Companion Diagnostics Development Services Market (2nd Edition): Distribution by Type of Service Offered (Feasibility Studies, Assay Development, Analytical Validation, Clinical Validation and Manufacturing), Analytical Technique Used (Next Generation Seq

Companion Diagnostics Development Services 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

INTRODUCTION

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) 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, a total of 44 companion diagnostics have been approved by the USFDA. 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%.

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 companion 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 diagnostics development operations. In fact, around 80% of the companies are known to rely on third-party service providers for companion diagnostics development, primarily owing to the lack of in-house expertise for the development of these tests. As a result, many companies 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 this domain. 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 companion diagnostic developers / service providers is likely to witness a sustained growth over the coming years.

SCOPE OF THE REPORT

The “Companion Diagnostics Development Services Market (2nd Edition), 2022-2035” report features an extensive study of the current market landscape, offering an informed opinion on the likely outsourcing of diagnostic development and manufacturing operations during 2022-2035. It features an in-depth analysis, highlighting the capabilities of various stakeholders involved in the companion diagnostics development value chain. Amongst other elements, the report includes:

A detailed review of the overall landscape of the companion diagnostics development services 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 companion diagnostics service providers, 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 this domain. Each company profile includes a brief overview of the company, its financial information (if available), information on its companion diagnostics-related service portfolio, recent developments, and an informed future outlook.

A comprehensive assessment of the current market landscape of companion 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 companion 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 companion diagnostics service providers. 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 this domain, 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 this domain. 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 companion diagnostics, providing information on their commercial availability, type of molecule, route of administration, and number of corresponding marketed companion 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 diagnostic developers, service providers, 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 the report was to estimate the existing market size and the potential future growth opportunities for companion diagnostics development service providers. Based on multiple parameters, such as the service cost of various steps involved in companion 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 time 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 forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

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

Mike Klein (Chief Executive Officer, Genomenon)
Mark Kiel (Founder and Chief Scientific Officer, Genomenon)
Candace Chapman (Vice President of Marketing, Genomenon)
Anton Iliuk (President and Chief Technology Officer, Tymora Analytical Operations)
Paul Kortschak (Former Senior Vice President, Novodiax)
Pablo Ortiz (Chief Executive officer, OWL Metabolomics)
Lawrence M. Weiss (Former Chief Scientific Officer, NeoGenomics Laboratories)

MARKET SEGMENTATIONS

Companion Diagnostics Development Services: Market Segmentations
Market Segments Details
Forecast Period 2022 – 2035
Type of Service Offered Feasibility Studies
Assay Development
Analytical Validation
Clinical Validation
Manufacturing
Type of Analytical Technique Used Next Generation Sequencing (NGS)
Polymerase Chain Reaction (PCR)
Immunohistochemistry / in situ Hybridization (IHC / ISH)
Liquid Biopsy
Others
Therapeutic Areas Oncological
Non-oncological
Key Geographical Regions North America
Europe
Asia-Pacific and Rest of the World

Source: Roots Analysis

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in this domain (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 technology segments. Wherever 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

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED

Who are the leading players offering services for the development of companion diagnostics?
What are the key geographies where companion diagnostics development service providers are located?
Which analytical techniques are leveraged by the service providers engaged in this domain?
Who are the leading companion diagnostics developers?
Which biomarkers are most commonly targeted by the marketed products / investigational programs?
Which partnership models are commonly adopted by stakeholders offering companion diagnostics development services?
Which drug developers are most likely to partner with the service providers to seek their expertise?
What are the key value drivers of the merger and acquisition activity within this domain?
Which biomarker-focused targeted drugs developed by big pharmaceutical companies are likely to be administered with companion diagnostics?
How is the current and future opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES

Chapter 2 is an executive summary of the insights captured in our research. It offers a high- level view on the likely evolution of the companion diagnostics services market in the mid to 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 various analytical techniques that form the basis for such tests. In addition, the chapter highlights the key considerations while selecting a contract diagnostics partner (CDO), along with key market drivers and challenges associated with outsourcing the development and manufacturing of companion diagnostics.

Chapter 4 provides an overview of the companion diagnostics services market, including information on 150 players offering contract services for one or multiple steps involved in the development and manufacturing of companion diagnostics. It features an in-depth analysis of the industry players, based on a number of parameters, such as year of establishment, company size, ownership, geographical location of headquarters, companion diagnostics-related service portfolio (biomarker discovery / identification, biomarker development, assay development, feasibility studies, analytical validation, clinical validation, regulatory assistance, commercialization, manufacturing and other supporting services), analytical techniques used (enzyme-linked immune sorbent assay (ELISA), flow cytometry, in situ hybridization (ISH), immunohistochemistry (IHC), microarray, next generation sequencing (NGS), polymerase chain reaction (PCR), sanger sequencing and spectroscopy), and regulatory certification / accreditation (College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and International Organization for Standardization (ISO)).

