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2034858

바이오의약품 안전성 시험 시장 : 제공 제품별, 시험 유형별, 용도별, 최종사용자별, 지역별 - 예측(-2031년)

Biologics Safety Testing Market by Product (Kits, Reagents, Instruments), Services, Test Type (Mycoplasma, Sterility, Endotoxin, Bioburden), Product & Services by Application (Vaccines, mAbs, CGT), End User, Competition, Region - Global Forecast to 2031

발행일: | 리서치사: 구분자 MarketsandMarkets | 페이지 정보: 영문 527 Pages | 배송안내 : 즉시배송

    
    
    




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※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

세계의 바이오의약품 안전성 시험 시장 규모는 2026년 55억 7,000만 달러에서 2031년까지 96억 6,000만 달러에 이를 것으로 추정며, 2026-2031년의 예측 기간에 CAGR 11.6%로 성장할 전망입니다.

세계 바이오의약품 안전성 시험 시장은 바이오의약품 및 바이오시밀러 파이프라인의 확대와 세포 및 유전자 치료, mRNA 제품 등 첨단 치료법의 성장에 힘입어 예측 기간 동안 높은 성장세를 보일 것으로 예측됩니다.

조사 범위
조사 대상 기간 2026-2031년
기준 연도 2025년
예측 기간 2026-2031년
대상 단위 금액(10억 달러)
부문 제공 제품별, 시험 유형별, 용도별, 최종사용자별, 지역별
대상 지역 북미, 유럽, 아시아태평양, 라틴아메리카, 중동 및 아프리카

발표된 업계 정보를 기반으로 한 시장 예측에 따르면, 바이오 의약품 개발 및 제조의 현저한 확대와 제품 품질을 보장하기 위한 엄격한 안전성 테스트에 대한 수요 증가를 배경으로 2031년까지 견조한 성장이 예상되고 있습니다. 그러나 고급 테스트 장비의 높은 비용, 전문 지식의 부족, 지역 간 규제 차이 등이 시장의 추가 확장을 억제하는 주요 요인으로 남을 것으로 예측됩니다.

Biologics Safety Testing Market-IMG1

"2025년 생물학적 제제 안전성 시험 시장에서 제품별로는 분석, 키트, 시약 부문이 가장 큰 점유율을 차지했습니다. "

제품별로 살펴보면, 생물학적 제제 안전성 시험 시장은 크게 분석, 키트 및 시약, 장비로 구분됩니다. 2025년 분석, 키트 및 시약은 내독소, 마이코플라즈마, 무균 및 바이러스 검출 테스트와 같은 일상적인 응용 분야에서 널리 사용되면서 생물학적 제제 안전성 테스트 시장에서 가장 큰 점유율을 차지할 것으로 예측됩니다. 사용 편의성, 신뢰성, 자동화 및 하이스루풋 시스템과의 호환성으로 인해 모든 실험실에서 필수적인 제품으로 자리 잡았습니다. 또한, 높은 비용 효율성과 신속하고 재현성 있는 결과를 제공하는 능력은 전 세계 바이오 제약사, CRO, 연구기관으로부터의 안정적인 수요를 뒷받침하고 있습니다.

"2025년 생물학적 제제 안전성 시험 제품 용도별 시장에서 단일클론항체 및 치료용 단백질 부문이 가장 큰 점유율을 차지했습니다. "

용도별로 세계 생물학적 제제 안전성 시험 제품 시장은 백신, 단클론 항체 및 치료용 단백질, 세포 및 유전자 치료 제품, 혈액 및 혈액제제, 기타 용도에 따라 분류됩니다. 2025년 생물학적 제제 안전성 시험 제품 시장에서 단일클론항체 및 치료용 단백질 부문이 가장 큰 점유율을 차지할 것으로 예측됩니다. 이는 만성 및 복합 질환의 치료에 이러한 제제가 광범위하게 사용되고 있는 데 따른 것입니다. 이러한 생물학적 제제의 파이프라인 확장, 승인 건수 증가 및 대규모 상업 생산에는 엄격한 안전성 테스트가 필요합니다. 또한, 엄격한 규제 요건과 제품의 순도, 효능 및 일관성을 보장해야 할 필요성은 전 세계적으로 이 분야 시장 지위를 더욱 공고히 하고 있습니다.

"2026년부터 2031년까지 생물학적 제제 안전성 시험 시장에서 아시아태평양이 가장 높은 CAGR로 성장할 것으로 예측됩니다. "

생물학적 제제 안전성 시험 시장은 북미, 유럽, 아시아태평양, 라틴아메리카, 중동 및 아프리카로 구분됩니다. 예측 기간 동안 아시아태평양은 바이오의약품 제조 확대, 바이오의약품 및 바이오시밀러 채택 증가, 임상시험 활동의 활성화에 힘입어 가장 높은 CAGR을 나타낼 것으로 예측됩니다. 또한, 삼성바이오로직스, 우시 앱텍과 같은 주요 지역 및 세계 기업들이 바이오의약품 개발 및 안전성 시험 역량을 적극적으로 강화하고 있는 가운데, 규제 체계의 개선도 성장을 가속하고 있습니다.

