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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
USD 9.66 BN
MARKET SIZE, 2031
CAGR 11.6%
(2026-2031)
270
REPORT PAGES
260
MARKET TABLES
BIOLOGICS SAFETY TESTING MARKET SIZE, SHARE & GROWTH SNAPSHOT
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
The global biologics safety testing market is projected to grow from USD 5.57 billion in 2026 to USD 9.66 billion by 2031, at a CAGR of 11.6% during the forecast period. The market was valued at USD 4.97 billion in 2025. Biologics safety testing comprises analytical products and services used to detect microbial contamination, endotoxins, mycoplasma, viruses, and process-related impurities, ensuring the safety, quality, and regulatory compliance of biologic products. The market includes assays, kits and reagents, instruments, and specialized testing services that support biologics development, manufacturing, and batch release across monoclonal antibodies, vaccines, cell and gene therapies, blood products, and other biologics.
KEY TAKEAWAYS
-
BY REGION
North America accounted for the largest market share, by region, in 2025: 43%.
-
BY OFFERING
By offering, in 2025, the product segment had the largest share of 41.9%.
-
BY END USER
Pharmaceutical & biotechnology companies dominated the biologics safety testing products market in 2025 with a share of 56.0%.
-
COMPETITIVE LANDSCAPE - Key Players
Thermo Fisher Scientific Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), Charles River Laboratories (US) were identified as some of the star players in the global biologics safety testing market, given their strong market share and product and service footprint.
-
COMPETITIVE LANDSCAPE - Startups
Clean Biologics (France), PathoQuest (France), ARL Bio Pharma, Inc.(US), have distinguished themselves among startups and SMEs by securing strong footholds in specialized niche areas, underscoring their potential as emerging market leaders.
The global biologics safety testing market is expanding steadily, driven by the growing development of biologics, increasing regulatory focus on product safety, and rising demand for advanced testing solutions across development and manufacturing.
TRENDS & DISRUPTIONS IMPACTING CUSTOMERS' CUSTOMERS
The biologics safety testing market is advancing steadily, driven by innovations in rapid microbiological methods, analytical technologies, automation, and evolving regulatory standards aligned with increasingly complex biologics development. The growing global demand for monoclonal antibodies, vaccines, biosimilars, and advanced therapies is accelerating the need for sensitive, reliable safety testing solutions. Expanding use of advanced assays, automated platforms, and specialized testing services is supporting more efficient detection of microbial contamination, endotoxins, mycoplasma, viruses, and process-related impurities. Scalable and validated testing technologies are gaining wider adoption, improving quality control, supporting regulatory compliance, and aligning with evolving manufacturing and quality expectations across major biopharmaceutical markets.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
MARKET DYNAMICS
Drivers
Impact
Level
-
Rising Biologics and Biosimilars Pipeline
-
Stringent and Evolving Regulatory Requirements
RESTRAINTS
Impact
Level
-
High Cost of Advanced Testing Equipment and Limited Specialized Expertise
-
Regulatory Divergence Across Regions
OPPORTUNITIES
Impact
Level
-
Growing focus on next-generation therapeutics
-
Shift Toward Animal-Free Testing Approaches
CHALLENGES
Impact
Level
-
Assay Standardization Gap
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
The expanding biologics and biosimilars pipeline is driving demand for safety testing, as these products require rigorous validation at each development stage. Increasing approvals and complex modalities are accelerating the adoption of advanced assays to ensure quality, compliance, and faster commercialization timelines.
High costs of advanced biologics safety testing equipment and limited skilled expertise hinder market growth. Technologies such as rapid microbial detection and molecular assays require significant investment and technical capabilities, thereby restricting adoption among smaller biotech firms and emerging players, especially in developing regions.
The shift toward next-generation therapeutics, including cell and gene therapies, creates strong opportunities for biologics safety testing. These complex products require highly sensitive methods, driving innovation and increasing demand for specialized testing solutions to ensure safety, efficacy, and regulatory compliance globally.
Lack of assay standardization across biologics safety testing creates major challenges. Differences in protocols, validation requirements, and regulatory expectations lead to inconsistencies, complicating global development and approvals, while increasing costs, timelines, and operational complexity for manufacturers operating across multiple regions and product types.
