米国の感染症診断市場の評価：製品別、サンプルタイプ別、設定別、検査タイプ別、適応症別、エンドユーザー別、地域別、機会、予測、2018年～2032年

米国の感染症診断市場は、2025年から2032年の予測期間中にCAGR5.65％を記録し、2024年の101億4,000万米ドルから、2032年には154億8,000万米ドルに成長すると予測されています。感染症診断市場は、感染症の流行拡大、多様な診断検査の利用可能性、ポイントオブケア診断検査技術への選好の高まりといった要因の影響を受けて成長すると予想されます。業界主要企業による革新的な疾病診断・モニタリング技術の開発は、市場の拡大に大きく寄与しています。疾患モデル解析の改善への投資の増加や主要企業の戦略的活動も市場拡大に寄与しています。

感染症診断には、適合する臨床疾患を持つ患者において、細菌、ウイルス、真菌、寄生虫などの感染症の原因物質を同定することが含まれます。このプロセスは、最も効果的な治療を決定するために不可欠です。診断方法には、血液、尿、組織サンプルなどの臨床検査や、病気の原因となっている微生物の証拠を明らかにするための画像検査が含まれます。病原体の検出は、培養、細胞培養での分離、生化学的、抗原的、遺伝学的な同定によって行うことができます。さらに、特に資源が乏しい環境では、正確な診断のために特異的な免疫反応や分子技術が用いられます。

しかし、感染症診断薬市場の成長は、新しい診断ソリューションに対する認識不足、規制ガイドラインの未整備、劣悪な検査室環境による陽性率の低下によって阻害される可能性があります。市場プレーヤーは市場拡大のため、戦略的製品投入や事業戦術に積極的に取り組んでいます。

2025年1月、Inflammatix, Inc.は米国食品医薬品局（FDA）からTriVerity Test System（TriVerity）の販売承認を取得しました。急性感染症や敗血症が疑われる場合の最先端の分子検査として、TriVerityは患者の免疫反応を正確に測定します。TriVerityは、細菌感染とウイルス感染の鑑別に成功し、全体的な重症度を評価することで、臨床医に広範かつ迅速な患者の状態概要を提供します。このようなFDA認可の増加は、革新的な診断能力をもたらし、正確な患者評価への信頼感を与えることにより、米国における感染症診断薬市場の成長を大幅に促進すると予想されます。

目次

第1章 プロジェクトの範囲と定義

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 米国の感染症診断市場の展望、2018年～2032年

• 市場規模の分析と予測
  • 金額別
• 市場シェア分析と予測
  • 製品別
    • 試薬、キット、消耗品
    • 機器
    • ソフトウェア
  • サンプルタイプ別
    • 血液と成分
    • 尿
    • その他
  • 設定別
    • 臨床検査
    • ポイントオブケア検査
  • 検査タイプ別
    • 分子検査
    • 血清学的検査
    • 抗原検査
    • 文化テスト
    • 血液検査
    • 画像検査
  • 適応症別
    • 細菌感染症
    • ウイルス感染
    • 中枢神経系感染症
    • 心血管感染症
    • 真菌感染症
    • 消化管感染症
    • 性感染症
    • その他
  • エンドユーザー別
    • 診断検査室
    • 学術機関・医療機関
    • 病院
    • 外来診療所
    • 在宅ヘルスケア
    • その他
  • 地域別
    • 北東部
    • 中西部
    • 西部
    • 南部
  • 企業別市場シェア分析（上位5社とその他-金額別、2024年）
• 市場マップ分析、2024年
  • 製品別
  • サンプルタイプ別
  • 設定別
  • 検査タイプ別
  • 適応症別
  • エンドユーザー別
  • 地域別

第5章 需要供給分析

第6章 バリューチェーン分析

第7章 ポーターのファイブフォース分析

第8章 PESTLE分析

第9章 価格分析

第10章 市場力学

• 市場促進要因
• 市場の課題

第11章 市場の動向と発展

第12章 規制枠組みとイノベーション

• 特許情勢
• 規制当局の承認
• イノベーション/新興技術

第13章 ケーススタディ

第14章 競合情勢

• 市場リーダー上位5社の競合マトリックス
• 上位5企業のSWOT分析
• 市場上位10の主要企業の情勢
  • Becton, Dickinson and Company
  • 会社概要
  • 主要経営陣
  • 製品とサービス
  • 財務状況（報告通り）
  • 主な市場フォーカスと地理的プレゼンス
  • 最近の動向/コラボレーション/パートナーシップ/合併と買収
  • 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

上記の企業は市場シェアに基づいて注文を保留しておらず、調査作業中に入手可能な情報に基づいて変更される可能性があります。

第15章 戦略的提言

第16章 調査会社について・免責事項

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

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