ポイントオブケア診断の米国市場の評価：製品別、処方別、エンドユーザー別、地域別、機会、予測（2017年～2031年）

米国のポイントオブケア診断の市場規模は、2023年の174億7,000万米ドルから2031年に258億1,000万米ドルに達すると予測され、予測期間の2024年～2031年にCAGRで5.00%の成長が見込まれます。市場の成長は、国内における感染症患者数の増加、早期発見に対する意識の高まり、小型で携帯可能な診断機器への選好の高まり、民間と政府からの資金提供の増加、研究開発投資の増加、技術の進歩などによって支えられています。

COVID-19パンデミック後、信頼性が高く迅速で利用しやすい検査の必要性がより明らかになるにつれ、ポイントオブケア診断（PCOD）市場は大きな成長を示しています。パンデミック時の医療システムにおける課題から、特に遠隔地に住むすべての人々にとって、十分な質のケアが必要であることが明らかになっています。医療の優先順位は変化しており、継続的な患者アクセスと信頼できる診断ツールの必要性が高まっています。AI、バイオセンサー、ナノテクノロジー、スマートフォンプラットフォームなどの技術革新は、ポイントオブケアにおける診断の精度と速度の能力を向上させています。これらの先進技術を電子カルテ（EHR）と統合し、CLIA免除検査を増加させることも、患者ケアへの重要な移行です。米国における研究開発への資金提供の増加も、価格の手頃さと利用しやすさを追求する市場を加速させ、国全体の健康転帰を改善しています。

さらに、企業は革新的な技術に投資し、承認プロセスを合理化することで、検査へのアクセスを高め、最終的に患者転帰の改善を促しています。例えば2024年6月、Co-Diagnostics, Inc.は、Co-Dx PCR Proデバイスの市販前承認（PMA）申請を行っています。このデバイスは、ゴールドスタンダードのPCR検査を、これまで制限されてきた大規模で複雑な検査室から移行させ、発展途上国での感染症診断をより身近なものにするものです。同社は小型化され、スマートフォンで制御可能なデバイスを開発し、特許取得済みのCo-Dx Co-Primers技術によりFDA 510（k）認可を目指しています。

当レポートでは、米国のポイントオブケア診断市場について調査分析し、市場規模と予測、市場力学、主要企業の情勢などを提供しています。

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 米国のポイントオブケア診断市場の見通し（2017年～2031年）

• 市場規模の分析と予測
  • 金額
• 市場シェアの分析と予測
  • 製品別
  • 処方別
  • エンドユーザー別
  • 地域別
  • 市場シェア分析：企業別（金額）（上位5社とその他 - 2023年）
• 市場マップ分析（2023年）
  • 製品別
  • 処方別
  • エンドユーザー別
  • 地域別

第5章 需給分析

第6章 輸入と輸出の分析

第7章 バリューチェーン分析

第8章 ポーターのファイブフォース分析

第9章 PESTLE分析

第10章 価格分析

第11章 市場力学

• 市場促進要因
• 市場の課題

第12章 市場の動向と発展

第13章 規制枠組みとイノベーション

• 規制当局の承認

第14章 特許情勢

第15章 ケーススタディ

第16章 競合情勢

• マーケットリーダー上位5社の競合マトリクス
• 上位5社のSWOT分析
• 主要企業上位10社の情勢
  • F. Hoffmann-La Roche Ltd
  • GE HealthCare Technologies Inc.
  • Abbott Laboratories
  • Cepheid Inc.
  • Co-Diagnostics, Inc.
  • Visby Medical, Inc.
  • SEKISUI Diagnostics LLC
  • Becton, Dickinson and Company
  • BioMerieux SA
  • Nova Biomedical Corporation

