Number of pages: 100 | Report Format: PDF | Published date: February 21, 2023
Historical Years – 2020 | Base Year – 2021 | Forecasted Years – 2022-2030
According to the deep-dive market assessment study by Growth Plus Reports, the global bioburden testing market was valued at US$ 950.0 million in 2021 and is expected to register a revenue CAGR of 12.7% to reach US$ 2,786.4 million by 2030.
Global Bioburden Testing Market Fundamentals
Bioburden is referred to as the quantity and varieties of bacterial and fungal flora found on or in a device, substrate, or chemical. Bioburden plays a significant role in determining the necessity to achieve sterility, which affects the presence of toxins. Bioburden testing is the activity necessary to quantify microbial contamination in water, raw materials, or finished products to ensure the safety of a manufactured product. Bioburden testing is also important in determining the number of bacteria on a material and is also useful for determining its resistance to various treatments. Effective quality control and reliable test findings are critical for reducing consumer risks and are needed in regulated manufacturing environments.
Global Bioburden Testing Market Dynamics
The growing development in the biotech and pharma industries is the major driving factor of the global bioburden testing market. Moreover, the expanding medical devices industries and increase in the demand for implantable devices are playing a significant role in the revenue growth of the global market. Similarly, the rising concerns regarding the safety of food and beverage products are boosting the growth of the global market. The continuous recall of products due to microbial or fungal infections is increasing the demand for bioburden testing. The rise in investment by the major companies in R&D activities is propelling the market. Moreover, the possibility of losing the potency of the product due to infections is encouraging companies to adopt bioburden testing. Additionally, government authorities are issuing new guidelines for microbial testing, which is also fueling the growth of the global market.
However, the high expenditure cost of microbial enumeration instruments is restricting the revenue growth of the global bioburden testing market. Moreover, the high cost of consumables and instruments used in the detection is also hampering the revenue growth of the global market.
Global Bioburden Testing Market Ecosystem
The global bioburden testing market has been analyzed from five perspectives: product, application, test type, end user, and region.
Bioburden Testing Market by Product
Based on product, the global bioburden testing market is segmented into instruments and consumables.
The consumable segment accounted for the largest revenue share of the global bioburden testing market in 2021. The consumable segment is further sub-segmented into culture media and reagents & kits. The large share of the consumable segment can be attributed to the repeated purchases of the regents and testing media. Moreover, the cost of the reagent and testing media is much lower than the instrument used in detection, thus boosting segmental growth. Additionally, carrying out testing using reagents and media is much easier than handling instruments.
Bioburden Testing Market by Application
Based on the application, the global bioburden testing market is segmented into raw material testing, in-process material testing, sterilization validation testing, medical device testing, and equipment cleaning validation.
The raw material testing segment dominated the global bioburden testing market with the largest revenue share in 2021. The rising standard of the finished products is increasing the demand for raw material testing. Moreover, microbial contamination is impacting pharmaceuticals and biologic production. The increasing safety concerns regarding food and beverages are also increasing the demand for raw materials testing.
Bioburden Testing Market by Test Type
Based on test type, the global bioburden testing market is segmented into aerobic count testing, fungi/mold count testing, anaerobic count testing, and spore count testing.
The aerobic count testing segment dominated the global market with the largest revenue share in 2021. Aerobic count testing has a range of applications in bacterial testing; thus, there is rise in the demand for aerobic counts testing. Furthermore, these tests are used to determine the sterility of medical devices, pharmaceutical products, formulations, tissue materials, and other products, thus fueling the growth of the segment.
Bioburden Testing Market by End User
Based on the end user, the global bioburden testing market is segmented into pharmaceutical & biotechnology companies, contract manufacturing organizations, medical device manufacturers, manufacturers of food & beverage and agricultural products, and microbial testing laboratories.
The pharmaceutical & biotechnology companies accounted for the largest revenue share of the global market in 2021. This can be attributed to the expansion of the biotech and pharma industries. Moreover, rising investment in the development of novel drugs is also boosting segmental growth. Governments across countries are also supporting biotech and pharma companies, which is further propelling market revenue growth.
Bioburden Testing Market by Region
Based on region, the global bioburden testing market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World.
North America dominated the global bioburden testing market in 2021, followed by Europe and Asia Pacific. The rise in the development of novel drugs, biologics, and vaccines in the region is boosting market revenue growth. Moreover, the medical devices industry in the region is growing due to the adoption of advanced technologies, which is increasing the demand for bioburden testing in the region. The presence of the major biotech and pharma companies is also anticipated to boost the regional market growth.
The National Institute of Health (NIH) funding for biotechnology and rising R&D expenditures by well-known corporations, according to data published by the National Center for Biotechnology Information (NCBI), are anticipated to encourage businesses to adopt highly effective biological testing tools to prevent potential losses brought on by contamination. The NIH has spent over US$ 7 billion on biotechnology during the fiscal year 2020, according to statistics released in May 2022 by the NCBI. Federal spending for research and development has increased by 5.9% in 2020, according to data provided by the Federation of American Scientists. Thus, increase in research and development activities is expected to support market growth in North America in the next few years.
Global Bioburden Testing Market Competitive Landscape
The prominent players operating in the bioburden testing market are:
Global Bioburden Testing Market Strategic Developments
Bioburden testing is the activity necessary for quantifying microbial contamination in water, raw materials, or finished products to ensure the safety of a manufactured product. Bioburden testing is important for determining the number of bacteria on a material, and it is also useful for determining how resistant the bioburden is to various treatments.
The global bioburden testing market is expected to be valued at US$ 2,786.4 million by 2030.
The growing pharma, biotech, medical devices, and food & beverages industries are the major driving factor of the global market. Moreover, the increasing investment in R&D related to new drugs and vaccines is also increasing the demand for bioburden testing.
Charles River Laboratories International Inc., Merck KGaA, Becton Dickinson and Company, Nelson Laboratories Inc., and SGS SA are among the top market players.
Geographically, North America accounts for the largest revenue share of the market, followed by Europe; and Asia Pacific is the fastest-growing regional market for bioburden testing.
*Insights on financial performance are subject to the availability of information in the public domain