Market Overview:
The global pharmaceutical sterility testing market is expected to grow at a CAGR of 6.5% from 2018 to 2030. The growth in the market can be attributed to the increasing demand for sterile products and rising number of compounding pharmacies. In addition, the growing awareness about quality control and safety measures is also contributing to the growth of this market. On the basis of type, the global pharmaceutical sterility testing market is segmented into sterility testing, bioburden testing, and bacterial endotoxin testing. Sterility testing dominates this market owing to its wide application in various industries such as compounding pharmacies, medical devices companies, pharmaceutical companies, and others. On the basis of application, compounding pharmacies dominate this market followed by medical devices companies and pharmaceutical companies respectively.
Product Definition:
The sterility of a pharmaceutical product is its ability to be free of viable microorganisms. A product that is sterile can be safely administered to a patient. The sterility of a product must be verified before it can be marketed. This is usually done by growing the product in the presence of indicator microorganisms and then examining it for growth.
Sterility Testing:
The global pharmaceutical sterility testing market is expected to witness significant growth over the forecast period. The factors that propel the growth of this market include rising demand for drugs, increasing R&D activities by companies and government support for new drug development.
Bioburden Testing:
Bioburden testing is used for determining the number of microorganisms present on or in a product. It is also used to determine if these microorganisms are harmful or useful to the product. Bioburden tests are conducted by using various culture media and check methods such as colony counters, gram stain, and appearance under a microscope.
Application Insights:
The others application segment includes hospitals and clinical research organizations. The other applications of pharmaceutical sterilization tests include validation of process control in the manufacturing facilities, quality assessment for product batches, and compliance with regulatory requirements. Validation of process control in the manufacturing facilities is an important part to avoid any potential contamination during production or handling of products that are supposed to be sterile.
Medical devices companies are expected to dominate the North America pharmaceutical sterilization testing market owing to factors such as presence of multiple U.S., Canada-based medical device manufacturers; presence of a strong healthcare infrastructure supported by government policies; increasing number and popularity of surgical procedures performed using medical devices; rising awareness among consumers regarding safety associated with these products; high cost associated with product recalls due to microbial contamination during production or handling.; etc. These factors are projectededto boost demand for sterility testing services from medical device companies over the forecast period in North America region.
Regional Analysis:
North America dominated the global pharmaceutical sterility testing market in 2016. The presence of stringent regulatory bodies, such as the FDA and WHO, for maintaining high standards of drug safety & efficacy is one of the major factors responsible for this dominance. Moreover, increasing R&D investments by companies to develop new drugs is also expected to drive growth over the forecast period.
Asia Pacific region is anticipated to witness lucrative growth over the forecast period owing to rising healthcare expenditure and growing patient awareness levels regarding infectious diseases transmission rates & treatment options in emerging countries like India and China.
Key Companies Mentioned In This Report are: Abbott; Merck KGaA; Pfizer Inc.; Johnson & Johnson Services India Pvt Ltd.
Growth Factors:
- Increasing demand for sterile drugs and devices
- Rising incidence of hospital-acquired infections (HAIs)
- Stringent regulatory norms for drug and device manufacturing
- Growing popularity of contract manufacturing services
- Technological advancements in pharmaceutical sterility testing
Scope Of The Report
Report Attributes
Report Details
Report Title
Pharmaceutical Sterility Testing Market Research Report
By Type
Sterility Testing, Bioburden Testing, Bacterial Endotoxin Testing
By Application
Compounding Pharmacies, Medical Devices Companies, Pharmaceutical Companies, Others
By Companies
SGS SA, Toxikon, Inc., Pace Analytical Services, LLC, Boston Analytical, Charles River Laboratories International, Inc., Nelson Laboratories.
Regions Covered
North America, Europe, APAC, Latin America, MEA
Base Year
2021
Historical Year
2019 to 2020 (Data from 2010 can be provided as per availability)
Forecast Year
2030
Number of Pages
150
Number of Tables & Figures
105
Customization Available
Yes, the report can be customized as per your need.
Global Pharmaceutical Sterility Testing Market Report Segments:
The global Pharmaceutical Sterility Testing market is segmented on the basis of:
Types
Sterility Testing, Bioburden Testing, Bacterial Endotoxin Testing
The product segment provides information about the market share of each product and the respective CAGR during the forecast period. It lays out information about the product pricing parameters, trends, and profits that provides in-depth insights of the market. Furthermore, it discusses latest product developments & innovation in the market.
Applications
Compounding Pharmacies, Medical Devices Companies, Pharmaceutical Companies, Others
The application segment fragments various applications of the product and provides information on the market share and growth rate of each application segment. It discusses the potential future applications of the products and driving and restraining factors of each application segment.
