Driven by the Growing Demand for Personalized Therapies, the Companion Diagnostics Market is Anticipated to Grow at an Annualized Rate of ~7.5%, Predicts Roots Analysis

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May 29, 2019, 11:00 ET

LONDON, May 29, 2019 /PRNewswire/ -- Roots Analysis has announced the addition of "Companion Diagnostics Market (2^nd Edition), 2019-2030" report to its list of offerings.

Ishita Nanda and Rohan Mukhopadhyay, the principal analysts, stated, "Given the influx of novel technologies and growing demand for personalized medicine, companion diagnostics have gradually become a necessity for modern pharmacological interventions. Tailored therapies are expected to transform healthcare practices, offering improved treatment outcomes, eliminating adverse reactions and, in a way, reducing cost and time barriers associated with drug development and approval. Currently, over 140 companion diagnostics are available / under development for a range of disease indications."

The report presents opinions on several key aspects of the market. Among other elements, it includes:

A detailed assessment of the current market landscape of companies offering companion diagnostics, including information on their geographical location, availability to patients, corresponding drug(s) / drug class, affiliated biomarkers, 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). It is worth noting that around 87% of the pipeline candidates are being developed for the treatment of oncological indications; of these, more than 35% are being investigated for the treatment of breast and lung cancer. Examples include (in alphabetical order, no specific selection criteria) AmoyDx® EGFR 29 Mutations Detection Kit, FoundationOne CDx™, HER2 FISH pharmDx™ Kit, PathVysion HER-2 DNA Probe Kit, therascreen® EGFR RGQ PCR Kit and VENTANA PD-L1 (SP142) Assay.
Elaborate profiles of developers of companion diagnostics (shortlisted based on strength of product portfolio), featuring an overview of the company, its financial information (if available) and a detailed description of companion diagnostics available / under development. In addition, each profile includes a list of recent collaborations and the likely strategies that may be adopted by these players to support future growth.
An in-depth brand positioning analysis of leading industry players (shortlisted based on 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. It highlights the key strengths / competitive advantages, including our rationale justifying its position as a competitive entity in the market.
An analysis of the partnerships and collaborations pertaining to companion diagnostics for the period 2014-2019, featuring a comprehensive set of analyses based on parameters, such as the type of partnership (R&D collaborations, licensing agreements, acquisitions, product development and / or commercialization agreements, manufacturing agreements, clinical trial agreements, and other relevant deals), affiliated biomarkers, therapeutic areas and the most active players. It is worth noting that product development agreement was the most popular type of deal inked in this domain, representing 33% of the total number of collaborations.
A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) that are involved in this domain. The analysis features a qualitative assessment of the current and long-term needs of different stakeholders involved in this domain. It further compares the needs of the drug developers that are involved in development of companion diagnostic tests for their drug molecules, offering a combined perspective on the current and the future scenarios.
A discussion on various steps involved in the development of a companion diagnostic test, namely R&D, clinical assessment, manufacturing and assembly, payer negotiation and marketing / sales activities. It also includes and assessment of the cost requirements across each of the aforementioned stages. It is worth mentioning that presently R&D costs are estimated to account for 30-33% of the total expenditure involved in the development of a companion diagnostic.
A comprehensive clinical trial analysis of completed, ongoing and planned studies of 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. In the past few years, several organizations, such as (in alphabetic order), AbbVie, Amgen, AstraZeneca, Eli Lilly, Novartis emerged as the leading industry sponsors / collaborators that are engaged in clinical research efforts in this domain.
A comprehensive market forecast analysis based on the primary growth drivers, disease incidence, adoption of companion diagnostic tests and the likely prices, for the period 2019-2030.The report includes information on the likely distribution of the current and forecasted opportunity across the following segments:

Type of therapeutic area (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))
Type of techniques used (In situ hybridization, immunohistochemistry, next-generation sequencing, and polymerase chain reaction)
Key geographical regions (North America, Europe and Asia Pacific).

Companion diagnostics intended for the treatment of oncological disorders are expected to capture majority of the market share (~80%) by 2030, while those being evaluated for the treatment of neurological disorders are anticipated to grow at a relatively faster rate during the forecast period. Further, North America (primarily the US) and Europe are anticipated to capture the majority share by 2030, in terms of the sales-based revenues.

Mukhopadhyay further remarked, "Despite the increasing demand of personalized medicine, the full potential of companion diagnostics continues to remain untapped owing to an array of concerns associated with their development, regulations and affiliated reimbursement policies. It is worth mentioning that various pharma giants have opted to collaborate or acquire diagnostic developers having broad testing portfolios, in order to meet the growing demand in this domain".

The research covers detailed profiles and assesses product portfolios of several companies, including (illustrative list, no specific selection criteria):