Biologics Safety Testing Market Worth $7.2 billion | MarketsandMarkets™

Some factors contributing to the growth of the global market includes increasing R&D investments fundings in biopharmaceutical industry, growing development of biologics, stringent regulatory requirements for biologics safety testing, and increasing number of strategic alliances for the development of novel therapeutics. However, ethical concern regarding animal testing is expected to hinder market growth.

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Biologics Safety Testing Market Scope:

The services segment accounted for the largest share of the product & service segment in the biologics safety testing market in 2023. 

Based on product & service, the biologics safety testing market is segmented into services, consumables, and instrument. Services segment is further divided into endotoxin testing services, mycoplasma testing services, sterility testing services, bioburden testing services, virus safety testing services, and other testing services. Services segment dominated the market in 2023 and is expected to dominate the market in the forecast period. The largest share of the segment is attributed to surge in outsourcing of biologics safety testing services by biopharmaceutical companies.

The pharmaceutical & biotechnology companies segment is estimated to register the highest growth rate during the forecast period in the biologics safety testing market.

Based on end user, the biologics safety testing market is segmented into pharmaceutical & biotechnology companies, CROs and CDMOs, and academic and research institutes. The pharmaceutical & biotechnology companies segment is estimated to register the highest growth rate during the forecast period. The rising demand for biopharmaceuticals such as vaccine and monoclonal antibodies due to increasing incidence of chronic diseases is anticipated to promote the growth of pharmaceutical & biotechnology companies segment in coming years.

The Asia Pacific region is the fastest-growing region of the biologics safety testing market in 2023. 

Based on the region, the biologics safety testing market is segmented into six major regions: North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. The Asia Pacific is anticipated to register fastest growth in the biologics safety testing market owing to the increasing focus on development of advanced therapies such as cell and gene therapies, high government investments & fundings for R&D, and booming biotechnology industries.

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Biologics Safety Testing Market Dynamics:

Drivers:

1. Increasing development of mAbs and biosimilars

Restraints:

1. Ethical concern related to animal testing

Opportunities:

1. Increasing focus on next generation therapeutics

Challenge:

1. Challenges related to biologics complexity and heterogenicity

Key Market Players of Biologics Safety Testing Industry:

Key players in the biologics safety testing market include 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), BIOMÉRIEUX (France), Maravai LifeSciences (US), WuXi AppTec (China), SGS Société Générale 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).

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%

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Recent Developments of Biologics Safety Testing Industry:

• In January 2024, Chales River Laboratories launched Endosafe Trillium rCR cartridge, a new animal-free testing solution for robust bacterial endotoxin testing.
• In November 2023, Merck KGaA has developed biosafety testing laboratories in Shanghai, China. The facility aims to enable the clients to locally access a broad range of testing services for cell line characterization and lot release from pre-clinical development to commercialization.
• In March 2023, LabCorp collaborated with Forge Biologics for gene therapy development and manufacturing. Under this partnership gene therapy clients will have access to drug development services, manufacturing capabilities, scientific expertise, for adeno-associated virus (AAV) mediated gene therapy programs.

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), BIOMÉRIEUX (France), Maravai LifeSciences (US), WuXi AppTec (China), SGS Société Générale 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.

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