全球组织诊断市场规模（按疾病、技术、最终用户、地区和预测）

组织诊断的市场规模和预测

2024 年全球组织诊断市场规模为 48.9 亿美元，预计到 2032 年将达到 75.3 亿美元，2026 年至 2032 年的复合年增长率为 6.10%。

组织诊断是透过切片检查等诊断程序检测体内疾病（尤其是癌症、肿瘤和其他严重疾病）的关键过程。

这种方法对于早期发现疾病、及时介入和治疗起着至关重要的作用。

随着技术的发展，组织诊断有望取得巨大进步。数位病理学、次世代定序和先进成像等新工具正在提高组织分析的速度、准确性和深度。

这些创新使诊断更加精准，进而改善患者的治疗效果。此外，人工智慧 (AI) 和机器学习 (ML) 演算法与组织诊断的融合，正在透过自动化常规任务、提高诊断一致性以及深入了解疾病机制，彻底改变该领域。

全球组织诊断市场动态

影响全球组织诊断市场的关键市场动态是：

关键市场驱动因素

癌症发生率上升：根据世界卫生组织（WHO）（2022）预测，2020年癌症将导致约1,000万人死亡，约占全球死亡人数的六分之一。根据美国癌症协会预测，2024年美国将新增约190万例癌症病例。根据GLOBOCAN 2020数据，乳癌已成为全球最常见的癌症，2020年新增病例达230万例。

全球人口老化：联合国《2022年世界人口展望》报告显示，到2050年，全球每六人中就有一人年龄在65岁及以上，而2019年这一比例为每十一人中就有一人。世界卫生组织（2021年）预测，2020年至2032年间，60岁以上人口预计将增加38%。美国癌症研究所指出，美国约有80%的癌症患者年龄在55岁以上。

诊断技术的技术进步：根据实验室调查，2020 年至 2022 年间，领先医院采用数位病理解决方案的比例增加了 45%。美国病理学家学院报告称，到 2022 年，超过 60% 的病理实验室将实施某种形式的数位病理工具。

主要挑战

专业技能有限，劳动力短缺：根据美国病理学家学院（2022）的数据，约60%的病理实验室报告难以填补职缺。英国皇家病理学家学院（2021）的报告显示，英国整个英国体系的病理学顾问短缺率高达25%。根据世界卫生组织的数据，低收入国家每10万人中只有不到0.1名病理学家，而已开发国家每10万人中只有4-5名病理学家。

先进诊断设备和程序成本高昂：截至2022年，每台数位病理系统的平均成本为20万至40万美元。根据《医疗保健成本分析》（2021年），每位患者的组织诊断检测成本约为1000至3000美元。根据《实验室经济学》（2022年）的一项调查，45%的发展中地区实验室认为预算限制是采用新组织诊断技术的主要障碍。

监管挑战和品管问题：FDA 报告称，2021 年约有 20% 的实验室开发的测试存在品质问题或错误。根据 CLIA（临床实验室改进修正案），2022 年 12% 的组织诊断实验室未能通过合规性检查。美国病理学家学院 (2023) 的一项调查显示，30% 的实验室由于要求复杂而难以维持监管合规性。

主要趋势

数位病理学与人工智慧整合：根据数位病理学会 (2023) 的数据，人工智慧诊断工具在癌症检测中已证明准确率高达 95%。根据 Verified Market Research 的数据，数位病理学市场预计在 2026 年至 2032 年期间的复合年增长率将达到 13.64%。美国病理学家协会 (2022) 的一项调查显示，65% 的实验室已经采用或计划在 2024 年前采用人工智慧辅助诊断工具。

个人化医疗和伴随诊断：2022 年，FDA核准了25 种伴随诊断，比 2020 年增加 40%。 2020 年至 2022 年，组织诊断领域的精准医疗市场成长了 38%。根据 NIH 数据（2023 年），个人化医疗方法已将某些癌症的治疗反应率提高​​了 30%。

就地检验与远距离诊断：照护现场组织诊断市场部分在 2022 年成长了 28%。根据美国远端医疗协会的数据，从 2020 年到 2022 年，远距病理学咨询成长了 275%。远距离诊断功能已将参与医院的诊断等待时间缩短了 45%。

