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體外診斷生技設備

市場調查報告書

商品編碼

1732176

全球組織診斷市場規模（按疾病、技術、最終用戶、地區和預測）

Global Tissue Diagnostics Market Size By Disease (Prostate Cancer, Gastric Cancer), By Technology (Immunohistochemistry (IHC), In Situ Hybridization (ISH)), By End-User (Hospitals, Research Laboratories), By Geographic Scope And Forecast

出版日期: 2025年04月29日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

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簡介目錄

組織診斷的市場規模和預測

2024 年全球組織診斷市場規模為 48.9 億美元，預計到 2032 年將達到 75.3 億美元，2026 年至 2032 年的複合年成長率為 6.10%。

組織診斷是透過切片檢查等診斷程序檢測體內疾病（尤其是癌症、腫瘤和其他嚴重疾病）的關鍵過程。

這種方法對於早期發現疾病、及時介入和治療起著至關重要的作用。

隨著技術的發展，組織診斷有望取得巨大進步。數位病理學、次世代定序和先進成像等新工具正在提高組織分析的速度、準確性和深度。

這些創新使診斷更加精準，進而改善患者的治療效果。此外，人工智慧 (AI) 和機器學習 (ML) 演算法與組織診斷的融合，正在透過自動化常規任務、提高診斷一致性以及深入了解疾病機制，徹底改變該領域。

全球組織診斷市場動態

影響全球組織診斷市場的關鍵市場動態是：

關鍵市場促進因素

癌症發生率上升：根據世界衛生組織（WHO）（2022）預測，2020年癌症將導致約1,000萬人死亡，約佔全球死亡人數的六分之一。根據美國癌症協會預測，2024年美國將新增約190萬例癌症病例。根據GLOBOCAN 2020數據，乳癌已成為全球最常見的癌症，2020年新增病例達230萬例。

全球人口老化：聯合國《2022年世界人口展望》報告顯示，到2050年，全球每六人中就有一人年齡在65歲及以上，而2019年這一比例為每十一人中就有一人。世界衛生組織（2021年）預測，2020年至2032年間，60歲以上人口預計將增加38%。美國癌症研究所指出，美國約有80%的癌症患者年齡在55歲以上。

診斷技術的技術進步：根據實驗室調查，2020 年至 2022 年間，領先醫院採用數位病理解決方案的比例增加了 45%。美國病理學家學院報告稱，到 2022 年，超過 60% 的病理實驗室將實施某種形式的數位病理工具。

主要挑戰

專業技能有限，勞動力短缺：根據美國病理學家學院（2022）的數據，約60%的病理實驗室報告難以填補職缺。英國皇家病理學家學院（2021）的報告顯示，英國整個英國體系的病理學顧問短缺率高達25%。根據世界衛生組織的數據，低收入國家每10萬人中只有不到0.1名病理學家，而已開發國家每10萬人中只有4-5名病理學家。

先進診斷設備和程序成本高昂：截至2022年，每台數位病理系統的平均成本為20萬至40萬美元。根據《醫療保健成本分析》（2021年），每位患者的組織診斷檢測成本約為1000至3000美元。根據《實驗室經濟學》（2022年）的一項調查，45%的發展中地區實驗室認為預算限制是採用新組織診斷技術的主要障礙。

監管挑戰和品管問題：FDA 報告稱，2021 年約有 20% 的實驗室開發的測試存在品質問題或錯誤。根據 CLIA（臨床實驗室改進修正案），2022 年 12% 的組織診斷實驗室未能通過合規性檢查。美國病理學家學院 (2023) 的一項調查顯示，30% 的實驗室由於要求複雜而難以維持監管合規性。

主要趨勢

數位病理學與人工智慧整合：根據數位病理學會 (2023) 的數據，人工智慧診斷工具在癌症檢測中已證明準確率高達 95%。根據 Verified Market Research 的數據，數位病理學市場預計在 2026 年至 2032 年期間的複合年成長率將達到 13.64%。美國病理學家協會 (2022) 的一項調查顯示，65% 的實驗室已經採用或計劃在 2024 年前採用人工智慧輔助診斷工具。

個人化醫療和伴隨診斷：2022 年，FDA核准了25 種伴隨診斷，比 2020 年增加 40%。 2020 年至 2022 年，組織診斷領域的精準醫療市場成長了 38%。根據 NIH 數據（2023 年），個人化醫療方法已將某些癌症的治療反應率提高了 30%。

就地檢驗與遠距離診斷：照護現場組織診斷市場部分在 2022 年成長了 28%。根據美國遠端醫療協會的數據，從 2020 年到 2022 年，遠距病理學諮詢成長了 275%。遠距離診斷功能已將參與醫院的診斷等待時間縮短了 45%。

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.

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