Chapter 5 provides an insightful competitiveness analysis of the companion diagnostics development service providers based in North America, Europe and Asia- Pacific and Rest of the World. The analysis compares the capabilities of companies on the basis of their supplier strength (in terms of experience and company size) and service portfolio strength (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).

Chapter 6 includes detailed profiles the key players offering companion diagnostics development services. Each company profile features a brief overview of the company, its financial information (if available), information on its companion diagnostics-related service portfolio, recent developments, and an informed future outlook.

Chapter 7 provides a list of companion diagnostics along with information on their commercial availability (approved / investigational), assay technique used (enzyme-linked immune sorbent assay (ELISA), flow cytometry, in situ hybridization (ISH), immunohistochemistry (IHC), micro array, next generation sequencing (NGS), polymerase chain reaction (PCR), sanger sequencing and spectroscopy), target disease indications, therapeutic areas (oncological disorders, infectious diseases, metabolic disorders, neurological disorders, inflammatory disorders and others), type of sample analyzed (tumor tissue, blood, bone marrow and saliva), type of biomarker detected (alteration(s) in ALK, BCR, BRAF, BRCA, ErbB, MET, MSI / dMMR, NTRK, PD-L1, RAS, PGR, ROS and PIK3CA), chemical nature of biomarker (gene and protein), regulatory certification / accreditation (FDA PMA, CE Mark, MHLW, PMDA, NMPA and others) and expediated review designation (for marketed products), and year of initiation of development (for investigational programs). It also provides details on the developers, highlighting their year of establishment, company size, ownership and geographical location of their headquarters.

Chapter 8 presents an analysis of the partnerships and collaborations for companion diagnostics services established during 2017- 2021, featuring a detailed set of analyses based on various parameters, such as the type of partnership, year of partnership, analytical technique used, geographical location of involved companies and the most active players.

Chapter 9 features a list of 300+ stakeholders that are anticipated to partner with companion diagnostics services providers in the foreseen future. The players have been shortlisted based on a detailed analysis of relevant parameters, namely number of biomarker-focused clinical trials sponsored and the time to market their proprietary personalized medicine products.

Chapter 10 presents insights from a detailed analysis of the mergers and acquisitions reported in this domain, during the period 2017- 2021. It is worth mentioning that the data captured during our research was analyzed based on multiple parameters, such as year of agreement, type of deal, geographical location, size and ownership of the companies involved, key value drivers, and acquisition deal multiples (based on revenues).

Chapter 11 provides 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 this domain. 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.

Chapter 12 presents a value chain analysis featuring a discussion on various steps of the companion diagnostics development operations, namely R&D, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing activities, as well as the cost requirements across each of the aforementioned stages.

Chapter 13 provides a detailed clinical trial analysis of completed, ongoing and planned biomarker-driven oncology clinical trials sponsored by prominent big pharmaceutical companies, in the last five years. The analysis 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.

Chapter 14 is a case study presenting a list of therapies currently in use with companion diagnostics, providing information on their commercial availability, type of molecule, route of administration, and number of corresponding companion diagnostics products / 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.

Chapter 15 is a case study focused on the current market landscape of precision medicine software solutions that offer intelligent insights to facilitate informed decision making to different stakeholders in this industry. It presents a list of software solutions, along with 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 software solutions, along with analysis on their year of establishment, company size, ownership and geographical location of headquarters.

Chapter 16 presents an insightful market forecast analysis, highlighting the future potential of the companion diagnostics development and manufacturing services market, till 2035. We have segregated the opportunity of the market on the basis of Type of Service 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 Disorders), and Key Geographies (North America, Europe, Asia- Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022- 2035.

Chapter 17 summarizes the entire report, highlighting various facts related to contemporary market trend and the likely evolution of the companion diagnostics development services market.

Chapter 18 is a collection of interview transcripts of the discussions held with stakeholders in this market. In this chapter, we have presented the details of interviews held with Mike Klein, (Chief Executive Officer, Genomenon), Mark Kiel (Founder and Chief Scientific Officer, Genomenon), Candace Chapman (Vice President of Marketing, Genomenon), Anton Iliuk (President and Chief Technology Officer, Tymora Analytical Operations), Paul Kortschak (Former Senior Vice President, Novodiax), Pablo Ortiz (Chief Executive Officer, OWL Metabolomics) and Lawrence M. Weiss (Former Chief Scientific Officer, NeoGenomics Laboratories).

Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 20 is an appendix, which provides a list of companies and organizations mentioned in this report


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