This market research study involved the extensive use of secondary sources, directories, and databases to identify and collect information useful for this technical, market-oriented, and financial study of the global biologics safety testing market.
[185 Pages Report] The global biologics safety testing market is projected to reach USD 6.2 billion by 2026 from USD 3.4 billion in 2021, at a CAGR of 12.4% during the forecast period.
The growth of the global biologics safety testing market is driven by factors such as the growth in the biologics and biosimilars markets, growing concerns over cell culture contamination, and rising biopharmaceuticals R&D activities and investments. In addition, emerging markets and increasing biopharmaceutical outsourcing are expected to provide significant growth opportunities for players in the Biologics safety testing market.
- Growth in the biosimilars and biologics markets
- Growing concerns over cell culture contamination
- Rising biopharmaceuticals R&D activities and investments
- Emerging markets offer lucrative opportunities
- Increasing biopharmaceutical outsourcing
Many companies are investing heavily in the development of biologics and biosimilars. Currently, more than half of the drug candidates in the discovery stage are biologics, such as proteins, peptides, and monoclonal antibodies. Biologics are expected to contribute around half of the revenue generated by the top 100 pharmaceutical products in the coming years.
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Covid-19 Impact On The Global Biologics Saftey Testing Market
COVID-19 is an infectious disease caused by the most recently discovered novel coronavirus. Largely unknown before the outbreak began in Wuhan (China) in December 2019, COVID-19 has moved from a regional crisis to a global pandemic. The World Health Organization (WHO) officially declared the outbreak of COVID-19 a pandemic. A mix of established pharmaceutical and biopharmaceutical companies, along with the players of the Biologics safety testing market, have stepped forward to contribute to worldwide research efforts by providing biologics safety testing for developing safety test kits and testing for treatments and vaccines manufacturing that target the infection caused by the novel Coronavirus.
Based on application, the biologics safety testing market is segmented into monoclonal antibodies manufacturing, vaccines manufacturing, blood and blood products manufacturing, cellular and gene therapy products manufacturing, and other applications. In 2020, the monoclonal antibodies manufacturing segment accounted for the largest market share. The large share of this segment can be attributed to the rising prevalence of diseases and increasing government initiatives for the development of monoclonal antibody drugs.
The geographical regions mapped in the report are:
1. North America
4. Rest of the World (RoW)
5. Latin America
6. Middle East & Africa
North America accounted for the largest share of the biologics safety testing market in 2020. Rapid growth in the biopharmaceutical industry is the major factor driving the growth of the North American biologics safety testing market. Growing academic and government investments, rising demand for high-quality research tools for data reproducibility, increasing awareness among consumers about product safety, and the presence of major market players in this region are also driving the market for biologics safety testing in North America.
Some key players mentioned in the research report are:
Prominent players in the biologics safety testing market are Charles River Laboratories, Inc. (US), Lonza (Switzerland), Thermo Fisher Scientific, Inc. (US), Merck KGaA (Germany), SGS SA (Switzerland), WuXi AppTec (China), and Eurofins Scientific (Luxembourg). The key players in this market are focusing on strategic expansions, partnerships, and product launches and approvals to expand their presence in the market.
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- In 2021 Charles River Laboratories, Inc. (US) launched a new detection tool, EndoScan-V, a validated endotoxin detection and measurement software used to generate and report quantitative test data. The software performed the requisite measurements and calculations and created test reports with the convenience of digital signature report approval.
- In 2021, Charles River Laboratories, Inc. (US) acquired Cognate BioServices to expand its offerings in cell and gene therapy development, testing, and manufacturing, providing clients with an integrated solution from basic research and discovery through CGMP production.
- In 2021, Charles River Laboratories, Inc. (US) partnered with JADE Biomedical to expand its biological testing solutions capabilities geographically and cater to the increasing demand for biologics therapeutics, especially cell and gene therapies. This strategic relationship enabled JADE to expand its current global Good Manufacturing Practice (GMP) product testing operations in Shanghai into a second facility and further build upon its current offering of comprehensive biologics quality management and testing services.
- In 2021, Lonza launched the PyroTec PRO Automated Robotic Solution for endotoxin testing. The new PyroWave Reader add-on has been designed specifically for use with the sustainable PyroGene Recombinant Factor C (rFC) Assay.
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