CDx開発市場（第2版）：提供サービスの種類別（フィージビリティスタディ、アッセイ開発、分析バリデーション、臨床バリデーション、製造）、使用分析技術別（次世代シーケンシング（NGS）、ポリメラーゼ連鎖反応（PCR）、免疫組織化学/in situハイブリダイゼーション（IHC/ISH）、リキッドバイオプシー、その他）、治療領域別（腫瘍学的および非腫瘍学的）、主要地域別（北米、欧州、アジア太平洋地域、その他の地域）の分布：業界動向と世界予測、2022-2035年

CDx Development Market (2nd Edition): Distribution by Type of Service Offered (Feasibility Studies, Assay Development, Analytical Validation, Clinical Validation and Manufacturing), Analytical Technique Used (Next Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Immunohistochemistry / in situ Hybridization (IHC / ISH), Liquid Biopsy and Others), Therapeutic Areas (Oncological and Non-oncological) and Key Geographies (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022-2035

2022年現在、CDx開発市場は約6億6,400万ドルの規模を誇り、予測期間を通じて10.7％の年間平均成長率（CAGR）が見込まれている。近年、疾病の発症を支える分子メカニズムの解明が大幅に進み、疾病に関連する分子シ... もっと見る

出版社	出版年月	電子版価格	ページ数	言語
Roots Analysis ルーツアナリシス	2023年7月1日	US$4,799 シングルユーザライセンスライセンス・価格情報・注文方法はこちら	405	英語

サマリー

2022年現在、CDx開発市場は約6億6,400万ドルの規模を誇り、予測期間を通じて10.7％の年間平均成長率（CAGR）が見込まれている。近年、疾病の発症を支える分子メカニズムの解明が大幅に進み、疾病に関連する分子シグネチャーに対処するよう綿密に設計された標的療法の創出に向けた道が開かれつつある。コンパニオン診断薬（CDx診断薬）の重要な役割は、患者固有の遺伝子プロファイルについて医師に情報を提供し、個々のニーズに合わせた十分な情報に基づく治療方針の決定を促進する上で不可欠なものとなっている。

通常、治験薬と同時に開発されるこれらの診断検査は、薬剤の安全性、有効性、標的に対する治療効果を評価する上で重要な役割を担っている。1998年に米国食品医薬品局（USFDA）がトラスツズマブとHercepTest™を承認したことは画期的な出来事であり、診断検査によって誘導された数多くの新規標的がん治療薬が臨床段階を経て、あるいは商業用として承認されるという流れを引き起こした。年以降、USFDAは44のCDx診断薬を承認し、3つのCDx標的治療薬が進行卵巣がん、乳がん、非小細胞肺がんの承認を得た。

670を超える臨床試験における約200の薬理学的介入を網羅する広範な研究によれば、リード化合物が臨床開発段階をうまく通過して承認を得る確率はわずか11％である。患者募集に疾患特異的バイオマーカー情報を活用することは、試験の成功率を高めるだけでなく、試験コストを60％近く削減する。

このような多面的な利点を認識し、医療業界は従来の画一的な薬物療法からカスタマイズされた薬理学的介入へと徐々に移行しつつある。この移行は、CDx診断薬に対する需要をさらに高めることになる。しかし、医薬品とコンパニオン診断薬の共同開発には複雑さが伴うため、医薬品開発企業はCDx診断薬業務のアウトソーシングを希望している。驚くべきことに、約80%の企業が、検査開発における社内の専門知識不足を理由に、第三者サービスプロバイダーやCDx開発会社を選択している。その結果、多くのCDx開発企業は、ポリメラーゼ連鎖反応（PCR）、免疫組織化学（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）などの最先端のツールや技術に多額の投資を行い、CDx開発市場でスポンサー企業に包括的なエンドツーエンドサービスを提供している。

従来の分析技術だけでなく、デジタルPCR（dPCR）やデジタルイムノアッセイといった最先端のソリューションを取り入れてポートフォリオを多様化し、顧客の進化するニーズに応えている革新的企業もある。個別化治療に対する急増する需要と継続的な技術進歩により、CDx開発産業は予測期間を通じて大幅な市場成長を維持すると予想される。

主要市場セグメント
提供サービスの種類
 フィージビリティ・スタディ
 アッセイ開発
 分析バリデーション
 臨床バリデーション
 製造

使用分析技術
 次世代シーケンス（NGS）
 ポリメラーゼ連鎖反応（PCR）
 免疫組織化学／in situ ハイブリダイゼーション（IHC／ISH）
 リキッドバイオプシー
 その他

