表紙:米国の体外診断品 (IVD) 市場 (第4版)
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米国の体外診断品 (IVD) 市場 (第4版)

United States Market for In Vitro Diagnostic (IVD) Tests, 4th Edition

出版日: | 発行: Kalorama Information | ページ情報: 英文 220 Pages | 納期: 即日から翌営業日

価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=152.41円
米国の体外診断品 (IVD) 市場 (第4版)
出版日: 2022年10月06日
発行: Kalorama Information
ページ情報: 英文 220 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 目次
概要

米国のIVD市場は数十億米ドルの規模に達し、世界市場の中核をにぎっていますが、非常に流動的であり、無数の問題に対処しようとしており、そのすべてが世界で最もコストのかかる巨大なシステムと衝突しています。

当レポートでは、米国の体外診断薬 (IVD) 市場について分析し、市場の基本構造や近年の主な傾向、主な影響要因 (高齢化、新型コロナウイルス感染症 (COVID-19) など)、セグメント別の市場規模の動向見通し、主要企業のプロファイルと最新動向、といった情報を取りまとめてお届けいたします。

目次

第1章 エグゼクティブサマリー

  • 米国のIVD市場
  • 米国のIVD市場の参入企業:上位12位とランキング
  • 結論

第2章 米国の医療:概略

  • 米国と体外診断
  • 米国の患者数
  • 医療制度の活用
  • 高齢化
  • 病気の有病率と発生率
  • 米国の臨床研究費
  • 予防医療
  • 価値ベース価格設定に基づく製品イノベーション
  • メディケアの下での臨床試験 - 償還の削減と市場ベースの価格設定
  • PAMA法 (Protecting Access to Medicare Act of 2014)
  • PAMA法に対するCARES法の影響
  • 精密医療とNGS
  • LDT (薬事未承認検査)
  • COVID-19パンデミックによる変化
  • COVID-19の影響
  • 米国の医療インフラと検査チャネル
  • 病院
  • 独立系検査室
  • 開業医向け検査室
  • 在宅検査
  • 家庭での収集の傾向
  • リテールクリニック
  • 結論

第3章 米国のIVD市場の分析

  • 臨床化学
  • 微生物・ウイルス - ID/AST (同定/抗生物質感受性検査) と分子検査
  • 感染症分子検査
  • PoC (ポイントオブケア) 検査
  • 免疫検査
  • 非感染症免疫測定
  • 感染症免疫測定
  • 非感染症分子診断
  • 凝固
  • 組織検査
  • 血液検査
  • 血液検査・タイピング
  • 米国のIVD市場の合計

第4章 米国のIVD市場の大手企業

  • Abbott Diagnostics
  • Beckman Coulter, Inc. / Danaher
  • Beckman Coulter Life Sciences
  • bioMérieux
  • Bio-Rad Laboratories, Inc.
  • Cepheid / Danaher
  • Danaher Corporation
  • Hologic, Inc.
  • Ortho Clinical Diagnostics (QuidelOrtho)
  • QIAGEN N.V.
  • Quidel Corporation (QuidelOrtho)
  • PerkinElmer
  • Roche Diagnostics
  • Siemens Healthineers (Siemens)
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
目次
Product Code: 22-047c

The U.S. market dominates the IVD industry AND remains the core geographical IVD market in the world. Yet this major multi-billion-dollar IVD market is in a state of flux, trying to manage a myriad of issues, all of which collide with a huge system that costs more than any other in the world.

This latest report from Kalorama Information, “United States Market for In Vitro Diagnostic (IVD) Tests, 4th Edition ”, discusses the trends shaping the present and future of the IVD market in America, including an aging population and the lingering impact of COVID-19 for the foreseeable future.

The report discusses the following IVD market segments in the United States:

  • Clinical Chemistry
  • Microbiology (Traditional) - Identification and Antibiotic Susceptibility Testing (ID/AST)
  • Microbiology - Molecular- Infectious Disease
  • Point-of-Care (POC) Tests - Diabetes
  • Point-of-Care (POC) Tests - All Other
  • Immunoassays - Infectious Disease (non-POC)
  • Immunoassays - Other
  • Molecular - Non-infectious Disease
  • Hematology
  • Coagulation (non-POC)
  • Histology
  • Blood Testing and Typing
  • Others

In addition, the report profiles the top players in the U.S. IVD market. The profiles cover notable corporate events and developments from recent years.

