Novel Immuno-oncology Biomarker Testing: World Markets (2019-2030) with Profiles on Foundation Medicine, Lal PathLabs, NeoGenomics Labs, Novogene, Q2 Solutions, Personal Genome Diagnostics, and More

DUBLIN, July 22, 2019 /PRNewswire/ -- The "Novel Immuno-Oncology Biomarker Testing Market, 2019-2030" report has been added to ResearchAndMarkets.com's offering.

This report features an extensive study of the current landscape and future outlook of the immuno-oncology biomarkers testing market (focusing particularly on TMB, MSI and TILs (CD3+, CD4+, CD8+, FOXP3+)). It provides an in-depth analysis, highlighting the capabilities of the various companies engaged in this domain.

Over the last couple of decades, the healthcare market has witnessed the entry of several advanced and effective treatment options for cancer; these include a variety of targeted therapies, immunotherapies and certain anti-cancer vaccines as well. However, clinical cancer research is still plagued by high failure rates, various drug / therapy-related limitations, and treatment-based adverse effects, some of which have proven to be fatal.

A prominent concern is associated with deciding the type of treatment option to be used for specific cancers. Patients suffering from a singular type of cancer, who may be at the same stage of the disease, have been demonstrated to exhibit different molecular profiles, and thereby, may respond differently to recommended drug/therapy types. In order to address this concern, pharmaceutical developers and healthcare professionals have adopted a more personalized approach to disease diagnosis and treatment. Over time, several molecular markers have been identified and characterized, and many have been validated for use in making important treatment-related decisions.

The role of single analyte biomarkers, such as PD-L1, BRAF, and EGFR, has been well-established across multiple cancer indications. However, due to subtle differences in genomic makeup of individual patients, these biomarkers alone have been shown to be insufficient in determining how patients are likely to respond to various drug/therapy types.

Advances in biotechnology have enabled the development of several high throughput tools, which have led to the establishment of better biomarkers, based on genome/exome profiles. Novel biomarkers, such as tumor mutation burden (TMB), microsatellite instability (MSI) / mismatch repair (MMR) deficiency, tumor infiltrating lymphocytes (TILs) and certain others, are presently being investigated across numerous clinical studies.

Presently, several diagnostics-focused companies have developed/are developing analytical tests for these biomarkers, which are intended to assist physicians in making personalized treatment-related decisions. It is worth highlighting that many big pharmaceutical players have demonstrated an interest in this domain and have launched clinical research initiatives to investigate the relevance and applications of multiple novel biomarkers.

Amongst various elements, the report includes:

• A detailed analysis of ongoing, biomarker-based clinical trials initiated by big pharmaceutical companies, featuring details on immuno-oncology biomarkers and disease indications being investigated, based on trial registration year, phase of development, recruitment status, therapy design and type of cancer therapy.
• An analysis of the landscape of companies offering testing services for immuno-oncology biomarkers, namely TMB, MSI / MMR and TILs (including CD3+, CD4+, CD8+ and FOXP3+), based on a number of relevant parameters, such as year of establishment, size of employee base, location of headquarters, availability status of the test, biomarkers analyzed, application areas, disease indication(s) evaluated, analytical techniques utilized, turnaround time, sample input and others.
• An insightful 2X2 representation of the results of a detailed competitiveness analysis of various tests (segregated across different biomarker groups), taking into consideration the supplier power (size of employee base) and specific test related parameters, such as, the application area of the test, turnaround time and other key specifications.
• Elaborate profiles of leading analytical testing service providers focused on immuno-oncology biomarkers (shortlisted based on strength of service portfolio), featuring a brief overview of the company, its financial information (if available), information on biomarker testing related service(s), recent developments and an informed future outlook.
• A detailed publication analysis of over 180 research articles that have been published since 2016, highlighting the key focus areas of ongoing research activity related to immuno-oncology biomarkers, namely TMB, MSI / MMR and TILs. It highlights the prevalent research trends related to the year of publication, disease indications, an analytical technique used for biomarker assessment, and type of cancer therapy evaluated.
• A comprehensive clinical trial analysis of completed, ongoing and planned studies, focused on the assessment of novel immuno-oncology biomarkers, namely TMB, MSI / MMR and TILs, based on various parameters, such as trial registration year, trial recruitment status, trial phase, trial design, indication(s) evaluated, leading industry and non-industry players, and geographical locations of trials.
• A discussion on the upcoming opportunities (such as the development of companion diagnostics, emerging technologies for biomarker assessment, and others) that are likely to impact the evolution of this market over the coming years.
• A discussion on various steps involved in development operations of companion diagnostics, namely R&D, clinical evaluation, manufacturing and assembly, negotiations with payers/insurance providers and marketing/sales activities, and the cost requirements across each of the aforementioned stages.
• A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in the development of companion diagnostic products.

