The biologics safety testing market is projected to reach USD 7.2 billion by 2029 from an estimated USD 4.2 billion in 2024, at a CAGR of 11.1% from 2024 to 2029. The growth of this market can be attributed to the increasing focus on the development and manufacturing of novel biologics. The rising demand for advanced therapies such as cell and gene therapies due to the growing rate of chronic diseases is propelling the growth of biologics safety testing. This trend is expected to drive the growth of the biologics safety testing market in the coming years.
Scope of the Report
Years Considered for the Study
2022-2029
Base Year
2023
Forecast Period
2024-2029
Units Considered
Value (USD) Billion
Segments
Product & Service, Test Type, Application, and End User
Regions covered
North America, Europe, Asia Pacific, Latin America, Middle East, and Africa
"The monoclonal antibodies development and manufacturing segment accounted for the largest share of by application segment in 2023."
In 2023, the monoclonal antibodies development and manufacturing segment accounted for the largest share of the global biologics safety testing market by application. Growing investments and funding in the development of novel biotherapeutics and rising demand for biological therapies for the treatment of chronic diseases are promoting the segment's growth in the biologics safety testing market.
"The US has continued to dominate the biologics safety testing market from 2024 to 2029."
The US dominated the biologics safety testing market in North America in 2023. The US is the world's largest biopharmaceutical market and a leader in biopharmaceutical research/investments. Also, US has strong healthcare infrastructure which drives the research and development in life sciences sector. Additionally, US has large number of biopharmaceutical companies; thus, increasing number of biopharmaceutical companies and growing research activities in biotechnology sector are propelling the market growth in US. Moreover, increasing approvals for biosimilars are also driving the growth of biologics safety testing market.
The primary interviews conducted for this report can be categorized as follows:
By Respondent: Supply Side- 60% and Demand Side 40%
By Designation: Managers - 45%, CXO & Directors - 30%, and Executives - 25%
By Region: North America - 40%, Europe -25%, Asia-Pacific -25%, Latin America -5% and Middle East & Africa- 5%
List of Companies Profiled in the Report:
Thermo Fisher Scientific Inc. (US)
Merck KGaA (Germany)
Lonza (Switzerland)
FUJIFILM Corporation (Japan)
Sartorius AG (Germany)
F. Hoffmann-La Roche Ltd (Switzerland)
Charles River Laboratories (US)
BIOMERIEUX (France)
Maravai LifeSciences (US)
WuXi AppTec (China)
SGS Societe Generale de Surveillance SA. (Switzerland)
Sotera Health (Nelson Laboratories, LLC) (US)
Samsung Biologics (South Korea)
GenScript (US)
Agilent Technologies, Inc. (US)
Syngene International Limited (India)
Eurofins Scientific (Luxembourg)
Laboratory Corporation of America Holdings (US)
Bio-Rad Laboratories, Inc. (US)
QIAGEN (Netherlands)
Promega Corporation (US)
Catalent, Inc (US)
ASSOCIATES OF CAPE COD, INC. (US)
Pacific BioLabs (US)
Clean Biologics (France)
PathoQuest (France)
ARL Bio Pharma, Inc. (US)
Frontage Labs (US)
Creative Biogene (US)
Advaxia Biologics (Italy)
Research Coverage:
This research report categorizes the biologics safety testing market by product & service (services (mycoplasma testing services, sterility testing services, endotoxin testing services, virus safety testing services, bioburden testing services, and other testing services), consumables, and instrument), test type (residual host-cell proteins & DNA detection tests, mycoplasma tests, sterility tests, endotoxin tests, virus safety tests, bioburden tests, other biologics safety tests), application (monoclonal antibodies development and manufacturing, vaccine development and manufacturing, cellular & gene therapy products development and manufacturing, blood & blood products development and manufacturing, other applications), end user (pharmaceutical & biotechnology companies, CROs and CDMOs, and academic & research institutes), and by region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa). The scope of the report covers detailed information regarding the major factors, such as drivers, restraints, challenges, and opportunities, influencing the growth of the biologics safety testing market. A thorough analysis of the key industry players has been done to provide insights into their business overview, products, services, solutions, key strategies, collaborations, partnerships, and agreements. Also, it includes new product launches, collaborations and acquisitions, and recent developments associated with the biologics safety testing market.