治療領域
 腫瘍学的
 非腫瘍性

地域
 北米
 ヨーロッパ
 アジア太平洋
 その他の地域

調査範囲
 当レポートでは、CDx開発市場を提供サービスの種類、使用分析技術、治療分野、主要地域別に調査しています。
 市場成長に影響を与える要因（促進要因、阻害要因、機会、課題など）を分析しています。
 当レポートでは、市場関係者向けに市場内の潜在的な利点と障害を評価し、市場のトッププレイヤー向けに競争環境に関する情報を提供しています。
 主要地域に関する市場セグメントの収益を予測しています。
 業界プレイヤーのプロフィール、設立年、企業規模、所有権、本社所在地、提供サービス、使用分析技術、評価対象治療領域、規制認証/認定など、CDx診断薬市場の包括的な概要を掲載しています。
 CDx開発企業の地域競争力分析では、サプライヤーパワー（経験や企業規模）やポートフォリオの仕様（提供サービス、使用分析技術、評価対象治療領域、2017年以降に締結された精密医療関連取引）などの要因を考慮している。
 著名なCDx開発サービスプロバイダーの詳細プロフィール（会社概要、財務情報（入手可能な場合）、サービスポートフォリオ、最近の動向、将来の展望を含む）。
 CDx診断薬の現在の状況を評価し、上市済みおよび開発中の製品、アッセイ技術、対象疾患、バイオマーカーの詳細、サンプルの種類、関係規制当局、迅速審査指定、開発者のプロフィールを網羅。
 2017年から2021年にかけてのCDx診断サービスに関するパートナーシップと提携の分析。パートナーシップのタイプ、年、治療分野、企業所在地、活動中のプレーヤー別に分類。
 バイオマーカーに特化した臨床試験をスポンサーしている医薬品開発企業をリストアップし、試験数と市場投入までの期間に基づき、CDx開発企業と共同研究を開始する可能性の高い企業を分析。
 2017年から2021年にかけてのCDx開発市場におけるM&Aについて、買収企業数の推移を含め、買収年、ディールタイプ、本社所在地、企業規模、バリュードライバー、買収ディール倍率などの詳細とともに検証。
 CDx開発におけるステークホルダーのニーズを定性的に評価し、過去および現在のトレンドに基づく懸念事項や業界の潜在的な対応策を取り上げる。
 コンパニオン診断薬開発のバリューチェーン分析。R&D、臨床評価、製造、支払者との交渉、マーケティング活動を、コスト要件とともに網羅。
 主要製薬企業が過去5年間にスポンサーとなったバイオマーカー主導の腫瘍学臨床試験の完了、進行中、および計画中の評価を行い、様々な試験パラメータにおける主要トレンドを検証。
 CDx診断薬を使用した治療法のケーススタディで、その可用性、分子タイプ、投与経路、対応するCDx診断薬製品/プログラムを紹介しています。また、医薬品開発企業、設立年、企業規模、所有権、本社所在地に関する情報も提供しています。
 CDx開発、患者、医療専門家にインテリジェントな洞察を提供する精密医療ソフトウェアソリューションの現在の市場状況に関するケーススタディであり、使用プラットフォーム、目的、データタイプ、治療領域、エンドユーザー、開発者情報を含む。

本レポートを購入する主なメリット
 本レポートは、市場全体とそのサブセグメント両方の収益予測に関する貴重な洞察を市場リーダーおよび新規参入者に提供します。
 利害関係者は本レポートを活用することで、競合状況の理解を深め、ビジネスのポジショニングを改善し、より効果的な市場参入戦略をとることができます。
 当レポートは、容器閉鎖の完全性試験市場に関するパルスを関係者に提供し、重要な市場促進要因、障壁、機会、および課題に関する重要な情報を提供します。
 無料のPPTインサイトやエクセルデータパック/ダイナミックダッシュボードにアクセスし、複雑な分析/図表を簡単に閲覧することができます。

主要市場企業
 Almac Diagnostic Services
 バイオカルティス
 BGI Genomics
 セルバ・リサーチ
 ユーロフィンズ
 ジェニュイティクリニカルリサーチサービス
 インタースペース・バイオサイエンス
 ラブコープ（旧コバンス）
 MEDx (蘇州) トランスレーショナル・メディシン
 メディカル＆バイオロジカル・ラボラトリーズ（MBL）
 MLMメディカルラボ
 ノボジーン
 QIAGEN
 クエスト・ダイアグノスティックス
 Q² Solutions
 リサーチデックス

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1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Evolution of Personalized Medicines
3.3. Overview of Companion Diagnostics
3.3.1. Development of Companion Diagnostics
3.3.2. Analytical Techniques Used in Companion Diagnostic Tests
3.3.2.1. Immunohistochemistry
3.3.2.2. In situ Hybridization
3.3.2.3. Polymerase Chain Reaction (PCR)
3.3.2.4. DNA Sequencing / Next Generation Sequencing
3.3.2.5. Liquid Biopsy
3.3.2.6. Flow Cytometry
3.3.3. Advantages of Companion Diagnostics
3.4. Applications of Companion Diagnostics across Different Therapeutic Areas
3.4.1. Oncology
3.4.2. Infectious Diseases
3.4.3. Neurological Disorders
3.5. Regulatory Review and Approval Process for Companion Diagnostics
3.6. Existing Challenges
3.7. Key Guidelines for Selecting a Contract Diagnostics Organization (CDO)
3.8. Future Perspectives

