Bioburden Testing Market to Witness a Pronounce Growth by 2023

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Bioburden Testing Market - Global Industry Analysis, Size, Share,
Growth, Trends and Forecast 2015 - 2023
Bioburden is defined as the number in terms of percentage, colony or cell
count of bacteria that thrive on a given unsterilized surface. Bioburden
testing, also known as microbial limit testing provides quantification of the
bacterial cell cultures on a given unsterilized surface. The major application
of bioburden testing lies in implant fixation procedures that require testing
ofcertain tolerable bioburden limit before implantation in the human body.
The standard for bioburden testing in the US is regulated by the US FDA,
whereas global standards are maintained by the ISO (International
Organization for Standardization). The quantification for the standardization
process is done in terms of colony forming unit (CFU). Bioburden testing is
essential in limiting the presence of infection causing bacteria in an object
that is to be integrated into a human body as an implant. The testing is
important to eliminate the presence of bacterial residue and growth in any
object present in natural state. In addition it is almost impossible to remove
bacterial residue permanently in an object that is liable to be exposed to open
air. Hence sterilization process is performed on an implant object or a device
post understanding the bioburden limit. This helps to select the appropriate
sterilization technique in order to remove the bacterial burden just prior to the
medical (Or other related) procedure. Bioburden testing has therefore saved
numerous lives.
Based on technology, bioburden testing is segmented into microbial filter
method, advanced colorimetric method, and plate count method. Among
these, microbial filter method is the most commonly used method for
bioburden testing procedures. The plate count method is among the oldest
methods for bioburden testing, however is not used regularly on a large scale
commercial basis due to its time consuming procedure. Advanced
colorimetric method is presently the most promising and widely used
bioburden testing technology. The congregation of colometer and
computational capabilities has enabled advanced colometric methods to
deliver quick results of quantifying bioburden.
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Based on equipment, bioburden testing market can be segmented into PCR
(polymerase chain reaction) instruments, cell counters, and automated
microbial identification systems that are software integrated. Application
segment for bioburden testing includes healthcare, aerospace (satellite
production & development), supercomputer (super- microprocessor
manufacturing) designing, and others (raw material, equipment cleaning,
food & beverage). The healthcare industry is the largest application area of
bioburden testing.
Geographically, the bioburden testing market is primarily concentrated in the
North America and Asia Pacific region. The demand for bioburden testing in
the Asia Pacific region is expected to grow, and very likely to replace the
North America market soon. Australia, Japan, and China form the largest
markets in the Asia Pacific region. South Asia and South East Asia on the
other hand show great potential in terms of life sciences and raw material
applications; although at present a majority of the growing bioburden testing
market consists of life science applications. Besides this, a large number of
contract manufacturers reside in the Asia Pacific region. On the other hand,
European industries continue to remain a strong point in the global bioburden
testing market mainly due to the high quality of products services offered,
presence of numerous quality manufacturers and their increased reliability.
However certain significant restrictions for bioburden testing remains valid in
the European and North American region, such as dearth of trained
technicians, overwhelming volume of service demand, and high cost of
services, to name a few. The bio-burden testing market in the Rest of the
World (ROW) region is expected to grow at a steady rate, albeit slower than
the major economies of the world.
Some of the well known manufacturers/service providers of bioburden testing
equipment/service include: Charles River Laboratories International, Inc.,
Sigma-Aldrich Corporation, SGS S.A., WuXi PharmaTech (Cayman), and
Inc., Merck & Co., Inc., Becton, Dickinson and Company, North American
Science Associates, Inc., Nelson Laboratories, Pacific Biolabs, and ATS
Labs, Inc.
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