Bioburden Testing Market

Global Bioburden Testing Market Size (2023 to 2028)

The global market size for bioburden testing is forecasted to hike at a CAGR of 14.12% from 2023 to 2028 and be worth USD 2132 million by 2028 from USD 1258.4 million in 2023.

Bioburden testing involves investigating bacterium and other microorganisms on the surface of medical devices, pharmaceuticals, and other instruments; due to their frequent use, they need to be checked thoroughly and sterilized, providing that the testing must be accomplished without fail. In addition, the requirement of a quality check ensures that the drug and other pharmaceutical products have no microorganisms before ingestion. The various processes include removing bacteria and other organisms, one of which is delusion, meaning clearing the bacterium via a solvent. Ultrasonication, Shaking, Vortex mixing, and Flushing Blending is some methods used. The non-elution includes Contact placing, Agar overlay, and Most Probable Number (MPN). The Incubation and enumeration include Total aerobic count, Spore-forming colony count, and Total yeast and mold count.

Impact of COVID-19 on the global bioburden testing market:

The onset of COVID-19 was the reason behind the hindrance of supply chains, disturbing the supply and demand of various products and services. At the same time, the imposing lockdown further obstructed growth in multiple sectors. Bioburden refers to the presence of microorganisms categorized as pathogens or harmful bacteria on the surface, be it the surgical instruments or the clinical means to perform procedures; there lies a burden to clean them from the externals hence the word bioburden.

The COVID-19 pandemic, however, has proven to be highly beneficial to the bioburden testing market.

The spread of covid led to the immense need for respirators, and there was a need to reuse the particulate filtering facepiece respirators with the help of bioburden testing. Additionally, the United States Food Drug Administration (FDA) found it necessary to regulate the safety of Food and drug intake by providing strict sterilization guidelines to be compulsorily followed. The sterilization included that the bioburden testing is carried out successfully, due to which the demand for the market found its growth potential, as the post covid sanitization along with the awareness about the proper hygiene, these factors are propelling the growth of the market.

MARKET DRIVERS:

Growing usage of medical devices, increased safety concerns connected to food and beverage goods, and a rising number of product recalls due to microbial contamination are propelling the bioburden testing market growth.

Due to the increased awareness of hygiene, pharmaceutical companies along with Food and beverages companies are looking forward to better bio-testing methods, one of which accounts for polymerized chain reaction system is expected to become popular in the field of bio-parent testing as the molecular methods help identify pathogens with high precision and detection of various microorganism bacteria fungi virus.

The ever-increasing investment for better research done by academic and economic companies, specifically the rising trend of R&D investments, is anticipating the market's growth. The ever increasing demand for bioburden testing in contract manufacturing organizations is advancing as these organizations regulate drug manufacturing and its quality. Demand for bioburden testing tends to rise to determine and analyze the amount of contamination and product safety. Instruments and numerical materials used by the public need to ensure a minimum level of bioburden on the external surface as the risk of contamination of certain communication diseases threatens the company's growth. Many organizations are now aware of the importance of bioburden testing.

MARKET RESTRAINTS:

The lack of availability of skilled professionals, along with the expensive cost of instruments and lengthy procedures for the approval of specific processes, including a particular type of bioburden testing, is causing a hindrance to the market's growth; as in the Us, the cost of Mba production accounts for 100 USD per gram whereas the soaring cost of labor is USD 120 per hour the monoclonal antibiotic drugs follow production challenges. In addition, some restrainers are as filtration can result in an ineffective response against a specific virus. 

This market research report on the global bioburden testing market has been segmented and sub-segmented based on product, application, end-user, and region.

Bioburden Testing Market – By Product:

• Consumables
  • Culture Media and Reagents & Kits
  • Other Consumables
• Instruments
  • Automated Microbial Identification Systems
  • PCR
  • Microscopes
  • Other Instruments

Based on the product, the consumables segment is expected to contribute to significant growth as it comprises leading reagent easy to use systems an easily detect microorganisms The toolkits such as Merck KGaA offers Milliflex quantum bioburden testing tool kit aided with I.D. Technology provides consistent results, thus becoming helpful for the pharmaceutical and food industry.

Bioburden Testing Market – By Application:

• Raw Material Testing
• Medical Devices Testing
• In-process Testing
• Sterilization Validation Testing

Bioburden Testing Market – By End-User:

• Pharmaceutical and Biotechnology Companies
• Medical Device Companies
• Contract Manufacturing Organizations (CMOs)
• Food and Beverages Companies

Based on the end-user, the pharmaceutical and biotechnology companies segment led the market in 2021. More excellent production of drugs and funding and support through government organizations to the pharmaceutical industry and biotechnology companies, and the increasing production of medical devices along with research outbreaks in fields are providing outcomes for the market growth.

Bioburden Testing Market – By Region:

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

North America is dominating the bioburden testing market in terms of share and growth owing to several factors such as R&D investments by pharmaceutical and biotechnology industries along with increasing contamination in Food and beverages and government initiatives related to the accuracy of the safety process of drugs and devices in countries like the U.S. and Canada significantly contribute to the growth of the market.

The market for Asia-Pacific is expected to grow with the fastest CAGR during the forecast period due to the factors like solid investments, increased awareness of the advantages of biological safety testing tools, and rising healthcare costs. Furthermore, the rising expansion of the pharmaceutical and biotechnology industries, demand for better infrastructure in laboratory and clinical research, small-scale and affordable clinical research techniques, and the development of the pharmaceutical and biotechnology industries further promote the bioburden testing market in the Asia-Pacific.

The European region is also anticipated to account for a substantial share of the global market during the forecast period.

KEY MARKET PARTICIPANTS:

Charles River Laboratories International Inc., Sigma-Aldrich Corporation, SGS S.A., Wuxi Pharmatech (CAYMAN) Inc., Merck & Co. Inc., Becton, Dickinson, and Company, North American Science Associates Inc., Nelson Laboratories Inc., Pacific Biolabs, and ATS Labs Inc. are some of the prominent companies operating in the global bioburden testing market.

RECENT MARKET HAPPENINGS:

• Almac Sciences, a member of the Almac Group, announced the expansion of biologics testing to its existing portfolio of analytical solutions in 2020.
• The new Milliflex Oasis system, available from 2021, is an all-in-one filtration solution that includes sterilized, ready-to-use filtration units and pharmacopeia-compliant media for unparalleled comfort and peace mind when it comes to water and bioburden testing.
• In July 2022, to assist the Indian life science community in developing its microbiological quality control competence, Merck announced the opening of its first Microbiology Application and Training (MAT) Lab in Jigani, Bengaluru. This lab will provide facilities and technical expertise. The MAT Centre is 1,100 square feet and costs €200,000 to build. Sterility testing, quick bioburden testing, pyrogen testing, advanced membrane filtration, and other pharma Q.C. microbiology applications are among the testing services provided in the lab.