Global Bioburden Testing Market by Test Type (Anaerobic Count, Aerobic Count), by Application (Medical Device Testing, Raw Material Testing) and Region (North America, Latin America, Europe, Asia Pacific and Middle East & Africa), Forecast To 2028

Summary of the Report

Global bioburden testing market was worth USD 727.0 million in 2018. It is projected to grow at a 13.7% CAGR over the forecast period. The growth is expected to be driven by the growing pharmaceutical, medical device, food and beverage, and HTML3_ biotechnology HTML3_ industries.

The demand will rise due to increased government initiatives to encourage bioburden testing tools. The high risk of bioburden and microbial contamination during pharmaceutical and biologics manufacturing are key factors that encourage governments and private companies to adopt biological safety measures. Microbial contamination can have a significant impact on pharmaceutical and biologics manufacturing. This can lead to product variation and significant loss in potency.

Many government agencies are increasingly involved in the issuing of guidelines and microbial contamination prevention strategy, which will promote bioburden testing and contribute to market growth. The future growth prospects are also being enhanced by the publication of a variety of publications that promote safety testing tools.

Food safety standards are increasing, which has led to a high demand for microbiological bioburden tests in the food and drink industry. Key players are increasing their range of microbial testing tools in food and beverages. Merck, for example, has a ready-to-use culture media portfolio (RTU), to test microbiological bioburden in non-sterile foods and beverages.

Companies are expected to invest more in R&D and reduce their research costs to develop highly efficient biological testing tools that can counter contamination losses. Bristol-Myers Squibb, for example, invested in the production of investigational medicines to support clinical trials. Additionally, FDA (U.S. Food and Drug Administration) requires sterilization validation. This creates a need to test for bioburden in medical devices.

Product Insights

Due to the repeated use of culture media, reagents and kits, the consumables segment dominated bioburden testing in 2018. The U.S., European and Japanese Pharmacopeias have agreed to produce the solid and liquid media used for the detection of aerobic microorganisms.

The Instruments segment held a significant market share in 2018, owing to the availability advanced technologies for rapid microbiological testing. This segment can be divided into two types: automated microbial identification system and PCR instruments. The segment will continue to grow due to the advancements in PCR instruments.

Test Type Insights

The largest market share for aerobic count testing was in 2018, due to its broad application for determining total bacterial populations on samples. It is also used to inspect and check for food safety, organoleptic checks, and sanitary inspection. Anaerobic counts tests are required, since anaerobic bacteria is a common cause of infection.

There are two types of bioburden testing. The first phase consists of a quantitative analysis that identifies the total number of yeast, aerobic bacteria, and mold. The second phase consists of a qualitative analysis that determines the presence or absence specific microorganisms. Spore count tests can also be used to determine the bioburden percent recover, and are therefore an alternative to the above types of testing.

Application Insights

The market leader in raw material testing was 2018 thanks to rising standards for quality to ensure safety of final products and services. Manufacturers of pharmaceutical, biotechnology, food, and beverage products are constantly improving the quality of their finished products by rigorous bioburden testing.

In 2018, medical device testing accounted for a significant share. In 2018, medical device testing accounted for a significant share of the market. It measures the total microbial count in medical devices before they are used or implanted. On the other hand, in-process material testing are used to determine the quality, strength, or purity of products as they are being manufactured. Sterilization validation tests are used to identify the amount of bioburden in order to determine the sterilization dose.

End Use Insights

Due to the growing pharma and biotech industries and the rise in drug manufacturing, pharmaceutical and biotechnology companies are the most lucrative revenue-generating segments. The growth is expected to be driven by rising government support for the pharmaceutical and biotechnology sectors. The market will see a rise in medical device manufacturers in the coming years.

The Contract Manufacturing Organizations segment (CMOs), is expected to experience lucrative growth during the forecast period. Biotech and pharmaceutical companies are outsourcing bioburden testing services to approve products on parameters like accuracy, specificity and linearity. Food and beverage companies are increasingly outsourcing microbiological testing to detect bacteria and spores.

Regional Insights

North America accounted for the majority of 2018's revenue. This is due to increased R&D investments in the pharmaceutical and biotechnology sectors. Bioburden testing services are also in high demand due to the development of new drugs, biologics, and vaccines in the United States. Technological advancements are also driving the growth of the U.S. medical device sector. This is expected to be a positive factor for the region's future market growth.

It is believed that the increase in awareness about the benefits of biosafety testing tools has led to the lucrative growth in the Asia Pacific market for bioburden test. Other factors contributing to the growth are rising healthcare spending, increased demand for better infrastructure in laboratory research and clinical research, as well as the adoption of low-cost and compact clinical research techniques.

Bioburden Testing Market Share Insights

Charles River Laboratories International, Inc., Merck KGaA, Merck KGaA, Becton, Dickinson and Company, Wuxi Apptec, North American Science Associates Inc., Nelson Laboratories, LLC, Biomerieux SA, Thermo Fisher Scientific, and Pacific Biolabs are some of the market leaders.

Strategic initiatives are undertaken by key companies, including geographic expansion, product development and mergers and acquisitions. The demand is also driven by technologically advanced products made by key players. Milliflex Quantum from Merck Millipore is an advanced filter for quick bioburden detection. These methods are more reliable and faster than traditional bioburden testing methods.

