生物学的安全性試験の市場規模、シェア、成長分析：製品・サービス別、試験タイプ別、用途別、エンドユーザー別、地域別 - 産業予測 2025～2032年

生物学的安全性試験2023年の市場規模は52億5,000万米ドルで、2024年の58億6,000万米ドルから2032年には142億1,000万米ドルに拡大し、予測期間（2025-2032年）のCAGRは11.7%で成長する見通しです。

生物学的安全性試験は、生物学的供給源に由来するバイオ医薬品や医療機器の安全性確保に焦点を当てた不可欠なプロセスです。この包括的なアプローチは、汚染や生物学的悪影響を分析することにより、潜在的なリスクを評価し、軽減することを目的としています。厳格な規制基準を遵守することは、これらの材料の純度、力価、および全体的な安全性を確認する上で極めて重要です。無菌試験、エンドトキシン評価、セルベースアッセイなどの主要技術は、厳格な安全性ベンチマークへの準拠を評価する上で重要な役割を果たしています。安全で効果的な医療製品への需要が高まるにつれ、生物学的安全性試験市場は、規制要件の増加や公衆衛生と患者の安全への関心の高まりに後押しされ、拡大に向かっています。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次と一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析

生物学的安全性試験市場規模：製品・サービス別& CAGR（2025-2032）

• 市場概要
• 消耗品
  • マイコプラズマ検査サービス
  • 滅菌検査サービス
  • エンドトキシン検査サービス
  • ウイルス安全性試験サービス
  • バイオバーデン試験サービス
• 機器
• サービス
• 試薬とキット
• その他の生物学的安全性試験サービス

生物学的安全性試験市場規模：試験タイプ別& CAGR（2025-2032）

• 市場概要
• エンドトキシン検査
• 滅菌試験
• マイコプラズマ検査
• バイオバーデン試験
• 残留宿主細胞タンパク質およびDNA検出検査
• ウイルス安全性試験
• 外来性病原体検出試験
• その他の試験タイプ

生物学的安全性試験市場規模：用途別& CAGR（2025-2032）

• 市場概要
• モノクローナル抗体の開発と製造
• ワクチンの開発と製造
• 細胞・遺伝子治療製品の開発と製造
• 血液・血液製品の開発と製造
• その他の用途

生物学的安全性試験市場規模：エンドユーザー別& CAGR（2025-2032）

• 市場概要
• 製薬・バイオテクノロジー企業
• CRO＆CDMO
• 学術調査機関

生物学的安全性試験市場規模：地域別& CAGR（2025-2032）

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 最近の市場動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 企業の詳細
  • 製品ポートフォリオ分析
  • 企業のセグメント別シェア分析
  • 収益の前年比比較（2022-2024）

主要企業プロファイル

• Charles River Laboratories（United States）
• Lonza Group（Switzerland）
• bioMerieux SA（France）
• SGS Societe Generale de Surveillance SA（Switzerland）
• Eurofins Scientific（Luxembourg）
• Samsung Biologics（South Korea）
• FUJIFILM Wako Pure Chemical Corporation（Japan）
• Thermo Fisher Scientific Inc.（United States）
• Sartorius AG（Germany）
• Merck KGaA（Germany）
• WuXi AppTec（China）
• Intertek Group plc（United Kingdom）
• West Pharmaceutical Services, Inc.（United States）
• Ajinomoto Bio-Pharma Services（United States）
• Gateway Analytical（United States）
• Reading Scientific Services Ltd.（RSSL）（United Kingdom）
• Tentamus Group（Germany）
• IQVIA（United States）

結論と提言

Biologics Safety Testing Market size was valued at USD 5.25 billion in 2023 and is poised to grow from USD 5.86 billion in 2024 to USD 14.21 billion by 2032, growing at a CAGR of 11.7% during the forecast period (2025-2032).

Biological safety testing is an essential process focused on ensuring the safety of biopharmaceuticals and medical devices derived from biological sources. This comprehensive approach aims to assess and mitigate potential risks by analyzing contamination and adverse biological effects. Adhering to stringent regulatory standards is crucial for confirming the purity, potency, and overall safety of these materials. Key techniques, including sterility testing, endotoxin assessment, and cell-based assays, play vital roles in evaluating compliance with rigorous safety benchmarks. As the demand for safe and effective medical products grows, the biological safety testing market is poised for expansion, driven by increasing regulatory requirements and a heightened focus on public health and patient safety.

