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體外診斷 POC診斷

市場調查報告書

商品編碼

1712499

日本即時診斷市場 - 2025 年至 2033 年

Japan Point-of-Care Diagnostics Market - 2025-2033

出版日期: 2025年04月22日 | 出版商:

DataM Intelligence | 英文 126 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

2024 年，日本即時診斷市場規模達到 8.3204 億美元，預計到 2033 年將達到 19.2562 億美元，在 2025-2033 年預測期內的複合年成長率為 9.8%。

即時診斷是指在病患照護地點或附近而不是在集中實驗室或醫院環境中進行的醫療診斷測試過程。這些測試旨在提供快速可靠的結果，幫助醫療保健提供者就患者的診斷和治療做出快速、明智的決定。目標是能夠立即做出決策，而無需患者等待結果或前往另一個地點進行測試。

即時診斷是一個快速發展的領域，它使醫療保健專業人員和患者能夠在護理現場或附近進行診斷測試。隨著應用和創新的不斷增加，即時診斷正在透過使診斷更快、更方便、更有效率來改變醫療保健服務。

市場動態：

駕駛員和約束裝置

即時診斷技術不斷進步

日本即時診斷（POCD）市場成長的最重要驅動力之一是診斷技術的快速進步。隨著醫療保健系統轉向更快、更分散的護理，技術創新對於使 POCD 工具更加準確、方便用戶使用並能夠處理日益複雜的診斷任務至關重要。

日本以其在電子、機器人和精密工程領域的領先地位而聞名，一直處於開發緊湊高效的診斷設備的前沿，這些設備可以在患者照護端或附近提供可靠的結果。診斷設備的小型化使得攜帶式手持設備能夠在臨床和非臨床環境中提供即時資料。這對日本尤其有益，因為日本人口老化和農村醫療保健差距需要能夠將醫療服務延伸到醫院以外的解決方案。

例如，攜帶式血液分析儀、穿戴式生物感測器和移動尿液分析工具擴大用於直接從患者家中監測糖尿病和腎臟疾病等慢性疾病。這些創新減少了醫院就診次數，減輕了醫療機構負擔。例如，2023 年 4 月，分子診斷領域的全球領導者 QIAGEN 宣布其 QIAstat-Dx 症候群檢測系統很快就會在日本上市，該系統配備 SARS-CoV-2 呼吸道檢測面板。

QIAstat-Dx 是一個綜合檢測平台，該系統可以同時從一個患者樣本中檢測多種病原體。它使用即時 PCR 技術來提供快速、準確的結果。隨著日本繼續面臨人口老化和慢性病發病率上升的雙重挑戰，這些技術發展將在維持和改善全國醫療服務品質方面發揮關鍵作用。

嚴格的監管要求

阻礙日本即時診斷（POCD）市場成長的主要限制因素之一是該國對醫療器材和體外診斷（IVD）的嚴格而複雜的監管框架。在日本，所有醫療設備和診斷設備（包括 POCD 工具）都必須符合日本藥品和醫療器材綜合機構 (PMDA) 規定的要求，並獲得日本厚生勞動省 (MHLW) 的批准才能上市。這個核准過程通常非常漫長、非常詳細且需要大量資源，這使得國內外製造商的市場進入都面臨特別大的挑戰。

日本的法規核准流程涉及廣泛的臨床驗證、安全測試和文檔，通常超過美國或歐盟等其他全球市場所要求的標準。這雖然保證了為大眾提供高品質、安全的保健產品，但也導致了商業化的延遲，增加了POCD企業的開發成本。

對於資源有限的新創公司或小型企業來說，應對這種情況可能是一個重大障礙，阻礙創新並減緩先進診斷技術的採用。雖然日本透過其監管體系維持了高標準的安全和質量，但這些要求的嚴格性和複雜性對 POCD 市場的成長構成了重大挑戰。

