組織診断の世界市場規模：疾患別、技術別、エンドユーザー別、地域別・予測

組織診断の市場規模と予測

世界の組織診断の市場規模は、2024年に48億9,000万米ドルと評価され、2026年～2032年にCAGR6.10%で成長し、2032年には75億3,000万米ドルに達すると予測されます。

組織診断は、生検のような診断手順を通じて体内の疾患、特にがん、腫瘍、その他の深刻な状態を検出するための重要なプロセスです。

このアプローチは、病気を早期に発見し、タイムリーな介入と治療を可能にする上で不可欠な役割を果たしています。

技術の進化に伴い、組織診断学は大きな進歩を遂げることが期待されています。デジタル病理学、次世代シークエンシング、高度画像診断などの新たなツールは、組織分析のスピード、精度、深度を向上させています。

これらの技術革新により、より正確な診断が可能となり、患者の予後改善につながります。さらに、人工知能（AI）と機械学習（ML）アルゴリズムを組織診断に統合することで、ルーチン作業の自動化、診断の一貫性の向上、疾患メカニズムへの深い洞察の発見により、この分野に革命をもたらしています。

世界の組織診断市場力学

世界の組織診断市場を形成している主な市場力学は以下の通りです：

主な市場促進要因

がん罹患率の上昇：WHO（2022年）によると、がんは2020年に約1,000万人の死因となり、世界の死亡者数の約6人に1人を占めています。米国がん協会によると、2024年には米国で約190万人が新たにがんと診断される見込みです。GLOBOCAN 2020のデータによると、乳がんは世界的に最も多いがんとなり、2020年には230万人が新たにがんと診断されました。

世界人口の高齢化：国連のWorld Population Prospects 2022は、2050年までに世界の6人に1人が65歳以上になり、2019年の11人に1人から増加すると報告しています。WHO（2021年）によると、2020年～2032年の間に、60歳以上の人口は38％増加すると予想されています。米国国立がん研究所は、米国における全がんの約80％が55歳以上で診断されると指摘しています。

診断技術の技術的進歩：検査室調査によると、主要病院におけるデジタル病理ソリューションの採用は2020年～2022年の間に45％増加しました。米国病理学会（College of American Pathologists）は、2022年までに病理検査室の60%以上が何らかのデジタル病理ツールを導入すると報告しています。

主な課題

限られた熟練専門家と労働力不足：米国病理学会（College of American Pathologists、2022年）によると、病理検査施設の約60％が空席を埋めることが困難であると報告しています。英国王立病理専門医協会（Royal College of Pathologists、2021年）は、英国のヘルスケアシステム全体で病理コンサルタントが25％不足していると報告しています。WHOのデータによると、低所得国の病理医は人口10万人当たり0.1人以下であるのに対し、先進国では10万人当たり4～5人です。

高度な診断機器と手技の高いコスト：デジタル病理システムの平均コストは、2022年現在、1台当たり20万～40万米ドルです。ヘルスケアコスト分析（2021年）によると、組織診断検査には患者1人当たり1,000米ドルから3,000米ドルの費用がかかります。Laboratory Economicsの調査（2022年）によれば、発展途上地域の検査室の45％が、新しい組織診断技術を採用する際の主な障壁として予算の制約を挙げています。

規制上の課題と品質管理の問題：FDAの報告によると、2021年には検査室で開発された検査の約20％に品質上の問題やエラーがありました。CLIA（Clinical Laboratory Improvement Amendments）では、2022年に組織診断検査施設の12％がコンプライアンス検査に不合格でした。米国病理学会（College of American Pathologists、2023年）の調査では、複雑な要件のために30％の検査室が規制遵守の維持に苦慮していることが明らかになりました。

主要動向

デジタル病理学とAIの統合：デジタル病理学協会（2023年）によると、AIを搭載した診断ツールはがん検出において95％の精度を示しました。Verified Market Researchによると、デジタル病理学市場は2026年～2032年にCAGR13.64％で成長する見込みです。米国病理学会（College of American Pathologists、2022年）の調査では、検査室の65％がAI支援診断ツールを導入済み、または2024年までに導入予定であることが明らかになりました。

個別化医療とコンパニオン診断：FDAが2022年に承認したコンパニオン診断薬は25種類で、2020年から40%増加しました。組織診断における精密医療市場は2020年～2022年に38%成長しました。NIHのデータ（2023年）によると、個別化医療のアプローチにより、特定のがんでは治療反応率が最大30％改善しました。

ポイントオブケア検査と遠隔診断：ポイントオブケア組織診断市場セグメントは2022年に28%成長しました。米国遠隔医療協会（American Telemedicine Association）によると、遠隔病理学診察は2020年～2022年に275%増加しました。遠隔診断機能により、参加病院では診断待ち時間が45%短縮されました。

目次

第1章 世界の組織診断市場のイントロダクション

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 世界の組織診断市場の展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 組織診断の世界市場：疾患別

• 概要
• 前立腺がん
• 乳がん
• 胃がん
• 非小細胞肺がん

第6章 組織診断の世界市場：技術別

• 概要
• 免疫組織化学（IHC）
• In Situハイブリダイゼーション（ISH）
• デジタル病理検査とワークフロー管理
• 特殊染色

第7章 組織診断の世界市場：エンドユーザー別

• 概要
• 病院
• 研究機関
• 製薬会社
• 契約研究機関

第8章 組織診断の世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他アジア太平洋
• 世界のその他の地域
  • ラテンアメリカ
  • 中東・アフリカ

第9章 世界の組織診断市場の競合情勢

• 概要
• 各社の市場ランキング
• 主な発展戦略

第10章 企業プロファイル

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

第11章 主な発展

• 製品発売/開発
• 合併と買収
• 事業拡大
• パートナーシップと提携

第12章 付録

• 関連調査

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