세계의 생물학적 안전성 시험 시장 규모, 점유율, 성장 분석 : 제품별, 시험 유형별, 용도별, 지역별 - 산업 예측(2025-2032년)
Biological Safety Testing Market Size, Share, Growth Analysis, By Product (Reagents & Kits, Services), By Test Type (Endotoxin Tests, Sterility Tests), By Application, By Region - Industry Forecast 2025-2032
상품코드:1630764
리서치사:SkyQuest Technology Consulting Pvt. Ltd.
발행일:2025년 01월
페이지 정보:영문 157 Pages
라이선스 & 가격 (부가세 별도)
한글목차
생물학적 안전성 시험 세계 시장 규모는 2023년 52억 달러로 평가되었습니다. 2024년 58억 1,000만 달러에서 2032년 140억 8,000만 달러로 성장할 것으로 예상되며, 예측 기간(2025-2032년) 동안 연평균 11.7%의 연평균 복합 성장률(CAGR)을 나타낼 전망입니다.
세계 생물학적 안전성 시험 시장은 제약 및 생명공학 분야의 연구개발의 급증, 감염성 질환 증가, 헬스케어 품질 관리에 대한 인식이 높아짐에 따라 큰 폭의 성장이 예상되고 있습니다. 이 시장은 백신, 혈액제제, 세포 기반 치료제와 같은 생물학적 제제의 안전성 및 유효성 평가에 중점을 두고 있으며, 유해성 위험을 줄이기 위해 철저한 시험을 의무화하는 엄격한 규제 기준을 준수하고 있습니다. 핵산 증폭 및 염기서열 분석을 포함한 첨단 검사 기술의 출현은 오염 물질 검출의 민감도를 높이고 환자의 안전을 향상시킵니다. 또한, 세포 기반 분석 및 면역 분석과 같은 체외 검사 방법의 사용이 증가하고 있으며, 더 빠르고 비용 효율적인 결과를 제공하고 동물 실험에 대한 의존도를 줄임으로써 시장 확대가 가속화되고 있습니다.
목차
서론
조사 목적
조사 범위
정의
조사 방법
정보 조달
2차 데이터와 1차 데이터 방법
시장 규모 예측
시장 전제조건과 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
Porter의 Five Forces 분석
주요 시장 인사이트
중요 성공 요인
경쟁 정도
주요 투자 기회
시장 생태계
시장의 매력 지수(2024년)
PESTEL 분석
거시경제 지표
밸류체인 분석
가격 분석
규제 상황
사례 연구
기술 진보
생물학적 안전성 시험 시장 규모 : 제품별 & CAGR(2025-2032년)
시장 개요
시약 및 키트
서비스
기기
생물학적 안전성 시험 시장 규모 : 시험 유형별 & CAGR(2025-2032년)
시장 개요
엔도톡신 검사
무균 시험
세포주 인증 및 특성 평가 시험
바이오바덴 시험
외래 성병원체 감지 시험
잔류 숙주 오염 감지 시험
기타
생물학적 안전성 시험 시장 규모 : 용도별 & CAGR(2025-2032년)
시장 개요
백신 및 치료제
백신
단클론항체
재조합 단백질
혈액 및 혈액 관련 제품
유전자 치료
조직 및 조직 기반 제품
줄기세포
기타
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
주요 5개사 비교
주요 기업의 시장 포지셔닝(2024년)
주요 시장 기업이 채택한 전략
시장 최근 동향
기업의 시장 점유율 분석(2024년)
주요 기업 개요
기업 개요
제품 포트폴리오 분석
부문별 점유율 분석
매출 전년대비 비교(2022-2024)
주요 기업 개요
bioMerieux S.A.(France)
Charles River Laboratories International, Inc.(United States)
Eurofins Scientific SE(Luxembourg)
Lonza Group Ltd.(Switzerland)
Merck KGaA(Germany)
Samsung Biologics(South Korea)
Sartorius AG(Germany)
SGS Societe Generale de Surveillance SA(Switzerland)
Thermo Fisher Scientific Inc.(United States)
Avance Biosciences(United States)
Promega Corporation(United States)
Toxikon Corporation(United States)
WuXi AppTec(China)
Pace Analytical Services LLC(United States)
Nelson Laboratories, LLC(United States)
BioReliance Corporation(United States)
Microbac Laboratories, Inc.(United States)
Intertek Group plc(United Kingdom)
Covance Inc.(United States)
결론과 추천 사항
LSH
영문 목차
영문목차
Global Biological Safety Testing Market size was valued at USD 5.2 billion in 2023 and is poised to grow from USD 5.81 billion in 2024 to USD 14.08 billion by 2032, growing at a CAGR of 11.7% during the forecast period (2025-2032).
