Introduction:
The US market for in vitro diagnostics will exhibit slow, steady growth over the forecast period, driven by the aging population in the US and rising incidence of chronic diseases that require diagnostic testing.
This Medtech 360 Report provides comprehensive data and analysis on the current state of the market for in vitro diagnostics in the US, with market projections 5 years into the future.
We have up-to-date reports on a wide range of medical device markets worldwide.
Questions Answered in This Report:
*
Saturation of traditional IVD segments—
such as microbiology, clinical chemistry, and immunoassay—
is occurring in the US market. Which tests in these saturated markets will experience the highest growth through the forecast period?
At what rate is the emerging
MDx market growing, and what will be the largest segment in the overall
IVD market throughout the forecast period?
*
Over the forecast period, increasing centralization of clinical laboratories in the US will occur.How are vendors adjusting their strategies to adapt to this trend?
How are testing volumes shifting between the different facility types over the forecast period?
*
The IVD competitive landscape consists of large MNCs as well as smaller niche competitors specializing in specific segments and diseases. Who were the leaders in the
IVD market in 2012?
What types of strategies are these two types of competitors employing to gain market share?
What are the key purchasing criteria laboratories consider when selecting an
IVD manufacturer?
Scope:
Geographies Covered: US
Procedures Covered: Our analysis uses the following breakdown of procedures:
|
Facility Type
|
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Hospital-Related Laboratories
|
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POLs
|
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Reference Laboratories/Other
|
|
Application
|
|
Clinical Chemistry
|
Test Type
|
|
General Chemistry
|
Test Type
|
|
Metabolic Panel including Total Calcium
|
|
Comprehensive Metabolic Panel
|
|
Lipid Panel
|
|
Hepatic Panel
|
|
Diabetes
|
Test Type
|
|
Urine Glucose
|
|
Blood Glucose Monitor
|
|
Blood Glucose Reagent Strip
|
|
Glucose Tolerance
|
|
HbA1c
|
|
Microalbumin Quantitative
|
|
Insulin
|
|
TDM
|
Test Type
|
|
Carbamazepine
|
|
Cyclosporine
|
|
Phenobarbital
|
|
Phenytoin Total
|
|
Theophylline
|
|
Vancomycin
|
|
DAT
|
Test Type
|
|
Ethanol
|
|
Acetaminophen
|
|
Salicylate
|
|
Specific Protein
|
Test Type
|
|
Myoglobin
|
|
Prealbumin
|
|
C-Reactive Protein
|
|
Rheumatoid Factor
|
|
Haptoglobin
|
|
Immunoassay
|
Test Type
|
|
Allergy IgE
|
|
Anemia
|
Test Type
|
|
Vitamin B-12
|
|
Erythropoietin
|
|
Ferritin
|
|
Intrinsic Factor Antibody
|
|
Bone Metabolism
|
Test Type
|
|
Parathormone
|
|
HGH
|
|
Vitamin D 25 Hydroxy
|
|
Cardiac Marker
|
Test Type
|
|
Creatine Kinase
|
|
CK-MB
|
|
BNP
|
|
Troponin
|
|
Fertility/Hormone
|
Test Type
|
|
ACTH
|
|
Estradiol
|
|
FSH
|
|
LH
|
|
Progesterone
|
|
Testosterone
|
|
Thyroid
|
Test Type
|
|
Total Thyroxine
|
|
Free Thyroxine
|
|
TSH
|
|
Thyroid (T3 or T4)
|
|
Tumor Marker
|
Test Type
|
|
PSA Total
|
|
PSA Free
|
|
CA 15-3
|
|
CA 19-9
|
|
CA 125
|
|
Alpha-Fetoprotein Serum
|
|
Carcinoembryonic Antigen
|
|
Infectious Disease
|
Test Type
|
|
Epstein-Barr Virus
|
|
Acute Hepatitis
|
|
HSV
|
|
HSV Type 2
|
|
HIV-1/HIV-2
|
|
Parvovirus
|
|
Influenza A/B
|
|
Respiratory Syncytial Virus
|
|
Rotavirus
|
|
CMV
|
|
Microbiology
|
Test Type
|
|
Pathological Culture
|
Test Type
|
|
Salmonella and Shigella (Stool Culture)
|
|
Other Pathogens (Stool Culture)
|
|
Mycobacteria Culture
|
|
Aerobic Bacterial Culture (Non-Urine, -Blood, -Stool)
|
|
Anaerobic Bacterial Culture (Non-Urine, -Blood, -Stool)
|
|
Urine Bacteria Culture
|
|
Blood Culture
|
|
ID/AST
|
Test Type
|
|
Anaerobic Culture Identification
|
|
Aerobic Culture Identification
|
|
Microbe Susceptible Disk
|
|
MIC
|
|
Yeast Identification
|
|
Immunologic Culture Identification
|
|
Hemostasis
|
Test Type
|
|
General Screening and Anticoagulation Monitoring
|
Test Type
|
|
Complete CBC with Automated White Blood Cell Count
|
|
Complete CBC Automated
|
|
Blood Smear with Differential White Blood Cell Count
|
|
Automated Platelet Count
|
|
Hematocrit
|
|
Hemoglobin
|
|
Prothrombin Time
|
|
D-Dimer
|
|
Fibrin Formation and Degradation
|
Test Type
|
|
aPTT
|
|
Fibrinogen
|
|
MDx
|
Test Type
|
|
Infectious Disease
|
Test Type
|
|
Hepatitis C
|
|
HSV
|
|
Gonorrhea
|
|
HPV
|
|
Chlamydia
|
Products Covered: Our analysis uses the following breakdown of products in the market:
|
Facility Type
|
|
Hospital-Related Laboratories
|
|
POLs
|
|
Reference Laboratories/Other
|
|
Application
|
|
Clinical Chemistry
|
Product Type
|
|
Tests
|
Test Type
|
|
General Chemistry
|
|
Diabetes
|
|
TDM
|
|
DAT
|
|
Specific Protein
|
|
Instrumentation
|
|
Immunoassay
|
Product Type
|
|
Tests
|
Test Type
|
|
Allergy
|
|
Anemia
|
|
Bone Metabolism
|
|
Cardiac Marker
|
|
Fertility/Hormone
|
|
Thyroid
|
|
Tumor Marker
|
|
Infectious Disease
|
|
Instrumentation
|
|
Microbiology
|
Product Type
|
|
Tests
|
Test Type
|
|
Pathological Culture
|
|
Blood Culture
|
|
ID/AST
|
|
Instrumentation
|
|
Hemostasis
|
Product Type
|
|
Tests
|
Test Type
|
|
General Screening and Anticoagulation Monitoring
|
|
Prothrombin Time
|
|
D-Dimer
|
|
Fibrin Formation and Degradation
|
|
Instrumentation
|
|
MDx
|
Product Type
|
|
Tests
|
Test Type
|
|
Infectious Disease
|
|
Genetic Disease
|
|
Oncology
|
|
Instrumentation
|
Note: Market forecasts include test volumes and market revenues. ASP are discussed qualitatively only.
Market Forecast Features: Based on primary research with industry professionals, we use our proprietary forecasting model to provide an in-depth examination of current and future trends in procedure volumes and market values over a 7-year period (2010–2016).
Competitive Analysis: We provide a detailed analysis of the competitive landscape and market shares for leading competitors.
Authors:
Mickel Phung
ContributorsApril Chan
Lynn Gierszewski
Samuli Heilala, M.Sc.
Nancy Huynh
Veronica Ross