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コンパニオン診断 (CDx) の世界市場:2018年〜2025年の予測 - 技術・適応症・国別の分析、規制の枠組みと競合情勢

Global Companion Diagnostics (CDx) Market: Focus on Technology, Indication, Country-wise Analysis, Regulatory Framework, and Competitive Landscape - Analysis and Forecast, 2018-2025

発行 BIS Research Inc. 商品コード 709671
出版日 ページ情報 英文 296 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=111.53円で換算しております。
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コンパニオン診断 (CDx) の世界市場:2018年〜2025年の予測 - 技術・適応症・国別の分析、規制の枠組みと競合情勢 Global Companion Diagnostics (CDx) Market: Focus on Technology, Indication, Country-wise Analysis, Regulatory Framework, and Competitive Landscape - Analysis and Forecast, 2018-2025
出版日: 2018年09月24日 ページ情報: 英文 296 Pages
担当者のコメント
パーソナライズドメディスンの調査領域において定評のあるBIS Researchより発行、がん治療の分野で今後注目を集めるコンパニオン診断 (CDx) にフォーカスしたレポートになります。
概要

世界のコンパニオン診断市場は、2018年から2025年にかけて2桁成長が見込まれており、2025年には41億米ドルに達することが予測されています。この成長の主な要因として、次世代シーケンシング (NGS) ベースのコンパニオン診断に対する需要の増加が挙げられます。

当レポートでは、世界におけるコンパニオン診断 (CDx) 市場の動向と今後の予測を技術、地域および適応症別に提供しており、主要コンパニオン診断メーカーのプロファイルなどとともにお届けします。

Figure 5.1 Global Companion Diagnostics Market, 2017-2025

第1章 市場概要

  • コンパニオン診断の分類
  • コンパニオン診断の歴史
  • コンパニオン診断開発の要素
  • コンパニオン診断の重要な要素
  • コンパニオン診断の将来性

第2章 市場力学

  • 概要
  • 氷山分析 (Iceberg Analysis)
  • 影響度分析
  • 市場発展因子
    • 癌発症数の増加
    • 精密医療に対する需要の増加
    • 治療薬との共同開発
  • 市場発展阻害因子
  • 市場機会
    • 新たな適応症領域
    • 次世代シーケンシングが加速させる遺伝子治療
    • コンパニオン診断用途のためのデータサイエンス

第3章 競合の洞察

  • 主要戦略と開発
  • ジョイントベンチャー・提携・協業
  • 製品の承認
  • 買収
  • 製品発売とその他の開発
  • 市場シェア分析
    • 技術別
    • 適応症別
    • 地域別
    • 産業の魅力度

第4章 規制の枠組み

  • FDAによる法的要件と枠組み
  • EMAによる法的要件と枠組み
  • MHLWによる法的要件と枠組み

第5章 世界のコンパニオン診断市場:分析と予測

  • 市場規模算出の前提条件と限界
  • 市場概要

第6章 世界のコンパニオン診断市場:技術別

  • 概要
  • ポリメラーゼ連鎖反応 (PCR)
  • 免疫組織染色 (IHC)
  • in situ ハイブリダイゼーション (ISH)
  • 次世代シーケンシング (NGS)

第7章 世界のコンパニオン診断市場:適応症別

  • 概要
  • 肺癌
  • 乳癌
  • 大腸癌
  • 胃癌
  • 白血病
  • 黒色腫
  • その他
  • 癌以外の疾患

第8章 世界のコンパニオン診断市場:地域別

  • 概要
  • 北米
    • 米国
    • カナダ
  • 欧州
    • 英国
    • ドイツ
    • フランス
    • イタリア
    • スペイン
    • その他
  • アジア太平洋地域
    • 中国
    • 日本
    • インド
    • オーストラリア
    • シンガポール
    • その他
  • その他の地域

第9章 企業プロファイル

  • 概要
  • Abbott Laboratories
  • Agilent Technologies, Inc.
  • ARUP Laboratories
  • bioMerieux SA
  • Danaher Corporation
  • F. Hoffmann-La Roche AG
  • Illumina, Inc.
  • Invivoscribe Technologies, Inc.
  • MolecularMD Corporation
  • Myriad Genetics, Inc.
  • QIAGEN N.V.
  • Thermo Fisher Scientific Inc.
  • ArcherDx, Inc.
  • Exosome Diagnostics, Inc.
  • NeoGenomics, Inc.
  • MDxHealth, Inc.
  • NanoString Technologies, Inc.

