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組織診斷市場 - 2023-2028 年預測
市場調查報告書
商品編碼
1295392

組織診斷市場 - 2023-2028 年預測

Tissue Diagnostics Market - Forecasts from 2023 to 2028
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 140 Pages | 商品交期: 最快1-2個工作天內

價格
簡介目錄

2021 年組織診斷市場價值 14.68 億美元，預計在預測期內復合年增長率為 7.81%，到 2028 年達到 24.84 億美元。

組織診斷市場是指涉及用於檢查組織樣本以診斷疾病和評估各種醫療狀況的診斷測試和工具的開發、生產和商業化的行業。 該市場包括儀器、耗材、配件、免疫組織化學 (IHC)、原位雜交 (ISH)、數字病理學和特種染色技術等多種產品。 組織診斷在癌症診斷、傳染病診斷、自身免疫性疾病診斷、心血管疾病診斷等領域發揮著重要作用。

慢性病患病率和患病率增加

癌症、心血管疾病和神經系統疾病等慢性疾病的患病率不斷上升，將組織診斷的需求推向前所未有的高度。 世界衛生組織 (WHO) 報告稱，慢性病佔每年死亡人數的 74%，並奪去了大約 4100 萬人的生命。 組織診斷包括各種組織病理學技術和分子測定，對於促進準確的疾病診斷和個性化治療策略至關重要。 這些慢性疾病的複雜性需要全面了解其潛在的組織異常和分子改變，這可以通過組織診斷來有效實現。

人口老齡化

此外，到2021年，60歲及以上的人口還在增加。 由於這個年齡段容易患癌症，人口增長支撐了對組織診斷服務不斷增長的需求。 醫療保健提供者和診斷公司必須擴大資源，以滿足對準確的癌症診斷和治療決策日益增長的需求。 組織診斷技術的進步可以在解決這些人群的癌症負擔和改善患者預後方面發揮重要作用。

政府舉措：

世界各國政府越來越認識到組織診斷技術對醫療保健和疾病管理產生重大影響的潛力。 這些技術為疾病診斷、個性化治療計劃和監測患者對治療的反應提供了寶貴的見解。 通過支持組織診斷的引入和發展，政府旨在提高醫療保健效果並改善患者護理。

組織診斷市場的主要公司

組織診斷市場的主要參與者包括 Abbott Laboratories、Agilent Technologies、BD（Becton、Dickinson 和 Company）、BioGenex 和 Cardinal Health。 這些公司大力投資研發，開發新技術和解決方案，以滿足不斷增長的需求。 例如，2021年，Roche子公司Roche診斷公司推出了“Ventana HER2 Dual ISH DNA Probe Cocktail”。 該產品用於檢測乳腺癌和胃癌組織樣本中人表皮生長因子受體2（HER2）基因擴增情況。 它為臨床醫生提供了寶貴的信息，以確定適當的治療方式，包括 HER2 抑製劑等靶向治療。

診斷創新顯著增加

過去幾年，隨著領先公司推出先進產品，免疫組織化學 (IHC) 市場的增長見證了診斷創新的顯著增長。 例如，Roche的 DISCOVERY ULTRA 系統具有 30 個獨立的滑動抽屜，提高了同時運行手動和全自動實驗的能力，而不會遇到同步問題。 使用該系統可以完全自動化進行各種 IHC 和 ISH 實驗，包括 FISH、蛋白質 IHC/ISH 和多重測定。 同樣，Creative Diagnostics 於 2021 年 12 月發布了一系列全面的免疫組織化學病理學抗體。

醫院使用高比例的組織診斷解決方案。

基於醫院組織的診斷測試正在取代傳統的測試技術。 這是因為組織學診斷檢查比傳統技術花費的時間更少。 慢性病患病率的上升也增加了醫院對組織診斷的需求。 例如，根據美國癌症協會 2022 年 1 月發布的《2022 年癌症事實和數據》，預計 2022 年將確診 190 萬個新癌症病例。 癌症患病率的上升和其他慢性疾病的沉重負擔增加了對準確診斷和治療的需求。