Featured companies include:

  • Abbott Diagnostics
  • Beckman Coulter, Inc. / Danaher
  • Becton, Dickinson and Company (BD)
  • bioMérieux
  • Bio-Rad Laboratories, Inc.
  • Cepheid / Danaher
  • Danaher Corporation
  • Dexcom
  • Exact Sciences
  • Hologic, Inc.
  • Illumina
  • Ortho Clinical Diagnostics (QuidelOrtho)
  • QIAGEN N.V.
  • Quidel Corporation (QuidelOrtho)
  • PerkinElmer
  • Roche Diagnostics
  • Siemens Healthineers (Siemens)
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.

Table of Contents

Chapter 1: Executive Summary

  • U.S. IVD Market
    • Table 1-1: U.S. IVD Market by Segment (Clinical Chemistry, Microbiology - ID/AST, Molecular, Molecular Infectious Disease Molecular - non, Infectious Disease, POC Diabetes, POC - Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Typing, and Others), 2022-2027 (in millions $)
    • Figure 1-1: U.S. IVD Market Segments (Clinical Chemistry, Microbiology - ID/AST, Molecular, Molecular Infectious Disease Molecular - non, Infectious Disease, POC Diabetes, POC - Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Grouping, and Others), by % of the total U.S. IVD Market, 2022
  • Top 12 U.S. IVD Market Participants and Rankings
    • Table 1-2: U.S. IVD Market Rankings, by Estimated 2022 US Revenue - Top 12 Companies (Abbott Diagnostics, Roche Diagnostics, Danaher Corporation, Siemens Healthcare Diagnostics, Thermo Fisher Scientific, Becton, Dickinson & Co. (BD), Hologic, Illumina, Dexcom, bioMérieux, Exact Sciences, and Ortho Clinical)
  • Conclusions

Chapter 2: Introduction to U.S. Health Care

  • The United States and In Vitro Diagnostics
  • U.S. Patient Population
  • Healthcare System Utilization
  • Aging
    • Figure 2-1: U.S. Projects of Older Adult Population, 2016-2060
  • Disease Prevalence and Incidence
    • Table 2-1: U.S. New Cancer Cases 2022 Estimates, by Type (Female Breast, Prostate, Lung and Bronchus, Colon and Rectum, Corpus and Uterus, Melanomas of the Skin, Urinary Bladder, Non-Hodgkin Lymphoma, Kidney and Renal Pelvis, Thyroid, and Pancreas)
    • Table 2-2 U.S. Estimated Cancer Deaths, by Cancer Type (Lung and Bronchus, Female Breast, Prostate, Colon and Rectum, Pancreas, Ovary, Liver and Intrahepatic Bile Duct, Leukemias, Non-Hodgkin Lymphoma, and Corpus and Uterus), 2022
    • Table 2-3: Reported Cases of Selected Notifiable Diseases (Arboviral Diseases [incl. West Nile], Babesiosis, Brucellosis, Chlamydia, Cholera, Coccidiodomycosis, Cryptosporidiosis, Dengue, Ehrlichiosis/Anaplasmosis, Giardiasis, Gonorrhea, Hepatitis A, Hepatitis B, Hepatitis C, HIV/AIDS, Legionellosis, Listeriosis, Lyme Disease, Malaria, Meningococcal Disease, Pertussis, Q Fever, Salmonellosis, Shiga toxin-producing E Coli, Shigellosis, Spotted Fever Rickettsiosis, Syphilis, Tuberculosis, Vancomycin-intermediate Staphylococcus aureus, Vibriosis), U.S., 2016-2019, by Case Count
  • U.S. Clinical Lab Expenditure
    • Table 2-4: U.S. Clinical Lab Market by Channel (Hospital Labs/Acute Care Labs, Independent Labs, and Physician Office Labs/Outpatient Labs), 2021-2026 (% of Market)
  • Preventive Health Care
  • Product Innovation from Value-Based Pricing
  • Clinical Testing Under Medicare - Reimbursement Cuts and Market-Based Pricing
  • Protecting Access to Medicare Act of 2014 (PAMA)
    • Table 2-5: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2025
  • Impact of CARES Act on PAMA
  • Precision Medicine and NGS
  • Laboratory-Developed Tests (LDTs)
  • Changes Resulting from COVID-19 Pandemic
  • COVID-19 Impact
  • U.S. Healthcare Infrastructure and Testing Channels
  • Hospitals
  • Independent Labs
  • Physician Office Laboratories
  • At-Home Testing
  • Home Collection Trend
  • Retail Clinics
  • Conclusions