본 보고서에서 다룬 기업 프로파일 목록

  • Thermo Fisher Scientific Inc.
  • Merck KGaA
  • Lonza
  • FUJIFILM Corporation
  • Sartorius AG
  • F. Hoffmann- La Roche Ltd.
  • Charles River Laboratories
  • bioMerieux
  • WuXi AppTec
  • SGS Societe Generale de Surveillance SA
  • Sotera Health
  • Samsung Biologics
  • GenScript
  • Agilent Technologies, Inc.
  • Syngene International Limited
  • Eurofins Scientific
  • Laboratory Corporation of America Holdings
  • Bio-Rad Laboratories, Inc.
  • QIAGEN

조사 범위

본 조사 보고서는 생물학적 제제 안전성 시험 시장을 제공 내용, 시험 유형, 용도(제품 및 서비스 용도), 최종사용자(제품 및 서비스 최종사용자), 지역별로 분류하여 분석하였습니다. 연구 범위에는 생물학적 제제 안전성 테스트 시장의 성장에 영향을 미치는 주요 요인(촉진요인, 과제, 기회 및 제약)에 대한 자세한 정보가 포함되어 있습니다. 주요 업계 기업들에 대한 상세한 분석을 통해 사업 개요, 제품 포트폴리오, 제품 및 서비스 승인 및 출시, 제휴, 파트너십, 사업 확장, 계약 및 생물학적 제제 안전성 시험 시장과 관련된 최근 동향과 같은 주요 전략에 대한 인사이트를 제공합니다. 본 보고서는 생물학적제제 안전성 시험 시장 생태계의 주요 기업 및 신생 스타트업의 경쟁적 고찰을 다루고 있습니다.

본 보고서 구매의 주요 이점

이 보고서는 전체 생물학적 제제 안전성 시험 시장과 그 하위 부문의 매출에 대한 가장 정확한 추정치를 제공함으로써 시장 리더와 신규 시장 진출기업에게 도움이 될 것입니다. 또한, 이해관계자들이 경쟁 구도를 더 깊이 이해하고, 비즈니스를 더 효과적으로 포지셔닝하고, 적절한 시장 진출 전략을 수립할 수 있는 인사이트를 얻을 수 있도록 돕습니다. 이 보고서는 이해관계자들이 시장 동향을 파악할 수 있도록 주요 시장 성장 촉진요인, 억제요인, 기회 및 과제에 대한 정보를 제공합니다.

본 보고서에서는 다음과 같은 사항에 대한 인사이트를 제공합니다.

  • 주요 촉진요인(바이오의약품 및 바이오시밀러 파이프라인 증가, 엄격하고 진화하는 규제 요건, 세포 및 유전자 치료, mRNA 제품 등 첨단 치료법의 성장, CDMO 확대 및 시험 아웃소싱으로의 구조적 변화), 제약 요인(첨단 시험 장비의 고비용 및 전문성 부족, 지역별 규제 차이), 기회(차세대 치료제에 대한 관심 증가, 동물을 사용하지 않는 시험법으로의 전환) 및 과제(분석 표준화의 차이). 부족, 지역 간 규제 차이), 기회요인(차세대 치료제에 대한 관심 증가, 동물을 사용하지 않는 시험법으로의 전환) 및 과제(분석법 표준화의 격차) 등 생물학적제제 안전성 시험 시장의 성장에 영향을 미치는 요인에 대해 분석하였습니다.
  • 제품 개발/혁신 : 생물학적 제제 안전성 시험 시장의 신규 출시 제품에 대한 심층 분석
  • 시장 개발: 수익성 높은 시장에 대한 종합적인 정보 - 이 보고서는 다양한 지역의 생물학적 제제 안전성 시험 시장을 분석합니다.
  • 시장 다각화 : 생물학적제제 안전성 시험 시장의 신제품, 미개척 지역, 최근 동향 및 투자에 대한 종합적인 정보
  • 경쟁사 분석 : Thermo Fisher Scientific Inc.(미국), Merck KGaA(독일), Lonza(스위스), FUJIFILM Corporation(일본), Sartorius AG(독일), F. Hoffmann-La Roche Ltd.), Charles River Laboratories(미국) 등 주요 기업의 시장 점유율, 성장전략, 제품 라인업에 대한 상세 평가

자주 묻는 질문

  • 세계의 바이오의약품 안전성 시험 시장 규모는 어떻게 예측되나요?
  • 2025년 생물학적 제제 안전성 시험 시장에서 가장 큰 점유율을 차지하는 제품은 무엇인가요?
  • 2025년 생물학적 제제 안전성 시험 제품 용도별 시장에서 가장 큰 점유율을 차지하는 부문은 무엇인가요?
  • 아시아태평양 지역의 생물학적 제제 안전성 시험 시장 성장 전망은 어떤가요?
  • 바이오의약품 안전성 시험 시장의 성장에 영향을 미치는 주요 요인은 무엇인가요?
  • 바이오의약품 안전성 시험 시장의 주요 기업은 어디인가요?

목차

제1장 서론

제2장 주요 요약

제3장 프리미엄 인사이트

제4장 시장 개요

제5장 업계 동향

제6장 기술 진보, AI의 영향, 특허, 혁신, 그리고 향후 응용

제7장 규제 상황과 지속가능성 이니셔티브

제8장 고객 현황과 구매 행동

제9장 바이오의약품 안전성 시험 시장(제공 제품별)

제10장 바이오의약품 안전성 시험 시장(시험 유형별)

제11장 바이오의약품 안전성 시험 제품 시장(용도별)

제12장 바이오의약품 안전성 시험 서비스 시장(용도별)

제13장 바이오의약품 안전성 시험 제품 시장(최종사용자별)

제14장 바이오의약품 안전성 시험 서비스 시장(최종사용자별)

제15장 바이오의약품 안전성 시험 시장(지역별)

제16장 경쟁 구도

제17장 기업 개요

제18장 조사 방법

제19장 부록

LSH 26.06.01

The global biologics safety testing market is estimated to reach USD 9.66 billion by 2031 from USD 5.57 billion in 2026, at a CAGR of 11.6% during the forecast period of 2026 to 2031. The global biologics safety testing market is projected to witness strong growth over the forecast period, supported by the rising biologics and biosimilars pipeline and the growth of advanced modalities such as cell & gene therapies and mRNA products.

