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市場調查報告書

美國的體外診斷檢驗 (IVD) 市場

United States Market for In Vitro Diagnostic Tests

出版商 Kalorama Information 商品編碼 298921
出版日期 內容資訊 英文 210 Pages
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美國的體外診斷檢驗 (IVD) 市場 United States Market for In Vitro Diagnostic Tests
出版日期: 2016年06月27日 內容資訊: 英文 210 Pages
簡介

本報告以美國的IVD市場為焦點,提供各種明確趨勢,以及帶給廠商和投資者的影響,美國的醫療制度相關的說明和各主要企業的簡介等,為您概述為以下內容。

第1章 摘要整理

  • 簡介
  • 市場指標 - 醫療制度的使用概況
  • 市場指標 - 高齡化
  • 市場指標 - 疾病
  • 市場指標 - 醫療和臨床檢驗相關的總支出額及保險者
  • 市場指標 - 各種頻道臨床檢驗
  • 醫療費負擔合理化法 (ACA)的影響
  • 確保獲得醫療保險法 (PAMA) 和藥事未核准檢驗法 (LDT) 改革的影響
  • 美國的IVD市場
  • 美國的IVD市場進入主要企業和排行榜
  • 結論

第2章 美國的醫療制度

  • 美國與IVD
  • 美國的患者數
    • 醫療制度的使用概況
    • 高齡化
    • 罹患率與發生情形
  • 美國的醫療保險與醫療費負擔合理化法 (ACA)
    • 醫療相關的支出
    • 臨床檢驗相關的支出
    • 醫療費負擔合理化法 (ACA)
  • 醫療保險的臨床檢驗 - 償付金額的削減與再評估
    • 確保獲得醫療保險法 (PAMA)
  • 分子診斷和醫療保險政策
  • 藥事未核准檢驗法(LDT) 活化市場,挑戰法規機關
  • 美國的醫療基礎建設和臨床檢驗的頻道
    • 醫院
    • 獨立型檢驗室
    • 把POL (診察等作為主要目的診療設施)
    • 自診斷
    • 快速門診
  • 結論

第3章 美國IVD市場分析

  • 臨床化學
  • 微生物學,病毒學 - 微生物鑑定/抗菌藥敏銳度檢驗(ID/AST),分子診斷
  • 就地檢驗
  • 免疫測量
  • 尿液檢查
  • 分子診斷
  • 血液凝固檢驗
  • 組織學的檢驗
  • 血液學的檢驗
  • 血液檢驗和血型判斷
  • 流式細胞技術
  • 美國IVD整體市場

第4章 美國IVD市場主要企業

  • Abbott Diagnostics
  • Alere
  • Beckman Coulter(Danaher)
  • Becton, Dickinson and Company (BD)
  • bioMerieux
  • Bio-Rad Laboratories
  • Cepheid
  • Danaher Corporation
  • Hologic
  • Johnson & Johnson (Incl. Janssen Diagnostics)
  • Ortho-Clinical Diagnostics
  • QIAGEN
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific

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目錄
Product Code: KLI15035998

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

Table of Contents

1: Executive Summary

  • Introduction
  • Market Metrics - Utilization
  • Market Metrics - Aging
  • Market Metrics - Disease
  • Market Metrics - U.S. Total Health and Clinical Lab Expenditures and Payers
  • Market Metrics - U.S. Clinical Testing by Channel
  • Impacts of the Affordable Care Act
  • Impacts of PAMA and LDT Reform
  • U.S. IVD Market
  • Top Tier U.S. IVD Market Participants and Rankings
  • Conclusions

2: Introduction to U.S. Health Care

  • The United States and In Vitro Diagnostics
  • U.S. Patient Population
    • Healthcare System Utilization
    • Aging
    • Disease Prevalence and Incidence
  • Health Insurance in the United States and the Affordable Care Act
    • U.S. Health Expenditure
    • U.S. Clinical Lab Expenditure
    • Affordable Care Act (ACA)
  • Clinical Testing under Medicare - Reimbursement Cuts and Market-Based Pricing 55
    • Protecting Access to Medicare Act of 2014 (PAMA)
  • Molecular Diagnostics and Medicare Policy
  • Laboratory-Developed Tests (LDTs) Invigorate Market, Challenge Regulators
  • U.S. Healthcare Infrastructure and Testing Channels
    • Hospitals
    • Independent Labs
    • Physician Office Laboratories
    • Self-Testing
    • Retail Clinics
  • Conclusions

