ポイントオブケア検査装置の世界市場 - 2025年～2033年

ポイントオブケア検査装置の世界市場は2024年に497億3,000万米ドルに達し、2033年には1,015億1,000万米ドルに達すると予測され、予測期間2025～2033年のCAGRは8.6%で成長する見込みです。

Point-of-Care Testing（POCT）とは、医療診断検査であり、患者の治療時点またはその近くで実施され、治療方針の決定に役立つ迅速な結果をもたらします。この戦略は、サンプルを中央検査室に輸送し、結果が出るまで数時間から数日待つことが多い標準的な検査室検査とは異なります。POCTの基本的な目的は、迅速な診断と治療につながる情報を即座に提供することにより、患者管理を改善することです。POCTは、ハンドヘルド電子機器、検査キット、ポータブル分析器など、幅広い検査方法と技術をカバーしています。一般的な例としては、血糖モニタリング、迅速な溶連菌検査、妊娠検査などがあります。これらの機器は、病院、クリニック、薬局、さらには家庭など、さまざまな場所で使用することができ、ヘルスケアをより身近で効率的なものにしています。POCT技術は驚異的な成長を遂げ、機器の小型化と強化によって精度と使いやすさが向上しました。

技術の進歩は、予測期間中の市場を牽引する要因です。例えば、Masimoは、MightySat MedicalがFDAの認可を取得したと発表しました。これによりMightySat Medicalは、処方箋なしで消費者に店頭販売（OTC）される最初で唯一のFDA認可医療用指先パルスオキシメータとなった。この認可により、世界中の病院や診療所が毎年2億人以上の患者をモニターするために使用しているのと同じ技術であるMasimo SETパルスオキシメトリーを搭載したパルスオキシメーター医療ガジェットを顧客に提供することができます。

市場力学：

促進要因と抑制要因

技術的進歩

技術の進歩は、世界のポイントオブケア検査装置市場の成長において重要な要因となることが予想されます。技術の進歩は、世界のポイントオブケア検査（POCT）機器市場の拡大に大きな影響を与えると予想されます。ヘルスケアの進化に伴い、迅速で正確、かつ利用しやすい診断ソリューションへのニーズが高まっています。バイオセンサー、マイクロ流体工学、ラボオンチップシステムなど数多くの技術革新が診断を変化させ、より効率的で信頼性の高いものにしています。例えば、2024年9月、Abbott Laboratories社は、市販の持続グルコースモニターLingoが米国で発売されたことを発表しました。Abbott社の主な目標の1つは、Lingoユーザーがグルコーススパイクについて学ぶのを助けることです。

さらに2024年8月、DEXISはDEXIS CBCTおよび口腔内センサー機器向けの新しいプロアクティブ・サービス・プラットフォームであるDEXIS Connect Proを発表しました。このユニークなプラットフォームは、モノのインターネット（IoT）技術を利用してこれらの機器の健康状態を継続的にチェックし、機器が最高のパフォーマンスで動作することを保証します。DEXIS Connect Proは、潜在的な問題を自動的に認識し、必要に応じてサポートや機器の交換を手配することで、機器の稼働時間を大幅に向上させることを目指しています。

さらに2024年4月、バイオ・ラッド・ラボラトリーズは、同社初の超高感度多重デジタルPCRアッセイであるddPLEX ESR1変異検出キットを発売しました。このアッセイは、極めて高感度で多重化された変異検出アッセイがトランスレーショナルリサーチ、薬剤選択、疾患モニタリングを強化するがん業界における同社のDroplet Digital PCR（ddPC）ポートフォリオに追加されます。これらの最近の発売とFDA承認は、最新の技術的進歩とともに診断結果を効率的かつ迅速にし、市場を牽引しています。

高い初期投資コスト

初期投資コストの高さなどが、ポイントオブケア検査装置の世界市場を阻害すると予想されます。POCTは、迅速な結果や従来の検査室以外での検査能力など様々な利点を提供するが、これらの機器の調達に関連する金銭的コストが医療機関の使用を思いとどまらせる可能性があります。POCT機器への初期投資は、特に診断能力の向上が期待される先端技術の場合、多額になる可能性があります。このような経済的負担は、医療資金が乏しい資源制約のある環境では特に深刻であり、施設が新しい診断法への投資を優先することを困難にしています。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
  • 技術的進歩
  • 抑制要因
  • 初期投資コストが高い
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• 償還分析
• 特許分析
• SWOT分析
• DMIの見解

