COMPANION DIAGNOSTICS (CDX) DEVELOPMENT MARKET: OVERVIEW
As per Roots Analysis, the global companion diagnostics (CDx) development market is estimated to grow from USD 892 million in current year to USD 1,796 million by 2035, at a CAGR of 7.3% during the forecast period, till 2035.
The market sizing and opportunity analysis has been segmented across the following parameters:
Type of Services Offered
- Feasibility Studies
- Assay Development
- Analytical Validation
- Clinical Validation
- Manufacturing
Analytical Techniques Used
- NGS
- PCR
- IHC
- Flow Cytometry
- Others
Target Therapeutic Area
- Oncological Disorders
- Non-oncological Disorders
End User
- Industry Players
- Non-industry Players
Key Geographical Regions
- North America
- Europe
- Asia-Pacific
COMPANION DIAGNOSTICS (CDX) DEVELOPMENT MARKET: GROWTH AND TRENDS
A companion diagnostic is a type of in-vitro diagnostic (IVD) device / test that enables researchers to collect crucial information for the safe and efficient use of a compatible drug or biological product. Recently, there has been a gradual shift towards understanding the molecular mechanisms involved in disease pathogenesis, and the information collected from companion diagnostic tools aids in the development of targeted therapies to treat these diseases. As a result, companion diagnostics have 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 that, since 2022, the FDA has approved close to 44 CDx diagnostics. 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. However, the development of such tests is a long process that starts from the identification of a suitable biomarker (specific to a particular disease indication) and extends to validating a precise method for detecting and quantifying its presence in biological samples. Given the complexities involved in the development of such diagnostic tests, drug developers prefer outsourcing this process to contract service providers having the necessary expertise.

Presently, numerous companies claim to offer a variety of services for diagnostic development, including biomarker identification and discovery, biomarker selection and validation, assay development, analytical validation, clinical validation, commercialization, manufacturing, services related to companion diagnostic kits, reagent development and regulatory assistance.
COMPANION DIAGNOSTICS (CDX) DEVELOPMENT MARKET: KEY INSIGHTS
The report delves into the current state of the companion diagnostics (CDx) development market and identifies potential growth opportunities within the industry. Some key findings from the report include:
- 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.
- 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 for CDx; 65% of acquisition agreements were signed to incorporate additional capabilities into 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 experiences 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.
- The companion diagnostic development services market is anticipated to grow at a CAGR of 7.3%, till 2035; North America is expected to capture the majority share (over 65%) of the market by 2035.

COMPANION DIAGNOSTICS (CDX) DEVELOPMENT MARKET: KEY SEGMENTS
Clinical Validation Service Segment Occupies the Largest Share of the Companion Diagnostics (CDx) Development Market
Based on the type of services offered, the market is segmented into feasibility studies, assay development, analytical validation, clinical validation and manufacturing. At present, the clinical validation service segment holds the maximum share of the global companion diagnostics (CDx) development market. Additionally, the analytical validation service segment is likely to grow at a faster pace during the forecasted period.
By Analytical Techniques Used, IHC (Immunohistochemistry) is the Fastest Growing Segment of the Global Companion Diagnostics (CDx) Development Market
Based on the analytical techniques used, the market is segmented into NGS, PCR, IHC, flow cytometry and others. Currently, the next generation sequencing (NGS) segment captures the highest proportion of the global companion diagnostics (CDx) development market owing to the various benefits offered by this analytical technique, such as lower sample input, higher throughput and greater sensitivity. Further, the companion diagnostics (CDx) development market for the IHC segment is likely to grow at a relatively higher CAGR.
Oncological Disorders Segment Occupies the Largest Share of the Companion Diagnostics (CDx) Development Market by Target Therapeutic Area
Based on the target therapeutic area, the market is segmented into oncological disorders and non-oncological disorders. At present, companion diagnostics for oncological disorders hold the maximum share of the companion diagnostics (CDx) development market. This trend is likely to remain the same during the forecasted period. Further, it is worth highlighting that the companion diagnostics (CDx) development market for non-oncological disorders segment is likely to grow at a relatively higher CAGR.
Currently, the Industry Players Segment Holds the Largest Share of the Companion Diagnostics (CDx) Development Market
Based on end user, the global market is segmented into industry players and non-industry players. Currently, the industry players segment holds the largest market share. However, the companion diagnostics (CDx) development market for non-industry players segment is expected to witness substantial growth in the coming years.
North America Accounts for the Largest Share of the Market
Based on key geographical regions, the market is segmented into North America, Europe and Asia-Pacific. Currently, North America dominates the global companion diagnostics (CDx) development market and accounts for the largest revenue share. However, the market in Europe is expected to grow at a higher CAGR in the coming years.
