Biological Safety Testing Market, By Products and Services (Products {Kits and Reagents, Instruments}, Services), By Test (Endotoxin Test, Sterility Test, Adventitious Agent Detection Test), By Application (Blood & Blood-based Products, Vaccines & Therapeutics, Stem Cells), By End-use (Pharmaceutical and Biotechnology Companies, Contract Development and Manufacturing Companies, Research and Academia), Industry Analysis Report, Regional Outlook, Application Potential, Competitive Market Share & Forecast, 2019 – 2025

Published Date: Oct 2019  |  Report ID: GMI4278  |  Authors: Sumant Ugalmugle, Rupali Swain

Report Format: PDF   |   Pages: 150   |   Base Year: 2018




Summary Table of Contents Industry Coverage Methodology

Industry trends

Biological Safety Testing Market size crossed 2 billion in 2018 and is projected to achieve 12.2% CAGR up to 2025.
 

Biological Safety Testing Market

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Biological safety testing is conducted to assure contamination-free biopharmaceutical products such as drugs, therapeutics, vaccines, blood and blood-derived products, stem cell, tissue banks and other biologics. The global biological safety testing industry includes products and services for controlled manufacturing of biologics. The products segment is further classified as kits & regents and instruments.
 

Biological safety testing industry can be dated back to the 1960s when the American Biological Safety Association was formed. Several years later, the American Biological Safety Association started conducting annual conferences on biological safety testing for controlled manufacturing of biologicals and providing information about controlled good manufacturing practices. Later in 1980s, the U.S. FDA started implementing biological safety practices across food, pharmaceutical and biotechnology sectors.
 

Currently, biological safety testing services are being widely implemented by pharma and biotech manufacturers. Thus, growing contract research and development sector will offer future growth prospects to the overall biological safety testing industry in the foreseeable future.
 

Rising drug approvals by the U.S. FDA will create huge demand for biological safety testing

Biological safety testing market will foresee robust demand in the future owing to rising number of drug approvals coupled with numerous drugs in pipeline by leading biopharmaceutical companies. The Center for Drug Evaluation and Research (CDER) approved more than 50 novel drugs and biologics in 2018. In addition, the number of new products approved in 2018 increased by two-fold than the average number of annual drug approvals. Thus, with growing need of pharmaceutical manufacturing companies to avoid disease transmission and maximize drug safety, the adoption of biological safety testing instruments and services will escalate over the coming years.
 

With increasing burden of biological hazards, the need for biological safety testing is estimated to significantly boost in the upcoming period. Governmental associations and regulatory bodies have set standards and guidelines for laboratories and manufacturing facilities to ensure minimal contamination. Similarly, biosafety levels have been established for laboratory practices, facilities and equipment including biological safety cabinets to limit contamination. The biosafety levels range from level one to four, with increasing degree of specific controls for microbe containment. Hence, rising need of biopharmaceutical firms to be cGMP-compliant, the demand for biologics safety testing will significantly expand.
 

However, lack of skilled professional for conducting biological safety testing procedure and high investment cost associated with biological safety cabinets may limit the market expansion to a certain extent.
 

Biological Safety Testing Market Report Coverage
Report Coverage Details
Base Year: 2018 Market Size in 2018: USD 2.2 Billion
Historical Data for: 2014 to 2018 Forecast Period: 2019 to 2025
Forecast Period 2019 to 2025 CAGR: 12.2% 2025 Value Projection: USD 5.0 Billion
Pages: 150 Tables, Charts & Figures: 153
Geographies covered (19): U.S., Canada, UK, Germany, France, Italy, Spain, Russia, China, India, Japan, South Korea, Australia, Brazil, Mexico, Argentina, Saudi Arabia, South Africa, UAE
Segments covered: Products & Services, Test, Application, End-use and Region
Companies covered (11): Eurofins Scientific, Merck KGaA, Lonza, Charles River, SGS SA, Thermo Fisher Scientific, Pharmabiotic Corporation, WuXi Biologics, Toxikon, Promega Corporation, Sartorius AG
Growth Drivers:
  • Rising focus on drug development
  • High investment in clinical research
  • Growing number of laboratories and biopharmaceutical firms
  • Stringent regulatory guidelines regarding safety of biologics
Pitfalls & Challenges:
  • Lack of trained professionals
  • High cost of biological safety testing cabinets

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Cloud-based biological safety cabinets (BSC) will mark significant impact in biological safety testing market

U.S. Biological Safety Testing Market Projections, By Product, 2025 (USD Million)
U.S. Biological Safety Testing Market Projections, By Product, 2025 (USD Million)

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Biological safety testing market by instruments segment includes biological safety cabinets that forms a crucial apparatus in biological safety testing. Thus, technological advancements in cabinets assists the laboratory professionals by providing superior productivity and optimizing contamination control. The recent cloud-enabled BSC by Thermo Fisher Scientific allows secure remote collection along with data storage, thereby facilitating superlative analytical dependability and traceability of outcomes. Moreover, advances in other instruments such as incubators, laminar airflow systems and UV lamps will further offer lucrative segmental growth in the forecast years.
 

