美国的感染疾病诊断市场评估:各产品，各样品类型，不同设定，各检验类型，各适应症，各终端用户，各地区，机会，预测，2018年～2032年

美国传染病诊断市场预计将从 2024 年的 101.4 亿美元增长到 2032 年的 154.8 亿美元，在预测期内（2025-2032 年）的复合年增长率为 5.65%。由于传染病病率不断上升、各种诊断测试的普及以及对即时诊断测试技术的偏好日益增加等因素，传染病诊断市场预计将出现成长。产业主要参与者开发创新疾病诊断和监测技术，为市场扩张做出了重大贡献。增加对改善疾病模型分析和主要参与者策略活动的投资也促进了市场扩张。

传染病诊断涉及识别患有相应临床疾病的患者体内的传染病病原体，例如细菌、病毒、真菌或寄生虫。这个过程对于确定最有效的治疗方法至关重要。诊断方法包括血液、尿液和组织样本等实验室测试，以及揭示致病微生物证据的影像学测试。病原体的检测可以透过培养、细胞培养分离、生化、抗原和基因鑑定来实现。此外，特定的免疫反应和分子技术可用于准确诊断，特别是在资源匮乏的环境中。

然而，对新诊断解决方案缺乏认识、缺乏监管指南以及实验室条件差导致阳性率低可能会阻碍传染病诊断市场的成长。市场参与者正在积极致力于策略性产品发布和商业策略以扩大市场。

2025 年 1 月，Inflammatix, Inc. 获得美国食品药物管理局 (FDA) 批准销售 TriVerity 测试系统 (TriVerity)。作为针对疑似急性感染或败血症的尖端分子检测，TriVerity 可以准确测量患者的免疫反应。 TriVerity 成功区分细菌和病毒感染并评估整体严重程度，为临床医生提供患者病情的广泛且快速的概述。 FDA 批准的增加预计将带来创新的诊断能力并为准确的患者评估提供信心，从而显着促进美国传染病诊断市场的成长。

目录

第1章 计划的范围和定义

第2章 调查手法

第3章 摘要整理

第4章 美国的感染疾病诊断市场展望，2018年～2032年

• 市场规模的分析与预测
  • 各金额
• 市场占有率分析与预测
  • 各产品
    • 试剂，套件，消耗品
    • 设备
    • 软体
  • 各样品类型
    • 血液和成分
    • 尿
    • 其他
  • 不同设定
    • 临床检验
    • 就地检验
  • 各检验类型
    • 分子检验
    • 血清学的检验
    • 抗原检验
    • 文化试验
    • 血液检验
    • 影像检查
  • 各适应症
    • 细菌感染疾病
    • 病毒感染
    • 中枢神经系统感染疾病
    • 心血管感染疾病
    • 真菌感染疾病
    • 消化管感染疾病
    • 性感染疾病
    • 其他
  • 各终端用户
    • 诊断检验室
    • 学术机构·医疗机关
    • 医院
    • 门诊病人诊疗所
    • 家庭医疗保健
    • 其他
  • 各地区
    • 东北部
    • 中西部
    • 西部
    • 南部
  • 各企业市场占有率分析(前五名公司和其他-各金额，2024年)
• 市场地图分析，2024年
  • 各产品
  • 各样品类型
  • 不同设定
  • 各检验类型
  • 各适应症
  • 各终端用户
  • 各地区

第5章 需求供给分析

第6章 价值链分析

第7章 波特的五力分析

第8章 大环境分析

第9章 价格分析

第10章 市场动态

• 推动市场要素
• 市场课题

第11章 市场趋势与发展

第12章 法规结构和革新

• 专利形势
• 法规当局的认证
• 革新/新兴技术

第13章 案例研究

第14章 竞争情形

• 前五名市场领导公司的竞争矩阵
• 前五大企业的SWOT分析
• 前十名市场主要企业的形势
  • Becton, Dickinson and Company
  • 公司概要
  • 主要经营团队
  • 产品和服务
  • 财务状况(如报告)
  • 主要市场焦点和地理存在感
  • 最近的趋势/合作/伙伴关係/合併和收购
  • Cepheid Inc.
  • Abbott Laboratories
  • BioMerieux SA
  • Hologic Inc
  • Bio-Rad Laboratories Inc.
  • Danaher Corporation
  • Thermo Fisher Scientific Inc.
  • DiaSorin SpA
  • F. Hoffmann-La Roche AG