Some of the companies that are profiled in this report are:
- SGS SA
- Toxikon, Inc.
- Pace Analytical Services, LLC
- Boston Analytical
- Charles River Laboratories International, Inc.
- Nelson Laboratories.
Highlights of The Pharmaceutical Sterility Testing Market Report:
- The market structure and projections for the coming years.
- Drivers, restraints, opportunities, and current trends of market.
- Historical data and forecast.
- Estimations for the forecast period 2030.
- Developments and trends in the market.
- By Type:
- Sterility Testing
- Bioburden Testing
- Bacterial Endotoxin Testing
- By Application:
- Compounding Pharmacies
- Medical Devices Companies
- Pharmaceutical Companies
- Others
- Market scenario by region, sub-region, and country.
- Market share of the market players, company profiles, product specifications, SWOT analysis, and competitive landscape.
- Analysis regarding upstream raw materials, downstream demand, and current market dynamics.
- Government Policies, Macro & Micro economic factors are also included in the report.
We have studied the Pharmaceutical Sterility Testing Market in 360 degrees via. both primary & secondary research methodologies. This helped us in building an understanding of the current market dynamics, supply-demand gap, pricing trends, product preferences, consumer patterns & so on. The findings were further validated through primary research with industry experts & opinion leaders across countries. The data is further compiled & validated through various market estimation & data validation methodologies. Further, we also have our in-house data forecasting model to predict market growth up to 2030.
Regional Analysis
- North America
- Europe
- Asia Pacific
- Middle East & Africa
- Latin America
Note: A country of choice can be added in the report at no extra cost. If more than one country needs to be added, the research quote will vary accordingly.
The geographical analysis part of the report provides information about the product sales in terms of volume and revenue in regions. It lays out potential opportunities for the new entrants, emerging players, and major players in the region. The regional analysis is done after considering the socio-economic factors and government regulations of the countries in the regions.
How you may use our products:
- Correctly Positioning New Products
- Market Entry Strategies
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- Product & Brand Management
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8 Reasons to Buy This Report
- Includes a Chapter on the Impact of COVID-19 Pandemic On the Market
- Report Prepared After Conducting Interviews with Industry Experts & Top Designates of the Companies in the Market
- Implemented Robust Methodology to Prepare the Report
- Includes Graphs, Statistics, Flowcharts, and Infographics to Save Time
- Industry Growth Insights Provides 24/5 Assistance Regarding the Doubts in the Report
- Provides Information About the Top-winning Strategies Implemented by Industry Players.
- In-depth Insights On the Market Drivers, Restraints, Opportunities, and Threats
- Customization of the Report Available
Frequently Asked Questions?
Pharmaceutical sterility testing is a process used to ensure the safety and effectiveness of pharmaceutical products. Sterility testing is used to determine whether a drug or other product can be administered safely and without causing any adverse effects.
Some of the major companies in the pharmaceutical sterility testing market are SGS SA, Toxikon, Inc., Pace Analytical Services, LLC, Boston Analytical, Charles River Laboratories International, Inc., Nelson Laboratories..
The pharmaceutical sterility testing market is expected to register a CAGR of 6.5%.
