In Vitro Diagnostic Products

An aging society, greater incidence of diseases and disorders, and the extension of health insurance coverage by the Affordable Care Act of 2010, will all spur US gains for IVD products.

US demand to approach $25 billion in 2016

US demand for in vitro (IVD) diagnostic products is forecast to rise 6.1 percent annually to $24.7 billion in 2016. A growing volume of patient care activity, spurred by aging demographic patterns, a heightened incidence of diseases and disorders, and the extension of health insurance coverage by the Affordable Care Act of 2010, will underlie gains. Advances in technology, along with the introduction of new and improved reagents and instruments, will drive up demand in most IVD product segments.

Molecular diagnostic IVD products to grow fastest

Demand for molecular diagnostic products will grow the fastest among all IVD products due to their throughput, accuracy, and speed advantages in the detection of infectious diseases, tumors, and genetic disorders. The US market for these products will benefit from the introduction of new, high value-added polymerase chain reaction (PCR) and related tests to post double-digit gains through 2016. Over the same period, demand for blood testing reagents and instruments will rise 3.4 percent per year to $2.6 billion. Competition from new immunoassay and molecular tests will moderate growth in demand.

Uses in patient health screening and diabetes self-monitoring, coupled with the widening availability of integrated and point-of-care systems offering greater productivity and operating ease, will boost demand for clinical chemistry products. The expansion of test menus for therapeutic drug monitoring, infectious disease detection, and cardiovascular and cancer testing, along with advances in chemiluminescent and other advanced systems, will promote gains for immunoassay products. Companion diagnostics used to determine the safety and effectiveness of drug therapies will provide especially strong growth for these products.

Cellular analysis reagents and instruments will continue to generate sizable demand from uses in ovarian and breast cancer screening and HIV monitoring. By contrast, demand for anatomical pathology reagents and instruments will expand well above the overall average growth pace of IVD products as clinical and forensic laboratories upgrade testing capabilities. The market for microbiology products will rise at a comparatively slow pace as molecular diagnostic and immunoassay technologies penetrate cancer and infectious disease testing procedures.

Hospital laboratories to remain dominant market

Hospital laboratories will continue to be the largest and most diverse market for IVD products based on extensive inpatient, emergency, and post-surgical testing activities. The home health care segment will expand at the fastest pace, with the vast majority of demand remaining concentrated in diabetes monitoring products. Through upgrading and broadening testing capabilities, independent clinical laboratories will continue to form the second largest overall and second fastest growing market served by the IVD industry.

Study Scope

This study analyzes the $18.4 billion US IVD products industry, with forecasts for 2016 and 2021 by product type (e.g., clinical chemistry, immunoassay, molecular diagnostic, blood testing, cellular analysis, anatomical pathology, microbiology), application (e.g., infectious disease testing, cancer testing, diabetes testing, heart disease testing, blood grouping and screening, drug testing) and market (e.g., hospitals, independent clinical laboratories).

The study also considers market environment factors, details industry structure, evaluates company market share and profiles 27 industry players, including Roche, Johnson & Johnson and Danahar.

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  1. In Vitro Diagnostic Products