上述公司不依市场占有率排序，并且可能会根据研究工作期间获得的资讯进行更改。

第15章 策略性建议

第16章 关于查公司·免责声明

United States infectious disease diagnostics market is projected to witness a CAGR of 5.65% during the forecast period 2025-2032, growing from USD 10.14 billion in 2024 to USD 15.48 billion in 2032. The infectious disease diagnostics market is expected to thrive under the influence of factors like the growing prevalence of infectious diseases, the availability of a diverse range of diagnostic tests, and the increasing preference for point-of-care diagnostic testing techniques. The development of innovative disease diagnosis and monitoring technologies by key industry players greatly contributes to the market's expansion. Increasing investments in improving disease model analysis and the strategic activities of key players are also contributing to market growth.

Infectious disease diagnostics involve the identification of the causative agent of an infectious disease, such as bacteria, viruses, fungi, or parasites, in a patient with a compatible clinical illness. The process is essential for determining the most effective treatment. Diagnostic methods include laboratory tests, such as blood, urine, and tissue samples, as well as imaging scans to reveal evidence of the microbe causing the disease. The detection of the pathogen can be done through cultivation, isolation in cell culture, and identification biochemically, antigenically, or genetically. Additionally, specific immune responses and molecular technologies are used for accurate diagnosis, especially in low-resource settings.

However, the growth of the infectious disease diagnostics market may be hindered by a lack of awareness of novel diagnostic solutions, the absence of compiled regulatory guidelines, and lower positivity rates due to inferior laboratory conditions. Market players are actively involved in strategic product launches and business tactics to expand the market.

In January 2025, Inflammatix, Inc. received U.S. Food and Drug Administration (FDA) approval for marketing the TriVerity Test System (TriVerity). As a cutting-edge molecular test for suspected acute infection or sepsis, TriVerity provides accurate measurements of a patient's immune response. It successfully differentiates between bacterial and viral infections and assesses overall illness severity, giving clinicians an extensive and fast patient status summary. Such increased FDA approval is expected to considerably enhance the growth of the infectious disease diagnostics market in the U.S. by bringing innovative diagnostic capabilities and instilling confidence in accurate patient evaluations.

Growing Prevalence of Infectious Diseases

Infectious diseases have been on the rise in the 21st century, with outbreaks such as COVID-19, SARS, and swine flu having a devastating impact on lives and livelihoods globally. Factors contributing to the emergence and spread of infectious diseases include ecological, environmental, or demographic factors that place people in increased contact with a previously unfamiliar microbe, as well as increasing prevalence of these factors. The growing prevalence of infectious diseases is directly proportional to the demand for infectious disease diagnostic solutions, further expanding the market. Infectious diseases are one of the leading causes of death, and a suitable treatment plan can be effectively utilized through efficient diagnostics. According to the World Health Organization (WHO), in 2023, Tuberculosis (TB) was the top infectious disease. The Centers for Disease Control and Prevention (CDC) noted an increase in the number of TB cases in the USA from 8,332 in 2022 to 9,633 in 2023, representing a 15.6% increase. The increase in TB cases is fueling the growth of the US infectious disease diagnostics market by emphasizing the need for better diagnostic equipment.

Rising Prevalence of Infectious Diseases

Several factors have led to an upsurge of infectious diseases in the United States, including increased international traveling, urbanization, antibiotic resistance, and climatic changes that affect the disease vectors. Other factors include the aged population and increased vulnerability to disease. According to the U.S. Centers for Disease Control and Prevention, new HIV infections occurred in the United States in the year 2022. The country aims to reduce this figure from 32,800 in 2022 to 9,300 in 2025 and even lower to 3,000 in 2030. As these infections increase, the need for infectious disease diagnostics (POCD) also rises, mainly because of the urgent demand for quick access to testing and rapid therapy. POCD facilitates early detection and treatment, which is fundamental to controlling epidemics and better patient care. Therefore, such increasing demand propels the point-of-care diagnostic market in the United States.

Given the surging demand, companies and governments are working. For example, in April 2025, Cepheid Inc., a subsidiary of Danaher Corporation, received WHO prequalification for its Xpert HIV-1 Qual XC-an in vitro test that is available for the detection of HIV-1 in blood samples.