3: U.S. IVD Market Analysis

  • Clinical Chemistry
  • Microbiology and Virology - ID/AST and Molecular
  • Point-of-Care Testing
  • Immunoassays
  • Urinalysis
  • Molecular Diagnostics
  • Coagulation
  • Histology
  • Hematology
  • Blood Testing and Typing
  • Flow Cytometry
  • Total U.S. IVD Market

4: Top Tier U.S. IVD Market Players

  • Abbott Diagnostics
    • Core Lab
    • Hematology
    • Molecular
    • Blood Testing
    • Mass Spectrometry ID/AST
    • Diabetes Testing
    • Point-of-Care (POC) Diagnostics
  • Alere
    • Critical Care
    • Lipids and Cardiac Markers
    • Diabetes Testing
    • Coagulation
    • Toxicology / Drugs of Abuse
    • Infectious Diseases
  • Beckman Coulter (Danaher)
    • Immunoassays
    • Clinical Chemistry
    • Hematology
    • Microbiology
    • Urinalysis
    • Flow Cytometry
    • Molecular
  • Becton, Dickinson and Company (BD)
    • Microbiology
    • Mass Spectrometry
    • Immunoassays
    • Molecular
    • Histology/Cytology
    • Flow Cytometry
  • bioMérieux
    • Microbiology
    • Mass Spectrometry
    • Immunoassays
    • Molecular
    • Sequencing
  • Bio-Rad Laboratories
    • Microbiology
    • Hemoglobinopathy and Diabetes Testing
    • Immunoassays
    • Blood Typing and Testing
    • Tissue Typing
    • Sequencing
  • Cepheid
    • Molecular Hospital-Acquired Infection (HAI) Testing
    • Molecular Sexual Health and Women's Health Testing
    • Molecular Critical Infectious Disease Testing
    • Molecular Oncology Testing
  • Danaher Corporation
    • Histology
    • Point-of-Care Testing
  • Hologic
    • Molecular Cytology / Histology (HPV)
    • Other Molecular (STIs, HIV, HCV, TB, Respiratory)
    • Microbiology (AccuProbe Molecular Culture ID Tests)
    • Blood Testing (Molecular PROCLEIX Tests)
  • Johnson & Johnson (Incl. Janssen Diagnostics)
  • Ortho-Clinical Diagnostics
    • Core Lab
    • Blood Testing and Typing
  • QIAGEN
    • Molecular Infectious Disease
    • Companion Diagnostics
    • Immunoassays
    • Next-Generation Sequencing
  • Roche Diagnostics
    • Professional Diagnostics
    • Immunoassays
    • Point-of-Care Diagnostics
    • Diabetes Care
    • Tissue Diagnostics
    • Molecular Diagnostics
    • Blood Testing
    • Sequencing
    • Microbiology (GeneWeave)
  • Siemens Healthcare Diagnostics
    • Clinical Chemistry
    • Immunoassays
    • Hematology
    • Molecular Diagnostics and Histology
    • Urinalysis
    • Coagulation
    • Point-of-Care Diagnostics
  • Sysmex Corporation
    • Hematology
    • Coagulation
    • Urinalysis
  • Thermo Fisher Scientific
    • Immunoassays
    • Drug Testing
    • Histology
    • Mass Spectrometry
    • Microbiology
    • Molecular
    • Sequencing

L I S T O F E X H I B I T S

CHAPTER ONE: EXECUTIVE SUMMARY

  • Table 1-1: U.S. Commercially Insured Members' Encounters with Ambulatory Physicians (per 1,000 Members) (2005-2014)
  • Table 1-2: Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
  • Table 1-3: U.S. IVD Market by Segment (2015/2020)
  • Table 1-4: U.S. IVD Market Rankings by Estimated 2015 Revenue - Top 15 Companies

