查看购物车
  • Traditional Chinese
  • Japanese
  • Korean
美国的体外诊断(IVD)市场:全面的市场概要(2024年～2029年)
市场调查报告书
商品编码
1592138

美国的体外诊断(IVD)市场:全面的市场概要(2024年～2029年)

In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029
出版日期: | 出版商: Kalorama Information | 英文 210 Pages | 商品交期: 最快1-2个工作天内

价格
简介目录

美国体外诊断（IVD）市场仍是全球最大、最具影响力的市场。这个价值数十亿美元的产业是尖端医疗技术的孵化器，推动创新并为全球诊断标准设定基准。然而，这个充满活力的市场正在经历一段转型期，以适应人口迅速老化和对精准诊断不断增长的需求，同时平衡成本压力、监管变化和COVID-19 所面临的挥之不去的影响等课题。

本报告考察了美国体外诊断 (IVD) 市场，概述了市场和 20 多家主要公司的策略，包括推动这一重要行业的趋势、技术、新兴趋势和併购。

目录

第1章 摘要整理

第2章 美国的医疗制度的简介

  • 美国与体外诊断
  • 美国患者群
  • 医疗保健系统的利用
  • 老化
  • 疾病盛行率和发病率
  • 美国的临床测试费用
  • 预防医学
  • 透过基于价值的定价进行产品创新
  • 基于医疗保险的临床试验 - 报销减少和基于市场的定价
  • 2014 年保护医疗保险法案 (PAMA)
  • CARES 法案对 PAMA 的影响
  • 《保护测验服务进入法》(SALSA)
  • 高阶临床测试 (ADLT)
  • 个人化医疗
  • 伴随诊断
  • 人工智慧在美国液体切片领域的应用
  • 远距医疗
  • 临床测试 (LDT)
  • FDA
  • 美国医疗保健基础设施和侦测管道
  • 医院
  • 独立实验室
  • 医院实验室
  • 在家测试
  • 家庭医疗趋势
  • 零售诊所
  • 结论

第3章 美国的IVD市场分析

  • 临床化学
  • 微生物学和病毒学 - ID/AST 和分子
  • 分子感染
  • 即时侦测
  • 免疫分析
  • 非传染性疾病免疫分析
  • 传染病免疫分析
  • 非传染性疾病分子诊断
  • 凝固
  • 组织学
  • 血液学
  • 血液检测与类型确定
  • 美国 IVD 市场总量

第4章 美国的IVD市场竞争企业

  • 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.
简介目录
Product Code: 24-031

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