Scope of the Report
Years Considered for the Study2026-2031
Base Year2025
Forecast Period2026-2031
Units ConsideredValue (USD billion)
SegmentsOffering, Test Type, Product Application, Service Application, Product End User, Service End User
Regions coveredNorth America, Europe, the Asia Pacific, Latin America, the Middle East, and Africa

Market estimates from published industry sources indicate robust growth through 2031, driven by strong expansion in biologics development and manufacturing, as well as rising demand for stringent safety testing to ensure product quality. However, the high cost of advanced testing equipment, limited specialized expertise, and regulatory divergence across regions are expected to remain key factors restraining broader market expansion.

Biologics Safety Testing Market - IMG1

"The assays, kits, and reagents segment accounted for the largest share by product in the biologics safety testing market in 2025."

Based on product, the biologics safety testing market is broadly segmented into assays, kits & reagents, and instruments. In 2025, assays, kits, and reagents accounted for the largest share of the biologics safety testing market, driven by their widespread use in routine applications such as endotoxin, mycoplasma, sterility, and viral detection testing. Their ease of use, reliability, and compatibility with automated and high-throughput systems make them essential across laboratories. Additionally, their cost-effectiveness and ability to deliver rapid, reproducible results support consistent demand from biopharmaceutical companies, CROs, and research institutions globally.

"The monoclonal antibodies and therapeutic proteins segment accounted for the largest share of the biologics safety testing product applications market in 2025."

Based on application, the global biologics safety testing product market is segmented into vaccines, monoclonal antibodies & therapeutic proteins, cellular & gene therapy products, blood & blood products, and other applications. The monoclonal antibodies & therapeutic proteins segment accounted for the largest share of the biologics safety testing product market in 2025, driven by their extensive use in treating chronic and complex diseases. The growing pipeline, increasing approvals, and large-scale commercial production of these biologics require rigorous safety testing. Additionally, stringent regulatory requirements and the need to ensure product purity, potency, and consistency further contribute to the segment's market position globally.

"The Asia Pacific is growing at the highest CAGR in the biologics safety testing market from 2026 to 2031."

The biologics safety testing market is segmented into North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa. During the forecast period, the Asia Pacific region is estimated to grow at the highest CAGR, supported by expanding biopharmaceutical manufacturing, increasing adoption of biologics and biosimilars, and rising clinical trial activity. Growth is further driven by improving regulatory frameworks, and the presence of key regional and global players such as Samsung Biologics and WuXi AppTec is actively strengthening biologics development and safety testing capabilities.

The primary interviews conducted for this report can be categorized as follows:

  • By Respondent: Supply Side - 70% and Demand Side - 30%
  • By Company Type: Tier 1 - 40%, Tier 2 - 30%, and Tier 3 - 30%
  • By Designation: CXOs and Directors - 30%, Managers - 45%, and Others - 25%
  • By Region: North America - 40%, Europe - 25%, Asia Pacific - 20%, Latin America - 10%, and the Middle East - 5%

List of Companies Profiled in the Report

  • Thermo Fisher Scientific Inc.
  • Merck KGaA
  • Lonza
  • FUJIFILM Corporation
  • Sartorius AG
  • F. Hoffmann- La Roche Ltd.
  • Charles River Laboratories
  • bioMerieux
  • WuXi AppTec
  • SGS Societe Generale de Surveillance SA
  • Sotera Health
  • Samsung Biologics
  • GenScript
  • Agilent Technologies, Inc.
  • Syngene International Limited
  • Eurofins Scientific
  • Laboratory Corporation of America Holdings
  • Bio-Rad Laboratories, Inc.
  • QIAGEN

Research Coverage

This research report categorizes the biologics safety testing market by offering, by test type, by application (product & service applications), by end user (product & service end users), and by region. The scope of the report covers detailed information regarding the major factors, such as drivers, challenges, opportunities, and restraints, influencing the growth of the biologics safety testing market. A detailed analysis of the key industry players has been done to provide insights into their business overview, product portfolio, key strategies such as product and service approvals and launches, collaborations, partnerships, expansions, agreements, and recent developments associated with the biologics safety testing market. This report covers competitive analysis of top players and upcoming startups in the biologics safety testing market ecosystem.

Key Benefits of Buying the Report

The report will help market leaders/new entrants by providing the closest approximations of revenue for the overall biologics safety testing market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to position their business more effectively and develop suitable go-to-market strategies. This report will enable stakeholders to understand the market's pulse and provide information on key market drivers, restraints, opportunities, and challenges.

