Biosensors and Bioelectronics 18 (2003) 841
/846

www.elsevier.com/locate/bios

Industry review

Market analysis of biosensors for food safety

Evangelyn C. Alocilja *, Stephen M. Radke
Agricultural Engineering Department, Michigan State University, 204 Farrall Hall, East Lansing, MI 48824, USA

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.

Keywords: Commercialization; Biosensor; Pathogen; Biological recognition

1. Introduction rate as high as 50% among the elderly. Recent food

Escherichia coli are bacteria that naturally occur in
the intestinal tracts of humans and warm-blooded
animals to help the body synthesize vitamins. A
particularly dangerous type referred to as enterohemor-
rhagic E. coli O157:H7 or EHEC, has been associated
with foodborne outbreaks traced to undercooked meats,
apple juice or cider, salad, salami, and milk (Doyle et al.,
1997). Outbreaks have also been traced in contaminated
well water and improperly disinfected swimming pools
(Keene et al., 1994). EHEC produces toxins that can
damage the lining of the intestine, cause anemia,
stomach cramps and bloody diarrhea, and a serious
complication called hemolytic uremic syndrome (HUS)
and thrombotic thrombocytopenic purpura (TTP). In
North America, HUS is the most common cause of
acute kidney failure in children, who are particularly
susceptible to this complication. TTP has a mortality
safety data indicates that cases of EHEC and other
foodborne pathogen infections are rising both in the US
and in other industrialized nations (Käferstein et al.,
1997).
It is estimated that 76 million foodborne illnesses
occur each year in the US and account for 325 000
hospitalizations and 5000 deaths (Mead et al., 2000).
The United States Department of Agriculture (USDA)
estimates $2.9
/$6.7 billion will be lost annually due to
medical costs and lost productivity caused by major
food pathogens (Buzby et al., 1996). The four major
foodborne pathogens are Salmonella , Listeria monocy-
togenes , Campylobacter, and E. coli O157:H7 and are
Table 1
Food illnesses in the US caused by major foodborne pathogens (CDC,
1999)
Pathogen Number of cases Hospitalizations Deaths

Campylobacter 1 963 141 10 539 99

* Corresponding author. Tel.: /1-517-355-0083; fax: /1-517-432- E. coli O157:H7 62 458 1843 52
2892. L. monocytogenes 2498 2298 499
E-mail addresses: alocilja@egr.msu.edu (E.C. Alocilja), Salmonella 1 342 532 16 102 556
radkeste@egr.msu.edu (S.M. Radke).

