Pune, India, June 15, 2021 (GLOBE NEWSWIRE) -- The global biologics safety testing market has been estimated to reach USD 3.0 billion in 2021 and is projected to grow at a CAGR of 12.3% during the forecast period till 2030. Biopharmaceuticals are important solutions during the treatment of various diseases related to immunity, chronic diseases, and others. Thus, the approval of biologic products and their safety are the utmost priority in the biopharmaceutical industry.
Biologics safety testing is conducted on drugs, vaccines, therapeutics, stem or tissue cells, and other blood derived products. The testing ensures contamination-free products. The growth in biopharmaceutical product pipelines will accelerate the market growth of biologics safety testing. The present COVID-19 pandemic situation is further increasing vaccine testing and trials to develop corona vaccines. Government initiatives and vaccine production for the same will, therefore, drive the market.
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The presence of various organizations like FDA and CDC for approvals and testing of drugs has a huge impact on the biologics safety testing market. Factors like rising investments in clinical research and drug development, increasing numbers of testing laboratories, and high prevalence of diseases will drive the market growth in the coming years.
Technological innovations, continuous development of products by key players, and patents regarding safety testing will provide a major stimulus to the market. For instance, in April 2021, Lonza expanded its robotic solution for endotoxin testing. However, lack of skilled professional can be a challenge for market growth. Additionally, high costs of testing equipment can hamper the growth of the biologics safety testing market.
On the other hand, the collaboration between the key players will play an important role in the market growth. For instance, in May 2021, Hamilton and Insphero announced their collaboration in improving the handling of spheroids. The collaboration will open up new opportunities in microtissue storage and sorting and drug efficacy and safety testing.
Some Significant Market Developments Considered in the Report:
- In May 2021, Roche Diagnostics announced its partnership with Canadian Blood Services for serology tests, i.e., Elecsys Anti-SARS-CoV-2-S and Elecsys Anti-SARS-CoV-2 to understand the immune response by comparing the level of COVID-19 virus after natural infection and COVID-19 vaccine.
- In May 2021, Moderna announced the supply of 0.025 billion doses to Australia, including 0.010 billion doses of Moderna’s mRNA-1273 ancestral strain and 0.015 billion of updated variant booster.
- In January 2020, Lonza Bioscience launched the PyroCell MAT system, a reliable and sustainable solution for in vito pyrogen testing. The system will ensure the safety of parental pharmaceuticals during product development, manufacture, and release.
COVID-19 Impact on the Global Biologics Safety Testing Market
The QMI team is closely monitoring the impact of COVID-19 on the global biologics safety testing industry, and it has been observed by our team that the demand for biologics safety testing is normal during the pandemic time. But it is anticipated to grow sharply during the analysis period. To control the spread of the pandemic, many countries across the globe have enforced strict lockdown norms, which is hampering all kinds of business activities. The demand for and supply of raw materials and product manufacturing and distribution have been completely disrupted due to the closing down of the marketplace. Among various industries, transportation, energy, manufacturing, and other industries have suffered huge financial losses. However, biologics safety testing has played a significant role in various drug and vaccine testing during the pandemic. All these factors have been analyzed in details in this report.
Global Biologics Safety Testing Market, By Product
Based on product, the biologics safety testing market is divided into consumables, instruments, and services. The instruments and services segments will witness significant growth in the market during the analysis period. The rising demand for instruments including test kits and reagents in the coming years will boost the market. Furthermore, the rising prevalence of diseases will improve the demand for instruments and services. The adoption of digitalization will also have a positive impact on biologics safety testing services. These services can include drug safety science, operations & management, and safety communication. From the early stage of product development to final surveillance and risk management after the premarket testing, will enhance the demand for digital services in biologics safety testing market.
Global Biologics Safety Testing Market, By Test type
Based on the test type, the biologics safety testing market is segmented into endotoxin, mycoplasm, sterility test and others. The mycoplasm test is related to the measurement of antibodies in blood. The mycoplasm contamination can be a major economic and safety risk in biopharmaceuticals, which will increase the demand for mycoplasm testing. Sterility test will also grow due to its demand for testing of pharmaceutical drugs and biopharmaceutical therapeutics. The sterility test ensures the safety of sterile medical devices, materials, and drugs by microbiology testing. The increasing demand for injectable products and implantable devices in contact with blood requires testing of bacterial endotoxins and hence, will drive the market.
