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市場調查報告書

腫瘤搭配診斷檢查 - 世界市場分析與預測

MediPoint: Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts

出版商 GlobalData 商品編碼 301411
出版日期 內容資訊 英文 128 Pages
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腫瘤搭配診斷檢查 - 世界市場分析與預測 MediPoint: Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts
出版日期: 2016年12月21日 內容資訊: 英文 128 Pages
簡介

2016年目前全世界已實施250萬件搭配診斷、其中最多的是乳癌檢查、再來是非小細胞肺癌 (NSCLC) 檢查。地區分類目前美國是最大市場、今後將維持高成長率、亞太地區各國 (日本、中國、印度) 預計將急速成長。

本報告針對世界主要國家腫瘤搭配診斷檢查市場分析、提供疾病概要與市場構造、主要市場促進、控制因素、現在的未滿足需求、今後市場機會、市場動向預測 (過去2年、今後8年)、已上市/治療中的主要製品、現在治療進展狀況、主要企業檔案調查。

第1章 目錄

第2章 簡介

第3章 市場機會

  • 市場促進因素
    • 促進「成本效率醫療」
    • 新技術使用可能性
    • FDA (美國食品藥品局) 規範
    • 藥品開發的經濟優勢
    • 癌症患者數量增加
    • 標的治療需求
  • 市場阻礙因素
    • 醫療費補償環境
    • 臨床使用限制
    • 使用同一生物標的競爭企業
    • LDT (研究室開發的檢查方法)與競爭
    • 次世代型基因序列登場
    • 檢查方法與特定檢查機器結合、研究室選擇限制
    • 醫生的抵抗
  • 未滿足需求
    • 現有癌症治療選項改善
    • 客關測試需求
    • 高通量檢查需要
    • 醫療費補償的確實性
    • 必要的體內組織數量
    • 檢查期明確化
    • 檢查正確性
    • 檢查複雜化使流程問題增加

第4章 市場連結

  • 概要
  • 規範問題與回收
    • FDA歸範
    • 回收
  • 各國醫療費補償趨勢 (主要10國)
  • 企業合併、收購 (M&A)/合作夥伴

第5章 產品評價

  • 技術概要
    • 免疫組織化學
    • 原位雜合
    • 聚合□連鎖反應
    • 次世代型序列
  • 已上市製品
    • 乳癌搭配診斷檢查
    • 大腸癌搭配診斷檢查
    • 黑色素瘤搭配診斷檢查
    • 非小細胞肺癌搭配診斷檢查
  • 生產線製品
  • 治療動向

第6章 市場競爭評價

  • 市場佔有率分析
    • 世界市場分析
    • 美國國內企業佔有率分析
  • 企業策略傾向
  • 企業檔案
    • Abbott Laboratories
    • Agilent Technologies (Dako)
    • bioMerieux
    • Illumina
    • Leica Microsystems
    • Life Technologies (Thermo Fisher Scientific)
    • Qiagen
    • Roche

第7章 檢查趨勢

  • 乳癌搭配診斷檢查
  • 大腸癌搭配診斷檢查
  • 黑色素瘤搭配診斷檢查
  • NSCLC搭配診斷檢查

第8章 市場未來展望

  • 世界市場概況
  • 美國
  • 法國
  • 德國
  • 義大利
  • 西班牙
  • 英國
  • 日本
  • 中國
  • 印度
  • 巴西

第9章 附錄

圖表一覽

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目錄

Companion diagnostic test is defined as an in vitro diagnostic device or an imaging tool whose use allows the safe application of a therapy.

Companion diagnostic test market is growing, particularly in the emerging markets of Japan and China. The US currently has the largest share of the companion diagnostic market, with 27.9% of total market revenue, as is expected to remain the largest market throughout the forecast period of 2016-2023. The companion diagnostics market in China and Japan is expected to increase at compound annual growth rates (CAGRs) of 9.4% and 7.9%, respectively, driving growth in the Asia-Pacific (APAC: Japan, China, and India) region.

Overall, 2.5 Million companion diagnostic tests were performed in 2016. Breast cancer diagnostic tests accounted for the majority of tests conducted globally, followed by non-small cell lung cancer (NSCLC). Melanoma companion diagnostic testing remains low, due to the lower incidence rate, accounting for 5.5% of the market volume. Moreover, the majority of companion diagnostic tests performed are for human epidermal growth factor receptor 2 (HER2), because the tests performed are typically the cheaper immunohistochemistry (IHC) test, they only account for 26.3% of market value.

Reimbursement remains a significant challenge in the companion diagnostics market. Adoption is highly dependent upon reimbursement policies, so approval of new tests does not necessarily signify immediate adoption. If the molecular test cannot be reimbursed, adoption will be low. If the new therapy cannot be reimbursed, there will be no need for uptake of the companion diagnostic test, unless a secondary use can be found that is of utility to the physician in managing the patient's condition.