Top-down and bottom-up approaches were used to estimate and validate the size of the Biologics Safety Testing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Biologics Safety Testing Market Segments Analysis

Global Biologics Safety Testing Market is segmented by Product and Services, Test Type, Application, End User and region. Based on Product and Services, the market is segmented into Consumables, Instruments, Services, Reagents and kits and Other Biologics Safety Testing Services. Based on Test Type, the market is segmented into Endotoxin tests, Sterility tests, Mycoplasma tests, Bioburden tests, Residual host-cell proteins and DNA detection tests, Virus safety tests, Adventitious agent detection tests and Other test types. Based on Application, the market is segmented into Monoclonal Antibodies Development And Manufacturing, Vaccines Development And Manufacturing, Cellular & Gene Therapy Products Development And Manufacturing, Blood & Blood Products Development And Manufacturing and Other Applications. Based on End User, the market is segmented into Pharmaceutical & Biotechnology Companies, Cros & Cdmos and Academic & Research Institutes. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Biologics Safety Testing Market

Recent expansions in the pharmaceutical and biotechnology sectors, driven by significant investments in research and development, mark a critical phase in the evolution of healthcare. These industries are at the leading edge of developing pharmaceuticals, biologics, and vaccines, effectively tackling complex healthcare challenges, particularly in the fight against intricate diseases. This wave of innovation inherently heightens the demand for rigorous safety assessments, where biologics safety testing becomes essential in ensuring patient safety. As the landscape of healthcare continues to evolve, the importance of robust safety testing mechanisms will become increasingly vital in maintaining public health standards and fostering trust in new therapeutic solutions.

Restraints in the Biologics Safety Testing Market

The Biologics Safety Testing market faces several challenges that may hinder its growth. Key restraints include stringent regulatory requirements that can complicate the testing processes, alongside the high costs associated with developing and maintaining testing protocols. Furthermore, the constantly evolving landscape of biologics, coupled with the rapid advancement of biotechnology, necessitates ongoing updates in testing methodologies, which can be resource-intensive. Additionally, the limited availability of skilled professionals in the field may impede market expansion. These factors create significant hurdles for stakeholders aiming to navigate the complexities of biologics safety testing, ultimately affecting their ability to innovate and maintain compliance.

Market Trends of the Biologics Safety Testing Market

The Biologics Safety Testing market is experiencing significant growth, driven by intensified regulatory scrutiny on biopharmaceutical products, which emphasizes patient safety and product quality. As global regulatory bodies enforce stringent safety evaluations, biological safety testing has become essential for drug approvals, compelling pharmaceutical and biotech companies to prioritize compliance. This shift not only underscores the importance of comprehensive safety assessments but also stimulates heightened demand for specialized testing services. Consequently, the market is solidifying its position as a critical component in pharmaceutical development, ensuring that companies can navigate the complexities of regulatory requirements and achieve timely market entry.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global Biologics Safety Testing Market Size by Product and Services & CAGR (2025-2032)

• Market Overview
• Consumables
  • Mycoplasma Testing Services
  • Sterility Testing Services
  • Endotoxin Testing Services
  • Virus Safety Testing Services
  • Bioburden Testing Services
• Instruments
• Services
• Reagents and kits
• Other Biologics Safety Testing Services

Global Biologics Safety Testing Market Size by Test Type & CAGR (2025-2032)

• Market Overview
• Endotoxin tests
• Sterility tests
• Mycoplasma tests
• Bioburden tests
• Residual host-cell proteins and DNA detection tests
• Virus safety tests
• Adventitious agent detection tests
• Other test types

Global Biologics Safety Testing Market Size by Application & CAGR (2025-2032)

• Market Overview
• Monoclonal Antibodies Development And Manufacturing
• Vaccines Development And Manufacturing
• Cellular & Gene Therapy Products Development And Manufacturing
• Blood & Blood Products Development And Manufacturing
• Other Applications

Global Biologics Safety Testing Market Size by End User & CAGR (2025-2032)

• Market Overview
• Pharmaceutical & Biotechnology Companies
• Cros & Cdmos
• Academic & Research Institutes

Global Biologics Safety Testing Market Size & CAGR (2025-2032)

• North America (Product and Services, Test Type, Application, End User)
  • US
  • Canada
• Europe (Product and Services, Test Type, Application, End User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Product and Services, Test Type, Application, End User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Product and Services, Test Type, Application, End User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Product and Services, Test Type, Application, End User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Charles River Laboratories (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lonza Group (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• bioMerieux SA (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• SGS Societe Generale de Surveillance SA (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eurofins Scientific (Luxembourg)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Samsung Biologics (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• FUJIFILM Wako Pure Chemical Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sartorius AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Merck KGaA (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi AppTec (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intertek Group plc (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• West Pharmaceutical Services, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Ajinomoto Bio-Pharma Services (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Gateway Analytical (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Reading Scientific Services Ltd. (RSSL) (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Tentamus Group (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• IQVIA (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations