Companion Diagnostic (CDx) Development Market Size Worth over USD 1.8 Billion in 2035 | Roots Analysis

Several factors contribute to the growth of the market. The updated regulatory requirements for therapeutic approval, technological innovation and the growing demand for personalized medicine are among the most important growth drivers of the CDx development market.

Further, the substantial development seen in this industry is mainly the result of stringent drug approval guidelines and growing focus on developing patient centric tailored treatments. Furthermore, the increasing adoption of companion diagnostics (CDx)-guided drug development, coupled with the lack of well-equipped infrastructure and expertise among drug developers for CDx development, is likely to lead to a rise in the outsourcing of CDx development to service providers. 

In addition, service providers are dedicated to upgrading their services by integrating advanced technologies like artificial intelligence and machine learning. This integration aims to elevate the quality of companion diagnostic development and optimize services, ensuring that they align with regulatory requirements to accelerate the drug approval process for serious and life-threatening diseases. Therefore, many drug developers are compelled to outsource the CDx development operations to contract service providers, thereby contributing to the growth of this market.

Key Report Takeaways

§  Over 155 service providers presently claim to have the required expertise to support multiple steps involved in companion diagnostic development; ~30% of these are established players with more than 500 employees

§  Companies offer services to develop analytical tests to identify disease specific biomarkers; oncology is the more popular area wherein developers are exploring personalized diagnostic regimens

§  In pursuit of building a competitive edge in this field, stakeholders are actively upgrading their existing capabilities and adding new competencies in order to enhance their respective service portfolios

§  Close to 300 companion diagnostic products, based on various analytical platforms, are available / under development to facilitate biomarker detection from different types of biological specimens

§  More than 80% of the companion diagnostic products have received approval for the treatment of oncological disorders; of these, 95% of the products are currently intended for use with drugs targeting solid tumors

§  A comprehensive set of profiles of prominent / emerging players offers valuable insights into their current strategic focus and future initiatives, empowering stakeholders with crucial information

§  The rising interest of stakeholders is evident from the rise in partnership activity; in fact, more than 80 agreements related to companion diagnostic development services were inked in the last two years

§  The surge in mergers and acquisitions is driven by the increasing demand of CDx; 65% of acquisition agreements were signed to incorporate additional capabilities to their existing portfolio offerings

§  As drug developers continue to build a robust portfolio of biomarker-based targeted therapies, they are actively seeking partnerships with CDx service providers, in order to leverage the latter’s expertise in this domain

§  Over the years, several big pharma players have sponsored multiple biomarker focused clinical trials; the use of companion diagnostic tests to stratify patient population in these trials offers significant cost reduction (~60%)

§  The advent of bioinformatics and artificial intelligence tools has led to the development of over 125 software applications that integrate clinical and diagnostic data to deliver personalized experience to patients

§  Over 115 players currently offer software applications for diagnostic, therapeutic and analytical purposes; these solutions are also capable of handling variable data types across a range of therapeutic areas

§  The companion diagnostic development value chain involves several drug and diagnostics developers, service providers, along with other key stakeholders, each having a discrete set of priorities and requirements

§  Driven by the increasing pace of innovation and partnership activity, the market for companion diagnostic development services is poised to witness steady growth in foreseeable future

§  The companion diagnostic development services market is anticipated to grow at a CAGR of 11%, till 2035; North America is expected to capture the majority share (over 65%) of the market by 2035

Competitive Landscape of Oligonucleotide Synthesis Market

The current market landscape features the presence of over 155 contract service providers offering a variety of services related to companion diagnostics (CDx) development; these include biomarker identification / discovery, biomarker selection / development, assay development, analytical validation, clinical validation, regulatory assistance, manufacturing and commercialization. It is worth highlighting that more than 90% of these service providers have received regulatory accreditations / certifications, namely ISO, CLIA, CAP, GLP and GCP. 

Further, the companion diagnostics (CDx) development market features the presence of small, mid-sized and large companies having the required expertise to offer contract manufacturing services across the globe. In addition, they have undertaken several initiatives, such as entering into partnerships, and expanding their existing capabilities and capacities, with the aim to actively cater to the increasing demand for companion diagnostics.

Regional Outlook

Based on the key geographical regions, the market can be segmented into three major regions, including North America, Europe and Asia Pacific. Led by the US, North America is anticipated to capture the majority share of the companion diagnostics (CDx) development market in 2024. The growth of the companion diagnostic development market in North America is driven by the stringent regulatory guidelines, and partnerships and collaborations established by various stakeholders involved in the development of companion diagnostics in this region.

CDx Development Market Key Players

Examples of key companies engaged in CDx development market (which have also been detailed profiled in this market report; the complete list of companies is available in the full report) include Almac Diagnostic Services, BGI Genomics, Eurofins, Geneuity Clinical Research Services, Labcorp, MEDICAL & BIOLOGICAL LABORATORIES, Q² Solutions, QIAGEN, Quest Diagnostics, ResearchDx

Market Segments

Based on the research, Roots Analysis has segmented the Companion Diagnostic (CDx) Development Market into Type of Service Offered, Analytical Technique Used, Target Therapeutic Area, End User and Key Geographical Regions.

by Type of Service Offered

§  Feasibility Studies

§  Assay Development

§  Analytical Validation

§  Clinical Validation

§  Manufacturing

by Analytical Technique Used 

§  NGS

§  PCR

§  IHC

§  Flow Cytometry

§  Other Analytical Techniques

by Target Therapeutic Area

§  Oncological Disorders

§  Non-oncological Disorders

by End User

§  Industry Players

§  Non-industry Players

by Key Geographical Regions 

§  North America

§  Europe

§  Asia-Pacific

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