Key Benefits of Buying the Report:
The report will help market leaders/new entrants by providing the closest approximations of the revenue numbers 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 better and make suitable go-to-market strategies. This report will enable stakeholders to understand the market's pulse and provide them with information on the key market drivers, restraints, opportunities, and challenges.
The report provides insights on the following pointers:
Analysis of key drivers (growing development of mAbs and biosimilars, rising investments and fundings in biopharmaceutical industry, and stringent regulatory guidelines for biologics safety), restraints (ethical concern regarding animal testing), opportunities (growing opportunities in emerging economies, increasing focus on next generation therapeutics), and Challenges (high cost of biologics) influencing the growth of the 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 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: Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Lonza (Switzerland), FUJIFILM Corporation (Japan), Sartorius AG (Germany), F. Hoffmann-La Roche Ltd (Switzerland), Charles River Laboratories (US), BIOMERIEUX (France), Maravai LifeSciences (US), WuXi AppTec (China), SGS Societe Generale de Surveillance SA. (Switzerland), Sotera Health (Nelson Laboratories, LLC) (US), Samsung Biologics (South Korea), GenScript (US), Agilent Technologies, Inc. (US), Syngene International Limited (India), Eurofins Scientific (Luxembourg), Laboratory Corporation of America Holdings (US), Bio-Rad Laboratories, Inc. (US), QIAGEN (Netherlands), Promega Corporation (US), Catalent, Inc (US), ASSOCIATES OF CAPE COD, INC. (US), Pacific BioLabs (US), Clean Biologics (France), PathoQuest (France), ARL Bio Pharma, Inc. (US), Frontage Labs (US), Creative Biogene (US), Advaxia Biologics (Italy), among others in the market.
TABLE OF CONTENTS
1 INTRODUCTION
1.1 STUDY OBJECTIVES
1.2 MARKET DEFINITION
1.2.1 INCLUSIONS & EXCLUSIONS
1.3 STUDY SCOPE
1.3.1 MARKET SEGMENTATION
1.3.2 REGIONS COVERED
1.4 YEARS CONSIDERED
1.5 CURRENCY CONSIDERED
1.6 STAKEHOLDERS
1.7 LIMITATIONS
1.8 SUMMARY OF CHANGES
1.9 RECESSION IMPACT
2 RESEARCH METHODOLOGY
2.1 RESEARCH DATA
FIGURE 1 RESEARCH DESIGN
2.1.1 SECONDARY DATA
2.1.2 PRIMARY DATA
FIGURE 2 BIOLOGICS SAFETY TESTING MARKET: BREAKDOWN OF PRIMARIES
2.2 MARKET ESTIMATION METHODOLOGY
2.2.1 GLOBAL MARKET SIZE ESTIMATION (BOTTOM-UP APPROACH)
8.2 MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING
8.2.1 GROWING REGULATORY APPROVALS FOR MONOCLONAL ANTIBODIES TO SUPPORT MARKET GROWTH
TABLE 142 BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY REGION, 2022-2029 (USD MILLION)
TABLE 143 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 144 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 145 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 146 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 147 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY REGION, 2022-2029 (USD MILLION)
TABLE 148 GCC: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
8.3 VACCINES DEVELOPMENT AND MANUFACTURING
8.3.1 RISING PREVALENCE OF INFECTIOUS DISEASES TO DRIVE GROWTH
TABLE 149 BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY REGION, 2022-2029 (USD MILLION)
TABLE 150 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 151 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 152 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 153 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 154 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY REGION, 2022-2029 (USD MILLION)
TABLE 155 GCC: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
8.4 CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING
8.4.1 INCREASING INVESTMENTS FOR DEVELOPMENT OF CELLULAR & GENE THERAPIES TO DRIVE GROWTH
TABLE 156 BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY REGION, 2022-2029 (USD MILLION)
TABLE 157 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 158 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 159 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 160 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 161 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY REGION, 2022-2029 (USD MILLION)
