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腫瘍向けコンパニオン診断検査 - 世界市場の分析と予測

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

発行 GlobalData 商品コード 301411
出版日 ページ情報 英文 128 Pages
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腫瘍向けコンパニオン診断検査 - 世界市場の分析と予測 MediPoint: Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts
出版日: 2016年12月21日 ページ情報: 英文 128 Pages
概要

2016年現在、全世界で250万件のコンパニオン診断が実施されていますが、その中で最も多いのが乳がん検査で、次いで非小細胞肺がん (NSCLC) 検査となっています。地域別では、現在は米国が最大の市場で、今後も高い成長率を維持しますが、アジア太平洋地域諸国 (日本・中国・インドなど) もまた急速に成長する見通しです。

当レポートでは、世界の主要国における腫瘍向けコンパニオン診断検査の市場について分析し、疾患の概要や市場構造、主な市場促進・抑制要因、現在のアンメットニーズ、今後の市場機会、市場動向見通し (過去2年間・今後8年間分)、上市済み/治験中の主要製品、現在の治験の進展状況、主要企業のプロファイルなどを調査しております。

第1章 目次

第2章 イントロダクション

第3章 市場機会

  • 市場促進要因
    • 「コスト効率的な医療」の推進の動き
    • 新技術の利用可能性
    • FDA (米国食品医薬品局) の規制
    • 医薬品開発の経済的利点
    • がんの有病者数の増大
    • 標的治療の需要
  • 市場阻害要因
    • 医療費償還環境
    • 臨床利用の制限
    • 同一のバイオマーカーを使う競合企業
    • LDT (研究室で開発された検査法) との競合
    • 次世代型遺伝子シーケンシングの登場
    • 検査方法と特定の検査機器との結びつきに伴う、研究室の選択肢の制約
    • 医師側の抵抗
  • アンメットニーズ
    • 既存のがん治療の選択肢の改善
    • 客観テストのニーズ
    • 高スループット検査のニーズ
    • 医療費償還の確実性
    • 必要な体内組織の量
    • 検査時期の明確化
    • 検査の正確性
    • 検査の複雑化によるプロセス障害の増加

第4章 市場へのアクセス

  • 概要
  • 規制上の問題とリコール
    • FDAの規制
    • リコール
  • 各国での医療費償還の傾向 (主要10ヶ国の場合)
  • 企業合併・買収 (M&A)/パートナーシップ

第5章 製品評価

  • 技術概要
    • 免疫組織化学
    • in situハイブリダイゼーション
    • ポリメラーゼ連鎖反応
    • 次世代型シーケンシング
  • 上市済み製品
    • 乳がん向けコンパニオン診断検査
    • 大腸がん向けコンパニオン診断検査
    • メラノーマ (悪性黒色腫) 向けコンパニオン診断検査
    • 非小細胞肺がん (NSCLC) 向けコンパニオン診断検査
  • パイプライン製品
  • 治験動向

第6章 市場競争の評価

  • 市場シェア分析
    • 世界市場の分析
    • 米国国内の企業別シェア分析
  • 企業戦略の傾向
  • 企業プロファイル
    • Abbott Laboratories
    • Agilent Technologies (Dako)
    • bioMerieux
    • Illumina
    • Leica Microsystems
    • Life Technologies (Thermo Fisher Scientific)
    • Qiagen
    • Roche

第7章 検査の傾向

  • 乳がん向けコンパニオン診断検査
  • 大腸がん向けコンパニオン診断検査
  • メラノーマ向けコンパニオン診断検査
  • NSCLC向けコンパニオン診断検査

第8章 市場の将来展望

  • 世界市場の概況
  • 米国
  • フランス
  • ドイツ
  • イタリア
  • スペイン
  • 英国
  • 日本
  • 中国
  • インド
  • ブラジル

第9章 付録

図表一覧

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目次

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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