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Market Analysis of Biosensors For Food Safety: Industry Review
Market Analysis of Biosensors For Food Safety: Industry Review
Market Analysis of Biosensors For Food Safety: Industry Review
www.elsevier.com/locate/bios
Industry review
Received 25 May 2002; received in revised form 25 September 2002; accepted 24 October 2002
Abstract
This paper is presented as an overview of the pathogen detection industry. The review includes pathogen detection markets and
their prospects for the future. Potential markets include the medical, military, food, and environmental industries. Those industries
combined have a market size of $563 million for pathogen detecting biosensors and are expected to grow at a compounded annual
growth rate of 4.5%. The food market is further segmented into different food product industries. The overall food-pathogen testing
market is expected to grow to $192 million and 34 million tests by 2005. The trend in pathogen testing emphasizes the need to
commercialize biosensors for the food safety industry as legislation creates new standards for microbial monitoring. With quicker
detection time and reusable features, biosensors will be important to those interested in real time diagnostics of disease causing
pathogens. As the world becomes more concerned with safe food and water supply, the demand for rapid detecting biosensors will
only increase.
# 2003 Elsevier Science B.V. All rights reserved.
0956-5663/03/$ - see front matter # 2003 Elsevier Science B.V. All rights reserved.
doi:10.1016/S0956-5663(03)00009-5
842 E.C. Alocilja, S.M. Radke / Biosensors and Bioelectronics 18 (2003) 841 /846
Table 2
Sample of recent product recalls due to pathogen contamination in the USA (USDA FSIS, 2002)
characterized in Table 1. Sample recall data due to (agar plates or slants). Depending on pathogen and
contamination of pathogens is shown in Table 2. method, tests typically require 3 /7 days to obtain a
result. Rapid methods, however, are based on immuno-
1.1. Testing laboratories chemical or nucleic acid technologies.
Commercially available rapid tests can provide results
Food-pathogen testing is performed in various loca- in 8/48 h. However, results from these screening tests
tions. These include government laboratories, reference are considered presumptive by the USDA, which
laboratories, centralized corporate laboratories and on- requires an isolated organism as proof of contamina-
site laboratories at food-processing plants. Over the past tion.
few years, there has been a shift toward more pathogen The two key technological metrics for any commercial
testing on-site in food-processing plants. This shift can rapid detection method are sensitivity and speed.
be attributed to several factors. One reason is that Sensitivity refers to the concentration of bacteria present
increased testing volumes, largely due to the implemen- in a sample needed for detection by the biosensor. Most
tation of Hazard Analysis and Critical Control Point biosensors have a sensitivity of 10 /10 000 colony form-
(HACCP) plans and other regulations, have made it ing units (CFU)/ml. Time is the other critical technolo-
more economical for processing plants to set up gical variable. Culture-based tests are sensitive,
laboratories on-site rather than continue to send sam- however, they take days to produce results. This is a
ples to outside reference or corporate laboratories problem since time is a critical factor in the risk for
(Brunelle, 2001). The second reason is that the USDA exposure.
requires that raw meat products be held in inventory In the biosensor market today, the consumer has to
until test results are confirmed. make a choice between time and sensitivity. The
One example is the USDA Pathogen Reduction commercialization of current research in biosensor
Performance Standards for Salmonella. All slaughter technology would provide consumers with real-time
plants and facilities producing raw ground meat pro- biosensors capable of maintaining sensitivity better
ducts must ensure that the Salmonella contamination than 100 CFU/ml. Consumers will buy biosensors
rate is below the current national baseline incidence. because they are sensitive and work in real time.
This is the first regulatory performance standard for a
pathogen on raw meat and poultry. USDA requires
comprehensive Salmonella testing in conjunction with 2. Market overview
the implementation of HACCP in an effort to ensure
real progress in reducing harmful bacteria (Crutchfield, The biosensor industry is growing. The market is
1999). comprised of four segments, namely: medical, environ-
On-site tests produce results quickly, shortening the mental, food, and military, with medical applications
length of time products must be held in inventory and being the dominant player. Ninety percent of sales come
subsequently lowering storage cost. Additionally, if a from glucose-detecting biosensors for medical applica-
recall is issued, on-site testing provides a rapid response tions.
