Point of Care Testing: Evaluating the Return to Evidence Based Medicine, Novel Technologies and the Competitive Landscape
Scripp Business Insights, January 2010, Pages: 283
Diagnostic practice is undergoing a quiet revolution, with IVD tests moving out of the centralized hospital laboratory to point of care testing (POCT) locations. POC tests are more expensive than lab-based tests, but promise to reduce the overall cost of healthcare while improving the quality of outcomes. They are thus attractive to manufacturers and increasingly in demand by physicians, patients, and healthcare providers.
This report explores the opportunities for POC testing provided by recent technology improvements, disease trends, and new marketing channels. It examines established and emerging health-related applications of POC diagnostics based on immunoassays, clinical chemistry, and nucleic acid testing. Within each POCT market sector, leading companies and their strategies and products are examined.
Key features of this report
- Examines different types of POC testing technologies and information they provide in clinical situations.
- Assesses current market satisfaction, areas of need and competition for POC testing in the areas of: diabetes; fertility; hemostasis; cardiology; infectious disease; drugs of abuse; automated urine/blood analysis; and cancer screening.
- Surveys analytes/biomarkers incorporated in commercial POCT products on the market and in commercial development in all the major application areas.
Scope of this report
- Understand the role of POC tests in diagnosis and monitoring in different clinical situations.
- Gain an insight into how the market for POC tests is shaping up in each of the major application areas.
- Identify competitors or potential collaborators developing improved or novel POC technologies and products.
- Assess established and emerging marketing channels for POC tests.
Key Market Issues
- In most countries, the average spending on IVDs is a very low percentage of the healthcare budget, but spending on POC IVDs which offer speed, convenience, and improved outcomes is set to grow at an increased rate.
- Since 2006, wider adoption of POC testing in the US has been driven by the issuance of testing guidelines by the National Academy of Clinical Biochemistry; the US market now represents more than half of the global POC testing market.
- Expanding medical and non-medical POC testing locations, which include fast-growing retail health clinics in the US, provide new marketing opportunities for manufacturers of POC tests.
Key findings from this report
- The POC testing market is forecast to grow from $13.4 billion in 2008 to $22.5 billion in 2013. The POCT market currently represents 25% of the total IVD market.
- There are many players in the POCT market and many diverse products. Examples of leading companies include Abbott Laboratories (glucose monitoring and blood analysis products), Inverness Medical Innovations (various consumer and professional products), Quidel (pregnancy and infectious disease products), and Cepheid (first POC molecular tests on the market).
- 130 companies have had their POC products CLIA waived by the FDA in the 3 year period prior to November 2009. Amongst these companies were 53 companies with glucose monitoring products and 39 companies with pregnancy testing products.
- Sales of glucose monitoring products accounted for 76% of the POCT market in 2008 and this sector is expected to remain the leading sector in 2013. However, POC testing for HbA1c is assuming increasing importance in diabetes.
Key questions answered
- What are the applications for POCT technologies in healthcare?
- Which are the prominent companies and products within each POCT market sector?
- How are the key players making an impact on the POCT market?
- Which POC tests have been CLIA waived in the last 3 years?
Point of Care Testing
Executive summary
Market overview
POC testing in diabetes
Fertility-related tests
Hemostasis testing
Cardiology tests
Infectious disease tests
Drugs of abuse testing
Clinical chemistry and other rapid tests
Company profiles
Market analysis and forecasts
Chapter 1 Market overview
Summary
The shift to POC diagnostic testing
Locations for POC testing
Background on IVD technologies
Clinical chemistry
Immunoassays
Nucleic acid testing
Technologies for POC testing
Lateral-flow tests
Next-generation lateral-flow devices
Electrochemical enzymatic tests
Advances in microfluidics
Data management and connectivity
Market drivers
Market restraints
Regulation of in vitro diagnostic tests (US)
CLIA
Chapter 2 POC testing in diabetes
Summary
Diabetes diagnostics and monitoring
Meter systems for blood glucose monitoring
Increasing performance requirements
Examples of POC device manufacturers
Roche Diagnostics
Arkray
Home Diagnostics
Abbott Diabetes Care
Nova Biomedical
Epocal
Diagnostic Devices
HemoCue
Luminous Medical
Health-Chem Diagnostics
Continuous glucose monitoring systems
Examples of POC device manufacturers
DexCom
Medtronic MiniMed
Abbott Diabetes Care
HbA1c testing
Examples of POC device manufacturers
Diazyme Laboratories
HemoCue
Bio-Rad Laboratories
Siemens
Trinity Biotech