The report "MediPoint: Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts" provides an analysis of the companion diagnostic market for four major cancers in the US, the 5EU (France, Germany, Italy, Spain, and UK), Asia-Pacific (APAC) regions (Japan, China, and India) and South America. Additionally, it identifies the unmet needs in this companion diagnostics market and analyses companion diagnostic tests used in breast, colorectal, melanoma and non-small cell lung cancer. This report also discusses physician attitudes towards current companion diagnostic tests, and the future of companion diagnostic tests.

Scope

  • Competitive assessment: Currently marketed companion diagnostic products and evolving competitive landscape
  • In-depth analysis of unmet needs and adoption trends of different companion diagnostic tests
  • Insightful review of the key industry drivers, opportunities, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications
  • Pipeline analysis: Emerging products and technologies.
  • Annualized total companion diagnostic market volume and revenue by segment, and market outlooks by country from 2014-2023.
  • Other key topics covered include strategic competitive assessment, market characterization, identification of unmet needs, market dynamics, and implications of the emerging technologies on the market.

Reasons to buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline
  • Develop business strategies by understanding the trends shaping and driving the global market
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage
  • Track device sales in the global market from 2014-2023
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Companion Diagnostics Overview
  • 2.2. Catalyst
  • 2.3. Related Reports

3. Market Opportunities

  • 3.1. Market Drivers
    • 3.1.1. Increased Emphasis on Cost-Effective Healthcare
    • 3.1.2. Availability of New Technologies
    • 3.1.3. FDA Regulations
    • 3.1.4. Economic Benefits in Drug Development
    • 3.1.5. Rising Prevalence of Cancer
    • 3.1.6. Demand for Targeted Therapies
  • 3.2. Market Barriers
    • 3.2.1. Reimbursement Landscape
    • 3.2.2. Limited Clinical Use
    • 3.2.3. Competitors Using the Same Biomarkers
    • 3.2.4. Competition with Laboratory-Developed Tests
    • 3.2.5. Emergence of Next Generation Sequencing
    • 3.2.6. Linking Tests to Specific Instruments Limits Laboratories
    • 3.2.7. Physician Resistance
  • 3.3. Unmet Needs
    • 3.3.1. Improving Selection for Existing Cancer Treatments
    • 3.3.2. Need for Objective Tests
    • 3.3.3. Need for High-Throughput Tests
    • 3.3.4. Certainty of Reimbursement
    • 3.3.5. Quantity of Tissue Required
    • 3.3.6. Clarification on When to Test Patients
    • 3.3.7. Accuracy of Techniques
    • 3.3.8. Test Complexity Leading to Increased Process Failure

4. Market Access

  • 4.1. Overview
  • 4.2. Regulatory Issues and Recalls
    • 4.2.1. FDA Regulation
    • 4.2.2. Recalls
  • 4.3. Reimbursement Trends
    • 4.3.1. US
    • 4.3.2. France
    • 4.3.3. Germany
    • 4.3.4. Italy
    • 4.3.5. Spain
    • 4.3.6. UK
    • 4.3.7. China
    • 4.3.8. India
    • 4.3.9. Japan
    • 4.3.10. Brazil
  • 4.4. Mergers, Acquisitions, and Key Partnerships

5. Product Assessment

  • 5.1. Technology Overview
    • 5.1.1. Immunohistochemistry
    • 5.1.2. In Situ Hybridization
    • 5.1.3. Polymerase Chain Reaction
    • 5.1.4. Next Generation Sequencing
  • 5.2. Marketed Products
    • 5.2.1. Breast Cancer Companion Diagnostic Tests
    • 5.2.2. Colorectal Cancer Companion Diagnostic Tests
    • 5.2.3. Melanoma Companion Diagnostic Tests
    • 5.2.4. Non-Small Cell Lung Cancer Companion Diagnostic Tests
  • 5.3. Pipeline Products
  • 5.4. Clinical Trials

6. Competitive Assessment

  • 6.1. Company Share Analysis
    • 6.1.1. Global Analysis
    • 6.1.2. US Company Share Analysis
  • 6.2. Trends in Corporate Strategy
  • 6.3. Company Profiles
    • 6.3.1. Abbott Laboratories
    • 6.3.2. Agilent Technologies (Dako)
    • 6.3.3. bioMerieux
    • 6.3.4. Illumina
    • 6.3.5. Leica Microsystems
    • 6.3.6. Life Technologies (Thermo Fisher Scientific)
    • 6.3.7. Qiagen
    • 6.3.8. Roche

7. Testing Trends

  • 7.1. Breast Cancer Companion Diagnostic Tests
  • 7.2. Colorectal Cancer Companion Diagnostic Tests
  • 7.3. Melanoma Companion Diagnostic Tests
  • 7.4. Non-Small Cell Lung Cancer Companion Diagnostic Tests