第10章 調査の範囲と手法

図表

List of Tables

  • Table 2.1: Impact Analysis of Market Drivers
  • Table 2.2: Impact Analysis of Market Restraints
  • Table 2.3: Impact Analysis of Market Opportunities
  • Table 3.1: R&D Revenue of Major CDx Companies (as of FY2017)
  • Table 6.1: PCR-Based Companion Diagnostics Manufacturers
  • Table 6.2: PCR-Based Companion Diagnostics Service Providers
  • Table 6.3: IHC-Based Companion Diagnostics Manufacturers
  • Table 6.4: IHC-Based Companion Diagnostics Service Providers
  • Table 6.5: ISH-Based Companion Diagnostics Manufacturers
  • Table 6.6: ISH-Based Companion Diagnostics Service Providers
  • Table 6.7: NGS-Based Companion Diagnostics Manufacturers
  • Table 6.8: NGS-Based Companion Diagnostics Service Providers
  • Table 7.1: Cancer Type- Incidence and Mortality
  • Table 7.2: Available Companion Diagnostic Tests for Lung Cancer
  • Table 7.3: Available Companion Diagnostic Tests for Breast Cancer
  • Table 7.4: Available Companion Diagnostic Tests for Colorectal Cancer
  • Table 7.5: Available Companion Diagnostic Tests for Stomach Cancer
  • Table 7.6: Available Companion Diagnostic Tests for Leukemia
  • Table 7.7: Available Companion Diagnostic Tests for Melanoma
  • Table 7.8: Available Companion Diagnostics for Others
  • Table 9.1: Abbott Laboratories: Partnerships, Agreements, and Collaborations
  • Table 9.2: Abbott Laboratories: Product Approvals
  • Table 9.3: Agilent Technologies, Inc.: Acquisition
  • Table 9.4: Agilent Technologies, Inc.: Collaborations
  • Table 9.5: ARUP Laboratories: Collaboration
  • Table 9.6: bioMérieux SA: Approval
  • Table 9.7: Danaher Corporation: Collaborations and Partnership
  • Table 9.8: F. Hoffmann-La Roche AG: Collaborations, Agreements, and Partnerships
  • Table 9.9: F. Hoffmann-La Roche AG: Product Approvals
  • Table 9.10: Illumina, Inc.: Collaborations, Agreements, and Partnerships
  • Table 9.11: Illumina, Inc.: Acquisition
  • Table 9.12: Illumina, Inc.: Product Approval
  • Table 9.13: Invivoscribe Technologies, Inc.: Product Approval
  • Table 9.14: MolecularMD Corporation: Agreement and Partnership
  • Table 9.15: Invivoscribe Technologies, Inc.: Product Approval
  • Table 9.16: Myriad Genetics, Inc.: Collaborations and Agreements
  • Table 9.17: Illumina, Inc.: Product Approval
  • Table 9.18: QIAGEN N.V.: Acquisition
  • Table 9.19: QIAGEN N.V.: Collaborations, Partnership, and Agreement
  • Table 9.20: QIAGEN N.V.: Product Approval
  • Table 9.21: Thermo Fisher Scientific Inc.: Collaborations, Partnership, and Agreement
  • Table 9.22: Thermo Fisher Scientific Inc.: Product Approval
  • Table 9.23: ArcherDX, Inc.: Collaborations, Partnership, and Agreement
  • Table 9.24: Exosome Diagnostics, Inc.: Collaborations and Partnerships
  • Table 9.25: NeoGenomics, Inc.: Acquisition
  • Table 9.26: NeoGenomics, Inc.: Collaboration and Agreement
  • Table 9.27: NeoGenomics, Inc.: Product Launch
  • Table 9.28: MDxHealth, Inc.: Partnerships and Agreements
  • Table 9.29: NanoString Technologies, Inc.: Partnership, Collaboration and Agreement