Example Players in the Companion Diagnostics (CDx) Development Market
- Almac Diagnostics
- BGI Genomics
- Eurofins
- Geneuity Clinical Research Services
- Labcorp
- MEDICAL & BIOLOGICAL LABORATORIES
- Q2 Solutions
- QIAGEN
- Quest Diagnostics
- ResearchDx
COMPANION DIAGNOSTICS (CDX) DEVELOPMENT MARKET: RESEARCH COVERAGE
- Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global companion diagnostics (CDx) development market, focusing on key market segments, including [A] type of services offered, [B] analytical techniques used, [C] target therapeutic area, [D] end user and [E] key geographical regions.
- Service Providers Market Landscape: A comprehensive evaluation of the companion diagnostics (CDx) development industry players, based on several relevant parameters, such as [A] year of establishment, [B] company size, [C] ownership, [D] geographical location of headquarters, [E] types of services offered, [F] affiliated services, [G] AI support, [H] analytical techniques used, [I] therapeutic areas and [J] regulatory certifications / accreditations.
- Company Competitiveness Analysis: A comprehensive competitive analysis of service providers in the companion diagnostics (CDx) development industry, examining factors, such as [A] developer strength and [B] product portfolio strength.
- Detailed Company Profiles: In-depth profiles of key service providers engaged in the companion diagnostics (CDx) development market, focusing on [A] overview of the company, [B] financial information (if available), [C] service portfolio, and [D] recent developments and [E] an informed future outlook.
- Short Company Profiles: Tabulated profiles of key service providers engaged in the companion diagnostics (CDx) development market, focusing on [A] overview of the company and [B] service portfolio.
- Companion Diagnostic Products Market Landscape: A comprehensive evaluation of the companion diagnostic products, based on several relevant parameters, such as [A] analytical techniques used, [B] target disease indication, [C] therapeutic areas, [D] type of biomarker detected, [E] type of sample used, [F] regulatory authority involved, [G] expediated review designation, [H] leading companion diagnostic developers and [I] most popular companion drugs. Additionally, a comprehensive evaluation of the companion diagnostic developers, based on several relevant parameters, such as [J] year of establishment, [K] company size, [L] ownership and [M] geographical location of headquarters.
- Partnerships and Collaborations: An insightful analysis of the deals inked by stakeholders in the companion diagnostics (CDx) development market, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] type of technology, [D] target therapeutic area, [E] type of partner, [F] most active players (in terms of the number of partnerships signed) and [G] geographical distribution of partnership activity.
- Likely Partner Analysis: An in-depth analysis of 300+ drug developers sponsoring clinical trials of therapies targeting several disease-specific biomarkers, shortlisted based on relevant parameters, such as [A] number of biomarker-focused clinical trials sponsored and [B] time to market their proprietary personalized medicine products.
- Mergers and Acquisitions: An in-depth analysis of various mergers and acquisitions in this domain, based on relevant parameters, such as [A] year of agreement, [B] type of deal, [C] geographical location of headquarters, [D] company size, [E] key value drivers and [F] acquisition deal multiples (based on revenues). Additionally, an ownership change matrix provides a summary of the involvement of private and public sector companies in this domain.
- Stakeholder Needs Analysis: An insightful analysis of the current and long-term needs of different stakeholders, along with the key areas of concern associated with this industry.
- Value Chain Analysis: An in-depth analysis of the companion diagnostics value chain, based on various relevant parameters, such as [A] various steps of development operations and [B] the cost requirements across each step.
- Big Pharma Initiatives: An in-depth analysis of oncology clinical trials sponsored by prominent big pharmaceutical companies in the companion diagnostics domain, based on various relevant parameters, such as [A] trial registration year, [B] phase of development, [C] trial sponsors, [D] recruitment status, [E] therapy design, [F] enrolled patient population, [G] popularity of biomarkers and [H] popularity of target indications.
- Case Study: A detailed discussion on the current market landscape of precision medicine software solutions that offer intelligent insights to diagnostic developers, service providers, patients and healthcare experts, based on [A] type of platform utilized, [B] purpose of software solution, [C] type of data processed, [D] therapeutic area, and [E] types of end users. Additionally, a comprehensive evaluation of software solutions developers, based on several relevant parameters, such as [A] year of establishment, [B] company size, [c] ownership and [D] geographical location of headquarters.
- Market Impact Analysis: A thorough analysis of various factors, such as drivers, restraints, opportunities, and existing challenges that are likely to impact market growth.
KEY QUESTIONS ANSWERED IN THIS REPORT
- How many companies are currently engaged in this market?
- Which are the leading companies in this market?
- What factors are likely to influence the evolution of this market?
- What is the current and future market size?
- What is the CAGR of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
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