The Global Biologics Safety Testing Market size was valued at USD 3.0 Bn in 2020 and is expected to reach USD 6.9 Bn by 2027, with a growing CAGR of 12.4 % during the forecast period.
Market Definition
The Biological safety testing are performed to ensure the contamination free and quality check for healthcare institutions, biologic medicines, laboratories, pharmaceutical companies, and biotechnology companies. These procedure of testing and validating are conducted to qualify the safety of biologic substances composed from organic sources such as proteins, living organisms, nucleic acid, or a coalescence. Therefore, the increasing production of biologics by pharmaceuticals and other manufacturing units will escalate the safety testing of its products favoring the biologics safety testing market.
Market Dynamics
The safety of development and research department can be attributed to the propel the market. The increasing biopharmaceutical research and development expenditure and growing funding and strengthening biologics market are also driving the market growth. The expeditious development and production of tests, products, drugs, reagents, and kits by the manufacturers favored the growth of biologics safety testing market.
The product launches by market players accelerate the growth of the market, for instance, in October 2020, Cadila Pharmaceuticals has launched NuPTH and Cadalimab onto the Indian market. These launches were announced for the treatment of autoimmune disorders. The awareness for molecular analysis for various such diagnoses is the major factor influencing the growth of the market.
Biologics Safety Testing Market Segmentation:
By Product & Services
By Application
By Test Type
By Region
Based on product & services, the service segment held the largest market share in 2020 for biologics safety testing market due to the increasing production of biologics and their need of safety validation
Based on products, the service segment has gained a tremendous market share in 2020 and is expected to expand during the forecast period. This is due to the outsourcing of biologics safety testing to the service providers. The complex manufacturing requirements, increasing clinical trials and the drugs development pipelines, and the reduction of marketing time of developed drugs factors promote the segment growth.
Based on application, the monoclonal antibodies manufacturing segment held the dominance in 2020 due to the rise in testing and analysis for infectious diseases
Based on application, the monoclonal antibodies manufacturing segment accounted for the largest market share in 2020. This is due to the rising prevalence of various infectious diseases and the requirement of developing monoclonal antibodies against such infections. During the pandemic, the monoclonal antibodies against the SARS-CoV-2 was considered to be beneficiary in prophylactic and therapeutic applications to steer the vaccine development and formulation.
Based on test type, the residual host-cell proteins and DNA detection tests segment held the largest market share in 2020 for biologics safety testing market due to the rise in demand of residual host-cell proteins analysis and DNA detection tests for various bioprocesses.
Based on test type, the residual host-cell proteins and DNA detection tests segment have accounted for the largest market share for biologics safety testing market in 2020. This is due to the ongoing bioprocesses in the research and development of drugs and the increasing focus on the quality analysis of drugs. For instance, a clinical trial is started on August 15, 2021, on the ARCT-154 Self-Amplifying RNA Vaccine Efficacy Study for COVID vaccine sponsored by Vinbiocare Biotechnology Joint Stock Company. The study is currently in phase II and expected to complete by August 31, 2023.
Based on region, North America accounted for the largest market shares in 2020 and is expected to maintain the dominance during the forecast period in biologics safety testing market.
Based on region, North America dominated the market in 2020. This is due to the wide usage and availability of biologics safety testing by leading players in the region. The increased manufacturing of biologics and biosimilars, and the well-established biopharmaceutical units favor the biologics safety testing market in the region.
The region has a high demand for biologics safety testing due to the increasing molecular analysis for research and development of vaccines and other bioprocesses. The region is attributed to the largest share due to its increasing healthcare expenditure and well-established healthcare infrastructure leading to the expansion of biologics safety testing market.
Asia Pacific in biologics safety testing market is expected to grow at the highest rate during the forecast period due to the rising life science research and development activities, ongoing clinical trials in various biological fields, and increasing investments by pharmaceutical & biotechnology players.
Company Profiles and Competitive Intelligence
The key players operating in the biologics safety testing market are:
The report also provides in-depth analysis of biologics safety testing market dynamics such as drivers, restraints, opportunities, and challenges
Drivers
Restraints
Opportunities
Challenges
COVID-19 Impact on the Biologics Safety Testing market analysis
The COVID-19 has positively impacted the biologics safety testing market. Vaccine production and its bacterial safety testing are important so as to maintain the quality for patient safety. This was due to the high demand for molecular analysis and diagnosis for the individuals suffering or infected from the virus. The leading players of the biologics safety testing market contributed and continue to do so towards research and development around the world. The companies are providing biologics safety testing for treatments and vaccine manufacturing that target the infection caused by the novel coronavirus.
For instance, in July 2020, a pioneer in the biosafety testing market, SGS, signed an agreement with AstraZeneca to analytical testing, provide safety, quality control services in production of COVID-19 vaccine named as AZD 1222. The company is focused to carry out a bulk harvest and drug substance testing by Biosafety Center of Excellence in Scotland.
The growing adoption of biologics safety testing technology for COVID-19-related research, coupled with the increasing developments by key players to support vaccine development, is expected to favor the growth of the biologics safety testing market. For instance, the increasing adoption of endotoxin and its testing for research in drug development propelled the biologics safety testing market growth.
The report also provides an in-depth analysis of key trends in biologics safety testing market
The report also provides an in-depth analysis of recent news developments and investments in biologics safety testing market
The unique insights provided by this report also includes the following:
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