List of Figures

  • Figure 1: Escalating Healthcare Expenditure, 2016-2020
  • Figure 2: Impact of Market Drivers and Market Restraints, 2017 and 2025
  • Figure 3: Global Companion Diagnostics (CDx) Market Snapshot
  • Figure 4: Dominating Segments of Global Companion Diagnostics Market, 2017 and 2025
  • Figure 5: Global Companion Diagnostics Market (by Technology), 2017 and 2025
  • Figure 6: Global Companion Diagnostics Market (by Indication), 2017 and 2025
  • Figure 7: Global Companion Diagnostics Market (by Region), 2017 and 2025
  • Figure 8: Growth Share Matrix for Global Companion Diagnostics Market (by Country), 2018 and 2025
  • Figure 9: Market Statistics
  • Figure 10: Market Share Analysis: Global Companion Diagnostics Market (2017)
  • Figure 11: Growth Share Matrix for Global Companion Diagnostics Market (by Indication), 2017
  • Figure 1.1: Classification of Companion Diagnostics (CDx)
  • Figure 1.2: Evolution of Companion Diagnostics (CDx)
  • Figure 1.3: Components Required to Develop Companion Diagnostics
  • Figure 1.4: Applications of Companion Diagnostics (CDx)
  • Figure 1.5: Potential of Companion Diagnostics (CDx)
  • Figure 2.1: Market Dynamics
  • Figure 2.2: Iceberg Analysis
  • Figure 2.3: Cancer Incidence by WHO Region (2012) per 100,000
  • Figure 2.4: Fully Aligned Drug-Diagnostic Co-Development
  • Figure 2.5: CDx Leakage for Oncology
  • Figure 3.1: Competitive Landscape (January 2014-July 2018)
  • Figure 3.2: Share of Key Developments and Strategies (January 2014-July 2018)
  • Figure 3.3: Joint Venture, Partnership, and Collaboration Share by Companies (January 2014-July 2018)
  • Figure 3.4: Product Approval Share by Companies (January 2014-July 2018)
  • Figure 3.5: Acquisition Share by Companies (January 2014-July 2018)
  • Figure 3.6: Market Share Analysis for the Global Companion Diagnostics Market (2016)
  • Figure 3.7: Market Share Analysis for the Global Companion Diagnostics Market (2017)
  • Figure 3.8: Growth Share Matrix for Global Companion Diagnostics Market (by Technology), 2017
  • Figure 3.9: Growth Share Matrix for Global Companion Diagnostics Market (by Indication), 2017
  • Figure 3.10: Growth Share Matrix for Global Companion Diagnostics Market (by Indication), 2018 and 2025
  • Figure 3.11: Industy Attractieness (Porter's Five Forces Analysis)
  • Figure 3.12: Bargaining Power of Suppliers: Overall Impact
  • Figure 3.13: Bargaining Power of Buyers: Overall Impact
  • Figure 3.14: Threat of New Entrants: Overall Impact
  • Figure 3.15: Threat of Substitute Products: Overall Impact
  • Figure 3.16: Intensity of Competitive Rivalry: Overall Impact
  • Figure 4.1: FDA Guidelines for CDx Approval
  • Figure 5.1: Global Companion Diagnostics Market, 2017-2025
  • Figure 6.1: Companion Diagnostics Market (by Technology)
  • Figure 6.2: Global Companion Diagnostics Market (by Technology), 2017-2025
  • Figure 6.3: Global Companion Diagnostics Market (by PCR Technology), 2017-2025
  • Figure 6.4: Global Companion Diagnostics Market (by IHC Technology), 2017-2025
  • Figure 6.5: Global Companion Diagnostics Market (by ISH Technology), 2017-2025
  • Figure 6.6: Global Companion Diagnostics Market (by NGS Technology), 2017-2025
  • Figure 7.1: Global Companion Diagnostics Market (by Indication), 2017-2025
  • Figure 7.2: Global Companion Diagnostics Market (by Lung Cancer), 2017-2025
  • Figure 7.3: Total Market Size for Lung Cancer Companion Diagnostics (2017 and 2020)
  • Figure 7.4: Global Companion Diagnostic Market (by Breast Cancer), 2017-2025
  • Figure 7.5: Total Market Size for Breast Cancer Companion Diagnostics (2017 and 2020)
  • Figure 7.6: Global Companion Diagnostics Market (by Colorectal Cancer), 2017-2025
  • Figure 7.7: Total Market Size for Colorectal Cancer Companion Diagnostics (2017 and 2020)
  • Figure 7.8: Global Companion Diagnostics Market (by Stomach Cancer), 2017-2025
  • Figure 7.9: Total Market Size for Stomach Cancer Companion Diagnostics (2017 and 2020)
  • Figure 7.10: Global Companion Diagnostics Market (by Leukemia), 2017-2025
