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市場調查報告書
商品編碼
1652144

美國的感染疾病診斷市場評估:各產品，各樣品類型，不同設定，各檢驗類型，各適應症，各終端用戶，各地區，機會，預測，2018年～2032年

United States Infectious Disease Diagnostics Market Assessment, By Product, By Sample Type, By Setting, By Type of Testing, By Indication, By End-user, By Region, Opportunities and Forecast, 2018-2032F
出版日期: | 出版商: Market Xcel - Markets and Data | 英文 137 Pages | 商品交期: 3-5個工作天內

價格

美國傳染病診斷市場預計將從 2024 年的 101.4 億美元增長到 2032 年的 154.8 億美元，在預測期內（2025-2032 年）的複合年增長率為 5.65%。由於傳染病病率不斷上升、各種診斷測試的普及以及對即時診斷測試技術的偏好日益增加等因素，傳染病診斷市場預計將出現成長。產業主要參與者開發創新疾病診斷和監測技術，為市場擴張做出了重大貢獻。增加對改善疾病模型分析和主要參與者策略活動的投資也促進了市場擴張。

傳染病診斷涉及識別患有相應臨床疾病的患者體內的傳染病病原體，例如細菌、病毒、真菌或寄生蟲。這個過程對於確定最有效的治療方法至關重要。診斷方法包括血液、尿液和組織樣本等實驗室測試，以及揭示致病微生物證據的影像學測試。病原體的檢測可以透過培養、細胞培養分離、生化、抗原和基因鑑定來實現。此外，特定的免疫反應和分子技術可用於準確診斷，特別是在資源匱乏的環境中。

然而，對新診斷解決方案缺乏認識、缺乏監管指南以及實驗室條件差導致陽性率低可能會阻礙傳染病診斷市場的成長。市場參與者正在積極致力於策略性產品發布和商業策略以擴大市場。

2025 年 1 月，Inflammatix, Inc. 獲得美國食品藥物管理局 (FDA) 批准銷售 TriVerity 測試系統 (TriVerity)。作為針對疑似急性感染或敗血症的尖端分子檢測，TriVerity 可以準確測量患者的免疫反應。 TriVerity 成功區分細菌和病毒感染並評估整體嚴重程度，為臨床醫生提供患者病情的廣泛且快速的概述。 FDA 批准的增加預計將帶來創新的診斷能力並為準確的患者評估提供信心，從而顯著促進美國傳染病診斷市場的成長。

目錄

第1章 計劃的範圍和定義

第2章 調查手法

第3章 摘要整理

第4章 美國的感染疾病診斷市場展望，2018年～2032年

  • 市場規模的分析與預測
    • 各金額
  • 市場佔有率分析與預測
    • 各產品
      • 試劑，套件，消耗品
      • 設備
      • 軟體
    • 各樣品類型
      • 血液和成分
      • 尿
      • 其他
    • 不同設定
      • 臨床檢驗
      • 就地檢驗
    • 各檢驗類型
      • 分子檢驗
      • 血清學的檢驗
      • 抗原檢驗
      • 文化試驗
      • 血液檢驗
      • 影像檢查
    • 各適應症
      • 細菌感染疾病
      • 病毒感染
      • 中樞神經系統感染疾病
      • 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
    • 各終端用戶
      • 診斷檢驗室
      • 學術機構·醫療機關
      • 醫院
      • 門診病人診療所
      • 家庭醫療保健
      • 其他
    • 各地區
      • 東北部
      • 中西部
      • 西部
      • 南部
    • 各企業市場佔有率分析(前五名公司和其他-各金額，2024年)
  • 市場地圖分析，2024年
    • 各產品
    • 各樣品類型
    • 不同設定
    • 各檢驗類型
    • 各適應症
    • 各終端用戶
    • 各地區

第5章 需求供給分析

第6章 價值鏈分析

第7章 波特的五力分析

第8章 大環境分析

第9章 價格分析

第10章 市場動態

  • 推動市場要素
  • 市場課題

第11章 市場趨勢與發展

第12章 法規結構和革新

  • 專利形勢
  • 法規當局的認證
  • 革新/新興技術

第13章 案例研究

第14章 競爭情形

  • 前五名市場領導公司的競爭矩陣
  • 前五大企業的SWOT分析
  • 前十名市場主要企業的形勢
    • Becton, Dickinson and Company
      • 公司概要
      • 主要經營團隊
      • 產品和服務
      • 財務狀況(如報告)
      • 主要市場焦點和地理存在感
      • 最近的趨勢/合作/夥伴關係/合併和收購
    • 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

上述公司不依市場佔有率排序，並且可能會根據研究工作期間獲得的資訊進行更改。

第15章 策略性建議

第16章 關於查公司·免責聲明

Product Code: MX12711

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