4. COMPANION DIAGNOSTICS SERVICE PROVIDERS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Companion Diagnostics Service Providers: List of Players
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Company Ownership
4.2.4. Analysis by Location of Headquarters
4.2.5. Analysis by Type of Service Offered
4.2.6. Analysis by Other Affiliated Services Offered
4.2.7. Analysis by Type of Analytical Technique Used
4.2.8. Analysis by Therapeutic Area
4.2.9. Grid Representation: Analysis by Company Size, Location of Headquarters and Type of Service Offered
4.2.10. Grid Representation: Analysis by Company Size, Location of Headquarters and Type of Analytical Technique Used
4.2.11. Analysis by Regulatory Accreditation / Certification

5. COMPANION DIAGNOSTICS SERVICE PROVIDERS: COMPANY COMPETITIVENESS ANALYSIS
5.1 Chapter Overview
5.2 Methodology
5.3 Assumptions / Key Parameters
5.4 Competitiveness Analysis: Companion Diagnostics Service Providers
5.4.1 Companion Diagnostics Service Providers based in North America
5.4.2 Companion Diagnostics Service Providers based in Europe
5.4.3 Companion Diagnostics Service Providers based in Asia-Pacific and Rest of the World
5.5. Summary of Key Players

6. COMPANION DIAGNOSTICS SERVICE PROVIDERS: COMPANY PROFILES
6.1. Chapter Overview
6.2. Key Players in North America
6.2.1. Geneuity Clinical Research Services
6.2.1.1. Company Overview
6.2.1.2. Service Portfolio
6.2.1.3. Recent Developments and Future Outlook
6.2.2. Interpace Biosciences
6.2.2.1. Company Overview
6.2.2.2. Service Portfolio
6.2.2.3. Financial Information
6.2.2.4. Recent Developments and Future Outlook
6.2.3. Labcorp (formerly known as Covance)
6.2.3.1. Company Overview
6.2.3.2. Service Portfolio
6.2.3.3. Financial Information
6.2.3.4. Recent Developments and Future Outlook
6.2.4. Quest Diagnostics
6.2.4.1. Company Overview
6.2.4.2. Service Portfolio
6.2.4.3. Financial Information
6.2.4.4. Recent Developments and Future Outlook
6.2.5. Q² Solutions
6.2.5.1. Company Overview
6.2.5.2. Service Portfolio
6.2.5.3. Financial Information
6.2.5.4. Recent Developments and Future Outlook
6.2.6. ResearchDx
6.2.6.1. Company Overview
6.2.6.2. Service Portfolio
6.2.6.3. Recent Developments and Future Outlook
6.3. Key Players in Europe
6.3.1. Almac Diagnostic Services
6.3.1.1. Company Overview
6.3.1.2. Service Portfolio
6.3.1.3. Financial Information
6.3.1.4. Recent Developments and Future Outlook
6.3.2. Biocartis
6.3.2.1. Company Overview
6.3.2.2. Service Portfolio
6.3.2.3. Financial Information
6.3.2.4. Recent Developments and Future Outlook
6.3.3. Cerba Research
6.3.3.1. Company Overview
6.3.3.2. Service Portfolio
6.3.3.3. Recent Developments and Future Outlook
6.3.4. Eurofins
6.3.4.1. Company Overview
6.3.4.2. Service Portfolio
6.3.4.3. Financial Information
6.3.4.4. Recent Developments and Future Outlook
6.3.5. MLM Medical Labs
6.3.5.1. Company Overview
6.3.5.2. Service Portfolio
6.3.5.3. Recent Developments and Future Outlook
6.3.6. QIAGEN
6.3.6.1. Company Overview
6.3.6.2. Service Portfolio
6.3.6.3. Financial Information
6.3.6.4. Recent Developments and Future Outlook
6.4. Key Players in Asia-Pacific and Rest of the World
6.4.1. BGI Genomics
6.4.1.1. Company Overview
6.4.1.2. Service Portfolio
6.4.1.3. Recent Developments and Future Outlook
6.4.2. MEDx (Suzhou) Translational Medicine (formerly known as QIAGEN (Suzhou) Translational Medicine)
6.4.2.1. Company Overview
6.4.2.2. Service Portfolio
6.4.2.3. Recent Developments and Future Outlook
6.4.3. MEDICAL & BIOLOGICAL LABORATORIES (MBL)
6.4.3.1. Company Overview
6.4.3.2. Service Portfolio
6.4.3.3. Recent Developments and Future Outlook
6.4.4. Novogene
6.4.4.1. Company Overview
6.4.4.2. Service Portfolio
6.4.4.3. Recent Developments and Future Outlook

