CDx Development Market

CDx Development Market (2nd Edition): Distribution by Type of Service Offered, Analytical Technique Used, Therapeutic Areas and Key Geographies: Industry Trends and Global Forecasts, 2022-2035

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CDx Development Market Overview

The CDx development market is estimated to be worth $664 million in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 10.7% during the forecast period. Over the past few years, the improved understanding of molecular mechanisms involved in disease pathogenesis has resulted in the development of several targeted therapies. These therapies are tailored to target specific disease-related molecular signatures and require appropriate companion diagnostics (CDx diagnostics) in order to make physicians aware of patients’ unique genetic profiles, enabling them to make informed treatment related decisions. These tests are most often developed parallel to an investigational drug in order to identify the latter’s safety and efficacy and measure its therapeutic effect on the target. With the approval of trastuzumab and HercepTest™ (an IHC-based companion diagnostic assay designed for determination of HER2 overexpression) by the USFDA in 1998, several novel targeted cancer drugs guided by a diagnostic assay, have progressed into clinical stages or are approved for commercial use. In fact, since 2020, the USFDA has approved 44 CDx diagnostics, of which, three CDx targeted therapies were approved for advanced ovarian cancer, breast cancer and non-small cell lung cancer. Further, a study of nearly 200 unique pharmacological interventions evaluated across more than 670 clinical trials, suggests that the likelihood of a lead compound passing through various phases of clinical development and eventually getting approved is only 11%. The use of disease-specific biomarker information to recruit patients not only increases the success rates of the studies, but also reduces the trial costs by nearly 60%.

This image provides list of Companion Diagnostics Development Service Providers. Over 150 service providers presently claim to have the required expertise to support multiple steps involved in companion diagnostic test development; ~30% of these are established players with more than 500 employees This image presents current market landscape of Companion Diagnostics Development Service Providers. A gamut of services are being offered to develop analytical tests identifying disease specific biomarkers; so far, oncology seems to be the most popular area where developers are exploring personalized diagnostic regimens This image highlights competitive analysis of players engaged in the domain of Companion Diagnostics Development Services. In order to successfully navigate the evolving regulatory landscape, the needs of innovators are evolving; as a result, service providers are constantly expanding their portfolios to cater to customized requests of their clients

Given the various benefits, the healthcare industry is gradually shifting from the conventional, one-drug-for-all, paradigm to using tailored pharmacological interventions, which is expected to increase the need for CDx diagnostics as well. However, given the complexities involved in the co-development of a drug and the affiliated companion diagnostic test, drug developers have demonstrated the preference to outsource the CDx diagnostics operations. In fact, around 80% of the companies are known to rely on third-party service providers  / cdx development company for CDx diagnostics, primarily owing to the lack of in-house expertise for the development of these tests.  As a result, many CDx development company have made heavy investments in order to install robust tools and technologies, such as polymerase chain reaction (PCR), immunohistochemistry (IHC), in situ hybridization (ISH), next generation sequencing (NGS) and offer end-to-end services to sponsor companies engaged in CDx development market. In addition to conventional analytical techniques, several innovators have made latest upgrades in their portfolio by installing novel solutions, including digital PCR (dPCR) and digital immunoassay, in order to cater to the evolving needs of their customers. Given the growing demand for personalized therapies and ongoing innovations in technologies, we are led to believe that the opportunity for CDx development company is likely to witness a sustained market growth during the forecast period.

Key CDx Development Company in CDx Development Market

Examples of key companies engaged in CDx development market (which have also been profiled in this market report; the complete list of CDx development company is available in the full report) include Almac Diagnostic Services, Biocartis, BGI Genomics,  Cerba Research, Eurofins, Geneuity Clinical Research Services, Interpace Biosciences, Labcorp (formerly known as Covance), MEDx (Suzhou) Translational Medicine, MEDICAL & BIOLOGICAL LABORATORIES (MBL), MLM Medical Labs, Novogene, QIAGEN, Quest Diagnostics, Q² Solutions and ResearchDx. This CDx development market report includes an easily searchable excel database of all the CDx development company providing CDx diagnostics services, worldwide.