目录

第一章全球组织诊断市场简介

• 市场概览
• 研究范围
• 先决条件

第二章执行摘要

第三章：已验证的市场研究调查方法

• 资料探勘
• 验证
• 第一手资料
• 资料来源列表

第四章全球组织诊断市场展望

• 概述
• 市场动态
  • 驱动程式
  • 限制因素
  • 机会
• 波特五力模型
• 价值链分析

第五章 全球组织诊断市场（依疾病类型划分）

• 概述
• 摄护腺癌
• 乳癌
• 胃癌
• 非小细胞肺癌

6. 全球组织诊断市场（依技术划分）

• 概述
• 免疫组织化学（IHC）
• 原位杂合反应（ISH）
• 数位病理学和工作流程管理
• 特殊染色

第七章全球组织诊断市场（依最终使用者）

• 概述
• 医院
• 研究所
• 製药公司
• 合约研究组织

第八章全球组织诊断市场（按地区）

• 概述
• 北美洲
  • 美国
  • 加拿大
  • 墨西哥
• 欧洲
  • 德国
  • 英国
  • 法国
  • 其他欧洲国家
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 其他亚太地区
• 世界其他地区
  • 拉丁美洲
  • 中东和非洲

第九章全球组织诊断市场的竞争格局

• 概述
• 各公司市场排名
• 主要发展策略

第十章 公司简介

• Abbott
• Agilent Technologies
• Roche
• Thermo Fisher Scientific
• Merck
• Sakura Finetek Japan
• Qiagen
• Abcam
• BD
• Danaher

第十一章 重大进展

• 产品发布/开发
• 合併与收购
• 业务扩展
• 伙伴关係与合作

第十二章 附录

• 相关调查

Tissue Diagnostics Market Size and Forecast

Tissue Diagnostics Market size was valued at USD 4.89 Billion in 2024 and is projected to reach USD 7.53 Billion by 2032, growing at a CAGR of 6.10% from 2026 to 2032.

Tissue diagnostics is a critical process for detecting diseases in the body, particularly cancer, tumors, and other serious conditions through diagnostic procedures like biopsies.

This approach plays an essential role in identifying diseases at an early stage, allowing for timely intervention and treatment.

As technology evolves, tissue diagnostics is expected to see major improvements. Emerging tools such as digital pathology, next-generation sequencing, and advanced imaging modalities are enhancing the speed, accuracy, and depth of tissue analysis.

These innovations enable more precise diagnosis, leading to better patient outcomes. Moreover, integrating artificial intelligence (AI) and machine learning (ML) algorithms into tissue diagnostics is revolutionizing the field by automating routine tasks, increasing diagnostic consistency, and uncovering deeper insights into disease mechanisms.

Global Tissue Diagnostics Market Dynamics

The key market dynamics that are shaping the global Tissue Diagnostics Market include:

Key Market Drivers

Rising Cancer Incidence Rates: According to the WHO (2022), cancer was responsible for nearly 10 million deaths in 2020, accounting for nearly one in six deaths globally. The American Cancer Society reported that in 2024, approximately 1.9 million new cancer cases were expected to be diagnosed in the United States. The GLOBOCAN 2020 data showed that breast cancer became the most common cancer globally, with 2.3 million new cases in 2020

Aging Global Population: The UN World Population Prospects 2022 reported that by 2050, 1 in 6 people worldwide will be over age 65, up from 1 in 11 in 2019. According to the WHO (2021), between 2020 and 2032, the number of people aged 60 years and over is expected to increase by 38%. The National Cancer Institute noted that approximately 80% of all cancers in the United States are diagnosed in people 55 years or older

Technological Advancements in Diagnostic Techniques: According to laboratory surveys, the adoption of digital pathology solutions in major hospitals increased by 45% between 2020 and 2022. The College of American Pathologists reported that over 60% of pathology laboratories will implement some form of digital pathology tools by 2022.

Key Challenges

Limited Skilled Professionals and Workforce Shortages: According to the College of American Pathologists (2022), approximately 60% of pathology practices reported difficulty filling open positions. The Royal College of Pathologists (2021) reported a 25% shortfall in pathology consultants across the UK healthcare system. According to the WHO data, indicated that low-income countries have less than 0.1 pathologists per 100,000 population, compared to 4-5 per 100,000 in developed nations

High Costs of Advanced Diagnostic Equipment and Procedures: The average cost of digital pathology systems ranges from $200,000 to $400,000 per unit as of 2022. According to healthcare cost analyses (2021), tissue diagnostic tests can cost between $1,000 to $3,000 per patient. A survey by Laboratory Economics (2022) found that 45% of laboratories in developing regions cited budget constraints as the primary barrier to adopting new tissue diagnostic technologies.

Regulatory Challenges and Quality Control Issues: FDA reports showed that approximately 20% of laboratory-developed tests had quality issues or errors in 2021. The Clinical Laboratory Improvement Amendments (CLIA) documented that 12% of tissue diagnostic laboratories failed compliance inspections in 2022. A College of American Pathologists survey (2023) revealed that 30% of laboratories struggle with maintaining regulatory compliance due to complex requirements.

