Global Pharmaceutical Sterility Testing Market to grow with a CAGR of 10.30 %.
Increasing
healthcare infrastructure and a supportive regulatory environment are the major
drivers for the Global Pharmaceutical Sterility Testing Market
According
to TechSci Research report, “Global Pharmaceutical Sterility Testing Market Industry
Size, Share, Trends, Competition, Opportunity and Forecast, 2018-2028”, Global Pharmaceutical
Sterility Testing Market has valued at USD 1.10 billion in 2022 and is
anticipated to witness an impressive growth in the forecast period with a CAGR
of 10.30% through 2028. This can be due to collaborations and partnerships
among leading companies with a diverse approach to merge the expertise of
individual companies and to strengthen their position in the market. Market
expansion in emerging economies is a significant driver of the demand for
pharmaceutical sterility testing. Many emerging economies, such as India,
China, Brazil, and South Africa, have witnessed substantial growth in their
pharmaceutical industries. These countries have become major hubs for
pharmaceutical manufacturing, leading to an increased demand for sterility
testing to ensure product safety and quality. As emerging economies become key
players in drug manufacturing, the need for comprehensive sterility testing
services has risen. The local production of pharmaceuticals often requires
compliance with international quality standards and regulatory requirements,
including rigorous sterility testing. To export pharmaceutical products to
established markets in North America, Europe, and other regions, manufacturers
in emerging economies must adhere to strict regulatory standards. Sterility
testing is a critical component of these standards, enabling market access and
international trade. Many emerging economies are focusing on improving
healthcare and public health outcomes. This involves the development and
manufacturing of pharmaceuticals. Sterility testing plays a pivotal role in
ensuring the safety and effectiveness of these products. As healthcare
infrastructure and access to medicines improve in emerging economies, there is
a growing domestic demand for pharmaceuticals. Sterility testing ensures that
domestically produced drugs meet quality and safety standards.
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In February 2021, the World Health
Organization (WHO) reported that cardiovascular diseases constitute a
significant global cause of mortality, resulting in approximately 17.9 million
annual deaths. This escalating disease burden is projected to contribute to the
increased need for pharmaceuticals, thus serving as a catalyst for market
expansion in the foreseeable future. To meet the surging demand for healthcare
services, numerous developing nations have streamlined their regulatory
procedures for drug approvals and expedited the introduction of new
pharmaceuticals. In April 2023,
STEMart, a U.S.-based company specializing in comprehensive services for every
stage of medical device development, has recently introduced Bioburden and
Sterility Testing services for medical devices, following the ISO 11731 method.
Ensuring sterility is a critical aspect of manufacturing safe medical products
for medical device manufacturers. Regulatory bodies like the FDA require the
validation of sterilization processes, making Bioburden and Sterility Testing a
necessary procedure. Both tests serve the purpose of detecting microorganisms,
but Sterility Testing has broader implications. There are three methods for
Bioburden Testing: membrane filtration, pour plate, and spread plate methods.
Prior to conducting Bioburden Testing on medical devices, suitability testing
is performed to confirm the method's effectiveness in recovering microorganisms
from the devices and to demonstrate that it supports the growth of
microorganisms specific to the devices.
Data
integrity and documentation are critical challenges in the global
pharmaceutical sterility testing market. Regulatory agencies, such as the FDA
and EMA, have stringent requirements for data integrity and documentation in
sterility testing. Any deviations or inaccuracies can result in non-compliance,
leading to regulatory actions and delays in product approval. Sterility testing
often involves complex testing protocols, including multiple steps and data
points. Ensuring that every step is properly documented and validated can be
challenging. The transition to electronic record-keeping systems brings both
benefits and challenges. Ensuring the security and integrity of electronic
records is crucial, as is compliance with data integrity regulations. Human
errors during data entry can result in inaccuracies in the documentation of
test results. Even small errors can have significant consequences in sterility
testing. The review and approval of test data can introduce potential
bottlenecks and errors, especially in high throughput testing laboratories. Effective
data storage and retrieval systems are essential for ensuring the availability
of historical data and documentation, as well as easy access for regulatory
audits.
Global Pharmaceutical Sterility Testing Market is
segmented based on Type, Product Type, Test Type, and by region.
Based
on the Test Type, Global Pharmaceutical Sterility Testing Market is segmented
into Sterility Testing,
Membrane filtration, Direct inoculation, Bioburden Testing, Bacterial Endotoxin
Testing. Bioburden testing is an important component of pharmaceutical
sterility testing, and it focuses on assessing the total microbial population
or bioburden present in a pharmaceutical product, raw material, or medical
device. It is a critical quality control measure to ensure the safety and
sterility of pharmaceutical products. Bioburden testing is conducted to
determine the level of microbial contamination in pharmaceutical products, raw
materials, and medical devices. It helps ensure that the microbial load is
within acceptable limits and does not compromise product safety or efficacy. Understanding
the bioburden of a product is crucial for sterility assurance. The test helps
identify potential sources of contamination and aids in the development of
effective sterilization processes. All aspects of bioburden testing, including
sample collection, methods, results, and any deviations from the standard
procedure, are documented. These records are essential for compliance and
traceability. Based on Region, North
America held the largest share in the Global
Pharmaceutical Sterility Testing Market. North American laboratories
often have access to state-of-the-art technology and equipment for sterility
testing, which enables them to offer high-quality testing services. The United States
and Canada are major hubs for clinical trials, both for domestic and
international pharmaceutical companies. Sterility testing is a key aspect of
clinical trial compliance, further boosting the demand for these services in
the region. North American pharmaceutical companies often collaborate with
contract testing laboratories and service providers to outsource sterility
testing, creating a thriving ecosystem of service providers in the region.
North American pharmaceutical companies have a substantial global presence, and
their products are distributed worldwide. This necessitates rigorous sterility
testing to meet international regulatory requirements.
Some of the major companies
operating in the Global Pharmaceutical
Sterility Testing Market include:
- Pacific
BioLabs Inc.
- STERIS
- Boston
Analytical
- Nelson
Laboratories, LLC
- Sartorius
AG
- SOLVIAS
AG
- Charles
River Laboratories
- Thermo
Fisher Scientific, Inc.
- Rapid
Micro Biosystems, Inc.
- Almac
Group
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“Certain areas, particularly in North
America, are projected to exert significant demand for Pharmaceutical Sterility
Testing. The growth in the competitive landscape and the presence of
well-established companies in the market, committed to enhance the overall
wellbeing of people each year, are expected to contribute to a remarkable
growth of the Global Pharmaceutical Sterility Testing Market in the forecast
period," said Mr. Karan Chechi, Research Director with TechSci Research, a
research-based Global management consulting firm.
Global Pharmaceutical
Sterility Testing Market By
Type (In-house, Outsourcing), By Product Type (Kits and Reagents, Instruments, Service),
by Test Type (Sterility Testing, Membrane filtration, Direct inoculation, Bioburden
Testing, Bacterial Endotoxin Testing), By Region, By Competition
Forecast & Opportunities, 2018-2028F has evaluated the future growth
potential of Global Pharmaceutical Sterility Testing Market and provides
statistics & information on market size, structure, and future market
growth. The report intends to provide innovative market intelligence and help
decision makers take sound investment decisions. Besides, the report also
identifies and analyzes the emerging trends along with essential drivers,
challenges, and opportunities in Global Pharmaceutical Sterility Testing Market.
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