A look at the POCT (point of care testing) market and the main drivers for its growth.

1. Point of Care: Revenue
Growth, New Entrants,
Investment
This White Paper, based on information from Kalorama
Information’s latest report on the testing market, The World Market
for Point of Care Diagnostics, estimates the market and identifies
drivers and conditions where point of care tests will be essential.
Point-of-care (POC) tests are diagnostic tests that are performed at or
near the site where the patient is located. Thus, these tests are performed in decentralized settings, outside
of centralized laboratories. Other terms used to describe POC testing include near-patient testing,
physician’s office laboratory (POL) testing, patient self-testing or patient self-management, bedside
testing, remote testing, or satellite testing. Over the years, the increasing introduction of transportable,
portable, and handheld instruments has resulted in the migration of POC testing from the hospital
environment to a range of medical environments including the workplace, home, disaster care and most
recently, convenience clinics. Some of these alternate terms
actually describe segments of the POC testing market.
The menu for point-of-care testing continues to expand.
The traditional set of POC tests includes: blood glucose testing,
blood gas and electrolytes analysis, rapid coagulation testing,
rapid cardiac markers diagnostics, drugs of abuse screening, urine
strips testing, pregnancy testing, fecal occult blood analysis,
hemoglobin diagnostics, infectious disease testing and cholesterol
screening. HgA1c, B-Type Natriuretic Peptide (BNP), whole-
blood lactate, D-Dimer, C-Reactive Protein (CRP) are among
those recently supplementing point of care test menus.
Moreover, POC test devices have contributed significantly to the growth of the overall
diagnostics market over the past 10 years. More diagnostic manufacturers have pursued CLIA waiver
status for their POC devices and CE Mark for POC or self-use. At the same time more decentralized test
venues invest in non-waived rapid tests and instruments, POC testing appears to be headed for an even
bigger role in diagnosis and monitoring patient care. New technologies are allowing POC devices to
produce quantitative lab-quality test results that can be transferred automatically to an information
system, a remote caregiver service for consultation or an electronic medical record.
10,000
11,000
12,000
13,000
14,000
15,000
16,000
17,000
18,000
19,000
2013 2014 2015 2016
POC Diagnostics Market, 2013‐2016 ($M)

2. Globally, millions of dollars are spent annually on POC diagnostic testing, both
professional and self-testing. In 2014, sales of POC testing reached $17 billion and this should
grow to 18.7 billion in 2016, as indicated on the chart on the preceding page. Below, the drivers
of the point of care testing market are discussed:
POC Industry Drivers
One of the key benefits and market drivers for the POC testing market is the ability to
have rapid results that can be used immediately for patient treatment decisions. While this is a
major benefit of POC testing, many other factors are also driving growth of this market.
Factors driving the development of POC tests include:
Patient-Focused Drivers
• Rapid results can be used immediately for patient treatment decisions in physicians offices,
and clinics.
• Demand for faster turnaround times for critical test results in hospital locations such as
emergency departments and intensive care units.
Medical/Healthcare-Related Drivers
• Introduction of POC tests for new targets such as additional infectious diseases and other
new analytes which previously could not be tested in the POC setting. Introduction of new
therapies that require rapid feedback with diagnostic tests.
• Growth of personalized healthcare and personalized medicine, and the need for rapid tests
to support this.
Technology Drivers
• Advances in miniaturization, microfluidics, and other technologies that have made it
possible to expand the numbers and types of tests that can be performed in POC settings.
Economic Drivers
• Growth in specialty clinics, retail clinics and other decentralized locations for patient care.
• Economic factors driving the need to reduce the length of patient stays in hospitals, reduce
backlog in areas such as emergency departments as patients wait for test results, etc.
Other Drivers
• Need for robust but also simple diagnostic tools for military applications outside of
military hospitals.
• Need for disaster preparedness.
• Need for robust but also simple diagnostic tools for developing countries.

