Bio safety Testing Market By Product (Reagents and Kits, Instruments, and Other Products), By Test (Sterility Tests, Cell Line Authentication and Characterization Tests, Bioburden Tests, Endotoxin Tests, Adventitious Agent Detection Tests, and Other Tests), By Application (Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy, and Other Applications), and By Region - Trends, Analysis, and Forecast till 2029

Report Code: PMI427820 | Publish Date: May 2023 | No. of Pages: 180

Global Bio Safety Testing Market Overview

Bio Safety Testing Market accounted for USD 3.1 Billion in 2019 and is estimated to be USD 10.5 Billion by 2029 and is anticipated to register a CAGR of 13.1%.

Bio safety testing deals with testing methods that are carried out to confirm non-contamination of biopharmaceuticals and vaccines and to comply with regulations concerning the same. This includes several types of characterization tests, sterility tests, cell line authentication and bioburden tests, adventitious agent detection tests, endotoxin tests, and residual host contamination detection tests, among others. 

Global Bio Safety Testing Market Drivers & Restraints

Unprecedented growth has been observed in the number of biopharmaceutical companies due to rising need for biologics. Manufacturers are involved in improving aspects of manufacturing processes such as cost-efficiency and productivity in order to growing competition to develop therapeutically advanced drugs on a large scale. Therefore, key player are implementing good manufacturing practices involving thorough biological testing at numerous levels of production cycle, thereby propelling market growth. Companies are providing services such as bioburden testing, toxicology testing, and analytical testing, which assess products on parameters such as specificity, accuracy, range, and linearity.

High rate of microbial contamination and bioburden while manufacturing pharmaceuticals and biologics is projected to fuel government and private organizations to enhance underlying biological safety practices. Further, increasing number of government initiatives to indorse biological safety testing products and services is expected to motivate overall growth in the coming years.

Conversely, there remain some potential safety concerns, which usually rise from the manufacturing processes and structural characteristics and complex biological of these products. Further, time-consuming approval process also hampers growth of the target market.

Global Bio Safety Testing Market Segmentations & Regional Insights

The global bio safety testing market is segmented based on product, test, application, and region.

On the basis of product, the global bio safety testing market is segmented into reagents and kits, instruments, and other products. Based on test, the target market is segmented into sterility tests, cell line authentication and characterization tests, bioburden tests, endotoxin tests, adventitious agent detection tests, and other tests. On the basis of application, the target market is segmented into vaccines and therapeutics, cellular and gene therapy, blood and blood-based therapy, and other applications.

Regional Insights:

On region the global bio safety testing market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America accounts highest share of the global market in 2019, owing to increased adoption in cancer research, high investments in biotechnology, and development of new vaccines, drugs, & biologics. Additionally, growing number of R&D investments by companies is one of the factors accountable for growth. Presence of major market players adopting extensive expansion strategies is also projected to drive the target market. Also, growing burden of chronic diseases is expected to increase the usage of advanced technologies by healthcare professionals and researchers in this region.  The Asia Pacific market is expected to grow at a lucrative CAGR in the coming years due to growing healthcare spending and rising awareness about the benefits of these products. Moreover, Asia?Pacific Biosafety Association trains concerned professionals on biosafety principles and practices across the region, therefore spreading growth prospects in this region.

Report Scope:

Attribute

Details

Base year for estimation

2019

Forecast period

2019 – 2029

Market representation

Revenue in USD Million & CAGR from 2019 – 2029

Market Segmentation

By Product- Reagents and Kits, Instruments, and Other Products

By Test– Sterility Tests, Cell Line Authentication and Characterization Tests, Bioburden Tests, Endotoxin Tests, Adventitious Agent Detection Tests, and Other Tests

By Application– Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy, and Other Applications

Regional scope

North America - U.S., Canada

Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe

Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific

Latin America - Brazil, Mexico, Argentina, Rest of Latin America

Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa

Report coverage

Revenue forecast, company share, competitive landscape, growth factors, and trends

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2019 to 2029. For the purpose of this study, has segmented the global bio safety testing market report based on product, test, application, and region.

Global Bio safety Testing Market, By Product:

  • Reagents and Kits
  • Instruments
  • Other Products

Global Bio safety Testing Market, By Test:

  • Sterility Tests
  • Cell Line Authentication and Characterization Tests
  • Bioburden Tests
  • Endotoxin Tests
  • Adventitious Agent Detection Tests
  • Other Tests

Global Bio safety Testing Market, By Application:

  • Vaccines and Therapeutics
  • Cellular and Gene Therapy
  • Blood and Blood-based Therapy
  • Other Applications

Global Bio safety Testing Market, By Region:

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

Global Bio Safety Testing Market Competitive Landscape & Key Players

The key players operating in the global bio safety testing market includes Avance Biosciences, Cytovance Biologics, Thermo Fisher Scientific, Merck KGaA, Eurofins Scientific, Lonza, Promega Corporation, Toxikon, and WuXi AppTec. Companies are engaged in extensive R&D for producing technologically advanced testing and cost-efficient products. Additionally, various strategies are being adopted by these companies to improve market presence are projected to create lucrative growth opportunities in the near future. For instance, in 2018, Charles River Laboratories, Inc. acquired MPI Research, increasing its ability to offer drug discovery and development services.

Global Bio Safety Testing Market Company Profile

FAQs

The global bio safety testing market is segmented based on product, test, application, and region.

Growth in the manufacturing processes of bio-pharmaceutical companies is the major propelling factor for the growth of the target market.

North America accounts highest share of the global market in 2019, owing to increased adoption in cancer research, high investments in biotechnology, and development of new vaccines, drugs, & biologics.

In 2018, Charles River Laboratories, Inc. acquired MPI Research, increasing its ability to offer drug discovery and development services.