Bioburden Testing Market Analysis

Global Bioburden Testing Market Overview

Bioburden Testing Market Size valued at USD 1.24 Billion in 2023. The Bioburden Testing market industry is projected to rise from USD 1.40 Billion in 2024 to USD 3.30 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 11.30% during the forecast period (2024 - 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.

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

In November 2023, Charles River Laboratories Inc., one of the leading organizations in life sciences, introduced CliniPrime Cryopreserved Leukopaks, thus growing its variety of GMP-compliant cellular products.

Sotera Health LLC (Nelson Laboratories LLC), in collaboration with BSI, announced a strategic partnership on November 16th, 2023. As far as quality control in the healthcare industry concerns regulatory enforcement among others for pharmaceutical firms plus medical device manufacturers, this alliance is viewed as significant. Henceforth, Nelson Laboratories and BSI are fusing their information sources towards providing those institutions supplying goods requiring product certification so as to be compliant internationally with all-encompassing testing procedures around them.

In September 2023, the Milliflex Rapid System 2.0 was launched by Merck Millipore’s life science branch, a feature specifically designed for the pharmaceuticals industry that provides quick tests of bioburden and sterility, which are adaptable to both stand-alone or networked operation.

In August 2022, Lonza introduced the Nebula Multimode Reader in August 2022, a multimode reader certified for use with Lonza's turbidimetric, chromogenic and recumbent endotoxin detection methods.

Merck inaugurated its first Microbiology Application Training (MAT) Lab in the Jigani area of Bengaluru in July 2022, to provide facilities and technical skills to enhance microbiological quality control capabilities of the Indian life science community at large. The MAT Centre, costing EUR 200,000, covers an area of 1,100 square feet.

Berkshire Sterile Manufacturing unveiled its sterility isolator in June 2022 that will allow on-site sterility testing for GMP batches thus enabling most clients' results to be released faster.

One lot of Allergy Bee Gone for Kids Nasal Swab Remedy was voluntarily recalled by Buzzagogo in June 2022 due to microbial contamination that was identified as Bacillus cereus, a gram-positive bacterium by FDA, as well as high levels of yeast and mold.

In June 2022, The first Microbiology Application and Training Laboratory (MAT Lab) was officially opened by Merck KGaA in Jigani Bengaluru. This state-of-the-art space occupies an area of approximately eleven hundred square feet with investments totaling two hundred thousand euros. The Indian life science community hopes that MAT Lab would equip modern tools plus technical know-how that would allow them to improve their microbiological quality control capabilities.

In November 2022, Symbiosis Pharmaceutical Services invested around US1.3m into its own analytic services capability. Such an investment was designed to strengthen both analytical chemistry as well as its microbiology internal testing capabilities.

In February 2021 Element Materials Technology purchased Avomeen, which is a pharma analytics start-up business enterprise. This acquisition was expected to help in strengthening the Element Life Sciences North America business unit since Avomeen is one of the top percentile analytics testing services companies for core lifesciences end markets, sharply focused on pharmaceutical testing, biotech, and FDA-regulated consumer products.

In August 2020, that Nelson Labs acquired Gibraltar Laboratories based in New Jersey, a strategic move aimed at expanding the company’s outsourced testing capabilities in order to better serve the pharmaceutical and medical device sectors. Compendial microbiology, sterility assurance and analytical chemistry testing are among other things for which Gibraltar is famous.

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, 2023 & 2032 (USD Billion) 

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 2023 (USD Billion) 

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 2024 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