Chapter 3: U.S. IVD Market Analysis

  • Clinical Chemistry
    • Table 3-1: U.S. Clinical Chemistry Market (General Chemistry, Blood Gases, and Urinalysis) 2022-2027 (in millions $) est
    • Figure 3-1: U.S. Clinical Chemistry Market, 2022-2027 ($ millions)
  • Microbiology and Virology - ID/AST and Molecular
    • Table 3-2: US ID/AST Microbiology ID/AST Market (ID/AST Auto, ID/AST Panels, Blood Culture, Chromogenic Media, and Rapid Micro) 2022-2027 ($ millions)
    • Figure 3-2: U.S. ID/AST Microbiology Market (Auto ID/AST, Manual ID/AST, Blood Culture, Chromogenic Media, Rapid, Micro) 2022-2027 ($ millions)
  • Molecular Infectious Disease
    • Table 3-3: U.S. Molecular Infectious Disease, Market Distribution Estimates by Segment (HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Molecular including Parasitology, Mycology, Malaria, Chagas, Dengue, etc.), 2022-2027 (%)
    • Figure 3-3: U.S. Molecular Microbiology / Virology Market Distribution Estimates by Segment, (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology), 2022 (%)
  • Point-of-Care Testing
    • Table 3-4: U.S. Point-of-Care (POC) Diagnostics Markets (Glucose, Blood & Electrolytes, Coagulation, Cardiac Markers, Drugs of Abuse, Pregnancy & Fertility, Fecal Occult Blood, Infectious Disease, Lipid, Cancer Tumor Markers, Urine, Miscellaneous), 2022 and 2027 ($ millions)
    • Figure 3-4: U.S. POC Diabetes Market, 2022-2027 (in millions $)
    • Figure 3-5: U.S. POC Market without Diabetes, 2022-2027 (in millions $)
  • Immunoassays
  • Non-Infectious Disease Immunoassay
    • Table 3-5: U.S. Immunoassays Market - Non Infectious (Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, others) 2022-2027 ($ millions)
    • Figure 3-6: U.S. Immunoassay-Non-infectious (Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, others), 2022-2027 (in millions) $)
  • Infectious Disease Immunoassay
    • Table 3-6: U.S. Immunoassays Market - Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Others), 2022-2027 (in millions $)
    • Figure 3-7: U.S. Immunoassay Infectious Disease (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAI/Sepsis, Others), 2022-2027 (in millions $)
  • Molecular Non-Infectious Disease Diagnostics
    • Figure 3-8: U.S. Molecular Non-Infectious Disease Diagnostics Market, 2022-2027 ($ millions)
  • Coagulation
    • Table 3-7: U.S. Coagulation Diagnostics Market by Segment , PT/INR, Molecular-lab Thrombophilia SNPs, D-Dimer, 2022-2027 (in millions $)
    • Figure 3-9: U.S. Coagulation Diagnostics Market, 2022-2027 ($ millions)
  • Histology
    • Table 3-8: U.S. Histology/Cytology IVD Market by Segment (Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional non-Pap Stains, HPV Molecular) 2022-2027 ($ millions)
    • Figure 3-10: U.S. Histology and Cytology Diagnostics Market, 2022-2027 ($ millions)
  • Hematology
    • Table 3-9: U.S. Lab-based Hematology Market by Analyte Segment (CBC, Hemoglobin, and Other), 2022-2027 (in millions $)
    • Figure 3-11: U.S. Hematology Diagnostics Market, 2022-2027 ($ millions)
  • Blood Testing and Typing
    • Table 3-10: U.S. Blood Testing and Typing by Segment (ABO Grouping/Typing and Screening), 2022-2027 (in millions $)
    • Figure 3-12: U.S. Blood Grouping and Typing Diagnostics Market, 2022-2027 ($ millions)
    • Figure 3-13: U.S. Blood Screening Diagnostics Market (Immunoassay Blood Screening and NAT Blood Screening), 2022-2027 ($ millions)
  • Total U.S. IVD Market
    • Table 3-11: U.S. IVD Market including COVID-19, by Segment (Clinical Chemistry, Microbiology - ID/AST, Molecular, Molecular Infectious Disease Molecular - non, Infectious Disease, POC Diabetes, POC - Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Typing, and Others), 2022-2027 (in millions $)
    • Figure 3-14: U.S. IVD Market Segments (Clinical Chemistry, Microbiology - ID/AST, Molecular, Molecular Infectious Disease Molecular - non, Infectious Disease, POC Diabetes, POC - Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Typing, and Others), 2022 (%)

