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Bioburden Testing Market

Bioburden Testing Market Size, Share & Trends Analysis Report By Product (Aerobic Count Testing, Anaerobic Count Testing, Fungi/Mold Count Testing, Spores Count Testing), By Application (Raw Material Testing, Medical Device Testing, In-process Testing, Sterilization Validation Testing, Equipment Cleaning Validation), By End User (Pharmaceutical and Biotechnology Companies, Medical Device Manufacturers, Contract Manufacturing Organizations (CMOs), Manufacturers of Food & Beverage and Agricultural Products, Microbial Testing Laboratories) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Report Code: SRHI318DR
Study Period 2020-2032 CAGR 15.4%
Historical Period 2020-2022 Forecast Period 2024-2032
Base Year 2023 Base Year Market Size USD XX Billion
Forecast Year 2032 Forecast Year Market Size USD XX Billion
Largest Market North America Fastest Growing Market Europe
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Market Overview

The Bioburden testing market size was valued at USD 652 million in 2017 and is expected to grow at a CAGR of 15.4% during the forecast period 2019-2026.

Bioburden testing is a modern day application used to measure the total number of viable micro-organisms on medical devices, raw material, and packaging food as the presence of these organisms can cause severe health issues. The prevalence of food poisoning is increasing at an alarming rate. To address to the situation, governments around the world are making it mandatory for the hospitals, dairy farms, and food industry among others to run their instruments through bio-burden testing before using them. Moreover, increasing application of bioburden testing in the pharmaceutical and biotechnology, medical device, food & beverage and agricultural products manufacturing industry is driving the market growth. Globally, the pharmaceuticals market is expected to grow from USD 1 trillion in 2015 to USD 1.3 trillion by 2020 at an annual growth rate of 4.9%.


Regional Analysis

Geographically, the global bioburden testing market is segmented into North America, Europe, Asia Pacific, Latin America and the Middle East & Africa (LAMEA).

North America accounted for largest share of bioburden testing market. Increasing prevalence of food borne illness in U.S. due to increasing contamination in Food and beverages is influencing demand for bioburden testing.  For instance, Centres for Diseases Control and Prevention, in 2018, around 48 million people affected due to food borne illness in U.S. Moreover, Government regulation and general guidelines for pharmaceutical industries for bioburden testing is major factor for the growth of market. For instance, Federal Regulations such as (CFR) 21 CFR 211.113 and recommended USP microbiological examination of pharmaceutical nonsterile products. Adoption of new technologies has led to harmonization of quality and standards in the healthcare industry.  Furthermore, around 2.7% of GDP of U.S. spend on research & development is major opportunity for market growth. Moreover, increasing incidence of food recall adulterated due to possible product contamination due to microorganisms is also influencing demand for bioburden testing market. For instance, In July 2019, The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced recalled around 712 lbs. of raw beef and pork products due to contamination.

Europe is accounted for significant market revenue and expected to grow in the forecast period. 

High prevalence of Infectious diseases, such as HIV, human papilloma virus (HPV), and hepatitis B and C, are infectious diseases spread through food. For instance, according to the World Health Organization, in 2016, approximately 3,813 cases of hepatitis A found in the U.K.  Thus, growing incidences of such diseases is increasing the demand for the bioburden testing market. In addition, expansion of medical devices, and pharmaceutical and biotechnology in this region is influence demand of bioburden testing market.  Furthermore, innovation and technological advancement in bioburden testing is rapid determination of burden of microorganism. For instance, amplified bioluminescence technology determine the presence or absence of viable micro-organisms in products. It is effective method for screen bacteria, yeast and Mold. It take less time as compared to other method of bioburden testing. Apart from this, increasing number of product recalls due to microbial contamination is major factor for the growth of market. For instance, In 2019, M & A pharmachem limited announced recall of paracetamol.

Report Scope

Report Metric Details
By Product
  1. Aerobic Count Testing
  2. Anaerobic Count Testing
  3. Fungi/Mold Count Testing
  4. Spores Count Testing
By Application
  1. Raw Material Testing
  2. Medical Device Testing
  3. In-process Testing
  4. Sterilization Validation Testing
  5. Equipment Cleaning Validation
By End User
  1. Pharmaceutical and Biotechnology Companies
  2. Medical Device Manufacturers
  3. Contract Manufacturing Organizations (CMOs)
  4. Manufacturers of Food & Beverage and Agricultural Products
  5. Microbial Testing Laboratories
Company Profiles Charles River (U.S.) Merck KGaA (Germany) SGS SA (Switzerland) WuXi AppTec (China) BD Company (U.S.) North Americanscience Associates Inc. (U.S.) Nelson Laboratories LLC (U.S.) Thermo Fisher Scientific (US) biomérieux SA (France) Pacific BioLabs (U.S.)
Geographies Covered
North America U.S. Canada
Europe U.K. Germany France Spain Italy Russia Nordic Benelux Rest of Europe
APAC China Korea Japan India Australia Taiwan South East Asia Rest of Asia-Pacific
Middle East and Africa UAE Turkey Saudi Arabia South Africa Egypt Nigeria Rest of MEA
LATAM Brazil Mexico Argentina Chile Colombia Rest of LATAM
Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends
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Segmental Analysis

The global bioburden testing market is segmented by product, type, application, end user, and regions.

By product, the global bioburden testing market is segmented into consumables and instruments. The consumables is sub-segmented into culture media, reagents, and kits. The instrument segment is further classified into automated microbial identification systems, PCR instruments, and microscopes.

The consumables segment is leading the bioburden testing market on account of significantly growing demand from the pharmaceutical and food industry. In addition, for bioburden testing, the consumables reagents and kits are available in ready to use culture media. For instance, Merck KGaA, offers Milliflex Quantum bioburden testing reagent kit for easy-to-use system and rapid detection of organisms. Bioburden testing is a non-destructive technology that can easily recover and collect any microorganisms using existing ID technology. In addition, it is an easy to use, flexible technology it can aslo provide consistent results across all applications.

By type, bioburden testing market is segmented into aerobic count testing, anaerobic count testing, fungi/mold count testing, and spores count testing.  Aerobic count testing segment holds the largest market share. In the environment, there are millions of pathogenic micro-organisms that has the potential to create severe complications, here’s where aerobic count testing steps in. Moreover, it is mandatory for the manufacturers to calculate the total aerobic microbial count in the pharmaceutical, food, and cosmetics industries.

Market Size By Product

Market Size By Product
  • Aerobic Count Testing
  • Anaerobic Count Testing
  • Fungi/Mold Count Testing
  • Spores Count Testing
  • Top Key Players

    Bioburden Testing Market Share of Key Players

    Bioburden Testing Market Share of Key Players
    Charles River (U.S.) Merck KGaA (Germany) SGS SA (Switzerland) WuXi AppTec (China) BD Company (U.S.) North Americanscience Associates Inc. (U.S.) Nelson Laboratories LLC (U.S.) Thermo Fisher Scientific (US) biomérieux SA (France) Pacific BioLabs (U.S.) Others

    Frequently Asked Questions (FAQs)

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