The report provides insights into the following pointers:

  • Analysis of key drivers (rising biologics and biosimilars pipeline, stringent and evolving regulatory requirements, growth of advanced modalities like cell & gene therapies and mRNA products, expansion of CDMOs and the structural shift toward outsourced testing), restraints (high cost of advanced testing equipment and limited specialized expertise, regulatory divergence across regions), opportunities (growing focus on next-generation therapeutics, the shift toward animal-free testing approaches) and challenges (assay standardization gap) influencing the growth of biologics safety testing market
  • Product Development/Innovation: Detailed insights on newly launched products of the biologics safety testing market
  • Market Development: Comprehensive information about lucrative markets - the report analyses the biologics safety testing market across varied regions
  • Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the biologics safety testing market
  • Competitive Assessment: In-depth assessment of market shares, growth strategies, and product offerings of leading players such as Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Lonza (Switzerland), FUJIFILM Corporation (Japan), Sartorius AG (Germany), F. Hoffmann-La Roche Ltd. (Switzerland), and Charles River Laboratories (US), among others

TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 STUDY OBJECTIVES
  • 1.2 MARKET DEFINITION
    • 1.2.1 INCLUSIONS & EXCLUSIONS
  • 1.3 MARKET SCOPE
    • 1.3.1 MARKETS COVERED
    • 1.3.2 YEARS CONSIDERED
    • 1.3.3 CURRENCY CONSIDERED
  • 1.4 STAKEHOLDERS
  • 1.5 SUMMARY OF CHANGES

2 EXECUTIVE SUMMARY

  • 2.1 KEY INSIGHTS AND MARKET HIGHLIGHTS
  • 2.2 KEY MARKET PARTICIPANTS: SHARE INSIGHTS AND STRATEGIC DEVELOPMENTS
  • 2.3 DISRUPTIVE TRENDS SHAPING THE MARKET
  • 2.4 HIGH-GROWTH SEGMENTS & EMERGING FRONTIERS
  • 2.5 SNAPSHOT: GLOBAL MARKET SIZE, GROWTH RATE, AND FORECAST

3 PREMIUM INSIGHTS

  • 3.1 BIOLOGICS SAFETY TESTING MARKET OVERVIEW
  • 3.2 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY OFFERING & REGION
  • 3.3 BIOLOGICS SAFETY TESTING MARKET: GEOGRAPHIC SNAPSHOT

4 MARKET OVERVIEW

  • 4.1 INTRODUCTION
  • 4.2 MARKET DYNAMICS
    • 4.2.1 DRIVERS
      • 4.2.1.1 Rising biologics and biosimilars pipeline
      • 4.2.1.2 Stringent and evolving regulatory requirements
      • 4.2.1.3 Growth of advanced modalities like cell & gene therapies and mRNA products
      • 4.2.1.4 Rising demand for outsourced development/manufacturing and testing
    • 4.2.2 RESTRAINTS
      • 4.2.2.1 High cost of advanced testing equipment and limited specialized expertise
      • 4.2.2.2 Regulatory divergence across regions
    • 4.2.3 OPPORTUNITIES
      • 4.2.3.1 Growing focus on next-generation therapeutics
      • 4.2.3.2 Shift toward animal-free testing approaches
    • 4.2.4 CHALLENGES
      • 4.2.4.1 Assay standardization gap
  • 4.3 UNMET NEEDS AND WHITE SPACES
  • 4.4 INTERCONNECTED MARKETS & CROSS-SECTOR OPPORTUNITIES
  • 4.5 STRATEGIC MOVES BY TIER-1/2/3 PLAYERS

5 INDUSTRY TRENDS

  • 5.1 PORTER'S FIVE FORCES ANALYSIS
    • 5.1.1 THREAT OF NEW ENTRANTS
    • 5.1.2 THREAT OF SUBSTITUTES
    • 5.1.3 BARGAINING POWER OF BUYERS
    • 5.1.4 BARGAINING POWER OF SUPPLIERS
    • 5.1.5 INTENSITY OF COMPETITIVE RIVALRY
  • 5.2 MACROECONOMIC OUTLOOK
    • 5.2.1 INTRODUCTION
    • 5.2.2 GDP TRENDS AND FORECAST
    • 5.2.3 TRENDS IN GLOBAL BIOLOGICS SAFETY TESTING MARKET
  • 5.3 VALUE CHAIN ANALYSIS
  • 5.4 ECOSYSTEM ANALYSIS
  • 5.5 PRICING ANALYSIS
    • 5.5.1 AVERAGE SELLING PRICE TREND, BY KEY PLAYER, 2023-2025
    • 5.5.2 INDICATIVE SELLING PRICE, BY REGION, 2025
  • 5.6 KEY CONFERENCES & EVENTS
  • 5.7 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS' BUSINESSES
  • 5.8 INVESTMENT/FUNDING ACTIVITY
  • 5.9 IMPACT OF US TARIFFS-BIOLOGICS SAFETY TESTING MARKET
    • 5.9.1 INTRODUCTION
    • 5.9.2 KEY TARIFF RATES
    • 5.9.3 PRICE IMPACT ANALYSIS
    • 5.9.4 IMPACT ON COUNTRIES/REGIONS
      • 5.9.4.1 North America
      • 5.9.4.2 Europe
      • 5.9.4.3 Asia Pacific
    • 5.9.5 IMPACT ON END-USE INDUSTRIES
      • 5.9.5.1 Pharmaceutical and biotechnology companies
      • 5.9.5.2 CROs & CDMOs
      • 5.9.5.3 Academic & Research Institutes

