）
  • 治療領域別（腫瘍学、自己免疫疾患、糖尿病、感染症、神経学、その他）
  • エンドユーザー別（製薬・バイオテクノロジー企業、開発調査委託機関、学術調査機関、その他）
  • 企業別（2024）
  • 地域別
• 市場マップ

第6章 北米のバイオシミラー検査サービス市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • メキシコ
  • カナダ

第7章 欧州のバイオシミラー検査サービス市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • 英国
  • イタリア
  • スペイン

第8章 アジア太平洋地域のバイオシミラー検査サービス市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • 韓国
  • 日本
  • オーストラリア

第9章 南米のバイオシミラー検査サービス市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカのバイオシミラー検査サービス市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 合併と買収
• 製品上市
• 最近の動向

第13章 混乱：紛争、パンデミック、貿易障壁

第14章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第15章 競合情勢

• 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.

第16章 戦略的提言

第17章 調査会社について・免責事項

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