Bioburden Testing Market Research Report - Forecast till 2032

Bioburden Testing Market Research Report: Information By Product (Consumable and Instruments), By End User (Pharmaceutical & Biotechnology Companies, Medical Device Manufacturers, Food & Beverage and Others) And By Region (North America, Europe, Asia-Pacific, And Rest Of The World) –Market Forecast Till 2032

ID: MRFR/LS/5253-HCR | 90 Pages | Author: Kinjoll Dey | March 2024         

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Global Bioburden Testing Market Overview


Bioburden Testing Market Size valued at USD 1.1 Billion in 2022. The Bioburden Testing market industry is projected to rise from USD 1.24 Billion in 2023 to USD 3.30 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 13.00% during the forecast period (2023 - 2032).Increased food safety concerns, growing medical spending and increasing product recalls owing to microbial contamination are the key market drivers encouraging the growth of market.


Bioburden Testing Market


Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review


Bioburden Testing Market Trends



  • Growth in the medical devices, the pharmaceutical and the biotechnology industries is driving the growth of the market.


Market CAGR for bioburden testing is being driven by the growth in the medical devices, the pharmaceutical and biotechnology industries. Bioburden testing is done at all levels of manufacturing in the medical devices, biotechnology industries, and pharmaceuticals to reduce the risk. Bioburden testing is the process that measures the viable microorganisms on medical devices, packages, and raw materials. This process assists in parameter determination for its sterilization process in order to ensure the effectiveness and safety of medical devices.


Bioburden testing helps in routine monitoring of components, raw materials and assembly processes in the process of manufacturing. The testing is utilized for the assessment of cleaning processes, and the packaging of products is conducted to make sure safety. The increase in medical devices, growing product recalls because of microbial contamination, and pharmaceuticals are driving the growth of bioburden testing market. Additionally, the growing food & beverage and biotechnology industry's safety concerns boost the market growth. The rising preference for contract manufacturing and developing economies are generating opportunities in the market of bioburden testing. The growth in the initiatives of the government for promoting bioburden testing tools is anticipated to boost the demand for the high risk of microbial contamination, and bioburden throughout the biologics and pharmaceutical manufacturing is taken as a key factor boosting private and government organizations for introducing different biological safety practices. Microbial contamination possesses a huge effect on pharmaceutical and biologics manufacturing, leading to significant loss of potency and product variability.


Growing investments in R&D by the major market players and research costs are anticipated to boost the companies for adopting highly efficient biological testing tools in order to counter the possible losses caused by the contamination. Several government authorities are increasingly getting involved in setting up guidelines and microbial contamination prevention strategies, which is foreseen to fuel bioburden testing; also, the number of publications released by the organization for promoting awareness related to safety testing tools is widening the future growth of the market. Thus, driving the Bioburden Testing market revenue.


Bioburden Testing Market Segment Insights


Bioburden Testing Product Insights


The Bioburden Testing market segmentation, based on product, includes Consumables and Instruments. The consumable segment dominated the market, accounting for the largest market revenue due to rising demand from the pharmaceutical and food industry, as there is a requirement for frequent repeat purchases of kits and reagents. The consumables are further sub-segmented into reagents, culture media and kits; the consumables kits and reagents are available in the ready-to-use culture media. Further, the instrument segment is expected to witness steady growth as instruments are one-time investments.


Figure 1: Bioburden Testing Market, by Product, 2022 & 2032 (USD Billion) 


Bioburden Testing Market, by Product, 2022 & 2032


Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review


 Bioburden Testing End User Insights


The Bioburden Testing market segmentation, based on end users, includes Pharmaceutical & Biotechnology Companies, Medical Device Manufacturers, Food & Beverage and Others. The pharmaceutical & biotechnology company segment is anticipated to be the dominating market during the forecast period due to the vast scale of their respective industries and the rising number of medication production plants. These companies are continuously increasing the outsourcing of bioburden testing services, approving the products on parameters like specificity, accuracy, linearity and range. Further, the growing support of the government for pharmaceutical and biotechnology companies is expected to boost market growth. The medical device manufacturers segment is foreseen to witness the rapid growth throughout the forecast period.


