Bioburden Testing Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2028

Published Date : Jan 2021 | No. of Pages : 250 Pages | Category : Healthcare

The global Bioburden Testing market size is expected to be worth around US$ 2.06 billion by 2028, according to a new report by Vision Research Reports.

The global Bioburden Testing market size was valued at US$ 727.04 million in 2020 and is anticipated to grow at a CAGR of 13.10% during forecast period 2021 to 2028.

Growth Factors

The market is expected to showcase upward trend in the forthcoming years owing to growing concerns about product safety. This has led to various government initiatives to promote microbiological safety testing tools.

A number of publications released by organizations to promote awareness regarding microbiological safety testing is broadening the future growth prospects of bioburden testing. For instance, the U.S. Department of Health and Human Services and Centers for Disease Control published Biosafety in Microbiological and Biomedical Laboratories (BMBL), which includes information pertaining to laboratory biosecurity and risk assessment, decontamination and sterilization, and biological toxins and biosafety levels in laboratories.

Growth of pharmaceutical, biotechnology, medical device, and food and beverage industries have contributed to the high growth of the bioburden testing market. In addition, increase in R&D investments by prominent companies is expected to encourage end users to adopt highly efficient bioburden testing tools to counter possible losses due to microbial contamination. Merck is planning to invest USD 16 billion in R&D over the next five years, in addition to its annual investment of USD 7 billion. Moreover, requirement for basic drug safety data requirements for preclinical studies is expected to fuel the demand for bioburden testing tools.

Report Highlights

Consumables segment dominated the bioburden testing market in 2020 due to the repetitive use of these culture media, reagents, and kits. The solid and liquid culture media for detecting aerobic microorganisms are manufactured based on the harmonized standards of the U.S., European, and Japanese Pharmacopeias.

Instruments segment held significant market share in 2020 due to the availability of advanced technologies for rapid microbial testing. The segment is broken down into two categories, namely, automated microbial identification systems and PCR instruments. Advancements in PCR instruments are expected to further drive the segment growth over the forecast period.

Aerobic count testing generated the largest market share in 2020 due to its wide application for determining the total bacterial population on a sample. In addition, it is used for sanitary inspection and organoleptic check especially food products. Anaerobic count tests, on the other hand, are also necessary, as anaerobic bacteria are common causes of infection.

Bioburden testing is classified into two phases. In the first phase, quantitative analysis of total number of aerobic bacteria, mold, and yeast are identified. In the second phase, a qualitative analysis is conducted wherein the presence or absence of specified microorganisms is determined. Spore count tests are also used for determining the bioburden percent recovery, thus, can be considered as an alternative to the aforementioned testing types.

Raw material testing dominated the market with the highest revenue share in 2020 due to the rising quality standards to maintain the safety of final goods and services. Pharmaceutical, biotechnology, and food and beverage manufacturers are continuously enhancing the quality of the finished products through and rigorous bioburden testing of raw materials.

Medical device testing also held significant shares in 2020. It helps measure the total microbial count on medical devices as a pre-sterilization quality control method before their final use or implantation. In-process material tests, on the other hand, are performed to identify the quality, strength, and purity of products during manufacturing process. The sterilization validation test works with the identification of the number of bioburden to set the sterilization dose for quality control.

Pharmaceutical and biotechnology companies is the largest revenue generating segment, due to the booming pharma and biotech industry and rise in the number of drug manufacturing. In addition, rising government support for pharmaceutical and biotechnology industries is expected to drive the growth. Rise in the number of medical device manufacturers is also anticipated to propel the overall market growth in the forthcoming years.

Contract Manufacturing Organizations (CMOs) segment is expected to showcase lucrative growth over the forecast period. Pharmaceutical and biotech companies are increasingly outsourcing bioburden testing services that approve products on parameters such as accuracy, specificity, linearity, and range. Increasing food safety guidelines has also led the food and beverage manufacturers to undertake effective microbiological testing for detecting bacteria and spores, such as thermophilic anaerobic microorganisms in canned food.

North America held the largest revenue share in 2020 due to the rise in R&D investments by pharmaceutical and biotechnology industries. In addition, development of new biologics, vaccines, and drugs in U.S. is creating high demand for bioburden testing services. The medical devices sector in U.S. is also booming owing to the technological advancements. this factor is anticipated to bode well for the regional market growth in near future.

The lucrative growth registered in Asia Pacific market for bioburden testing is believed to be an outcome of the rise in awareness pertaining to the benefits of biological safety testing tools. Some other factors driving the growth include growing healthcare spending, demand for better infrastructure in laboratory and clinical research, and adoption of compact and low-cost techniques in clinical research.

Key Players

Charles River Laboratories International, Inc.; SGS SA; Merck KGaA; Becton, Dickinson and Company; Wuxi Apptec; North American Science Associates Inc.; Nelson Laboratories, LLC; Biomérieux SA; Thermo Fisher Scientific; Pacific Biolabs.

Market Segmentation

  • Product Outlook 

    • Consumables

      • Culture Media

      • Reagents and Kits

    • Instruments

      • Automated Microbial Identification Systems

      • PCR Instruments

  • Test Type Outlook 

    • Aerobic Count Testing

    • Anaerobic Count Testing 

    • Fungi/Mold Count Testing 

    • Spore Count Testing

  • Application Outlook 

    • Raw Material Testing 

    • Medical Device Testing

    • In-Process Material Testing 

    • Sterilization Validation Testing

    • Equipment Cleaning Validation

  • End Use Outlook 

    • Pharmaceutical & Biotechnology Companies 

    • Medical Device Manufacturers 

    • Contract Manufacturing Organizations 

    • Manufacturers of Food & Beverage and Agricultural Products 

    • Microbial Testing Laboratories

  • Regional Outlook 

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • U.K.

      • France

      • Italy

      • Spain

      • Russia

    • Asia Pacific

      • Japan

      • China

      • India

      • South Korea

      • Australia

      • Singapore

    • Latin America

      • Brazil

      • Mexico

      • Argentina

    • MEA

      • South Africa

      • Saudi Arabia

      • UAE

The Bioburden 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 Bioburden Testing market for the base year 2020 and the forecast between 2021 and 2028. 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 Bioburden Testing market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Bioburden 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 Bioburden 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 Bioburden 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 Bioburden 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 Bioburden Testing market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2028. 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 Bioburden Testing market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Bioburden 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 Bioburden 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 Bioburden 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 Bioburden 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 Bioburden 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 Bioburden Testing market. These factors have benefited the growth of the global market for Bioburden 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 Bioburden 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 Bioburden Testing are as follows:

  • Historic Year: 2017-2020
  • Base Year: 2020
  • Forecast Year 2021 to 2028

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 (2021-2028);
  • 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.

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