6 TECHNOLOGICAL ADVANCEMENTS, AI-DRIVEN IMPACT, PATENTS, INNOVATIONS, AND FUTURE APPLICATIONS

  • 6.1 KEY TECHNOLOGIES
    • 6.1.1 POLYMERASE CHAIN REACTION (PCR)
    • 6.1.2 NEXT-GENERATION SEQUENCING (NGS)
  • 6.2 ADJACENT TECHNOLOGIES
    • 6.2.1 BIOINFORMATICS AND COMPUTATIONAL BIOLOGY
  • 6.3 COMPLEMENTARY TECHNOLOGIES
    • 6.3.1 LAB-ON-A-CHIP (LOC) SYSTEMS
    • 6.3.2 HIGH-CONTENT SCREENING (HCS)
  • 6.4 TECHNOLOGY/PRODUCT ROADMAP
  • 6.5 PATENT ANALYSIS
    • 6.5.1 TOP APPLICANTS/OWNERS (COMPANIES) FOR BIOLOGICS SAFETY TESTING PATENTS, 2015-2025
  • 6.6 FUTURE APPLICATIONS
  • 6.7 IMPACT OF AI/GEN AI ON BIOLOGICS SAFETY TESTING MARKET
    • 6.7.1 TOP USE CASES AND MARKET POTENTIAL
    • 6.7.2 CASE STUDIES OF AI IMPLEMENTATION IN BIOLOGICS SAFETY TESTING MARKET
    • 6.7.3 INTERCONNECTED ADJACENT ECOSYSTEM AND IMPACT ON MARKET PLAYERS
    • 6.7.4 CLIENTS' READINESS TO ADOPT GENERATIVE AI IN BIOLOGICS SAFETY TESTING MARKET

7 REGULATORY LANDSCAPE AND SUSTAINABILITY INITIATIVES

  • 7.1 REGIONAL REGULATIONS AND COMPLIANCE
    • 7.1.1 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS
    • 7.1.2 REGULATORY FRAMEWORK
    • 7.1.3 INDUSTRY STANDARDS
  • 7.2 SUSTAINABILITY IMPACT AND REGULATORY POLICY INITIATIVES
  • 7.3 CERTIFICATIONS, LABELING, AND ECO-STANDARDS

8 CUSTOMER LANDSCAPE & BUYER BEHAVIOR

  • 8.1 DECISION-MAKING PROCESS
  • 8.2 BUYER STAKEHOLDERS AND BUYING EVALUATION CRITERIA
    • 8.2.1 KEY STAKEHOLDERS IN BUYING PROCESS
    • 8.2.2 KEY BUYING CRITERIA
  • 8.3 ADOPTION BARRIERS & INTERNAL CHALLENGES
  • 8.4 UNMET NEEDS FROM VARIOUS END-USE INDUSTRIES
  • 8.5 MARKET PROFITABILITY

9 BIOLOGICS SAFETY TESTING MARKET, BY OFFERING

  • 9.1 INTRODUCTION
  • 9.2 SERVICES
    • 9.2.1 VIRUS SAFETY TESTING SERVICES
      • 9.2.1.1 Rising focus on development of advanced therapies to drive growth
    • 9.2.2 STERILITY TESTING SERVICES
      • 9.2.2.1 Need for sterility testing at each stage of drug development to propel growth
    • 9.2.3 MYCOPLASMA TESTING SERVICES
      • 9.2.3.1 Increasing focus on development of biologics and biosimilars to promote growth
    • 9.2.4 ENDOTOXIN TESTING SERVICES
      • 9.2.4.1 Stringent regulatory requirements to drive market
    • 9.2.5 BIOBURDEN TESTING SERVICES
      • 9.2.5.1 Rising adoption of advanced testing solutions for contamination risk mitigation to propel the growth
    • 9.2.6 OTHER BST SERVICES
  • 9.3 PRODUCTS
    • 9.3.1 ASSAYS, KITS, AND REAGENTS
      • 9.3.1.1 Detection kits
        • 9.3.1.1.1 Expanding advanced biologics pipelines and faster QC workflows are lifting demand for high-sensitivity detection kits
      • 9.3.1.2 Endotoxin testing reagents
        • 9.3.1.2.1 Regulatory acceptance of recombinant methods and shift to simpler, animal-free QC workflows are accelerating demand for endotoxin testing reagents
      • 9.3.1.3 Sterility testing media & kits
        • 9.3.1.3.1 Rapid release needs and shift toward standardized aseptic QC strengthen demand for sterility testing media and kits
      • 9.3.1.4 Bioburden enumeration
        • 9.3.1.4.1 Stricter contamination control expectations and faster microbiology workflows drive demand for bioburden enumeration solutions
      • 9.3.1.5 Other BST assays, kits, and reagents
    • 9.3.2 INSTRUMENTS
      • 9.3.2.1 Detection & imaging systems
        • 9.3.2.1.1 Rapid molecular testing, automated microbiology, and standardized QC workflows are increasing the demand
      • 9.3.2.2 Sequencing instruments
        • 9.3.2.2.1 Wider adoption of NGS-based viral safety workflows and smaller, more accessible platforms support demand
      • 9.3.2.3 Automated sterility testing systems
        • 9.3.2.3.1 Shorter release timelines and wider adoption of rapid microbiology to drive growth
      • 9.3.2.4 Other BST instruments

10 BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE

  • 10.1 INTRODUCTION
  • 10.2 VIRUS SAFETY TESTS
    • 10.2.1 GROWING DEMAND FOR BIOLOGICS AND BIOSIMILARS TO DRIVE SEGMENT GROWTH
  • 10.3 STERILITY TESTS
    • 10.3.1 MANDATORY STERILITY TESTING AT EACH STAGE IN DRUG DEVELOPMENT AND PRODUCTION PROCESS TO PROMOTE SEGMENT GROWTH
  • 10.4 ENDOTOXIN TESTS
    • 10.4.1 GROWING R&D ACTIVITIES FOR DEVELOPMENT OF BIOLOGICS TO PROMOTE THE GROWTH OF THE SEGMENT
  • 10.5 MYCOPLASMA TESTS
    • 10.5.1 RISING CONCERN FOR CELL CULTURE CONTAMINATION TO DRIVE THE SEGMENT GROWTH
  • 10.6 BIOBURDEN TESTS
    • 10.6.1 GROWING CONCERNS FOR DRUG SAFETY STANDARDS HAVE INCREASED THE DEMAND FOR MICROBIOLOGICAL BIOBURDEN TESTING IN THE BIOLOGICS INDUSTRY
  • 10.7 RESIDUAL HCP & DNA DETECTION TESTS
    • 10.7.1 STRINGENT REGULATORY GUIDELINES FOR BIOLOGIC DRUG MANUFACTURING TO CONTRIBUTE TO THE SEGMENT GROWTH
  • 10.8 OTHER TESTS

