A
recurring theme in healthcare is that the diagnostics industry is
on the cusp of a major transformation that will see an evolved role for
point-of-care (POC) tests that can be run at the bedside, in doctors’ offices,
at pharmacies or in people’s homes. This industry tends to transform with the
computing revolution rendering many types of mainframe computers obsolete, as
the price of manufacturing POC tests drops and the potential for running
multiplex tests in miniature expands.
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| Point of Care Testing (POCT) Devices Market |
Shift to
Self Care Diagnosis
Emphasis of care has
shifted from the prevention and early detection of disease to the ability to
get involved and diagnose themselves. Dominant area in POC is glucose
monitoring, which require self-monitor and diagnose as diabetes patients needs
to be regularly test themselves means that the ease of access to, and
functionality of, POC testing is perfectly suited to their conditions.
Portability:
Trend in POCT
Trend of wearable devices ,
smartphones and lab-on-a-chip technology is the major factor for the
recent growth in POC testing. In addition, portability and usability of these
devices also means that this testing has huge potential from a humanitarian
perspective. In hard-hit areas of Africa, a quicker, cheaper diagnosis of life
threatening disease could be life changing or lifesaving for millions of people
in order to see a POC test for HIV, TB or malaria from a smartphone, enabling
patients to diagnose themselves – avoiding lengthy trips to hospitals or
healthcare providers. As of now, USA is dominating the POCT market, however
Middle East & Africa and Asia-Pacific are the potential areas for the
growth owing to the production and innovations in the healthcare sector.
Alere
& Roche in Competition for POCT Market
Alere received the FDA
grant for a nucleic acid-based test, that was quickly followed up by Roche’s
own FDA approved Cobas product portfolio. On the basis of Poct market share,
Roche, Alere and Siemens lead the way in POC market. Siemens, BD and
Hologic are preparing to wade in the molecular POC market. According to the
National Centre of Biotechnology Information (NCBI), in 2011 the POC testing
market was around USD 15 billion and tends to grow at the rate of 4% over the
forecast period.
POCT
Solutions: Opportunistic Market
Much opportunity exists to
create POC solutions to help minimize the time spent by nurses walking to and
from centralized charting and monitoring areas. Additionally, many current
systems are inconvenient and time consuming, actually putting patients at risk.
Point-of-care testing at retail pharmacies can reduce the number of undiagnosed
HIV patients (14% of undiagnosed HIV patients cause 33% of new infections) -
leading to the reduction in new infections. The 20 minute visit is light-speeds
faster than the 2-weeks needed when sending tests to established laboratories.
OJ-Bio's Xtalline product range measures the biomarker C-Reactive Protein
(CRP), a biomarker of inflammatory disease allowing determination of whether an
infection is caused by bacteria. The test then can be used to determine whether
antibiotics are required immediately at the point-of-use. It's designed to be
simple enough for anyone to use.
Parallax's
Target System Technology
The commercial success of
the current generation of small, simple to use diagnostic devices which provide
rapid results in POC applications has been limited by their inability to
provide precise, highly sensitive, quantitative measurement. Parallax's Target
System technology addresses these limitations by applying sophisticated
immunochemical and optical methods to detect and quantify virtually any analyte
present in a liquid. Development data indicates that sensitivity will be
comparable to expensive and complicated laboratory-based analyzers.
Major
Players: Competitive Analysis
Key vendors in this market
are -Abbott Diagnostics, Alere, Roche Diagnostics, Siemens, Abaxis, Acon Laboratories,
Avioq, Bio-Rad Laboratories, Cavidi, Cepheid, Chembio Diagnostic Systems,
Clarity Diagnostics, Hologic, Thermo Fisher Scientific, Landwind Medical,
Mindray, i-Sens, Nipro Diagnostics, Randox Laboratories, Span Diagnostics,
Sysmex, Trivitron Healthcare, and URIT.
