米国の体外診断薬（IVD）市場：包括的な市場概要（2024年～2029年）

米国の体外診断用医薬品（IVD）市場は、依然として世界最大かつ最も影響力のある市場です。この数十億米ドル規模の産業は、最先端の医療技術のインキュベーターとして、技術革新を推進し、世界の診断基準のベンチマークを設定しています。しかし、このダイナミックな市場は、急速な高齢化と精密診断に対する需要の高まりに適応しながら、コスト圧力、規制の変更、COVID-19の影響の残存といった課題のバランスを取りながら、変革の時期に直面しています。

当レポートは、米国の体外診断薬（IVD）市場について調査し、市場の概要とともに、この重要な分野を牽引する動向、技術、新興動向やM&Aを含む20社以上の主要企業の戦略やイノベーションなどを包括的に分析しています。

目次

第1章 エグゼクティブサマリー

第2章 米国の医療制度のイントロダクション

• 米国と体外診断
• 米国の患者人口
• ヘルスケアシステムの活用
• 高齢化
• 疾患の有病率と発症率
• 米国の臨床検査費用
• 予防医療
• 価値に基づく価格設定別製品イノベーション
• メディケアに基づく臨床試験- 償還削減と市場ベースの価格設定
• 2014年メディケアへのアクセス保護法（PAMA）
• CARES法がPAMAに与える影響
• 検査サービスへのアクセス保護法（SALSA）
• 高度臨床検査（ADLT）
• 個別化医療
• コンパニオン診断
• 米国の液体生検分野におけるAIの活用
• 遠隔医療
• 臨床検査（LDT）
• FDA
• 米国のヘルスケアインフラと検査チャネル
• 病院
• 独立系ラボ
• 病院検査室
• 在宅検査
• 在宅医療動向
• 小売クリニック
• 結論

第3章 米国のIVD市場分析

• 臨床化学
• 微生物学とウイルス学-ID/ASTと分子
• 分子感染症
• ポイントオブケア検査
• 免疫測定
• 非感染性疾患免疫測定
• 感染症免疫測定
• 分子非感染性疾患診断
• 凝固
• 組織学
• 血液学
• 血液検査と型判定
• 米国IVD市場全体

第4章 米国のIVD市場の競合企業

• Abbott Diagnostics
• Becton, Dickinson and Company (BD)
• bioMerieux
• BIOFIRE Diagnostics Business
• Danaher Corporation
• Beckman Coulter
• Cepheid
• Dexcom
• Exact Sciences
• Hologic, Inc.
• Panther Molecular System
• Panther Fusion
• Illumina
• Natera
• QuidelOrtho Corporation
• The Solana Business
• Roche Diagnostics
• cobas Liat System - POC
• Siemens Healthineers
• Thermo Fisher Scientific Inc.

The U.S. IVD market is a cornerstone of global healthcare innovation-but it is also a market in transition "In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029", the fifth edition in Kalorama's ongoing series, offers unparalleled access to insights on the trends and technologies that will define the industry's future.

This report is essential for:

• Identifying market gaps and opportunities for product innovation.
• Gaining a competitive edge with strategic insights into the U.S. diagnostic landscape.
• Making informed decisions by understanding market dynamics and future potential.
• Staying updated on how evolving regulations are shaping the IVD market.

The U.S. in vitro diagnostics (IVD) market remains the largest and most influential in the world This multi-billion-dollar industry serves as the incubator for cutting-edge medical technologies, driving innovation and setting the benchmark for diagnostic standards worldwide. Yet, this dynamic market faces a period of transformation, balancing challenges such as cost pressures, regulatory changes, and the lingering impacts of COVID-19-all while adapting to a rapidly aging population and increasing demand for precision diagnostics.

Kalorama Information's latest report, "In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029", delivers a comprehensive analysis of the trends, technologies, and players driving this critical sector. With data-backed insights, this report is your definitive guide to understanding the complexities of the U.S. IVD market.

What's in the Report

• Comprehensive Market Analysis: Gain detailed insights into key U.S. IVD segments, including:
  • 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
• Stay Ahead of the Curve: Understand how demographic shifts, technological advancements, and public health challenges are reshaping the market.
• Competitive Intelligence: Explore profiles of leading IVD companies, such as Roche Diagnostics, Abbott, Siemens Healthineers, and Thermo Fisher Scientific, and stay informed about their latest developments.
• Data-Driven Insights: With market data spanning 2024-2029, this report equips readers with the knowledge to identify growth opportunities and make informed decisions.

Report Highlights

• Extensive Market Coverage: Dive deep into U.S. IVD segments, from microbiology and hematology to histology and blood typing.
• Top Company Profiles: Learn about the strategies and innovations of 20+ key players, including emerging trends and M&A activities.
• Actionable Insights: Leverage the report's findings to assess the current standard of care, forecast future trends, and anticipate market penetration for new tests and technologies.

Table of Contents

Chapter 1: Executive Summary

• U.S. IVD Market
  • Table 1-1: U.S. IVD Market by Segment 2024-2029 ($ million) (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & mass spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others)
  • Figure 1-1: U.S. IVD Market Segments by % of the Total U.S. IVD Market, 2024 (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & Mass Spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others)
• Top 12 U.S. IVD Market Participants and Rankings
  • Table 1-2: U.S. IVD Market Rankings by Estimated 2024 US Revenue - Top 12 Companies (Abbott Diagnostics, Becton, Dickinson & Co. [BD], bioMerieux, Danaher Corporation [Beckman Coulter, Leica Biosystems, Radiometer, Cepheid], Dexcom, Exact Sciences, Illumina, Natera, QuidelOrtho, Roche Diagnostics, Siemens Healthcare Diagnostics, Thermo Fisher Scientific)
• Scope and Methodology
• 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 (million)
• Disease Prevalence and Incidence
  • Table 2-1: U.S. Cancer Cases, Estimates 2024
  • Table 2-2: Reported Cases of Selected Notifiable Diseases, U.S., 2022
• U.S. Clinical Lab Expenditure
  • Table 2-3: U.S. Clinical Lab Market, by Channel, 2023 (% 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 2-4: Implemented and Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2027
• Impact of CARES Act on PAMA
• Saving Access to Laboratory Service Act (SALSA)
• Advanced Laboratory Tests (ADLT)
  • Table 2-5: List of Approved ADLTs, March 2024
• Personalized Medicine
• Companion Diagnostics
  • Table 2-6: FDA Approved Companion Cancer Diagnostics, 2024
• AI Use in U.S. Liquid Biopsy Segment
  • Table 2-7: Selected S. AI/Liquid Biopsy Initiatives
• Telehealth
• Laboratory-Developed Tests (LDTs)
• FDA
• U.S. Healthcare Infrastructure and Testing Channels
• Hospitals
• Independent Labs
• Physician Office Laboratories
• At-Home Testing
• Home Collection Trend
  • Table 2-8: Home Collection Test Kit Market, by Category, Worldwide, 2022 (% Estimated Share) (Cholesterol, Drug of Abuse, Fertility Testing, Genetic, Infectious Disease [COVID-19, STDs, HIV, etc.], Tumor DNA Markers, Other [Hormone, Allergies, HbA1c, Heavy Metals, etc.])
  • Table 2-9: Selected Molecular Tests EUAs for Home Collection SARS-CoV-2 Tests, 2020-2024
• Retail Clinics
• Conclusions