The global biological safety testing market is poised for substantial growth, fueled by a surge in research and development across pharmaceutical and biotechnology sectors, an increase in infectious diseases, and heightened awareness of healthcare quality control. This market focuses on the safety and efficacy evaluation of biological products like vaccines, blood products, and cell-based therapies, adhering to stringent regulatory standards that mandate thorough testing to mitigate adverse risks. The advent of advanced testing technologies, including nucleic acid amplification and sequencing, enhances sensitivity in contaminant detection, thus improving patient safety. Furthermore, the rising utilization of in vitro testing methods, such as cell-based assays and immunoassays, is expediting market expansion by providing quicker, cost-effective results and reducing animal testing reliance.
Top-down and bottom-up approaches were used to estimate and validate the size of the Global Biological 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.
Global Biological Safety Testing Market Segmental Analysis
Global Biological Safety Testing Market is segmented by Product, Test Type, Application and region. Based on Product, the market is segmented into Reagents & Kits, Services and Instruments. Based on Test Type, the market is segmented into Endotoxin Tests, Sterility Tests, Cell Line Authentication & Characterization Tests, Bioburden Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests and Others. Based on Application, the market is segmented into Vaccines & Therapeutics, Blood & Blood-based Products, Gene Therapy, Tissue & Tissue-based Products, Stem Cell and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
Driver of the Global Biological Safety Testing Market
The Global Biological Safety Testing market is being significantly influenced by the rising adoption of in vitro testing methods, including cell-based assays and immunoassays. These innovative approaches are favored due to their numerous benefits over conventional animal testing, such as faster results, decreased reliance on animal subjects, and enhanced cost-effectiveness. The urgency to combat the growing prevalence of infectious diseases, highlighted by the COVID-19 pandemic, has intensified the focus on biological safety testing. This has increased the demand for advanced testing techniques that can reliably detect and mitigate the risks posed by pathogens and contaminants, further propelling market expansion.
Restraints in the Global Biological Safety Testing Market
One of the significant challenges facing the Global Biological Safety Testing market is the shortage of skilled professionals with expertise in this specialized field. The intricate methodologies involved in biological safety testing demand a high level of training and experience, particularly in areas such as sample handling, result interpretation, and adherence to regulatory compliance. This scarcity of qualified personnel can significantly hinder market growth, as organizations may struggle to find individuals capable of executing these complex tests efficiently. Consequently, the lack of available talent may restrict market expansion and innovation within the biological safety testing sector.
Market Trends of the Global Biological Safety Testing Market
The Global Biological Safety Testing market is experiencing a notable upward trend, driven by an increasing emphasis on patient safety within the healthcare sector. The demand for rigorous testing protocols is propelled by heightened awareness of the repercussions associated with contaminated or low-quality biological products. As healthcare providers, regulatory authorities, and manufacturers prioritize stringent quality control measures to safeguard patient wellbeing, the market is witnessing growth in comprehensive testing services. This trend reflects a broader commitment to enhance safety standards, positioning biological safety testing as an essential component in the lifecycle of biological products, thus driving innovation and investment across the industry.
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
Regulatory Landscape
Case Studies
Technological Advancement
Global Biological Safety Testing Market Size by Product & CAGR (2025-2032)
Market Overview
Reagents & Kits
Services
Instruments
Global Biological Safety Testing Market Size by Test Type & CAGR (2025-2032)
Market Overview
Endotoxin Tests
Sterility Tests
Cell Line Authentication & Characterization Tests
Bioburden Tests
Adventitious Agent Detection Tests
Residual Host Contamination Detection Tests
Others
Global Biological Safety Testing Market Size by Application & CAGR (2025-2032)
Market Overview
Vaccines & Therapeutics
Vaccines
Monoclonal Antibodies
Recombinant Protein
Blood & Blood-based Products
Gene Therapy
Tissue & Tissue-based Products
Stem Cell
Others
Global Biological Safety Testing Market Size & CAGR (2025-2032)
North America (Product, Test Type, Application)
US
Canada
Europe (Product, Test Type, Application)
Germany
Spain
France
UK
Italy
Rest of Europe
Asia Pacific (Product, Test Type, Application)
China
India
Japan
South Korea
Rest of Asia-Pacific
Latin America (Product, Test Type, Application)
Brazil
Rest of Latin America
Middle East & Africa (Product, Test Type, Application)
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
bioMerieux S.A. (France)
Company Overview
Business Segment Overview
Financial Updates
Key Developments
Charles River Laboratories International, Inc. (United States)
Company Overview
Business Segment Overview
Financial Updates
Key Developments
Eurofins Scientific SE (Luxembourg)
Company Overview
Business Segment Overview
Financial Updates
Key Developments
Lonza Group Ltd. (Switzerland)
Company Overview
Business Segment Overview
Financial Updates
Key Developments
Merck KGaA (Germany)
Company Overview
Business Segment Overview
Financial Updates
Key Developments
Samsung Biologics (South Korea)
Company Overview
Business Segment Overview
Financial Updates
Key Developments
Sartorius AG (Germany)
Company Overview
Business Segment Overview
Financial Updates
Key Developments
SGS Societe Generale de Surveillance SA (Switzerland)
