The biologics safety testing industry is constantly evolving
with advancements in technologies and the development of new and improved
safety testing programs across various industries. Highly skilled professionals
are required to keep pace with the continuing changes in analytical
technologies and safety testing methodologies.
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Expected Revenue Growth:
[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 overall market size was used in the top-down approach to
estimate the sizes of other individual markets (mentioned in the market
segmentation—by product & service, test type, application, and region)
through percentage splits from secondary and primary research.
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Biologics Safety Testing Market segmentation
• By
Product & Service
• By Test
Type
• By
Application
• By
Region
The residual host-cell proteins and DNA detection tests
segment accounted for the largest share of the Biologics Safety Testing market
in 2020.
Based on test type, the biologics safety testing market is
segmented into residual host-cell proteins and DNA detection tests, endotoxin
tests, sterility tests, mycoplasma tests, bioburden tests, and virus safety
tests. In 2020, the residual host-cell proteins and DNA detection tests segment
accounted for the largest market share. The rising demand for residual HCP and
DNA detection tests for recombinant proteins and increasing focus on the
quality of drugs are the major factors driving the growth of this segment.
The monoclonal antibodies manufacturing segment accounted
for the largest market share of the Biologics safety testing market in 2020.
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 Asia Pacific region is the fastest growing region of
the Biologics safety testing market in 2020.
The Asia Pacific market is projected to witness the highest
growth rate during the forecast period, primarily due to the expansion of key
market players in emerging Asia Pacific countries, increasing expenditure on
life science research, and the increasing trend of pharmaceutical outsourcing
to Asia Pacific countries.
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.
Recent Developments
·
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.
Critical questions the report answers:
What is the current size of the Biologics safety testing
market?
Who are the leading players in the biologics safety testing
market?
What are the major drivers of the biologics safety testing
market?
What is the COVID-19 impact on the biologics safety testing
market?
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