第6章 製品別

• 血糖値モニタリング製品
• 感染症検査製品
• 妊娠および生殖能力検査製品
• 腫瘍/がんマーカー検査製品
• 血液検査製品
• その他

第7章 用途別

• 輸血
• 心臓モニタリング
• 血糖値
• 血液学
• 非侵襲的SPO2およびCO2モニタリング
• その他

第8章 テストの種類別

• 免疫測定
• 細胞ベースのアッセイ
• 核酸増幅検査
• 臨床化学検査
• 血液学
• その他

第9章 流通チャネル別

• 病院薬局
• 小売薬局
• オンライン薬局

第10章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州地域
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• M&A分析

第12章 企業プロファイル

• Abbott
  • 会社概要
  • 製品ポートフォリオと概要
  • 財務概要
  • 主な発展
• F. Hoffmann-La Roche
• BD
• Siemens Healthcare Private Limited
• Bio-Rad Laboratories, Inc.
• Danaher Corporation
• SEKISUI Diagnostics
• Trinity Biotech
• Beckman Coulter, Inc.
• Nova Biomedical

第13章 付録

The global point-of-care testing devices market reached US$ 49.73 billion in 2024 and is expected to reach US$ 101.51 billion by 2033, growing at a CAGR of 8.6% during the forecast period 2025-2033.

Point-of-Care Testing (POCT) is medical diagnostic testing that is performed at or near the patient's point of care, providing for quick outcomes that may assist in treatment decisions. This strategy differs from standard laboratory testing, which frequently involves transporting samples to central labs and waiting hours or days for findings. The fundamental purpose of POCT is to improve patient management by giving immediate information, which can lead to faster diagnosis and treatment. POCT covers a wide range of testing methods and technologies, such as handheld electronics, test kits, and portable analyzers. Common examples are blood glucose monitoring, quick strep testing, and pregnancy tests. These devices can be used in a variety of venues, including hospitals, clinics, pharmacies, and even the home, making healthcare more accessible and efficient. POCT technology has grown tremendously, with downsizing and enhanced instrumentation increasing accuracy and ease of use.

The technological advancements is the driving factor that drives the market over the forecast period. For instance, Masimo announced that MightySat Medical has received FDA clearance, making it the first and only FDA-cleared medical fingertip pulse oximeter offered over-the-counter (OTC) to consumers without a prescription. This approval provides customers a pulse oximeter medical gadget powered by Masimo SET pulse oximetry, the same technology used by hospitals and clinics around the world to monitor over 200 million patients every year.

Market Dynamics: Drivers & Restraints

Technological advancements

The technological advancements is expected to be a significant factor in the growth of the global point-of-care testing devices market. Technological advances are expected to play a significant influence in the expansion of the global point-of-care testing (POCT) devices market. As healthcare evolves, there is an increasing need for quick, accurate, and accessible diagnostic solutions. Innovations in numerous technologies, including as biosensors, microfluidics, and lab-on-a-chip systems, have altered diagnostics, making them more efficient and reliable. For instance, in September 2024, Abbott Laboratories announced that its over-the-counter continuous glucose monitor Lingo is available in the U.S. One of Abbott's primary goals is to help Lingo users learn about glucose spikes, which occur when the amount of sugar present in the bloodstream rapidly increases and then decreases.

Moreover in August 2024, DEXIS Launched DEXIS Connect Pro, a New Proactive Service Platform for DEXIS CBCT and Intraoral Sensor Devices, Focused on Increasing Device Uptime. This unique platform uses Internet of Things (IoT) technology to continuously check the health of these devices, ensuring they run at peak performance. DEXIS Connect Pro seeks to significantly improve device uptime by automatically recognizing potential difficulties and arranging for support or equipment replacements as needed, which is crucial for dental offices that rely on consistent operation to provide patient care.