Recent Developments in CDx Development Market:

Several recent developments have taken place in the field of CDx diagnostics. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In August 2023, Tempus announced that the FDA has granted the breakthrough device designation for its HLA-LOH assay as a companion diagnostic (CDx) test. The test will use machine learning model to analyze sequence data. 
  • In July 2023, Allarity Therapeutics and DRP® Companion Diagnostics inked a deal with FivepHusion in order to support clinical development of Deflexifol™ used for the treatment of solid tumors. 
  • In July 2023, Tempus announced collaboration with TScan Therapeutics with an aim to develop a companion diagnostic (CDx) test for patients suffering from cancer.

Scope of the Report

The CDx Development Market (2nd Edition): Distribution by Type of Service Offered (Feasibility Studies, Assay Development, Analytical Validation, Clinical Validation and Manufacturing), Analytical Technique Used (Next Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Immunohistochemistry / in situ Hybridization (IHC / ISH), Liquid Biopsy and Others), Therapeutic Areas (Oncological and Non-oncological) and Key Geographies (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022-2035 market report features an extensive study of the current market landscape, market size, market forecast and future opportunities for the companies involved in CDx diagnostics development and manufacturing operations during forecast period 2022-2035. It features an in-depth analysis, highlighting the capabilities of various stakeholders involved in the CDx diagnostics development value chain.

This image provides list of Companion Diagnostic Tests. More than 220 in-vitro diagnostic tests, based on various analytical platforms, are available / under development to facilitate biomarker detection from different types of biological specimens This image presents current market landscape of Companion Diagnostic Tests. Over 45% of the companion diagnostic tests have received approvals from regulatory bodies operating in various regions, primarily for the purpose of detecting alterations in oncogenes associated with various tumor types This image presents the likely partner analysis. 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

Amongst other elements, the market report includes:

  • A detailed review of the overall landscape of the CDx diagnostics market, highlighting the contributions of industry players, along with information on their year of establishment, company size, ownership, geographical location of headquarters, types of services offered, types of analytical techniques used, therapeutic areas assessed and regulatory certifications / accreditations.
  • A region-wise competitiveness analysis of companies, highlighting the prominent CDx development company, by taking into consideration their supplier power (in terms of their experience and company size) and portfolio specifications (in terms of number of services offered, number of analytical techniques used, therapeutic areas assessed, and number of precision medicine related deals signed since 2017).
  • Elaborate profiles of prominent service providers in CDx development market. Each company profile includes a brief overview of the company, its financial information (if available), information on its CDx diagnostics related service portfolio, recent developments, and an informed future outlook.
  • A comprehensive assessment of the current market landscape of CDx diagnostics that are either marketed / being developed by various stakeholders, providing information on the assay technique used, target disease indication, therapeutic areas, type of biomarker detected and its chemical nature, type of sample used, regulatory authority involved and expediated review designation (for marketed products), and year of initiation of development (for investigational programs). It also provides details on the diagnostic developers, highlighting their year of establishment, company size, ownership and geographical location of their headquarters.
  • An analysis of the partnerships and collaborations established for CDx diagnostics services during 2017- 2021, featuring a detailed set of analyses based on various parameters, such as the type of partnership, year of partnership, therapeutic areas involved, geographical location of the companies involved and the most active players.
  • An insightful analysis of companies segregated on the basis of their likelihood to enter into collaborations with CDx development company. The chapter features a list of 300+ drug developers sponsoring clinical trials of therapies targeting several disease-specific biomarkers. The players have been shortlisted based on relevant parameters, namely number of biomarker-focused clinical trials sponsored and the time to market their proprietary personalized medicine products.
  • A detailed analysis of various mergers and acquisitions of companies in CDx development market, highlighting the trend in the number of companies acquired during the time period between 2017- 2021, based on several relevant parameters, such as year of agreement, type of deal, geographical location of headquarters, company size, key value drivers and acquisition deal multiples (based on revenues). In addition, it presents an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain.
  • A qualitative assessment of the current and long-term needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in CDx development market. In addition, it highlights key areas of concerns associated with this industry, along with our opinion (based on past and prevalent trends) on how the industry is anticipated to address them over the coming years.
  • A value chain analysis featuring a discussion on various steps of development operations, namely R&D, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing activities, of a companion diagnostic, as well as the cost requirements across each of the aforementioned stages.
  • An assessment of the completed, ongoing and planned biomarker-driven oncology clinical trials sponsored by prominent big pharmaceutical companies, in the last five years. The chapter highlights the key trends associated with these clinical studies across various parameters, such as trial registration year, phase of development, trial sponsors, recruitment status, therapy design, enrolled patient population, popularity of biomarkers, and popularity of target indications. 
  • A case study on various therapies in use with CDx diagnostics, providing information on their commercial availability, type of molecule, route of administration, and number of corresponding marketed CDx diagnostics products / investigational programs. In addition, it provides details on drug developers, including information on their year of establishment, company size, ownership and geographical location of their headquarters.
  • A case study on the current market landscape of precision medicine software solutions that offer intelligent insights to CDx development company, patients and healthcare experts, for making informed decisions.  The chapter features information on the type of platform utilized, purpose of software solution, type of data processed, therapeutic area, and types of end users. In addition, it presents a list of developers of the software solutions, along with analysis on their year of establishment, company size, ownership and geographical location of headquarters.