Bioburden Testing Regional Insights


By region, the study gives market insights into the North America, Europe, Asia-Pacific and the Rest of the World. The Asia Pacific Bioburden Testing market area dominates the market because of the rise in awareness and concerns about the benefits of biological safety testing tools. Also, the increase in healthcare spending, adoption of compact and low-cost techniques in clinical research, and demand for better infrastructure in laboratory and the clinical research.


Further, the major countries studied in the market report are the US, Canada, German, France, the UK, Italy, Spain, Japan, India, China, Australia, South Korea, and Brazil.


Figure 2: BIOBURDEN TESTING MARKET SHARE BY REGION 2022 (USD Billion) 


BIOBURDEN TESTING MARKET SHARE BY REGION 2022


Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review


The North American Bioburden Testing Market accounts for the second-largest market revenue due to the presence of large biotechnology industries, the development of new biologics, drugs and vaccines and the booming medical device sector due to the advancement in technology in this region. Moreover, the US Bioburden Testing market held the largest market share, and the Canadian Bioburden Testing market was the rapid-growing market in the North American region.


Europe's Bioburden Testing market is expected to grow at the rapid CAGR from 2023 to 2032. This is due to the availability of huge funds for research by government and private sectors in this region. Further, the German Bioburden Testing market held the largest market share, and the UK Bioburden Testing market was the rapid-growing market in the European region.


Bioburden Testing Key Market Players & Competitive Insights


Leading market players are investing hugely in research and development in order to expand their product lines, which will help the Bioburden Testing market grow even more. Market players are also undertaking a variety of strategic activities to spread their footprint, with important market developments including new product launches, mergers and acquisitions, contractual agreements, higher investments, and collaboration with other organizations. To spread and survive in a more competitive and rising market climate, the Bioburden Testing industry must offer cost-effective items.


Manufacturing locally to reduce the operational costs is one of the key business tactics utilized by the manufacturers in the Bioburden Testing industry to benefit the clients and increase the market sector. In recent years, the Bioburden Testing industry has offered some of the most significant advantages to the medicine. Major players in the Bioburden Testing market, including Charles River Laboratories International Inc., Merck & Co., Inc., Lonza, Becton, Dickinson and Company, Pacific BioLabs Inc., Sotera Health, North American Science Associates Inc., ATS Laboratories, SGA SA, Wuxi Pharmatech Inc., and others, are trying to increase market demand by investing in the research and development operations.


Merck & Co. Inc., founded in the year 1668, and headquartered in Rahway, New Jersey, is an American multinational pharmaceutical company. The company involves in the provision of health solutions via its vaccines, prescribed medicines, animal health, biological therapies and consumer care products. The company does business in pharmaceuticals, healthcare services, animal health and alliances. In July 2022, the company launched the first Microbiology Application and Training (MAT) Lab in the Jigani neighborhood of Bengaluru. This will offer technical skills and facilities in order to assist the Indian life science community in improving microbiological quality control capabilities. The MAT Centre covers an area of 1,100 square feet, costing EUR 200,000.


Charles River Laboratories International Inc., founded in the year 1947, an American pharmaceutical company specializing in a variety of preclinical and clinical laboratory, the cell and gene therapy services for the medical devices, pharmaceutical and biotechnology industries. The company also offers outsourcing services, assorted biomedical products and animals for research and development in the pharmaceutical industry and provides support in the field of drug discovery, basic research, clinical support, and manufacturing. In 2020, the company acquired a premier safety assessment, contract development and manufacturing (CDMO) service provider, WIL Research. This acquisition was focused on strengthening the position of the company as a leading early-stage CRO. The company also acquired a premier non-clinical contract research organization, MPI Research, in order to enhance the capacity of the company to partner with clients throughout the drug discovery and development industry.


Key Companies in the Bioburden Testing market include




  • Charles River Laboratories International Inc.




  • Merck & Co., Inc.




  • Lonza




  • Becton, Dickinson and Company




  • Pacific BioLabs Inc.