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)
Company Product recalled
ConAgra, CO Ground beef
Cargill Turkey, TX Poultry products
Bar-S Foods, GA Meat and poultry
Excel Corp, GA Ground beef/pork
American Foods, WI Ground beef
Savoie’s, LA Cajun dressing mix
Zartic, GA Chopped beef steak
characterized in Table 1. Sample recall data due to
contamination of pathogens is shown in Table 2.
1.1. Testing laboratories
Food-pathogen testing is performed in various loca-
tions. These include government laboratories, reference
laboratories, centralized corporate laboratories and on-
site laboratories at food-processing plants. Over the past
few years, there has been a shift toward more pathogen
testing on-site in food-processing plants. This shift can
be attributed to several factors. One reason is that
increased testing volumes, largely due to the implemen-
tation of Hazard Analysis and Critical Control Point
(HACCP) plans and other regulations, have made it
more economical for processing plants to set up
laboratories on-site rather than continue to send sam-
ples to outside reference or corporate laboratories
(Brunelle, 2001). The second reason is that the USDA
requires that raw meat products be held in inventory
until test results are confirmed.
One example is the USDA Pathogen Reduction
Performance Standards for Salmonella. All slaughter
plants and facilities producing raw ground meat pro-
ducts must ensure that the Salmonella contamination
rate is below the current national baseline incidence.
This is the first regulatory performance standard for a
pathogen on raw meat and poultry. USDA requires
comprehensive Salmonella testing in conjunction with
the implementation of HACCP in an effort to ensure
real progress in reducing harmful bacteria (Crutchfield,
1999).
On-site tests produce results quickly, shortening the
length of time products must be held in inventory and
subsequently lowering storage cost. Additionally, if a
recall is issued, on-site testing provides a rapid response
time, thus reducing corporate liability costs.
1.2. Performance criteria for rapid methods
Science-based pathogen-specific tests can be divided
into the categories of conventional and rapid methods.
Conventional methods involve enriching the food sam-
ple and performing various media-based metabolic tests
Contaminant Amount recalled
E. coli O157: H7 8.6 million kg
L. monocytogenes 7.6 million kg
L. monocytogenes 6.6 million kg
E. coli O157:H7 86 000 kg
E. coli O157:H7 240 000 kg
Salmonella 225 000 kg
Salmonella 1.2 million kg
(agar plates or slants). Depending on pathogen and
method, tests typically require 3
/7 days to obtain a
result. Rapid methods, however, are based on immuno-
chemical or nucleic acid technologies.
Commercially available rapid tests can provide results
in 8
/48 h. However, results from these screening tests
are considered presumptive by the USDA, which
requires an isolated organism as proof of contamina-
tion.
The two key technological metrics for any commercial
rapid detection method are sensitivity and speed.
Sensitivity refers to the concentration of bacteria present
in a sample needed for detection by the biosensor. Most
biosensors have a sensitivity of 10
/10 000 colony form-
ing units (CFU)/ml. Time is the other critical technolo-
gical variable. Culture-based tests are sensitive,
however, they take days to produce results. This is a
problem since time is a critical factor in the risk for
exposure.
In the biosensor market today, the consumer has to
make a choice between time and sensitivity. The
commercialization of current research in biosensor
technology would provide consumers with real-time
biosensors capable of maintaining sensitivity better
than 100 CFU/ml. Consumers will buy biosensors
because they are sensitive and work in real time.
2. Market overview
The biosensor industry is growing. The market is
comprised of four segments, namely: medical, environ-
mental, food, and military, with medical applications
being the dominant player. Ninety percent of sales come
from glucose-detecting biosensors for medical applica-
tions.
The market is generating a need for pathogen detect-
ing biosensors across all segments. The pathogen
specific testing market is expected to grow for all
segments at a compounded annual growth rate
(CAGR) of 4.5% with a total market value of $563
million by 2003 (Frost and Sullivan, 1997). The best
overall growth rate is predicted for the food and military
segments at an estimated CAGR of 6.0 and 6.8%,
 E.C. Alocilja, S.M. Radke / Biosensors and Bioelectronics 18 (2003) 841
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respectively. Strong efforts in research and development
have already produced workable biosensors for a variety
of applications in the medical field. However, only a few
biosensors for the detection of pathogenic bacteria are
commercially available or are approaching commercia-
lization.
2.1. Medical-infection control
The largest market for pathogen testing is the medical
industry. Infection control is one market segment
applicable to a pathogen detecting biosensor. Normal
flora found in the human gastrointestinal tract are
considered benign to healthy individuals. Those with
weakened immune systems, e.g. HIV/AIDS, cancer, and
organ transplant patients and premature infants, are
highly susceptible to infections caused by low levels of
pathogenic organisms spread from one patient to
another. The most common problem is when micro-
organisms normally found in one system (i.e. gastro-
intestinal) are inadvertently transferred to another
patient and a different system (i.e. blood). Normally,
these infections can be treated with antibiotics but
several pathogens have evolved resistance to the only
known drugs with which they can be treated. The results
are often fatal to patients with suppressed or undeve-
loped immune systems.
Biosensor applications range from diagnostic tests for
common diseases, such as streptococcus and mononu-
cleosis, to hospital tests for contagious bacteria, such as