    $5,100.00

    1. 1 INTRODUCTION

      $89.00

    2. 2 EXECUTIVE SUMMARY

      $116.00

      1. Table | IVD PRODUCT DEMAND (million dollars)

    3. 3 MARKET ENVIRONMENT

      $1,813.00

      1. 3.1 General

        $82.00

      2. 3.2 Macroeconomic Outlook

        $143.00

        1. Table | MACROECONOMIC INDICATORS (billion 2005 dollars)

      3. 3.3 Population & Age Distribution

        $113.00

        1. Table | RESIDENT POPULATION BY AGE GROUP (million)

      4. 3.4 Trends in Health Care

        $928.00

        1. 3.4.1 Medical Conditions

          $175.00

          1. Table | ACUTE CONDITIONS BY TYPE (million)

          2. Table | CHRONIC CONDITIONS BY TYPE (million)

        2. 3.4.2 Health Insurance Coverage

          $106.00

          1. Table | HEALTH INSURANCE COVERAGE OF THE US POPULATION (million)

        3. 3.4.3 National Health Expenditures

          $184.00

          1. Table | NATIONAL HEALTH EXPENDITURES BY CATEGORY (billion dollars)

          2. Table | NATIONAL HEALTH EXPENDITURES BY SOURCE (billion dollars)

        4. 3.4.4 Medical Providers

          $287.00

          1. Table | HOSPITALS & HOSPITAL BEDS

          2. Table | NUMBER OF OUTPATIENT FACILITIES BY TYPE

          3. Table | PHYSICIANS & PHYSICIANS' OFFICES (thousand)

          4. Table | HOME HEALTH CARE INDICATORS

          5. Table | NUMBER OF OTHER MEDICAL PROVIDERS BY TYPE

        5. 3.4.5 Patient Activity

          $159.00

          1. Table | HOSPITAL ACTIVITY

          2. Table | SURGICAL PROCEDURES BY SITE (thousand)

          3. Table | OUTPATIENT EPISODES BY TYPE (million)

      5. 3.5 IVD Market Composition

        $351.00

        1. 3.5.1 Regulation

          $148.00

        2. 3.5.2 Technology

          $82.00

        3. 3.5.3 Trends in IVD Testing

          $128.00

          1. Table | IVD TESTS BY TECHNOLOGY (million)

          2. Table | IVD TESTING SITES (thousand)

      6. 3.6 Historical Market Trends

        $82.00

        1. Table | IVD PRODUCT MARKET, 2001-2011

      7. 3.7 US Trade

        $82.00

        1. Table | US TRADE IN IVD PRODUCTS (million dollars)

      8. 3.8 World IVD Demand

        $108.00

        1. Table | WORLD IVD PRODUCT DEMAND BY REGION (million dollars)

    4. 4 PRODUCTS

      $4,147.00

      1. 4.1 General

        $98.00

        1. Table | IVD PRODUCT DEMAND BY TYPE (million dollars)

      2. 4.2 Product Segments

        $229.00

        1. Table | IVD PRODUCT DEMAND BY TECHNOLOGY (million dollars)

        2. 4.2.1 Reagents & Consumables

          $109.00

          1. Table | IVD REAGENT & CONSUMABLE DEMAND BY TECHNOLOGY (million dollars)

        3. 4.2.2 Instruments & Systems

          $82.00

          1. Table | IVD INSTRUMENT & SYSTEM DEMAND BY TECHNOLOGY (million dollars)

      3. 4.3 Clinical Chemistry Products

        $607.00

        1. Table | CLINICAL CHEMISTRY PRODUCT DEMAND BY TYPE (million dollars)

        2. 4.3.1 Reagents & Consumables

          $336.00

          1. Table | CLINICAL CHEMISTRY REAGENT & CONSUMABLE DEMAND BY TYPE (million dollars)

        3. 4.3.2 Instruments & Systems

          $92.00

          1. Table | CLINICAL CHEMISTRY INSTRUMENT & SYSTEM DEMAND BY TYPE (million dollars)

        4. 4.3.3 Applications

          $82.00

          1. Table | CLINICAL CHEMISTRY PRODUCT DEMAND BY APPLICATION (million dollars)

        5. 4.3.4 Producers

          $82.00

      4. 4.4 Immunoassay Products

        $507.00

        1. Table | IMMUNOASSAY PRODUCT DEMAND BY TYPE (million dollars)

        2. 4.4.1 Reagents & Consumables

          $232.00

          1. Table | IMMUNOASSAY REAGENT & CONSUMABLE DEMAND BY TYPE (million dollars)

        3. 4.4.2 Instruments & Systems

          $92.00

          1. Table | IMMUNOASSAY INSTRUMENT & SYSTEM DEMAND BY TYPE (million dollars)

        4. 4.4.3 Applications

          $82.00

          1. Table | IMMUNOASSAY PRODUCT DEMAND BY APPLICATION (million dollars)

        5. 4.4.4 Producers

          $100.00

      5. 4.5 Molecular Diagnostic Products

        $782.00

        1. Table | MOLECULAR DIAGNOSTIC PRODUCT DEMAND BY TYPE (million dollars)

        2. 4.5.1 Technology Overview

          $148.00

        3. 4.5.2 Reagents & Consumables

          $175.00

          1. Table | MOLECULAR DIAGNOSTIC REAGENT & CONSUMABLE DEMAND BY TYPE (million dollars)

        4. 4.5.3 Instruments & Systems

          $120.00

          1. Table | MOLECULAR DIAGNOSTIC INSTRUMENT & SYSTEM DEMAND BY TYPE (million dollars)

        5. 4.5.4 Applications

          $82.00

          1. Table | MOLECULAR DIAGNOSTIC PRODUCT DEMAND BY APPLICATION (million dollars)

        6. 4.5.5 Producers

          $210.00

      6. 4.6 Blood Testing Products