TABLE 162 GCC: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
8.5 BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING
8.5.1 GROWING DEMAND FOR BLOOD PRODUCTS TO PROPEL GROWTH
TABLE 163 BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY REGION, 2022-2029 (USD MILLION)
TABLE 164 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 165 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 166 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 167 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 168 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY REGION, 2022-2029 (USD MILLION)
TABLE 169 GCC: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022-2029 (USD MILLION)
8.6 OTHER APPLICATIONS
TABLE 170 BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY REGION, 2022-2029 (USD MILLION)
TABLE 171 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 172 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 173 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 174 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 175 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY REGION, 2022-2029 (USD MILLION)
TABLE 176 GCC: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2022-2029 (USD MILLION)
9 BIOLOGICS SAFETY TESTING MARKET, BY END USER
9.1 INTRODUCTION
TABLE 177 BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022-2029 (USD MILLION)
9.2 PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES
9.2.1 INCREASING PHARMACEUTICAL R&D SPENDING AND GROWING STRATEGIC ALLIANCES TO DRIVE GROWTH
FIGURE 32 GLOBAL PHARMACEUTICAL R&D SPENDING, 2014-2028 (USD BILLION)
TABLE 178 BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY REGION, 2022-2029 (USD MILLION)
TABLE 179 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 180 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 181 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 182 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 183 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY REGION, 2022-2029 (USD MILLION)
TABLE 184 GCC: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2022-2029 (USD MILLION)
9.3 CROS & CDMOS
9.3.1 INCREASING FOCUS ON EXPANSION OF CROS AND CDMOS TO PROPEL GROWTH
TABLE 185 BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY REGION, 2022-2029 (USD MILLION)
TABLE 186 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 187 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 188 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 189 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 190 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY REGION, 2022-2029 (USD MILLION)
TABLE 191 GCC: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY COUNTRY, 2022-2029 (USD MILLION)
9.4 ACADEMIC & RESEARCH INSTITUTES
9.4.1 SURGE IN R&D ACTIVITIES FOR DEVELOPMENT OF ADVANCED THERAPIES TO BOOST MARKET GROWTH
TABLE 192 BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY REGION, 2022-2029 (USD MILLION)
TABLE 193 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 194 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 195 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 196 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 197 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY REGION, 2022-2029 (USD MILLION)
TABLE 198 GCC: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2022-2029 (USD MILLION)
TABLE 428 ASSOCIATES OF CAPE COD, INC.: COMPANY OVERVIEW
12.3.4 CLEAN BIOLOGICS
TABLE 429 CLEAN BIOLOGICS: COMPANY OVERVIEW
12.3.5 PATHOQUEST
TABLE 430 PATHOQUEST: COMPANY OVERVIEW
12.3.6 PACIFIC BIOLABS
TABLE 431 PACIFIC BIOLABS: COMPANY OVERVIEW
12.3.7 ARL BIO PHARMA, INC.
TABLE 432 ARL BIO PHARMA, INC.: COMPANY OVERVIEW
12.3.8 FRONTAGE LABS
TABLE 433 FRONTAGE LABS: COMPANY OVERVIEW
12.3.9 CREATIVE BIOGENE
TABLE 434 CREATIVE BIOGENE: COMPANY OVERVIEW
12.3.10 ADVAXIA BIOLOGICS
TABLE 435 ADVAXIA BIOLOGICS: COMPANY OVERVIEW
*Details on Business Overview, Products Offered, Recent Developments, and MnM View (Key strengths/Right to Win, Strategic Choices Made, and Weaknesses and Competitive Threats) might not be captured in case of unlisted companies.