![]() |
市場調査レポート
商品コード
1696299
ポイントオブケア診断の世界市場:2025年~2033年Global Point of Care Diagnostics Market - 2025-2033 |
||||||
カスタマイズ可能
適宜更新あり
|
ポイントオブケア診断の世界市場:2025年~2033年 |
出版日: 2025年03月25日
発行: DataM Intelligence
ページ情報: 英文 180 Pages
納期: 即日から翌営業日
|
世界のポイントオブケア診断の市場規模は、2024年に154億6,000万米ドルに達し、2033年には326億3,000万米ドルに達すると予測され、2025年から2033年の予測期間中に8.7%のCAGRで拡大する見込みです。
ポイントオブケア診断とは、集中的な検査室や病院ではなく、患者の診療現場またはその近くで行われる医療診断検査プロセスを指します。これらの検査は、ヘルスケアプロバイダーが患者の診断と治療に関して迅速かつ十分な情報に基づいた意思決定を行えるよう、迅速かつ信頼性の高い結果を提供するよう設計されています。その目的は、患者が結果を待ったり、検査のために別の場所に移動したりする必要なく、即座に意思決定ができるようにすることです。
ポイントオブケア診断学は、ヘルスケア専門家と患者が、医療現場またはその近くで診断検査を実施できるようにする、急速に進歩している分野です。導入と技術革新が進むにつれ、ポイントオブケア診断は、診断をより迅速に、よりアクセスしやすく、より効率的にすることで、ヘルスケア提供に変革をもたらしつつあります。
ポイントオブケア(POC)診断における進歩の高まりは、世界のPOC診断市場の主要促進要因です。分子診断、マイクロ流体、バイオセンサーなどの新技術により、ポイントオブケア診断装置の精度とスピードが向上しています。これらの進歩により、検査を迅速に、多くの場合30分以内に低コストで実施できるようになっています。
例えば、2024年1月、3EO Healthは3TR技術を利用したCOVID-19検査についてFDA緊急使用認可(EUA)を取得しました。3TR技術は、サンプル調製、高価な消耗品、複雑な装置を不要にし、「高効率」POC検査という新しいカテゴリーを創出します。高効率とは、サンプル調製が不要で、1検査あたり20ドル以下の低コストで使いやすい分子検査と定義されます。
人工知能(AI)が検査結果の解釈に果たす役割はますます大きくなっており、より迅速で正確な意思決定が可能になっています。AIを搭載したポイントオブケア診断は、診断データを分析し、臨床医が低コストでより迅速かつ正確な診断を下せるよう支援することができます。例えば、2025年2月、Avitiaは、迅速かつポイントオブケアでのがん検査のためのAI搭載プラットフォームを発表しました。Avitiaのプラットフォームにより、検査室と臨床医は高度な分子検査を利用できるようになっています。この技術により、ヘルスケア・チームはがんに関する洞察を正確に得ることができるようになり、コストを削減しながら患者の治療を迅速に開始できるようになります。
また2024年5月、MolBioは血液学、がん、抗菌薬耐性(AMR)、次世代シーケンシング(NGS)、シンドロミック検査などの分野で、多くの画期的なポイントオブケア技術に取り組んでいると発表しました。同社は、全血球算定(CBC)を含む様々な血液学向けに、人工知能(AI)対応のポイントオブケア検査TruSightを開発しています。このプラットフォームは、最終的にはPAPスメア、マラリア寄生虫、精子計数、鎌状赤血球症、サラセミアなどにも使用される可能性があります。
ポイントオブケア診断技術の普及を阻む主な障害の一つは、機器、ヘルスケアITシステム、電子カルテ間の相互運用性の欠如です。多くのヘルスケア環境では、診断機器、電子医療システム、患者データプラットフォームが統合されていないため、患者データを統合してリアルタイムでアクセスすることが困難です。
ポイントオブケア診断機器は機密性の高い健康データを送信することが多いため、この情報のセキュリティとプライバシーの維持は極めて重要です。データ統合が不十分だと、患者情報が不正アクセスにさらされる可能性があり、ヘルスケアプロバイダーがデータ保護規制(米国のHIPAAや欧州のGDPRなど)に確実に準拠することが難しくなります。
例えば、HIPAAジャーナルによると、2023年8月には2,300万件のヘルスケア記録の漏洩が報告されています。過去12ヶ月間、毎月平均998万9,003件のヘルスケア記録が漏洩しています。2024年8月31日までの1年間で、500件以上のデータ漏洩が491件発生し、少なくとも5,866万8,002件が漏洩したことが判明しています。相互運用性の課題、データ・セキュリティの懸念、手作業によるデータ入力、クラウド・ストレージの非効率性など、接続性とデータ統合に関連する問題は、市場の成長にとって大きな障壁となっています。
当レポートでは、世界のポイントオブケア診断市場について調査し、市場の概要とともに、製品別、技術別、用途別、エンドユーザー別、地域別動向、競合情勢、および市場に参入する企業のプロファイルなどを提供しています。
The global point of care diagnostics market reached US$ 15.46 billion in 2024 and is expected to reach US$ 32.63 billion by 2033, growing at a CAGR of 8.7 % during the forecast period of 2025-2033.
Point-of-care diagnostics refers to a medical diagnostic testing process that takes place at or near the site of patient care, rather than in a centralized laboratory or hospital setting. These tests are designed to deliver rapid and reliable results that help healthcare providers make quick, informed decisions regarding patient diagnosis and treatment. The goal is to enable immediate decision-making without the need for a patient to wait for results or travel to another location for testing.