Chapter 1 Executive Summary
Chapter 2 Assumptions and Acronyms Used
Chapter 3 Research Methodology
Chapter 4 Pharmaceutical Sterility Testing Market Overview
4.1 Introduction
4.1.1 Market Taxonomy
4.1.2 Market Definition
4.1.3 Macro-Economic Factors Impacting the Market Growth
4.2 Pharmaceutical Sterility Testing Market Dynamics
4.2.1 Market Drivers
4.2.2 Market Restraints
4.2.3 Market Opportunity
4.3 Pharmaceutical Sterility Testing Market - Supply Chain Analysis
4.3.1 List of Key Suppliers
4.3.2 List of Key Distributors
4.3.3 List of Key Consumers
4.4 Key Forces Shaping the Pharmaceutical Sterility Testing Market
4.4.1 Bargaining Power of Suppliers
4.4.2 Bargaining Power of Buyers
4.4.3 Threat of Substitution
4.4.4 Threat of New Entrants
4.4.5 Competitive Rivalry
4.5 Global Pharmaceutical Sterility Testing Market Size & Forecast, 2018-2028
4.5.1 Pharmaceutical Sterility Testing Market Size and Y-o-Y Growth
4.5.2 Pharmaceutical Sterility Testing Market Absolute $ Opportunity
Chapter 5 Global Pharmaceutical Sterility Testing Market Analysis and Forecast by Type
5.1 Introduction
5.1.1 Key Market Trends & Growth Opportunities by Type
5.1.2 Basis Point Share (BPS) Analysis by Type
5.1.3 Absolute $ Opportunity Assessment by Type
5.2 Pharmaceutical Sterility Testing Market Size Forecast by Type
5.2.1 Sterility Testing
5.2.2 Bioburden Testing
5.2.3 Bacterial Endotoxin Testing
5.3 Market Attractiveness Analysis by Type
Chapter 6 Global Pharmaceutical Sterility Testing Market Analysis and Forecast by Applications
6.1 Introduction
6.1.1 Key Market Trends & Growth Opportunities by Applications
6.1.2 Basis Point Share (BPS) Analysis by Applications
6.1.3 Absolute $ Opportunity Assessment by Applications
6.2 Pharmaceutical Sterility Testing Market Size Forecast by Applications
6.2.1 Compounding Pharmacies
6.2.2 Medical Devices Companies
6.2.3 Pharmaceutical Companies
6.2.4 Others
6.3 Market Attractiveness Analysis by Applications
Chapter 7 Global Pharmaceutical Sterility Testing Market Analysis and Forecast by Region
