The global pharmaceutical sterility testing market is estimated at US$ 1.3 billion in 2022 and is expected to grow at a significant CAGR of over 10% during the forecast period of 2019-2028.
Market Scope and Report Overview
According to a deep-dive market assessment by RationalStat, the global Pharmaceutical Sterility Testing Market has been analyzed on the basis of market segments, including industry, and geography/regions (incl. North America, Latin America, Western Europe, Eastern Europe, Middle East & Africa, and Asia Pacific). The report also offers global and regional market sizing for the historical period of 2019-2022 and the forecast period of 2019-2028.
Market intelligence for the global Pharmaceutical Sterility Testing Market covers market sizes on the basis of market value (US$/EUR Million) and volume (‘000 units/tons/liters) by various products/services/equipment, demand assessment across the key regions, customer sentiments, price points, cost structures, margin analysis across the value chain, financial assessments, historical and forecast data, key developments across the industry, import-export data, trade overview, components market by leading companies, etc.
In addition, the long-term sector and products/services 10-year outlook and its implications on the global pharmaceutical sterility testing market. It also includes the industry's current state – Production Levels, Capacity Utilization, Tech quotient, etc. Key information will be manufacturing capacity by country, installed base, import volumes, market size, key players, market size, dynamics, market data, and insights, etc.
Period Covered include data for 2019-2028 along with year-wise demand estimations
The Pharmaceutical Sterility Testing Market report analyzes the market on the basis of global economic situations, regional geopolitics, import-export scenarios, trade duties, market developments, organic and inorganic strategies, mergers and acquisitions, product launches, government policies, new capacity addition, technological advancements, R&D investments, and new market entry, replacement rates, penetration rates, installed base/fleet size, global and regional production capacity, among others.
RationalStat offers market analysis and consulting studies on the basis of dedicated and robust desk/secondary research supported by a strong in-house data repository. In addition, the research leverages data based on the real-time insights gathered from primary interviews. Market estimations and insights are based on primary research (covering more than 240 entities) and secondary research by leveraging international benchmarking.
The global Pharmaceutical Sterility Testing Market report also covers value chain and supply chain analysis that provides in-depth information about the value chain margins and the role of various stakeholders across the value chain. Market dynamics provided in the market study include market drivers, restraints/challenges, trends, and their impact on the market throughout the analysis period.
In the competition analysis section, the global Pharmaceutical Sterility Testing Market provides a detailed competition benchmarking analysis based on the market share of the leading companies/brands/producers/suppliers, a market structure overview with detailed company profiles of more than 25 players with their financials, product/service offerings, major developments, business models, etc. This enables, clients and report buyers to make strong, precise, and timely decisions.
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Macroeconomic Scenario and the Impact of COVID-19 on Regional Economic Sentiment
In the latest RationalStat analysis, geopolitical conflicts and inflation are the cited economic risks, while concerns about the volatility across energy sectors prevail in Europe and other parts of the world. Some of the potential risks to the economic growth in the leading regions, including Asia Pacific, Europe, North America, the Middle East & Africa, and other developing regions, are inflation, volatile energy prices, supply chain disruptions, geopolitical instability, labor shortages, rising interest rates, and COVID-19 pandemic.
The global economy experienced heavy headwinds, throughout 2019-2021, as some countries witnessed subdued growth, while other countries continued to grapple with economic slowdowns. The COVID-19 pandemic has levied undue pressure across the majority of industries globally and has caused a major economic crisis in the US, India, Italy, the UK, Germany, India, Japan, South Korea, the UK, and many others. Besides, the exit of the UK from the European Union earlier in 2020 and the Russo-Ukraine war in 2022 exacerbated the ever-heightened global uncertainty.
In addition to this, the global economic growth slowed in 2022 to 3.3%, weaker than expected at the end of 2021, mainly weighed down by Russia’s war in Ukraine and the associated cost-of-living crisis in many countries. However, improvement in economic activities during the forecast period is expected. Growth is projected to remain at lower rates in 2023 and 2024, at 2.6% and 2.9% respectively.
