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CDx Development Market Revenue to Cross USD 2,500 Million by 2035 | Roots Analysis

Published: February 2024

According to a recently published report by Roots Analysis, the growing prevalence of target-specific therapies that require advanced disease diagnostic tools to understand molecular mechanisms has led to a surge in demand for CDx diagnostics.

Global CDx Development Market Overview

The global CDx development market is anticipated to grow at a CAGR of 10.77% from 2023-2035, reaching USD 2,500 million by 2035.

CDx or companion diagnostics refers to the class of medical devices used as in-vitro diagnostics devices that enable researchers to collect information for the effective and safe use of pharmaceutical products. Recently, there has been a gradual shift towards understanding the molecular mechanisms involved in disease pathogenesis. The information collected from the companion diagnostic tools helps develop targeted therapies to treat various diseases. Companion diagnostics has become an integral part of the healthcare sector to provide information about the unique genetic profiles of patients that further allow clinicians to develop treatment plans. It is worth noting here that, since 2022, the FDA has approved close to 44 CDx diagnostics. Out of these, three CDx-targeted therapies have received approval for advanced ovarian cancer, breast cancer, and non-small cell lung cancer. Using these companion diagnostics to collect disease-specific information helps increase the success rate of target-specific therapies and improve overall patient outcomes. Driven by the ongoing adoption of CDx in drug discovery and diagnosis, the CDx development market is estimated to grow faster during the forecast period.

The 405-page report contains a detailed Table of Contents on "CDx Development Market," Type of Service Offered, Analytical Technique Used, Therapeutic Areas, and Global Forecasts, 2023-2035” here: https://www.rootsanalysis.com/reports/companion-diagnostics-services/297.html

Market Drivers

The growing shift towards personalized medicine based on patient characteristics has increased the requirement for companion diagnostic tools. Furthermore, the CDx development market is also driven by the increasing focus on target-specific therapies, specifically in the field of oncology. CDx plays a vital role in identifying disease-specific molecules to develop target therapies that improve patient outcomes. The ongoing advancements in genomics and molecular biology technologies have also led to the development of companion diagnostic biomarkers.

Market Restraints

The high cost of CDx development and testing modality may reduce the accessibility for healthcare systems and patients. A limited understanding of specific biomarkers for disease diagnosis may impede the market's growth during the forecast period. Furthermore, the integration of companion diagnostics into existing healthcare systems may face interoperability challenges. Therefore, ensuring a breakthrough communication between electronic health records and diagnostic tools for effective integration can be complex.

Growth Factors

Several factors propelling growth in the CDx development market include rising support from the regulatory agencies and a growing focus on biomarker discovery. The ongoing research of new biomarkers has contributed to expanding companion diagnostics applications across various therapeutic areas. Furthermore, the growing emphasis on a patient-centric approach drives the demand for tailored treatment plans that require CDx to develop personalized medicine based on individual patient characteristics. The ongoing collaborations and partnerships between key market players to integrate diagnostics into drug discovery and development are the key growth factors.

CDx Development Market Segments

Based on the Types of Services Offered, the CDx Development Market is Segmented into Feasibility Studies, Assay Development, Analytical Validation, Clinical Validation and Manufacturing.

  • Clinical validation will dominate the CDx development market, capturing 46% of the overall revenue share by 2035.
  • Analytical validation will grow at a higher CAGR value of 10.8% during the forecast period.

Based on the Analytical Technique Used, the CDx Development Market is Segmented Into Next Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Immunohistochemistry / in situ Hybridization (IHC / ISH), Liquid Biopsy and Others

  • Based on the analytical technique used, next generation sequencing will dominate the market, capturing 36% of overall revenue share by 2035.
  • Immunohistochemistry / in situ Hybridization (IHC / ISH) will grow at a higher CAGR of 10.77% during the forecast period.

Based on Targeted Therapeutic Areas, the CDx Development Market is Segmented Into Oncological and Non-Oncological.

  • Oncology areas will dominate the market during the forecast period and are anticipated to capture 88% of the revenue share by 2035.
  • Non-oncology areas will grow during the forecast period at a higher compounded annual growth rate (CAGR) of 10.77%.

Based on the Key Geographical Insight, the CDx Development Market is Segmented into North America, Europe, Asia-Pacific and Rest of the World.

  • North America will dominate the CDx development market and is anticipated to capture 59% of overall revenue share by 2035.
  • In Europe, the CDx development market will grow at a higher CAGR of 10.766% during the forecast period.

Key Companies Profiled

The CDx development market report also includes detailed profiles of key players (listed below) that offer disease diagnostic tools and solutions.

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

You Can Download Free Sample PDF Copy of This Report At:

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About Roots Analysis

Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists, and strategic investors for over a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serving our clients in the best possible way.

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