United States Market for In Vitro Diagnostic Tests (Molecular Assays, Microbiology, Histology, Chemistry, Hematology, Blood Banking, POC and Other Tests)

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Published Jun 27, 2016 | 210 Pages | Pub ID: KLI15035998

United States Market for In Vitro Diagnostic Tests

The United States represents the world’s largest in vitro diagnostics (IVD) market, projected to outpace other IVD markets in the developed world such as Western Europe and Japan. Growth in core lab test markets (hematology, clinical chemistry, urinalysis, non-infectious immunoassays) have been boosted in recent years by increased routine testing. The Affordable Care Act (ACA) has increased the ranks of the U.S. insured population and reduced out-of-pocket (OOP) costs for preventive health services including routine lab testing. This report, United States Market for In Vitro Diagnostic Tests, takes a considered look at the market and examines what current market trends mean for diagnostic manufacturers and investors.

This report includes important tools for business planners; this volume can provide a uniform standard for U.S. in vitro diagnostic market numbers. Included within the report are market size estimates and forecasts for the following U.S. IVD segments:
  • Clinical Chemistry Market (2015/2020)
  • Identification and Antibiotic Susceptibility Testing (ID/AST) Microbiology (Traditional) Market – Automated ID/AST, Manual/Semi‐Auto ID/AST, Blood Culture, Chromogenic Media, Rapid Micro (2015/2020)
  • Molecular Microbiology / Virology Market – HAIs/BSIs, HIV, Hepatitis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other (2015/2020)
  • Point-of-Care (POC) Diagnostics Markets – Professional (Drugs of Abuse, Infectious Disease, Pregnancy, Glucose, HbA1c, Lipids, Cardiac Markers, FOB, Critical Care, Coagulation, Hematology, Other), OTC Diabetes, OTC Other (2015/2020)
  • Immunoassays Market – Non Infectious (Cardiac Markers, Tumor Markers, HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D) (2015/2020)
  • Immunoassays Market – Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Others) (2015/2020)
  • Urinalysis Lab Diagnostics Market (2015/2020)
  • Molecular Diagnostics Market (2015/2020)
  • Coagulation Diagnostics Market (2015/2020)
  • Histology and Cytology Diagnostics Market (2015/2020)
  • Hematology Diagnostics Market (2015/2020)
  • Blood Testing and Typing Diagnostics Market (2015/2020)
  • Clinical Flow Cytometry Market (2015/2020)
The report discusses market factors and trends, including:
  • continued expansion of the insured population under the ACA and increased healthcare utilization baselines;
  • demographic aging that increases demand for clinical testing paid for through the country’s leading vehicle for lab payments (Medicare);
  • relatively optimistic macroeconomic indicators vis-à-vis the domestic outlook five years ago or other developed markets in the world;
  • continued product innovation and industry responsiveness to clients’ needs in the world’s largest IVD market.
The report discusses market metrics, providing key market data points of the U.S. IVD market, including:
  • Clinical Laboratory Market by Segment - Hospital, Independent, Physician Office (2013-2020)
  • U.S. Hospital Inpatient Admissions and Outpatient Visits Per 1,000 Persons (1994-2013)
  • U.S. Commercially Insured Members’ Encounters with Ambulatory Physicians (per 1,000 Members) (2005-2014)
  • Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
  • U.S. Cancer Incidence – Aggregate, Lung, Colon, Prostate, Breast (per 100,000 persons) (2002-2012)
  • Selected Notifiable Infectious Disease Incidences in the United States (per 100,000 persons) (2003-2013)
  • U.S. National Health Expenditure by Payer (Out-of-Pocket, Private Health Insurance, Medicare, Medicaid) (2013-2020)
The report tracks developments, both challenging and positive, in the United States IVD market. Conclusions about the market are made concerning issues such as distribution of market share in IVD market segments, future U.S. IVD market growth, anticipated market obstacles, the growth of the molecular diagnostics market, and core lab IVD market growth.

United States Market for In Vitro Diagnostic Tests profiles in-depth the top tier U.S. IVD market participants. The total combined IVD sales of these 16 top tier companies are estimated by Kalorama to represent nearly 70% of the total U.S. IVD market. The report ranks these firms and notes the IVD strengths of each. Companies discussed include:
  • Abbott Diagnostics
  • Beckman Coulter (Danaher)
  • Cepheid
  • Ortho-Clinical Diagnostics
  • Roche Diagnostics
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