Chapter 3 Fertility-related tests
Summary
Introduction
Pregnancy (hCG) tests
Detection of hCG variants
Ovulation tests
OTC pregnancy test kits
Examples of manufacturers of pregnancy tests
Inverness Medical Innovations
Swiss Precision Diagnostics
Church & Dwight
Siemens Healthcare Diagnostics
Applied DNA Technologies
Quidel
BTNX
Germaine Laboratories
Other fertility-related tests
Chapter 4 Hemostasis testing
Summary
Introduction
Hemostasis modulation
Use of anticoagulants
Use of antiplatelets
Hemostasis testing
Coagulation testing
Prothrombin time
Activated partial thromboplastin time
Activated coagulation time
Guidelines on POC coagulation testing (US)
Examples of manufacturers of POC tests
Abbott Laboratories
Axis-Shield
Siemens
Instrumentation Laboratory
Haemoscope
Helena Point of Care
Inverness Medical Innovations
International Technidyne
Roche Diagnostics
Akers Biosciences
Platelet function tests
POC testing
Examples of manufacturers of POC tests
Helena Point of Care
Siemens Healthcare Diagnostics
Accumetrics
Chapter 5 Cardiology tests
Summary
Overview of cardiovascular disease
Lipids associated with atherosclerosis
Lipid management guidelines (US)
Laboratory lipid profiling
Mail-in fingerstick tests
Point-of-care lipid tests
Routine assay methods
Examples of manufacturers of CLIA waived tests
AccuTech
Inverness Medical Innovations
Polymer Technology Systems
Abaxis
Cardiac protein biomarker diagnostics
Biomarkers of necrosis
Biomarkers of hemodynamic stress
Biomarker panels for risk stratification
The need for POC testing
Examples of manufacturers of POC tests
Siemens
Inverness Medical Innovations
ELITech Group
Roche Diagnostics
Response Biomedical
Abbott Point of Care
Chapter 6 Infectious disease tests
Summary
Introduction
POC testing
Rapid immunoassays
Nucleic acid testing
Sexually-transmitted diseases
HIV
Chlamydia
HPV
HSV-2
Trichomonas vaginalis
Gonorrhea
Respiratory infections
Influenza A and B
Influenza A swine flu
RSV
Strep A
Legionella
M. tuberculosis
Gastrointestinal infections
H. pylori
C. difficile
Parasites
Other infections/conditions
Enteroviral meningitis
Infectious mononucleosis
Hepatitis C
Strep B
MRSA
Sepsis
Malaria
Acute conjunctivitis
Platelet-associated bacteria
Periodontal disease
Urine infection
Chapter 7 Drugs of abuse testing
Summary
Introduction
Point-of-care urine-based testing
Commonly abused prescription drugs
Opioids
Central nervous system depressants
Stimulants
Psychoactive drugs
Methadone
Illicit drugs
Methamphetamine
Cocaine
Heroin
Phencyclidine
Cannabinoids
POC testing sites
CLIA waived DOA rapid tests
Examples of POC DOA test manufacturers
Inverness Medical Innovations
Nanogen
Bio-Rad Laboratories
Siemens Healthcare Diagnostics
Instant Technologies
NOVX Systems
Detection of DOA in oral fluids
Chapter 8 Clinical chemistry and other rapid tests
Summary
Introduction
Urinalysis reagent strips
Automated urinalysis
POC clinical chemistry analyzers
Examples of manufacturers
Abaxis
Abbott Laboratories
Arkray
Cancer POC testing
Colon cancer screening
Bladder cancer screening
Other products
Chapter 9 Company profiles
Summary
Abaxis Inc
Company description
POC technology/products
Abbott Laboratories
Company description
POC technology/products
Accumetrics
Company description
POC technology/products
AccuTech LLC
Company description
POC technology/products
Akers Biosciences Inc
Company description
POC technology/products
American Bio Medica Corporation
Company description
POC technology/products
AmniSure International LLC
Company description
POC technology/products
Arkray USA Inc
Company description
POC technology/products
Banyan Biomarkers Inc
Company description
POC technology/products
BioHelix Corporation
Company description
POC technology/products
Bio-Rad Laboratories Inc
Company description
POC technology/products
BiOracle Ltd
Company description
POC technology/products
Calypte Biomedical Corporation
Company description
POC technology/products
Cepheid
Company description
POC technology/products
Diazyme Laboratories
Company description
POC technology/products
- Abaxis Inc
- Abbott Diabetes Care
- Abbott Laboratories
- Accumetrics
- AccuTech LLC
- Akers Biosciences Inc
- American Bio Medica Corporation
- AmniSure International LLC
- Arkray USA Inc
- Banyan Biomarkers Inc
- BioHelix Corporation
- BiOracle Ltd
- Bio-Rad Laboratories
- Calypte Biomedical Corporation
- Cepheid
- DexCom
- Diazyme Laboratories
- ELITech Group
- Enigma Diagnostics Ltd
- Epocal
- GeneEx Inc
- Health-Chem Diagnostics LLC
- Helena Laboratories Corporation
- HemoCue
- Home Diagnostics Inc
- International Technidyne Corporation
- Inverness Medical Innovations Inc
- Luminous Medical
- Medtronic MiniMed
- Meso Scale Diagnostics LLC
- Micronics
- Molecular Vision Ltd
- Nova Biomedical
- NOVX Systems Inc
- OraSure Technologies Inc
- Phadia AB
- PointCare Technologies Inc
- Polymer Technology Systems Inc
- Princeton BioMeditech Corporation
- Qualigen Inc
- Quidel Corporation
- Rapid Pathogen Screening Inc
- Response Biomedical Corporation
- Roche Diagnostics Corporation
- Siemens
- Siemens Healthcare Diagnostics Inc
- Trinity Biotech Plc
- Verax Biomedical Inc
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