Diagnostic and Biotech

New Frontiers in the US Point-of-Care/POC Diagnostic Testing: Business Challenges, Emerging Technologies, Competitive Landscape

  • VPG16176
  • 1172 Pages
  • May 2014
  • Diagnostic and Biotech

New Frontiers in the US Point-of-Care/POC Diagnostic Testing: Business Challenges, Emerging Technologies, Competitive Landscape is Venture Planning Groups new report, which provides comprehensive analysis of theten POC market segments, including their dynamics, size, growth, regulatory requirements, technological trends, competitive landscape, and emerging opportunities for instrument and consumable suppliers.


Rationale


The growing economic pressures on hospitals, coupled with advances in diagnostic technologies, intensifying competition among suppliers and physicians, and changing consumer demands are shifting diagnostic testing from hospitals and commercial laboratories closer to the patient.


Market Segmentation


- Review of theten POC market segments, including their dynamics, trends, structure, size, growth and major suppliers.


- Five-year test volume and reagent sales forecasts for over 300 chemistry,

immunodiagnostic, microbiology, hematology and coagulation procedures by market

segment:


- Home/Personal Testing

- Physician Offices/Group Practices

- Emergency Rooms

- Operating/Recovery Suites

- ICUs/CCUs

- Cancer Clinics

- Ambulatory Care Centers

- Surgery Centers

- Nursing Homes

- Birth Centers



and by test category:


- Routine and Special Chemistry

- Microbiology/Infectious Diseases

- Hematology

- Flow Cytometry

- Coagulation

- Immunoproteins

- Drugs of Abuse

- TDM

- Endocrine Function

- Tumor Markers


Sales and Market Share Analysis


- Sales and market shares ofmajor reagent and instrument suppliers.


Current and Emerging Tests and Instrumentation


- Analysis of over 130 diagnostic procedures.


- Review of leading chemistry, immunoassay, hematology and coagulation analyzers market by

Abaxis, Abbott, Alfa Wasserman, Awareness Technologies, Beckman Coulter/Danaher, Becton Dickinson, Behnk Elektronik, Biocode, Bio/Data, bioMerieux, Cardiovascular Diagnostics, Carolina Chemistries, Diagnostica Stago, Diesse Ves Matic, Drew-Scientific, Helena Laboratories, Horiba, Instrumentation Laboratory, Inverness, ITC Hemochron, Medica, Menarini, Nihon Kohden, Nova Biomedical, Ortho-Clinical Diagnostics, Polymedco, Randox, Roche, Siemens, Sysmex, Teco Medical Instruments, Trinity Biotech, and other suppliers.


Routine Clinical Chemistry Tests


Albumin, Alkaline Phosphatase, ALT/SGPT, Ammonia, Amylase, AST/SGOT, Bilirubin, Blood Gases, BUN (Blood Urea Nitrogen), Calcium, Cholesterol, Cholinesterase, Creatinine, CK-MB, Electrolytes (Carbon Dioxide/Bicarbonate, Chloride, Potassium, Sodium), Ferritin, Follate/Folic Acid, Fructosamine, GGT, Glucose, HDL, Iron, LDH, Magnesium, Phosphorus, Potassium, Protein, Sodium, Triglycerides, Troponin, Uric Acid, Urinalysis, Vitamin B12.

Infectious Disease Tests


AIDS/HIV, Adenovirus, Aeromonads, Bartonella, Blastocystis Hominis, Campylobacter, Candida, Chancroid, Chlamydia, Clostridium, Coronavirus, Coxsackievirus, Cryptosporidium, Cyclospora, CMV, E. Coli, Echovirus, Encephalitis, Enterovirus, EBV, Giardia, Gonorrhea, Granuloma Inguinale, Hantavirus, H. Pylori, Hepatitis (A, B, C, D, E), Herpes Simplex Virus, Human Herpes Virus-6 (HHV-6), Influenza, Legionella, Lyme disease, Pymphogranuloma, Malaria, Measles, Meningitis, Mononucleosis, Microsporidium, Mononucleosis, Mumps, Mycoplasma, Polyomaviruses, Parvovirus B19, Pneumonia, Polyomaviruses, Pseudomonas, Rabies, RSV, Rhinovirus, Rheumatoid Arthritis, Rotavirus , Rubella, Salmonellosis, Septicemia, Shigella, Staphylococci, Streptococci, Syphilis, Toxoplasmosis, Trichomonas, Tuberculois, Vibrio, West Nile, Yersenia.

Tumor Markers



ACTH, AFP, Beta-2 Microglobulin, CA 15-3/27.29, CA 19-9, CA 125, Calcitonin, Cathepsin, CEA,

Chromogranin, Colon-Specific Antigen, Cytokeratins, Estrogen Receptor, Ferritin, Gastrin, HCG,

Insulin, Interferons, Interleukins, Lymphocyte Subtyping, Neuron-Specific Enolase, Nucleolar,

Occult Blood, Oncogenes, Pancreatic Oncofetal Antigen, Pap Smear, Parathyroid Hormone,

Progesterone Receptor, Prostatic Acid Phosphatase, Prostatic Specific Antigen, S-100 Protein,

Serotonin, Sialic Acid, Squamous Cell Carcinoma Ag, TDT, Thymidine Kinase, Thyroglobulin,

Tissue Polypeptide Antigen, and others.