  • Figure 7.11: Total Market Size for Leukemia Companion Diagnostics (2017 and 2020)
  • Figure 7.12: Global Companion Diagnostics Market (by Melanoma), 2017-2025
  • Figure 7.13: Total Market Size for Melanoma Companion Diagnostics (2017 and 2020)
  • Figure 7.14: Global Companion Diagnostics Market (by Others), 2017-2025
  • Figure 7.15: Total Market Size for Others Companion Diagnostics (2017 and 2020)
  • Figure 8.1: Global Companion Diagnostics Market (by Region), 2017 and 2025
  • Figure 8.2: Global Companion Diagnostics Market (by Region), 2017-2025
  • Figure 8.3: Global Companion Diagnostics Market Share (by Region), 2017
  • Figure 8.4: Global Companion Diagnostics Market Share (by Region), 2025
  • Figure 8.5: North America Companion Diagnostics Market, 2017-2025
  • Figure 8.6: North America: Market Dynamics
  • Figure 8.7: North America Companion Diagnostics Market (by Country), 2017-2025
  • Figure 8.8: North America Companion Diagnostics Market (by Indication), 2017-2025
  • Figure 8.9: The U.S. Companion Diagnostics Market, 2017-2025
  • Figure 8.10: Canada Companion Diagnostics Market, 2017-2025
  • Figure 8.11: Overview of Reimbursement Policies across Europe
  • Figure 8.12: Europe Companion Diagnostics Market, 2017-2025
  • Figure 8.13: Europe: Market Dynamics
  • Figure 8.14: Europe Companion Diagnostics Market (by Country), 2017-2025
  • Figure 8.15: Europe Companion Diagnostics Market (by Indication), 2017-2025
  • Figure 8.16: The U.K. Companion Diagnostics Market, 2017-2025
  • Figure 8.17: Germany Companion Diagnostics Market, 2017-2025
  • Figure 8.18: France Companion Diagnostics Market, 2017-2025
  • Figure 8.19: Italy Companion Diagnostics Market, 2017-2025
  • Figure 8.20: Spain Companion Diagnostics Market, 2017-2025
  • Figure 8.21: Rest-of-Europe Companion Diagnostics Market, 2017-2025
  • Figure 8.22: APAC Companion Diagnostics Market, 2017-2025
  • Figure 8.23: APAC: Market Dynamics
  • Figure 8.24: APAC Companion Diagnostics Market (by Country), 2017-2025
  • Figure 8.25: APAC Companion Diagnostics Market (by Indication), 2017-2025
  • Figure 8.26: China Companion Diagnostics Market, 2017-2025
  • Figure 8.27: Japan Companion Diagnostics Market, 2017-2025
  • Figure 8.28: India Companion Diagnostics Market, 2017-2025
  • Figure 8.29: Australia Companion Diagnostics Market, 2017-2025
  • Figure 8.30: Singapore Companion Diagnostics Market, 2017-2025
  • Figure 8.31: Rest-of-APAC Companion Diagnostics Market, 2017-2025
  • Figure 8.32: Rest-of-the-World Companion Diagnostics Market, 2017-2025
  • Figure 9.1: Total Number of Company Profiles
  • Figure 9.2: Abbott Laboratories: Overall Product Portfolio
  • Figure 9.3: Abbott Laboratories: Product Portfolio for Companion Diagnostics Market
  • Figure 9.4: Abbott Laboratories: Overall Financials, 2015-2017
  • Figure 9.5: Abbott Laboratories: Revenue (by Segment), 2015-2017
  • Figure 9.6: Abbott Laboratories: Revenue (by Region), 2015-2017
  • Figure 9.7: Abbott Laboratories: Global Presence
  • Figure 9.8: SWOT Analysis: Abbott Laboratories
  • Figure 9.9: Agilent Technologies, Inc.: Overall Product Portfolio
  • Figure 9.10: Agilent Technology, Inc.: Product Portfolio for Companion Diagnostics Market
  • Figure 9.11: Agilent Technologies, Inc.: Overall Financials, 2015-2017
  • Figure 9.12: Agilent Technologies, Inc.: Revenue (by Region), 2015-2017
  • Figure 9.13: Agilent Technologies, Inc.: Revenue (by Segment), 2015-2017
  • Figure 9.14: Agilent Technologies, Inc.: Global Presence
  • Figure 9.15: Agilent Technologies, Inc. SWOT Analysis
  • Figure 9.16: ARUP Laboratories: Overall Product Portfolio
  • Figure 9.17: ARUP Laboratories: Product Portfolio for Companion Diagnostics Market
  • Figure 9.18: ARUP Laboratories: SWOT Analysis
  • Figure 9.19: bioMérieux SA: Overall Product Portfolio
  • Figure 9.20: bioMérieux SA: Product Portfolio for Companion Diagnostics Market
  • Figure 9.21: bioMérieux SA: Overall Financials, 2015-2017
