생물학적 제제 안전성 시험 시장 규모, 점유율, 성장 분석 : 제품 및 서비스별, 시험 유형별, 용도별, 최종사용자별, 지역별 - 업계 예측(2026-2033년)

Biologics Safety Testing Market size was valued at USD 5.86 Billion in 2024 and is poised to grow from USD 6.55 Billion in 2025 to USD 15.87 Billion by 2033, growing at a CAGR of 11.7% during the forecast period (2026-2033).

Market insights into biologics safety testing reveal a vital segment within the healthcare sector focused on ensuring the safety and efficacy of biological products, particularly biopharmaceuticals and medical devices. This field employs a variety of meticulous procedures designed to identify and mitigate risks, including contamination and adverse biological effects. Compliance with stringent regulatory standards is crucial, as it guarantees the purity, potency, and overall safety of biological materials. Key techniques such as sterility testing, endotoxin assessment, and cell-based assays play significant roles in rigorous evaluations, confirming adherence to safety benchmarks. This systematic approach not only safeguards clinical applications but also upholds public health, making biologics safety testing an essential component of product development and market readiness.

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

The growth of the pharmaceutical and biotechnology industries, driven by significant investments in research and development, represents a crucial period in the advancement of healthcare. As these sectors lead the way in developing new pharmaceuticals, biologics, and vaccines, they are actively tackling various healthcare challenges, particularly in the fight against complex diseases. This wave of innovation creates a heightened demand for rigorous safety assessments, highlighting the essential role of biological safety testing in ensuring the health and safety of patients. The urgency to maintain high standards of safety further emphasizes the importance of this market in the evolving landscape of healthcare.

Restraints in the Biologics Safety Testing Market

The Biologics Safety Testing market faces several constraints that can impact its growth and development. One significant challenge is the complexity and variability associated with biologics and biosimilars, which are produced from living cells and often require extensive testing to ensure safety and efficacy. This inherent complexity can lead to longer and more costly testing processes, potentially hindering market expansion. Additionally, regulatory challenges are prevalent, as the approval process for biologics typically involves rigorous scrutiny to meet safety standards, which can further delay product availability. Overall, these factors contribute to a constrained environment for the Biologics Safety Testing market.

Market Trends of the Biologics Safety Testing Market

The Biologics Safety Testing market is experiencing a significant upward trend driven by escalating regulatory scrutiny and an unwavering commitment to patient safety and product quality. As biopharmaceutical companies face stringent safety evaluation requirements, biological safety testing has become integral to the drug approval process. This evolution underscores the necessity for pharmaceutical and biotech firms to comply with evolving standards, which is crucial for securing product approvals and facilitating market entry. Consequently, the growing focus on compliance is propelling demand for advanced testing services, solidifying the critical position of biological safety testing in the biopharmaceutical landscape.

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, 2025
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global Biologics Safety Testing Market Size by Product and Services & CAGR (2026-2033)

• 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 (2026-2033)

• 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 (2026-2033)

• 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 (2026-2033)

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

Global Biologics Safety Testing Market Size & CAGR (2026-2033)

• 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, 2025
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2025
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2023-2025)

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