Companion Diagnostics Market, 2030

DUBLIN, June 26, 2019 /PRNewswire/ -- The "Companion Diagnostics Market (2nd Edition), 2019-2030" report has been added to ResearchAndMarkets.com's offering.

The Companion Diagnostics Market (2nd Edition), 2019-2030 report features an extensive study of the current market landscape and the likely adoption of these diagnostic tests over the next decade. The study features an in-depth analysis, highlighting the capabilities of the various stakeholders in this domain.

The introduction of personalized medicine has brought about a paradigm shift within the healthcare sector. Over the years, many cases have been identified where conventional treatment options have failed to demonstrate any therapeutic benefit. It is estimated that nearly 50% of prescribed drugs/therapies fail to show adequate clinical benefits. In fact, adverse drug-related reactions/side effects are reported to be the fourth leading cause of death in the US. To mitigate challenges associated with adverse drug reactions, there are multiple therapeutic products in the market, and many more under development, which have been tailored to effectively treat disease with unique molecular/genetic signatures.

Personalized therapies demand companion diagnostics to make physicians aware of patients' unique genetic profiles, thereby, enabling them to make informed decisions. A study of nearly 200 unique pharmacological interventions, across 670 clinical trials, concluded that the likelihood of a lead compound passing through all the phases of clinical development and eventually getting approved is only 11%. The same study highlighted that correlating disease-specific biomarker data with therapeutic susceptibility and using this information to recruit patients for clinical research demonstrated a six fold increase in trial success rates. It is also worth highlighting that companion diagnostic guided drug development efforts have been estimated to help reduce clinical trial costs by almost 60%.

One of the key objectives of the report was to estimate the existing market size and the future opportunity for companion diagnostics developers, over the next decade. Based on multiple parameters, such as the disease incidence, adoption of companion diagnostic tests and the likely prices, we have provided informed estimates on the evolution of the market for the period 2019-2030.

The report also features the likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (oncological disorders (breast cancer, colorectal cancer, leukemia, lymphoma, melanoma, non-small cell lung cancer and ovarian cancer) and non-oncological disorders (Alzheimer's disease and HIV/AIDs), [B] important assay techniques (in situ hybridization (ISH), immune histochemistry (IHC), next-generation sequencing (NGS), polymerase chain reaction (PCR) and others) and [C] key geographical regions (US, EU5, Japan, China and Australia). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.

The opinions and insights presented in this study were also influenced by discussions conducted with stakeholders in this domain. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

Scope of the Report

• A detailed assessment of the current market landscape of companies offering companion diagnostics, including information on their geographical location, corresponding drug(s) / drug class, affiliated biomarker, assay technique involved (in situ hybridization (ISH), immunohistochemistry (IHC), next-generation sequencing (NGS), polymerase chain reaction (PCR) and others), therapeutic area (oncological disorders, infectious diseases, metabolic disorders, neurological disorders, inflammatory disorders and others) and the type of sample required (tumor tissue, blood, bone marrow and others).
• Detailed profiles of developers of companion diagnostics (shortlisted on the basis of the strength of product portfolio), featuring an overview of the company, its financial information (if available), a detailed description of companion diagnostics available / under development and recent collaborations. In addition, each profile includes a list of the likely strategies that may be adopted by these players to support future growth.
• A detailed brand positioning analysis of leading industry players (shortlisted on the basis of strength of product portfolio), highlighting the current perceptions regarding their proprietary brands, taking into consideration several relevant aspects, such as strength of product portfolio, geographical presence / reach, recent collaborations, diversity in therapeutic focus and overall market position of each company.
• An analysis of the partnerships and collaborations pertaining to companion diagnostics, featuring a comprehensive set of analyses based on various parameters, such as the type of partnership, affiliated biomarkers, therapeutic areas and the most active players.
• A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain.
• A discussion on various steps of the development operations, namely research and development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing/sales activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages.
• A comprehensive analysis of completed, ongoing and planned clinical trials featuring the key biomarkers across different type of therapies and cancer indications. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, key indications, type of therapy, biomarkers evaluated, enrolled patient population and regional distribution of trials.

Key Topics Covered:

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Evolution of Personalized Medicine
3.2. An Overview of Companion Diagnostics
3.2.1. Development of Companion Diagnostics
3.2.2. Analytical Techniques Used in Companion Diagnostic Tests
3.2.2.1. Immunohistochemistry
3.2.2.2. In situ Hybridization
3.2.2.3. Polymerase Chain Reaction
3.2.2.4. DNA Sequencing/Next Generation Sequencing
3.2.3. Advantages of Companion Diagnostics
3.3. Applications of Companion Diagnostics across Different Therapeutic Areas
3.4. Regulatory Review and Approval Process for Companion Diagnostics
3.5. Existing Challenges and Future Roadmap

