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Companion Diagnostics Development Services Market is estimated to be worth over USD 800 million in 2030

Stella Wilson

In the last couple of years, a record number of personalized therapeutic products were approved in the US, establishing an urgent need for companion diagnostics and causing many drug developers to actively seek external support and expertise.

Roots Analysis is pleased to announce the publication of its recent study, titled, “Companion Diagnostics Development Services Market, 2020-2030”

The report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of diagnostic development services over the next decade. It features an in-depth analysis, highlighting the capabilities of the various stakeholders in this domain. In addition to other elements, the study includes:

  • A detailed assessment of the current market landscape of more than 180 companies offering companion diagnostics services.
  • Tabulated profiles of companion diagnostics service providers (shortlisted on the basis of the number of services offered).
  • An analysis of the partnerships that have been established in this domain, in the recent past.
  • A list of stakeholders generated based on a detailed analysis of a set of relevant parameters, which are anticipated to partner with companion diagnostics services providers in the foreseen future.
  • A detailed competitiveness analysis of companion diagnostics services providers, featuring insightful pictorial summaries and representations.
  • A comparative analysis of the needs of different stakeholders involved in this domain.
  • A discussion on various steps of the development operations of a companion diagnostic and the cost requirements across each of the stages.
  • An analysis of completed, ongoing and planned clinical trials featuring disease-specific biomarkers.

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A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Type of Services

  • Feasibility Studies
  • Assay Development
  • Analytical Validation
  • Clinical Validation
  • Manufacturing

Type of Analytical Technique

  • in situ hybridization / Immunohistochemistry
  • Next Generation Sequencing
  • Polymerase Chain Reaction
  • Others

Key Geographical Region

  • North America
  • Europe
  • Asia-Pacific and the Rest of the World
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Transcripts of interviews held with the following senior level representatives of stakeholder companies

  • Anton Iliuk (President, Chief Technology Officer Tymora Analytical Operations)
  • Paul Kortschak (Senior Vice President, Novodiax)
  • Pablo Ortiz (Chief Executive Officer, OWL Metabolomics)
  • Lawrence M. Weiss (Chief Scientific Officer, NeoGenomics Laboratories)

Key companies covered in the report

  • Almac Diagnostic Services
  • Asuragen
  • BARD1 Life Sciences
  • BioMarCare Technologies
  • Covance
  • Gencurix
  • Geneuity
  • Leica Biosystems
  • Macrogen
  • MD Biosciences
  • R-Biopharm
  • ResearchDx
  • Tepnel Pharma Services

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Chapter Outlines

Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the current state of the market for companion diagnostics services, in the short-mid-term and long term.

Chapter 3 is an introductory chapter that highlights the importance of companion diagnostics in relation to personalized medicine. The chapter describes the approaches used to develop a companion diagnostic, along with information on the various analytical techniques that form the basis for such tests. It also provides details on key market drivers and challenges within this industry.

Chapter 4 provides a list of companion diagnostics services providers. It includes information on the companion diagnostics-related service portfolio (biomarker research / identification, feasibility studies, assay development, analytical validation, clinical validation, regulatory assistance, commercialization, manufacturing and other supporting services), analytical techniques (flow cytometry, in situ hybridization (ISH), immunohistochemistry (IHC), micro array, next generation sequencing (NGS), polymerase chain reaction (PCR), and sanger sequencing), regulatory certification / accreditation, along with the information of service provider year of establishment, company size and geographical location.

Chapter 5 provides tabulated profiles of some of the leading stakeholders in this field (shortlisted on the basis of the strength of product portfolio). Each profile presents a brief overview of the company, financial information (if available) and an informed future outlook.

Chapter 6 features an elaborate analysis and discussion of the various collaborations and partnerships that have been inked amongst players since 2017. It includes a brief description of various types of partnership models that have been adopted by stakeholders in this domain. It also includes a schematic representation that showcases the companies that have established the maximum number of alliances, highlighting key analytical techniques and disease indications.

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Chapter 7 presents the of stakeholders that are anticipated to partner with companion diagnostics services providers in the foreseen future based on a detailed analysis of relevant parameters, namely, number of clinical trials sponsored by a developer and the time to market for proprietary personalized medicine products.

Chapter 8 presents a competitiveness analysis of the companion diagnostics service providers based on supplier power of the developers and portfolio strength. The analysis was designed to enable stakeholder companies to compare their existing capabilities within and beyond their respective peer groups and identify opportunities to achieve a competitive edge in the industry.

Chapter 9 provides information on the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain. The chapter qualitatively assesses the various companion diagnostics-related needs of these stakeholders, highlighting their respective perspectives regarding the importance of each need.

Chapter 10 presents a value chain analysis featuring a discussion on various steps of the development operations, namely R&D development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing activities, of a companion diagnostics and the cost requirements across each of the aforementioned stages.

Chapter 11 provides a detailed clinical trial analysis of completed, ongoing and planned studies, related to disease-specific biomarkers, being sponsored by the top pharmaceutical players. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, key indications, type of therapy, biomarkers evaluated, enrolled patient population and regional distribution of trials

Chapter 12 features a comprehensive market forecast analysis, highlighting the likely growth of companion diagnostics services market till the year 2030. We have provided inputs on the likely distribution of the opportunity based on the services offered (biomarker discovery, feasibility studies, assay development, clinical validation, analytical validation and manufacturing), assay techniques (in situ hybridization (ISH), immune histochemistry (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others), and key geographical regions (North America, Europe, Asia and rest of the world).

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Chapter 13 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the companion diagnostics industry.

Chapter 14 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of interviews held with Pablo Ortiz (Chief Executive Officer, OWL Metabolomics), Paul Kortschak (Senior Vice President, Novodiax) and Lawrence M. Weiss (Chief Scientific Officer, NeoGenomics Laboratories).

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About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

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Stella Wilson

I am an Expertise in Business Development and Marketing Management with more than 5+ years in Healthcare and Pharmaceutical Industry.

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