Bioburden Testing Market Size, Share & Trends Analysis Report By Product, By Test Type (Aerobic Count, Anaerobic Count), By Application (Raw Material Testing, Medical Device Testing), By End Use, And Segment Forecasts, 2019 - 2026

Report Overview

The global bioburden testing market size was valued at USD 727.0 million in 2018 and is expected to witness lucrative CAGR of 13.7% over the forecast period. Growing pharmaceutical, biotechnology, medical device, and food and beverage industries is expected to drive the growth.

Rise in government initiatives to promote bioburden testing tools is expected to drive the demand. High risk of microbial contamination and bioburden during pharmaceutical and biologics manufacturing is considered a key factor encouraging governments and private organizations to introduce various biological safety practices. Microbial contamination exerts a huge impact on biologics and pharmaceuticals manufacturing, generally, leading to product variability and significant loss of potency.

Various government authorities are also increasingly getting involved in issuing guidelines and microbial contamination prevention strategies, which is anticipated to promote bioburden testing, thereby contributing to the market growth. In addition, a number of publications released by the organizations to promote awareness regarding safety testing tools is broadening the future growth prospects.

Increasing food safety standards have led to high need for microbiological bioburden testing in the food and beverage industry. Hence, key players are expanding their portfolio in microbial testing tools for food and beverage. For instance, Merck has ready-to-use (RTU) culture media portfolio to test microbiological bioburden for non-sterile food and beverages.

Increasing R&D investments by prominent companies and research costs are expected to encourage companies to adopt highly efficient biological testing tools to counter the possible losses caused by contamination. For instance, Bristol-Myers Squibb invested in production of investigational medicine to support clinical trials. Furthermore, regulatory bodies, such as the U.S. Food and Drug Administration (FDA) requires sterilization validation, creating a need for bioburden testing for medical devices.

Product Insights

Consumables segment dominated the bioburden testing market in 2018 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 2018 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.

Test Type Insights

Aerobic count testing generated the largest market share in 2018 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.

Application Insights

Raw material testing dominated the market with the highest revenue share in 2018 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 2018. 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.

End Use Insights

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.

Regional Insights

North America held the largest revenue share in 2018 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.

Bioburden Testing Market Share Insights

Some of the key market players include 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; and Pacific Biolabs.

Key companies engage in strategic initiatives, such as geographic expansion, product development, and mergers and acquisitions. In addition, technologically advanced products manufactured by the key players are driving the demand. For instance, Milliflex Quantum by Merck Millipore are advanced filters for rapid bioburden detection. These are faster and more reliable methods compared to the traditional bioburden testing methods.

Bioburden Testing Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2015 to 2026. For the purpose of this study, Grand View Research has segmented the global bioburden testing market report on the basis of product, test type, application, end use, and region:

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

  • Consumables

    • Culture Media

    • Reagents and Kits

  • Instruments

    • Automated Microbial Identification Systems

    • PCR Instruments

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

  • Aerobic Count Testing

  • Anaerobic Count Testing 

  • Fungi/Mold Count Testing 

  • Spore Count Testing

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

  • Raw Material Testing 

  • Medical Device Testing

  • In-Process Material Testing 

  • Sterilization Validation Testing

  • Equipment Cleaning Validation

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

  • Pharmaceutical & Biotechnology Companies 

  • Medical Device Manufacturers 

  • 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