日本即时诊断市场 - 2025 年至 2033 年

2024 年，日本即时诊断市场规模达到 8.3204 亿美元，预计到 2033 年将达到 19.2562 亿美元，在 2025-2033 年预测期内的复合年增长率为 9.8%。

即时诊断是指在病患照护地点或附近而不是在集中实验室或医院环境中进行的医疗诊断测试过程。这些测试旨在提供快速可靠的结果，帮助医疗保健提供者就患者的诊断和治疗做出快速、明智的决定。目标是能够立即做出决策，而无需患者等待结果或前往另一个地点进行测试。

即时诊断是一个快速发展的领域，它使医疗保健专业人员和患者能够在护理现场或附近进行诊断测试。随着应用和创新的不断增加，即时诊断正在透过使诊断更快、更方便、更有效率来改变医疗保健服务。

市场动态：

驾驶员和约束装置

即时诊断技术不断进步

日本即时诊断（POCD）市场成长的最重要驱动力之一是诊断技术的快速进步。随着医疗保健系统转向更快、更分散的护理，技术创新对于使 POCD 工具更加准确、用户友好并能够处理日益复杂的诊断任务至关重要。

日本以其在电子、机器人和精密工程领域的领先地位而闻名，一直处于开发紧凑高效的诊断设备的前沿，这些设备可以在患者护理点或附近提供可靠的结果。诊断设备的小型化使得便携式手持设备能够在临床和非临床环境中提供即时资料。这对日本尤其有益，因为日本人口老化和农村医疗保健差距需要能够将医疗服务延伸到医院以外的解决方案。

例如，便携式血液分析仪、穿戴式生物感测器和移动尿液分析工具越来越多地用于直接从患者家中监测糖尿病和肾臟疾病等慢性疾病。这些创新减少了医院就诊次数，减轻了医疗机构负担。例如，2023 年 4 月，分子诊断领域的全球领导者 QIAGEN 宣布其 QIAstat-Dx 症候群检测系统很快就会在日本上市，该系统配备 SARS-CoV-2 呼吸道检测面板。

QIAstat-Dx 是一个综合检测平台，该系统可以同时从一个患者样本中检测多种病原体。它使用即时 PCR 技术来提供快速、准确的结果。随着日本继续面临人口老化和慢性病发病率上升的双重挑战，这些技术发展将在维持和改善全国医疗服务品质方面发挥关键作用。

严格的监管要求

阻碍日本即时诊断（POCD）市场成长的主要限制因素之一是该国对医疗器材和体外诊断（IVD）的严格而复杂的监管框架。在日本，所有医疗设备和诊断设备（包括 POCD 工具）都必须符合日本药品和医疗器材综合机构 (PMDA) 规定的要求，并获得日本厚生劳动省 (MHLW) 的批准才能上市。这个审批过程通常非常漫长、非常详细且需要大量资源，这使得国内外製造商的市场进入都面临特别大的挑战。

日本的监管审批流程涉及广泛的临床验证、安全测试和文檔，通常超过美国或欧盟等其他全球市场所要求的标准。这虽然保证了为大众提供高品质、安全的保健产品，但也导致了商业化的延迟，增加了POCD企业的开发成本。

对于资源有限的新创公司或小型企业来说，应对这种情况可能是一个重大障碍，阻碍创新并减缓先进诊断技术的采用。虽然日本透过其监管体系维持了高标准的安全和质量，但这些要求的严格性和复杂性对 POCD 市场的成长构成了重大挑战。

目录

第一章：市场介绍和范围

• 报告目标
• 报告范围和定义
• 报告范围

第二章：高阶主管见解与关键要点

• 市场亮点和战略要点
• 主要趋势和未来预测
• 按产品分类的片段
• 技术片段
• 按应用程式截取的程式码片段
• 最终用户的程式码片段

第三章：动态

• 影响因素
  • 驱动程式
    • 即时诊断技术不断进步
    • 人口老化与慢性疾病
  • 限制
    • 严格的监管要求
    • 高级诊断成本高昂
  • 机会
    • 扩大居家检测
    • 数位和行动医疗融合的进步
  • 影响分析

第四章：战略洞察与产业展望

• 市场领导者和先驱者
  • 新兴先锋和杰出参与者
  • 拥有最大销售品牌的既定领导者
  • 拥有成熟产品的市场领导者
• CXO 观点
• 最新进展与突破
• 案例研究/正在进行的研究
• 监管和报销情况
• 波特五力分析
• 供应链分析
• 专利分析
• SWOT分析
• 未满足的需求和差距
• 市场进入和扩张的推荐策略
• 情境分析：最佳情况、基本情况和最坏情况预测
• 定价分析和价格动态
• 关键意见领袖

第五章：日本即时诊断市场（按产品）

• 传染病检测产品
• 血糖产品
• 血气和电解质产品
• 尿液分析产品
• 血液学检测产品
• 妊娠和生育测试产品
• 肿瘤/癌症分析产品
• 滥用药物产品
• 其他的

第六章：日本即时诊断市场（依技术）

• 侧向层析检测
• 免疫测定
• 分子诊断
• 微流体
• 其他的

第 7 章：日本即时诊断市场（按应用）

• 传染病
• 心臟病学
• 肿瘤学
• 内分泌学
• 血液学
• 神经病学
• 药物检测
• 其他的

第 8 章：日本即时诊断市场（以最终用户划分）

• 医院和诊所
• 诊断实验室
• 居家照护环境
• 门诊手术中心（ASC）

第九章：竞争格局与市场定位

• 竞争概况和主要市场参与者
• 市占率分析与定位矩阵
• 策略伙伴关係、併购
• 产品组合和创新的关键发展
• 公司基准化分析

第十章：公司简介

• Becton, Dickinson and Company (BD)
• 公司概况
• 产品组合
  • 产品描述
  • 产品关键绩效指标 (KPI)
  • 历史和预测产品销售
  • 产品销售量
• 财务概览
  • 公司收入
  • 地区收入份额
  • 收入预测
• 关键进展
  • 併购
  • 关键产品开发活动
  • 监管部门批准等
• 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：假设与研究方法

• 资料收集方法
• 数据三角测量
• 预测技术
• 数据验证和确认

第 12 章：附录

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.

Table of Contents

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.

LIST NOT EXHAUSTIVE

11. Assumptions and Research Methodology

• 11.1. Data Collection Methods
• 11.2. Data Triangulation
• 11.3. Forecasting Techniques
• 11.4. Data Verification and Validation

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us