Market Highlights
The
global Host Cell Protein Testing Market is expected to register a CAGR of 5.20%
during the forecast period and is expected to hit USD 1.26 billion by 2032.
The
Host Cell Protein (HCP) Testing Market has seen significant growth driven by
the increasing demand for biopharmaceuticals and the necessity to ensure
product safety and efficacy. Host cell proteins are contaminants produced by
host cells during the manufacturing process of biologics, posing a potential
risk to patient safety and product quality. As a result, robust assays such as
the host cell protein assay have become essential in the biopharmaceutical
industry to detect and quantify these impurities. The host cell protein
assay market is propelled by the stringent regulatory requirements
imposed by regulatory bodies like the FDA and EMA, mandating thorough testing
to ensure product safety and compliance with quality standards. Additionally,
advancements in analytical technologies have led to the development of more
sensitive and accurate assays, further fuelling market growth.
Moreover,
the increasing adoption of biopharmaceuticals across various therapeutic areas
such as oncology, autoimmune diseases, and infectious diseases drives the
demand for host cell protein testing. Biopharmaceutical manufacturers are
focusing on implementing comprehensive testing strategies to mitigate the risks
associated with host cell proteins effectively. This includes the integration
of innovative technologies and automation in assay development and testing
processes to enhance efficiency and reliability. Furthermore, collaborations
between biopharmaceutical companies and contract research organizations (CROs)
for outsourcing HCP testing services contribute to market expansion, providing
specialized expertise and infrastructure for comprehensive host cell protein
analysis. Overall, the host cell protein testing market is poised for continued
growth as biopharmaceutical production continues to expand, necessitating
stringent quality control measures to ensure patient safety and regulatory
compliance.
Key Players:
The host cell protein
testing companies are Enzo Life Sciences, Inc. (US), Cytiva (US), Thermo
Fisher Scientific Inc.(US) , Bio-Rad Laboratories, Inc. (US), Cygnus
Technologies, Llc (US), Biogenes Gmbh (Germany), Cisbio Bioassays (Europe),
Charles River Laboratories International, Inc. (US), Rockland Immunochemicals,
Inc.(US), Abcam Plc (UK).
Segment Analysis
The
global host cell protein testing market is mainly segmented into type and end
user.
- On the basis of type, the host
cell protein testing market has been sub-segmented into PCR-based assays,
ELISA-based assays, and mass spectrometry-based assays.
- On the basis of end
user, the
host cell protein testing market has been segmented into contract research
organizations, and biopharmaceutical companies.
Regional Analysis
The
global host cell protein
testing market insights has been segmented on the basis of
region into North America, Europe, Asia-Pacific, and the Rest of the World. The
North American market is further divided into the US and Canada. The European
host cell protein testing market has been segmented into Germany, France, the
UK, Italy, Spain, and the rest of Europe. The host cell protein testing market
in Asia-Pacific has been segmented into China, India, Japan, Australia, South
Korea, and the rest of Asia-Pacific. The Rest of the World host cell protein
testing market includes the Middle East, Africa, and Latin America.
North
America accounted for a market size of USD 406.24 million in 2020 and is
expected to exhibit a CAGR of 5.18% during the forecast period. It dominated
the global host cell protein testing market due to various factors, such as
developments in the biopharmaceutical industries, increasing investment in
R&D activities, and well-established healthcare infrastructure in the
region. The US has minimal barriers and the most supportive domestic
environment for the development and commercialization of pharmaceuticals. This
attracts capital investments in biopharmaceutical enterprises startups.
Moreover, the collaboration and partnerships of the market players are expected
to bring about highly innovative, industry-leading products driving the demand
for host cell protein testing across the region. Canada also has a high number
of biotechnology companies. According to the Canadian Life Sciences Database,
currently, the number of biotech companies in Canada is 1,042. This is fueling
the growth of the host cell protein testing market in the region.
Europe
has also evolved as a prominent market for host cell protein testing, with
well-established R&D facilities across the region, the presence of
supportive regulatory systems, development of innovative and cost-effective
host cell protein testing solutions by the companies. According to Statista, in
2020, USD 1,232.07 million (1,045 million euros) were spent on R&D by
listed biotechnology companies. The UK has a unique worldwide health and life
sciences ecosystem and a strong track record of scientific breakthroughs with
next-generation technologies and services. The government provides an R&D
platform for the companies in the market. Government initiatives and research
funding are also fueling the growth of this market.
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