vancomycin resistant Enterococcus (VRE) and methi-
cillin resistant Staphylococcus aureus (MRSA). These
are naturally occurring bacterial strains that have
mutated to become resistant to antibiotics. Hospitals
are especially concerned because VRE and MRSA are
fatal to immune compromised people. Any patient
carrying VRE or MRSA must be isolated to prevent
infection of other patients.
Hospitals typically use their own laboratory for
identifying bacterial pathogens. A swab of urine,
sputum or blood sample is sent to the laboratory. Tests
are then performed to determine if the pathogen is
present. Testing requires 24 h and with laboratory back-
ups, results can take up to 4 days. The costs to hospitals
are significant. Nosocomial bloodstream infections have
been reported to cost between $3517 and $33 268 per
hospital per year. VRE bacteria have been reported to
result in significant increases in excess stay costing more
than $27 000 per episode (Farr et al., 2001). These costs
will be reduced if patients are regularly screened and
kept isolated from other patients.
The number of people infected with the VRE is rising.
Since 1989, the percentage of resistant cases has gone
from 2% to 25% (Farr et al., 2001). Researchers believe
that healthcare professionals only know a small percen-
tage of VRE or MRSA carrying patients, who are either
843
flagged as VRE or MRSA positive on their record or
show signs of clinical infections.
2.2. Environmental monitoring
Water treatment is a critical means of pathogen
defence because communities can suffer rapid large-
scale exposure if contamination occurs. As a result,
treated drinking water in the US typically undergoes
several steps in the treatment process including treat-
ment with lime, filtering and chlorination. Once the
water has been treated, it is necessary to monitor it
throughout the distribution system to ensure that a pipe
has not cracked and allowed microbes to infect the
water supply. In the case of untreated water systems,
fecal coliforms may enter rivers and streams through
agricultural runoff and non-point source pollution.
Current tests require up to 18 h to culture the
organism, depending on the pathogen. When pathogen
contamination is found in the water supply, customers
are advised to boil their water and take other precau-
tions while additional testing is performed throughout
the system. Rapid turnaround in testing therefore helps
control potential outbreaks by rapidly spotting contam-
ination. It also helps reduce the inconvenience to the
public by allowing officials to declare the water ‘safe’
much sooner. Potential outbreaks from cracked pipes
occur several times per year in large metropolitan areas.
Increased public concern over the safety of our
environment will foster a need to monitor pathogens
in field and stream. With greater pressure to recycle
water, minimize the use of antibacterial agents and
maintain quality discharges, manufacturers in a wide
variety of industries are seeking technologies to rapidly
identify contamination problems at source. Biosensors
capable of detecting an organism quickly will be
important in the environmental monitoring of patho-
gens.
2.3. Military-biodefense
Within the military sector there are two distinct
market segments; research and development of biologi-
cal warfare agents (BWAs) and rapid detection after an
attack. To date only cursory research has been per-
formed on these two segments. Customers in the
research and development segment are scientists from
research centers and universities. Scientists have an
interest in identifying new strains of pathogens and
determining the exact nature of differences between
existing strains. Time, therefore, is not believed to be a
critical factor while accuracy, sensitivity and specificity
are.
With the focus of US warfare shifting to rogue states
and terrorist organizations, there is a definite and
increasing need for rapid detection of BWAs in real
844 E.C. Alocilja, S.M. Radke / Biosensors and Bioelectronics 18 (2003) 841
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Table 3
US food industry total microbial tests per sector
Sector Number of plants Total tests Average/plant/
week
Beef and poultry 1679 32 212 471 369
Dairy 1388 45 887 576 636
Fruit/vegetables 652 13 981 305 412
Processed foods 2260 52 196 282 444
Total 5979 144 277 634 464
Strategic Consulting (2000).
time. Customers in the rapid detection segment include
any prominent American foreign presence. This includes
approximately 180 embassies and several hundred US
military facilities throughout the world.
Troops stationed overseas also represent a sizeable
population with increased exposure risks though many
are vaccinated. Military units facing an enemy with the
potential use of deploying biological weapons require
the ability to monitor the environment rapidly to
identify contaminated air, water, food and equipment.
Field-ready systems now being deployed for environ-
mental surveillance do not immediately produce effects.
Currently, samples taken from the environment, such as
soil and water, and most clinical samples must be
collected, cultured and tested before a reliable identifi-
cation is available. In the future, biosensors will play an
important role in quickly identifying BWAs.
2.4. Food safety
The detection and identification of foodborne patho-
gens continue to rely on conventional culturing techni-
ques. These are very elaborate, time-consuming and
expensive. The existing test methods are completed in a
microbiology laboratory and are not suitable for on-site
monitoring. Pathogen detection using existing methods,
such as enzyme linked immunosorbent assays (ELISA)
and culture techniques for determining and quantifying
pathogens in food have been well established (Cohn,
1998). In terms of speed, these methods cannot ade-
quately serve the needs of food processors and regula-
tory agencies. As a result, the food industry needs real
time, portable pathogen detection sensors with higher
sensitivity. Rapid detection biosensors will minimize the