Chapter 3: U.S. IVD Market Analysis

• Clinical Chemistry
  • Table 3-1: U.S. Clinical Chemistry Market, by Segment, 2024-2029 ($ million) (Blood Gases, General Chemistry, Urinalysis)
  • Figure 3-1: U.S. Clinical Chemistry Market, 2024-2029 ($ million)
• Microbiology and Virology - ID/AST and Molecular
  • Table 3-2: US ID/AST Microbiology ID/AST Market, by Segment, 2024-2029 ($ million) (Auto ID/AST, Manual ID/AST, Blood Culture, Chromogenic Media, Rapid, Micro)
  • Figure 3-2: U.S. ID/AST Microbiology Market, 2024-2029 ($ million)
• Molecular Infectious Disease
  • Table 3-3: U.S. Molecular Infectious Disease, Market Distribution Estimates by Segment, 2024 (%) (HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology)
  • Figure 3-3: U.S. Molecular Microbiology/Virology Market Distribution Estimates, by Segment, 2024 (%) (HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology)
• Point-of-Care Testing
  • Table 3-4: U.S. Point-of-Care (POC) Diagnostics Markets by Segment, 2024-2029 ($ million) (Glucose, Blood & Electrolytes, Coagulation, Cardiac Markers, Drugs of Abuse, Pregnancy & Fertility, Fecal Occult Blood, Infectious Disease, Lipid, Cancer Tumor Markers, Urine, Miscellaneous)
  • Figure 3-4: U.S. POC Diabetes Market, 2024-2029 ($ million)
  • Figure 3-5: U.S. POC Market without Diabetes, 2024-2029 ($ million)
• Immunoassays
• Non-Infectious Disease Immunoassay
  • Table 3-5: U.S. Immunoassays Market - Non Infectious, by Segment, 2024-2029 ($ million) (Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, Others)
  • Figure 3-6: U.S. Immunoassays Market - Non Infectious, 2024-2029 ($ million)
• Infectious Disease Immunoassay
  • Table 3-6: U.S. Immunoassays Market - Infectious, 2024-2029 ($ million) (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Others)
  • Figure 3-7: U.S. Immunoassay Infectious Disease, 2024-2029 ($ million)
• Molecular Non-Infectious Disease Diagnostics
  • Figure 3-8: U.S. Molecular - Non-Infectious Disease Diagnostics Market, 2024-2029 ($ million)
• Coagulation
  • Table 3-7: U.S. Coagulation Diagnostics Market, by Segment, 2024-2029 ($ million) (PT/INR, Molecular-lab Thrombophilia SNPs, D-Dimer)
  • Figure 3-9: U.S. Coagulation Diagnostics Market, 2024-2029 ($ million)
• Histology
  • Table 3-8: U.S. Histology/Cytology IVD Market, by Segment, 2024-2029 ($ million) Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional non-Pap Stains, HPV Molecular)
  • Figure 3-10: U.S. Histology and Cytology Diagnostics Market, 2024-2029 ($ million)
• Hematology
  • Table 3-9: U.S. Lab-based Hematology Market, by Analyte 2024-2029 ($ million)
  • Figure 3-11: U.S. Hematology Diagnostics Market, 2024-2029 ($ million)
• Blood Testing and Typing
  • Table 3-10: U.S. Blood Testing and Typing, by Segment, 2024-2029 ($ million) (ABO Grouping/Typing, Screening)
  • Figure 3-12: U.S. Blood Grouping and Typing Diagnostics Market, 2024-2029 ($ million)
  • Figure 3-13: U.S. Blood Screening Diagnostics Market, 2024-2029 ($ million)
• Total U.S. IVD Market
  • Table 3-11: U.S. IVD Market by Segment 2024-2029 ($ million) (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & mass spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others)
  • Figure 3-14: U.S. IVD Market Segments by % of the Total U.S. IVD Market, 2024 (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & Mass Spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others)