time, thus reducing corporate liability costs. The market is generating a need for pathogen detect-
ing biosensors across all segments. The pathogen
1.2. Performance criteria for rapid methods specific testing market is expected to grow for all
segments at a compounded annual growth rate
Science-based pathogen-specific tests can be divided (CAGR) of 4.5% with a total market value of $563
into the categories of conventional and rapid methods. million by 2003 (Frost and Sullivan, 1997). The best
Conventional methods involve enriching the food sam- overall growth rate is predicted for the food and military
ple and performing various media-based metabolic tests segments at an estimated CAGR of 6.0 and 6.8%,
E.C. Alocilja, S.M. Radke / Biosensors and Bioelectronics 18 (2003) 841 /846 843
respectively. Strong efforts in research and development flagged as VRE or MRSA positive on their record or
have already produced workable biosensors for a variety show signs of clinical infections.
of applications in the medical field. However, only a few
biosensors for the detection of pathogenic bacteria are 2.2. Environmental monitoring
commercially available or are approaching commercia-
lization. Water treatment is a critical means of pathogen
defence because communities can suffer rapid large-
2.1. Medical-infection control scale exposure if contamination occurs. As a result,
treated drinking water in the US typically undergoes
The largest market for pathogen testing is the medical several steps in the treatment process including treat-
industry. Infection control is one market segment ment with lime, filtering and chlorination. Once the
applicable to a pathogen detecting biosensor. Normal water has been treated, it is necessary to monitor it
flora found in the human gastrointestinal tract are throughout the distribution system to ensure that a pipe
considered benign to healthy individuals. Those with has not cracked and allowed microbes to infect the
weakened immune systems, e.g. HIV/AIDS, cancer, and water supply. In the case of untreated water systems,
organ transplant patients and premature infants, are fecal coliforms may enter rivers and streams through
highly susceptible to infections caused by low levels of agricultural runoff and non-point source pollution.
pathogenic organisms spread from one patient to Current tests require up to 18 h to culture the
another. The most common problem is when micro- organism, depending on the pathogen. When pathogen
organisms normally found in one system (i.e. gastro- contamination is found in the water supply, customers
intestinal) are inadvertently transferred to another are advised to boil their water and take other precau-
patient and a different system (i.e. blood). Normally, tions while additional testing is performed throughout
these infections can be treated with antibiotics but the system. Rapid turnaround in testing therefore helps
several pathogens have evolved resistance to the only control potential outbreaks by rapidly spotting contam-
known drugs with which they can be treated. The results ination. It also helps reduce the inconvenience to the
are often fatal to patients with suppressed or undeve- public by allowing officials to declare the water ‘safe’
loped immune systems. much sooner. Potential outbreaks from cracked pipes
Biosensor applications range from diagnostic tests for occur several times per year in large metropolitan areas.
common diseases, such as streptococcus and mononu- Increased public concern over the safety of our
cleosis, to hospital tests for contagious bacteria, such as environment will foster a need to monitor pathogens
vancomycin resistant Enterococcus (VRE) and methi- in field and stream. With greater pressure to recycle
cillin resistant Staphylococcus aureus (MRSA). These water, minimize the use of antibacterial agents and
are naturally occurring bacterial strains that have maintain quality discharges, manufacturers in a wide
mutated to become resistant to antibiotics. Hospitals variety of industries are seeking technologies to rapidly
are especially concerned because VRE and MRSA are identify contamination problems at source. Biosensors
fatal to immune compromised people. Any patient capable of detecting an organism quickly will be
carrying VRE or MRSA must be isolated to prevent important in the environmental monitoring of patho-
infection of other patients. gens.