7. COMPANION DIAGNOSTICS: MARKET LANDSCAPE
7.1. Chapter Overview
7.2. Companion Diagnostics: List of Marketed Products / Investigational Programs
7.2.1. Analysis by Assay Technique Used
7.2.2. Analysis by Target Disease Indication
7.2.3. Analysis by Therapeutic Area
7.2.4. Analysis by Type of Biomarker Detected
7.2.5. Analysis by Chemical Nature of Biomarker
7.2.6. Analysis by Type of Sample Used
7.2.7. Analysis by Commercial Availability and Therapeutic Area
7.2.8. Investigational Programs: Analysis by Year of Initiation of Development
7.2.9. Marketed Products: Analysis by Year of Approval
7.2.10. Marketed Products: Analysis by Regulatory Authority Involved
7.2.11. Marketed Products: Analysis by Year of Approval and Regulatory Authority Involved
7.2.12. Marketed Products: Analysis by Expediated Review Designation and Type of Biomarker
7.2.13. Heat Map Representation: Analysis by Target Disease Indication and Assay Technique Used
7.3. Companion Diagnostic Devices: List of Developers
7.3.1. Analysis by Year of Establishment
7.3.2. Analysis by Company Size
7.3.3. Analysis by Company Ownership
7.3.4. Analysis by Location of Headquarters
7.3.5. Most Active Players: Analysis by Number of Marketed Products and Investigational Programs
7.3.6. Most Active Players: Analysis by Number of Marketed Products
7.3.7. Most Active Players: Analysis by Number of Target Disease Indications