APAC
Expected To Be The Largest POCT Market
APAC point of care testing
market to reach USD 6.23 billion by 2024. the market has clocked revenues of
USD 3.45 billion in 2016.Adoption of miniaturized technology and hospitals
looking for a quicker means to reduce turnaround times for test result to reduce
the patient stay in hospitals. APAC is the opportunistic market for the POCT
due to the demand for the traditional care settings in order to reduce hospital
stay, overcrowding of emergency room and increase speed of diagnosis of
patient.
In operation theraters,
recovery rooms, cath labs and intensive care units POCT is preferred in order
to deliver the quicker results. Glucose point of care, haemetology, cardiac and
pregnency testing tends to enable the selective opportunities in APAC.
Stakeholders are educating physicians about POCT being more on the perception
of the medical personnel, in addition offering the rental and direct sales of
product to decrease distributor and retailer costs.
Quality
Diagnostics Products
Point-of-care line QDx (QDx
stands for Quality Diagnostics) of DiaSys is committed to introduce
technologically advanced products under its mother brand QDx. DiaSys POC
products helps patients and their caregivers get timely and actionable
information to achieve better patient compliance, better treatment outcomes,
better health, and higher quality of care. QDx range of POC products do not
replace the laboratories, rather complement the lab’s efforts by providing
quick results at patient’s bedside especially for critical care test like PCT (Procalcitonin)
and CTnI (Cardiac Troponin I).
The HemoCue POCT solutions
are used in a broad spectrum of clinical settings all over the world like
hematology, diabetes, connectivity solutions, etc. EKF Diagnostics Holdings plc
sold over21,500 point-of-care analyzers in 2016. Trinity Biotech plc's point-of-care
revenues increased from USD 20 million in 2015 to USD 22 million in 2016, which
represents an increase of 1.4%.
Monitoring
Of Coagulation Abnormalities
With increasing burden on
healthcare systems, care providers today are under greater pressure than ever
to optimize procedures, provide cost- and time-efficient care and bring care
close to the patient. The benefits of point-of-care testing (POCT) have been
well documented, however POCT is still not widely implemented in
hospitals.
In many instances,
hospitals still use central laboratories to process tests, which can impact
efficiency, the length of stay of a patient as well as costs. Minicare H-300*,
point-of-care hemostasis system to aid in the diagnosis and monitoring of
coagulation abnormalities: In critical care settings, such as a heavy blood
trauma or massive surgery, it can be crucial for the physician to know the
accurate coagulation status of a patient.
Hand-Held
versus Bench-Top POCT Devices
According to accreditation
Canada, POCT is “any test conducted outside a lab, in a hospital, in a clinic
or by a health care organization providing ambulatory care.” POCT devices are
categorized into two types: Hand-Held and Bench-Top on the basis of size. With
the revolution of healthcare sector, devices
are synchronizing along with it. It provides with rapid results that are useful
in making clinical decision by the doctor making it convenient for patients and
care providers as well.
POCT
Devices Types & Benefits
The POCT devices are
segmented on the basis of system are as follows: Blood gas family, Cardiac,
Diabetes, Urinalysis, and Informatics. Blood Gas Systems provide test data
quickly with minimal operator interaction. Major application areas of POCT:
self-monitoring; community testing in the pharmacy; general practice; and the
emergency department. The dominant model of laboratory testing throughout the
world remains the centralised laboratory in which more and more of the analytical
processes are automated to enable the analysis of large numbers of samples at
relatively low cost.
This trend is well
established in biochemistry and haematology and is now extending to other
disciplines including microbiology and anatomical pathology. Point-of-care
instruments vary widely and can be categorized as “transportable,” “portable,”
or “handheld,” based on the format. Some are capable of testing specific
analytes, while others are capable of performing an array of tests (eg,
electrolytes and blood gases).
End User
Analysis
In the hospitals, clinics,
diagnostic labs and home care settings POCT devices are being used for
immediate test results that lead to quicker decisions for earlier treatment.
Critical patient results are needed in the laboratory as well as the OR, ER,
ICU, critical care units and other hospital testing locations.