市場領導者和先驅者
- 新興先鋒和傑出參與者
- 擁有最大銷售品牌的既定領導者
- 擁有成熟產品的市場領導者
CXO 觀點
最新進展與突破
案例研究/正在進行的研究
監管和報銷情況
波特五力分析
供應鏈分析
專利分析
SWOT分析
未滿足的需求和差距
市場進入和擴張的推薦策略
情境分析：最佳情況、基本情況和最壞情況預測
定價分析和價格動態
關鍵意見領袖

第5章：日本即時診斷市場（按產品）

傳染病檢測產品
血糖產品
血氣和電解質產品
尿液分析產品
血液學檢測產品
妊娠和生育測試產品
腫瘤/癌症分析產品
濫用藥物產品
其他

第6章：日本即時診斷市場（依技術）

側向層析檢測
免疫測定
分子診斷
微流體
其他

第 7 章：日本即時診斷市場（按應用）

傳染病
心臟病學
腫瘤學
內分泌學
血液學
神經病學
藥物檢測
其他

第 8 章：日本即時診斷市場（以最終用戶分類）

醫院和診所
診斷實驗室
居家照護環境
門診手術中心（ASC）

第9章：競爭格局與市場定位

競爭概況和主要市場參與者
市佔率分析與定位矩陣
策略夥伴關係、併購
產品組合和創新的關鍵發展
公司基準化分析

第10章：公司簡介

Becton, Dickinson and Company (BD)

公司概況
產品組合
- 產品描述
- 產品關鍵績效指標 (KPI)
- 歷史和預測產品銷售
- 產品銷售量
財務概覽
- 公司收入
- 地區收入佔有率
- 收入預測
關鍵進展
- 併購
- 關鍵產品開發活動
- 監管部門批准等
SWOT分析

Quidel Corporation
QIAGEN
Trinity Biotech
BioMerieux SA
Roche Diagnostics
Siemens Healthineers
Abbott Laboratories
Danaher Corporation
SEKISUI MEDICAL CO., LTD.

第 11 章：假設與研究方法

資料收集方法
數據三角測量
預測技術
數據驗證和確認

第 12 章：附錄

簡介目錄

Product Code: PH9493

The Japan point-of-care diagnostics market reached US$ 832.04 million in 2024 and is expected to reach US$ 1,925.62 million by 2033, growing at a CAGR of 9.8 % during the forecast period 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

One of the most significant drivers of growth in Japan's point-of-care diagnostics (POCD) market is the rapid advancement in diagnostic technologies. As healthcare systems shift toward faster, more decentralized care, technological innovation has been essential in making POCD tools more accurate, user-friendly, and capable of handling increasingly complex diagnostic tasks.

Japan, known for its leadership in electronics, robotics, and precision engineering, has been at the forefront of developing compact and efficient diagnostic devices that can deliver reliable results at or near the point of patient care. The miniaturization of diagnostic equipment has allowed for portable, handheld devices that provide real-time data in both clinical and non-clinical settings. This is particularly beneficial in Japan, where an aging population and rural healthcare disparities require solutions that can extend care beyond hospitals.

For example, portable blood analyzers, wearable biosensors, and mobile urinalysis tools are increasingly used to monitor chronic diseases like diabetes and kidney conditions directly from patients' homes. These innovations reduce hospital visits and ease the burden on overstretched healthcare facilities. For instance, in April 2023, QIAGEN, a global leader in molecular diagnostics, announced that its QIAstat-Dx syndromic testing system will soon be available in Japan, featuring a SARS-CoV-2 Respiratory Panel.

QIAstat-Dx is a syndromic testing platform, a system that can simultaneously test for multiple pathogens from one patient sample. It uses real-time PCR technology to deliver fast, accurate results. As Japan continues to confront the dual challenges of an aging population and rising chronic disease rates, these technological developments will play a pivotal role in sustaining and improving the quality of healthcare delivery across the country.

Stringent Regulatory Requirements

One of the major restraints hindering the growth of the point-of-care diagnostics (POCD) market in Japan is the country's stringent and complex regulatory framework for medical devices and in vitro diagnostics (IVDs). In Japan, all medical devices and diagnostics, including POCD tools, must comply with the requirements set forth by the Pharmaceuticals and Medical Devices Agency (PMDA) and receive approval from the Ministry of Health, Labour and Welfare (MHLW) before being marketed. This approval process is often lengthy, highly detailed, and resource-intensive, making market entry particularly challenging for both domestic and foreign manufacturers.