11 BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY APPLICATION

  • 11.1 INTRODUCTION
  • 11.2 MONOCLONAL ANTIBODIES & THERAPEUTIC PROTEINS
    • 11.2.1 GROWING REGULATORY APPROVALS FOR MONOCLONAL ANTIBODIES TO CONTRIBUTE TO THE MARKET SHARE
  • 11.3 VACCINES
    • 11.3.1 EXPANDING VACCINE PLATFORM COMPLEXITY AND STRICTER GLOBAL QUALITY EXPECTATIONS TO DRIVE MARKET GROWTH
  • 11.4 CELLULAR & GENE THERAPY PRODUCTS
    • 11.4.1 GROWING PRODUCT MANUFACTURING COMPLEXITY IS ACCELERATING DEMAND
  • 11.5 BLOOD & BLOOD PRODUCTS
    • 11.5.1 GROWING DEMAND FOR BLOOD PRODUCTS TO PROMOTE MARKET GROWTH
  • 11.6 OTHER APPLICATIONS

12 BIOLOGICS SAFETY TESTING SERVICES MARKET, BY APPLICATION

  • 12.1 INTRODUCTION
  • 12.2 MONOCLONAL ANTIBODY & THERAPEUTIC PROTEIN SAFETY TESTING
    • 12.2.1 EXPANDING ANTIBODY PIPELINES AND RISING BIOSIMILAR MANUFACTURING ARE DRIVING GROWTH
  • 12.3 VACCINE SAFETY TESTING
    • 12.3.1 EXPANSION OF VACCINE SAFETY TESTING DRIVEN BY ADVANCED PLATFORMS AND REGULATORY STRINGENCY
  • 12.4 CELLULAR & GENE THERAPY SAFETY TESTING
    • 12.4.1 EXPANDING ADVANCED THERAPY MANUFACTURING AND TIGHTER STERILITY REQUIREMENTS TO ACCELERATE DEMAND
  • 12.5 BLOOD & BLOOD PRODUCT SAFETY TESTING
    • 12.5.1 PLASMA PRODUCT SAFETY REQUIREMENTS AND NEW ASSAY APPROVALS TO DRIVE MARKET GROWTH
  • 12.6 OTHER APPLICATIONS

13 BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY END USER

  • 13.1 INTRODUCTION
  • 13.2 PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES
    • 13.2.1 RISING ADOPTION OF SAFETY TESTING PRODUCTS BY BIOPHARMA MANUFACTURERS
  • 13.3 CROS & CDMOS
    • 13.3.1 RISING OUTSOURCING OF BIOLOGICS DEVELOPMENT AND MANUFACTURING ACCELERATES MARKET GROWTH
  • 13.4 ACADEMIC & RESEARCH INSTITUTES
    • 13.4.1 EXPANDING TRANSLATIONAL BIOLOGICS RESEARCH AND EARLY-STAGE PLATFORM DEVELOPMENT DRIVES MARKET GROWTH
  • 13.5 OTHER END USERS

14 BIOLOGICS SAFETY TESTING SERVICES MARKET, BY END USER

  • 14.1 INTRODUCTION
  • 14.2 PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES
    • 14.2.1 GROWING OUTSOURCING OF SAFETY TESTING SERVICES BY BIOPHARMA COMPANIES TO AID GROWTH
  • 14.3 ACADEMIC & RESEARCH INSTITUTES
    • 14.3.1 RISING TRANSLATIONAL RESEARCH IS DRIVING ADOPTION OF BIOLOGICS SAFETY TESTING SERVICES IN ACADEMIC INSTITUTES
  • 14.4 OTHER END USERS