Moreover in April 2024, Bio-Rad Laboratories has launched its first ultrasensitive multiplexed digital PCR assay, the ddPLEX ESR1 Mutation Detection Kit. The assay adds to the company's Droplet Digital PCR (ddPC) portfolio in the cancer industry, where extremely sensitive and multiplexed mutation detection assays enhance translational research, medication selection, and disease monitoring. These recent launches and FDA approvals along with latest technological advancements in them makes the diagnostic results efficient and quick which drives the market.

High initial investment costs

Factors such as high initial investment costs are expected to hamper the global point-of-care testing devices market. Although POCT provides various benefits, such as rapid results and the ability to test outside of traditional laboratory settings, the financial costs associated with procuring these devices may dissuade healthcare organizations from using them. The initial investment for POCT equipment might be significant, especially for advanced technologies that promise improved diagnostic capabilities. This financial burden is particularly acute in resource-constrained environments where healthcare funds are tight, making it difficult for facilities to prioritize investment in novel diagnostic methods.

Segment Analysis

The global point-of-care testing devices market is segmented based on product , application, testing type, distribution channel and region.

Glucose monitoring products segment is expected to dominate the global point-of-care testing devices market share

The glucose monitoring products segment is predicted to dominate the global point-of-care testing (POCT) devices market due to a number of compelling factors, including increased diabetes prevalence, technological improvements, and an increase in demand for rapid diagnostic solutions. Diabetes remains a huge public health challenge around the world, thus effective management strategies are more important than ever. The increasing prevalence is one of the major reasons for the dominance of this segment. For instance, according to the National Institute of Health, approximately 462 million individuals were affected by type 2 diabetes corresponding to 6.28% of the world's population.

In the recent times, there are launches and FDA approvals of glucose monitoring devices. For instance, in September 2024, Abbott Laboratories announced that its over-the-counter continuous glucose monitor Lingo is available in the U.S. One of Abbott's primary goals is to help Lingo users learn about glucose spikes, which occur when the amount of sugar present in the bloodstream rapidly increases and then decreases.

Moreover, in June 2024, Prevounce Health, a leading provider of remote care management software, devices, and services, announced the launch of its first remote blood glucose monitoring device, Pylo GL1-LTE. The blood glucose meter has been scientifically tested and linked to numerous cellular networks to guarantee more dependable data transmission across the United States. The GL1-LTE is compatible with the Prevounce remote care management platform and may be integrated with other health software using the Pylo cloud API. Prevounce's Pylo cellular-connected gadgets include blood pressure monitors and weight scales.

Geographical Analysis

North America is expected to hold a significant position in the global point-of-care testing devices market share

North America is expected to hold a significant portion of the global point-of-care testing devices market. North America is projected to account for a significant portion of the global point-of-care testing (POCT) device market, owing to a mix of factors such as a strong healthcare infrastructure, rising chronic illness incidence, and technological improvements. The increased prevalence of chronic diseases, such as diabetes, cardiovascular problems, and infectious diseases, is a major driver of market expansion in North America. For instance, according to the Centers for Disease Control and Prevention, in 2024 more than 38 million Americans have diabetes (about 1 in 10), and about 90% to 95% of them have type 2 diabetes. Type 2 diabetes most often develops in people 45 or older, but more and more children, teens, and young adults are also developing it.

There are recent launches in this region due to the presence of major players. For instance, in September 2024, Abbott Laboratories announced that its over-the-counter continuous glucose monitor Lingo is available in the U.S. One of Abbott's primary goals is to help Lingo users learn about glucose spikes, which occur when the amount of sugar present in the bloodstream rapidly increases and then decreases.

Asia Pacific is growing at the fastest pace in the global point-of-care testing devices market

The Asia Pacific region is experiencing rapid growth in the global point-of-care testing (POCT) device market. Several significant factors contribute to this expansion, including rising healthcare costs, increased awareness of early disease diagnosis, and the demand for quick and precise diagnostic results. The need for POCT has increased as these devices have proven invaluable for the early diagnosis and monitoring of a variety of health disorders, thereby improving disease management results throughout the region.