Point-of-care diagnostics is a rapidly advancing field that enables healthcare professionals and patients to perform diagnostic tests at or near the site of care. With growing adoption and innovations, point-of-care diagnostics is transforming healthcare delivery by making diagnostics faster, more accessible and more efficient.
Market Dynamics: Drivers & Restraints
Rising Advancements in Point-of-Care Diagnostics
Rising advancements in point-of-care (POC) diagnostics are a key driver of the global POC diagnostics market. New technologies like molecular diagnostics, microfluidics and biosensors have improved the accuracy and speed of point-of-care diagnostic devices. These advancements allow tests to be performed rapidly, often in less than 30 minutes at a low cost.
For instance, in January 2024, 3EO Health received FDA Emergency Use Authorization (EUA) for its COVID-19 test utilizing 3TR technology. 3TR technology eliminates the need for sample preparation, expensive consumables and complex equipment, creating a new category of "high efficiency" point-of-care molecular testing. High efficiency is defined as low-cost, easy-to-use molecular testing under $20 per test with no sample preparation required.
Artificial Intelligence (AI) is playing an increasing role in the interpretation of test results, offering quicker and more accurate decision-making. AI-powered point-of-care diagnostics can analyze diagnostic data and help clinicians make faster, more accurate diagnoses at low costs. For instance, in February 2025, Avitia launched an AI-powered platform for rapid & point-of-care cancer testing. With Avitia's platform, laboratories and clinicians now have access to advanced molecular testing. This technology will allow a healthcare team to accurately obtain cancer insights and begin treating patients faster all at reduced costs.
Also, in May 2024, MolBio announced that it is working on many pathbreaking point-of-care technologies in the areas of hematology, cancer, anti-microbial resistance (AMR), next-generation sequencing (NGS), syndromic testing, etc. The company is developing artificial intelligence (AI)-enabled point-of-care test TruSight for various hematology applications, including complete blood count (CBC). This platform could also be eventually used for PAP smears, malaria parasites, sperm counting, sickle cell disease, thalassemia, etc.
Connectivity & Data Integration Issues
One of the primary barriers to the widespread adoption of point-of-care diagnostic technologies is the lack of interoperability between devices, healthcare IT systems and electronic health records. In many healthcare environments, diagnostic devices, electronic health systems and patient data platforms are not integrated, making it difficult to consolidate and access patient data in real-time.