第17章 戦略的推奨

第18章 当社について、免責事項

List of Tables

• Table 1. Pricing Analysis of Products from Key Players
• Table 2. Competition Matrix of Top 5 Market Leaders
• Table 3. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 4. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. United States Point-of-Care Diagnostics Market, By Value, In USD Billion, 2017-2031F
• Figure 2. United States Point-of-Care Diagnostics Market Share (%), By Product, 2017-2031F
• Figure 3. United States Point-of-Care Diagnostics Market Share (%), By Prescription, 2017-2031F
• Figure 4. United States Point-of-Care Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 5. United States Point-of-Care Diagnostics Market Share (%), By Region, 2017-2031F
• Figure 6. By Product Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 7. By Prescription Size Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 8. By End-user Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 9. By Region Map-Market Size (USD Billion) & Growth Rate (%), 2023

United States point-of-care diagnostics market is projected to witness a CAGR of 5.00% during the forecast period 2024-2031, growing from USD 17.47 billion in 2023 to USD 25.81 billion in 2031. The market growth is supported by influenced by the rising number of infectious cases in the country, increasing awareness for early detection, increasing preference for compact and portable diagnostic devices, growing private and government funding, increased research and development investments, and technological advancements.

The point-of-care diagnostics (PCOD) market is witnessing significant growth post-COVID-19 pandemic as the need for reliable, rapid, and accessible testing becomes more apparent. Challenges in the healthcare system during the pandemic have revealed the need for adequate quality care, particularly for all those in more remote areas. Healthcare priorities are changing, and there is a growing need for continuous patient access and trusted diagnostic tools. Innovations such as artificial intelligence, biosensors, nanotechnology, and smartphone platforms improve the capabilities of the accuracy and speed of diagnostics at the point-of-care. Integrating these advanced technologies with electronic health records (EHR) and the growth of CLIA-waived tests are also a significant transition to patient care. Increased funding for research and development in the United States also accelerates the market toward affordability and accessibility, improving health outcomes across the country.

Moreover, companies are investing in innovations and streamlining the approval process to boost testing access, ultimately driving improved patient outcomes. For instance, in June 2024, Co-Diagnostics, Inc. submitted its pre-market approval (PMA)application for the Co-Dx PCR Pro device that will eventually migrate the gold-standard PCR test from the large, complex laboratories to which it has been confined to this point and make infectious disease diagnostics more accessible in the developing world. The company created miniaturized, smartphone-controllable devices and is pursuing FDA 510(k) clearance through patented Co-Dx Co-Primers technology.

Technological Advancements Drive Market Growth

Technological advancements in the United States Point-of-Care Diagnostics (POCD) market improve the accuracy and efficiency of tests conducted in the Point-of-Care Diagnostics environment. Mobile equipment, such as handheld analyzers, portable ultrasound machines, and mobile labs, enable healthcare providers to make quicker assessments outside traditional settings and, therefore, has improved access in other underserved areas. For example, in June 2024, Cepheid Inc. received FDA marketing authorization for its Xpert HCV test, and GeneXpert Xpress System, the first in the family of hepatitis C virus testing solutions that will be used in the approved point-of-care setting for diagnosing individuals at risk for hepatitis C. Lastly, artificial intelligence is also reshaping diagnostics as it assists in interpreting outcome results, detecting trends, and forecasting outcomes.

For instance, in October 2024, HueDx, Inc. (HueDx) published a study demonstrating the utility of its smartphone-based, paper-driven quantitative diagnostic platform, HueTools and HueLab. Such innovation finally overcomes earlier limitations of demonstrating reliable point-of-care clinical chemistry colorimetric results without additional hardware. These innovations make the diagnosis process easier and provide a healthy boost for the whole market due to portable solutions for testing, improved patient care, and accessibility throughout the country.

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 the year 2025 and even lower to 3000 in 2030. As these infections increase, the need for Point-of-Care 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 are 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 2024, 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.

