Biological safety testing forms the basis of ensuring decontamination of biologic medicines, laboratories, and healthcare institutions. As the world fights the COVID-19 pandemic it has become important to ensure that pharmaceuticals, and medical equipment used in treating patients are tested for contamination.
The soaring fatalities from COVID-19, coupled with the rapid rate of infection from the virus mandates biological safety testing practices. These practices are generally employed to test safety of biologic substances extracted from organic sources such as living organisms, proteins, nucleic acid, or a combination of these substances. Market players are innovating biological safety testing products that specifically cater to COVID-19 related contamination testing.
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Importance of Biological Safety Testing
A pillar of strength for the growth of biopharmaceuticals and vaccines, biological safety testing products provide the necessary proof of safety for innovative organic pharmaceutical development. Prevalent adoption of bio-based medicinal drugs by health conscious consumers furthers the development of biopharmaceuticals. As the production of these pharmaceuticals increases, so will the safety testing of its products. With the help of biological safety testing organizations, pharmaceutical companies are integrating improved manufacturing processes that conduct tests while the product is being manufactured. This further increases the cost efficiency and safety of products for biopharmaceuticals.
The rampant adoption can also be attributed to the increasingly stringent regulatory norms by statutory bodies such as the US FDA regarding the safety of innovative biopharmaceuticals. For instance, Epidolex is the only CBD based medicine that has received formal approval from the FDA to be sold as an over the counter drug. The legalization of hemp farming by the US has created a spurt in the number of research initiatives in developing hemp based medicinal drugs. This also contributes to the growing demand for biological safety testing products.
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Biological Safety Testing Products to be a Hotbed of Opportunities for Manufacturers
There are four biosafety levels issued by the Center for Disease Control and Prevention (CDC). These levels of biological safety govern the series of protection relegated to autoclave-related activities of a biological lab. Meant to serve as a guideline for manufacturers, and laboratories, the BSL levels have never been more relevant than during the current COVID-19 scenario. Here are the four levels of biological safety issued by the CDC:
- BSL - 1: This safety level applies to personnel working with low-risk microbes that post mild threats to adults. The nonpathogenic strain of E. coli is a popular example of microbes covered under BSL-1. A research setting of BSL-1 typically is a non-contained, bench based working system where scientists and lab assistants work in a designated area of the lab without insulation. BSL-1 covers standard activities such as:
- Mechanical pipetting
- Safe sharps handling
- Avoiding splashes or aerosols
- Daily decontamination
- Hand Washing
- Prohibition of extra-curricular activities
- Personal protective equipment
- Biohazard warnings
- BSL-2: The safety level encompasses laboratories and biological safety testing that deals with human diseases that present moderate health hazards. Viruses such as HIV come under this category. On top of the BSL-1 safety measures, the biosafety level-2 also advises:
- Advanced personal protective equipment including eye, and face shields.
- Infectious procedures to be performed in biological safety cabinets.
- Autoclave or alternative method for proper disposals.
- Contactless laboratory doors.
- Sterilization stations.
- BSL-3: Microbes that can cause lethal ramification upon inhalation are covered under BSL-3. Examples of BSL-3 microbes are, yellow fever, West Nile virus, and tuberculosis bacteria. Added measures to be undertaken along with BSL-1 and BSL-2 safety precautions are:
- Personal protective equipment with respirators as and when required.
- Solid-front wraparound gowns, scrub suits, and coveralls.
- Appropriate biological safety cabinets for all procedures involving the microbe.
- Hand-free sterilization stations
- Sustained ventilation for continuous fresh air
- Separate infrastructure allocated for BSL-3 testing
- BSL-4: Although rare, BSL-4 measures are undertaken for highly infectious disease microbes without a cure. Ebola, and Marburg viruses are two most deadly examples of microbes that require BSL-4 safety measures. Measures to be taken in addition to previous levels are:
- Change of clothing before entering and shower post trials.
- Continuous decontamination of all materials.
- Addition of full body, air-supplied, positive pressure suits along with personal protective gear from previous levels.