  • Sotera Health




  • North American Science Associates Inc.




  • ATS Laboratories




  • SGA SA




  • Wuxi Pharmatech Inc.




Bioburden Testing Industry Developments


August 2022:The Nebula Multimode Reader, launched by Lonza, is the first multimode reader certified for the utilization of chromogenic, turbidimetric and recombinant endotoxin detection methodologies.


January 2022:Solace Nutrition, is a US-based medical nutrition company, bought R-Kane Nutritionals' assets. This asset acquisition enables the Solace Nutrition in order to develop synergy between both brands, accelerate growth, and establish the position in an adjacent nutrition sector. The R-Kane Nutritionals is a firm established in the US that specializes in high-protein meal replacement products for weight loss.


October 2018:IBR Inc., an organization for non-clinical contract research, was acquired by SGS SA. IBR INC. emphasizes important services for the production of biologics, vaccines and biosimilars in biopharmaceutical research and provides a range of filter testing and particle counting services.


Bioburden Testing Market Segmentation


 Bioburden Testing Product Outlook




  • Consumable




  • Instruments




Bioburden Testing End User Outlook


  • Pharmaceutical & Biotechnology Company




  • Medical Device Manufacturers




  • Food & Beverage




  • Others




Bioburden Testing Regional Outlook




  • North America






  • US




  • Canada






  • Europe






  • Germany




  • France




  • UK




  • Italy




  • Spain




  • Rest of Europe






  • Asia-Pacific




    • China




    • Japan




    • India




    • Australia




    • South Korea




    • Australia




    • Rest of Asia-Pacific






  • Rest of the World




    • Middle East




    • Africa




    • Latin America





Report Scope:

Report Attribute/Metric Details
Market Size 2022 USD 1.1 Billion
Market Size 2023 USD 1.24 Billion
Market Size 2032 USD 3.30 Billion
Compound Annual Growth Rate (CAGR) 13.00% (2023-2032)
Base Year 2022
Market Forecast Period 2023-2032
Historical Data 2018- 2022
Market Forecast Units Value (USD Billion)
Report Coverage Revenue Forecast, The Market Competitive Landscape, Growth Factors, and Trends
Segments Covered Product, End User and Region
Geographies Covered North America, Europe, Asia Pacific, and the Rest of the World
Countries Covered The US, Canada, German, France, UK, Italy, Spain, Japan, India, China, Australia, South Korea, and Brazil
Key Companies Profiled Charles River Laboratories International Inc., Merck & Co., Inc., Lonza, Becton, Dickinson and Company, Pacific BioLabs Inc., Sotera Health, North American Science Associates Inc., ATS Laboratories, SGA SA, Wuxi Pharmatech Inc.  
Key Market Opportunities R&D amongst key market players and new product launches.
Key Market Dynamics Increased food safety concerns, growing medical spending and rising product recalls because of microbial contamination.




Frequently Asked Questions (FAQ) :

The Bioburden Testing market size valued at USD 1.1 Billion in 2022.

The market is foreseen to rise at a CAGR of 13.00% during the forecast period, 2023-2032.

The Asia Pacific had largest share of the market

The key players in the market are Charles River Laboratories International Inc., Merck & Co., Inc., Lonza, Becton, Dickinson and Company, Pacific BioLabs Inc., Sotera Health, North American Science Associates Inc., ATS Laboratories, SGA SA, and Wuxi Pharmatech Inc.

The consumables category dominated the market in 2022.

The Pharmaceutical & Biotechnology Company had the largest share in the market.

Key Questions Answered

  • Global Market Outlook
  • In-depth analysis of global and regional trends
  • Analyze and identify the major players in the market, their market share, key developments, etc.
  • To understand the capability of the major players based on products offered, financials, and strategies.
  • Identify disrupting products, companies, and trends.
  • To identify opportunities in the market.
  • Analyze the key challenges in the market.
  • Analyze the regional penetration of players, products, and services in the market.
  • Comparison of major players’ financial performance.
  • Evaluate strategies adopted by major players.
  • Recommendations
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