8. PARTNERSHIPS AND COLLABORATIONS
8.1. Chapter Overview
8.2. Partnership Models
8.3. List of Partnerships and Collaborations
8.3.1. Analysis by Year of Partnership
8.3.2. Analysis by Type of Partnership
8.3.3. Analysis by Type of Partner
8.3.4. Analysis by Year of Partnership and Type of Partner
8.3.5. Analysis by Type of Partnership and Type of Partner
8.3.6. Analysis by Therapeutic Area
8.3.7. Most Active Players: Analysis by Number of Partnerships
8.3.8. Regional Analysis
8.3.9. Intercontinental and Intracontinental Agreements
9. LIKELY PARTNER ANALYSIS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Scoring Criteria and Key Assumptions
9.4. Likely Partners for Companion Diagnostics Service Providers: Alzheimer’s Disease
9.4.1. Potential Strategic Partners for Initiatives on Amyloid Beta Biomarker
9.4.1.1. Companies Working on the Amyloid Beta Biomarker
9.4.1.2. World Map Representation: Amyloid Beta Biomarker Focused Clinical Trials
9.4.2. Potential Strategic Partners for Initiatives on Tau Biomarker
9.4.2.1. Companies Working on the Tau Biomarker
9.4.2.2. World Map Representation: Tau Biomarker Focused Clinical Trials
9.5. Likely Partners for Companion Diagnostics Service Providers: Breast Cancer
9.5.1. Potential Strategic Partners for Initiatives on BRCA Biomarker
9.5.1.1. Companies Working on the BRCA Biomarker
9.5.1.2. World Map Representation: BRCA Biomarker Focused Clinical Trials
9.5.2. Potential Strategic Partners for Initiatives on HER Biomarker
9.5.2.1. Companies Working on the HER Biomarker
9.5.2.2. World Map Representation: HER Biomarker Focused Clinical Trials
9.5.3. Potential Strategic Partners for Initiatives on HR Biomarker
9.5.3.1. Companies Working on the HR Biomarker
9.5.3.2. World Map Representation: HR Biomarker Focused Clinical Trials
9.5.4. Potential Strategic Partners for Initiatives on PD-L1 Biomarker
9.5.4.1. Companies Working on the PD-L1 Biomarker
9.5.4.2. World Map Representation: PD-L1 Biomarker Focused Clinical Trials
9.6. Likely Partners for Companion Diagnostics Service Providers: Colorectal Cancer
9.6.1. Potential Strategic Partners for Initiatives on BRAF Biomarker
9.6.1.1. Companies Working on the BRAF Biomarker
9.6.1.2. World Map Representation: BRAF Biomarker Focused Clinical Trials
9.6.2. Potential Strategic Partners for Initiatives on EGFR Biomarker
9.6.2.1. Companies Working on the EGFR Biomarker
9.6.2.2. World Map Representation: EGFR Biomarker Focused Clinical Trials
9.6.3. Potential Strategic Partners for Initiatives on KRAS Biomarker
9.6.3.1. Companies Working on the KRAS Biomarker
9.6.3.2. World Map Representation: KRAS Biomarker Focused Clinical Trials
9.6.4. Potential Strategic Partners for Initiatives on MSI Biomarker
9.6.4.1. Companies Working on the MSI Biomarker
9.6.4.2. World Map Representation: MSI Biomarker Focused Clinical Trials
9.6.5. Potential Strategic Partners for Initiatives on NRAS Biomarker
9.6.5.1. Companies Working on the NRAS Biomarker
9.6.5.2. World Map Representation: NRAS Biomarker Focused Clinical Trials
9.7. Likely Partners for Companion Diagnostic Service Providers: HIV
9.7.1. Potential Strategic Partners for Initiatives on CCR5 Biomarker
9.7.1.1. Companies Working on the CCR5 Biomarker
9.7.1.2. World Map Representation: CCR5 Biomarker Focused Clinical Trials
9.8. Likely Partners for Companion Diagnostics Service Providers: Lung Cancer
9.8.1. Potential Strategic Partners for Initiatives on ALK Biomarker
9.8.1.1. Companies Working on the ALK Biomarker
9.8.1.2. World Map Representation: ALK Biomarker Focused Clinical Trials
9.8.2. Potential Strategic Partners for Initiatives on EGFR Biomarker
9.8.2.1. Companies Working on the EGFR Biomarker
9.8.2.2. World Map Representation: EGFR Biomarker Focused Clinical Trials
9.8.3. Potential Strategic Partners for Initiatives on PD-L1 Biomarker
9.8.3.1. Companies Working on the PD-L1 Biomarker
9.8.3.2. World Map Representation: PD-L1 Biomarker Focused Clinical Trials
9.8.4. Potential Strategic Partners for Initiatives on RET Biomarker
9.8.4.1. Companies Working on the RET Biomarker
9.8.4.2. World Map Representation: RET Biomarker Focused Clinical Trials
9.8.5. Potential Strategic Partners for Initiatives on ROS Biomarker
9.8.5.1. Companies Working on the ROS Biomarker
9.8.5.2. World Map Representation: ROS Biomarker Focused Clinical Trials
9.9. Likely Partners for Companion Diagnostics Service Providers: NASH / NAFLD
9.9.1. Potential Strategic Partners for Initiatives on AST Biomarker
9.9.1.1. Companies Working on the AST Biomarker
9.9.1.2. World Map Representation: AST Biomarker Focused Clinical Trials
9.10. Likely Partners for Companion Diagnostics Service Providers: Ovarian Cancer
9.10.1. Potential Strategic Partners for Initiatives on BRCA Biomarker
9.10.1.1. Companies Working on the BRCA Biomarker
9.10.1.2. World Map Representation: BRCA Biomarker Focused Clinical Trials
9.10.2. Potential Strategic Partners for Initiatives on CA-125 Biomarker
9.10.2.1. Companies Working on the CA-125 Biomarker
9.10.2.2. World Map Representation: CA-125 Biomarker Focused Clinical Trials
9.11. Likely Partners for Companion Diagnostics Service Providers: Prostate Cancer
9.11.1. Potential Strategic Partners for Initiatives on AR-V7 Biomarker
9.11.1.1. Companies Working on the AR-V7 Biomarker
9.11.1.2. World Map Representation: AR-V7 Biomarker Focused Clinical Trials

10. MERGERS AND ACQUISITONS
10.1. Chapter Overview
10.2. Merger and Acquisition Models
10.3. List of Mergers and Acquisitions
10.3.1. Analysis by Type of Deal
10.3.2. Analysis by Year of Deal
10.3.3. Regional Analysis
10.3.3.1. Continent-wise Distribution
10.3.3.2. Intercontinental and Intracontinental Deals
10.3.3.3. Country-wise Distribution
10.3.4. Analysis by Company Size
10.3.5. Ownership Change Matrix
10.3.6. Analysis by Key Value Drivers
10.3.7. Valuation Analysis: Acquisition Deal Multiples
10.3.8. Key Players: Analysis by Number of Deals

11. STAKEHOLDER NEEDS ANALYSIS
11.1. Chapter Overview
11.2. Companion Diagnostics: Needs of Different Stakeholders
11.3. Comparison of Needs of Various Stakeholders
11.3.1. Needs of Drug Developers
11.3.2. Needs of Companion Diagnostics Developers
11.3.3. Needs of Regulatory Authorities
11.3.4. Needs of Testing Laboratories
11.3.5. Needs of Payers / Insurance Providers
11.3.6. Needs of Physicians
11.3.7. Needs of Patients

12. VALUE CHAIN ANALYSIS
12.1. Chapter Overview
12.2. Companion Diagnostics Value Chain: Cost Distribution
12.2.1. Research and Product Development
12.2.2. Manufacturing and Assembly
12.2.3. Clinical Trials, FDA Approval and Other Administrative Tasks
12.2.4. Payer Negotiation and KOL Engagement
12.2.5. Marketing and Sales
12.3. Companion Diagnostics Development Operations: Key Cost Contributors
12.4. Companion Diagnostics Co-Development Operations: Key Cost Contributors