One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for novel immuno-oncology biomarker testing services over the coming decade. Based on several parameters, the research provides an informed estimate of the likely evolution of this market in the short to mid-term and long term, for the period 2019-2030.

In addition, the report provides the likely distribution of the future opportunity based on:

• [A] biomarker (MSI / MMR, TILs, TMB)
• [B] disease indications (blood cancer, blood cancer, colon cancer, colorectal cancer, lung cancer, melanoma, prostate cancer and others)
• [C] analytical technique used (immunohistochemistry, next-generation sequencing, polymerase chain reaction and others)
• [D] application area (research use, clinical use, commercial use)
• [E] key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).

In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, the research has provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry's evolution.

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.

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. Chapter Overview
3.2. Cancer Immunotherapy
3.2.1. Cancer Immunotherapy Biomarkers
3.2.2. Identification of a Candidate Biomarker
3.2.3. Need for Novel Immuno-Oncology Biomarkers
3.3. Tumor Mutation Burden (TMB)
3.3.1. Overview
3.3.2. Variation of TMB across Multiple Indications
3.3.3. Methods for Measurement of TMB
3.3.4. Factors Affecting Measurement of TMB
3.3.5. Initiatives for Assessment of TMB as a Potential Biomarker
3.4. Microsatellite Instability/Mismatch Repair Deficiency (MSI/MMR)
3.4.1. Overview
3.4.2. Variation of MSI across Multiple Indications
3.4.3. Methods of Measurement of MSI
3.5. Tumor Infiltrating Lymphocytes and Other Novel Biomarkers

4. CURRENT MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Novel Immuno-Oncology Biomarker Testing Services: Overall Market Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Geographical Location
4.2.4. Analysis by Test Availability
4.2.5. Analysis by Type of Biomarker
4.2.6. Analysis by Application Area
4.2.7. Analysis by Disease Indication
4.2.8. Analysis by Analytical Technique Used
4.2.9. Analysis by Turnaround Time
4.2.10. Analysis by Sample Input
4.2.11. Analysis by Nucleic Acid Tested
4.2.12. Key Players: Analysis by Type of Biomarker
4.3. TMB Tests
4.3.1. Analysis by Application Area
4.3.2. Analysis by Disease Indication
4.3.3. Analysis by Analytical Technique Used
4.3.4. Analysis by Turnaround Time
4.3.5. Analysis by Genes Evaluated
4.3.6. Analysis by Sample Input
4.4. MSI/MMR Tests
4.4.1. Analysis by Application Area
4.4.2. Analysis by Disease Indication
4.4.3. Analysis by Analytical Technique Used
4.4.4. Analysis by Turnaround Time
4.4.6. Analysis by Sample Input
4.5. TIL-based Tests
4.5.1. Analysis by Application Area
4.5.2. Analysis by Disease Indication
4.5.3. Analysis by Analytical Technique Used
4.5.4. Analysis by Turnaround Time
4.5.6. Analysis by Sample Input
4.6. Market Landscape Summary: Analysis by Type of Biomarker and Disease Indication

5. PRODUCT COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Product Competitiveness Analysis: Key Assumptions and Methodology
5.2.1. Tests for the Assessment of TMB
5.2.2. Tests for the Assessment of MSI/MMR
5.2.3. Tests for the Assessment of TILs

