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Key Inclusions

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 cancer 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 cancer 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

The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

  • Type of test

Laboratory Developed Tests (LDTs)

Companion Diagnostic Tests (CDx)

  • Type of disease indication

Breast cancer

Blood cancer

Colon / Colorectal cancer

Lung Cancer


Prostate Cancer

  • Type of cancer biomarker




  • Type of analytical technique

Next Generation Sequencing (NGS)

Polymerase Chain Reaction (PCR)

Immunohistochemistry (IHC)


  • Key geographical regions

North America





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Key Questions Answered

  • What are key cancer indications for which novel cancer biomarker-based tests are available / under development?
  • Who are the leading service providers in this emerging market? How do such tests compare to each other (in terms of key specifications and strengths of developer entities)?
  • What are the prevalent R&D trends related to novel cancer biomarkers (in terms of clinical development activity, and number of publications)?
  • What are the major applications of biomarker-based analytical tests?
  • What are the different initiatives undertaken by big pharmaceutical companies to advance their cancer biomarker tests (in terms of clinical research activity)?
  • What are the upcoming opportunities for biomarker testing service providers that are likely to impact the evolution of the market over the coming years?
  • How is the current and future market opportunity likely to be distributed across key market segments, including different cancer indications (breast cancer, blood cancer, colon / colorectal cancer, lung cancer, melanoma, and prostate cancer)?

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