As per our research report, between 2022 to 2027, the global market for biological safety testing is predicted to expand at a 14.13% compound annual growth rate (CAGR). As a result, the market is expected to be worth USD 3.12 billion in 2021, USD 3.56 billion in 2022, and USD 6.9 billion by 2027.
In the COVID-19 investigation, researchers used a variety of biologics safety testing technologies and services to understand the Coronavirus better. Bacterial safety testing will be a vital quality assurance technique to protect patient safety, according to COVID-19’s positive impact on the biologics safety testing market. Since the virus’s debut, several pharmaceuticals, biotechnology, and increased R&D activity businesses have created novel therapies and vaccinations to tackle COVID-19. The need for biological safety studies has increased due to the launch of novel COVID-19 medicines.
Since its debut, several pharmaceutical and biotechnology companies have been working on new medications and vaccines to combat COVID-19. This increased R&D activity positively impacted the market for biological safety testing. For example, Regeneron and Sanofi started developing their biologic Kevzara to treat COVID-19 patients in March 2020. The IL-6 pathway is also inhibited by Kevzara (Sarilumab), a drug developed jointly by Regeneron and Sanofi. Biological safety testing is critical for guaranteeing vaccination and other biological product purity. As a result of the development of new COVID-19 treatments, the necessity for biological safety testing has increased.
Pandemics and viral diseases are expected to drive global biological safety testing market growth.
In recent years, infectious diseases and pandemics have grown far more widespread. In addition, the market is being driven by the growth of the pharmaceutical and biotechnology sectors, significant R&D spending by major life sciences businesses, and an increase in the number of new drug launches in recent years. Because of these factors, the global market for biological safety testing is predicted to increase.
When it comes to quality control, conventions and regulations are scrupulously followed. The medicine’s microbial contamination could damage patients’ health and lead to long-term repercussions, including cancer or other health issues. These variables add up to a substantial market expansion opportunity. Furthermore, increasing markets and growing biopharmaceutical outsourcing are projected to create significant potential prospects for global biological safety testing market participants. Biologicals, or biotechnology-derived goods, have found their way into many aspects of healthcare, including disease detection, prevention, and treatment.
However, various safety problems may arise due to the manufacturing processes and the products’ complex biological and structural features. As a result, these products must undergo thorough and systematic biological safety testing, which will allow for a proper safety assessment before any clinical investigation. As a result, the market is expected to rise over the next few years.
The rapidly growing pharmaceutical and biotechnology industries and increased investments and manufacture of new biologics as a result of the high disease burden are some of the major factors driving the market growth. Six of the top eight revenue-generating drugs in 2019 were biologics. For example, Humira (adalimumab), manufactured by AbbVie to treat rheumatoid arthritis, psoriasis, Crohn’s disease, and other autoimmune disorders, produced USD 19 billion in sales, according to the Top 15 Best-selling Drugs of 2019 report. Humira grew the fastest of any biological drug.
Biologicals, or biotechnology-derived products, have made their way into various healthcare fields, including diagnosis, prevention, and therapy. However, there are some potential safety concerns, which stem from the manufacturing processes and the products’ complex biological and structural characteristics. As a result, detailed and systematic biological safety testing is required for these products, eventually allowing for an adequate safety assessment before any clinical investigation. As a result, the market is likely to grow during the coming years.
The scarcity of skilled specialists to conduct biological safety testing processes and the high upfront expenditures of biological safety cabinets may limit market expansion to some extent. Acceptance of the product is also seen as a stumbling block to the market’s overall development. The limitations and regulations governing the use of UV lamps in safety cabinets are also considered a significant impediment to the market’s growth.
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KEY MARKET INSIGHTS:
The services segment of the worldwide biological safety testing market held the most significant share in 2021. However, biopharmaceutical manufacturers’ limited financial resources, capacity constraints, the need to reduce time to market, complex manufacturing requirements, significant investments required to set up manufacturing facilities, and the growing drugs pipeline, a shift toward outsourcing biologics safety testing to service providers has occurred.
North America now holds the majority of the market share and is projected to continue to do so in the future. The United States is likely to play a significant role in expanding the region’s market. Increased R&D spending connected to COVID-19 due to the outbreak has had a beneficial impact on market growth.
The region’s developing biotechnology and pharmaceutical sectors are directly responsible for the growth of the biological safety testing industry. The industry’s rapid growth can also be attributed to innovative technologies and favorable government policies. Furthermore, the increasing need to validate medication and device production processes is expected to boost demand for the market in question. According to the US Food and Drug Administration (FDA), the country will have 4,676 drug manufacturing facilities in 2019.
Additionally, improved healthcare infrastructure and increased R&D spending are expected to raise income. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the pharmaceutical business in the United States spent around USD 83 billion on R&D. As a result, and market growth is expected to accelerate over the next several years.
During the projected period, Asia-Pacific is expected to be one of the fastest-growing biologics safety testing market. This is owing to the pharmaceutical and medical industries’ rapid expansion. Furthermore, rising academic and government investments, rising demand for high-quality research tools for data reproducibility, rising consumer awareness about product safety, and significant market players in this region are all helping to drive the growth of the APAC biologics safety testing market.
The Chinese market for biologics safety testing is expected to develop at a healthy rate during the projected period. In addition, the Chinese government invested in life science innovation programs to aid research institutes in finding solutions for chronic ailments. Similarly, in 2019, McKinsey & Co. formed the Indian Pharmaceutical Alliance (IPA) with stakeholders from research-based pharmaceutical companies, intending to improve India’s life science industry.
Japan and India’s most prevalent biological safety tests include endotoxin tests, residual host contamination detection tests, bioburden testing, and sterility testing. In addition, cellular and gene therapy, vaccinations, blood and blood-related products, and tissue and tissue-related products all use these assays.
The market for biological safety testing is fiercely competitive, with only a few big competitors. Avance Biosciences, Cytovance Biologics, Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation, Thermo Fisher Scientific, Toxikon, and WuXi AppTec are just a few of the companies that dominate the market.
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SEGMENTS ANALYZED UNDER THIS REPORT:
By-Products & Services:
By Test Type:
- Sterility Tests
- Bioburden Tests
- Endotoxin Tests
- Vaccine Manufacturing
- Monoclonal Antibodies Manufacturing
- Cellular & Gene Therapy Products Manufacturing
- Blood and Blood Products Manufacturing
- Pharmaceutical and Biotechnology Companies
- Contract Development and Manufacturing Companies
- Research and Academia
- North America
- Latin America
- Middle East and Africa
BROWSE REGIONAL REPORTS:
- North America Biologics Safety Testing Market
- Europe Biologics Safety Testing Market
- APAC Biologics Safety Testing Market
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