The regulatory approval process in Japan involves extensive clinical validation, safety testing, and documentation, often exceeding the standards required in other global markets like the U.S. or the EU. While this ensures high-quality and safe healthcare products for the public, it also leads to delayed commercialization and increases the cost of development for POCD companies.

For startups or smaller players with limited resources, navigating this landscape can be a major barrier, discouraging innovation and slowing down the adoption of advanced diagnostic technologies. While Japan maintains a high standard of safety and quality through its regulatory systems, the rigidity and complexity of these requirements pose a significant challenge to the growth of the POCD market.

Segment Analysis

The Japan point-of-care diagnostics market is segmented based on product, technology, application, and end-user.

Product:

The infectious disease testing products segment in the product is expected to dominate the Japan point-of-care diagnostics market share

Infectious disease testing products play a pivotal role in the early identification and containment of infectious conditions. These diagnostic tools are specifically designed to detect pathogens such as bacteria, viruses, and other microorganisms directly from patient samples. Their use is essential for limiting the spread of contagious diseases and guiding timely medical intervention, especially within Japan's aging population and densely populated urban centers.

A wide range of products is available in the market, each tailored to detect specific infectious agents or biomarkers linked to diseases like influenza, SARS-CoV-2, Clostridium difficile, HIV, Group A streptococcus, sexually transmitted infections (STIs), and Lyme disease. Among these, rapid diagnostic tests are particularly valuable, as they deliver accurate results within minutes at or near the point of care, facilitating immediate decision-making by healthcare providers.

The performance and accessibility of these testing tools in Japan have significantly improved over recent years due to a wave of product innovations, technological advancements, and high-impact product launches. These developments are driven by the growing demand for faster, more portable, and multiplex-capable solutions that can operate in decentralized healthcare settings, such as clinics, pharmacies, and home-care environments.

The Japan point-of-care diagnostics market is witnessing significant growth, driven by the increasing need for rapid and accurate detection of infectious diseases. Key factors such as early diagnosis, the shift toward decentralized testing, and rising concerns over antimicrobial resistance are accelerating market demand. Additionally, government efforts to enhance diagnostic capabilities and preparedness, particularly in response to public health threats, are further strengthening market expansion.

Competitive Landscape

The major players in the Japan point-of-care diagnostics market include Becton, Dickinson and Company (BD), Quidel Corporation, QIAGEN, Trinity Biotech, BioMerieux SA, Roche Diagnostics, Siemens Healthineers, Abbott Laboratories, Danaher Corporation, and SEKISUI MEDICAL CO., LTD., among others.

Key Developments

In June 2023, Sysmex Corporation, a major Japanese diagnostics company headquartered in Kobe, launched a new rapid testing system in Europe aimed at detecting antimicrobial susceptibility, a critical tool in the fight against antimicrobial resistance.

Why Purchase the Report?

Pipeline & Innovations: Reviews ongoing clinical trials and product pipelines and forecasts upcoming advancements in medical devices and pharmaceuticals.
Product Performance & Market Positioning: Analyze 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: This covers recent regulatory changes, new policies, and emerging technologies.
Competitive Strategies: Analyze 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.
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 Japan point-of-care diagnostics market report delivers a detailed analysis with 42 key tables, more than 45 visually impactful figures, and 126 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.
Application & 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.

1. Market Introduction and Scope

1.1. Objectives of the Report
1.2. Report Coverage & Definitions
1.3. Report Scope

2. Executive Insights and Key Takeaways

2.1. Market Highlights and Strategic Takeaways
2.2. Key Trends and Future Projections
2.3. Snippet by Product
2.4. Snippet by Technology
2.5. Snippet by Application
2.6. Snippet by End-User