  • Figure 9.22: bioMérieux SA: Revenue (by Segment), 2015-2017
  • Figure 9.23: bioMérieux SA: Revenue (by Region), 2015-2017
  • Figure 9.24: bioMérieux SA: Global Presence
  • Figure 9.25: bioMérieux SA: SWOT Analysis
  • Figure 9.26: Danaher Corporation: Overall Product Portfolio
  • Figure 9.27: Danaher Corporation: Product Portfolio for Companion Diagnostics Market
  • Figure 9.28: Danaher Corporation: Overall Financials, 2015-2017
  • Figure 9.29: Danaher Corporation: Net Revenue (by Region), 2015-2017
  • Figure 9.30: Danaher Corporation: Net Revenue (by Business Segment), 2015-2017
  • Figure 9.31: Danaher Corporation: Global Presence
  • Figure 9.32: Danaher Corporation: SWOT Analysis
  • Figure 9.33: F. Hoffmann-La Roche AG: Overall Product Portfolio
  • Figure 9.34: F. Hoffmann-La Roche AG: Product Portfolio for Companion Diagnostics Market
  • Figure 9.35: F. Hoffmann-La Roche AG: Overall Financials, 2015-2017
  • Figure 9.36: F. Hoffmann-La Roche AG: Net Revenue (by Region), 2015-2017
  • Figure 9.37: F. Hoffmann-La Roche AG: Net Revenue (by Business Segment), 2015-2017
  • Figure 9.38: F. Hoffmann-La Roche AG: Global Presence
  • Figure 9.39: F. Hoffmann-La Roche AG: SWOT Analysis
  • Figure 9.40: Illumina, Inc.: Overall Product Portfolio
  • Figure 9.41: Illumina, Inc.: Product Portfolio for Global Companion Diagnostics Market
  • Figure 9.42: Illumina, Inc.: Overall Financials, 2015-2017
  • Figure 9.43: Illumina, Inc.: Net Revenue (by Region), 2015-2017
  • Figure 9.44: Illumina, Inc.: Net Revenue (by Business Segment), 2015-2017
  • Figure 9.45: Illumina, Inc.: Global Presence
  • Figure 9.46: Illumina, Inc.: SWOT Analysis
  • Figure 9.47: Invivoscribe Technologies, Inc.: Overall Product Portfolio
  • Figure 9.48: Invivoscribe Technologies, Inc.: Product Portfolio for Global Companion Diagnostics Market
  • Figure 9.49: Invivoscribe Technologies, Inc.: SWOT Analysis
  • Figure 9.50: MolecularMD Corporation: Overall Product Portfolio
  • Figure 9.51: MolecularMD Corporation: Product Portfolio for Global Companion Diagnostics Market
  • Figure 9.52: MolecularMD Corporation: SWOT Analysis
  • Figure 9.53: Myriad Genetics, Inc.: Overall Product Portfolio
  • Figure 9.54: Myriad Genetics, Inc.: Product Portfolio for Global Companion Diagnostics Market
  • Figure 9.55: Myriad Genetics, Inc.: Overall Financials, 2015-2017
  • Figure 9.56: Myriad Genetics, Inc.: Net Revenue (by Business Segment), 2015-2017
  • Figure 9.57: Myriad Genetics, Inc.: Global Presence
  • Figure 9.58: Myriad Genetics, Inc.: SWOT Analysis
  • Figure 9.59: QIAGEN N.V.: Overall Product Portfolio
  • Figure 9.60: QIAGEN N.V.: Product Portfolio for Global Companion Diagnostics Market
  • Figure 9.61: QIAGEN N.V.: Overall Financials, 2015-2017
  • Figure 9.62: QIAGEN N.V.: Net Revenue (by Business Segment), 2015-2017
  • Figure 9.63: QIAGEN N.V.: Net Revenue (by Region), 2015-2017
  • Figure 9.64: QIAGEN N.V.: Global Presence
  • Figure 9.65: QIAGEN N.V.: SWOT Analysis
  • Figure 9.66: Thermo Fisher Scientific Inc.: Overall Product Portfolio
  • Figure 9.67: Thermo Fisher Scientific Inc.: Product Portfolio for Global Companion Diagnostics Market
  • Figure 9.68: Thermo Fisher Scientific Inc.: Overall Financials, 2015-2017
  • Figure 9.69: Thermo Fisher Scientific Inc.: Net Revenue (by Business Segment), 2015-2017
  • Figure 9.70: Thermo Fisher Scientific Inc.: Net Revenue (by Region), 2015-2017
  • Figure 9.71: Thermo Fisher Scientific Inc.: Global Presence
  • Figure 9.72: Thermo Fisher Scientific Inc.: SWOT Analysis
  • Figure 10.1: Global Companion Diagnostics Market Segmentation
  • Figure 10.2: Global Companion Diagnostics Market Research Methodology
  • Figure 10.3: Primary Research
  • Figure 10.4: Secondary Research
  • Figure 10.5: Data Triangulation
  • Figure 10.6: Bottom-Up Approach (Segment-Wise Analysis)
  • Figure 10.7: Top-Down Approach (Segment-Wise Analysis)
  • Figure 10.8: Assumptions and Limitations
  • Figure 10.9: Considered Factors for Data Prediction and Modeling
目次
Product Code: BH067A