本地見解：

按地區劃分，組織診斷市場分為北美、南美、歐洲、中東和非洲以及亞太地區。 北美地區，尤其是美國，擁有完善的醫療基礎設施和先進的診斷技術，使其成為組織診斷的強大市場。 歐洲也是組織診斷的重要市場，德國、法國和英國等國家在市場規模和診斷技術進步方面處於領先地位。 該地區重視早期診斷、完善的醫療保健系統以及不斷增強的癌症篩查和預防意識。

美國處於組織診斷市場的前沿，是北美最大、最具活力的市場。 憑藉其先進的醫療基礎設施、廣泛的研發能力和高癌症發病率，該國為組織診斷的增長和創新提供了肥沃的土壤。 美國擁有許多行業領先企業，推動了競爭和技術進步。 隨著醫療保健提供者努力尋求準確的診斷和個性化的治療方法，對精準醫療和個性化醫療保健的重視進一步推動了組織診斷的採用。 美國專注於研究、合作和尖端技術，在塑造組織診斷的未來、改善患者治療結果和推動醫療診斷領域發展方面發揮著關鍵作用。

市場趨勢：

  • 2021年5月，全球分子診斷領域領導者QIAGEN推出了therascreen(R) KRAS RGQ PCR試劑盒，作為首個獲得美國FDA批准的NSCLC腫瘤組織伴隨診斷試劑盒，對市場影響做出了重大貢獻。 這一創新解決方案可識別 NSCLC 中普遍存在的 KRAS G12C 突變，並為指導治療決策提供重要見解。
  • 例如，Oncotype DX 是領先的個性化醫療診斷技術之一，它分析 21 個基因來識別無需化療即可治療的乳腺癌患者。 2021年，個性化醫療將贏得近三分之一的FDA新藥批准，並在過去七年中佔FDA批准的25%以上。 AstraZeneca等大型製藥公司已證實，精準醫療約佔其研發收入的 90%。

內容

第一章簡介

  • 市場概況
  • 市場定義
  • 調查範圍
  • 市場細分
  • 貨幣
  • 先決條件
  • 基準年和預測年時間表

第 2 章研究方法

  • 調查設計
  • 調查數據
  • 驗證

第 3 章執行摘要

  • 主要發現

第 4 章市場動態

  • 市場驅動因素
  • 市場製約因素
  • 波特五力分析
  • 行業價值鏈分析

第 5 章組織診斷市場：按產品

  • 簡介
  • 消耗品
    • 抗體
    • 套件
    • 探測
    • 試劑
  • 設備
    • 幻燈片掃描儀
    • 載玻片染色系統
    • 組織微陣列
    • 組織處理系統
    • 其他

第 6 章：組織診斷市場：按技術劃分

  • 簡介
  • 數字病理學和工作流程管理
  • 免疫組織化學 (IHC)
  • 原位雜交 (ISH)
  • 初級特種染色

第 7 章：組織診斷市場：按應用劃分

  • 簡介
  • 乳腺癌
  • 宮頸癌
  • 結直腸癌
  • 胃癌
  • 肺癌
  • 其他

第 8 章：組織診斷市場：按最終用戶劃分

  • 簡介
  • 合同研究組織 (CRO)
  • 醫院
  • 診斷中心
  • 其他

第 9 章：組織診斷市場：按地區

  • 簡介
  • 北美
    • 按產品
    • 按技術
    • 按用途
    • 按最終用戶
    • 按國家/地區
  • 南美洲
    • 按產品
    • 按技術
    • 按用途
    • 按最終用戶
    • 按國家/地區
  • 歐洲
    • 按產品
    • 按技術
    • 按用途
    • 按最終用戶
    • 按國家/地區
  • 中東和非洲
    • 按產品
    • 按技術
    • 按用途
    • 按最終用戶
    • 按國家/地區
  • 亞太地區
    • 按產品
    • 按技術
    • 按用途
    • 按最終用戶
    • 按國家/地區

第10章競爭格局與分析

  • 主要公司及戰略分析
  • 新興公司和市場盈利能力
  • 合併、收購、協議與合作
  • 供應商競爭力矩陣

第 11 章公司簡介

  • Abbott Laboratories
  • Agilent Technologies, Inc.
  • BD（Becton, Dickinson, and Company）
  • BioGenex
  • Cardinal Health
  • Danaher
  • Exact Sciences Corporation
  • F. Hoffmann-La Roche Ltd
  • Medtronic
  • Merck KGaA
  • Thermo Fisher Scientific Inc.
簡介目錄
Product Code: KSI061610034

The tissue diagnostics market was valued at US$1.468 billion in 2021 and is expected to grow at a CAGR of 7.81% over the forecast period to reach a market size of US$2.484 billion by 2028.