Routine and Special Hematology Tests


CBC + 5-Part Differential, Manual Differential/Review, Hematocrit (Automated, Manual),

Hemoglobin (Automated, Manual), Sedimentation Rate, Reticulocytes, WBC (Automated, Manual),

Platelets (Automated, Manual), Bone Marrow Analysis, RBC, Eosinophils and others.


Flow Cytometry Tests


Cell Surface Markers (CD4/CD8/T&B Lymphocytes, CD34, Others), Chemotherapy Monitoring (Leukemia/Lymphoma, Others), HLA Typing, Sperm Analysis, Cell Cycle Kinetics, Cell Function Testing, Chromosomal Abnormalities, Fetal Cell Analysis, Granulocyte Function, Receptor DNA/RNA Analysis, Cell Culturing.


Endocrine Function Tests


Cortisol, Estradiol, FSH, HCG, Gastrin, LH, Progesterone, PTH/IO PTH,

Prolactin, T3, T3 Uptake, Free T3, T4, Free T4, TBG, Testosterone, TSH.


Therapeutic Drug Monitoring (TDM) Tests


Amikacin, Carbamazepine, Digoxin, Gentamicin, Lidocaine, Lithium, Methotrexate,

Phenobarbital, Phenytoin/Dilatin, NAPA/Procainamide, Quinidine, Theophylline, Tobramycin,

Valproic Acid, Vancomycin.


Coagulation Tests


Activated Clotting Time (ACT) (1), Activated Protein C Resistance,

Activated PTT (APTT), Alpha 2-Antiplasmin, Antithrombin III, Bleeding Time,

D-Dimer, Factor II, Factor V, Factor V Leiden, Factor VII, Factor VIII, Factor IX,

Factor Ixa, Factor X (Stuart Factor), Factor Xa, Factor XI, Factor XII, Factor XIII,

Fibrin Degradation Products, Fibrinogen, Fletcher Factor/Pre-Kallikrein Factor Activation,

Heparin/Anti-Factor Xa, Heparin-Induced Thrombocytopenia, Plasmin, Plasminogen,

Plasminogen Activator Inhib., Platelet Function/Aggregation, Protein C, Protein S,

Prothrombin Mutation, Prothrombin Time (PT), Reptilase Time, Thrombin Time,

Von Willebrand's Factor Fav/Ag, and others.


Immunoprotein Tests


C3, C4, CRP, IgA, IgE Soecific, IgE Total, IgG, Immunoglobulins, Protein Electrophoresis,

and others.


Drugs of Abuse


Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids/Marijuana, Cocaine,

LSD, Methadone, Methaqualone, Opiates, Phencyclidine, Propoxyphene, and others.


Technology Review


- Emerging technologies and their applications for POC testing.


- Comprehensive listings of companies developing or marketing POC diagnostic technologies

and products, by test.


Strategic Recommendations


- Specific opportunities for new POC instruments and reagent systems with potentially

significant market appeal during the next five years.


- Design criteria for POC testing products.


- Alternative business expansion strategies.


- Potential market entry barriers and risks.


Competitive Assessments


- Assessments of major suppliers and emerging market entrants, including their sales, product

portfolios, marketing tactics, joint ventures, and new products in R&D.


- The companies analyzed in the report include:


- Abbott

- ADI/America Diagnostica

- Agilent Technologies

- Axis-Shield

- Beckman Coulter/Danaher

- Becton Dickinson

- Bio/Data

- Biomerieux

- Bio-Rad

- Biosite/Inverness/Alere

- Cepheid

- Chrono-Log

- Corgenix

- Decode

- Diadexus

- Diagnocure

- Diagnostica Stago/Trinity Biotech

- Diamedix

- Diasorin

- Eiken Chemical

- EKF Diagnostics

- Fujirebio/Innogenetics

- Grifols

- Helena Laboratories

- Hologic/Gen-Probe

- Horiba

- Instrumentation Laboratory

- International Technidyne/Nexus DX

- Kreatech

- Kyowa Medex

- Lonza

- Mackay Life Sciences

- Matritech

- Nihon Kohden

- Ortho-Clinical Diagnostics

- Polartechnics

- Polymedco

- Qiagen

- Roche

- SDIX

- Sequenom

- Siemens

- Sienco

- Sysmex

- Takara Bio

- ThermoFisher/Life Technologies

- Tosoh

- Wako

- Zycare/Alere


Methodology


This report is based on a combination of primary and secondary sources of information, including review of recent technical and business publications, manufacturer product literature, industry analyst reports, and Venture Planning Group's proprietary data files.


Contains 1,172 pages and256 tables

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