CHAPTER TWO: INTRODUCTION

  • Figure 2-1: U.S. IVD Market (2015/2020)
  • Table 2-1: U.S. Hospital Inpatient Admissions and Outpatient Visits Per 1,000 Persons (1994-2013)
  • Table 2-2: U.S. Commercially Insured Members' Encounters with Ambulatory Physicians (per 1,000 Members) (2005-2014)
  • Table 2-3: Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
  • Table 2-4: U.S. Cancer Incidence - Aggregate, Lung, Colon, Prostate, Breast (per 100,000 persons) (2002-2012)
  • Table 2-5: Selected Notifiable Infectious Disease Incidences in the United States (per 100,000 persons) (2003-2013)
  • Table 2-6: U.S. National Health Expenditure by Payer (Out-of-Pocket, Private Health Insurance, Medicare, Medicaid) (2013-2020)
  • Table 2-7: U.S. Clinical Laboratory Market by Segment - Hospital, Independent, Physician Office (2013-2020)
  • Figure 3-1: U.S. Clinical Chemistry Market (2015/2020)
  • Figure 3-2: U.S. ID/AST Microbiology Market (2015/2020)
  • Figure 3-3: U.S. Molecular Microbiology / Virology Market (2015/2020)

CHAPTER THREE: MARKET ANALYSIS

  • Table 3-1: U.S. ID/AST Microbiology Market - Automated ID/AST, Manual/Semi-Auto ID/AST, Blood Culture, Chromogenic Media, Rapid Micro (2015/2020)
  • Table 3-2: U.S. Molecular Microbiology / Virology Market - HAIs/BSIs, HIV, Hepatitis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other (2015/2020)
  • Figure 3-4: U.S. Point-of-Care (POC) Diagnostics Markets - Professional, OTC Diabetes, OTC Other (2015/2020)
  • Table 3-3: U.S. 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)
  • Figure 3-5: U.S. Immunoassays Markets - Infectious and Non-Infectious (2015/2020)
  • Table 3-4a: U.S. Immunoassays Market - Non Infectious (Cardiac Markers, Tumor Markers, HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D) (2015/2020)
  • Table 3-4b: U.S. Immunoassays Market - Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Others)
  • Figure 3-6: U.S. Urinalysis Lab Diagnostics Market (2015/2020)
  • Figure 3-7: U.S. Molecular Diagnostics Market (2015/2020)
  • Figure 3-8: U.S. Coagulation Diagnostics Market (2015/2020)
  • Figure 3-9: U.S. Histology and Cytology Diagnostics Market (2015/2020)
  • Figure 3-10: U.S. Hematology Diagnostics Market (2015/2020)
  • Figure 3-11: U.S. Blood Testing and Typing Diagnostics Market (2015/2020)
  • Figure 3-12: U.S. Clinical Flow Cytometry Market (2015/2020)
  • Table 3-5: U.S. IVD Market by Segment (2015/2020)

CHAPTER FOUR: COMPANY PROFILES

  • Table 4-1: Abbott Diagnostics Revenue (2012-2015)
  • Table 4-2: Alere Revenue (2012-2015)
  • Table 4-3: Beckman Coulter Revenue (2012-2015)
  • Table 4-4: BD Revenue (FY 2012-FY 2015)
  • Table 4-5: bioMérieux Revenue (2012-2015)
  • Table 4-6: Bio-Rad Laboratories Revenue (2012-2015)
  • Table 4-7: Cepheid Revenue (2012-2015)
  • Table 4-8: Danaher Diagnostics Group Subsidiary Revenue (Beckman Coulter, Radiometer, Leica Biosystems) (2012-2015)
  • Table 4-9: Hologic Revenue (FY 2012-FY 2015)
  • Table 4-10: Johnson & Johnson Diagnostics Revenue (2012-2015)
  • Table 4-11: QIAGEN Revenue (2012-2015)
  • Table 4-12: Roche Diagnostics Revenue (2012-2015)
  • Table 4-13: Siemens Healthcare Diagnostics Revenue (FY 2012-FY 2015)
  • Table 4-14: Sysmex Corporation Revenue (FY 2012-FY 2015)
  • Table 4-15: Thermo Fisher Scientific Revenue (2012-2015)
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