생물학적 안전성 시험 시장 규모, 점유율, 성장 분석 : 제품 및 서비스별, 시험 유형별, 용도별, 최종사용자별, 지역별 - 산업 예측(2025-2032년)
Biologics Safety Testing Market Size, Share, and Growth Analysis, By Product and Services (Consumables, Instruments), By Test Type (Endotoxin tests, Sterility tests), By Application, By End User, By Region - Industry Forecast 2025-2032
상품코드:1663872
리서치사:SkyQuest Technology Consulting Pvt. Ltd.
발행일:2025년 02월
페이지 정보:영문 219 Pages
라이선스 & 가격 (부가세 별도)
한글목차
생물학적 안전성 시험 2023년 시장 규모는 52억 5,000만 달러로 평가되며, 2024년 58억 6,000만 달러에서 2032년 142억 1,000만 달러로 예측 기간(2025-2032년) 동안 11.7%의 CAGR로 성장할 것으로 예상됩니다.
생물학적 안전성 시험은 생물학적 공급원으로부터 유래한 바이오의약품 및 의료기기의 안전성 확보에 초점을 맞춘 필수적인 프로세스입니다. 이 종합적인 접근 방식은 오염 및 생물학적 부작용을 분석하여 잠재적 위험을 평가하고 완화하는 것을 목표로 합니다. 엄격한 규제 기준을 준수하는 것은 이러한 물질의 순도, 역가 및 전반적인 안전성을 확인하는 데 매우 중요합니다. 무균 시험, 내독소 평가, 세포 기반 분석과 같은 주요 기술은 엄격한 안전성 벤치마크를 준수하는지 평가하는 데 중요한 역할을 합니다. 안전하고 효과적인 의료 제품에 대한 수요가 증가함에 따라 생물학적 안전성 시험 시장은 규제 요건의 증가와 공중 보건 및 환자 안전에 대한 관심 증가에 힘입어 확대되고 있습니다.
목차
소개
조사 목적
조사 범위
정의
조사 방법
정보 조달
2차와 1차 데이터 방법
시장 규모 예측
시장 가정과 제한
주요 요약
세계 시장 전망
공급과 수요 동향 분석
부문별 기회 분석
시장 역학과 전망
시장 개요
시장 규모
시장 역학
성장 촉진요인과 기회
성장 억제요인과 과제
Porters 분석
주요 시장 인사이트
핵심성공요인
경쟁 정도
주요 투자 기회
시장 생태계
시장 매력 지수(2024년)
PESTEL 분석
거시경제 지표
밸류체인 분석
가격 분석
생물학적 안전성 시험 시장 규모 : 제품 및 서비스별 & CAGR(2025-2032년)
시장 개요
소모품
마이코플라스마 검사 서비스
멸균 검사 서비스
엔도톡신 검사 서비스
바이러스 안전성 시험 서비스
바이오버든 시험 서비스
기기
서비스
시약과 키트
기타 생물학적 안전성 시험 서비스
생물학적 안전성 시험 시장 규모 : 시험 유형별 & CAGR(2025-2032년)
시장 개요
엔도톡신 검사
멸균 시험
마이코플라스마 검사
바이오버든 시험
잔류 숙주 세포 단백질 및 DNA 검출 검사
바이러스 안전성 시험
외래성 병원체 검출 시험
기타 시험 유형
생물학적 안전성 시험 시장 규모 : 용도별 & CAGR(2025-2032년)
시장 개요
단클론항체 개발과 제조
백신 개발과 제조
세포 및 유전자 치료 제품 개발과 제조
혈액·혈액 제품 개발과 제조
기타 용도
생물학적 안전성 시험 시장 규모 : 최종사용자별 & CAGR(2025-2032년)
시장 개요
제약·바이오테크놀러지 기업
CRO&CDMO
학술조사기관
생물학적 안전성 시험 시장 규모 : 지역별 & CAGR(2025-2032년)
북미
미국
캐나다
유럽
독일
스페인
프랑스
영국
이탈리아
기타 유럽
아시아태평양
중국
인도
일본
한국
기타 아시아태평양
라틴아메리카
브라질
기타 라틴아메리카
중동 및 아프리카
GCC 국가
남아프리카공화국
기타 중동 및 아프리카
경쟁 정보
상위 5개사의 비교
주요 기업의 시장 포지셔닝(2024년)
주요 시장 기업이 채용한 전략
최근의 시장 동향
기업의 시장 점유율 분석(2024년)
주요 기업 개요
기업 상세
제품 포트폴리오 분석
기업 부문별 점유율 분석
매출 전년비 비교(2022-2024년)
주요 기업 개요
Charles River Laboratories(United States)
Lonza Group(Switzerland)
bioMerieux SA(France)
SGS Societe Generale de Surveillance SA(Switzerland)
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)