As point-of-care diagnostic devices often transmit sensitive health data, maintaining the security and privacy of this information is critical. Poor data integration can expose patient information to unauthorized access, making it difficult for healthcare providers to ensure compliance with data protection regulations (such as HIPAA in the U.S. or GDPR in Europe).
For instance, according to the HIPAA Journal, in August 2023, 23 million breached healthcare records were reported. Over the past 12 months, an average of 9,989,003 healthcare records were breached each month. In the year to August 31, 2024, there have been 491 data breaches of 500 or more records, and at least 58,668,002 records are known to have been breached. The issues related to connectivity and data integration, such as interoperability challenges, data security concerns, manual data entry and cloud storage inefficiencies are significant barriers to the growth of the market.
The global point of care diagnostics market is segmented based on product, technology, application, end-user, and region.
The infectious disease testing products segment in the product is expected to dominate the global point of care diagnostics market with the highest market share
Infectious disease test products are diagnostic tools used to detect pathogens like bacteria or viruses in the body. They are crucial in identifying and controlling the spread of infectious diseases. Manufacturers offer various types of products, each tailored to detect specific pathogens or markers associated with specific diseases. Rapid tests provide quick results, often within minutes, and are commonly used for point-of-care testing.
Moreover, diagnostic testing capabilities for infectious diseases like influenza, SARS-CoV-2, Clostridium difficile, HIV, Group A streptococcus, STIs, and Lyme disease have significantly improved over the past few years due to significant launches, product innovations, and other various factors. For instance, in February 2023, Thermo Fisher Scientific announced that its Applied Biosystems TaqPath PCR products for infectious diseases like MTB MDR, MT B, HBV, HCV, HIV, and HLA B27 have received licensing rights from the Central Drugs Standard Control Organization (CDSCO). The products will be manufactured in India in association with Mylab Discove1Y Solutions.
Also, growth for rapid and accurate diagnostics of infectious diseases, driven by early detection, decentralized testing, and antimicrobial resistance, is expanding. Government initiatives to improve diagnostic capabilities, especially in low- and middle-income countries, further support market expansion. These factors have solidified the segment's position in the global point of care diagnostics market.
North America is expected to hold a significant position in the global point of care diagnostics market with the highest market share
North America, particularly the United States and Canada, holds a dominant position in the global POC diagnostics market. This market includes a wide range of diagnostic products such as blood glucose monitors, cardiac markers, pregnancy tests, infectious disease testing, and cholesterol testing.
The North American market is well-established with a high demand for diagnostic testing across various healthcare settings, including hospitals, clinics, urgent care centers, and even homecare environments. The increasing incidence of chronic diseases such as diabetes, cardiovascular diseases, respiratory disorders, and cancer is one of the primary drivers of the POC diagnostics market in North America. These conditions require regular monitoring and testing, which is facilitated by POC devices.
Key players in the region are receiving regulatory approvals and launching their products in the region. For instance, in January 2025, Roche received FDA clearance with a CLIA waiver for its cobas Liat molecular tests designed to diagnose sexually transmitted infections (STIs) at the point of care. Roche's cobas Liat molecular tests have met the regulatory standards for safety and effectiveness in the U.S. market. This is a significant milestone, as it ensures that the tests can be used legally and widely in healthcare settings. Thus, the above factors are consolidating the region's position as a dominant force in the global point of care diagnostics market.
The major global players in the point of care diagnostics market include BD, QuidelOrtho Corporation, QIAGEN, Trinity Biotech plc., BioMerieux SA, F. Hoffmann-La Roche Ltd, Siemens Healthineers AG, Abbott Laboratories, Danaher Corporation, and SEKISUI MEDICAL CO., LTD. among others.
The global point of care diagnostics market report delivers a detailed analysis with 70+ key tables, more than 70+ visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
LIST NOT EXHAUSTIVE