Key Trends

Digital Pathology and AI Integration: According to the Digital Pathology Association (2023), AI-powered diagnostic tools showed a 95% accuracy rate in cancer detection. According to the Verified Market Research, the Digital Pathology Market is expected to grow at a CAGR of 13.64% from 2026 to 2032. A College of American Pathologists survey (2022) revealed that 65% of laboratories have implemented or plan to implement AI-assisted diagnostic tools by 2024.

Personalized Medicine and Companion Diagnostics: The FDA approved 25 companion diagnostic tests in 2022, a 40% increase from 2020. The precision medicine market in tissue diagnostics grew by 38% between 2020-2022. According to NIH data (2023), personalized medicine approaches have improved treatment response rates by up to 30% in certain cancers

Point-of-Care Testing and Remote Diagnostics: The point-of-care Tissue Diagnostics Market segment grew by 28% in 2022. Telepathology consultations increased by 275% during 2020-2022, according to the American Telemedicine Association. Remote diagnostic capabilities have reduced diagnosis waiting times by 45% in participating hospitals.

Global Tissue Diagnostics Market Regional Analysis

Here is a more detailed regional analysis of the global Tissue Diagnostics Market:

North America

North America substantially dominates the global tissue diagnostic market driven by the high cancer incidence and advanced healthcare infrastructure.

According to the American Cancer Society (2023), approximately 1.9 million new cancer cases were diagnosed in the US.

The National Cancer Institute reported that healthcare spending on cancer reached USD 200.7 Billion in 2022, a 13% increase from 2020.

CDC data showed that 89% of U.S. hospitals have comprehensive cancer diagnostic facilities as of 2022.

The NIH allocated USD 7.1 Billion for cancer research in 2024, a 15% increase from 2021.

North American companies filed over 450 patents related to tissue diagnostics technology between 2020-2022.

According to ClinicalTrials.gov, the U.S. hosted 42% of global clinical trials in tissue diagnostics in 2022.

Medicare coverage for molecular diagnostic tests increased by 35% between 2020-2022.

The average insurance coverage for tissue diagnostic procedures reached 85% in the US by 2024.

The Canadian healthcare system reported a 28% increase in tissue diagnostic test reimbursements from 2020 to 2022.

Asia Pacific

Asia Pacific is anticipated to witness the fastest growth in the global tissue diagnostic market during the forecast period owing to the rapidly growing healthcare infrastructure and investment.

China's healthcare spending reached USD 1.3 Trillion in 2022, representing a 12% increase from 2020.

According to the Asian Development Bank (2022), healthcare infrastructure investments in Southeast Asia grew by 45% between 2020-2022.

India added over 300 new diagnostic centers in 2022, with 60% equipped for advanced tissue diagnostics.

WHO Western Pacific Region reported that cancer incidence in Asia Pacific increased by 35% from 2020 to 2022.

According to GLOBOCAN 2022, Asia accounts for nearly half (48%) of all new cancer cases globally.

Japan's aging population (28% over 65) drove a 25% increase in tissue diagnostic test demand in 2022.

South Korea increased its healthcare budget by 30% in 2022, with 15% allocated to diagnostic infrastructure.

Singapore's Precision Medicine Initiative invested USD 400 Million in diagnostic capabilities between 2020-2023.

The Chinese government's Healthy China 2032 initiative led to a 40% increase in diagnostic facility funding

Global Tissue Diagnostics Market: Segmentation Analysis

The Global Tissue Diagnostics Market is segmented on the basis of Disease, Technology, and End-User.

Tissue Diagnostics Market, By Disease

• Prostate Cancer
• Gastric Cancer
• Breast Cancer
• Non-Small Cell Lung Cancer

Based on the Disease, the Global Tissue Diagnostic Market is bifurcated into Prostate Cancer, Gastric Cancer, Breast Cancer, and Non-Small Cell Lung Cancer. The breast cancer segment leads the global Tissue Diagnostics Market, driven by the critical role tissue diagnostics play in the detection, diagnosis, and treatment planning of this prevalent disease. Advanced techniques such as immunohistochemistry and in situ hybridization are increasingly utilized to analyze breast tissue samples, allowing for precise tumor characterization. This growing reliance on sophisticated diagnostic methods has significantly boosted the demand for tissue diagnostics products and services specifically designed for breast cancer diagnosis and management.

