Growth of pharmaceutical & biotechnology companies, increasing number of drug launches, government support for pharmaceutical and biotechnology industries, increasing R&D investment in life sciences, and increasing strategic initiatives such as product launch or collaboration are key factors contributing to high CAGR of Sterility Testing Market during forecast period.
Market Size – USD 466.0 million in
2018, Market Growth - CAGR of 12.4% Market Trends – Increasing technological
advancements
The Global Sterility Testing Market was valued at USD 466.0 million in
2018 and is expected to reach USD 1.18 billion by the year 2026, at a CAGR of
12.4%. Sterility testing is an assessment of the product/surface to determine
the presence of the microorganism in a given sample. This process plays a
crucial role throughout the drug development and production process. Sterility
testing studies help analyze the effectiveness of each step of the
manufacturing process to remove or detect microbial contamination. Sterility
testing is carried out at all manufacturing levels in the pharmaceutical and
biopharmaceutical industries to minimize the risk of product contamination. It
is carried out in a wide range of fields, including pharmaceuticals and
biologicals, medical devices, water purification, biopharmaceutical, and
laboratory glass products. In this type of testing, the product or raw
materials to be monitored are incubated in the medium (FTM/SCDM) and then
examined. Assessment of large equipment/containers or hollow devices is carried
out by using the product flush method, or the sample is extracted from the
required surface and is then filtered through the membrane. Rapid sterility
method is the new advanced methodology used, which provide a quick result (3-4
times faster than the traditional tests). A substantial increase in
pharmaceutical outsourcing during previous years due to the high costs
associated with the setup of the testing infrastructure. It is anticipated to
be an excellent opportunity for the players in the market to procure the
untapped market potentials.
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Companies are highly focused on
research and development to bring more reliable products with less turnaround
time making the market highly competitive and posing a threat to the companies
operating on the conventional approach. Moreover, Biotechnology is one of the
most sophisticated industries in the healthcare sector. According to the
International Trade Administration, U.S. Department of Commerce, the worldwide
pharmaceutical market is expected to rise from USD 1 trillion in 2015 to USD
1.3 trillion by 2020. The sterility monitoring market will be strengthened by
strong growth in the pharmaceutical and biopharmaceutical industries.
Further key findings from the report suggest
·
Several industry players are focusing
on expanding the product portfolio in the field. For instance, Merck one of the
leading provider of sterility testing device, launched its new sterility
testing device- Steritest NEO. Charles River Laboratories International, Inc.
in 2019 announced the launch of two new products in its microbial solutions
portfolio. Thus helping the sterility testing of the products with its new
technology. WuXi AppTec in November 2018, announced its new medical device
laboratory testing center opened in Suzhou, China to form a globally integrated
medical device testing platform to serve medical device customers and offer
sterility testing services
·
Various key players are focused in
developing the advanced technologies in testing sterility for wide application
area. For instance, recently Alcami Corp. has launched its new rapid sterility
offering, a service that leverages cutting-edge microbiological testing
technology to deliver faster testing results
·
During 2019-2026, sterility testing market
is expected to register a CAGR of 13.3% in Asia Pacific; followed by North
America and Europe, with 12.4% and 12.1% CAGR, respectively. Increasing drug
release in developed as well as developing nation and favorable government
policies for sterility testing are key factors driving the market demand
·
The membrane filtration system test
method of sterility testing segment dominates the field with highest market
share in the year 2018. It is estimated to grow at a CAGR of 12.4% during the
forecast period to reach USD 616.7 million by 2026
·
Based on application segment, raw