BIOLOGICS SAFETY TESTING MARKET: COMMERCIAL USE CASES ACROSS INDUSTRIES
| COMPANY | USE CASE DESCRIPTION | BENEFITS |
|---|---|---|
|
|
Utilizes endotoxin detection kits, rapid sterility testing, and mycoplasma detection solutions to ensure the safety of biologics, including cell and gene therapies, across raw materials, in-process samples, and final products | Enables highly sensitive detection of contaminants such as endotoxins and mycoplasma, reducing batch failure risks, improving product quality, and supporting regulatory compliance through faster and more reliable safety testing workflows |
|
|
Provides comprehensive biologics safety testing, including endotoxin (LAL-based) assays, mycoplasma detection, sterility, and viral safety testing across raw materials, in-process samples, and final biologic products, supporting cell and gene therapy manufacturing and regulatory submissions | Enables rapid, highly sensitive contamination detection with reduced turnaround times, improving product release efficiency, ensuring global regulatory compliance, and minimizing the risk of batch failure through robust, end-to-end safety testing strategies. |
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET ECOSYSTEM
The global biologics safety testing market is a highly interconnected ecosystem in which biopharmaceutical companies, biotechnology firms, and research institutions collaborate to ensure the safety and quality of complex biologics. Testing service providers and technology companies offer advanced solutions for endotoxin detection, sterility testing, mycoplasma screening, and viral safety. Contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) support testing across development and manufacturing stages. Regulatory authorities and healthcare systems across regions such as North America and Europe establish stringent guidelines, driving compliance and ensuring safe commercialization of biologics.
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET SEGMENTS
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
In 2025, services dominated the biologics safety testing market due to increasing outsourcing to CROs and CDMOs, rising complexity of biologics, and the need for specialized expertise, driving higher adoption of end-to-end testing solutions across development and manufacturing stages.
Assays, kits, and reagents held a significant share in 2025, driven by their widespread use in routine safety testing, including endotoxin, mycoplasma, and sterility testing, and by their ease of use, rapid results, and compatibility with standardized laboratory workflows.
Residual host cell protein and DNA detection tests accounted for a major share in 2025, owing to stringent regulatory requirements for impurity testing and their critical role in ensuring product purity and safety in biologics manufacturing.
Monoclonal antibodies and therapeutic proteins dominated in 2025 due to their large pipeline, increasing approvals, and extensive safety testing requirements across all stages of development and commercial production.
Vaccine safety testing held a highest share in 2025, supported by ongoing global immunization programs, increased vaccine development, and stringent regulatory requirements for batch release and quality assurance.
In 2025, pharmaceutical & biotechnology companies accounted for the largest share among product end users, driven by high biologics production, in-house testing needs, and continuous demand for quality control and regulatory compliance.
Pharmaceutical & biotechnology companies also led in service end users in 2025, as they increasingly outsource complex safety testing to specialized providers to reduce costs, improve efficiency, and accelerate time-to-market.
REGION
Asia Pacific to be fastest-growing region in market during forecast period
During the forecast period, the Asia Pacific is expected to emerge as a fast-growing region in the global biologics safety testing market, driven by expanding biopharmaceutical manufacturing, increasing investments in biotechnology, and improving regulatory frameworks. Rising adoption of biologics, including biosimilars and vaccines, along with growing clinical trial activity, is boosting demand for safety testing. Additionally, the presence of cost-effective CROs and CDMOs, coupled with increasing outsourcing by global companies and advancements in testing capabilities, is further accelerating regional market growth.