The tissue diagnostics market refers to the industry that involves the development, production, and commercialization of diagnostic tests and tools used to examine tissue samples to diagnose diseases or assess various medical conditions. This market includes multiple products such as instruments, consumables, accessories, and technologies like immunohistochemistry (IHC), in situ hybridization (ISH), digital pathology, and special staining techniques. Tissue diagnostics play a crucial role in areas such as cancer diagnosis, infectious disease diagnosis, autoimmune disease diagnosis, cardiovascular disease diagnosis, and more.

Increasing prevalence and incidence of chronic diseases.

The rising prevalence of chronic diseases, including cancer, cardiovascular diseases, and neurological disorders, has propelled the demand for tissue diagnostics to unprecedented heights. Globally, chronic diseases are responsible for 74% of all deaths annually, resulting in the loss of approximately 41 million lives, as the World Health Organization (WHO) reported. Tissue diagnostics, comprising a range of histopathological techniques and molecular assays, are pivotal in facilitating accurate disease diagnosis and tailored treatment strategies. The intricate nature of these chronic conditions necessitates a comprehensive understanding of the underlying tissue abnormalities and molecular alterations, which can be effectively achieved through tissue diagnostics.

The growing geriatric population.

Additionally, the growing population of individuals aged 60 years and older has increased in 2021. As this age group is more susceptible to developing cancer, the rising population size underscores the increased demand for tissue diagnostics services. Healthcare providers and diagnostic companies must adapt and expand their resources to meet the growing need for accurate cancer diagnosis and treatment decision-making. Advancements in tissue diagnostic technologies can play a crucial role in addressing the burden of cancer in these demographics and improving patient outcomes.

Favorable government initiatives:

Governments worldwide are increasingly recognizing the potential of tissue diagnostics technologies, including their significant impact on healthcare and disease management. These technologies offer valuable insights into disease diagnosis, personalized treatment planning, and monitoring patient response to therapy. Governments aim to enhance healthcare outcomes and improve patient care by supporting the adoption and advancement of tissue diagnostics.

Key players in the tissue diagnostics market

Key players in the tissue diagnostics market include Abbott Laboratories, Agilent Technologies, BD (Becton, Dickinson, and Company), BioGenex, and Cardinal Health. These companies invest heavily in research and development to develop new technologies and solutions to meet the growing demand. For instance, in 2021, "Ventana HER2 Dual ISH DNA Probe Cocktail" was launched by Roche Diagnostics, a subsidiary of F. Hoffmann-La Roche Ltd. This product is used to detect human epidermal growth factor receptor 2 (HER2) gene amplification in breast and gastric cancer tissue samples. It provides clinicians with valuable information for determining the appropriate treatment approach, such as targeted therapies like HER2 inhibitors.

Significant increase in diagnostic innovation

The previous few years have seen a significant increase in diagnostic innovation, due to which major corporations have introduced advanced products for the growing immunohistochemistry (IHC) market. For instance, the DISCOVERY ULTRA system by Roche enhances the capacity to execute manual and completely automated experiments concurrently without experiencing synchronization issues because of its 30 independent slide drawers. A wide variety of IHC and ISH experiments, comprising FISH, protein IHC/ISH, and multiplex assays, among others, can be fully automated using the system. Similarly, Creative Diagnostics released a comprehensive array of immunohistochemistry pathology antibodies in December 2021.

Hospitals use tissue diagnostic solutions at high rates.

