Market Highlights
According to MRFR analysis, the global Pharmaceutical
Sterility Testing Market Share is expected to register a CAGR of 6.10% from
2023 to 2032. Sterility can be defined as the non-appearance of viable
microorganisms, dust, fibers, foreign particles, and other biological agents.
Pharmaceutical sterility testing is performed on a wide range of biological
medicinal products, including blood products, vaccines, biotechnology products,
cell products, and tissue products, in accordance with WHO sterility
requirements. Sterility testing is carried out by companies such as
pharmaceutical companies, biotechnology companies, and medical device
manufacturers to assess process control, raw material quality, and product
validity.
The industry players focus on technological developments to
dominate the global Pharmaceutical Sterility Testing Market. In addition, the
key players are involved in new product launches, acquisitions, and joint
ventures to augment their market positions. For instance, in July 2020, Neogen
Corporation (US) has launched Soleris, an advanced test system that can rapidly
detect a wide variety of microorganisms in a fraction of the time.
Key Players
Some of the Pharmaceutical Sterility Testing Market Players are.
§ Merck
KGaA (Germany),
§ Rapid
Micro Biosystems (US),
§ Sartorius
AG (Germany),
§ Solvias
AG (Switzerland),
§ SGS
SA (Switzerland),
§ Boston
Analytical (US),
§ bioMérieux,
Inc. (France),
§ Charles
River Laboratories International, Inc. (US),
§ Thermo
Fisher Scientific, Inc. (US),
§ Pace
Analytical Services, LLC (US),
§ Toxikon,
Inc. (US),
§ Sotera
Health (US),
§ Pacific
Biolabs Inc. (US),
§ STRERIS
Corporation (US),
§ WuXi
AppTec (China).
Regional Analysis
North America is anticipated to dominate the global pharmaceutical
sterility testing market outlook, owing to the presence of several key
players in the region and the rise in R&D investments by public and private
players in the healthcare sector. Moreover, the increase in the number of
pipeline products and the launch of advanced drugs based on the
biopharmaceutical that requires unique pharmaceutical sterility testing
processes are also propelling the market growth.
The European pharmaceutical sterility testing market
has been categorized into Germany, France, the UK, Italy, Spain, and the rest
of Europe. Increasing government initiatives and extensive availability of
research grants in the European countries are expected to propel the growth of
the pharmaceutical sterility testing market in the region. Furthermore, the
presence of outsourcing companies for pharmaceutical sterility testing is also
supporting the growth of the pharmaceutical sterility testing market.
Asia-Pacific is anticipated to be the fastest-growing
regional market over the forecast period due to the increasing harmonization of
the regulatory standards with the International Council for Harmonisation (ICH)
standards in developing nations, technological advances, and increasing
investment in healthcare infrastructure. In addition, growing investment by
governments from the China and India for offering cost-effective medications is
providing lucrative opportunities for the growth of the pharmaceutical
sterility testing market over the forecast period.
In the Middle East,
the UAE is the largest market due to the healthcare industry's development.
Developing countries such as Argentina, Brazil, and Colombia, among others in
Latin America, are also key contributors to the growth of the pharmaceutical
sterility testing market insights.
Segmentation
The global sterility testing microbiology market has been
segmented based on sample, product type, type, test type, and end user. By
sample, the market has been segregated into sterile drugs, medical devices, and
biologics. The sterile drugs segment is expected to witness high growth in
2020, Owing to the high adoption of several techniques adopted for product
safety across the globe.
·
Based on product type, the global
pharmaceutical sterility testing market has been classified into instruments,
kits & reagents, and services. Kits & reagents held the largest segment
share in 2020, owing to the repetitive purchase of these products by end users
all around the world. In addition, cost efficiency and ease of use are related
to the product.
·
Based on type, the global pharmaceutical
sterility testing market has been classified into in-house and outsourcing.
·
Based on test type, the global
pharmaceutical sterility testing market has been classified into sterility
testing, bioburden testing, and bacterial endotoxin testing. The bacterial
endotoxin testing segment held a major market share in 2020 due to the ongoing
technological advancements in this segment.
·
Based on end user, the pharmaceutical
sterility testing market is classified into compounding pharmacies, medical
devices companies, pharmaceutical companies, and others. Pharmaceutical
companies held the largest market share in 2020 due to the high growth of
pharmaceutical and biological industries across the globe, and new drug
approvals will boost the pharmaceutical sterility testing market during the
forecasting period.
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