Novel Immuno-Oncology Biomarker Testing Market, 2019-2030

NEW YORK, July 17, 2019 /PRNewswire/ --

INTRODUCTION
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 a specific cancer. 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.



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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 interest in this domain and have launched clinical research initiatives to investigate the relevance and applications of multiple novel biomarkers.

SCOPE OF THE REPORT
The 'Novel Immuno-Oncology Biomarker Testing Market, 2019-2030' 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. 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, 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, 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 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, we have provided 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, we have provided 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), and [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, we have 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.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts' views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the state of the novel immuno-oncology biomarkers testing market in the short to mid-term and long term.

Chapter 3 provides a brief introduction to cancer immunotherapy and the various types of immunotherapies, including details on their mechanism of action and key advantages. It elaborates on the importance and applications of biomarkers, specifically in determining patients' response towards checkpoint inhibitor-based immunotherapies. The chapter also highlights the key steps involved in the identification of a candidate biomarker, namely biomarker discovery, analytical validation, clinical relevance and clinical utility. In addition, it highlights the need for novel immuno-oncology biomarkers. Further, it includes a discussion on emerging classes of biomarkers, namely TMB, MSI / MMR and others, along with details regarding expression across various indications, analytical assessment methods and factors influencing expression.

Chapter 4 includes a comprehensive market landscape analysis of companies that offer testing services for novel immuno-oncology biomarkers, particularly for checking response towards immunotherapies. The chapter presents detailed analyses on the basis of year of establishment, size of employee base, location of headquarters, availability status of test (available / under development), biomarkers analyzed (TMB, MSI / MMR and TILs (CD3+, CD4+, CD8+ and FOXP3+), application area(s) (clinical use, research use, commercial use and both clinical / research use), disease indication(s) evaluated, analytical technique(s) utilized (immunohistochemistry, next generation sequencing, polymerase chain reaction and others), turnaround time, sample input, number of genes analyzed and type of nucleic acid utilized. The chapter also provides a list of kits / test panels that are currently commercialized for testing of these biomarkers.

Chapter 5 features a comprehensive 2X2 analysis offering a comparative summary of all the tests within each biomarker category that we came across during our research. It compares the competitiveness of tests, by taking into consideration the supplier power (based on size of employee base) and certain test-related parameters, such as, application area of the test (clinical use, research use, commercial use, both clinical and research use), turnaround time, number of genes analyzed, sample input (cancer tissue only, both normal and cancer tissue) and technique utilized for biomarker assessment.

Chapter 6 provides detailed profiles of some of the important immuno-oncology biomarker testing services providers (shortlisted based on strength of service portfolio). Each company profile includes a brief overview of the company, its financial data (if available), information on biomarker testing related service(s), recent developments and an informed future outlook.

Chapter 7 features a detailed publication analysis of over 180 research articles related to immuno-oncology biomarkers including TMB, MSI / MMR and TILs that have been published since 2016. The analysis was done for publications under each biomarker category and takes into consideration several parameters, including year of publication, disease indications, analytical technique on which the study was focused, most popular journal in which the study was published, and type of cancer therapy evaluated.

Chapter 8 provides information on the innovative clinical trial designs being used for conducting biomarker-based studies for oncology drugs. It provides details on the structure of each study design, highlighting their respective advantages and challenges.

Chapter 9 presents a comprehensive clinical trial analysis of completed, ongoing and planned studies involving immuno-oncology biomarkers (TMB, MSI / MMR and TILs). The analysis was done for clinical trials under each biomarker category across various parameters, such as current trial status, trial registration year, trial recruitment status, trial phase, trial design, indication(s) evaluated, leading industry and non-industry players, and geographical locations of trials.

Chapter 10 features a comprehensive market forecast, highlighting the future potential of novel immuno-oncology biomarkers testing services market till 2030. We have segmented the market on the basis of [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] type of analytical technique used (immunohistochemistry, next generation sequencing, polymerase chain reaction and others), [D] application area (research use, clinical use, commercial use), and [E] key geographical regions (North America, Europe, Asia-Pacific / Rest of the World).

Chapter 11 features a detailed discussion on the upcoming opportunities for testing services providers (such as rise in the number of biomarker-based oncology clinical trials, increasing focus on precision medicine, development of companion diagnostic products and others) in this field that are likely to impact the evolution of the market over the coming years.

Chapter 12 provides information on the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in the development of companion diagnostic products. The chapter qualitatively assesses the various companion diagnostics-related needs of these stakeholders, highlighting their respective perspectives regarding the importance of each need.

Chapter 13 presents a value chain analysis featuring a discussion on various steps of the development operations, namely R&D development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages.

Chapter 14 features a holistic view of ongoing, biomarker-based, oncology-focused clinical trials initiated by big pharmaceutical companies. For the purpose of understanding the prime focus of these players, we looked at the active clinical studies that have been registered post 2016. Further, the clinical trial data was analyzed on the basis of various parameters, such as trial registration year, phase of development, recruitment status, therapy design (monotherapy, combination therapy, multiple monotherapies, multiple combination therapies and, both monotherapies and combination therapies), type of cancer therapy, biomarker(s) evaluated (most popular biomarker, moderately popular biomarker and other biomarkers), disease indication(s) evaluated (most popular indications, moderately popular indications and other indications), and geographical location of the trials. In addition, we looked at the activity of each pharmaceutical player considered for the analysis across multiple aforementioned parameters. The chapter presents the data on cancer therapies that are being evaluated in these trials with information on targeted cancer indication and biomarker.

Chapter 15 is a collection of interview transcript(s) of discussions held with industry stakeholders, wherever the participants didn't request anonymity.

Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 17 is an appendix, which contains the list of companies and organizations mentioned in the report.

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