13. CLINICAL RESEARCH ON CANCER BIOMARKERS: BIG PHARMA PERSPECTIVE
13.1. Chapter Overview
13.2. Methodology
13.3. Big Pharma Sponsored Biomarker Focused Clinical Trials: List of Likely Drug Candidates for IVD Developers
13.4. Clinical Trial Analysis
13.4.1. Analysis of Trials by Trial Registration Year
13.4.2. Analysis of Trials by Phase of Development
13.4.3. Analysis of Trials by Sponsor
13.4.4. Analysis of Trials by Recruitment Status
13.4.5. Analysis of Trials by Therapy Design
13.4.6. Analysis of Trials by Geography
13.4.7. Analysis of Trials by Enrolled Patient Population
13.4.8. Analysis of Trials by Popularity of Biomarkers
13.4.8.1. Most Popular Biomarkers
13.4.8.2. Moderately Popular Biomarkers
13.4.8.3. Less Popular / Preliminary Stage Biomarkers
13.4.8.4. Other Emerging Biomarkers: Word Cloud
13.4.8.5. Analysis of Trials of Most Popular Biomarkers by Trial Registration Year
13.4.8.6. Analysis of Trials of Moderately Popular Biomarkers by Trial Registration Year
13.4.8.7. Analysis of Trials of Less Popular Biomarkers by Trial Registration Year
13.4.8.8. Analysis of Trials of Most Popular Biomarkers by Phase of Development
13.4.8.9. Analysis of Trials of Moderately Popular Biomarkers by Phase of Development
13.4.8.10. Analysis of Trials of Less Popular and Other Biomarkers by Phase of Development
13.4.8.11. Analysis of Trials of Most Popular Biomarkers by Sponsors
13.4.8.12. Analysis of Trials of Moderately Popular Biomarkers by Sponsors
13.4.8.13. Analysis of Trials of Less Popular and Other Biomarkers by Sponsors
13.4.9. Analysis of Trials by Popularity of Indications
13.4.9.1. Most Popular Indications
13.4.9.2. Moderately Popular Indications
13.4.9.3 Less Popular and Other Indications
13.4.9.4. Other Emerging Indications: Word Cloud
13.4.9.5. Analysis of Trials of Most Popular Indications by Trial Registration Year
13.4.9.6. Analysis of Trials of Moderately Popular Indications by Trial Registration Year
13.4.9.7. Analysis of Trials of Less Popular / Preliminary Stage Indications by Trial Registration Year
13.4.9.8. Analysis of Trials of Most Popular Indications by Phase of Development
13.4.9.9. Analysis of Trials of Moderately Popular Indications by Phase of Development
13.4.9.10. Analysis of Trials of Less Popular / Preliminary Stage Indications by Phase of Development
13.4.9.11. Analysis of Trials of Less Popular / Preliminary Stage Indications by Trial Registration Year
13.4.9.12. Analysis of Trials of Most Popular Indications by Sponsor
13.4.9.13. Analysis of Trials of Moderately Popular Indications by Sponsor
13.4.9.14. Analysis of Trials of Less Popular / Preliminary Stage Indications by Sponsor
13.5. Clinical Trials Summary

14. CASE STUDY ON BIOMARKER-DRIVEN TARGETED THERAPIES IN USE WITH COMPANION DIAGNOSTICS
14.1. Chapter Overview
14.2. Biomarker-Driven Targeted Therapies: Pipeline Review
14.2.1. Analysis by Commercial Availability
14.2.2. Analysis by Type of Molecule
14.2.3. Analysis by Commercial Availability and Type of Molecule
14.2.4. Analysis by Route of Administration
14.2.5. Leading Biomarker-Driven Targeted Therapies: Analysis by Number of Companion Diagnostic Products / Programs
14.3. Biomarker-Driven Targeted Therapies: Developer Landscape
14.3.1. Analysis by Year of Establishment
14.3.2. Analysis by Company Size
14.3.3. Analysis by Company Ownership
14.3.4. Analysis by Location of Headquarters
14.3.5. Leading Players: Analysis by Number of Drugs
14.4. Heat Map Representation: Analysis by Company Size, Location of Headquarters and Commercial Availability of Drug

15. CASE STUDY ON PRECISION MEDICINE SOFTWARE SOLUTIONS
15.1. Chapter Overview
15.2. Precision Medicine Software Solutions: List of Products
15.2.1. Analysis by Type of Platform
15.2.2. Analysis by Purpose of Software Applications
15.2.3. Analysis by Type of Data Handled
15.2.4. Analysis by Therapeutic Area
15.2.5. Analysis by Type of End User
15.3. Precision Medicine Software Solutions: List of Developers
15.3.1. Analysis by Year of Establishment
15.3.2. Analysis by Company Size
15.3.3. Analysis by Location of Headquarters