need for the estimated 60 000 US based food processors
to perform lengthy microbial testing and expensive
immunoassays on materials suspected of carrying food-
borne pathogens.
The market potential for detection and identification
of bacterial and viral pathogens in the food safety area is
estimated at around $150 million per year. Applications
include detecting contaminants in water supplies, pro-
cessing and assembly lines, raw food materials and food
products: all of which rely on conventional culturing
Fig. 1. US food industry total microbial tests per sector.
Fig. 2. US food industry total microbial tests by type.
techniques. Current detection techniques require food
producers either to hold onto inventory or release the
product and risk a recall. Real time testing will provide
value to food producers through the reduction of
product recalls and reduced treatment costs.
3. Food safety market analysis
Industry analysts expect that as regulations pertaining
to pathogen testing continue to be adopted, the shift
toward rapid-screening methods will continue. The
overall food product testing industry is growing steadily.
The US food industry performed around 144.3 million
microbiological tests in 1999 as shown in Table 3
(Strategic Consulting, 2000). The processed food sector
accounts for the largest number of tests, with over 52.2
million performed annually. This represents over 36%
(Fig. 1) of total tests performed and is likely driven by
the larger number of processing plants, which is 38% of
all plants. The dairy sector has the highest testing rate
per processing plant, averaging over 630 tests per plant
per week. The beef and poultry sectors perform the least
number of tests per plant averaging 369 tests per plant
per week. As a result, the beef and poultry sectors
account for only 22.3% of all testing in the industry. The
fruit and vegetable sector is currently the smallest of the
four sectors accounting for only 9.7% of testing. The
fruit and vegetable sector is becoming more of a focus
by the USDA Food Safety Inspection Service (FSIS)
and is expected to result in a substantial increase in
pathogen testing in the next few years. A program to
monitor the levels of foodborne pathogens is currently
being set up by the USDA Pesticide Data Program
(Whiddon, 2002). The program will create a database of
 E.C. Alocilja, S.M. Radke / Biosensors and Bioelectronics 18 (2003) 841
/846
Fig. 3. Pathogen specific testing and total market size.
Table 4
US market for food testing products
Segment ($ Millions) 2000
Pathogens 122.6
Pesticides 8.9
Genetically modified organisms 18.0
Total 149.5
expected pathogen loads based on testing the wash-
water of common fruits and vegetables.
Fig. 2 shows that in 1999, of all tests in the food
industry, 23.5 million (16.3%) were pathogen-specific
tests, 22.6 million (15.7%) were for yeast and mold, 44.4
million (30.8%) were for coliform and E. coli , and 53.6
million were for total viable organism testing (TVO).
TVO tests are routine microbiology tests used to detect
the presence of all microorganisms present in a food
sample.
Fig. 3 shows that the total number of pathogen
specific tests performed in 2000 was 27.5 million and is
expected to reach 34.1 million by 2005 (Business
Communications Company, 2000). Sales of pathogen
tests are expected to grow from $122.6 million in 2000 to
$192.5 million in 2005, at an average annual growth rate
(AAGR) of 9.4% (Table 4). Sales for pesticide-residue
tests will increase at an AAGR of 7.7% from $8.9
million in 2000 to $12.9 million in 2005. The GMO
testing market, which was worth $18 million in 2000, is
expected to have the fastest growth of 13.6% per year on
average and is thus expected to reach $34 million by
2005. Future legislation requiring mandatory testing of
GMOs has the potential to significantly increase the
market size.
Of the pathogen tests, bacteria are forecast to have the
larger share (82%) of sales as they are responsible for the
bulk of illnesses and are routinely tested in food
samples. Pathogen tests that screen for toxins are
projected to have faster growth, at the rate of 14.7%,
than tests to detect bacteria. There is a growing
845
($ Millions) 2005 AAGR% 2000
/2005
192.5 9.4
12.9 7.7
34.0 13.6
239.4 9.9
recognition of toxins as health risks, especially in grains
and fish/seafood, which are two fast-growing food
categories because consumers perceive them as healthy.
Combined sales in the US for pathogen, pesticide and
GMO testing products used by food processors are
projected to increase from $149.5 million in 2000 to
$239.4 million in 2005 at an AAGR of 9.9%.
4. Concluding remarks
There is a need for the commercialization of biosen-
sors in the food safety industry. Potential markets
include the medical profession, military, environmental
monitoring, government inspection agencies and anyone
else seeking a diagnostic tool for detecting pathogens
quickly and accurately. Those industries combined have
a market size of $563 million for pathogen detecting
biosensors. In the US there are over 60 000 food
processing facilities, 250 000 food retailing facilities
and 600 000 eating and drinking establishments. All
are potential customers for a quick, easy and reliable
pathogen testing device. In 1999, the food industry alone
performed 144 million microbial tests for all biological
agents. Additionally, 24 million pathogen-specific tests
were performed by the food industry representing a
market of $122 million. These markets are expected to
grow annually as legislation creates new standards for
microbial monitoring. Products with quicker detection
time and reusable features will be much coveted by those
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
safe food and water supply, the demand for rapid
detecting biosensors will only increase.
Acknowledgements
The assistance of Mr Mahendra Ramsinghani and Dr
Todd Zahn of the Michigan Economic Development
Corporation (MEDC) is greatly appreciated.
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