The global companion diagnostics market is expected to reach $4.1 billion by 2025. With increasing demand for NGS-based companion diagnostics, the global CDx market is expected to witness double digit growth rate during the forecast period 2018-2025.

In the era of precision medicine, the healthcare industry is focused on the development of advanced biomarker-based diagnostics to deliver improved patient care and enhance treatment outcome. The increasing prevalence of chronic disorders and improving regulatory framework for supporting drug-diagnostic co-development models are promoting the growth of the companion diagnostics market. Thereby, the advent of precision medicine approach and development of precision diagnostics are improving quality of life of the patients and reducing economic, societal, and clinical burden.

Presently, companion diagnostic (CDx) solutions are developed based on four technologies which include Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR). Till date, the healthcare industry has witnessed a number of successful procedures for parallel development of drug and its companion diagnostic, but mostly for oncology. However, successful commercialization and approval of companion diagnostics for multiple cancer types, including lung cancer, breast cancer, leukemia, colorectal cancer, gastric cancer, ovarian cancer, and melanoma, have further drawn the attention of several pharmaceutical and diagnostic companies to venture into this lucrative market by developing CDx solutions for non-oncology indications, including neurodegenerative diseases, infectious diseases, metabolic disorders, and cardiovascular diseases. Further, several players are now focusing on the development of multiple biomarker-based CDx development, which is anticipated to enhance the growth of NGS-based companion diagnostics market.

The purpose of this study is to gain a holistic view of the companion diagnostics market in terms of various influencing factors, such as recent trends, regulatory frameworks, and technological advancements in the market. The scope of this report constitutes a detailed study of the technologies associated with the global companion diagnostics market. The market has been segmented into ‘technology', ‘indication', and ‘region'. The report presents the reader with an opportunity to unlock comprehensive insights with respect to the market and helps in forming well-informed strategic decisions. The research uncovers some of the substantial parameters that must be taken into consideration before entering into the market.

This research report aims at answering various aspects of the global companion diagnostics market with the help of the key factors driving the market, the restraints, and the challenges that can possibly inhibit the overall market growth, and the current growth opportunities that are going to shape the future trajectory of the market expansion. The report includes an in-depth examination of the key players and recent developments taking place in this market. Moreover, the report includes chapters on market dynamics (market drivers, opportunities, and challenges) and industry analysis as well.

The research study highlights the factors governing the industry attractiveness with Porter's Five Forces for a comprehensive understanding of the global companion diagnostics market. Moreover, the study includes detailed product mapping, market estimation, and analysis of key trends in multiple geographical regions, growth of companion diagnostics market in each region for different cancer types, and the key strategies and developments by the prominent companion diagnostics manufacturers.

The answers to the following key questions can be derived from this report:

  • What are the major market drivers, challenges, and opportunities in the global companion diagnostics market?
  • What are the underlying structures resulting in the emerging trends within the companion diagnostics industry?
  • What was the market value of the leading segments and sub-segments of the global companion diagnostics systems market in 2017?
  • How will each segment of the global companion diagnostics market grow during the forecast period and what will be the revenue generated by each of the segments by the end of 2025?
  • What are the influencing factors that may affect the market share of the key players?
  • How will the industry evolve during the forecast period 2018- 2025?
  • What are the key developmental strategies which are being implemented by the key players to sustain in this competitive market?
  • What are the key technologies in companion diagnostics market? What are the major benefits of each technology?
  • How has the market been segmented on the basis of indication? Which indication is dominating the global companion diagnostics market and its reason?
  • What is the market share of the companies by CDx technologies which include Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR)?
  • Who are the key manufacturers in the companion diagnostics market and what are their contributions?
  • What is the scope of each companion diagnostic technology in North America, Europe, and Asia-Pacific?
  • What are the key regulatory implications in developed and developing regions for companion diagnostics?
  • What is the growth potential of companion diagnostics in each region?
  • Which companion diagnostic technology is having most promising growth and in which indication type?

The key manufacturers who have been contributing significantly to the companion diagnostics market include Abbott Laboratories, Agilent Technologies, Inc., ARUP Laboratories, bioMérieux S.A., Danaher Corporation, F. Hoffmann-La Roche AG, Illumina, Inc., Invivoscribe Technologies, Inc., MolecularMD Corporation, Myriad Genetics, Inc., QIAGEN N.V., Thermo Fisher Scientific Inc., among others.