Tissue Diagnostics Market, By Technology

• Immunohistochemistry (IHC)
• In Situ Hybridization (ISH)
• Digital Pathology and Workflow Management
• Special Staining

Based on the Technology, the Global Tissue Diagnostic Market is bifurcated into Immunohistochemistry (IHC), In Situ Hybridization (ISH), Digital Pathology and Workflow Management, and Special Staining. The Immunohistochemistry (IHC) segment holds a dominant position in the Global Tissue Diagnostics Market owing to its widespread application in clinical research and the development of cancer diagnostics and therapeutics. IHC is favored over traditional enzyme staining techniques as it enables precise differentiation between various tumor types, offering a higher level of specificity. While conventional methods are limited to detecting only a small range of tumor tissue structures, enzymes, and proteins, IHC provides more comprehensive and detailed insights, making it a preferred choice in modern cancer diagnostics.

Tissue Diagnostics Market, By End-User

• Hospitals
• Research Laboratories
• Pharmaceutical Companies
• Contract Research Organizations

Based on the End-User, the Global Tissue Diagnostic Market is bifurcated into Hospital, Research Laboratories, Pharmaceutical Companies, and Contract Research Organizations. The Hospital segment dominates the global Tissue Diagnostics Market, owing to the high consumption and utility rates of tissue diagnostic solutions in these settings. Physicians are increasingly transitioning from conventional testing procedures to tissue-based diagnostic techniques, as these tests offer faster results and reduced timelines.

Key Players

The "Global Tissue Diagnostics Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are Abbott, Agilent Technologies, Roche, Thermo Fisher Scientific, Merck, Sakura Finetek Japan, Qiagen, Abcam, BD, and Danaher.

• This section offers in-depth analysis through a company overview, position analysis, the regional and industrial footprint of the company, and the ACE matrix for insightful competitive analysis. The section also provides an exhaustive analysis of the financial performances of mentioned players in the given market.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Global Tissue Diagnostics Market Key Developments

• In June 2024, F. Hoffmann-La Roche Ltd gained 510(k) clearance from the US Food and Drug Administration (US FDA) for its Roche Digital Pathology Dx. Pathologists can use the newly cleared method to evaluate digital images and make correct diagnoses.
• In March 2024, Aptamer Group announced the launch of Optimer-Fc, a novel reagent for automated immunohistochemistry (IHC) procedures that identify cancer or other disease markers.
• In May 2021, Discovery Life Sciences, a global leader in biospecimens and biomarkers, announced the acquisition of Targos Molecular Pathology GmbH, a German molecular pathology lab.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL TISSUE DIAGNOSTICS MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL TISSUE DIAGNOSTICS MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL TISSUE DIAGNOSTICS MARKET, BY DISEASE

• 5.1 Overview
• 5.2 Prostate Cancer
• 5.3 Breast Cancer
• 5.4 Gastric Cancer
• 5.5 Non-Small Cell Lung Cancer

6 GLOBAL TISSUE DIAGNOSTICS MARKET, BY TECHNOLOGY

• 6.1 Overview
• 6.2 Immunohistochemistry (IHC)
• 6.3 In Situ Hybridization (ISH)
• 6.4 Digital Pathology and Workflow Management
• 6.5 Special Staining

7 GLOBAL TISSUE DIAGNOSTICS MARKET, BY END-USER

• 7.1 Overview
• 7.2 Hospitals
• 7.3 Research Laboratories
• 7.4 Pharmaceutical Companies
• 7.5 Contract Research Organizations

8 GLOBAL TISSUE DIAGNOSTICS MARKET, BY GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 U.K.
  • 8.3.3 France
  • 8.3.4 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Rest of Asia Pacific
• 8.5 Rest of the World
  • 8.5.1 Latin America
  • 8.5.2 Middle East & Africa

9 GLOBAL TISSUE DIAGNOSTICS MARKET COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Ranking
• 9.3 Key Development Strategies

10 COMPANY PROFILES

• 10.1 Abbott
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Agilent Technologies
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 Roche
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 Thermo Fisher Scientific
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Merck
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Sakura Finetek Japan
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.7 Qiagen
  • 10.7.1 Overview
  • 10.7.2 Financial Performance
  • 10.7.3 Product Outlook
  • 10.7.4 Key Developments
• 10.8 Abcam
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments
• 10.9 BD
  • 10.9.1 Overview
  • 10.9.2 Financial Performance
  • 10.9.3 Product Outlook
  • 10.9.4 Key Developments
• 10.10 Danaher
  • 10.10.1 Overview
  • 10.10.2 Financial Performance
  • 10.10.3 Product Outlook
  • 10.10.4 Key Developments

11 KEY DEVELOPMENTS

• 11.1 Product Launches/Developments
• 11.2 Mergers and Acquisitions
• 11.3 Business Expansions
• 11.4 Partnerships and Collaborations

12 Appendix

• 12.1 Related Research