Some of the prominent players operating in the pharmaceutical sterility testing market are Merck KGaA, bioMerieux SA, Thermo Fisher Scientific Inc., Charles River Laboratories International Inc., and others.
Competition Analysis and Market Structure
These players adopt various strategies in order to reinforce their market share and gain a competitive edge over other competitors in the market. Mergers & acquisitions, partnerships and collaborations, and product launches are some of the strategies followed by industry players. Some of the key developments in the global Pharmaceutical Sterility Testing Market include,
- In June 2022, Berkshire Sterile Manufacturing (BSM), a fill-finish CMO located in Lee, MA announced that its sterility testing isolator is ready to perform onsite sterility testing for its GMP batches. The new service is expected to shorten the release for most if not all the company’s clients.
- In September 2021, Nelson Labs and Sterigenics Germany GmbH announced the opening of a newly expanded center of excellence for microbiological laboratory testing as well as increased sterilization capacity in their Wiesbaden, Germany, facilities.
- In October 2019, Alcami Corporation, a provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, announced the launch of its new rapid sterility offering, a service that leverages cutting-edge microbiological testing technology to deliver significantly faster-testing results to clients. Alcami invested in the Milliflex Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for the detection of microorganisms after five days.
Market Segmentation: Global Pharmaceutical Sterility Testing Market Analysis
RationalStat has segmented the global pharmaceutical sterility testing market on the basis of product, application, test type, manufacturing type, end-use, and region.
- Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units/tons), and Market Share (2019-2028) Analysis by Product
- Kits and Reagents
- Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units/tons),and Market Share (2019-2028) Analysis by Application
- Sterile Drugs
- Medical Devices
- Biologics and Therapeutics
- Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units/tons), and Market Share (2019-2028) Analysis by Test Type
- Sterility Testing
- Membrane Filtration
- Direct Inoculation
- Bioburden Testing
- Bacterial Endotoxin Testing
- Container Closure Integrity Testing
- Rapid Micro Test
- ATP Bioluminescence
- Fluorescent Labeling
- Electrical Resistance
- Others (Antimicrobial Effectiveness Testing, etc.)
- Sterility Testing
- Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units/tons), and Market Share (2019-2028) Analysis by Manufacturing Type
- Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units/tons), and Market Share (2019-2028) Analysis by End User
- Compounding Pharmacies
- Medical Devices Companies
- Pharmaceutical Companies
- Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units/tons), and Market Share (2019-2028) Analysis by Region
- North America Pharmaceutical Sterility Testing Market
- Latin America Pharmaceutical Sterility Testing Market
- Rest of Latin America
- Western Europe Pharmaceutical Sterility Testing Market
- Rest of Western Europe
- Eastern Europe Pharmaceutical Sterility Testing Market
- Other CIS Countries
- Rest of Eastern Europe
- Asia Pacific Pharmaceutical Sterility Testing Market
- South Korea
- Rest of ASEAN
- Rest of Asia Pacific
- Middle East & Africa Pharmaceutical Sterility Testing Market
- Saudi Arabia (KSA)
- United Arab Emirates (UAE)
- Rest of the GCC
- South Africa
- Rest of the Middle East & Africa
- North America Pharmaceutical Sterility Testing Market
- Leading Companies and Market Players
- Charles River Laboratories International, Inc.
- Sartorius AG
- Merck KGaA
- Thermo Fisher Scientific Inc.
- bioMérieux SA
- WuXi AppTec Co., Ltd.
- SGS SA
- Nelson Laboratories, LLC
- Pace Analytical Services, LLC
- Toxikon Corporation
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Key Questions Answered in the Pharmaceutical Sterility Testing Market Report
- What will be the market value of the Global Pharmaceutical Sterility Testing Market by 2028?
- What is the market size of the Global Pharmaceutical Sterility Testing Market?
- What are the market drivers of the Global Pharmaceutical Sterility Testing Market?
- What are the key trends in the Global Pharmaceutical Sterility Testing Market?
- Which is the leading region in the Global Pharmaceutical Sterility Testing Market?
- What are the major companies operating in the Global Pharmaceutical Sterility Testing Market?
- What are the market shares by key segments in the Global Pharmaceutical Sterility Testing Market?
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