        $708.00

        1. Table | BLOOD TESTING PRODUCT DEMAND BY TECHNOLOGY (million dollars)

        2. 4.6.1 Hematology Products

          $208.00

          1. Table | HEMATOLOGY PRODUCT DEMAND BY TYPE (million dollars)

          2. Table | HEMATOLOGY PRODUCT DEMAND BY APPLICATION (million dollars)

        3. 4.6.2 Blood Bank Products

          $203.00

          1. Table | BLOOD BANK PRODUCT DEMAND BY TYPE (million dollars)

          2. Table | BLOOD BANK PRODUCT DEMAND BY APPLICATION (million dollars)

        4. 4.6.3 Hemostasis Products

          $267.00

          1. Table | HEMOSTASIS PRODUCT DEMAND BY TYPE (million dollars)

          2. Table | HEMOSTASIS PRODUCT DEMAND BY APPLICATION (million dollars)

      7. 4.7 Cellular Analysis Products

        $398.00

        1. Table | CELLULAR ANALYSIS PRODUCT DEMAND BY TECHNOLOGY (million dollars)

        2. 4.7.1 Flow Cytometry Products

          $172.00

          1. Table | FLOW CYTOMETRY PRODUCT DEMAND BY TYPE (million dollars)

          2. Table | FLOW CYTOMETRY PRODUCT DEMAND BY APPLICATION (million dollars)

        3. 4.7.2 Other Cellular Analysis Products

          $183.00

          1. Table | OTHER CELLULAR ANALYSIS PRODUCT DEMAND BY TYPE (million dollars)

          2. Table | OTHER CELLULAR ANALYSIS PRODUCT DEMAND BY APPLICATION (million dollars)

      8. 4.8 Anatomical Pathology Products

        $174.00

        1. Table | ANATOMICAL PATHOLOGY PRODUCT DEMAND BY TYPE (million dollars)

        2. 4.8.1 Reagents & Consumables

          $82.00

        3. 4.8.2 Instruments & Systems

          $82.00

        4. 4.8.3 Applications

          $82.00

          1. Table | ANATOMICAL PATHOLOGY PRODUCT DEMAND BY APPLICATION (million dollars)

        5. 4.8.4 Producers

          $82.00

      9. 4.9 Microbiology Products

        $243.00

        1. Table | MICROBIOLOGY PRODUCT DEMAND BY TYPE (million dollars)

        2. 4.9.1 Reagents & Consumables

          $82.00

        3. 4.9.2 Instruments & Systems

          $82.00

        4. 4.9.3 Applications

          $82.00

          1. Table | MICROBIOLOGY PRODUCT DEMAND BY APPLICATION (million dollars)

        5. 4.9.4 Producers

          $82.00

      10. 4.10 Other IVD Products

        $401.00

        1. Table | OTHER IVD PRODUCT DEMAND BY TECHNOLOGY (million dollars)

        2. 4.10.1 Effusion & Visual Inspection Products

          $250.00

          1. Table | EFFUSION & VISUAL INSPECTION PRODUCT DEMAND BY TYPE (million dollars)

          2. Table | EFFUSION & VISUAL INSPECTION PRODUCT DEMAND BY APPLICATION (million dollars)

        3. 4.10.2 Cytology Products

          $116.00

          1. Table | CYTOLOGY PRODUCT DEMAND BY TYPE (million dollars)

          2. Table | CYTOLOGY PRODUCT DEMAND BY APPLICATION (million dollars)

    5. 5 APPLICATIONS

      $2,384.00

      1. 5.1 General

        $89.00

        1. Table | IVD PRODUCT DEMAND BY APPLICATION (million dollars)

      2. 5.2 Infectious Disease Testing

        $625.00

        1. Table | INFECTIOUS DISEASE TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & CONDITION (million dollars)

        2. 5.2.1 Sexually Transmitted Diseases

          $363.00

          1. Table | SEXUALLY TRANSMITTED DISEASE (STD) TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & CONDITION (million dollars)

        3. 5.2.2 Other Infectious Diseases

          $210.00

          1. Table | OTHER INFECTIOUS DISEASE TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & CONDITION (million dollars)

      3. 5.3 Cancer Testing

        $439.00

        1. Table | CANCER TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & CONDITION (million dollars)

        2. 5.3.1 Cervical Cancer

          $85.00

        3. 5.3.2 Breast Cancer

          $102.00

        4. 5.3.3 Prostate Cancer

          $82.00

        5. 5.3.4 Colorectal Cancer

          $85.00

        6. 5.3.5 Other Cancers

          $82.00

        7. 5.3.6 Producers

          $82.00

      4. 5.4 Diabetes Testing

        $284.00

        1. Table | DIABETES TESTING IVD PRODUCT DEMAND BY TYPE (million dollars)

        2. 5.4.1 Reagents & Consumables

          $214.00

        3. 5.4.2 Instruments & Systems

          $82.00

      5. 5.5 Heart Disease Testing

        $232.00

        1. Table | HEART DISEASE TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & CONDITION (million dollars)

        2. 5.5.1 Lipid Profiling

          $82.00

        3. 5.5.2 Cardiac Markers

          $82.00

        4. 5.5.3 Blood Proteins

          $82.00

      6. 5.6 Blood Grouping & Screening

        $123.00

        1. Table | BLOOD GROUPING & SCREENING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & APPLICATION (million dollars)