Chapter 4: Top Tier U.S. IVD Market Players

  • Table 4-1: 2021 U.S. IVD Competitor Revenues ($ millions)
  • Abbott Diagnostics
    • Recent Revenue History
      • Table 4-2: Abbott Diagnostic Revenues 2017-2021 (millions $)
      • Figure 4-1: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-3: Global Abbott Diagnostic Revenues, 2017-2021 (millions $)
    • Core Lab
    • Hematology
    • Blood Banking
    • Infectious Diseases - Molecular
    • Diabetes
    • HIV Point of Care
    • i-STAT Business
    • COVID-19
  • Beckman Coulter, Inc. / Danaher
    • Recent Revenue History
      • Table 4-4: Beckman Coulter Diagnostic Revenues 2017-2021 (millions $)
      • Figure 4-2: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-5: Global Beckman Coulter Revenues in Selected Test Segments 2019-2021 (millions $) estimated
    • Hematology
    • Hematology IT
    • Clinical Chemistry
    • Immunoassays
    • Microbiology
    • Molecular Tissue Analysis
    • Flow Cytometry
    • Beckman Coulter Life Sciences
    • COVID-19
  • Becton, Dickinson and Company (BD)
    • Recent Revenue History
      • Table 4-6: BD Diagnostic Revenues 2017-2021 (millions $)
      • Figure 4-3: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-7: Global BD Revenues in Flow Cytometry 2017- 2021 (millions $)
    • Cytology
    • Molecular Microbiology
    • Traditional Microbiology - ID/AST
    • Blood Culture
    • Hospital Acquired Infections
    • Blood Collection
    • Mass Spectrometry
    • Flow Cytometry
    • COVID-19
  • bioMérieux
    • Recent Revenue History
      • Table 4-8: bioMérieux IVD Revenues, 2017-2021 (millions $)
      • Figure 4-4: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-9: bioMérieux Revenues in Selected Test Segments, 2017-2021 (millions $)
    • Traditional Microbiology
    • Blood Culture
    • Immunoassays
    • BIOFIRE Diagnostics Business
    • COVID-19
  • Bio-Rad Laboratories, Inc.
    • Recent Revenue History
      • Table 4-10: Bio-Rad Diagnostics Revenues 2017-2021 (millions $)
      • Figure 4-5: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-11: Global Bio-Rad Revenues in Selected Test Segments 2017-2021 (millions $)
    • Blood Bank
    • Diabetes
    • Immunoassays
    • COVID-19
  • Cepheid / Danaher
    • Recent Revenue History
      • Table 4-12: Cepheid Revenues 2017-2021 (millions $)
    • GeneXpert Xpress Line
    • Tuberculosis
    • Microbiology
    • POC Testing
    • Cancer
    • COVID-19
  • Danaher Corporation
    • Recent Revenue History
      • Table 4-13: Danaher Diagnostics Revenues 2017-2021 (millions $)
      • Figure 4-6: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
    • Dexcom
      • Table 4-14: 2017-2021 Dexcom Revenue History ($ million)
      • Figure 4-7: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
    • Exact Sciences
      • Table 4-15: Exact Sciences Revenue History, 2017-2021 (in $ millions)
      • Figure 4-8: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions)estimated
    • COVID-19
  • Hologic, Inc.
    • Recent Revenue History
      • Table 4-16: Hologic Revenues 2017-2021 (millions $)
      • Figure 4-9: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-17: Global Hologic Revenues in Selected Test Segments 2017-2021 (millions $)
    • PANTHER Molecular System
    • Panther Fusion
    • Infectious Diseases
    • Sexually Transmitted Infections
    • Cytology
    • COVID-19
    • Illumina
      • Table 4-18: Illumina Revenue History ($ million - not all revenues are for clinical products and services; estimated)