15 BIOLOGICS SAFETY TESTING MARKET, BY REGION

  • 15.1 INTRODUCTION
  • 15.2 NORTH AMERICA
    • 15.2.1 US
      • 15.2.1.1 Leading biopharma industry, federal funding, mature ecosystem, and biologics development activity to propel market growth
    • 15.2.2 CANADA
      • 15.2.2.1 Investments for expanding biomanufacturing capacity to propel market growth
  • 15.3 EUROPE
    • 15.3.1 GERMANY
      • 15.3.1.1 Expansion initiatives by key market players to support market growth
    • 15.3.2 UK
      • 15.3.2.1 Emphasis on vaccine manufacturing and biotech R&D to drive market
    • 15.3.3 FRANCE
      • 15.3.3.1 Strong government funding driving biologics innovation and testing demand
    • 15.3.4 ITALY
      • 15.3.4.1 Manufacturing investment and strong R&D intensity support market growth
    • 15.3.5 SPAIN
      • 15.3.5.1 Growing expansion of biotech companies and increasing R&D expenditure to drive market
    • 15.3.6 REST OF EUROPE
  • 15.4 ASIA PACIFIC
    • 15.4.1 CHINA
      • 15.4.1.1 Rising biologics development driving market growth
    • 15.4.2 JAPAN
      • 15.4.2.1 Government initiatives and expansion of biopharma companies to boost market
    • 15.4.3 INDIA
      • 15.4.3.1 Expanding biologics capabilities and rising demand for targeted oncology therapies drive market growth
    • 15.4.4 SOUTH KOREA
      • 15.4.4.1 Growing focus on advancing bioprocessing sector to drive market
    • 15.4.5 AUSTRALIA
      • 15.4.5.1 Strong regulatory framework, clinical innovation, and global partnerships drive market growth
    • 15.4.6 REST OF ASIA PACIFIC
  • 15.5 LATIN AMERICA
    • 15.5.1 BRAZIL
      • 15.5.1.1 Expanding biologics manufacturing investment and rising clinical development activity are driving market growth
    • 15.5.2 MEXICO
      • 15.5.2.1 Increasing government support for biopharmaceutical production to drive market
    • 15.5.3 REST OF LATIN AMERICA
  • 15.6 MIDDLE EAST
    • 15.6.1 GCC COUNTRIES
      • 15.6.1.1 Saudi Arabia
        • 15.6.1.1.1 Increasing healthcare expenditure and rising focus of key players on expansion to support growth
      • 15.6.1.2 United Arab Emirates
        • 15.6.1.2.1 Developing biopharma sector to drive market
      • 15.6.1.3 Rest of GCC countries
    • 15.6.2 REST OF MIDDLE EAST
  • 15.7 AFRICA
    • 15.7.1 RISING AWARENESS AND COLLABORATIVE INITIATIVES TO DRIVE ADOPTION

16 COMPETITIVE LANDSCAPE

  • 16.1 INTRODUCTION
  • 16.2 KEY PLAYER STRATEGIES/RIGHT TO WIN
  • 16.3 REVENUE ANALYSIS
  • 16.4 MARKET SHARE ANALYSIS
  • 16.5 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2025
    • 16.5.1 STARS
    • 16.5.2 EMERGING LEADERS
    • 16.5.3 PERVASIVE PLAYERS
    • 16.5.4 PARTICIPANTS
    • 16.5.5 COMPANY FOOTPRINT: KEY PLAYERS, 2025
      • 16.5.5.1 Company footprint
      • 16.5.5.2 Region footprint
      • 16.5.5.3 Offering footprint
      • 16.5.5.4 Test type footprint
      • 16.5.5.5 Application footprint of companies
  • 16.6 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2025
    • 16.6.1 PROGRESSIVE COMPANIES
    • 16.6.2 RESPONSIVE COMPANIES
    • 16.6.3 DYNAMIC COMPANIES
    • 16.6.4 STARTING BLOCKS
    • 16.6.5 COMPETITIVE BENCHMARKING: STARTUPS/SMES, 2025
      • 16.6.5.1 Detailed list of key startups/SMEs
      • 16.6.5.2 Competitive benchmarking of key startups/SMEs
  • 16.7 COMPANY VALUATION & FINANCIAL METRICS
  • 16.8 BRAND/PRODUCT COMPARATIVE ANALYSIS
  • 16.9 COMPETITIVE SCENARIO
    • 16.9.1 PRODUCT LAUNCHES
    • 16.9.2 DEALS
    • 16.9.3 EXPANSIONS