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Global Biologics Safety Testing Market, By Application
Based on applications, the biologics safety testing market is divided into vaccine & therapeutics, monoclonal antibodies, blood based products, cell & gene therapy, and others. Vaccine & therapeutics and monoclonal antibodies will grow significantly in the market during the analysis period. The testing and trials of vaccine is an important aspect for safety check, as they are the most efficient way to treat viruses. The organizations like Food and Drug Administrative (FDA) and Centers for Disease Control and Prevention (CDC) check the potency, purity, sterility, reliability, and the safety of drugs or vaccines, and approve the products accordingly. The rising prevalence of diseases and government initiatives regarding monoclonal drugs will drive the market. Monoclonal drugs support testing for diseases like HIV, AIDS, and others.
Global Biologics Safety Testing Market, By End-User
Based on the end-user, the biologics safety testing market is segmented into hospitals, pharmaceuticals & biotechnology and research & academia. The pharmaceutical and biotechnology companies will lead the market during the analysis period. Intense research & development activities and product launches in the healthcare industry will enhance the market growth. The various drug development, gene or culture line development and testing products will also influence the market.
The research & academia will also witness significant growth in the market. The increasing demand for sophisticated testing equipment in these areas will accelerate the market in the coming years. Developing countries like India are emerging in the biotechnology sector by focusing on vaccine developments and other drug discoveries, which will boost market growth during the forecast period.
Global Biologics Safety Testing Market, By Region
Based on region, the global biologics safety testing market is segmented into North America, Europe, Asia Pacific, the Middle East & Africa, and South America. North America and Asia Pacific regions are expected to witness significant growth during the forecast period. The presence of key players and technological advancements in the biopharmaceutical industry will promote market growth. Furthermore, increasing research & development activities and government approvals will improve the growth prospects for the market.
The presence of the fastest growing economies like China, South Korea, India, and Japan with their growing medical industry will drive the Asia Pacific market. Furthermore, resource availability, low labor wages, and industrial regulations will promote market development.
Some Major Findings of the Biologics Safety Testing Market Report Include:
- Major global market trend & forecasts analysis along with a country-specific market analysis for up to 25 countries.
- An in-depth global biologics safety testing market analysis by the aforementioned segments, along with an analysis of trend-based insights and factors.
- Profiles of major market players operating in the global biologics safety testing market, which include Maravai Lifesciences, Associates of Cape Cod, Inc., bioMérieux SA, Sartorius AG, F. Hoffmann-La Roche Ltd., Nelson Laboratories, LLC, Bio-Rad Laboratories, Inc, Agilent Technologies, Inc., Microcoat Biotechnologie GmbH, PromoCell GmbH, Almac Group, Lonza, Thermo Fisher Scientific, Inc., Merck KGaA, SGS SA, and WuXi AppTec.
- Competitive benchmarking, product offering details, and growth strategies adopted by the leading market players, along with their major investments in the last five years.
- Key impact factor analysis across regions that includes analysis, along with the drivers, restraints, opportunities, and challenges that are prevailing in the global biologics safety testing market.
- Impact of COVID-19 on the global biologics safety testing market.
Browse key industry insights spread across 195 pages with 135 market data tables and 91 figures & charts from the report, “Biologics Safety Testing Market by Product (Consumables, Instruments, and Services), Test Type (Endotoxin, Mycoplasm, Sterility Test, and Others), Application (Vaccine & Therapeutics, Monoclonal Antibodies, Blood Based Products, Cell & Gene Therapy, and Others), End-User (Hospitals, Pharmaceuticals & Biotechnology and Research & Academia) and Region (North America, Europe, Asia Pacific, Middle East & Africa, and South America) — Industry Trends and Forecast to 2030” in depth analysis along with the table of contents (ToC).
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