Adventitious agent and virus testing is gaining popularity in biological safety testing services

Biological safety tests are segmented as endotoxin test, sterility test, adventitious agent detection test and other test types. Adventitious agent detection test segment will witness rapid growth owing to rising number of service providers offering adventitious agent and virus testing. Adventitious agent detection testing is required during cell cultures due to elevated threat of contamination by viruses, endotoxins and mycoplasma among others. Risk of viral contamination poses a huge threat for human use of biological products. In addition, growing animal and microbe-derived biologics will further increase the necessity of adventitious agent detection tests, thereby impelling the segmental growth.
 

Numerous vaccines in developmental phase will drive the market demand

Global Biological Safety Testing Market Share, By Application, 2018 (USD Million)
Global Biological Safety Testing Market Share, By Application, 2018 (USD Million)

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Biological safety testing by application segment includes blood & blood-based products, vaccines & therapeutics, stem cells and others. Biological safety testing for vaccines and therapeutics will witness lucrative growth in the upcoming years. Growing disease burden along with increasing research & development for developing new vaccines and therapies will pose to be high impacting factor for segmental growth. As per The Association of the British Pharmaceutical Industry, there are more than 250 vaccines in pipeline for treatment and prevention of various diseases. Furthermore, several research institutes are offering affordable third-party services for maintaining product quality and making drug development procedure efficient and hassle-free, thereby boosting the adoption of biological safety testing.
 

Expansion of research and academic institutes will augment the demand for biological safety testing instruments

The end-users of biological safety testing products and services include pharma and biotech companies, contract development and manufacturing organizations, and research & academia, and others. Emerging countries including India are focusing on improving healthcare infrastructure through investment in research laboratories. Research laboratories offer extensive capacities such as drug discovery, cell line development and culture that will require biologics safety testing to offer pathogen-free products and reliable services. Also, expanding academic institutes require set-up of sophisticated equipment to comply with the biosafety guidelines. Thus, with increasing focus on research and development, the demand for biological safety testing will accelerate in the forecast timeframe.
 

Booming U.S. pharmaceutical sector will create opportunities for biological safety testing market

U.S. biological safety testing market share will foresee over 11.5% CAGR over the estimated timeframe. High growth can be attributed to increasing technological advancements in biosafety instruments coupled with increasing number biopharmaceutical manufacturers in the country. The first automated biological safety procedure was conducted in the U.S. This procedure offers high accuracy with minimum human interference and is anticipated to provide attractive opportunities biological safety testing industry. Moreover, growing number of biosafety 4 laboratories will accelerate the installation of biological safety cabinets in the foreseeable future, thus impacting the industry growth.
 

China market accounted for over USD 89.0 million in 2018. Several developed nations are outsourcing pharmaceutical drug development and manufacturing to the Chinese companies due to cost advantage. Thus, contract development and research organizations will create greater demand for biosafety testing kits & reagents as well as instruments. In addition, growing investment in research and development in the healthcare sector will further spur the demand for biological safety testing across China.
 

Set-up of biological safety testing facilities by leading firms forms the chief strategy in safety testing market

Few of the notable players operating in the global biological safety testing industry are Eurofins Scientific, Merck KGaA, Lonza, Charles River, Sartorius AG and SGS SA, among several others. Top players are adopting various strategies such as acquisitions, investment and product launch to strengthen their position in biological safety testing business.
 

Some of the recent industry developments:

  • In September 2018, Merck announced opening of scientific laboratory in Singapore. The new facility establishment aimed at increasing the firm’s competitiveness and customer base expansion.
     
  • In April 2018, Thermo Fisher Scientific announced about its first cloud-enabled biological safety cabinet, designed to fortify workflow connectivity and contamination control. The product helped the company to expand its footprint in biological safety cabinet market.
     

The biological safety testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2014 to 2025, for the following segments:

By Products and Services

  • Products
    • Kits & Reagents
    • Instruments
  • Services

By Test

  • Endotoxin Test
  • Sterility Test
  • Adventitious Agent Detection Test
  • Others

By Application

  • Blood & Blood-based Products
  • Vaccines & Therapeutics
  • Stem Cells
  • Others

By End-use

  • Pharmaceutical and Biotechnology Companies
  • Contract Development and Manufacturing Companies
  • Research and Academia
  • Others

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Spain
    • Italy
    • Russia
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East & Africa
    • Saudi Arabia
    • South Africa
    • UAE

Frequently Asked Questions (FAQ) :

Biological safety testing is conducted to assure contamination-free biopharmaceutical products such as drugs, therapeutics, vaccines, blood and blood-derived products, stem cell, tissue banks and other biologics.
The worldwide market for biological safety testing is witnessing double digit growth on account of expanding outsourcing activities for development and safety testing of biopharmaceutical products.
U.S. industry for biological safety testing will achieve over 11.5% CAGR from 2019 to 2025, as estimated by GMI.
The UK industry for biological safety testing exceeded a valuation of USD 35 million in 2018.

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