Pharmaceutical Sterility Testing Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2022-2030

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.

Growth Factors

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.

Type Insights

The outsourcing segment held the largest market share, accounting for 55.0%in 2021. Based on type, the market is segmented into outsourcing and in-house. Outsourcing sterility testing is an attractive alternative. Small and medium-sized pharmaceutical and medical device companies may lack the infrastructure to conduct quality sterility testing and therefore prefer to outsource these services to pass the FDA requirements.

Moreover, outsourcing also saves time and cost of pharmaceutical and medical device companies, as they don’t have to hire and train employees and they are also not required to invest in any new equipment. Big pharmaceutical companies are now trying to focus on their core competencies like R&D and marketing, therefore they outsource pharmaceutical sterility testing services. These factors have been a prime factor supporting the segment's growth.

The in-house segment is expected to grow with a CAGR of 11.3% during the forecast period. Quality issues and compliance issues associated with outsourcing pharmaceutical sterility testing are expected to promote the segment market throughout the forecast period. Small outsourcing firms lack the necessary infrastructure, and this is expected to hamper the quality of sterility testing. These reasons are likely to improve demand for in-house pharmaceutical sterility testing in the market.

Testing Type Insights

The bacterial endotoxin testing segment accounted for the highest market share of 39.4% in 2021. Based on testing type, the market is segmented into sterility testing, bioburden testing, bacterial endotoxin testing, membrane filtration, direct inoculation, container closure integrity testing, antimicrobial effectiveness testing, and Rapid micro test.

Bacterial endotoxin testing is required for all drugs administered via parenteral routes. These tests are also used for testing medical devices such as implants. The growing demand for parenteral drugs and implants is supporting the growth of the segment market. There is an increasing emphasis on product quality, along with a rising number of drug and medical device launches. This is anticipated to contribute towards the expansion of the segments.

Bioburden testing is expected to expand at the fastest rate of 11.6% CAGR during the forecast period. Bioburden testing is performed for pharmaceuticals, biologics, and all medical devices, including class I, II, and III. The growing demand for the aforementioned products is one of the major reasons supporting segment growth. Furthermore, this testing is very important during the production process, as microbial growth in the product could lead to recalls later.

Sample Insights

Pharmaceuticals held the largest market share of 37.7% in 2021. Based on the sample, the market is segmented into pharmaceuticals, medical devices, and biopharmaceuticals. Pharmaceutical includes products such as parenteral, aerosols, ointments, eye drops, and others. These are the most widely used dosage forms. Growing demand for the aforementioned dosage forms, globally, is one of the major factors supporting the market's growth. Furthermore, the rising number of recalls of these dosage forms due to the lack of sterility is further supporting the demand for sterility testing of pharmaceuticals.

The biopharmaceutical segment is expected to grow with a CAGR of 11.7% during the forecast period. This is attributed to the factors such as the growing demand for biologics and biosimilar drugs owing to their effectiveness in treating serious diseases like cancer, neurological disorders, infectious diseases, and others. The improvement in the approvals of biologics and biosimilars during the last 5 years and growing demand for the biologics such as COVID-19 vaccines have further supported the segment market growth.

End-Use Insights

The other segment is projected to expand at a CAGR of 11.7% during the forecast period. Based on end-use, the market is segmented into pharmaceutical companies, medical device companies, compounding pharmacies and others. Other segment includes biopharmaceutical firms and partnered CROs, hospitals, clinics, and research laboratories.

Research laboratories have to ensure that test subjects and lab equipment are free from the contamination. Other end-users require sterility testing for the routine quality control and detection of microbial contamination of the devices and pharmaceutical products, in order to ensure patient safety. This further supports the segment's growth.

The pharmaceutical companies segment has held the largest share of 42.9% in 2021. Pharmaceutical companies have to conduct sterility tests to ensure the safety of the products, especially oral dosage forms, as most of these products are ingested by the patients. There are specific guidelines set in the pharmacopeia of each country, which describe the necessary sterility tests that are required to be performed for a given drug.

Regional Insights

In terms of region, North America held the largest market share of 49.6% in 2021. This may be attributed to the increasing number of pharmaceutical industries within the U.S. and Canada. The presence of a large number of major market players in this region is expected to contribute significantly to the market growth. Stringent regulatory requirements for the sterility testing of pharmaceuticals and medical devices in this region further support the growth of the regional market.

Asia Pacific is anticipated to witness the fastest growth during the forecast period. This can be attributed to the 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 (collaborations that support outsourcing activities). Such initiatives are likely to contribute towards regional development.

Key Players

SGS SA; Toxikon, Inc.; Pace Analytical Services, LLC; Boston Analytical; Charles River Laboratories International, Inc.; and Nelson Laboratories. Regional expansions and M&A

Market Segmentation

• Type Outlook 

  • In-house

  • Outsourcing

• Test type Outlook 

  • Sterility Testing

  • Bioburden Testing

  • Bacterial Endotoxin Testing

• End-use Outlook 

  • Compounding Pharmacies

  • Medical Devices Companies

  • Pharmaceutical Companies

  • Others

• Sample Outlook

  • Sterile Drugs

  • Medical Devices

  • Biologics & Therapeutics

• Regional Outlook 

  • North America

    • The U.S.

    • Canada

  • Europe

    • The U.K.

    • Germany

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

    • Mexico

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

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:

• Historic Year: 2017-2020
• Base Year: 2021
• Forecast Year 2021 to 2030

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

Research Methodology:

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

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.

Primary Sources

 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:

• To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
• Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
• Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
• To define, describe and forecast the market by type, application and region.
• To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
• To identify significant trends and factors driving or inhibiting the market growth.
• To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
• To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
• To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
• To strategically profile the key players and comprehensively analyze their growth strategies.