6. COMPANY PROFILES
6.1. Chapter Overview
6.2. Foundation Medicine
6.2.1. Company Overview
6.2.2. Financial Information
6.2.3. Product/Service Portfolio
6.2.3.1. Novel Biomarker Testing Products/Services
6.2.3.1.1. FoundationOne CDx
6.2.3.1.2. FoundationOne Liquid
6.2.3.1.3. FoundationOne Heme
6.2.4. Recent Developments and Future Outlook
6.3. Lal PathLabs
6.3.1. Company Overview
6.3.2. Financial Information
6.3.3. Product/Service Portfolio
6.3.3.1. Novel Biomarker Testing Products/Services
6.3.3.1.1. Microsatellite Instability (MSI) by PCR
6.3.3.1.2. OncoPro NCCN Lung Cancer Panel (*9 Genes *MSI)
6.3.3.1.3. OncoPro Liquid Biopsy 73 Gene Panel with MSI
6.3.4. Recent Developments and Future Outlook
6.4. NeoGenomics Laboratories
6.4.1. Company Overview
6.4.2. Financial Information
6.4.3. Product/Service Portfolio
6.4.3.1. Novel Biomarker Testing Products/Services
6.4.3.1.1. NeoTYPE Discovery Profile for Solid Tumors
6.4.3.1.2. MSI Analysis/MMR Panel by IHC
6.4.3.1.3. MultiOmyx Tumor Infiltrating Lymphocyte Panel
6.4.4. Recent Developments and Future Outlook
6.5. Novogene
6.5.1. Company Overview
6.5.2. Product/Service Portfolio
6.5.2.1. Novel Biomarker Testing Products/Services
6.5.2.1.1. NovoPM Cancer Panel
6.5.2.1.2. NovoPM TMB
6.5.2.1.3. NovoPM bTMB
6.5.2.1.4. NovoPM MSI
6.5.3. Recent Developments and Future Outlook
6.6. Q2 Solutions
6.6.1. Company Overview
6.6.2. Product/Service Portfolio
6.6.2.1. Novel Biomarker Testing Products/Services
6.6.2.1.1. TMB Assay
6.6.2.1.2. MSI Assay
6.6.2.1.3. TILs Testing
6.6.3. Recent Developments and Future Outlook
6.7. Personal Genome Diagnostics
6.7.1. Company Overview
6.7.2. Product/Service Portfolio
6.7.2.1. Novel Biomarker Testing Products/Services
6.7.2.1.1. PGDx elio Tissue Complete Assay
6.7.2.1.2. PlasmaSELECT-R 64
6.7.2.1.3. CancerXOME-R
6.7.2.1.4. CancerSELECT-R 125
6.7.2.1.5. MutatorDETECT
6.7.3. Recent Developments and Future Outlook
6.8. Shenzhen Yuce Biotechnology
6.8.1. Company Overview
6.8.2. Product/Service Portfolio
6.8.2.1. Novel Biomarker Testing Products/Services
6.8.2.1.1. YuceOne Plus
6.8.2.1.2. YuceOne ICIs
6.8.2.1.3. ct-DNA TMB
6.8.2.1.4. Microsatellite (MSI) Test
6.8.3. Recent Developments and Future Outlook

7. PUBLICATION ANALYSIS
7.1. Chapter Overview
7.2. Methodology
7.3. Novel Immuno-Oncology Biomarkers: List of Publications
7.3.1. Analysis by Year of Publication, 2016-2019
7.3.2. Analysis by Year of Publication and Type of Biomarker
7.3.3. Analysis by Year of Publication and Disease Indication
7.3.4. Analysis by Year of Publication and Analytical Technique Used
7.3.5. Analysis by Year of Publication and Type of Cancer Therapy
7.3.6. Most Popular Journals
7.5. Publication Analysis: TMB
7.5.1. Analysis by Year of Publication, 2016-2019
7.5.2. Analysis by Disease Indication
7.5.3. Analysis by Analytical Technique Used
7.5.4. Most Popular Journals
7.6. Publication Analysis: MSI/MMR
7.6.1. Analysis by Year of Publication, 2016-2019
7.6.2. Analysis by Disease Indication
7.6.3. Analysis by Analytical Technique Used
7.6.4. Most Popular Journals
7.7. Publication Analysis: TILs
7.7.1. Analysis by Year of Publication, 2016-2019
7.7.2. Analysis by Disease Indication
7.7.3. Analysis by Analytical Technique Used
7.7.4. Most Popular Journals

8. INNOVATIVE DESIGNS FOR BIOMARKER-BASED CLINICAL TRIALS
8.1. Background and Context
8.2. Biomarker-based Clinical Trial Designs
8.2.1. Enrichment Design
8.2.2. All-Comers Design
8.2.3. Mixture/Hybrid Design
8.2.4. Adaptive Design
8.3 Regulatory Considerations

