The global Pharmaceutical Sterility Testing market size is expected to be worth around US$ 5.0 billion by 2030, according to a new report by Vision Research Reports.
The global Pharmaceutical Sterility Testing market size was valued at US$ 933.7 Million in 2020 and is anticipated to grow at a CAGR of 13.8% during forecast period 2021 to 2030.
Increasing number of drug launches coupled with the rising R&D expenditure across the globe is expected to be the key market growth drivers.
Technological advancements in sterility testing methods led to reduction of the procedural time and human intervention, thereby increasing the efficiency and accuracy of these tests. Latest advancements are flexible to suit the safety requirements of innovative products. The FDA also relaxed its regulatory requirements to allow the use of modern sterility tests for ensuring product safety.
Outsourcing of sterility testing is a strategy adopted by many companies in order to reduce cost. Moreover, several contract laboratories are available, which provide quality sterility testing at economic prices. Outsourcing of sterility testing also reduces the need for personnel training, equipment purchases, and manufacturing facility changes.
Regulatory framework for sterile products in pharmacies is increasingly becoming stringent owing to the several adverse events, such as meningitis outbreak (2012), associated with unsafe sterile products compounded in pharmacies. Moreover, the Drug Quality and Security Act provides the FDA authority to monitor and regulate the compounding of drugs, thereby, increasing adoption of sterility testing procedures by the compounding pharmacies.
Developing countries are harmonizing the regulatory framework with ICH standards and are also undertaking initiatives to boost the domestic production by providing incentives and tax concessions. Thus, developing nations are considered to be the future area for expansion of operations and outsourcing of sterility testing by multinational companies.
On the basis of type, the market is segmented into in-house and outsourcing. The outsourcing segment led the market share accounting for USD 400.9 million in 2016 and is projected to grow at a rapid pace over the forecast period.
The in-house sterility testing market is an essential part of quality assurance and Goof Manufacturing Practices (GMP) for the manufacturers of pharmaceutical, biopharmaceuticals, and medical devices. Sterility testing is mandatory for release of each batch, which facilitates the segment’s growth.
Outsourcing of sterility testing is an attractive alternative. Some companies do not have the infrastructure to conduct quality sterility testing and therefore prefer to outsource these services. Moreover, outsourcing also saves time and cost by reducing the need of training personnel and purchase of sterility testing equipment. However, the quality of sterility testing services depends on the outsourced lab as an ill-equipped lab can deliver inaccurate test results. This facilitates the demand to outsource to high-quality sterility testing laboratories.
The key end-use segments include compounding pharmacies, medical devices and pharmaceutical companies, and others such as hospitals, biopharmaceuticals, clinics, and research labs. The others segment is projected to register a lucrative CAGR over the forecast period owing to increasing R&D activities, outsourcing services, and rise in innovative biopharmaceutical products.
The pharmaceutical companies segment held the largest share in the pharmaceutical sterility testing market in 2016. This can be attributed to regulatory requirement to conduct sterility testing for each batch release to ensure product safety. These companies adhere to GMP and ICH standards prior to drug approval and launch, thereby contributing to market growth.
The bacterial endotoxin testing segment accounted for the highest market share in 2016 and is anticipated to register a lucrative CAGR over the forecast period. This can be attributed to the ongoing technological advancements in this segment.
The sterility and segments are anticipated to witness rapid growth over the forecast period. Increasing emphasis on product quality, along with the rising number of drug and medical devices launches, is anticipated to contribute towards the expansion of these segments.
Bioburden and sterility testing along with sterilization process validation are crucial aspects of GMP for assuring the safety of the end products. Sterility and bioburden testing are conducted on medical devices or its components to determine the total viable microorganism count prior to the sterilization process, thereby facilitating the growth of these segments.
Based on sample, the global market is segmented into sterile dugs, medical devices, and biologics and therapeutics. The sterile drugs held the largest market share in 2016 due to the high adoption of several techniques adopted for product safety.
The biologic and therapeutics segment would witness a remunerative growth over the forecast period. This is attributed to the factors such as growing number of technological advancements in sterility testing procedures, biosimilars, vaccines, and other biologics along with regulatory mandates to ensure the sterility of biologics & therapeutics.
In terms of region, North America held the largest market share in 2016 and is anticipated to expand at CAGR of 11.7.over the forecast period. This can be attributed to the presence of a large number of international and domestic players in this region. Asia Pacific is anticipated to witness the fastest growth during the forecast period.
This can be attributed to increasing harmonization of the regulatory standards with the ICH standards in developing nations. Moreover, many emerging economies in the region are undertaking various initiatives to boost the domestic pharmaceutical market and are encouraging multinational companies to set up operations in the region. Such initiatives are likely to contribute towards the regional development.
SGS SA; Toxikon, Inc.; Pace Analytical Services, LLC; Boston Analytical; Charles River Laboratories International, Inc.; and Nelson Laboratories. Regional expansions and M&A
Test type Outlook
Bacterial Endotoxin Testing
Medical Devices Companies
Biologics & Therapeutics
Middle East & Africa
The Pharmaceutical Sterility Testing market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.
The report provides size (in terms of volume and value) of Pharmaceutical Sterility Testing market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.
This report focuses on the global Pharmaceutical Sterility Testing market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Pharmaceutical Sterility Testing market development in United States, Europe and China.
It is pertinent to consider that in a volatile global economy, we haven’t just conducted Pharmaceutical Sterility Testing market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.
In terms of production side, this report researches the Pharmaceutical Sterility Testing capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.
In terms of consumption side, this report focuses on the consumption of Pharmaceutical Sterility Testing by regions (countries) and application.
Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Pharmaceutical Sterility Testing market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.
With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Pharmaceutical Sterility Testing market companies.
Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Pharmaceutical Sterility Testing market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.
The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.
Overall, this is an in-depth research report specifically for the Pharmaceutical Sterility Testing industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.
The Pharmaceutical Sterility Testing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Pharmaceutical Sterility Testing market.
Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Pharmaceutical Sterility Testing market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.
Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Pharmaceutical Sterility Testing market. These factors have benefited the growth of the global market for Pharmaceutical Sterility Testing. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.
New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Pharmaceutical Sterility Testing. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).
In this study, the years considered to estimate the market size of Pharmaceutical Sterility Testing are as follows:
Reasons to Purchase this Report:
- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.
This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.
Market Size Estimation
Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).
The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.
Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.
All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.
Market Breakdown and Data Triangulation
After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.
Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.
The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.
The study objectives of this report are:
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