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Companion Diagnostics Services Market, 2020-2030

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INTRODUCTION Personalized medicine has brought about a paradigm shift within the healthcare sector. However, therapies tailored to specific disease-related molecular signatures require appropriate companion diagnostics in order to make physicians aware of patients’ unique genetic profiles, enabling them to make informed treatment related decisions.

New York, March 24, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Companion Diagnostics Services Market, 2020-2030" - https://www.reportlinker.com/p05877765/?utm_source=GNW
In fact, a clinical study of nearly 200 unique pharmacological interventions, which were 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 same study pointed out that using disease-specific biomarker information (indicative of susceptibility to particular types of therapeutics) to recruit patients for clinical research has been associated with a manifold increase in trial success rates. In addition, it is w+orth noting that companion diagnostics guided drug development efforts have demonstrated to effectively reduce clinical trial costs by almost 60%.

Given the aforementioned advantages, the industry is gradually shifting from the traditional, one-drug-for-all, paradigm to using tailored pharmacological interventions. This shift is subsequently expected to increase the demand for companion diagnostics. However, given the complexity associated with the co-development of a drug and a corresponding companion diagnostic test, pharmaceutical developers have shown preference to outsource the diagnostics development operations. In fact, nearly 80% of the companies are known to rely on external diagnostics developers for companion diagnostics development, mostly owing to the lack of in-house expertise. As a result, numerous contract service providers are striving to expand their respective portfolios and developing the capabilities to offer end-to-end services to sponsor companies in this domain. Amidst tough competition, the availability of cutting-edge tools and technologies (such as in situ hybridization (ISH), immunohistochemistry (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR)) has emerged as a differentiating factor and is likely to grant a competitive advantage to certain service providers over other players in the industry.

SCOPE OF THE REPORT
The “Companion Diagnostics Services Market, 2020-2030” 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 companies offering companion diagnostics services, including information on the type of services offered, type of analytical technique used and regulatory certifications / accreditations, and other company-specific details (such as year of establishment, company size and geographical location).
• Tabulated profiles of companion diagnostics service providers (shortlisted on the basis of the number of services offered), featuring an overview of the company, its financial information (if available), and companion diagnostics-related service portfolio details. In addition, each profile includes a list of the likely strategies that may be adopted by these players to support future growth.
• An analysis of the partnerships and collaborations pertaining to companion diagnostics services from 2017 to 2019, featuring a detailed set of analyses based on various parameters, such as the type of partnership, year of partnership, analytical technique used and the most active players.
• A list of stakeholders generated based on a detailed analysis of a set of relevant parameters (namely number of clinical trials sponsored by a developer and the time to market for proprietary personalized medicine products), which are anticipated to partner with companion diagnostics services providers in the foreseen future.
• A detailed competitiveness analysis of companion diagnostics services providers, taking into consideration the supplier power (based on the year of establishment of developer) and key specifications, such as portfolio strength, type of available technology platform, number of deals signed between 2017-2019.
• A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain.
• A discussion on various steps of the development operations, namely research and development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing / sales activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages.
• An analysis of completed, ongoing and planned clinical trials featuring disease-specific biomarkers. 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.

One of the key objectives of the report was to estimate the existing market size and the future opportunity for companion diagnostic services providers, over the next decade. Based on multiple parameters, we have provided informed estimates on the evolution of the market for the period 2020-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] key services offered (biomarker discovery, assay development, clinical validation, analytical validation and manufacturing), [B] analytical techniques used (ISH, IHC, NGS, PCR and others), and [C] key geographical regions (North America, Europe, Asia 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.

The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of discussions held with the following industry stakeholders:
• Pablo Ortiz (Chief Executive Officer, OWL Metabolomics)
• Paul Kortschak (Senior Vice President, Novodiax)
• Lawrence M. Weiss (Chief Scientific Officer, NeoGenomics Laboratories)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via primary and secondary research. For most of our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts’ views

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.

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).

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).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 16 is an appendix, which contains a list of companies and organizations mentioned in this report.
Read the full report: https://www.reportlinker.com/p05877765/?utm_source=GNW

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