- Class-III biological safety cabinet
As far as COVID-19 is concerned, routine diagnostic testing can be carried out with BSL-1 measures. These include, processing initial samples, staining & microscopic analysis of fixed smears, examination of bacterial cultures and molecular analysis of extracted nucleic acid preparations. Rapid respiratory testing conducted at the point of care must use standard precautions to establish a barrier between specimen and healthcare personnel. Procedures that concentrate viruses, for instance, precipitation or membrane filtration must be performed in at least BSL-2 settings accompanied by Class-II biological safety cabinets. BSL-3 precautions such as respiratory protection is mandated for all healthcare institutions such as hospitals, and research labs.
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Vaccine Products to Present Sustainable Opportunities during the Pandemic
Manufacturers of biological safety testing products can hence target opportunities in the market based upon the severity levels of their operations. For instance, vaccine laboratories will require BSL-1, BSL-2, and BSL-3 biological safety testing products. Whereas, hospitals and other healthcare institutions require BSL-3 level testing products. The market competition will become feature intensive during the upcoming years, as the severity of COVID-19 is increasing with the fast paced social transmission of the virus.
The surge in research and clinical laboratory activities in a bid to devise a vaccine for COVID-19 sustains the demand for biological safety testing during the pandemic. Medical research institutions such as the Jenner Institute, SinoVac, and similar initiatives in different countries will generate considerable demand for biological safety testing of COVID-19 contamination and vaccine safety levels. Reagents & kits assays in particular, are witnessing rapid growth. The Centre of Disease Control labs in the USA is regularly issuing guidelines for manufacturers to manufacture COVID-19 reagents & kit assays.
On Feb 28, the FDA opened the emergency use authorization (EUA) process to CLIA labs, forging a new pathway for regulated and rampant assay development. The development of an effectivetive testing kit of COVID-19 has become a top priority for clinical research labs and biological safety testing products manufacturers. Many players are diverting their workforce to develop testing kits for COVID-19. Analytical and clinical validation for EUA has become increasingly important for successful product development. The high infection rate of novel coronavirus presents high risks to the clinical diagnostic workflow of the polymerase chain reaction tests, from sample collection and extraction to thermal cycling.
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Biological Safety Testing Market Competition
This FMI study, in addition to highlighting the crucial role of market factors in the growth of the biological safety testing market amid battling the COVID-19 pandemic, offers information on the developments in the competitive landscape.
Key players covered in the market study are, Charles River Laboratories International Inc., Lonza Group, Sigma-Aldrich Corporation, Wuxi Pharmatech (Cayman) Inc., Merck & Co. Inc., SGS S.A., Avance Biosciences Inc., Toxikon Corporation, Cytovance Biologics, Inc., and Bsl Bioservice.
The report covers exhaustive analysis of-
- Biological Safety Testing Products Market Segments
- Biological Safety Testing Products Market Dynamics
- Historical Actual Market Size, 2014 - 2018
- Biological Safety Testing Products Market Size & Forecast 2019 to 2029
- Biological Safety Testing Products Agents Current Trends/ Issues/ Challenges
- Competition & Companies involved
- Biological Safety Testing Products Market Drivers and Restraints
Regional analysis covers market performance in-
- North America
- Latin America
- South Asia
- East Asia
- Middle East & Africa
- Shifting Industry dynamics
- In-depth market segmentation
- Historical, current and projected industry size Recent industry trends
- Key Competition landscape
- Strategies for key players and product offerings
- Potential and niche segments/regions exhibiting promising growth
- A neutral perspective towards market performance
The biological safety testing market is progressing with growing applications in innovative pharmaceutical products. This testing is highly demanded to ensure product safety and quality in the pharmaceutical sector. Its wide use in production in cell banks to test purity, genetic stability, and sterility account for the plethora of growth opportunities in the market. The different end users of biological safety testing include cellular, vaccine, and gene therapy products along with tissue products and blood products. Contract testing laboratories are expected to generate major revenue in the market as end-users.
North America is expected to lead the market in growth owing to enhanced investments in the research & development activities in the region. Led by the robust progress of emerging economies such as China and India, the market of Asia Pacific is expected to exhibit rapid growth in the coming years. Several factors such as growing healthcare awareness, rising government initiatives, and increasing patient pool are known to be propelling the market growth in these developing economies.
Established players are investing in research and developments to develop enhanced and efficient testing technologies. The major players in the market are Sigma-Aldrich Corporation, Toxikon Corporation, Charles River Laboratories International, Inc., Bsl Bioservice., Lonza Group and Avance Biosciences, Inc.