3. Diseases with Point of Care Solutions
Colorectal Cancer
Colorectal cancer is the second leading cause of cancer-related deaths in the United
States There are approximately 93,090 new cases of colon cancer and 39,610 new cases of rectal
cancer estimated for 2015. Fortunately, through diligent screening and diagnostic testing, the
death rate from colorectal cancer has been dropping in both men and women. Cancer of the
colon and rectum may occur at any age but it is most prevalent over the age of 50. The 5-year
survival rate for early, localized cancers is 92% for colon cancer and 85% for rectal cancer,
whereas it remains 51% to 61% for cancer spread to adjacent organs and
lymph nodes.
Currently, there are three main types of tests that are used: fecal
occult blood tests (FOBT), fecal immunochemical tests (FIT), and stool
DNA tests (sDNA). Of these three, fecal occult blood tests are used the
most frequently – probably because they are inexpensive.
Routine colorectal cancer screening is something that tens of
millions of people in developed countries go through every few years.
Just about all developed countries have cancer screening programs that
offer free screening tests for colon cancer. After the age of 50 patients are encouraged to have a
colonoscopy every 5-10 years. Between these colonoscopies, they can use non-invasive tests
that can sometimes determine the presence of cancer or even precancers.
Cardiovascular Disease
Cardiovascular disease (CVD) continues to be a leading cause of death worldwide and
elevated cholesterol and triglycerides are among the important risk factors for this disease.
Patients are more aware of the fact that diet and exercise can alter blood levels of cholesterol as
well as drug therapy. CVD causes half of all deaths in several developed countries, and is the
major cause of adult death in many developing countries. More important, many cardiovascular
events aren't fatal but may be sufficiently debilitating to seriously affect functional ability. The
World Health Organization (WHO) estimates that 25% to 30% of the cardiovascular disease
burden arises from disabling sequelae of stroke or other forms of heart disease.
Atherosclerosis is the major cause of coronary artery disease (CAD). It is characterized by a
focal deposit of cholesterol and lipids, primarily within the intimal wall of the artery. The genesis
of plaque formation is the result of complex interactions between the components of blood and
the elements forming the vascular wall. The concept of endothelial injury is central to current
theories of atherogenesis, with endothelial injury being the leading theory for the cause of
atherosclerotic disease.
This White Paper is based
on results from Kalorama
Information's study:
The World Market for
Point of Care Diagnostics
http://www.kaloramainform
ation.com/Point-Care-POC-
9030928/

4. Roche offers the AccuCheck InstantPlus and the Reflotron cholesterol testing products. The
AccuCheck InstantPlus cholesterol test uses reflectance photometers for the quantitative
determination of cholesterol and triglycerides, with data output ports or data management
functions. Alere/Cholestech offers the LDX system, which measures the levels of total
cholesterol (TC), high-density lipoprotein, and triglycerides; calculates TC/HDL ratio; and
estimates levels of low-density lipoprotein and very-low-density lipoprotein.
Cardiac markers are biomarkers measured to evaluate heart function. Most of the early
markers were identified as enzymes. However, not all of the markers currently used are enzymes.
Physicians use cardiac markers in two ways--to diagnose a cardiac event in the hospital
emergency room or to evaluate the risk of a cardiovascular event occurring. The traditional
markers are CK-MB, troponin, and myglobin.
Ani Biotech Oy which offers the Biocard Troponin I test which is a one-step immuno
chromatographic assay for the rapid detection of cardiac specific troponin I from patient whole
blood samples. The company also offers myoglobin, MPO, hsCRP, quantitative reader, and CRP
cardiac marker tests.
Siemens offers the Stratus CS analyzer for near-patient care quantitative cardiac marker
testing from a whole blood sample in 14 minutes. The company also offers myoglobulin, CK-
MB, and cardiac troponin I tests.
Diabetes
The growing incidence of diabetes presents a health crisis in many countries. According to
the World Health Organization, 387 million people worldwide had diabetes as of 2014, with
deaths from diabetes projected to rise by more than 50% in the next 10 years. According to
International Diabetes Federation estimates, 35 million adults in Europe had diabetes in 2011 and
this is projected to increase to 43 million by 2030. This, according to WHO, is a diabetes
epidemic. People with diabetes have inadequate blood sugar control, which can lead to a range
of dangerous complications, including damage to the eyes, kidneys and heart. Approximately 4.9
million deaths worldwide are attributed to diabetes. The American Diabetes Association states
that diabetes is the primary cause of death for more than 69,000 Americans each year, and
contributes to the death of more than 234,000 Americans annually.
The first glucose meters for home use were commercialized in the early 1980s. Two models
were dominant in North America: Bayer’s Glucometer (now Bayer Diabetes Care) was
introduced in 1980 and Roche’s Accucheck meter in 1981. These two companies continue to
dominate glucose self-testing.
The situation is supported by data found in the Diabetes Atlas published by the International
Diabetes Federation (IDF, www.eatlas.idf.org); the global diabetes epidemic is projected to
affect 7% of the world's adult population by 2025 as developing countries embrace bad health
habits associated with affluence. Every year, 7 million people are afflicted with diabetes. The