There are recent launches of devices in this region making it the fastest growing region. For instance, in November 2023, UK-based LumiraDx Healthcare has launched its highly sensitive C-Reactive Protein (CRP) point of care (POC) antigen test across India. The point of care CRP test can be used in multiple clinical settings to help reduce unnecessary antibiotic prescribing that leads to antimicrobial resistance (AMR). From a tiny sample of finger-prick blood, the CRP test gives results within four minutes on the portable LumiraDx platform which weighs just over a kilogram.

Competitive Landscape

The major global players in the global point-of-care testing devices market include Abbott, F. Hoffmann-La Roche, BD, Siemens Healthcare Private Limited, Bio-Rad Laboratories, Inc., Danaher Corporation, SEKISUI Diagnostics, Trinity Biotech, Beckman Coulter, Inc., Nova Biomedical among others.

Emerging Players

PocDoc, Biocode, Sense4Med among others

Key Developments

• In January 2023, Cipla has announced the launch of Cippoint, a point-of-care testing device. This state-of-the-art device offers a wide range of testing parameters including cardiac markers, diabetes, infectious diseases, fertility, thyroid function, inflammation, metabolic markers, and coagulation markers. The device is CE IVD approved, indicating the device is approved by the European In-Vitro Diagnostic Device Directive, thus ensuring reliable testing solutions.
• In November 2024, Caris Life Sciences announced the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global point-of-care testing devices market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Product
• 3.2. Snippet by Application
• 3.3. Snippet by Testing Type
• 3.4. Snippet by Distribution Channel
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
  • 4.1.2. Technological Advancements
  • 4.1.3. Restraints
  • 4.1.4. High Initial Investment Costs
  • 4.1.5. Opportunity
  • 4.1.6. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Reimbursement Analysis
• 5.6. Patent Analysis
• 5.7. SWOT Analysis
• 5.8. DMI Opinion

6. By Product

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 6.1.2. Market Attractiveness Index, By Product
• 6.2. Glucose Monitoring Products*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Infectious Disease Testing Products
• 6.4. Pregnancy and Fertility Testing Products
• 6.5. Tumor/Cancer Marker Testing Products
• 6.6. Hematology Testing Products
• 6.7. Others

7. By Application

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 7.1.2. Market Attractiveness Index, By Application
• 7.2. Blood Transfusion*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Cardiac Monitoring
• 7.4. Blood Glucose
• 7.5. Haematology
• 7.6. Non-Invasive SPO2 and CO2 Monitoring
• 7.7. Others

8. By Testing Type

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
  • 8.1.2. Market Attractiveness Index, By Testing Type
• 8.2. Immunoassays*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Cell-Based Assays
• 8.4. Nucleic Acid Amplification Testing
• 8.5. Clinical Chemistry Assays
• 8.6. Hematology
• 8.7. Others

9. By Distribution Channel

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.1.2. Market Attractiveness Index, By Distribution Channel
• 9.2. Hospital Pharmacies*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Retail Pharmacies
• 9.4. Online Pharmacies

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Product
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  • 10.2.8. The U.S.
  • 10.2.9. Canada
  • 10.2.10. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Product
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  • 10.3.8. Germany
  • 10.3.9. UK
  • 10.3.10. France
  • 10.3.11. Italy
  • 10.3.12. Spain
  • 10.3.13. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Product
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  • 10.4.8. Brazil
  • 10.4.9. Argentina
  • 10.4.10. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Product
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  • 10.5.8. China
  • 10.5.9. India
  • 10.5.10. Japan
  • 10.5.11. South Korea
  • 10.5.12. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Product
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
  • 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. Abbott*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. F. Hoffmann-La Roche
• 12.3. BD
• 12.4. Siemens Healthcare Private Limited
• 12.5. Bio-Rad Laboratories, Inc.
• 12.6. Danaher Corporation
• 12.7. SEKISUI Diagnostics
• 12.8. Trinity Biotech
• 12.9. Beckman Coulter, Inc.
• 12.10. Nova Biomedical

LIST NOT EXHAUSTIVE

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us