Companion Diagnostics Development Services Industry, 2020-2030 – Gradually Shifting from the Traditional, One-Drug-For-All Paradigm to Using Tailored Pharmacological Interventions – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Companion Diagnostics Development Services Market, 2020-2030” report has been added to ResearchAndMarkets.com’s offering

The Companion Diagnostics Development 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.

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)
• [C] key geographical regions (North America, Europe, Asia and rest of the world)

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.

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 worth 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.

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.

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.

Key Topics Covered

1. Preface

2. Executive Summary

3. Introduction

4. Market Landscape

5. Company Profiles

6. Partnerships & Collaborations

7. Likely Partner Analysis

8. Company Competitiveness Analysis

9. Stakeholder Needs Analysis

10. Value Chain Analysis

11. Clinical Research on Cancer Biomarkers: Big Pharma Perspective

12. Market Forecast and Opportunity Analysis

13. Executive Insights

14. Concluding Remarks

Companies Mentioned

• 20/20 GeneSystems
• A&G Pharmaceutical
• A4PBio
• Abbott
• AbbVie
• Abcam
• Abnova
• AccuGenomics
• Acobiom
• ACT Genomics
• Active Motif
• AdeptBio
• Adial Pharmaceuticals
• Admera Health
• Advanced Cell Diagnostics
• Agena Bioscience
• Agendia
• Agilent Technologies
• Agiomix
• Agios Pharmaceuticals
• AgriGenome Labs
• AKESOgen
• Akoya Biosciences
• Almac Diagnostic Services
• AltheaDx
• Amgen
• Amoy Diagnostics
• ANGLE
• Annoroad Gene Technology
• Applied BioCode
• ARCA Biopharma
• ArcherDX
• Array BioPharma
• ARUP Laboratories
• Ascenda Biosciences
• Aspira Pathlab and Diagnostics
• Astellas Pharma
• AstraZeneca
• Asuragen
• AurKa Pharma
• Avant Diagnostics
• Ayala Pharmaceuticals
• BARD1 Life Sciences
• Bayer
• Beaufort Services
• Beckman Coulter
• BeiGene
• BGI Genomics
• Biocartis
• Biocept
• BioChain
• Biocrates Life Sciences
• Biodesix
• BioFire Diagnostics
• BioFluidica
• BioGenex
• BioIVT
• Biolidics
• BioMarCare Technologies
• BioMarker Strategies
• Biomarker Technologies
• bioMerieux
• Biotron Healthcare
• BioVendor
• Bliss Biopharmaceutical
• Blueprint Medicines
• Bosch Healthcare Solutions
• Bristol-Myers Squibb
• Brooks Automation
• CANbridge Life Sciences
• Cancer Genetics
• Cancer Treatment Centers of America
• CancerGuide Diagnostics
• Caprion Biosciences
• Caris Life Sciences
• CD Genomics
• CeGaT
• Celgene
• Celldex Therapeutics
• Cellestis
• CENTOGENE
• Chipscreen Biosciences
• Chronix Biomedical
• CIRCULOGENE
• Clarient
• Clinical Genomics
• Clinical Reference Laboratory
• Clovis Oncology
• Co-Diagnostics
• Companion Diagnostics Network
• ConquerX
• CORE Diagnostics
• Corgenix
• Covance
• Creative Biolabs
• Curidium Medica
• Cypher Genomics
• Cyprotex
• Daiichi Sankyo
• Debiopharm Group
• deCODE genetics
• Definiens
• Delee
• DiaCarta
• Diaceutics
• DiaDx
• Diversigen
• DNAnexus
• DRG International
• Drug Response Dx
• Eisai
• EKF Diagnostics
• Eli Lilly and Company
• Elypta
• EMD Serono
• Empire Genomics
• Enzo Biochem
• Eone-Diagnomics Genome Center
• Epigenomics
• Epizyme
• Eurofins
• European Network for Gynaecological Oncological Trial Groups (ENGOT)
• European Organization for the Research and Treatment of Cancer
• Ex5 Genomics
• Exagen
• Excilone
• ExonHit Therapeutics
• Exosome Diagnostics
• and many more!

For more information about this report visit https://www.researchandmarkets.com/r/v4z5ya

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