Tissue-based diagnostic testing by hospitals is replacing more conventional testing techniques. This is because tissue diagnostic tests take less time than traditional techniques. the rising prevalence of chronic diseases also increases the demand for tissue diagnostics in hospitals. For instance, an estimated 1.9 million new cancer cases were identified in 2022, according to Cancer Facts and Figures 2022, released in January 2022 by the American Cancer Society. The rising incidence of cancer and the heavy load of other chronic diseases enhance the need for precise diagnosis and treatment.

Geographical Insights:

Based on geography, the tissue diagnostics market is segmented into North America, South America, Europe, the Middle East and Africa, and Asia Pacific. The North American region, particularly the United States, has a well-established healthcare infrastructure and advanced diagnostic technologies, making it a prominent market for tissue diagnostics. Europe is another significant market for tissue diagnostics, with countries like Germany, France, and the United Kingdom leading in terms of market size and advancements in diagnostic technologies. The region benefits from a strong focus on early disease diagnosis, well-established healthcare systems, and increasing cancer screening and prevention awareness.

The United States is at the forefront of the tissue diagnostics market, representing North America's largest and most dynamic market. With its advanced healthcare infrastructure, extensive research and development capabilities, and high prevalence of cancer, the country offers a fertile ground for the growth and innovation of tissue diagnostics. The United States houses numerous leading players in the industry, driving competition and technological advancements. The emphasis on precision medicine and personalized healthcare further propels the adoption of tissue diagnostics as healthcare providers strive for accurate diagnoses and tailored treatment approaches. With a strong focus on research, collaborations, and cutting-edge technologies, the United States plays a pivotal role in shaping the future of tissue diagnostics, improving patient outcomes, and advancing the field of healthcare diagnostics.

Market Developments:

  • In May 2021, QIAGEN, a global leader in molecular diagnostics, made a significant contribution to the market by launching their therascreen® KRAS RGQ PCR Kit as the first US FDA-approved tissue companion diagnostic for NSCLC tumors. This innovative solution identifies the KRAS G12C mutation, a prevalent mutation in NSCLC, and provides crucial insights for guiding treatment decisions.
  • One of the advanced diagnostics for personalized medicine, Oncotype DX, for instance, analyses 21 genes to identify breast cancer patients who can be treated without chemotherapy. In 2021, personalized medicines received almost a third of all FDA approvals for new drugs and over 25% of all FDA approvals over the previous seven years. Major pharmaceutical firms like AstraZeneca confirm precision therapies provide about 90% of their research and development income.

Market Segmentation:

By Product

  • Consumables
  • Antibodies
  • Kits
  • Probes
  • Reagents
  • Instruments
  • Slide Scanners
  • Slide Staining Systems
  • Tissue Microarrays
  • Tissue Processing Systems
  • Others

By Technology

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

By Application

  • Breast cancer
  • Cervical cancer
  • Colorectal cancer
  • Gastric cancer
  • Lung cancer
  • Others

By End-Users

  • Contract Research Organizations (CROs)
  • Hospitals
  • Diagnostic Centers
  • Others

By Geography

  • North America
  • USA
  • Canada
  • Mexico
  • South America
  • Brazil
  • Argentina
  • Others
  • Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Others
  • Middle East and Africa
  • UAE
  • Saudi Arabia
  • Others
  • Asia Pacific
  • Japan
  • China
  • South Korea
  • India
  • Others

TABLE OF CONTENTS

1. INTRODUCTION

  • 1.1. Market Overview
  • 1.2. Market Definition
  • 1.3. Scope of the Study
  • 1.4. Market Segmentation
  • 1.5. Currency
  • 1.6. Assumptions
  • 1.7. Base, and Forecast Years Timeline

2. RESEARCH METHODOLOGY

  • 2.1. Research Design
  • 2.2. Research Data
  • 2.3. Validation

3. EXECUTIVE SUMMARY

  • 3.1. Key Findings

4. MARKET DYNAMICS

  • 4.1. Market Drivers
  • 4.2. Market Restraints
  • 4.3. Porter's Five Forces Analysis
    • 4.3.1. Bargaining Power of Suppliers
    • 4.3.2. Bargaining Power of Buyers
    • 4.3.3. Threat of New Entrants
    • 4.3.4. Threat of Substitutes
    • 4.3.5. Competitive Rivalry in the Industry
  • 4.4. Industry Value Chain Analysis