7.1 Introduction
7.1.1 Key Market Trends & Growth Opportunities by Region
7.1.2 Basis Point Share (BPS) Analysis by Region
7.1.3 Absolute $ Opportunity Assessment by Region
7.2 Pharmaceutical Sterility Testing Market Size Forecast by Region
7.2.1 North America
7.2.2 Europe
7.2.3 Asia Pacific
7.2.4 Latin America
7.2.5 Middle East & Africa (MEA)
7.3 Market Attractiveness Analysis by Region
Chapter 8 Coronavirus Disease (COVID-19) Impact
8.1 Introduction
8.2 Current & Future Impact Analysis
8.3 Economic Impact Analysis
8.4 Government Policies
8.5 Investment Scenario
Chapter 9 North America Pharmaceutical Sterility Testing Analysis and Forecast
9.1 Introduction
9.2 North America Pharmaceutical Sterility Testing Market Size Forecast by Country
9.2.1 U.S.
9.2.2 Canada
9.3 Basis Point Share (BPS) Analysis by Country
9.4 Absolute $ Opportunity Assessment by Country
9.5 Market Attractiveness Analysis by Country
9.6 North America Pharmaceutical Sterility Testing Market Size Forecast by Type
9.6.1 Sterility Testing
9.6.2 Bioburden Testing
9.6.3 Bacterial Endotoxin Testing
9.7 Basis Point Share (BPS) Analysis by Type
9.8 Absolute $ Opportunity Assessment by Type
9.9 Market Attractiveness Analysis by Type
9.10 North America Pharmaceutical Sterility Testing Market Size Forecast by Applications
9.10.1 Compounding Pharmacies
9.10.2 Medical Devices Companies
9.10.3 Pharmaceutical Companies
9.10.4 Others
9.11 Basis Point Share (BPS) Analysis by Applications
9.12 Absolute $ Opportunity Assessment by Applications
9.13 Market Attractiveness Analysis by Applications
Chapter 10 Europe Pharmaceutical Sterility Testing Analysis and Forecast
10.1 Introduction
10.2 Europe Pharmaceutical Sterility Testing Market Size Forecast by Country
10.2.1 Germany
10.2.2 France
10.2.3 Italy
10.2.4 U.K.
10.2.5 Spain
10.2.6 Russia
10.2.7 Rest of Europe
10.3 Basis Point Share (BPS) Analysis by Country
10.4 Absolute $ Opportunity Assessment by Country
10.5 Market Attractiveness Analysis by Country
10.6 Europe Pharmaceutical Sterility Testing Market Size Forecast by Type
10.6.1 Sterility Testing
10.6.2 Bioburden Testing
10.6.3 Bacterial Endotoxin Testing
10.7 Basis Point Share (BPS) Analysis by Type
10.8 Absolute $ Opportunity Assessment by Type
10.9 Market Attractiveness Analysis by Type
10.10 Europe Pharmaceutical Sterility Testing Market Size Forecast by Applications
10.10.1 Compounding Pharmacies
10.10.2 Medical Devices Companies
10.10.3 Pharmaceutical Companies
10.10.4 Others
10.11 Basis Point Share (BPS) Analysis by Applications
10.12 Absolute $ Opportunity Assessment by Applications
10.13 Market Attractiveness Analysis by Applications
Chapter 11 Asia Pacific Pharmaceutical Sterility Testing Analysis and Forecast
11.1 Introduction
11.2 Asia Pacific Pharmaceutical Sterility Testing Market Size Forecast by Country
11.2.1 China
11.2.2 Japan
11.2.3 South Korea
11.2.4 India
11.2.5 Australia
11.2.6 South East Asia (SEA)
11.2.7 Rest of Asia Pacific (APAC)
11.3 Basis Point Share (BPS) Analysis by Country
11.4 Absolute $ Opportunity Assessment by Country
11.5 Market Attractiveness Analysis by Country
11.6 Asia Pacific Pharmaceutical Sterility Testing Market Size Forecast by Type
11.6.1 Sterility Testing
11.6.2 Bioburden Testing
11.6.3 Bacterial Endotoxin Testing
11.7 Basis Point Share (BPS) Analysis by Type
11.8 Absolute $ Opportunity Assessment by Type
11.9 Market Attractiveness Analysis by Type
11.10 Asia Pacific Pharmaceutical Sterility Testing Market Size Forecast by Applications
11.10.1 Compounding Pharmacies
11.10.2 Medical Devices Companies
11.10.3 Pharmaceutical Companies
11.10.4 Others
11.11 Basis Point Share (BPS) Analysis by Applications
11.12 Absolute $ Opportunity Assessment by Applications
11.13 Market Attractiveness Analysis by Applications
Chapter 12 Latin America Pharmaceutical Sterility Testing Analysis and Forecast
12.1 Introduction
12.2 Latin America Pharmaceutical Sterility Testing Market Size Forecast by Country
12.2.1 Brazil
12.2.2 Mexico
12.2.3 Rest of Latin America (LATAM)
12.3 Basis Point Share (BPS) Analysis by Country
12.4 Absolute $ Opportunity Assessment by Country
12.5 Market Attractiveness Analysis by Country
12.6 Latin America Pharmaceutical Sterility Testing Market Size Forecast by Type
12.6.1 Sterility Testing
12.6.2 Bioburden Testing
12.6.3 Bacterial Endotoxin Testing
12.7 Basis Point Share (BPS) Analysis by Type
12.8 Absolute $ Opportunity Assessment by Type
12.9 Market Attractiveness Analysis by Type
12.10 Latin America Pharmaceutical Sterility Testing Market Size Forecast by Applications
12.10.1 Compounding Pharmacies
12.10.2 Medical Devices Companies
12.10.3 Pharmaceutical Companies
12.10.4 Others
12.11 Basis Point Share (BPS) Analysis by Applications
12.12 Absolute $ Opportunity Assessment by Applications
12.13 Market Attractiveness Analysis by Applications
Chapter 13 Middle East & Africa (MEA) Pharmaceutical Sterility Testing Analysis and Forecast
13.1 Introduction
13.2 Middle East & Africa (MEA) Pharmaceutical Sterility Testing Market Size Forecast by Country
13.2.1 Saudi Arabia
13.2.2 South Africa
13.2.3 UAE
13.2.4 Rest of Middle East & Africa (MEA)
13.3 Basis Point Share (BPS) Analysis by Country
13.4 Absolute $ Opportunity Assessment by Country
13.5 Market Attractiveness Analysis by Country
13.6 Middle East & Africa (MEA) Pharmaceutical Sterility Testing Market Size Forecast by Type
13.6.1 Sterility Testing
13.6.2 Bioburden Testing
13.6.3 Bacterial Endotoxin Testing
13.7 Basis Point Share (BPS) Analysis by Type
13.8 Absolute $ Opportunity Assessment by Type
13.9 Market Attractiveness Analysis by Type
13.10 Middle East & Africa (MEA) Pharmaceutical Sterility Testing Market Size Forecast by Applications
13.10.1 Compounding Pharmacies
13.10.2 Medical Devices Companies
13.10.3 Pharmaceutical Companies
13.10.4 Others
13.11 Basis Point Share (BPS) Analysis by Applications
13.12 Absolute $ Opportunity Assessment by Applications
13.13 Market Attractiveness Analysis by Applications
Chapter 14 Competition Landscape
14.1 Pharmaceutical Sterility Testing Market: Competitive Dashboard
14.2 Global Pharmaceutical Sterility Testing Market: Market Share Analysis, 2019
14.3 Company Profiles (Details – Overview, Financials, Developments, Strategy)
14.3.1 SGS SA
14.3.2 Toxikon, Inc.
14.3.3 Pace Analytical Services, LLC
14.3.4 Boston Analytical
14.3.5 Charles River Laboratories International, Inc.
14.3.6 Nelson Laboratories.