Bioburden Testing Market Report Scope

The Report Covers Certain Segments

This report predicts revenue growth at the global, regional and country level and offers an analysis of industry trends and opportunities for each sub-segment between 2015 and 2026. Grand View Research has divided the global bioburden market report by product, test type and application.

• Product Outlook (Revenue USD Million, 2015-2026)

  • Consumables

    • Culture Media

    • Reagents & Kits

  • Instruments

    • Automated Microbial Identification Systems

    • PCR Instruments

• Type Outlook Test (Revenue, USD million, 2015-2026)

  • Aerobic Count Testing

  • Anaerobic Count Test

  • Fungi/Mold Count Testing

  • Spore Count Testing

• Application Outlook (Revenue USD Million, 2015-2026)

  • Test of raw material

  • Medical Device Testing

  • Material Testing During Production

  • Sterilization Validation Testing

  • Equipment Cleaning Validation

• End Use Outlook (Revenue USD Million, 2015-2026)

  • Companies in Pharmaceutical & Biotechnology

  • Manufacturers of Medical Devices

  • Contract Manufacturing Organizations

  • Manufacturers of Food & Beverage and Agricultural Products

  • Microbial Testing Laboratories

• Regional Outlook (Revenue USD Million, 2015-2026)

  • 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

These are the most frequently asked questions about this report

b. Global bioburden testing market was valued at USD 818.3 Million in 2019, and is forecast to grow to USD 923.0 in 2020.

b. Global bioburden testing markets are expected to expand at a compound annual rate of 13.7% between 2019 and 2026, reaching USD 2.0 billion in 2026.

b. With a 36.7% share in 2019, North America was the dominant market for bioburden testing. This can be attributed to the rise in R&D investments made by the pharmaceutical and biotechnology sectors, as well as development of new biologics and vaccines in U.S. and technological advances.

b. b.

b. The market growth is driven by the growing pharmaceutical, medical device and food and drink industries as well as government initiatives to support bioburden testing tools.

Up Market Research published a new report titled “Bioburden Testing Market research report which is segmented by Test Type (Anaerobic Count, Aerobic Count), by Application (Medical Device Testing, Raw Material Testing), By Players/Companies Charles River Laboratories International, LLC; Biom©rieux SA; Thermo Fisher Scientific; and Pacific Biolabs, Inc; SGS SA; Merck KGaA; Becton, Dickinson and Company; Wuxi Apptec; North American Science Associates Inc; Nelson Laboratories”. As per the study the market is expected to grow at a CAGR of XX% in the forecast period.

The report covers comprehensive data on emerging trends, market drivers, growth opportunities, and restraints that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include products, applications, and competitor analysis.

Global Bioburden Testing Market Report Segments:

The market is segmented by Test Type (Anaerobic Count, Aerobic Count), by Application (Medical Device Testing, Raw Material Testing).

Bioburden Testing Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report.

Key Benefits for Industry Participants & Stakeholders:

• Industry drivers, restraints, and opportunities covered in the study
• Neutral perspective on the market performance
• Recent industry trends and developments
• Competitive landscape & strategies of key players
• Potential & niche segments and regions exhibiting promising growth covered
• Historical, current, and projected market size, in terms of value
• In-depth analysis of the Bioburden Testing Market

Overview of the regional outlook of the Bioburden Testing Market:

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa (MEA). North America region is further bifurcated into countries such as U.S., and Canada. The Europe region is further categorized into U.K., France, Germany, Italy, Spain, Russia, and Rest of Europe. Asia Pacific is further segmented into China, Japan, South Korea, India, Australia, South East Asia, and Rest of Asia Pacific. Latin America region is further segmented into Brazil, Mexico, and Rest of Latin America, and the MEA region is further divided into GCC, Turkey, South Africa, and Rest of MEA.

Highlights of The Bioburden Testing Market Report:

1. The market structure and projections for the coming years.
2. Drivers, restraints, opportunities, and current trends of Bioburden Testing Market.
3. Historical data and forecast.
4. Estimations for the forecast period 2028.
5. Developments and trends in the market.

                1. Anaerobic Count

                2. Aerobic Count

                1. Medical Device Testing

                2. Raw Material Testing

8. Market scenario by region, sub-region, and country.
9. Market share of the market players, company profiles, product specifications, SWOT analysis, and competitive landscape.
10. Analysis regarding upstream raw materials, downstream demand, and current market dynamics.
11. Government Policies, Macro & Micro economic factors are also included in the report.

We have studied the Bioburden 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 2028.

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Reasons to Purchase the Bioburden Testing Market Report:

• The report includes a plethora of information such as market dynamics scenario and opportunities during the forecast period
• Segments and sub-segments include quantitative, qualitative, value (USD Million,) and volume (Units Million) data.
• Regional, sub-regional, and country level data includes the demand and supply forces along with their influence on the market.
• The competitive landscape comprises share of key players, new developments, and strategies in the last three years.
• Comprehensive companies offering products, relevant financial information, recent developments, SWOT analysis, and strategies by these players.