5. IDF estimates that diabetes already affects 387 million across the world, up from just 30 million
twenty years ago. IDF experts reported that diabetes is emerging as one of the chief public
health challenges of the 21st century, especially in developing nations.
Physicians sometimes screen for autoantibodies to insulin or beta cells. The antibodies
indicate a very high risk for developing Type 1 diabetes and can be present up to eight years
before symptoms develop. According to the American Diabetes
Association, four autoantibodies are markers of beta cell autoimmunity in
type 1 diabetes: islet cell antibodies (ICA, against cytoplasmic proteins in
the beta cell), antibodies to glutamic acid decarboxylase (GAD-65),
insulin autoantibodies (IAA), and IA-2A antibodies to protein tyrosine
phosphatase. Autoantibodies against GAD-65 are found in 80% of type 1
diabetics at clinical presentation.
Hepatitis
Hepatitis B virus (HBV) is a DNA virus that is transmitted by percutaneous or
permucosal exposure to infectious blood, blood products, or other body fluids. Perinatal
transmission is also possible. HBV is a complex structure with three distinct antigens: the surface
antigen, the core antigen and the e-antigen. Each antigen has a corresponding antibody that may
be elicited during an attack of acute viral hepatitis. These antibodies can be detected in the serum
of individuals with prior experience to the antigenic virus. Hepatitis C is a viral infection that
can create liver inflammation. Approximately 3.2 million people carry the virus in the U.S.
Roughly 16,600 deaths were attributed to hepatitis C in 2010. As many as 20% of those infected
with chronic hepatitis C will develop cirrhosis.
Hepatitis C virus (HCV) is an RNA virus that is primarily transmitted percutaneously. Other
routes of transmission are sexual or perinatal. About 40% of cases have no known source. Alere
offers an expansive infectious disease test menu that includes POC tests for influenza A & B,
respiratory syncytial virus (RSV), strep throat, pneumonia, C. difficile, mononucleosis, HIV,
herpes simplex virus (HSV-2), hepatitis C (HCV), hepatitis B (HBV), malaria, Lyme disease,
Chlamydia, H. pylori, rubella, and other infectious diseases. Alere also provides laboratory
immunoassays, including indirect fluorescent antibody (IFA) format assays and ELISA format
assays.
This White Paper is based
on results from Kalorama
Information's study:
The World Market for
Point of Care Diagnostics
http://www.kaloramainform
ation.com/Point-Care-POC-
9030928/

6. The World Market for Point of
Care (POC) Diagnostics
The World Market for Point of Care (POC) Diagnostics presents
the most current and authoritative analysis of the POC diagnostics
industry and the role it plays in medical practice. This report takes
an in-depth look at the POC diagnostic testing market, both
professional and self-testing. The report provides exclusive market
sizing and growth projections for the following POC market
segments:
• Blood Glucose Tests
• Blood and Electrolytes Testing Market
• Rapid Coagulation
• Rapid Cardiac Markers
• Substance Abuse Testing
• Pregnancy and Fertility Testing
• Colon Cancer Screening/Fecal Occult Blood Testing
• Infectious Disease Testing
• Cholesterol Testing
• Cancer Testing
• Urine Strip Testing
• Miscellaneous POC Testing
Who are the top companies in the market? What types of point of care testing is selling fastest? What
disease areas will drive near-patient forward? Is POC earning its place in clinical practice? How is home
testing progressing? These questions and more are addressed in Kalorama
Information’s report. Past editions of the report have long been used by top
point of care test makers to conduct business planning.
The report’s geographic scope is worldwide with information for specific
geographical regions, world demographics, and other general issues
affecting the market. All market data pertain to the world market at the
manufacturers’ level. The market includes manufacturer tests excluding
services. The base year for data is 2014.
Historical data is provided for the years 2012 and 2014, with forecast data
provided for 2014 through 2019. Compound annual growth rates (CAGRs)
are provided for 2014-2019 periods for each segment covered. Competitive
analysis is provided for the year 2014.

7. Market analysis of the global POC testing market includes:
• Market Overview
• Market Analysis by Product Categories
• Market Analysis by Subcategory: POC Professional Testing, POC Self-Testing
• Market Analysis by Country: United States, Germany, France, UK, Switzerland, Japan,
China, India
• Market Conclusions
• Competitive Analysis
• Trend-Reimbursement Challenges
• Trend-Competition
• Trend-POC and Biosensors
• Trend-POC Connectivity
• Trend-The Emergence of Non-invasive Technologies
Among the top and/or innovative competitors discussed within the report's
Corporate Profiles:
• Abaxis
• Abbott Labs
• Accriva
• ACON
• Alere
• Arkray
• Beckman Coulter
• bioMerieux
• Church & Dwight
• Eiken Chemical
• EKF Diagnostics
• Enterix
• Helena Labs
• Insight Pharmaceutical
• Instrumentation Laboratories
• LifeScan
• Macherey-Nagel
• Meridian BioScience
• Nova Biomedical
• OPKO Health
• OraSure
• Ortho Clinical Diagnostics
• Polymed Therapeutics
• Polymer Technologies
• Quidel
• Radiometer Medical
• Response Biomedical
• Roche Diagnostics
• Siemens Healthcare
• Sysmex
• Trinity Biotech
FOR MORE INFORMATION OR TO ORDER
http://www.kaloramainformation.com/Point-Care-POC-9030928/