8. Market Outlook

  • 8.1. Global Overview
  • 8.2. US
  • 8.3. France
  • 8.4. Germany
  • 8.5. Italy
  • 8.6. Spain
  • 8.7. UK
  • 8.8. Japan
  • 8.9. China
  • 8.10. India
  • 8.11. Brazil

9. Appendix

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Report Methodology
    • 9.3.1. Overview
    • 9.3.2. Coverage
    • 9.3.3. Secondary Research
    • 9.3.4. Forecasting Methodology
    • 9.3.5. Primary Research - Key Opinion Leader Interviews
  • 9.4. About the Authors
    • 9.4.1. Analysts
    • 9.4.2. Tyler Fletcher, Global Head of Medical Devices
  • 9.5. About MediPoint
  • 9.6. About GlobalData
  • 9.7. Disclaimer

List of Tables

  • Table 1: Possible Companion Diagnostic Test Platform Technologies
  • Table 2: Regulatory Issues and Recalls, 2014-2016
  • Table 3: Mergers and Acquisitions, 2016
  • Table 4: Key Partnerships in 2016
  • Table 5: Breast Cancer Companion Diagnostic Tests, 2016
  • Table 6: CRC Companion Diagnostic Tests, 2016
  • Table 7: Melanoma Companion Diagnostic Tests, 2016
  • Table 8: NSCLC Companion Diagnostic Tests, 2016
  • Table 9: Companion Diagnostic Tests Pipeline, 2014
  • Table 10: Key Clinical Trials Utilizing Companion Diagnostic Tests Linked to Specific Drug Therapies
  • Table 11: Company Profile - Abbott Laboratories
  • Table 12: Abbott Laboratories Portfolio Assessment, 2016
  • Table 13: SWOT Analysis - Abbott Laboratories
  • Table 14: Company Profile - Agilent Technologies
  • Table 15: Agilent Technologies Portfolio Assessment, 2016
  • Table 16: SWOT Analysis - Agilent Technologies
  • Table 17: Company Profile - bioMerieux
  • Table 18: bioMerieux Portfolio Assessment, 2016
  • Table 19: SWOT Analysis - bioMerieux
  • Table 20: Company Profile - Illumina
  • Table 21: SWOT Analysis - Illumina
  • Table 22: Company Profile - Leica
  • Table 23: Leica Portfolio Assessment, 2016
  • Table 24: SWOT Analysis - Leica
  • Table 25: Company Profile - Life Technologies (Thermo Fisher Scientific)
  • Table 26: Life Technologies Portfolio Assessment, 2016
  • Table 27: SWOT Analysis - Life Technologies
  • Table 28: Company Profile - Qiagen
  • Table 29: Qiagen Portfolio Assessment, 2016
  • Table 30: SWOT Analysis - Qiagen
  • Table 31: Company Profile - Roche
  • Table 32: Roche Portfolio Assessment, 2016
  • Table 33: SWOT Analysis - Roche
  • Table 34: Breast Cancer Companion Diagnostic Testing Volume (thousands), 2014-2023
  • Table 35: CRC Companion Diagnostic Testing Volume (thousands), 2014-2023
  • Table 36: Melanoma Companion Diagnostic Testing Volume (thousands), 2014-2023
  • Table 37: NSCLC Companion Diagnostic Testing Volume (thousands), 2014-2023
  • Table 38: Global Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Table 39: US Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Table 40: France Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Table 41: Germany Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Table 42: Italy Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Table 43: Spain Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Table 44: UK Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Table 45: Japan Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Table 46: China Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Table 47: India Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Table 48: Brazil Cancer Companion Diagnostic Test Market Value ($m), 2014-2023

List of Figures

  • Figure 1: Reasons for Companion Diagnostic Test Failure in the SATURN trial
  • Figure 2: Female Breast Cancer Treatment Patterns by Stage, 2008
  • Figure 3: Colon Cancer Treatment Patterns by Stage, 2008
  • Figure 4: Lung Cancer Treatment Patterns by Stage, 2008
  • Figure 5: Global Company Share Analysis, 2016
  • Figure 6: US Company Share Analysis, 2016
  • Figure 7: Breast Cancer Companion Diagnostic Testing Volume, 2014-2023
  • Figure 8: CRC Companion Diagnostic Testing Volume, 2014-2023
  • Figure 9: Melanoma Companion Diagnostic Testing Volume, 2014-2023
  • Figure 10: NSCLC Companion Diagnostic Testing Volume, 2014-2023
  • Figure 11: Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Figure 12: US Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Figure 13: France Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Figure 14: Germany Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Figure 15: Italy Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Figure 16: Spain Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Figure 17: UK Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Figure 18: Japan Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Figure 19: China Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Figure 20: India Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
  • Figure 21: Brazil Cancer Companion Diagnostic Test Market Value ($m), 2014-2023
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