BIOLOGICS SAFETY TESTING MARKET: COMPANY EVALUATION MATRIX
In the global biologics safety testing market, Thermo Fisher Scientific is the star player, driven by its diverse portfolio of testing instruments, assay kits, and integrated services spanning endotoxin, sterility, and microbial detection. The company continues to lead through technological innovation, broad global reach, and strong partnerships with biopharma companies and CDMOs. Samsung Biologics is an emerging leader, with its expanding biologics manufacturing capabilities and integrated quality and safety testing services. Its focus on end-to-end bioprocessing support, advanced analytics, and strategic collaborations positions it strongly to capture growing demand for outsourced biologics safety testing.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
KEY MARKET PLAYERS
- Thermo Fisher Scientific Inc. (US)
- F. Hoffmann-La Roche Ltd. (Switzerland)
- Charles River Laboratories (US)
- Laboratory Corporation of America Holdings (US)
- Merck KGaA (Germany)
- Lonza (Switzerland)
- Fujifilm Corporation (Japan)
- BIOMERIEUX(France)
MARKET SCOPE
| REPORT METRIC | DETAILS |
|---|---|
| Market Size in 2025 (Value) | USD 4.97 Billion |
| Market Forecast in 2031 (Value) | USD 9.66 Billion |
| Growth Rate | CAGR of 11.6% from 2026–2031 |
| Years Considered | 2024–2031 |
| Base Year | 2025 |
| Forecast Period | 2026–2031 |
| Units Considered | Value (USD Million/Billion) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments Covered |
|
| Regions Covered | North America, Europe, Asia Pacific, Latin America, Middle East, Africa |
WHAT IS IN IT FOR YOU: BIOLOGICS SAFETY TESTING MARKET REPORT CONTENT GUIDE
DELIVERED CUSTOMIZATIONS
We have successfully delivered the following deep-dive customizations:
| CLIENT REQUEST | CUSTOMIZATION DELIVERED | VALUE ADDS |
|---|---|---|
| Evaluate competitive positioning of key players in the biologics safety testing market | Analyzed portfolios of leading biologics safety testing providers across sterility testing, endotoxin testing, mycoplasma testing, virus safety testing, bioburden testing, and residual impurity testing; benchmarked players by service breadth, product depth, technology capabilities, geographic reach, and end-user focus | Supports strategic decision-making by identifying competitive white spaces, capability gaps, partnership targets, and differentiation opportunities |
| Assess high-growth testing segments and technology opportunities | Evaluated demand across major test categories, rapid microbiology methods, PCR/qPCR, NGS-based viral safety, recombinant endotoxin reagents, and automation-linked QC workflows | Helps prioritize the most attractive growth pockets, investment themes, and innovation areas in the biologics safety testing market |
RECENT DEVELOPMENTS
- December 2025 : Thermo Fisher Scientific Inc. expanded its Bioprocess Design Centers in Asia to strengthen support for biologics, vaccines, and cell and gene therapy development and manufacturing.
- January 2026 : Charles River Laboratories, Inc. acquired PathoQuest SAS to strengthen its biologics testing business with rapid, in vitro NGS-based viral safety, biopharmaceutical characterization, and product release testing capabilities.
Table of Contents
Exclusive indicates content/data unique to MarketsandMarkets and not available with any competitors.