Table of Contents

Executive Summary

1. Market Overview

  • 1.1. Classification of Companion Diagnostics (CDx)
  • 1.2. CDx in a Historical Perspective
  • 1.3. Constituents for Companion Diagnostics (CDx) Development
  • 1.4. Significant Applications of Companion Diagnostics (CDx)
  • 1.5. Companion Diagnostics (CDx): Future Potential

2. Market Dynamics

  • 2.1. Overview
  • 2.2. Iceberg Analysis
  • 2.3. Impact Analysis
  • 2.4. Market Drivers
    • 2.4.1. Growing Incidence of Cancer
      • 2.4.1.1. Better Treatment Assurance
      • 2.4.1.2. Diagnostic and Treatment Availability for All Forms of Cancer
    • 2.4.2. Growing Demand of Precision Medicine
      • 2.4.2.1. Adverse Drug Reactions
      • 2.4.2.2. Boost in Predictive Biomarker Discovery
    • 2.4.3. Co-Development of Drugs and Diagnostics
  • 2.5. Market Restraints
    • 2.5.1. Uncertain Reimbursement Scenario
    • 2.5.2. Companion Diagnostics Leakage in Oncology
    • 2.5.3. Weak Synchronization between Therapeutics and Diagnostics in Marketing and Distribution Channels
  • 2.6. Opportunities within the Market
    • 2.6.1. New Indication Areas
    • 2.6.2. Next Generation Sequencing Accelerating Targeted Gene Therapy
    • 2.6.3. Data Science for Companion Diagnostics Applications

3. Competitive Insights

  • 3.1. Key Strategies and Developments
  • 3.2. Joint Ventures, Partnerships, and Collaborations
  • 3.3. Product Approvals
  • 3.4. Acquisitions
  • 3.5. Product Launches and Other Developments
  • 3.6. Market Share Analysis
  • 3.7. Growth Share Analysis
    • 3.7.1. Growth Share Analysis by Technology
    • 3.7.2. Growth Share Analysis by Indication
    • 3.7.3. Growth Share Analysis by Region
    • 3.7.4. Industry Attractiveness
      • 3.7.4.1. Bargaining Power of Suppliers
      • 3.7.4.2. Bargaining Power of Buyer
      • 3.7.4.3. Threat of New Entrants
      • 3.7.4.4. Threat of Substitute Products
      • 3.7.4.5. Intensity of Competitive Rivalry

4. Regulatory Framework

  • 4.1. Legal Requirements and Framework by the FDA
  • 4.2. Legal Requirements and Framework by the EMA
  • 4.3. Legal Requirements and Framework by the MHLW

5. Global Companion Diagnostics Market: Analysis and Forecast

  • 5.1. Assumptions & Limitations for Market Size Calculations
  • 5.2. Market Overview

6. Global Companion Diagnostics Market (by Technology)

  • 6.1. Overview
  • 6.2. Polymerase Chain Reaction (PCR)
  • 6.3. Immunohistochemistry (IHC)
  • 6.4. In-situ Hybridization (ISH)
  • 6.5. Next Generation Sequencing (NGS)

7. Global Companion Diagnostics Market (by Indication)

  • 7.1. Overview
  • 7.2. Lung Cancer
  • 7.3. Breast Cancer
  • 7.4. Colorectal Cancer
  • 7.5. Stomach Cancer
  • 7.6. Leukemia
  • 7.7. Melanoma
  • 7.8. Others
  • 7.9. Non-Oncology Diseases

8. Global Companion Diagnostics Market (by Region)

  • 8.1. Overview
  • 8.2. North America
    • 8.2.1. The U.S.
    • 8.2.2. Canada
  • 8.3. Europe
    • 8.3.1. The U.K.
    • 8.3.2. Germany
    • 8.3.3. France
    • 8.3.4. Italy
    • 8.3.5. Spain
    • 8.3.6. Rest-of-Europe
  • 8.4. Asia-Pacific
    • 8.4.1. China
    • 8.4.2. Japan
    • 8.4.3. India
    • 8.4.4. Australia
    • 8.4.5. Singapore
    • 8.4.6. Rest-of-APAC
  • 8.5. Rest-of-the-World

