한글목차

미국의 체외 진단약(IVD) 시장은 여전히 세계 최대이고 가장 영향력 있는 시장입니다. 그러나 역동적 인 시장은 급속한 고령화 및 정밀 진단에 대한 수요 증가에 적응하면서 비용 압력, 규제 변경 및 COVID-19의 영향의 잔존과 같은 과제의 균형을 유지하면서 변화의 시기에 직면하고 있습니다.

본 보고서는 미국의 체외진단약(IVD) 시장을 조사했으며, 시장 개요와 함께 이 중요한 분야를 견인하는 동향, 기술, 신흥 동향 및 M&A를 포함한 20개 이상의 주요 기업의 전략과 혁신 등을 종합적으로 분석했습니다.

목차

제1장 주요 요약

제2장 미국 의료제도의 소개

• 미국과 체외 진단
• 미국 환자 인구
• 헬스케어 시스템의 활용
• 고령화
• 질환의 유병률과 발병률
• 미국의 임상 검사 비용
• 예방의료
• 가치에 따른 가격 설정별 제품 혁신
• 메디케어를 기반으로 한 임상시험 - 상환 삭감과 시장 기반 가격 설정
• 2014년 메디케어에의 액세스 보호법(PAMA)
• CARES법이 PAMA에 미치는 영향
• 검사 서비스에의 액세스 보호법(SALSA)
• 고도 임상 검사(ADLT)
• 맞춤형 의료
• 동반진단
• 미국의 액체 생검 분야에 있어서의 AI의 활용
• 원격 의료
• 임상 검사(LDT)
• FDA
• 미국의 헬스케어 인프라와 검사 채널
• 병원
• 독립계 실험실
• 병원 검사실
• 재택 검사
• 재택치료 동향
• 소매 클리닉
• 결론

제3장 미국의 IVD 시장 분석

• 임상 화학
• 미생물학과 바이러스학-ID/AST와 분자
• 분자감염증
• 포인트 오브 케어 검사
• 면역 측정
• 비감염성 질환 면역 측정
• 감염증 면역 측정
• 분자 비감염성 질환 진단
• 응고
• 조직학
• 혈액학
• 혈액 검사와 형 판정
• 미국 IVD 시장 전체

제4장 미국의 IVD 시장 경쟁 기업

• 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.

영문목차

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