        2. 5.6.1 Blood Typing & Matching

          $82.00

        3. 5.6.2 Blood & Bleeding Disorders

          $82.00

      7. 5.7 Drug Testing

        $215.00

        1. Table | DRUG TESTING IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & FUNCTION (million dollars)

        2. 5.7.1 Therapeutic Drug Monitoring

          $82.00

        3. 5.7.2 Drugs-of-Abuse Testing

          $103.00

      8. 5.8 Forensic Medicine

        $138.00

        1. Table | FORENSIC MEDICINE IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & FUNCTION (million dollars)

        2. 5.8.1 DNA Analysis

          $82.00

        3. 5.8.2 Identity Testing

          $82.00

        4. 5.8.3 Other Applications

          $82.00

      9. 5.9 Other IVD Applications

        $238.00

        1. Table | OTHER APPLICATIONS IVD PRODUCT DEMAND BY TYPE, TECHNOLOGY, & FUNCTION (million dollars)

        2. 5.9.1 Disease Detection

          $82.00

        3. 5.9.2 General Health Screening

          $82.00

        4. 5.9.3 Pregnancy & Ovulation Testing

          $82.00

    6. 6 MARKETS

      $460.00

      1. 6.1 General

        $82.00

        1. Table | IVD PRODUCT DEMAND BY MARKET (million dollars)

      2. 6.2 Hospitals

        $84.00

        1. Table | HOSPITAL IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)

      3. 6.3 Independent Clinical Laboratories

        $98.00

        1. Table | INDEPENDENT CLINICAL LABORATORY IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)

      4. 6.4 Outpatient Facilities

        $82.00

        1. Table | OUTPATIENT FACILITY IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)

      5. 6.5 Home Health Care Market

        $82.00

        1. Table | HOME HEALTH CARE IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)

      6. 6.6 Physicians' Offices

        $82.00

        1. Table | PHYSICIANS' OFFICE IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)

      7. 6.7 Other Markets

        $82.00

        1. Table | OTHER MARKETS IVD PRODUCT DEMAND BY TYPE & TECHNOLOGY (million dollars)

    7. 7 INDUSTRY STRUCTURE

      $5,132.00

      1. 7.1 General

        $82.00

        1. Table | IVD PRODUCT SALES BY COMPANY, 2011 (million dollars)

      2. 7.2 Market Share

        $298.00

      3. 7.3 Competitive Strategies

        $82.00

      4. 7.4 Mergers & Acquisitions

        $100.00

        1. Table | SELECTED ACQUISITIONS & DIVESTITURES

      5. 7.5 Cooperative Agreements

        $274.00

        1. Table | SELECTED COOPERATIVE AGREEMENTS

      6. 7.6 Research & Development

        $82.00

      7. 7.7 Marketing & Distribution

        $97.00

      8. 7.8 Manufacturing

        $82.00

      9. 7.9 Company Profiles

        $4,221.00

        1. 7.9.1 Abbott Laboratories

          $266.00

        2. 7.9.2 Affymetrix Incorporated

          $82.00

        3. 7.9.3 Agilent Technologies Incorporated

          $82.00

        4. 7.9.4 Alere Incorporated

          $209.00

        5. 7.9.5 ARKRAY Incorporated

          $82.00

        6. 7.9.6 Bayer AG

          $91.00

        7. 7.9.7 Becton, Dickinson and Company

          $168.00

        8. 7.9.8 bioMerieux SA

          $230.00

        9. 7.9.9 Bio-Rad Laboratories Incorporated

          $110.00

        10. 7.9.10 CombiMatrix Corporation

          $82.00

        11. 7.9.11 Danaher Corporation

          $271.00

        12. 7.9.12 Gen-Probe Incorporated

          $215.00

        13. 7.9.13 Hologic Incorporated

          $82.00

        14. 7.9.14 Illumina Incorporated

          $92.00

        15. 7.9.15 Johnson & Johnson

          $203.00

        16. 7.9.16 Life Technologies Corporation

          $147.00

        17. 7.9.17 Meridian Bioscience Incorporated

          $124.00

        18. 7.9.18 Myriad Genetics Incorporated

          $94.00

        19. 7.9.19 PerkinElmer Incorporated

          $106.00

        20. 7.9.20 QIAGEN NV

          $221.00

        21. 7.9.21 Quest Diagnostics Incorporated

          $126.00

        22. 7.9.22 Roche Holding Limited

          $333.00

        23. 7.9.23 Sequenom Incorporated

          $88.00

        24. 7.9.24 Siemens AG

          $275.00

        25. 7.9.25 Sysmex Corporation

          $156.00

        26. 7.9.26 Thermo Fisher Scientific Incorporated

          $161.00

        27. 7.9.27 Trinity Biotech plc

          $128.00

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