Chapter 4: Competitor U.S. IVD Market Players

• Table 4-1: Top 12 U.S. IVD Competitor Revenues, 2024 ($ million) (Abbott Diagnostics, Becton, Dickinson & Co. [BD], bioMerieux, Danaher Corporation [Beckman Coulter, Leica Biosystems, Radiometer, Cepheid], Dexcom, Exact Sciences, Illumina, Natera, QuidelOrtho, Roche Diagnostics, Siemens Healthcare Diagnostics, Thermo Fisher Scientific)
• Abbott Diagnostics
• Abbott Diagnostic Recent Revenue History
  • Table 4-2: Global Abbott Diagnostics (and Diabetes Management) Revenues, 2019-2023 ($ million)
  • Figure 4-1: Abbott Diagnostics - IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
  • Table 4-3: Global Abbott Diagnostics Revenues, 2019-2023 ($ million)
• Core Lab
• Hematology
• Blood Banking
• Infectious Diseases - Molecular
• Diabetes
• HIV Point of Care
• i-STAT Business
• Becton, Dickinson and Company (BD)
• Recent Revenue History
  • Table 4-4: Global BD Life Sciences Revenues, 2019-2023 ($ million)
  • Figure 4-2: BD - IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
• Cytology
• Molecular Microbiology
• Traditional Microbiology - ID/AST
• Blood Culture
• Hospital Acquired Infections
• Blood Collection
• Mass Spectrometry
• Flow Cytometry
• bioMerieux
  • Table 4-5: Global bioMerieux IVD Revenues, 2019-2023 ($ million)
  • Figure 4-3: bioMerieux - IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
  • Table 4-6: Global bioMerieux Revenues in Selected Test Segments, 2019-2023 ($ million)
• Traditional Microbiology
• Immunoassays
• BIOFIRE Diagnostics Business
• Danaher Corporation
• Recent Revenue History
  • Table 4-7: Global Danaher Diagnostics Revenues, 2019-2023 ($ million)
  • Figure 4-4: Danaher - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
• Beckman Coulter
• Cepheid
• Dexcom
  • Table 4-8: Global Dexcom Revenue History 2019-2023 ($ million)
  • Figure 4-5: Dexcom - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
• Exact Sciences
• Recent Revenue History
  • Table 4-9: Global Exact Sciences Revenue History, 2019-2023 ($ million)
  • Figure 4-6: Exact Sciences - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
• Hologic, Inc.
• Recent Revenue History
  • Table 4-10: Hologic Revenues, 2019-2023 ($ million)
  • Figure 4-7: Hologic - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
  • Table 4-11: Global Hologic Revenues in Selected Test Segments, 2019-2023 ($ million) estimated
• Panther Molecular System
• Panther Fusion
• Infectious Diseases
• Sexually Transmitted Infections
• Cytology
• Illumina
  • Table 4-12: Global Illumina Revenue History, 2019-2023 ($ million - not all revenues are for clinical products and services; estimated)
  • Figure 4-8: IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated
  • Table 4-13: Global Illumina Diagnostic Revenues, by Segment, 2019-2023 ($ million) estimated
• Natera
• Recent Revenue History
  • Table 4-14: Natera Revenue History, 2019-2023 ($ million)
  • Figure 4-9: Natera - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated
• QuidelOrtho Corporation
  • Table 4-15: Global QuidelOrtho Revenue History, 2019-2023 ($ million)
  • Figure 4-10: QuidelOrtho - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated
  • Table 4-16: Global QuidelOrtho Diagnostic Revenues, by Segment, 2020-2023 ($ million) estimated
• Immunoassays
• Rapid Immunoassays
• The Solana Business
• Molecular - Savanna
• Blood Bank
• Roche Diagnostics
• Recent Revenue History
  • Table 4-17: Global Roche IVD Diagnostics Revenues, 2019-2023 ($ million)
  • Figure 4-11: Roche - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated
  • Table 4-18: Global Roche IVD Diagnostics Revenues, by Type, 2019-2023 (million) estimated
• Immunoassays
• Core Molecular
• Digital PCR
• Diabetes Care
• cobas Liat System - POC
• HPV
• Blood Bank
• Cancer Companion Testing
• Siemens Healthineers (Siemens)
• Recent Revenue History
  • Table 4-19: Global Siemens Healthineers IVD Revenues, 2019-2023 ($ million)
  • Figure 4-12: Siemens Healthineers - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
  • Table 4-20: Global Siemens Healthineers Diagnostic Revenues, by Segment, 2021-2023 ($ million) estimated
• Core Lab
• Immunoassays
• Hematology
• Molecular
• Thermo Fisher Scientific Inc.
• Recent Revenue History
  • Table 4-21: Global Thermo Fisher IVD Revenues, 2019-2023 ($ million)
  • Figure 4-13: Thermo Fisher - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
  • Table 4-22: Global Thermo Fisher IVD Revenues, by Type, 2019-2023 (million) estimated
• Immunoassays
• Microbiology
• Molecular Test Business
• Next Generation Sequencing
• qPCR
• Oncology Companion Diagnostics
• Mass Spectrometry