3. Dynamics

3.1. Impacting Factors
- 3.1.1. Drivers
  - 3.1.1.1. Rising Advancements in Point-of-Care Diagnostics
  - 3.1.1.2. Rising Aging Population and Chronic Diseases
- 3.1.2. Restraints
  - 3.1.2.1. Stringent Regulatory Requirements
  - 3.1.2.2. High Costs of Advanced Diagnostics
- 3.1.3. Opportunity
  - 3.1.3.1. Expansion of Home-Based Testing
  - 3.1.3.2. Advancements in Digital and Mobile Health Integration
- 3.1.4. Impact Analysis

4. Strategic Insights and Industry Outlook

4.1. Market Leaders and Pioneers
- 4.1.1. Emerging Pioneers and Prominent Players
- 4.1.2. Established leaders with the largest-selling Brand
- 4.1.3. Market leaders with established Product
4.2. CXO Perspectives
4.3. Latest Developments and Breakthroughs
4.4. Case Studies/Ongoing Research
4.5. Regulatory and Reimbursement Landscape
4.6. Porter's Five Forces Analysis
4.7. Supply Chain Analysis
4.8. Patent Analysis
4.9. SWOT Analysis
4.10. Unmet Needs and Gaps
4.11. Recommended Strategies for Market Entry and Expansion
4.12. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
4.13. Pricing Analysis and Price Dynamics
4.14. Key Opinion Leaders

5. Japan Point-of-Care Diagnostics Market, By Product

5.1. Introduction
- 5.1.1. Analysis and Y-o-Y Growth Analysis (%), By Product
- 5.1.2. Market Attractiveness Index, By Product
5.2. Infectious Disease Testing Products*
- 5.2.1. Introduction
- 5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
5.3. Blood Glucose Products
5.4. Blood Gas & Electrolyte Products
5.5. Urinalysis Products
5.6. Hemoatology Testing Products
5.7. Pregnancy and Fertility Testing Products
5.8. Tumor/Cancer Profiling Products
5.9. Drug-of-Abuse Products
5.10. Others

6. Japan Point-of-Care Diagnostics Market, By Technology

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 6.1.2. Market Attractiveness Index, By Technology
6.2. Lateral Flow Assays*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Immunoassays
6.4. Molecular Diagnostics
6.5. Microfluidics
6.6. Others

7. Japan Point-of-Care Diagnostics Market, 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. Infectious Diseases*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Cardiology
7.4. Oncology
7.5. Endocrinology
7.6. Hematology
7.7. Neurology
7.8. Drug Testing
7.9. Others

8. Japan Point-of-Care Diagnostics Market, By End-User

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 8.1.2. Market Attractiveness Index, By End-User
8.2. Hospitals & Clinics*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Diagnostic Laboratories
8.4. Home Care Settings
8.5. Ambulatory Surgery Centers (ASCs)

9. Competitive Landscape and Market Positioning

9.1. Competitive Overview and Key Market Players
9.2. Market Share Analysis and Positioning Matrix
9.3. Strategic Partnerships, Mergers & Acquisitions
9.4. Key Developments in Product Portfolios and Innovations
9.5. Company Benchmarking

10. Company Profiles

10.1. Becton, Dickinson and Company (BD)*
- 10.1.1. Company Overview
- 10.1.2. Product Portfolio
  - 10.1.2.1. Product Description
  - 10.1.2.2. Product Key Performance Indicators (KPIs)
  - 10.1.2.3. Historic and Forecasted Product Sales
  - 10.1.2.4. Product Sales Volume
- 10.1.3. Financial Overview
  - 10.1.3.1. Company Revenue
  - 10.1.3.2. Geographical Revenue Shares
  - 10.1.3.3. Revenue Forecasts
- 10.1.4. Key Developments
  - 10.1.4.1. Mergers & Acquisitions
  - 10.1.4.2. Key Product Development Activities
  - 10.1.4.3. Regulatory Approvals, etc.
- 10.1.5. SWOT Analysis
10.2. Quidel Corporation
10.3. QIAGEN
10.4. Trinity Biotech
10.5. BioMerieux SA
10.6. Roche Diagnostics
10.7. Siemens Healthineers
10.8. Abbott Laboratories
10.9. Danaher Corporation
10.10. SEKISUI MEDICAL CO., LTD.