Market Overview:

The global biological safety testing market reached a value of US$ 3.51 Billion in 2021. Looking forward, IMARC Group expects the market to reach US$ 7.16 Billion by 2027, exhibiting at a CAGR of 12.55% during 2022-2027. Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic. These insights are included in the report as a major market contributor.

Biopharmaceutical products are widely used in the diagnosis, prevention, and treatment of various diseases. However, their manufacturing process and the complex structural and biological characteristics pose several safety concerns. Therefore, health agencies of numerous countries have mandated a thorough biological safety testing on these products. Biological safety testing ensures products are free from contaminants before a clinical investigation takes place. Nowadays, several companies are providing comprehensive biological safety testing packages that are compliant with global stringent safety standards.

Biological Safety Testing Market Trends:

The coronavirus disease (COVID-19) outbreak and the urgent need for a potential treatment are among the key factors positively influencing the demand for biological safety testing worldwide. It evaluates the safety of candidate vaccines prior to their dispatch to manufacturers. Moreover, the escalating demand for biopharmaceutical products on account of the rising prevalence of targeted diseases and the easy access to healthcare services is fueling the market growth. Additionally, the rising number of novel drugs and biological products at clinical trials is contributing to the market growth. Apart from this, biological products derived from mammalian cell lines pose an inherent risk for microbial and viral contaminants. This is increasing the adoption of stringent safety testing to ensure biologic materials are safe and free of contaminants during the entire development process. Furthermore, due to the rising utilization of single-use medical items, pharmaceutical manufacturers are focusing on producing safe products and achieving sterility assurance, which, in turn, is driving the market. Besides this, market leaders are forming strategic partnerships with major research organizations to provide drug discovery and development services and produce cost-efficient and technologically advanced testing methods. This is anticipated to create a positive outlook for the market.

Key Market Segmentation:

IMARC Group provides an analysis of the key trends in each sub-segment of the global biological safety testing market, along with forecasts at the global, regional and country level from 2022-2027. Our report has categorized the market based on product and services, test type and application.

Breakup by Product and Services:

• Kits and Reagents
• Instruments
• Services
   

Breakup by Test Type:

• Endotoxin Tests
• Sterility Tests
• Cell Line Authentication and Characterization Tests
• Bioburden Tests
• Residual Host Contaminant Detection Tests
• Adventitious Agent Detection Tests
• Others
   

Breakup by Application:

• Vaccine Development
• Blood Products Testing
• Cellular and Gene Therapy
• Tissue and Tissue-related Products Testing
• Stem Cell Research
   

Breakup by Region:

• North America
  • United States
  • Canada
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

Competitive Landscape:

The competitive landscape of the industry has also been examined along with the profiles of the key players being Avance Biosciences, Charles River Laboratories, Creative Biogene, Eurofins Scientific, Lonza Group AG, Maravai LifeSciences, Pace Analytical Services Inc., Pacific BioLabs, Sartorius AG, SGS SA, ViruSure GmbH (Asahi Kasei Corporation) and WuXi Biologics.

Report Coverage:

Key Questions Answered in This Report:

• How has the global biological safety testing market performed so far and how will it perform in the coming years?
• What has been the impact of COVID-19 on the global biological safety testing market?
• What are the key regional markets?
• What is the breakup of the market based on the product and services?
• What is the breakup of the market based on the test type?
• What is the breakup of the market based on the application?
• What are the various stages in the value chain of the industry?
• What are the key driving factors and challenges in the industry?
• What is the structure of the global biological safety testing market and who are the key players?
• What is the degree of competition in the industry?