TITLE
PAGE NO
1
INTRODUCTION
15
2
EXECUTIVE SUMMARY
3
PREMIUM INSIGHTS
4
MARKET OVERVIEW
4.1
INTRODUCTION
4.2
MARKET DYNAMICS
4.2.1
DRIVERS
4.2.2
RESTRAINTS
4.2.3
OPPORTUNITIES
4.2.4
CHALLENGES
4.3
UNMET NEEDS AND WHITE SPACES
4.4
INTERCONNECTED MARKETS AND CROSS-SECTOR OPPORTUNITIES
4.5
STRATEGIC MOVES BY TIER-1/2/3 PLAYERS
5
INDUSTRY TRENDS
5.1
PORTER’S FIVE FORCES ANALYSIS
5.2
MACROECONOMIC OUTLOOK
5.2.1
INTRODUCTION
5.2.2
GDP TRENDS AND FORECAST
5.2.3
TRENDS IN THE 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 OF KEY PLAYERS, BY PRODUCT (2023-2025)
5.5.2
AVERAGE SELLING PRICE, BY REGION (2025)
5.6
KEY CONFERENCES AND EVENTS, 2026–2027
5.7
TRENDS/DISRUPTIONS IMPACTING CUSTOMER BUSINESS
5.8
INVESTMENT AND FUNDING SCENARIO
5.8.1
VC/PRIVATE EQUITY INVESTMENT TRENDS & STARTUP LANDSCAPE
5.9
IMPACT OF 2025 US TARIFF – GLOBAL BIOLOGICS SAFETY TESTING MARKET
5.10.2
INTRODUCTION
5.10.2
KEY TARIFF RATES
5.10.3
PRICE IMPACT ANALYSIS
5.10.4
IMPACT ON REGIONS
5.12.4.1
NORTH AMERICA
5.12.4.2
EUROPE
5.12.4.3
ASIA PACIFIC
5.11.5
IMPACT ON END-USE INDUSTRIES
6
TECHNOLOGICAL ADVANCEMENTS, AI-DRIVEN IMPACT, INNOVATIONS, AND FUTURE APPLICATIONS
6.1
KEY EMERGING 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
6.6
FUTURE APPLICATIONS
6.7
IMPACT OF AI/GEN AI ON THE GLOBAL BIOLOGICS SAFETY TESTING MARKET
6.7.1
TOP USE CASES AND MARKET POTENTIAL
6.7.2
CASE STUDIES OF AI IMPLEMENTATION IN THE GLOBAL 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 THE GLOBAL BIOLOGICS SAFETY TESTING MARKET
7
SUSTAINABILITY AND REGULATORY LANDSCAPE
7.1
REGIONAL REGULATIONS AND COMPLIANCE
7.1.1
REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS
7.1.2
INDUSTRY STANDARDS
7.2
SUSTAINABILITY IMPACT AND REGULATORY POLICY INITIATIVES
7.3
CERTIFICATIONS, LABELING, ECO-STANDARDS
8
CUSTOMER LANDSCAPE & BUYER BEHAVIOR
8.1
DECISION-MAKING PROCESS
8.2
BUYER STAKEHOLDERS AND BUYING EVALUATION CRITERIA
8.3
ADOPTION BARRIERS & INTERNAL CHALLENGES
8.4
UNMET NEEDS FROM VARIOUS END-USE INDUSTRIES
8.5
MARKET PROFITABILITY
9
GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY OFFERING, 2024-2031 (USD MILLION)
COMPARATIVE ASSESSMENT OF KEY PRODUCTS, THEIR MARKET POTENTIAL, AND REVENUE TRENDS
9.1
INTRODUCTION
9.2
SERVICES
9.2.1
ENDOTOXIN TESTING SERVICES
9.2.2
BIOBURDEN TESTING SERVICES
9.2.3
MYCOPLASMA TESTING SERVICES
9.2.4
STERILITY TESTING SERVICES
9.2.5
VIRUS SAFETY TESTING SERVICES
9.2.6
OTHER TESTING SERVICES
9.3
PRODUCTS
9.3.1
ASSAYS, KITS & REAGENTS
9.3.1.1
DETECTION KITS
9.3.1.2
STERILITY TESTING MEDIA AND KITS
9.3.1.3
ENDOTOXIN TESTING REAGENTS
9.3.1.4
BIOBURDEN ENUMERATION
9.3.1.5
OTHER ASSAYS, KITS & REAGENTS
9.3.2
INSTRUMENTS
9.3.2.1
DETECTION AND IMAGING SYSTEMS
9.3.2.2
SEQUENCING INSTRUMENTS
9.3.2.3
AUTOMATED STERILITY TESTING SYSTEMS
9.3.2.4
OTHER INSTRUMENTS
10
GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2024-2031 (USD MILLION)
COMPARATIVE ASSESSMENT OF KEY TEST TYPES, THEIR MARKET POTENTIAL, AND REVENUE TRENDS
10.1
INTRODUCTION
10.2
ENDOTOXIN TESTS
10.3
BIOBURDEN TESTS
10.4
MYCOPLASMA TESTS
10.5
STERILITY TESTS
10.6
VIRUS SAFETY TESTS
10.7
RESIDUAL HOST-CELL PROTEINS & DNA DETECTION TESTS
10.8
OTHER BIOLOGICS SAFETY TESTS
NOTE: OTHER BIOLOGICS SAFETY TESTS INCLUDE BULK-LOT TESTING, TUMORIGENICITY TESTING, AND REPLICATION-COMPETENT VIRUS TESTING.