Availability of a Diverse Range of Diagnostic Tests

A diverse range of diagnostic tests are available for infectious diseases, including laboratory tests, rapid diagnostic tests, serological testing, and polymerase chain reaction (PCR) testing. These tests can detect antibodies, antigens, and specific microorganisms to aid in the diagnosis of infectious diseases. Laboratory tests use samples of blood, urine, sputum, or other fluids to identify microorganisms through staining, culturing, or molecular methods. Rapid diagnostic tests, available in various formats and platforms, provide rapid results to inform clinical decision-making and enable point-of-care management. Serological testing looks for antibodies to verify previous exposure, while PCR testing detects the genetic material of microorganisms. These diverse testing methods are crucial in the accurate and timely diagnosis of infectious diseases. The diverse range is anticipated to contribute to the expansion of the market. Market players offer a variety of rapid diagnostic kits for different diseases.

In December 2024, Delve Bio, Inc. launched Delve Detect, a ground-breaking metagenomic test for infectious disease. Developed from the University of California San Francisco's platform, Delve Detect performs genomic testing of cerebrospinal fluid (CSF) for more than 68,000 pathogens and reports within 48 hours. Through easy room-temperature CSF transfer kits, overnight shipping, and access to qualified analysis, the launch expands diagnostic capacity and propels expansion in the U.S. infectious disease diagnostics market by responding to the demand for fast, reliable testing.

Reagents, Kits and Consumables Segment Accounts for Significant Market Share

The consumables and kits segment is leading the United States infectious disease diagnostics market at present. The segment is experiencing high growth, mainly attributed to repeat purchases and an increased emphasis on improving patient compliance with easy-to-use testing options. The recurring revenue from repeated purchases maintains its top position. Further, advances in molecular diagnostics, infectious disease incidence, and competitive conditions with many suppliers significantly promote the continued growth and market leadership of reagents, kits, and consumables. For instance, in December 2024, Panadea Diagnostics GmbH launched innovative Fc-receptor-based ELISA kits for detecting IgG antibodies against Zika, Dengue, and West Nile viruses, in addition to an IgM detection kit for Dengue. These innovative kits reflect the supremacy of kits and consumables in the USA infectious disease diagnostics market, substantially contributing to the market's growth by providing accurate and efficient diagnostic products.

Future Market Scenario (2025-2032F)

The diagnostic industry is witnessing growing regulatory approvals for infectious disease diagnostic solutions, which are expected to be marketed soon, further boosting the market. For instance, the Biomedical Advanced Research and Development Authority (BARDA) has supported a diverse portfolio of medical solutions, and these products have received a total of 86 FDA approvals, licensures, or clearances. Similarly, the Infectious Diseases Society of America (IDSA) has highlighted the need for new incentives and regulatory changes to spur R&D into new antibiotics and flexible regulations to allow innovative test development to keep pace with emerging infectious diseases. The increasing number of regulatory-approved products for infectious disease diagnosis is anticipated to land the market in the future and bring healthy competition among key players. The FDA has approved several diagnostic devices and authorized the emergency use of uncleared devices for infectious diseases, including influenza and respiratory syncytial virus.

Key Players Landscape and Outlook

These companies have a strong market presence with a vast product portfolio to offer in the field of diagnostics and research. With the growing infectious disease scenario, these players have strengthened their offerings through collaborations, mergers and acquisitions, and other market tactics.

In January 2025, F. Hoffmann-La Roche AG received FDA approval for the highly sensitive VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail test, which is to help in the diagnosis of B-cell lymphoma. This test helps pathologists differentiate B-cell malignancies from normal reactive infections, thus helping patients gain quicker access to treatment. This further solidifies Roche's leadership in the U.S. infectious disease diagnostics market through greater precision in the detection of disease.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. United States Infectious Disease Diagnostics Market Outlook, 2018-2032F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Product
    • 4.2.1.1. Reagents, Kits, and Consumables
    • 4.2.1.2. Instruments
    • 4.2.1.3. Software
  • 4.2.2. By Sample Type
    • 4.2.2.1. Blood and Components
    • 4.2.2.2. Urine
    • 4.2.2.3. Other
  • 4.2.3. By Setting
    • 4.2.3.1. Laboratory Testing
    • 4.2.3.2. Point-of-Care Testing
  • 4.2.4. By Type of Testing
    • 4.2.4.1. Molecular Tests
    • 4.2.4.2. Serological Tests
    • 4.2.4.3. Antigen Tests
    • 4.2.4.4. Culture Tests
    • 4.2.4.5. Blood Tests
    • 4.2.4.6. Imaging Tests
  • 4.2.5. By Indication
    • 4.2.5.1. Bacterial Infections
    • 4.2.5.2. Viral Infections
    • 4.2.5.3. CNS Infections
    • 4.2.5.4. Cardiovascular Infections
    • 4.2.5.5. Fungal Infections
    • 4.2.5.6. GI Infections
    • 4.2.5.7. Sexually Transmitted Diseases
    • 4.2.5.8. Other
  • 4.2.6. By End user
    • 4.2.6.1. Diagnostic Laboratories
    • 4.2.6.2. Academic And Medical Institutes
    • 4.2.6.3. Hospitals
    • 4.2.6.4. Ambulatory Clinics
    • 4.2.6.5. Home Healthcare
    • 4.2.6.6. Other
  • 4.2.7. By Region
    • 4.2.7.1. Northeast
    • 4.2.7.2. Midwest
    • 4.2.7.3. West
    • 4.2.7.4. South
  • 4.2.8. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 4.3. Market Map Analysis, 2024
  • 4.3.1. By Product
  • 4.3.2. By Sample Type
  • 4.3.3. By Setting
  • 4.3.4. By Type of Testing
  • 4.3.5. By Indication
  • 4.3.6. By End-user
  • 4.3.7. By Region