      • Figure 4-10: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-19: Illumina Diagnostic Revenues by Segment ($ million) est
    • COVID-19
  • Ortho Clinical Diagnostics (QuidelOrtho)
    • Recent Revenue History
      • Table 4-20: Ortho Clinical Diagnostics Revenues 2017-2021 (millions $)
      • Figure 4-11: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-21: Global Ortho Clinical Diagnostics Revenues in Selected Test Segments 2021 (millions $)
    • Blood Bank
    • Core Lab / Immunoassays
    • COVID-19
  • QIAGEN N.V.
    • Recent Revenue History
      • Table 4-22: QIAGEN N.V. IVD Revenues 2017-2021 (millions $)
      • Figure 4-12: 2021 QIAGEN IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-23: Global QIAGEN IVD Revenues by Type, 2017-2021 (million)
    • Tuberculosis
    • Lyme Disease
    • Molecular Expansion
    • Precision Medicine / Companion Diagnostics
    • Molecular Microbiology
    • Prenatal Testing
    • Next Generation Sequencing
    • Digital PCR
    • Liquid Biopsy
    • COVID-19
  • Quidel Corporation (QuidelOrtho)
    • Table 4-24: Quidel Revenue History ($ million)
    • Figure 4-13: 2021 QIAGEN IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
    • Table 4-25: Quidel Diagnostic Revenues by Segment ($ million) est
    • Immunoassays
    • Rapid Immunoassays
    • The Solana Business
    • Molecular - Savanna
    • COVID-19
  • PerkinElmer
    • Table 4-26: PerkinElmer Revenue History, 2017-2021 ($ million, estimated)
    • Figure 4-14: 2021 PerkinElmer IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
    • Table 4-27: PerkinElmer Diagnostic Revenues by Segment, 2017-2021 ($ million) est
    • Diagnostics
    • Sequencing /Genomics
    • Liquid Biopsy
    • Histology
    • Prenatal Business
    • Lab Services
    • Mass Spectrometry
    • COVID-19
  • Roche Diagnostics
    • Recent Revenue History
      • Table 4-28: Roche IVD Diagnostics Revenues 2017-2021 (millions $)
      • Figure 4-15: 2021 Roche IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-29: Global Roche IVD Diagnostics Revenues by Type, 2017-2021 (million)
    • Hematology
    • Immunoassays
    • Core Molecular
    • Digital PCR
    • Diabetes Care
    • cobas Liat System - POC
    • HPV
    • Blood Bank
    • Cancer Companion Testing
    • COVID-19
  • Siemens Healthineers (Siemens)
    • Recent Revenue History
      • Table 4-30: Siemens Healthineers IVD Revenues 2017-2021 (millions $)
      • Figure 4-16: 2021 Siemens Healthineers IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-31: Global Siemens Healthineers IVD Revenues by Type, 2021 (million)
    • Core Lab
    • Immunoassays
    • Hematology
    • Molecular
    • Acute Care - POC
    • COVID-19
  • Sysmex Corporation
    • Recent Revenue History
      • Table 4-32: Sysmex IVD Revenues 2017-2021 (millions $)
      • Figure 4-17: 2021 Sysmex IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-33: Global Sysmex IVD Revenues by Type, 2017-2021 (million)
    • Hematology
    • Coagulation
    • Urinalysis
    • Flow Cytometry
    • Precision Medicine / Companion Test Diagnostics
  • Thermo Fisher Scientific Inc.
    • Recent Revenue History
      • Table 4-34: Thermo Fischer IVD Revenues 2017-2021 (millions $)
      • Figure 4-18: 2021 Thermo Fisher IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
      • Table 4-35: Global Thermo Fisher IVD Revenues by Type, 2017-2021 (million)
    • Immunoassays
    • Microbiology
    • Molecular Test Business
    • Next Generation Sequencing
    • qPCR
    • Oncology Companion Diagnostics
    • Mass Spectrometry
    • COVID-19