9. CLINICAL TRIAL ANALYSIS
9.1. Chapter Overview
9.2. Methodology
9.3. Novel Immuno-Oncology Biomarkers: List of Clinical Trials
9.4. Clinical Trial Analysis: TMB
9.4.1. Analysis by Trial Registration Year
9.4.2. Analysis by Trial Recruitment Status
9.4.3. Analysis by Trial Phase
9.4.4. Analysis by Trial Design
9.4.5. Analysis by Disease Indication
9.4.6. Most Active Players
9.4.7. Analysis by Number of Clinical Trials and Geography
9.4.8. Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status
9.4.9. Analysis by Enrolled Patient Population and Geography
9.4.10. Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status
9.5. Clinical Trial Analysis: MSI/MMR
9.5.1. Analysis by Trial Registration Year
9.5.2. Analysis by Trial Recruitment Status
9.5.3. Analysis by Trial Phase
9.5.4. Analysis by Trial Design
9.5.5. Analysis by Disease Indication
9.5.6. Most Active Players
9.5.7. Analysis by Number of Clinical Trials and Geography
9.5.8. Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status
9.5.9. Analysis by Enrolled Patient Population and Geography
9.5.10. Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status
9.6. Clinical Trial Analysis: TILs
9.6.1. Analysis by Trial Registration Year
9.6.2. Analysis by Trial Recruitment Status
9.6.3. Analysis by Trial Phase
9.6.4. Analysis by Trial Design
9.6.5. Analysis by Disease Indication
9.6.6. Most Active Players
9.6.7. Analysis by Number of Clinical Trials and Geography
9.6.8. Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status
9.6.9. Analysis by Enrolled Patient Population and Geography
9.6.10. Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status
9.7 Clinical Trials Summary: Analysis by Registration Year and Biomarker
9.8 Clinical Trials Summary: Analysis by Registration Year and Disease Indication
9.9 Clinical Trials Summary: Analysis by Phase and Biomarker
9.10 Overall Clinical Trials Summary: Analysis by Phase and Disease Indication

10. MARKET FORECAST
10.1. Chapter Overview
10.2. Key Assumptions and Forecast Methodology
10.3. Global Novel Immuno-Oncology Biomarker Testing Market, 2019-2030
10.3.1. Global Novel Immuno-Oncology Biomarker Testing Market, 2019-2030 (By Value)
10.3.2. Global Novel Immuno-Oncology Biomarker Testing Market, 2019-2030 (By Volume)
10.4. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Type of Biomarker, 2019-2030 (By Value)
10.5. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Type of Biomarker, 2019-2030 (By Volume)
10.6. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Disease Indication, 2019-2030 (By Value)
10.7. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Disease Indication, 2019-2030 (By Volume)
10.8. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Analytical Technique Used, 2019-2030 (By Value)
10.9. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Analytical Technique Used, 2019-2030 (By Volume)
10.10. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Application Area, 2019-2030 (By Value)
10.11. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Application Area, 2019-2030 (By Volume)
10.12. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Geography, 2019-2030 (By Value)
10.13. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Geography, 2019-2030 (By Volume)

11. FUTURE GROWTH OPPORTUNITIES
11.1. Chapter Overview
11.1.1. Increasing Focus on Precision Medicine
11.1.2. Rise in Number of Biomarker-based Clinical Trials
11.1.3. Emerging Technologies for Biomarker Assessment
11.1.4. Development of Companion Diagnostic Products
11.1.5. Other Opportunities

12. CASE STUDY: ANALYSIS OF NEEDS OF STAKEHOLDERS IN THE COMPANION DIAGNOSTICS INDUSTRY
12.1. Chapter Overview
12.2. Companion Diagnostics: Needs of Different Stakeholders
12.3. Comparison of Needs of Various Stakeholders
12.3.1. Needs of Drug Developers
12.3.2. Needs of Companion Diagnostics Developers
12.3.3. Needs of Regulatory Authorities
12.3.4. Needs of Testing Laboratories
12.3.5. Needs of Payers/Insurance Providers
12.3.6. Needs of Physicians
12.3.7. Needs of Patients

13. CASE STUDY: ANALYSIS OF VALUE CHAIN IN THE COMPANION DIAGNOSTICS INDUSTRY
13.1. Chapter Overview
13.2. Companion Diagnostics: Components of the Value Chain
13.3. Companion Diagnostics Value Chain: Cost Distribution
13.3.1. Companion Diagnostics Value Chain: Costs Associated with Research and Product Development
13.3.2. Companion Diagnostics Value Chain: Costs Associated with Costs Associated with Manufacturing and Assembly
13.3.3. Companion Diagnostics Value Chain: Costs Associated with Clinical Trials, FDA Approval and Other Administrative Tasks
13.3.4. Companion Diagnostics Value Chain: Costs Associated with Payer Negotiation and KoL Engagement
13.3.5. Companion Diagnostics Value Chain: Costs Associated with Marketing and Sales