Increasing Funding or Investments Promote Market Growth

Increasing funding from the government and the private sector is a major driver in point-of-care diagnostics market growth in the United States. Such funding improves more advanced and reliable diagnostic technologies, thus furthering the capabilities and accessibility of tests. Funding for research and innovation results in the development of portable devices and efficient testing schemes that can be fitted into many healthcare settings. Therefore, the market is rapidly advancing in response to the growing requirements for more timely and accurate diagnostics. For instance, in April 2024, Binx Health Inc. raised USD 65 million in Series F funding toward further company growth. They plan to expand their point-of-care diagnostics growth by focusing on speeding up the time between diagnosis and treatment of sexually transmitted diseases. Binx io is the FDA-cleared platform by which Binx aims to accelerate the speed of diagnosis and treatment for sexually transmitted infections. Results from tests for chlamydia and gonorrhea return within 30 minutes.

Product Segment Accounts for Significant Market Share

The glucose monitoring segment is the most dominant in the Point-of-Care Diagnostics market, as diabetes prevails highly in the United States and constantly forces the demand for better self-monitoring products that are easy to use. The advancement of technologies, such as continuous glucose monitors and smart devices, which can be connected to a mobile application, drive this segment that gives the user real-time data and insights. Further, health initiatives that are coming up in the form of diabetes management and education are pushing for the adoption of these tools. Glucose monitoring is thus gaining dominance through the enormous investment it brings into market growth while improving patient engagement and outcomes, thus becoming an important area in the healthcare sector.

For instance, in August 2024, DexCom, Inc. introduced the Stelo, the first over-the-counter glucose biosensor in the U.S. This small device is used to be worn on the upper arm, uses advanced sensing technology to provide personalized glucose insights to the 125 million Americans who suffer from Type 2 diabetes and prediabetes.

Future Market Scenario (2024-2031F)

The integration of artificial intelligence and machine learning in diagnostic devices will ensure accurate and more efficient test results. A significant expansion of telehealth services would also occur since consultation through remote platforms often requires rapid turnaround solutions to ensure the timely treatment of patients. As the trends evolve, the scope for a point-of-care diagnostics market will flourish with a holistic transformation in healthcare delivery.

Increasing investments along with enhanced awareness are promising signs of further expansion of the point-of-care diagnostics market. For example, in April 2024, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) funded USD 1 million to Scout Health Inc. (previously known as Uh-Oh Labs, Inc.), a diagnostics and health-tech company, to develop the STI Scout test, which can differentiate Neisseria gonorrhoeae from Chlamydia trachomatis in just 30 minutes, quickly and affordably.

Key Players Landscape and Outlook

The major players for point-of-care diagnostics in the United States focus on strategic alliances, product innovation, and expanding their channel network distribution to enhance market positions. Investments in research and development will be utilized to introduce new diagnostic solutions at the cutting edge of healthcare demand.

In September 2024, Cepheid Inc. (Cepheid) collaborated with the Fleming Initiative and committed itself to combat global antimicrobial resistance, a global collaboration being spearheaded by Imperial College Healthcare NHS Trust and Imperial College London. Cepheid has become the first diagnostics company to join this endeavor as it applauds its new partnership at an event in New York to coincide with the UN General Assembly High-Level Meeting on AMR.

In June 2022, Visby Medical, Inc. added USD 35 million to its already existing funding round, Series E financing round, taking the total amount to over USD 135 million. Supported by Lightrock LLP, the new capital will help Visby Medical grow its production capacity, increase product lines with advanced respiratory health tests and antimicrobial resistance panels, and provide at-home PCR diagnostics.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. United States Point-of-Care Diagnostics Market Outlook, 2017-2031F