9. Company Profiles

  • 9.1. Overview
  • 9.2. Abbott Laboratories
    • 9.2.1. Company Overview
    • 9.2.2. Overall Product Portfolio
    • 9.2.3. Product Offering in CDx
    • 9.2.4. Financials
      • 9.2.4.1. Financial Summary
    • 9.2.5. Global Presence
    • 9.2.6. Recent Developments
    • 9.2.7. SWOT Analysis
  • 9.3. Agilent Technologies, Inc.
    • 9.3.1. Company Overview
    • 9.3.2. Overall Product Portfolio
    • 9.3.3. Financials
      • 9.3.3.1. Financial Summary
    • 9.3.4. Global Presence
    • 9.3.5. Recent Developments
    • 9.3.6. SWOT Analysis
  • 9.4. ARUP Laboratories
    • 9.4.1. Company Overview
    • 9.4.2. Overall Product Portfolio
    • 9.4.3. Product Offering
    • 9.4.4. Corporate Summary
    • 9.4.5. Recent Developments
    • 9.4.6. SWOT Analysis
  • 9.5. bioMérieux SA
    • 9.5.1. Company Overview
    • 9.5.2. Overall Product Portfolio
    • 9.5.3. Product Offering
    • 9.5.4. Financials
      • 9.5.4.1. Financial Summary
    • 9.5.5. Global Presence
    • 9.5.6. Recent Developments
    • 9.5.7. SWOT Analysis
  • 9.6. Danaher Corporation
    • 9.6.1. Company Overview
    • 9.6.2. Overall Product Portfolio
    • 9.6.3. Product Offering
    • 9.6.4. Financials
      • 9.6.4.1. Financial Summary
    • 9.6.5. Global Presence
    • 9.6.6. Recent Developments
    • 9.6.7. SWOT Analysis
  • 9.7. F. Hoffmann-La Roche AG
    • 9.7.1. Company Overview
    • 9.7.2. Overall Product Portfolio
    • 9.7.3. Product Offering
    • 9.7.4. Financials
      • 9.7.4.1. Financial Summary
    • 9.7.5. Global Presence
    • 9.7.6. Recent Developments
    • 9.7.7. SWOT Analysis
  • 9.8. Illumina, Inc.
    • 9.8.1. Company Overview
    • 9.8.2. Overall Product Portfolio
    • 9.8.3. Product Offering
    • 9.8.4. Financials
      • 9.8.4.1. Financial Summary
    • 9.8.5. Global Presence
    • 9.8.6. Recent Developments
    • 9.8.7. SWOT Analysis
  • 9.9 Invivoscribe Technologies, Inc.
    • 9.9.1. Company Overview
    • 9.9.2. Overall Product Portfolio
    • 9.9.3. Product Offering
    • 9.9.4. Corporate Summary
    • 9.9.5. Recent Developments
    • 9.9.6. SWOT Analysis
  • 9.10 MolecularMD Corporation
    • 9.10.1. Company Overview
    • 9.10.2. Overall Product Portfolio
    • 9.10.3. Product Offering
    • 9.10.4. Corporate Summary
    • 9.10.5. Recent Developments
    • 9.10.6. SWOT Analysis
  • 9.11 Myriad Genetics, Inc.
    • 9.11.1. Company Overview
    • 9.11.2. Overall Product Portfolio
    • 9.11.3. Product Offering
    • 9.11.4. Financials
      • 9.11.4.1. Financial Summary
    • 9.11.5. Global Presence
    • 9.11.6. Recent Developments
  • 9.12 QIAGEN N.V.
    • 9.12.1. Company Overview
    • 9.12.2. Overall Product Portfolio
    • 9.12.3. Product Offering
    • 9.12.4. Financials
      • 9.12.4.1. Financial Summary
    • 9.12.5. Global Presence
    • 9.12.6. Recent Developments
    • 9.12.7. SWOT Analysis
  • 9.13 Thermo Fisher Scientific Inc.
    • 9.13.1. Company Overview
    • 9.13.2. Overall Product Portfolio
    • 9.13.3. Product Offering
    • 9.13.4. Financials
      • . 9.13.4.1. Financial Summary
    • 9.13.5. Global Presence
    • 9.13.6. Recent Developments
    • 9.13.7. SWOT Analysis
  • 9.14. ArcherDx, Inc.
    • 9.14.1. Company Overview
    • 9.14.2. Corporate Summary
    • 9.14.3. Recent Developments
  • 9.15. Exosome Diagnostics, Inc.
    • 9.15.1. Company Overview
    • 9.15.2. Corporate Summary
    • 9.15.3. Recent Developments
  • 9.16. NeoGenomics, Inc.
    • 9.16.1. Company Overview
    • 9.16.2. Corporate Summary
    • 9.16.3. Recent Developments
  • 9.17. MDxHealth, Inc.
    • 9.17.1. Company Overview
    • 9.17.2. Corporate Summary
    • 9.17.3. Recent Developments
  • 9.18. NanoString Technologies, Inc.
    • 9.18.1. Company Overview
    • 9.18.2. Corporate Summary
    • 9.18.3. Recent Developments

10. Research Scope and Methodology

  • 10.1. Report Scope
  • 10.2. Companion Diagnostics Market: Research Methodology
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