14. CLINICAL TRIALS AND KEY BIOMARKERS: A BIG PHARMA PERSPECTIVE
14.1. Chapter Overview
14.2. Scope and Methodology
14.3. List of Biomarker-based Clinical Trials of Big Pharmaceutical Companies
14.3.1. Analysis by Trial Registration Year
14.3.2. Analysis by Phase of Development
14.3.3. Analysis by Recruitment Status
14.3.4. Analysis by Therapy Design
14.3.5. Analysis by Type of Cancer Therapy
14.3.6. Analysis by Type of Biomarker
14.3.6.1. Analysis by Trial Registration Year and Biomarker
14.3.6.1. Analysis by Phase of Development and Biomarker
14.3.7. Analysis by Disease Indication
14.3.7.1. Analysis by Trial Registration Year and Disease Indication
14.3.7.2. Analysis by Phase of Development and Disease Indication
14.3.8. Geographical Analysis of Clinical Trials
14.3.8.1. Analysis by Number of Clinical Trials and Geography
14.3.8.2. Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status
14.3.8.3. Analysis by Enrolled Patient Population and Geography
14.3.8.4. Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status
14.3.9. Analysis of Key Players
14.3.9.1. Key Players: Analysis by Trial Registration Year
14.3.9.1. Key Players: Analysis by Biomarker
14.3.9.1. Key Players: Analysis by Disease Indication

15. EXECUTIVE INSIGHTS

16. APPENDIX 1: TABULATED DATA

17. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Companies Mentioned

• AbbVie
• ACT Genomics
• Admera Health
• AITbiotech
• Ambry Genetics
• Amgen
• ARUP Laboratories
• Asper Biogene
• AstraZeneca
• Barbara Ann Karmanos Cancer Institute
• Bayer
• Biocartis
• Biodesix
• Biotype Innovation
• Boehringer Ingelheim
• Brigham and Women's Hospital
• Bristol-Myers Squibb
• Cancer Genetics
• Cancer Research Institute
• Cancer Treatment Centers of America
• Caprion Biosciences
• Caris Life Sciences
• CBLPath
• CeGaT
• Celator Pharmaceuticals (Subsidiary of Jazz Pharmaceuticals)
• Cell IDx
• CGC Genetics
• Chugai Pharmaceutical
• CIRCULOGENE
• City of Hope National Medical Center
• Clarient Diagnostic Services (Acquired by NeoGenomics Laboratories)
• Cofactor Genomics
• Columbia University
• Craig Hallum Capital Group
• CTOAM
• DIAN Diagnostics Group
• Dr Lal PathLabs
• EasyDNA
• Eli Lilly
• EMD Serono
• Epic Sciences
• European Organization for Research and Treatment of Cancer
• ExcellaBio
• Federal Association of German Pathologists
• Foundation Medicine
• Fox Chase Cancer Center
• Fred Hutchinson Cancer Research Center
• Genekor
• Genentech
• Genetron
• Genomics For Life
• Genoptix
• GenPath Diagnostics
• German Society of Pathology
• Gilead Sciences
• GlaxoSmithKline
• Gradalis
• Guardant Health
• HalioDx
• HistoGeneX
• Horizon Healthcare Services
• Illumina
• Immatics Biotechnologies
• Impact Genetics
• Innovent Biologics
• Intermountain Healthcare
• Invitae
• IQVIA
• Johns Hopkins University
• Johnson & Johnson
• KEW
• KingMed Diagnostics
• L.E.M laboratory
• LabCorp
• Lantheus Medical Imaging
• Massachusetts General Hospital
• MD Anderson Cancer Center
• MedImmune
• Memorial Sloan Kettering Cancer Center
• Merck
• Metropolis
• Miltenyi Biotec
• MultiVir
• Nanostring Technologies
• NantHealth
• National Cancer Institute
• NEO New Oncology
• NeoGenomics Laboratories
• Novartis
• Novogene
• OmniSeq
• OncoDNA
• PathGroup
• PentaBase
• PerkinElmer
• Personal Genome Diagnostics
• Personalis
• Pfizer
• PhenoPath
• Positive Bioscience
• Promega
• Q2 Solutions
• QIAGEN
• Quality Assurance Initiative Pathology
• Quest Diagnostics
• Regeneron Pharmaceuticals
• Roche
• Roswell Park Cancer Institute
• Sanofi
• Sarah Cannon Research Institute
• SeraCare Life Sciences
• Shanghai HAORAN Biotechnology
• Shenzhen Yuce Biotechnology
• Sidney Kimmel Comprehensive Cancer Center
• Sun Yat-sen University
• Sysmex
• Takeda Pharmaceutical
• Tempus
• The Institute of Cancer Research, London
• The Netherlands Cancer Institute
• Thermo Fisher Scientific
• UNICANCER
• University of Pittsburgh
• University of Washington
• Ventana Medical Systems
• Viapath
• Wake Forest University Health Sciences

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