16. COMPANION DIAGNOSTICS SERVICE PROVIDERS: MARKET FORECAST AND OPPORTUNITY ANALYSIS
16.1 Chapter Overview
16.2. Key Assumptions and Forecast Methodology
16.3. Global Companion Diagnostics Services Market, 2022-2035
16.3.1. Global Companion Diagnostics Services Market: Distribution by Type of Service Offered, 2022-2035
16.3.2. Global Companion Diagnostics Services Market: Distribution by Type of Analytical Technique Used, 2022-2035
16.3.3. Global Companion Diagnostics Services Market: Distribution by Therapeutic Area, 2022-2035
16.3.4. Global Companion Diagnostics Services Market: Distribution by Region, 2022-2035
16.4. Companion Diagnostics Services Market in North America, 2022-2035
16.4.1. Companion Diagnostics Services Market in North America: Distribution by Type of Service Offered, 2022-2035
16.4.2. Companion Diagnostics Services Market in North America: Distribution by Type of Analytical Technique Used, 2022-2035
16.4.3. Companion Diagnostics Services Market in North America: Distribution by Therapeutic Area, 2022-2035
16.5. Companion Diagnostics Services Market in Europe, 2022-2035
16.5.1. Companion Diagnostics Services Market in Europe: Distribution by Type of Service Offered, 2022-2035
16.5.2. Companion Diagnostics Services Market in Europe: Distribution by Type of Analytical Technique Used, 2022-2035
16.5.3. Companion Diagnostics Services Market in Europe: Distribution by Therapeutic Area, 2022-2035
16.6. Companion Diagnostics Services Market in Asia-Pacific and Rest of the World, 2022-2035
16.6.1. Companion Diagnostics Services Market in Asia-Pacific and Rest of the World: Distribution by Type of Service Offered, 2022-2035
16.6.2. Companion Diagnostics Services Market in Asia-Pacific and Rest of the World: Distribution by Type of Analytical Technique Used, 2022-2035
16.6.3. Companion Diagnostics Services Market in Asia-Pacific and Rest of the World: Distribution by Therapeutic Area, 2022-2035

17. EXECUTIVE INSIGHTS
17.1. Chapter Overview
17.2. Genomenon
17.2.1. Company Snapshot
17.2.2. Interview Transcript: Mike Klein, Chief Executive Officer; Mark Kiel, Founder and Chief Scientific Officer; and Candace Chapman, Vice President of Marketing
17.3. Tymora Analytical Operations
17.3.1. Company Snapshot
17.3.2. Interview Transcript: Anton Iliuk, President and Chief Technology Officer
17.4. Novodiax
17.4.1. Company Snapshot
17.4.2. Interview Transcript: Paul Kortschak, Former Senior Vice President
17.5. OWL Metabolomics
17.5.1. Company Snapshot
17.5.2. Interview Transcript: Pablo Ortiz, Chief Executive Officer
17.6. NeoGenomics Laboratories
17.6.1. Company Snapshot
17.6.2. Interview Transcript: Lawrence M. Weiss, Former Chief Scientific Officer
18. CONCLUDING REMARKS
18.1. Chapter Overview
18.2. Key Takeaways
19. APPENDIX 1: TABULATED DATA
20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

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Table of Contents

Summary

As of 2022, the CDx development market boasts a valuation of approximately $664 million, with a projected Compounded Annual Growth Rate (CAGR) of 10.7% anticipated throughout the forecast period. Recent years have witnessed a substantial enhancement in comprehending the molecular mechanisms underpinning disease pathogenesis, paving the way for the creation of targeted therapies meticulously designed to address disease-related molecular signatures. The integral role of Companion Diagnostics (CDx diagnostics) has emerged as indispensable in informing physicians about patients' unique genetic profiles, facilitating well-informed treatment decisions tailored to individual needs.

Typically developed in tandem with investigational drugs, these diagnostic tests play a crucial role in evaluating the safety, efficacy, and therapeutic impact of the drugs on the intended targets. The pivotal approval of trastuzumab and HercepTest™ by the USFDA in 1998 marked a milestone, triggering a trend where numerous novel targeted cancer drugs, guided by diagnostic assays, have progressed through clinical stages or gained approval for commercial use. In the period since 2020, the USFDA has greenlit 44 CDx diagnostics, with three CDx targeted therapies securing approval for advanced ovarian cancer, breast cancer, and non-small cell lung cancer.

An extensive study encompassing nearly 200 distinct pharmacological interventions across over 670 clinical trials has indicated that the probability of a lead compound successfully navigating clinical development phases and achieving approval is a mere 11%. Leveraging disease-specific biomarker information for patient recruitment not only elevates the success rates of studies but also slashes trial costs by nearly 60%.

