Bioburden Testing Market Size, Share & Trends Analysis Report By Product (Consumables, Instruments), By Test, By Application, By End-use, By Region, And Segment Forecasts, 2024 - 2030

Bioburden Testing Market Size & Trends

The global bioburden testing market size was valued at USD 1.28 billion in 2023 and is projected to grow at a CAGR of 14.3% from 2024 to 2030. Growing pharmaceutical, biotechnology, medical device, and food and beverage industries are expected to drive the growth. The rising concerns of consumers regarding food quality, is leading to the demand for bioburden testing. Additionally, effective quality assurance of pharmaceuticals is essential to reduce the risk and level of uncertainties that may occur in the future to the consumer’s health.

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 are anticipated to promote bioburden testing, thereby contributing to the market growth. In addition, several publications released by the organizations to promote awareness regarding safety testing tools are broadening the future growth prospects.

Increasing food safety standards have led to a 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 a 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 the 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

The consumables segment accounted for the largest market share of 66.3% in 2023 and is expected to register the fastest CAGR of 14.5% during the forecast period. The segment is further divided into culture media, reagents, and kits. Culture media offers essential nutrients for the development and cultivation of microorganisms, making it a pivotal component in bioburden testing. The increasing prevalence of personalized medicine, which relies heavily on diagnostic reagents and kits, is also contributing to the market growth.

The instruments segment is expected to register significant CAGR during the forecast period. The segment is further divided into automated microbial identification systems and PCR instruments. The tools provide increased sample processing capabilities, leading to quick testing. The automation reduces the possibilities of contamination and mistakes related to manual processes. The development of new pharmaceuticals and medical devices requires rigorous bioburden testing to deliver the most accurate and efficient result.

Test Insights

The aerobic count-testing segment accounted for the largest market share in 2023 and is expected to register the fastest CAGR during the forecast period. It is also known as standard plate count or total plate count which is a microbiological technique utilized for counting the overall quantity of living aerobic microorganisms such as yeast and mold. It ensures the overall cleanliness and hygiene of the environment and product as well. Many industries establish precise limits on aerobic bacteria counts to guarantee the safety and quality of their products.

The anaerobic count-testing segment is expected to register a significant CAGR during the forecast period. It is a microbiological technique used to ascertain the quantity of anaerobic bacteria in the sample provided. The anaerobic bacteria are the type of organisms, which survive and flourish in environments devoid of oxygen. The presence of high levels of these bacteria can contaminate the product and indicate spoilage, due to these factors the necessity for this segment rises.

Application Insights

The raw material testing segment accounted for the largest market share in 2023 and is expected to register the fastest CAGR during the forecast period. The increasing quality requirements in order to maintain the safety of products and services is driving the segment growth. Food and beverage, pharmaceutical, and biotechnology manufacturers are consistently improving the quality of their finished products by conducting thorough bioburden testing on raw materials.

The medical device-testing segment is expected to register a significant CAGR during the forecast period. It aids in assessing the overall amount of microbes present on medical equipment as a pre-sterilization quality check prior to their ultimate usage or placement. According to the World Health Organization (WHO), approximately 2 million, different kinds of medical devices are available globally, divided into over 7,000 generic device categories. The test on the devices is carried out to determine the durability, cleanliness, and quality of products while being manufactured. Device testing helps in getting optimal performance and better patient outcomes.

End-use Insights

The pharmaceutical & biotechnology companies segment accounted for the largest market share in 2023. The increase in drug production and thriving pharmaceutical and biotech industries are some of the key drivers attributing to the growth of the bioburden testing market. Moreover, growing government support for the pharmaceutical and biotechnology sectors is encouraging the expansion of market.

The contract manufacturing organizations segment is expected to register the fastest CAGR during the forecast period. The increasing demand for specialized expertise is resulting in the need for the requisite set of skills and resources to conduct bioburden tests with precision and effectiveness. The contract manufacturing organizations offer cost-efficient solutions by utilizing specialized equipment and economies of scale, leading to market growth.

Regional Insights

North America bioburden testing market held majority share of 35.66% in 2023. The increase in funding for research and development by the pharmaceutical and biotechnology sectors is driving market growth in the region.

U.S. Bioburden Testing Market Trends

The U.S. bioburden testing market dominated the North America market with a share of 85.6% in 2023 due to the development of new medical devices, drugs, and biologics to ensure patient’s safety and effective results. The increasing number of recalled drugs and devices is anticipated to drive the demand for validation of manufacturing processes.

Europe Bioburden Testing Market Trends

Europe bioburden testing market identified as a lucrative region in 2023 due to the increasing awareness among European consumers about product safety and cleanliness. The rising need for early detection of bioburden issues to protect and safeguard brand reputation along with consumer safety is becoming important in the region.

The UK bioburden testing market is expected to grow rapidly in the coming years due to the presence of a robust pharmaceutical and biotechnology industry. These industries play a vital role in driving the growth of the bioburden testing market.

Asia Pacific Bioburden Testing Market Trends

Asia Pacific bioburden testing market anticipated to witness significant growth. The market growth is a result of the growing recognition of the advantages of biological safety testing instruments. The increasing healthcare expenditures, improving clinical research infrastructure and the embracing of cost-effective and smaller technologies in clinical research are some of the drivers fueling the market growth.

Key Bioburden Testing Company Insights

Some key companies in bioburden testing market include Charles River Laboratories, Merck KGaA, WuXi AppTec, BD, Thermo Fisher Scientific Inc, and others. Major corporations engage in strategic initiatives, such as entering new markets, developing new products, and merging with or purchasing other companies.

• Charles River Laboratories has its service areas in drug discovery and development, research, manufacturing and commercialization. The company provides microbiology testing services such as bioburden testing, sterility testing, endotoxin testing for sterile products and microbial limits test, preservative efficacy testing for non-sterile products. 

Bioburden Testing Market Report Scope

Global Bioburden Testing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global bioburden testing market report based on product, test, application, end-use, and region.

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Consumables

    • Culture Media

    • Reagents and Kits

  • Instruments

    • Automated Microbial Identification Systems

    • PCR Instruments

• Test Outlook (Revenue, USD Million, 2018 - 2030)

  • Aerobic Count Testing

  • Anaerobic Count Testing 

  • Fungi/ Mold Count Testing 

  • Spore Count Testing 

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Raw Material Testing 

  • Medical Device Testing

  • In-process Material Testing 

  • Sterilization Validation Testing

  • Equipment Cleaning Validation 

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical & Biotechnology Companies 

  • Medical Device Manufacturers 

  • Contract Manufacturing Organizations 

  • Manufacturers of Food & Beverage and Agricultural Products 

  • Microbial Testing Laboratories 

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • KSA

    • UAE

    • South Africa

    • Kuwait