5. Demand Supply Analysis

6. Value Chain Analysis

7. Porter's Five Forces Analysis

8. PESTLE Analysis

9. Pricing Analysis

10. Market Dynamics

• 10.1. Market Drivers
• 10.2. Market Challenges

11. Market Trends and Developments

12. Regulatory Framework and Innovation

• 12.1. Patent Landscape
• 12.2. Regulatory Approvals
• 12.3. Innovations/Emerging Technologies

13. Case Studies

14. Competitive Landscape

• 14.1. Competition Matrix of Top 5 Market Leaders
• 14.2. SWOT Analysis for Top 5 Players
• 14.3. Key Players Landscape for Top 10 Market Players
  • 14.3.1. Becton, Dickinson and Company
    • 14.3.1.1. Company Details
    • 14.3.1.2. Key Management Personnel
    • 14.3.1.3. Products and Services
    • 14.3.1.4. Financials (As Reported)
    • 14.3.1.5. Key Market Focus and Geographical Presence
    • 14.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 14.3.2. Cepheid Inc.
  • 14.3.3. Abbott Laboratories
  • 14.3.4. BioMerieux SA
  • 14.3.5. Hologic Inc
  • 14.3.6. Bio-Rad Laboratories Inc.
  • 14.3.7. Danaher Corporation
  • 14.3.8. Thermo Fisher Scientific Inc.
  • 14.3.9. DiaSorin SpA
  • 14.3.10. F. Hoffmann-La Roche AG

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

15. Strategic Recommendations

16. About Us and Disclaimer

List of Tables

• Table 1. Competition Matrix of Top 5 Market Leaders
• Table 2. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 3. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. United States Infectious Disease Diagnostics Market, By Value, In USD Billion, 2018-2032F
• Figure 2. United States Infectious Disease Diagnostics Market Share (%), By Product, 2018-2032F
• Figure 3. United States Infectious Disease Diagnostics Market Share (%), By Sample Type, 2018-2032F
• Figure 4. United States Infectious Disease Diagnostics Market Share (%), By Setting, 2018-2032F
• Figure 5. United States Infectious Disease Diagnostics Market Share (%), By Type of Testing, 2018-2032F
• Figure 6. United States Infectious Disease Diagnostics Market Share (%), By Indication, 2018-2032F
• Figure 7. United States Infectious Disease Diagnostics Market Share (%), By End-user, 2018-2032F
• Figure 8. United States Infectious Disease Diagnostics Market Share (%), By Region, 2018-2032F
• Figure 9. By Product Map-Market Size (USD Billion) & Growth Rate (%), 2024
• Figure 10. By Sample Type Map-Market Size (USD Billion) & Growth Rate (%), 2024
• Figure 11. By Setting Size Map-Market Size (USD Billion) & Growth Rate (%), 2024
• Figure 12. By Type of Testing Size Map-Market Size (USD Billion) & Growth Rate (%), 2024
• Figure 13. By Indication Map-Market Size (USD Billion) & Growth Rate (%), 2024
• Figure 14. By End-user Map-Market Size (USD Billion) & Growth Rate (%), 2024
• Figure 15. By Region Map-Market Size (USD Billion) & Growth Rate (%), 2024