Recognizing the multifaceted advantages, the healthcare industry is gradually shifting from the conventional one-size-fits-all drug approach to customized pharmacological interventions. This transition is poised to intensify the demand for CDx diagnostics. However, the intricacies inherent in co-developing drugs and companion diagnostic tests have prompted drug developers to prefer outsourcing CDx diagnostics operations. Remarkably, approximately 80% of companies opt for third-party service providers or CDx development companies due to a lack of in-house expertise in test development. Consequently, many CDx development companies have made substantial investments in cutting-edge tools and technologies, including polymerase chain reaction (PCR), immunohistochemistry (IHC), in situ hybridization (ISH), and next-generation sequencing (NGS), to provide comprehensive end-to-end services to sponsor companies in the CDx development market.

Beyond conventional analytical techniques, several innovators have diversified their portfolios by incorporating state-of-the-art solutions, such as digital PCR (dPCR) and digital immunoassays, to meet the evolving needs of their clientele. With the burgeoning demand for personalized therapies and ongoing technological advancements, it is anticipated that the CDx development industry will sustain significant market growth throughout the forecast period.

Key Market Segments
Type of Service Offered
 Feasibility Studies
 Assay Development
 Analytical Validation
 Clinical Validation
 Manufacturing

Analytical Technique Used
 Next Generation Sequencing (NGS)
 Polymerase Chain Reaction (PCR)
 Immunohistochemistry / in situ Hybridization (IHC / ISH)
 Liquid Biopsy
 Others

Therapeutic Areas
 Oncological
 Non-oncological

Geographical Regions
 North America
 Europe
 Asia-Pacific
 Rest of the World

Research Coverage:
 The report studies the CDx development market by type of service offered, analytical technique used, therapeutic areas and key geographies.
 The report analyzes factors (such as drivers, restraints, opportunities, and challenges) affecting the market growth.
 The report assesses the potential advantages and obstacles within the market for those involved and offers information on the competitive environment for top players in the market.
 The report forecasts the revenue of market segments with respect to major regions.
 A comprehensive overview of the CDx diagnostics market, including profiles of industry players, year of establishment, company size, ownership, headquarters location, services offered, analytical techniques used, therapeutic areas assessed, and regulatory certifications/accreditations.
 A regional competitiveness analysis of CDx development companies, considering factors like supplier power (experience and company size) and portfolio specifications (services offered, analytical techniques used, therapeutic areas assessed, and precision medicine-related deals signed since 2017).
 Detailed profiles of prominent CDx development service providers, including company overviews, financial information (if available), service portfolios, recent developments, and future outlook.
 An assessment of the current landscape of CDx diagnostics, covering marketed and in-development products, assay techniques, target disease indications, biomarker details, sample types, regulatory authorities involved, expedited review designations, and developer profiles.
 Analysis of partnerships and collaborations for CDx diagnostics services from 2017-2021, categorized by partnership type, year, therapeutic areas, company locations, and active players.
 An analysis of companies likely to enter collaborations with CDx development companies, listing drug developers sponsoring biomarker-focused clinical trials, based on the number of trials and time to market.
 Examination of mergers and acquisitions in the CDx development market from 2017-2021, including trends in terms of the number of companies acquired, with details on year, deal type, headquarters location, company size, value drivers, and acquisition deal multiples.
 A qualitative assessment of the needs of stakeholders in CDx development, addressing concerns and potential industry responses based on past and current trends.
 Value chain analysis of companion diagnostic development, covering R&D, clinical assessment, manufacturing, payer negotiation, and marketing activities, along with cost requirements.
 Assessment of completed, ongoing, and planned biomarker-driven oncology clinical trials sponsored by major pharmaceutical companies over the last five years, examining key trends across various trial parameters.
 Case studies on therapies using CDx diagnostics, highlighting their availability, molecule type, route of administration, and corresponding CDx diagnostics products/programs. It also provides information on drug developers, establishment year, company size, ownership, and headquarters location.
 A case study on the current market landscape of precision medicine software solutions that offer intelligent insights for CDx development, patients, and healthcare experts, including the platform used, purpose, data type, therapeutic area, end users, and developer information.

Key Benefits of Buying this Report
 The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
 Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
 The report provides stakeholders with a pulse on the container closure integrity testing market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.
 You will get access to complimentary PPT insights and excel data packs / dynamic dashboards to easily navigate through complex analyses / charts.

Key Market Companies
 Almac Diagnostic Services
 Biocartis
 BGI Genomics
 Cerba Research
 Eurofins
 Geneuity Clinical Research Services
 Interpace Biosciences
 Labcorp (formerly known as Covance)
 MEDx (Suzhou) Translational Medicine
 MEDICAL & BIOLOGICAL LABORATORIES (MBL)
 MLM Medical Labs
 Novogene
 QIAGEN
 Quest Diagnostics
 Q² Solutions
 ResearchDx

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