4. CURRENT MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Companion Diagnostics: List of Developers
4.2.1. Analysis by Year of Establishment of Developer
4.2.2. Analysis by Company Size and Geographical Location
4.3. Companion Diagnostics: List of Available/Under Development Tests
4.3.1. Analysis by Assay Technique Used
4.3.2. Analysis by Target Therapeutic Area
4.3.3. Analysis by Target Indication
4.3.4. Analysis by Type of Biomarker
4.3.5. Grid Analysis: Analysis by Assay Technique Used and Therapeutic Area
4.3.6. Grid Analysis: Analysis by Target Indication and Type of Biomarker
4.3.7. Most Active Players
4.3.8. Analysis by Geographical Location

5. COMPANY PROFILES: COMPANION DIAGNOSTICS
5.1. Chapter Overview
5.2. Roche
5.2.1. Company Overview
5.2.2. Financial Information
5.2.3. Companion Diagnostics Portfolio
5.2.4. Recent Collaborations
5.2.5. Recent Developments and Future Outlook
5.3. Agilent Technologies
5.4. Abbott
5.5. QIAGEN
5.6. Myriad Genetics
5.7. Foundation Medicine

6. BRAND POSITIONING ANALYSIS OF KEY INDUSTRY PLAYERS
6.1. Chapter Overview
6.2. Scope and Methodology
6.3. Brand Positioning Matrix: Roche
6.4. Brand Positioning Matrix: Agilent Technologies
6.5. Brand Positioning Matrix: Abbott
6.6. Brand Positioning Matrix: QIAGEN
6.7. Brand Positioning Matrix: Myriad Genetics
6.8. Brand Positioning Matrix: Foundation Medicine
6.9. Comparison of Therapeutic Areas versus Assay Techniques
6.10. Comparison of Cancer Indications versus Assay Techniques

7. PARTNERSHIPS AND COLLABORATIONS
7.1. Chapter Overview
7.2. Partnership Models
7.3. Companion Diagnostics Market: List of Partnerships and Collaborations
7.4. Analysis by Year of Partnership
7.5. Analysis by Type of Partnership
7.6. Analysis by Type of Partnership 2014-2016 and 2016-2019
7.7. Analysis by Therapeutic Area
7.8. Analysis by Biomarkers Involved
7.9. Analysis by Drug Involved and Type of Partnership
7.10. Analysis by Technology Platform and Type of Agreement
7.11. Analysis by Drug Involved and Phase of Development
7.12. Most Active Players
7.13. Intercontinental and Intracontinental Agreements

8. STAKEHOLDER NEEDS ANALYSIS
8.1. Chapter Overview
8.2. Companion Diagnostics: Needs of Different Stakeholders
8.3. Comparison of Needs of Various Stakeholders

9. VALUE CHAIN ANALYSIS
9.1. Chapter Overview
9.2. Companion Diagnostics Value Chain: Cost Distribution
9.2.1. Research and Product Development
9.2.2. Manufacturing and Assembly
9.2.3. Clinical Trials, FDA Approval and Other Administrative Tasks
9.2.4. Payer Negotiation and KoL Engagement
9.2.5. Marketing and Sales
9.3. Companion Diagnostics Developer Operations: Key Cost Contributors
9.4. Companion Diagnostics Co-Development Operations: Key Cost Contributors

10. CLINICAL TRIALS AND KEY BIOMARKERS: A BIG PHARMA PERSPECTIVE
10.1. Chapter Overview
10.2. Scope and Methodology
10.3. List of Clinical Trials

11. MARKET FORECAST AND OPPORTUNITY ANALYSIS
11.1 Chapter Overview
11.2. Key Assumptions and Forecast Methodology
11.3. Global Companion Diagnostics Market, 2019-2030
11.3.1. Global Companion Diagnostics Market: Distribution by Region, 2019-2030
11.3.2. Global Companion Diagnostics Market: Distribution by Therapeutic Area, 2019-2030
11.3.3. Global Companion Diagnostics Market: Distribution by Target Indication, 2019-2030
11.3.3.1 Global Companion Diagnostics Market for Breast Cancer, 2019-2030
11.3.3.2 Global Companion Diagnostics Market for Lung Cancer, 2019-2030
11.3.3.3 Global Companion Diagnostics Market for Colorectal Cancer, 2019-2030
11.3.3.4 Global Companion Diagnostics Market for Ovarian Cancer, 2019-2030
11.3.3.5 Global Companion Diagnostics Market for Melanoma, 2019-2030
11.3.3.6 Global Companion Diagnostics Market for Leukemia, 2019-2030
11.3.3.7 Global Companion Diagnostics Market for Lymphoma, 2019-2030
11.3.3.8 Global Companion Diagnostics Market for Alzheimer's Disease, 2019-2030
11.3.3.9 Global Companion Diagnostics Market for HIV/AIDS, 2019-2030
11.3.4. Global Companion Diagnostics Market: Distribution by Analytical Technique Used, 2019-2030

12. CONCLUDING REMARKS

13. EXECUTIVE INSIGHTS

14. APPENDIX 1: TABULATED DATA

15. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/kfvfa2

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