In hospital POCT is
used in Inpatient (Operation Theater, Intensive care ward, Emergency
departments, etc) as well as outpatient care (Medical Practice, House Visits,
etc). While glucose monitoring and anti coagulant monitoring are commonly
utilized by patient self-monitoring category.
Regional
Market Scenario
North America has the
largest market for POCT devices followed by Europe. However, APAC is the emerging
market with the highest CAGR due to the multiple factors like growing
initiatives by major players to expand the distribution network, innovation in
healthcare, increasing patient population, and rising number of ventures among
POC providers are responsible for the growth of the Asia-Pacific point-of-care
device market.
The market is considered
evolving with growth opportunity. Developing and developed markets have scope
to grow due to an aging population worldwide. Europe POCT Device Market
is expected to reach USD 10.1 billion by 2024 from USD 5.2 billion in 2016, at
a CAGR of 8.6% in the forecast period 2016 to 2024. On the basis of
prescription mode, the Europe point-of-care testing market is segmented into
prescription based testing and over-the-counter (OTC) testing.
The OTC testing is
projected to witness higher growth rate of 9.1% during the forecast period to
reach a value of USD 3.98 billion by 2024. Some of the major factors driving
the market for rising scope of POCT devices, advancement in technology,
increasing incidence of chronic diseases, rising demand for self-testing
point-of-care testing devices, decentralized laboratory testing, and
technological advancements like microfluidic lab on a chip technology. These
factors increase the demand for devices such as blood glucose meter, CRP,
HBA1C, Homocystein.
Target of
Major Players in Diagnostics
Top players of POCT devices are Roche, Alere, Siemens,
Abaxis, Abbott, Bayer, Biosite, bioMerieux, etc. Like in IVD Category Roche is
the dominant player in POCT Devices. Coagulation and glucose testing are key
areas. In June 2015, Roche introduced the cobas c513 blood glucose analyzer. It
is a dedicated, high-throughput HbA1c analyzer suitable for diagnosis,
monitoring and risk identification of diabetes patients.
Future of
Point-of-Care Instruments and Testing
Point-of-care testing
undoubtedly will take a more active role in critical care settings. It will be
used more for on-site diagnostic testing and trend monitoring of patient
conditions, due in part to the increasing percentage of critically ill patients
in hospitals, the need for shorter therapeutic turnaround time, and
bidirectional connectivity of transportable, portable, and handheld devices.
While POCT may not necessarily replace centralized laboratory testing, it is
becoming an important modality for improving patient care and outcomes.
Point-of-care testing
services are anticipated to surpass immunizations to drive revenue [in retail
pharmacies]. Pressure from payers to detect high-cost diseases early will help
speed up the growth of pharmacy-based diagnostic screening services. Areas for
pharmacy-based POC tests include: Acute disease screening such as influenza or
strep, chronic disease management and monitoring such as diabetes (blood glucose
and A1C), cholesterol, HIV, hepatitis C and more and other important tests like
tests for blood lead levels or genetic tests.
Coeliac disease is a
lifelong autoimmune disease caused by a reaction to gluten which affects 1 in
100 people worldwide, that’s 650,000 people in the UK and 72 million worldwide.
Since 2005 they have contributed around 2 million euros towards research
into the fundamentals of the condition, finding out about immune mechanism
involved, the genetics, and complications like neurological problems, as well
as psychological and social factors associated with coeliac disease. The
development of innovative digital tools and point of care testing could offer
an optimum regime for self-care.
Home
Monitoring
The Diabetes Control and
Complications Trial demonstrated that glucose control in type 1 diabetic
patients reduced long-term microvascular complications. Normoglycemia is
recommended for all diabetic patients and is best attained in insulin-treated
type 1 and type 2 patients by intensive insulin therapy or 3 to 4 insulin
injections per day. The dose of insulin is determined by a blood glucose value
obtained by a fingerstick capillary blood specimen analyzed on a portable
glucose analyzer approved for home use by the US.
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