The companion diagnostics development services market, is anticipated to grow at a CAGR of over 10%, till 2035, claims Roots Analysis

Published: July 2022

Given the various challenges associated with co-development of companion diagnostics and drug / therapy, drug developers prefer to rely on third-party service providers that offer customized services and advanced technologies

Roots Analysis has announced the addition of CDx Development Market report to its list of offerings. 

The growing pipeline of patient-centric targeted therapies has led to a surge in demand for companion diagnostics; these tests are known to improve the success rates of late-stage trials by almost three-fold. The development and approval of these FDA classified high-risk devices requires multidisciplinary expertise and an established network of R&D and production facilities that can be accessed through service providers.  

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Key Market Insights

Over 150 companies claim to offer companion diagnostics development services, globally
Nearly 60% of the aforementioned players are based in North America, followed by the players located in Europe (30%). Further, this segment of the industry is dominated by the presence of mid-sized players (51-200 employees), which represent 40% of the total service providers.

Nearly 15% players claim to act as one-stop shops, offering services, ranging from biomarker discovery and development to manufacturing and commercialization
Most of the service providers (127) provide assay development services, followed by companies (124) offering services for biomarker discovery / identification. Further, NGS is the most popular technique, employed by over 100 service providers.

Over 90 companies are actively involved in the development of companion diagnostics
Nearly 91% of the total tests can detect mutations in a single biomarker. Amongst these, ErbB gene family (HER-2 and EGFR genes), PD-L1 genes, RAS gene family (KRAS and NRAS genes), BRCA gene family (BRCA1 and BRCA2) and BRAF emerged as the key genes which are assessed by majority of the companion diagnostics.

Partnership activity in this domain has increased at a CAGR of ~25%, between 2017 and 2021
Mergers and acquisitions, product development agreements and product development and commercialization agreements account for more than 60% of the total number of deals inked during the given time period. It is worth highlighting that nearly 25% of the total number of deals were signed in 2021. Further, the maximum number (177) of partnerships have been inked for companion diagnostics being developed for the treatment of oncological disorders.

North America is expected to capture ~60% share in the companion diagnostics development services market by 2035
Owing to the high costs associated with the clinical validation of companion diagnostics, a significant proportion (~46%) of service revenues is generated from this step, in 2035. In terms of analytical technique used, service contracts involving NGS are anticipated to contribute to more than 35% of the total service revenues generated in 2035. Further, close to 90% of the total service revenues, in 2035,  are generated from companion diagnostics development projects for cancer indications.

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Key Questions Answered

  • Who are the leading players offering services for the development of companion diagnostics?
  • Which are the key geographies where companion diagnostics development service providers are located?
  • Which analytical techniques are used by the service providers engaged companion diagnostics development services market?
  • Who are the leading companion diagnostics developers?
  • Which biomarkers are most commonly targeted by the marketed products / investigational programs? 
  • Which partnership models are commonly adopted by stakeholders offering companion diagnostics development services?
  • Which drug developers are most likely to partner with the service providers to seek their expertise?
  • What are the key value drivers of the merger and acquisition activity within companion diagnostics development services market?
  • Which biomarker-focused targeted drugs developed by big pharmaceutical companies are likely to be administered with companion diagnostics?
  • How is the current and future opportunity likely to be distributed across key market segments?

The financial opportunity within the companion diagnostics development services market has been analyzed across the following segments:

  • Type of Service Offered
    • Feasibility Studies
    • Assay Development
    • Analytical Validation
    • Clinical Validation
    • Manufacturing
  • Type of Technique Used
    • NGS
    • PCR
    • ICH / ISH
    • Liquid Biopsy
    • Others
  • Therapeutic Areas
    • Oncological
    • Non-oncological
  • Key Geographical Regions 
    • North America 
    • Europe
    • Asia-Pacific and Rest of the World

The report also features detailed transcripts of discussions (in reverse chronological order) held with the following experts:

  • Chief Executive Officer, Mid-sized Company, US
  • Founder and Chief Scientific Officer, Mid-sized Company, US
  • Vice President of Marketing, Mid-sized Company, US
  • President and Chief Technology Officer, Small Company, US
  • Former Senior Vice President, Small Company, US
  • Chief Executive Officer, Small Company, Spain
  • Former Chief Scientific Officer, Large Company, US

The research includes detailed profiles of key players (listed below), each profile features an overview of the company, its financial information (if available), drug portfolio, details on recent developments, and an informed future outlook. 

  • Almac Diagnostic Services
  • BGI Genomics
  • Biocartis
  • Cerba Research
  • Geneuity Clinical Research Services
  • Interpace Biosciences
  • Labcorp (formerly known as Covance)
  • MEDx (Suzhou) Translational Medicine (formerly known as QIAGEN (Suzhou) Translational Medicine)
  • MLM Medical Labs
  • Novogene
  • Q2 Solutions
  • Quest Diagnostics
  • ResearchDx

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Gaurav Chaudhary
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