Biologics is manufactured or produced from biological sources such as nucleic acid, living orgasms, and protein and combination of these substances. The main functions of biologics safety testing are to ensure non contamination of vaccines and biopharmaceuticals and to comply the standards and regulations regarding the same. Biologics safety testing is very important to for introducing or launching new products. Based on product type, different types of biologics safety testing such as autoclaves, laboratory centrifuges, and biological safety cabinet are used.

Market Dynamics

The growth of the biologics safety testing market is primarily driven by growing number of drug launches, stringent government regulations regarding biologics, increase in chronic diseases across the globe, and technological advancements in biologics safety testing. Furthermore, increase in number of new biologics by biotechnology and pharmaceutical key players and expanding base of various dieses patients worldwide, is estimated to boost the market growth. According to National Center for Biotechnology Information (NCBI) the number of products launched increased from 29 in 2003 to 56 in 2013. According to world Health Organization (WHO) and The International Agency for Research on Cancer (ICRA), around 19.3 million new cancer cases will be diagnosed per year, by 2025. Moreover, changing lifestyles of consumers across developed countries, growing pharmaceutical and medical industry, technological advancement and increase in the number of applications are expected to create opportunities for the manufacturers in the global market over the forecast period. However, high cost of research and development and risks associated for skilled professionals are expected to hamper the growth of the global biologics safety testing market in the coming years.

By Product Type, kits & reagents dominated the biologics safety testing market

The kits & reagents segment accounted for approximately 54% of the share in the global biologics safety testing market in 2018. Increase in demand for kits and reagents for performing blood and blood-related products testing, tissue and tissue-related products testing and cellular and gene therapy, and repeated and regular sales of kits & reagents as compared to instruments is further expected to raise segment over the forecast period.

By Application, vaccine and therapeutics development segment dominated the biologics safety testing market

The vaccine and therapeutics development segment accounted for approximately 32% of the share in the global biologics safety testing market in 2018. Growing demand for biologics safety testing for various diseases and cataract procedures and growing investment for vaccine and therapeutics development, and initiatives for immunization is further expected to raise segment over the forecast period. Owing to its growing number of applications, growing number of new drug launches, and supportive government initiatives for biologics safety testing in research and development centres further grows the demand for biologics safety testing in vaccine and therapeutics development applications during the forecast period.

By Test Type, endotoxin tests segment dominated the biologics safety testing market

The endotoxin tests segment accounted for approximately 27% of the share in the global biologics safety testing market in 2018. Rising prevalence of these tests in manufacturing and production of drugs and growing incidence of endotoxin testing, and rising demand for safe test is further expected to raise segment over the forecast period.

The market research study on “Biologics Safety Testing Market– Global Industry Analysis, Market Size, Opportunities and Forecast, 2019 – 2026”, offers a detailed insight into the global biologics safety testing market entailing insights on its different market segments. Market dynamics with drivers, restraints, and opportunities with their impact are provided in the report. The report provides insights into the global biologics safety testing market, its product type, application, test type, and major geographic regions. The report covers basic development policies and layouts of technology development processes. Secondly, the report covers global biologics safety testing market size and volume, and segment markets by product type, application, test type, and geography along with the information on companies operating in the market. The biologics safety testing market analysis is provided for major regional markets including North America, Europe, Asia Pacific, Latin America and Middle East and Africa. For each region, the market size and volume for different segments have been covered under the scope of the report.

In 2018, North America dominated the regional market with a maximum market share

North America accounted for the high market share of the biologics safety testing market and the region is also expected to maintain its dominance over the forecast period. The region is experiencing the maximum growth owing to the rapid consumption of biologics safety testing in various applications, presence of biologics safety testing companies, favorable reimbursement policies, and increased adoption in cancer research. High research and development in biotechnology and pharmaceutical, development and launching of new biologics and drugs, and developed healthcare infrastructure in the North America region are one of the key factors driving the consumption of biologics safety testing in this region. Moreover, highly skilled surgeons, growing number of laboratory and research centers in key countries such as US and Canada are also propelling the growth of biologics safety testing in the North America region. Europe is followed by the North America region in the biologics safety testing market.

Asia-Pacific is expected to hold the highest CAGR in the global market during the forecast period. The growing pharmaceutical and biotechnology and industry increase in innovation and development in biologics safety testing, and growing outsourcing industry, are expected to enhance the market growth in the global biologics safety testing market during the forecast.

The players profiled in the report include Charles River Laboratories, SGS SA, Lonza Group LTD, Merck KGaA, and WuXi Apptec, Thermo Fisher Scientific Inc., Sartorius AG, Cytovance Biologics, Inc., Pace Analytical Services Inc., Eurofins Scientific Se, Avance Biosciences Inc., Source Bioscience, and Toxikon Corporation among others. The companies are involved in mergers and acquisitions and new product development for expanding their market share and also for gaining competitive advantages over its competitors.

Market Segmentation

Market By Product Type

• Kits & Reagents
• Instruments

Market By Application

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

Market By Test Type

• Endotoxin Tests
• Sterility Tests
• Cell Line Authentication and Characterization Tests
• Residual Host Contamination Detection Tests
• Adventitious Agent Detection Tests
• Bioburden tests
• Other Tests

Market By Geography

• North America
  • U.S.
  • Canada
• Europe
  • UK
  • Germany
  • France
  • Spain
  • Rest of Europe
• Asia-Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • South Africa
  • Rest of Middle East & Africa