11
GLOBAL BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY APPLICATION, 2024-2031 (USD MILLION)
ASSESSMENT OF KEY APPLICATION, THEIR MARKET POTENTIAL, AND REVENUE TRENDS
11.1
INTRODUCTION
11.2
VACCINE
11.3
MONOCLONAL ANTIBODIES & THERAPEUTIC PROTEINS
11.4
CELLULAR & GENE THERAPY PRODUCTS
11.5
BLOOD & BLOOD PRODUCTS
11.6
OTHER APPLICATIONS
NOTE: OTHER APPLICATIONS INCLUDE BIOLOGICS SAFETY TESTING PRODUCTS USED FOR INSULIN, HORMONE THERAPY, TISSUE-BASED PRODUCTS, INTERFERONS, INTERLEUKINS, AND OTHER RECOMBINANT PROTEINS.
12
GLOBAL BIOLOGICS SAFETY TESTING SERVICES MARKET, BY APPLICATION, 2024-2031 (USD MILLION)
ASSESSMENT OF KEY SERVICES APPLICATION, THEIR MARKET POTENTIAL, AND REVENUE TRENDS
12.1
INTRODUCTION
12.2
MONOCLONAL ANTIBODIES & THERAPEUTIC PROTEINS SAFETY TESTING
12.3
VACCINES SAFETY TESTING
12.4
CELLULAR & GENE THERAPY SAFETY TESTING
12.5
BLOOD & BLOOD PRODUCTS SAFETY TESTING
12.6
OTHER APPLICATIONS
NOTE: OTHER APPLICATIONS INCLUDE BIOLOGICS SAFETY TESTING SERVICES USED FOR INSULIN, HORMONE THERAPY, TISSUE-BASED PRODUCTS, INTERFERONS, INTERLEUKINS, AND OTHER RECOMBINANT PROTEINS.
13
GLOBAL BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY END USERS, 2024-2031 (USD MILLION)
ASSESSMENT OF KEY END USERS, THEIR MARKET POTENTIAL, AND REVENUE TRENDS
13.1
INTRODUCTION
13.2
PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES
13.3
CROS AND CDMOS
13.4
ACADEMIC AND RESEARCH INSTITUTES
14
GLOBAL BIOLOGICS SAFETY TESTING SERVICES MARKET, BY END USERS, 2024-2031 (USD MILLION)
ASSESSMENT OF KEY END USERS, THEIR MARKET POTENTIAL, AND REVENUE TRENDS
14.1
INTRODUCTION
14.2
PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES
14.3
CROS AND CDMOS
14.4
ACADEMIC AND RESEARCH INSTITUTES
15
GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY REGION, 2024-2031 (USD MILLION)
ASSESSMENT OF GROWTH PATTERNS, INDUSTRY FORCES, REGULATORY LANDSCAPE, AND MARKET POTENTIAL ACROSS KEY GEOGRAPHIES AND COUNTRIES
15.1
INTRODUCTION
15.2
NORTH AMERICA
15.2.1
US
15.2.2
CANADA
15.3
EUROPE
15.3.1
GERMANY
15.3.2
UK
15.3.3
FRANCE
15.3.4
ITALY
15.3.5
SPAIN
15.3.6
REST OF EUROPE
15.4
ASIA PACIFIC
15.4.1
CHINA
15.4.2
JAPAN
15.4.3
INDIA
15.4.4
SOUTH KOREA
15.4.5
AUSTRALIA
15.4.6
REST OF ASIA PACIFIC
15.5
LATIN AMERICA
15.5.1
BRAZIL
15.5.2
MEXICO
15.5.3
REST OF LATIN AMERICA
15.6
MIDDLE EAST
15.6.1
GCC
15.6.1
.1 SAUDI ARABIA
15.6.1
.2 UAE
15.6.1
.3 REST OF GCC COUNTRIES
15.6.2
REST OF MIDDLE EAST
15.7
AFRICA
16
COMPETITIVE LANDSCAPE
STRATEGIC ASSESSMENT OF LEADING PLAYERS, MARKET SHARE, REVENUE ANALYSIS, COMPANY POSITIONING, AND COMPETITIVE BENCHMARKS INFLUENCING MARKET POTENTIAL
16.1
INTRODUCTION
16.2
KEY PLAYERS STRATEGY/ RIGHT TO WIN
16.3
REVENUE ANALYSIS, 2023-2025
16.4
MARKET SHARE ANALYSIS,
16.5
COMPANY EVALUATION MATRIX: KEY PLAYERS
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,
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
16.6
COMPANY EVALUATION MATRIX: START-UPS/SMES,
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,
16.6.5.1
DETAILED LIST OF KEY STARTUPS/ SMES
16.6.5.2
COMPETITIVE BENCHMARKING OF KEY EMERGING PLAYERS/STARTUPS
16.7
COMPETITIVE SCENARIO
16.7.1
PRODUCT LAUNCHES
16.7.2
DEALS
16.7.3
OTHER DEVELOPMENTS
16.8
BRAND/ PRODUCT COMPARATIVE ANALYSIS
16.9
VALUATION AND FINANCIAL METRICS
17
COMPANY PROFILES
17.1
KEY COMPANIES
17.1.1THERMO FISHER SCIENTIFIC INC.