One of the key objectives of this market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity for CDx development company. Based on multiple parameters, such as the service cost of various steps involved in CDx diagnostics development and manufacturing, and partnerships inked in the last few years for outsourcing of such operations, we have developed informed estimates on the evolution of the market for the forecast period 2022- 2035. Our year-wise projections of the current and forecasted opportunity have further been segmented across key services offered (feasibility studies, assay development, analytical validation, clinical validation and manufacturing), analytical techniques used (NGS, PCR, IHC-ISH, liquid biopsy and Others), therapeutic areas (oncological and non-oncological), and key geographical locations (North America, Europe and Asia- Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.  In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

This image provides information about completed, ongoing and planned clinical studies of biomarker-driven oncology. 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%) This image highlights the analysis of Companion Diagnostic Development Value Chain and Stakeholder Needs. 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 This image highlights the market segments of Companion Diagnostics Development Services Market. The surge in activity within the companion diagnostics market, anticipated to register a growth rate of ~15% in the next decade, is likely to offer immense opportunities to service providers engaged in this domain

The opinions and insights presented in the market report were influenced by discussions held with several key players in CDx development market. The market research report features detailed transcripts of interviews held with the following industry stakeholders: 

  • 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

Frequently Asked Questions

Question 1: What is companion diagnostics?

Answer: Companion diagnostics refer to a class of medical devices, primarily used as an in-vitro diagnostic (IVD) device, providing information for the safe and effective use of a pharmaceutical or biological product.

Question 2: How big is the CDx development market?

Answer: The CDx development market size is estimated to be worth $664 million in 2022.

Question 3: What is the projected market growth of the CDx development market?

Answer: The CDx development market is expected to grow at compounded annual growth rate (CAGR) of 10.7% during the forecast period 2022 - 2035.

Question 4: Who are the leading companies in the CDx development market?

Answer: Examples of key companies engaged in CDx development market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Almac Diagnostic Services, Biocartis, BGI Genomics, Cerba Research, Eurofins, Geneuity Clinical Research Services, Interpace Biosciences, Labcorp (formerly known as Covance), MEDx (Suzhou) Translational Medicine, MEDICAL & BIOLOGICAL LABORATORIES (MBL), MLM Medical Labs, Novogene, QIAGEN, Quest Diagnostics, Q² Solutions and ResearchDx.

Question 5: How many companies are currently engaged in the CDx development market?

Answer: Presently, more than 150 companies are engaged in the CDx development market.

Question 6: How many companion diagnostic tests have received approval from regulatory bodies till date?

Answer: Till date, over 45% of the companion diagnostic tests have received approval from various regulatory bodies, for detecting alterations in oncogenes associated with tumors.

Question 7: Which region is the hub for companies engaged in the CDx development market?

Answer: North America emerged as the hub for companies engaged in the CDx development market, with over 40% of the players established in the region.

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