5. TISSUE DIAGNOSTICS MARKET, BY PRODUCT

  • 5.1. Introduction
  • 5.2. Consumables
    • 5.2.1. Antibodies
    • 5.2.2. Kits
    • 5.2.3. Probes
    • 5.2.4. Reagents
  • 5.3. Instruments
    • 5.3.1. Slide Scanners
    • 5.3.2. Slide Staining Systems
    • 5.3.3. Tissue Microarrays
    • 5.3.4. Tissue Processing Systems
    • 5.3.5. Others

6. TISSUE DIAGNOSTICS MARKET, BY TECHNOLOGY

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

7. TISSUE DIAGNOSTICS MARKET, BY APPLICATION

  • 7.1. Introduction
  • 7.2. Breast cancer
  • 7.3. Cervical cancer
  • 7.4. Colorectal cancer
  • 7.5. Gastric cancer
  • 7.6. Lung Cancer
  • 7.7. Others

8. TISSUE DIAGNOSTICS MARKET, BY END-USER

  • 8.1. Introduction
  • 8.2. Contract Research Organizations (CROs)
  • 8.3. Hospitals
  • 8.4. Diagnostic Centers
  • 8.5. Others

9. TISSUE DIAGNOSTICS MARKET, BY GEOGRAPHY

  • 9.1. Introduction
  • 9.2. North America
    • 9.2.1. By Product
    • 9.2.2. By Technology
    • 9.2.3. By Application
    • 9.2.4. By End-User
    • 9.2.5. By Country
    • 9.2.5.1. United States
    • 9.2.5.2. Canada
    • 9.2.5.3. Mexico
  • 9.3. South America
    • 9.3.1. By Product
    • 9.3.2. By Technology
    • 9.3.3. By Application
    • 9.3.4. By End-User
    • 9.3.5. By Country
    • 9.3.5.1. Brazil
    • 9.3.5.2. Argentina
    • 9.3.5.3. Others
  • 9.4. Europe
    • 9.4.1. By Product
    • 9.4.2. By Technology
    • 9.4.3. By Application
    • 9.4.4. By End-User
    • 9.4.5. By Country
    • 9.4.5.1. Germany
    • 9.4.5.2. France
    • 9.4.5.3. United Kingdom
    • 9.4.5.4. Italy
    • 9.4.5.5. Others
  • 9.5. Middle East and Africa
    • 9.5.1. By Product
    • 9.5.2. By Technology
    • 9.5.3. By Application
    • 9.5.4. By End-User
    • 9.5.5. By Country
    • 9.5.5.1. UAE
    • 9.5.5.2. Saudi Arabia
    • 9.5.5.3. Others
  • 9.6. Asia Pacific
    • 9.6.1. By Product
    • 9.6.2. By Technology
    • 9.6.3. By Application
    • 9.6.4. By End-User
    • 9.6.5. By Country
    • 9.6.5.1. Japan
    • 9.6.5.2. China
    • 9.6.5.3. South Korea
    • 9.6.5.4. India
    • 9.6.5.5. Others

10. COMPETITIVE ENVIRONMENT AND ANALYSIS

  • 10.1. Major Players and Strategy Analysis
  • 10.2. Emerging Players and Market Lucrativeness
  • 10.3. Mergers, Acquisitions, Agreements, and Collaborations
  • 10.4. Vendor Competitiveness Matrix

11. COMPANY PROFILES

  • 11.1. Abbott Laboratories
  • 11.2. Agilent Technologies, Inc.
  • 11.3. BD (Becton, Dickinson, and Company)
  • 11.4. BioGenex
  • 11.5. Cardinal Health
  • 11.6. Danaher
  • 11.7. Exact Sciences Corporation
  • 11.8. F. Hoffmann-La Roche Ltd
  • 11.9. Medtronic
  • 11.10. Merck KGaA
  • 11.11. Thermo Fisher Scientific Inc.