15.1.2
CHARLES RIVER LABORATORIES
17.1.3
LABORATORY CORPORATION OF AMERICA HOLDINGS
17.1.4
F. HOFFMANN-LA ROCHE LTD
17.1.5
MERCK KGAA
17.1.6
SARTORIUS AG
17.1.7
LONZA
17.1.8
FUJIFILM CORPORATION
17.1.9
BIOMÉRIEUX
17.1.10
MARAVAI LIFESCIENCES
17.1.12
WUXI APPTEC
17.1.12
SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA
17.1.13
SOTERA HEALTH (NELSON LABORATORIES, LLC)
17.1.14
SAMSUNG BIOLOGICS
17.1.17
GENSCRIPT
17.1.16
AGILENT TECHNOLOGIES, INC.
17.1.17
SYNGENE INTERNATIONAL LIMITED
17.1.18
EUROFINS SCIENTIFIC
17.1.19
BIO-RAD LABORATORIES, INC.
17.1.20
QIAGEN
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
17.2.8
FRONTAGE LABS.
17.2.9
CREATIVE BIOGENE
17.2.10
ADVAXIA BIOLOGICS
NOTE 9: THE DETAILS ON BUSINESS OVERVIEW, FINANCIAL INFORMATION, PRODUCT PORTFOLIO, RECENT DEVELOPMENTS, AND MARKETSANDMARKETS VIEW WILL BE PROVIDED FOR KEY PLAYERS. THESE DETAILS MIGHT NOT BE CAPTURED FOR UNLISTED COMPANIES. THE PROVIDED LIST OF PLAYERS
18
RESEARCH METHODOLOGY
18.1
RESEARCH DATA
18.1.1
SECONDARY DATA
18.1.1.1
KEY SOURCES OF SECONDARY DATA
18.1.1.2
KEY OBJECTIVES OF SECONDARY DATA
18.1.2
PRIMARY DATA
18.1.2.1
BREAKDOWN OF PRIMARY INTERVIEWS
18.1.2.2
KEY OBJECTIVES OF PRIMARY RESEARCH
18.2
MARKET SIZE ESTIMATION
18.2.1
GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE ESTIMATION
18.2.1.1
COMPANY REVENUE ANALYSIS (BOTTOM-UP APPROACH)
18.2.1.2
MNM REPOSITORY ANALYSIS
18.2.1.3
SECONDARY ANALYSIS
18.2.1.4
PRIMARY RESEARCH
18.2.1.4.1
INSIGHTS FROM PRIMARY EXPERTS
18.3
MARKET GROWTH RATE PROJECTIONS
18.4
DATA TRIANGULATION
18.5
RESEARCH ASSUMPTIONS
18.6
RESEARCH LIMITATIONS AND RISK ASSESSMENT
19
APPENDIX
19.1
DISCUSSION GUIDE
19.2
KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL
19.3
AVAILABLE CUSTOMIZATIONS
19.4
RELATED REPORTS
19.5
AUTHOR DETAILS
Methodology
This study involved four major activities in estimating the current size of the biologics safety testing market. Exhaustive secondary research was conducted to gather information on the market, its peer markets, and its parent market. These findings, assumptions, and sizing were then validated with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. Following this, the data triangulation procedure was used to estimate the market size of segments and subsegments.