Hospitals typically use their own laboratory for
identifying bacterial pathogens. A swab of urine, 2.3. Military-biodefense
sputum or blood sample is sent to the laboratory. Tests
are then performed to determine if the pathogen is Within the military sector there are two distinct
present. Testing requires 24 h and with laboratory back- market segments; research and development of biologi-
ups, results can take up to 4 days. The costs to hospitals cal warfare agents (BWAs) and rapid detection after an
are significant. Nosocomial bloodstream infections have attack. To date only cursory research has been per-
been reported to cost between $3517 and $33 268 per formed on these two segments. Customers in the
hospital per year. VRE bacteria have been reported to research and development segment are scientists from
result in significant increases in excess stay costing more research centers and universities. Scientists have an
than $27 000 per episode (Farr et al., 2001). These costs interest in identifying new strains of pathogens and
will be reduced if patients are regularly screened and determining the exact nature of differences between
kept isolated from other patients. existing strains. Time, therefore, is not believed to be a
The number of people infected with the VRE is rising. critical factor while accuracy, sensitivity and specificity
Since 1989, the percentage of resistant cases has gone are.
from 2% to 25% (Farr et al., 2001). Researchers believe With the focus of US warfare shifting to rogue states
that healthcare professionals only know a small percen- and terrorist organizations, there is a definite and
tage of VRE or MRSA carrying patients, who are either increasing need for rapid detection of BWAs in real
844 E.C. Alocilja, S.M. Radke / Biosensors and Bioelectronics 18 (2003) 841 /846
Table 3
US food industry total microbial tests per sector
Table 4
US market for food testing products
expected pathogen loads based on testing the wash- recognition of toxins as health risks, especially in grains
water of common fruits and vegetables. and fish/seafood, which are two fast-growing food
Fig. 2 shows that in 1999, of all tests in the food categories because consumers perceive them as healthy.
industry, 23.5 million (16.3%) were pathogen-specific Combined sales in the US for pathogen, pesticide and
tests, 22.6 million (15.7%) were for yeast and mold, 44.4 GMO testing products used by food processors are
million (30.8%) were for coliform and E. coli , and 53.6 projected to increase from $149.5 million in 2000 to
million were for total viable organism testing (TVO). $239.4 million in 2005 at an AAGR of 9.9%.
TVO tests are routine microbiology tests used to detect
the presence of all microorganisms present in a food
sample. 4. Concluding remarks
Fig. 3 shows that the total number of pathogen
specific tests performed in 2000 was 27.5 million and is There is a need for the commercialization of biosen-
expected to reach 34.1 million by 2005 (Business sors in the food safety industry. Potential markets
Communications Company, 2000). Sales of pathogen include the medical profession, military, environmental
tests are expected to grow from $122.6 million in 2000 to monitoring, government inspection agencies and anyone
$192.5 million in 2005, at an average annual growth rate else seeking a diagnostic tool for detecting pathogens
(AAGR) of 9.4% (Table 4). Sales for pesticide-residue quickly and accurately. Those industries combined have
tests will increase at an AAGR of 7.7% from $8.9 a market size of $563 million for pathogen detecting
million in 2000 to $12.9 million in 2005. The GMO biosensors. In the US there are over 60 000 food
testing market, which was worth $18 million in 2000, is processing facilities, 250 000 food retailing facilities
expected to have the fastest growth of 13.6% per year on and 600 000 eating and drinking establishments. All
average and is thus expected to reach $34 million by are potential customers for a quick, easy and reliable
2005. Future legislation requiring mandatory testing of pathogen testing device. In 1999, the food industry alone
GMOs has the potential to significantly increase the performed 144 million microbial tests for all biological
market size. agents. Additionally, 24 million pathogen-specific tests
Of the pathogen tests, bacteria are forecast to have the were performed by the food industry representing a
larger share (82%) of sales as they are responsible for the market of $122 million. These markets are expected to
bulk of illnesses and are routinely tested in food grow annually as legislation creates new standards for
samples. Pathogen tests that screen for toxins are microbial monitoring. Products with quicker detection
projected to have faster growth, at the rate of 14.7%, time and reusable features will be much coveted by those
than tests to detect bacteria. There is a growing interested in real time diagnostics of disease causing
846 E.C. Alocilja, S.M. Radke / Biosensors and Bioelectronics 18 (2003) 841 /846
pathogens. As the world becomes more concerned with Crutchfield, S., 1999. New federal policies and programs for food
safe food and water supply, the demand for rapid safety. Food Safety 22, 2.
Doyle, M.P., Zhao, T., Meng, J., Zhao, S., 1997. Escherichia coli
detecting biosensors will only increase. O157:H7. In: Doyle, M., Beuchat, L., Montville, T. (Eds.), Food
Microbiology Fundamentals and Frontiers. American Society for
Microbiology, Washington, DC.
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