17 COMPANY PROFILES

  • 17.1 MAJOR PALYER
    • 17.1.1 THERMO FISHER SCIENTIFIC INC.
      • 17.1.1.1 Business overview
      • 17.1.1.2 Products/Services/Solutions offered
      • 17.1.1.3 Recent developments
        • 17.1.1.3.1 Service launches
        • 17.1.1.3.2 Deals
        • 17.1.1.3.3 Expansions
      • 17.1.1.4 MnM view
        • 17.1.1.4.1 Key strengths
        • 17.1.1.4.2 Strategic choices
        • 17.1.1.4.3 Weaknesses and competitive threats
    • 17.1.2 CHARLES RIVER LABORATORIES
      • 17.1.2.1 Business overview
      • 17.1.2.2 Products/Services/Solutions offered
      • 17.1.2.3 Recent developments
        • 17.1.2.3.1 Product and service launches
        • 17.1.2.3.2 Deals
      • 17.1.2.4 MnM view
        • 17.1.2.4.1 Key strengths
        • 17.1.2.4.2 Strategic choices
        • 17.1.2.4.3 Weaknesses and competitive threats
    • 17.1.3 LABORATORY CORPORATION OF AMERICA HOLDINGS
      • 17.1.3.1 Business overview
      • 17.1.3.2 Products/Services/Solutions offered
      • 17.1.3.3 Recent developments
        • 17.1.3.3.1 Deals
        • 17.1.3.3.2 Expansions
      • 17.1.3.4 MnM view
        • 17.1.3.4.1 Key strengths
        • 17.1.3.4.2 Strategic choices
        • 17.1.3.4.3 Weaknesses and competitive threats
    • 17.1.4 F. HOFFMANN-LA ROCHE LTD.
      • 17.1.4.1 Business overview
      • 17.1.4.2 Products/Services/Solutions offered
      • 17.1.4.3 Recent developments
        • 17.1.4.3.1 Product launches
        • 17.1.4.3.2 Expansions
      • 17.1.4.4 MnM view
        • 17.1.4.4.1 Key strengths
        • 17.1.4.4.2 Strategic choices
        • 17.1.4.4.3 Weaknesses and competitive threats
    • 17.1.5 MERCK KGAA
      • 17.1.5.1 Business overview
      • 17.1.5.2 Products/Services/Solutions offered
      • 17.1.5.3 Recent developments
        • 17.1.5.3.1 Expansions
      • 17.1.5.4 MnM view
        • 17.1.5.4.1 Key strengths
        • 17.1.5.4.2 Strategic choices
        • 17.1.5.4.3 Weaknesses and competitive threats
    • 17.1.6 SARTORIUS AG
      • 17.1.6.1 Business overview
      • 17.1.6.2 Products/Services/Solutions offered
      • 17.1.6.3 Recent developments
        • 17.1.6.3.1 Product launches
    • 17.1.7 LONZA
      • 17.1.7.1 Business overview
      • 17.1.7.2 Products/Services/Solutions offered
      • 17.1.7.3 Recent developments
        • 17.1.7.3.1 Product launches
        • 17.1.7.3.2 Deals
    • 17.1.8 FUJIFILM CORPORATION
      • 17.1.8.1 Business overview
      • 17.1.8.2 Products/Services/Solutions offered
      • 17.1.8.3 Recent developments
        • 17.1.8.3.1 Expansions
    • 17.1.9 BIOMERIEUX
      • 17.1.9.1 Business overview
      • 17.1.9.2 Products/Services/Solutions offered
      • 17.1.9.3 Recent developments
        • 17.1.9.3.1 Product launches
        • 17.1.9.3.2 Deals
    • 17.1.10 MARAVAI LIFESCIENCES
      • 17.1.10.1 Business overview
      • 17.1.10.2 Products/Services/Solutions offered
      • 17.1.10.3 Recent developments
        • 17.1.10.3.1 Deals
    • 17.1.11 WUXI APPTEC
      • 17.1.11.1 Business overview
      • 17.1.11.2 Products/Services/Solutions offered
    • 17.1.12 SGS SOCIETE GENERALE DE SURVEILLANCE SA
      • 17.1.12.1 Business overview
      • 17.1.12.2 Products/Services/Solutions offered
      • 17.1.12.3 Recent developments
        • 17.1.12.3.1 Service launches
        • 17.1.12.3.2 Expansions
    • 17.1.13 SOTERA HEALTH
      • 17.1.13.1 Business overview
      • 17.1.13.2 Products/Services/Solutions offered
      • 17.1.13.3 Recent developments
        • 17.1.13.3.1 Service launches
        • 17.1.13.3.2 Expansions
    • 17.1.14 SAMSUNG BIOLOGICS
      • 17.1.14.1 Business overview
      • 17.1.14.2 Products/Services/Solutions offered
      • 17.1.14.3 Recent developments
        • 17.1.14.3.1 Deals
        • 17.1.14.3.2 Expansions
    • 17.1.15 GENSCRIPT
      • 17.1.15.1 Business overview
      • 17.1.15.2 Products/Services/Solutions offered
    • 17.1.16 AGILENT TECHNOLOGIES, INC.
      • 17.1.16.1 Business overview
      • 17.1.16.2 Products/Services/Solutions offered
    • 17.1.17 SYNGENE INTERNATIONAL LIMITED
      • 17.1.17.1 Business overview
      • 17.1.17.2 Products/Services/Solutions offered
    • 17.1.18 EUROFINS SCIENTIFIC
      • 17.1.18.1 Business overview
      • 17.1.18.2 Products/Services/Solutions offered
      • 17.1.18.3 Recent developments
        • 17.1.18.3.1 Service launches
        • 17.1.18.3.2 Expansions
    • 17.1.19 BIO-RAD LABORATORIES, INC.
      • 17.1.19.1 Business overview
      • 17.1.19.2 Products/Services/Solutions offered
      • 17.1.19.3 Recent developments
        • 17.1.19.3.1 Product launches
        • 17.1.19.3.2 Deals
    • 17.1.20 QIAGEN
      • 17.1.20.1 Business overview
      • 17.1.20.2 Products/Services/Solutions offered
      • 17.1.20.3 Recent developments
        • 17.1.20.3.1 Product launches
  • 17.2 OTHER PLAYERS
    • 17.2.1 PROMEGA CORPORATION
    • 17.2.2 CATALENT, INC.
    • 17.2.3 ASSOCIATES OF CAPE COD, INC.
    • 17.2.4 CLEAN BIOLOGICS
    • 17.2.5 PATHOQUEST
    • 17.2.6 PACIFIC BIOLABS
    • 17.2.7 ARL BIO PHARMA, INC.
    • 17.2.8 FRONTAGE LABS
    • 17.2.9 CREATIVE BIOGENE
    • 17.2.10 ADVAXIA BIOLOGICS

18 RESEARCH METHODOLOGY

  • 18.1 RESEARCH DATA
    • 18.1.1 SECONDARY DATA
    • 18.1.2 PRIMARY DATA
  • 18.2 MARKET ESTIMATION METHODOLOGY
    • 18.2.1 MARKET SIZE ESTIMATION
    • 18.2.2 INSIGHTS OF PRIMARY EXPERTS
    • 18.2.3 TOP-DOWN APPROACH
  • 18.3 MARKET GROWTH RATE PROJECTIONS
  • 18.4 MARKET BREAKDOWN AND DATA TRIANGULATION
  • 18.5 RESEARCH ASSUMPTIONS
  • 18.6 RESEARCH LIMITATIONS
  • 18.7 RISK ANALYSIS

19 APPENDIX

  • 19.1 DISCUSSION GUIDE
  • 19.2 KNOWLEDGESTORE: MARKETSANDMARKETS' SUBSCRIPTION PORTAL
  • 19.3 CUSTOMIZATION OPTIONS
  • 19.4 RELATED REPORTS
  • 19.5 AUTHOR DETAILS
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