materials sterility testing is expected to account for the CAGR 12.8% of the
global market, as drastically growing incidences of raw material contamination
across the world
·
Asia Pacific is expected to account
for the CAGR 13.3% of the global sterility testing market. Developing nations
such China, and India are likely to witness high growth due to presence of
target population, rising industrial globalization and increased healthcare expenditure
and growing R&D investment
·
Based on end use biopharmaceutical
& pharmaceutical companies dominate the total market share of sterility
testing. Due to the growth registered in pharmaceutical & biotechnology
companies
·
Time-consuming and stringent regulatory
standards are the key factors likely to hamper growth of the sterility testing
market
·
Key participants include Charles
River, Merck KGaA, Biomérieux SA, SGS S.A., Danaher Corporation, Nelson
Laboratories, Pacific Biolabs, Thermo Fisher Scientific Inc., Sartorius AG,
Toxikon Corporation, Wuxi Apptec, Eurofins Scientific
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For the purpose of this report,
Reports and Data has segmented the sterility testing market on the basis of
test methods, applications, end use and region:
Test Methods Outlook (Revenue, USD
Million; 2016-2026)
·
Membrane Filtration System Sterility
Test
o
Instrument
o
Reagent/Kits
o
Consumables
o
Key Market Players
·
Direct Transfer Sterility Testing
o
Instrument
o
Reagent/Kits
o
Consumables
o
Key Market Players
·
Product Flush Sterility Testing
·
o
Instrument
o
Reagent/Kits
o
Consumables
o
Key Market Players
·
Others
o
Instrument
o
Reagent/Kits
o
Consumables
Applications Outlook (Revenue, USD
Million; 2016-2026)
·
Raw Materials
·
Personnel
·
Equipment
·
Manufacturing Environment
·
Pharmaceutical Preparations
o
Injectable
o
Biologics
o
Medical Devices
o
Transfusion Assembly
·
Vectors
·
Packaging/Bulk Finished Products
·
Others
End Use Outlook (Revenue, USD
Million; 2016-2026)
·
Biopharmaceutical &
Pharmaceutical Companies
·
Contract Research Organization (CRO)
·
Contract Manufacturing Organization
(CMO)
·
Cell Banks
·
Academic Research Institutes
Regional Outlook (Revenue in USD
Million; 2016–2026)
·
North America
o
U.S
o
Canada
·
Europe
o
Germany
o
France
o
UK
o
Spain
o
Italy
o
Rest of the Europe
·
Asia Pacific
o
China
o
India
o
Japan
o
Rest of Asia-Pacific
·
Middle East & Africa
·
Latin America
o
Brazil
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Key Features of the Sterility Testing Market
Report:
·
The
report encompasses details about the key companies, product portfolio along
with specifications, production valuation, and market shares
·
Extensive
study of key segments and sub-segments of the Sterility Testing market
·
Evaluation
of key current and emerging market trends and growth prospects
·
Brief
overview of industry with regards to research and development, technological
advancements, and product development
·
In-depth
assessment of upstream raw materials, downstream buyers, demands, and current
market scenario
·
Analysis
of key drivers, restraints, opportunities, growth prospects, limitations, and
threats
·
Strategic
recommendation to key players and new entrants to overcome entry-level barriers
in the Sterility Testing market over the forecast period
Table of Content:
Chapter 1. Market Synopsis
1.1. Market Definition
1.2. Research Scope & Premise
1.3. Methodology
1.4. Market Estimation Technique
Chapter 2. Executive Summary
2.1. Summary Snapshot, 2018 – 2026
Chapter 3. Indicative Metrics
3.1. Macroeconomic Indicators
3.1.1.
Increasing pharmaceutical outsourcing
3.1.2. Rising
industrial globalization
Chapter 4. Sterility Testing Segmentation & Impact
Analysis
4.1. Sterility Testing
Segmentation Analysis
4.2. Sterility Testing Market
Value Chain Analysis, 2016-2026
4.3. Regulatory framework
4.4. Sterility Testing Market
Impact Analysis
4.4.1. Market
driver analysis
4.4.1.1. Growth of pharmaceutical & biotechnology companies
4.4.1.2. Increasing number of drug launches
4.4.1.3. Government support for pharmaceutical and biotechnology
industries
4.4.1.4. Increasing R&D investment in life sciences
4.4.2. Market
restraint analysis
4.4.2.1. High capital investment
4.5. Key opportunities prioritized
4.6. Sterility Testing Pricing
Analysis
4.7. Industry analysis - Porter\'s
4.8. Sterility Testing PESTEL
Analysis
Chapter 5. Sterility Testing Market By Test Methods Insights
& Trends
Continued….
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