Secondary Research
Secondary research was primarily used to identify and gather information for the extensive, technical, market-oriented, and commercial study. The secondary sources referred for this research study include publications from government sources, such as the US Food and Drug Administration (FDA), World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), National Center for Biotechnology Information (NCBI), Organisation for Economic Co-operation and Development (OECD), National Institutes of Health (NIH), News Articles, Press Releases. Secondary sources also included corporate and regulatory filings (such as annual reports, SEC filings, investor presentations, and financial statements); business magazines and research journals; press releases; and trade, business, and professional associations. These sources were also used to obtain key information on major players, global product revenues, market classification, and segmentation by industry trends, regional/country-level markets, market developments, and technology perspectives. Secondary data were collected and analyzed to determine the overall size of the global biologics safety testing market, and the findings were validated through primary research.
Primary Research
In-depth interviews were conducted with primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, among others, to obtain and verify critical qualitative and quantitative information and assess market prospects. Various primary sources from both the supply and demand sides of the market were interviewed to obtain qualitative and quantitative information. The following is a breakdown of the primary respondents:
To know about the assumptions considered for the study, download the pdf brochure
Market Size Estimation
The global size of the biologics safety testing market was estimated through multiple approaches. A detailed market estimation approach was used to estimate and validate the market value and other dependent submarkets. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:
Data Triangulation
After estimating the overall market size from the market size estimation process, the total market was split into several segments. To complete the overall market engineering process and arrive at the exact statistics for all segments, the data triangulation procedure was employed; it involved studying various factors and trends from both the demand and supply sides.
Market Definition
The biological safety testing market comprises the products and services used to assess the safety, purity, potency, and quality of biologically derived products across their development, manufacturing, and release stages.
Key Stakeholders
- Biologics safety testing products and services companies
- National and regional research boards and organizations
- Research & development companies
- Clinical research organizations (CROs)
- Biotechnology companies
- Research laboratories & academic institutes
- Market research & consulting firms
- Regulatory bodies
Report Objectives
- To define, describe, and forecast the biologics safety testing market by offering, test type, product application, service application, product end user, service end user, and region
- To provide detailed information regarding the major factors influencing the market growth (such as drivers, restraints, opportunities, and challenges)
- To analyze the micromarkets with respect to individual growth trends, prospects, and contributions to the overall biologics safety testing market
- To analyze the opportunities for stakeholders and provide details of the competitive landscape for market leaders
- To forecast the size of the market segments with respect to six regions: North America (US and Canada), Europe (Germany, France, the UK, Italy, Spain, and the Rest of Europe), Asia Pacific (China, Japan, India, South Korea, Australia, and the Rest of Asia Pacific), Latin America (Brazil, Mexico, Argentina, and the Rest of Latin America), the Middle East [GCC (Saudi Arabia (KSA), United Arab Emirates (UAE), and the Rest of GCC) and the Rest of Middle East], and Africa
- To profile the key players and analyze their market shares and core competencies
- To track and analyze competitive developments, such as product launches, partnerships, agreements, collaborations, and expansions
- To benchmark players within the market using the proprietary “Company Evaluation Matrix” framework, which analyzes market players on various parameters within the broad categories of business and product excellence strategy.
Available customizations:
With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for the report:
Geographical Analysis
- Further breakdown of the Rest of Europe biologics safety testing market, by country
- Further breakdown of the Rest of Asia Pacific biologics safety testing market, by country
Company Information
- Detailed analysis and profiling of additional market players (up to five)
Segment Analysis
- Cross-segment analysis
⚡ Growth Signals
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- Triangulate with your Own Data
- Get Data as per your Format and Definition
- Gain a Deeper Dive on a Specific Application, Geography, Customer or Competitor
- Any level of Personalization
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Leading Pharmaceutical Company
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Bracco Diagnostics Inc.,
Italian Multinational in life sciences sector and a World Leader in imaging diagnostics
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3M Health Information Systems,
Leader in Health care Coding, Payment & Analytics Solutions.
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