• 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. Glucose Monitoring
      • 4.2.1.1.1. Strips
      • 4.2.1.1.2. Meters
      • 4.2.1.1.3. Lancets
    • 4.2.1.2. Cardiometabolic Testing Products
      • 4.2.1.2.1. Cardiac Marker Testing Products
        • 4.2.1.2.1.1. High Sensitive Troponin-I (hsTnl)
        • 4.2.1.2.1.2. Brain natriuretic peptide (BNP)
        • 4.2.1.2.1.3. D-dimer
        • 4.2.1.2.1.4. Creatine Kinase-MB (CK-MB)
        • 4.2.1.2.1.5. Myoglobin
        • 4.2.1.2.1.6. Others
      • 4.2.1.2.2. Blood Gas/Electrolytes Testing Products
      • 4.2.1.2.3. HbA1C Testing Products
    • 4.2.1.3. Infectious Disease Testing Products
      • 4.2.1.3.1. Sexually Transmitted Disease (STD) Testing Products
      • 4.2.1.3.2. Healthcare-associated Infection (HAI) Testing Products
      • 4.2.1.3.3. Respiratory Infection Testing Products
      • 4.2.1.3.4. Tropical Disease Testing Products
      • 4.2.1.3.5. Others
    • 4.2.1.4. Coagulation Testing Products
      • 4.2.1.4.1. PT/INR Testing Products
      • 4.2.1.4.2. Activated Clotting Time/Activated Partial Thromboplastin Clotting Time (ACT/APTT) Testing Products
    • 4.2.1.5. Pregnancy and Fertility Testing Products
      • 4.2.1.5.1. Pregnancy Testing Products
      • 4.2.1.5.2. Fertility Testing Products
    • 4.2.1.6. Tumor/Cancer Marker Testing Products
    • 4.2.1.7. Cholesterol Testing Products
    • 4.2.1.8. Hematology Testing Products
    • 4.2.1.9. Drug-of-Abuse (DoA) Testing Products
    • 4.2.1.10. Fecal Occult Testing Products
    • 4.2.1.11. Urinalysis Testing Products
    • 4.2.1.12. Others
  • 4.2.2. By Prescription
    • 4.2.2.1. OTC Testing
    • 4.2.2.2. Prescription-based Testing
  • 4.2.3. By End-user
    • 4.2.3.1. Hospitals
    • 4.2.3.2. Diagnostic Centers
    • 4.2.3.3. Research Laboratories
    • 4.2.3.4. Homecare Settings
    • 4.2.3.5. Others
  • 4.2.4. By Region
    • 4.2.4.1. Northeast
    • 4.2.4.2. Midwest
    • 4.2.4.3. West
    • 4.2.4.4. South
  • 4.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2023)
• 4.3. Market Map Analysis, 2023
  • 4.3.1. By Product
  • 4.3.2. By Prescription
  • 4.3.3. By End-user
  • 4.3.4. By Region

5. Demand Supply Analysis

6. Import and Export Analysis

7. Value Chain Analysis

8. Porter's Five Forces Analysis

9. PESTLE Analysis

10. Pricing Analysis

11. Market Dynamics

• 11.1. Market Drivers
• 11.2. Market Challenges

12. Market Trends and Developments

13. Regulatory Framework and Innovation

• 13.1. Regulatory Approvals

14. Patent Landscape

15. Case Studies

16. Competitive Landscape

• 16.1. Competition Matrix of Top 5 Market Leaders
• 16.2. SWOT Analysis for Top 5 Players
• 16.3. Key Players Landscape for Top 10 Market Players
  • 16.3.1. F. Hoffmann-La Roche Ltd
    • 16.3.1.1. Company Details
    • 16.3.1.2. Key Management Personnel
    • 16.3.1.3. Products and Services
    • 16.3.1.4. Financials (As Reported)
    • 16.3.1.5. Key Market Focus and Geographical Presence
    • 16.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 16.3.2. GE HealthCare Technologies Inc.
  • 16.3.3. Abbott Laboratories
  • 16.3.4. Cepheid Inc.
  • 16.3.5. Co-Diagnostics, Inc.
  • 16.3.6. Visby Medical, Inc.
  • 16.3.7. SEKISUI Diagnostics LLC
  • 16.3.8. Becton, Dickinson and Company
  • 16.3.9. BioMerieux SA
  • 16.3.10. Nova Biomedical Corporation

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

17. Strategic Recommendations

18. About Us and Disclaimer