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米国の体外診断検査 (IVD) 市場

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

発行 Kalorama Information 商品コード 298921
出版日 ページ情報 英文 210 Pages
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米国の体外診断検査 (IVD) 市場 United States Market for In Vitro Diagnostic Tests (Molecular Assays, Microbiology, Histology, Chemistry, Hematology, Blood Banking, POC and Other Tests)
出版日: 2016年06月27日 ページ情報: 英文 210 Pages
概要

当レポートは、米国のIVD市場に光を当て、各種のトレンドを明らかにするとともに、それがメーカーや投資家に及ぼす影響を分析したもので、米国の医療制度についての解説や主要企業各社のプロファイルなども盛り込んでお届けします。

第1章 エグゼクティブサマリー

  • イントロダクション
  • 市場の指標 - 医療制度の利用状況
  • 市場の指標 - 高齢化
  • 市場の指標 - 疾病
  • 市場の指標 - 医療と臨床検査関連の総支出額および保険者
  • 市場の指標 - 各種チャンネルでの臨床検査
  • 医療費負担適正化法 (ACA) の影響
  • メディケアアクセス保護法 (PAMA) と薬事未承認検査法 (LDT) 改革の影響
  • 米国のIVD市場
  • 米国のIVD市場に参入している主な企業とランキング
  • 結論

第2章 米国の医療制度

  • 米国とIVD
  • 米国の患者数
    • 医療制度の利用状況
    • 高齢化
    • 罹患率と発生状況
  • 米国の医療保険と医療費負担適正化法 (ACA)
    • 医療関連の支出
    • 臨床検査関連の支出
    • 医療費負担適正化法 (ACA)
  • メディケアによる臨床検査 - 償還金額の削減と再評価
    • メディケアアクセス保護法 (PAMA)
  • 分子診断とメディケア政策
  • 薬事未承認検査法(LDT) が市場を活性化し、規制機関に挑む
  • 米国の医療インフラストラクチャと臨床検査のチャンネル
    • 病院
    • 独立系検査室
    • POL (検診などを主な目的とした診療施設)
    • 自己診断
    • リテールクリニック
  • 結論

第3章 米国IVD市場の分析

  • 臨床化学
  • 微生物学、ウィルス学 - 微生物同定/抗菌薬感受性検査(ID/AST)、分子診断
  • ポイントオブケア検査
  • イムノアッセイ
  • 尿検査
  • 分子診断
  • 凝固検査
  • 組織学的検査
  • 血液学的検査
  • 血液検査と血液型判定
  • フローサイトメトリー
  • 米国IVD市場全体

第4章 米国IVD市場の主要企業

  • 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

図表リスト

目次
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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