Companion Diagnostics: Technologies and Markets

Companion Diagnostics: Technologies and Markets

  • August 2021 •
  • 254 pages •
  • Report ID: 5285120 •
  • Format: PDF
Report Scope:
This new report, “Companion Diagnostics: Global Markets,” provides a comprehensive analysis of the CDx market in the global context, including market forecasts and sales through 2026.The report analyzes the market by segmenting it into the various product offerings: consumables (reagents, kits and panels), services and software.

The segmentation also provides analysis by popular technology types such as PCR, next-generation sequencing, in situ hybridization (ISH), immunohistochemistry (IHC) and others.

This study surveys the CDx market by application into different therapeutic areas.The market is also assessed in three major geographic regions: North America, Europe and Asia-Pacific (APAC).

The APAC markets include countries like India, China, Korea, Japan, Taiwan, Australia and New Zealand.

The report features new product developments, clinical trials and patents boosting the growth of this market in the global context.

The new report provides comprehensive profiles of market players in the industry.The industry structure chapter focuses on the changing market trends, market players and their leading products.

This chapter also covers the mergers and acquisitions and any other collaborations or partnerships that happened during the evaluation period of this report that are expected to shape the industry.

Factors such as strengths, weaknesses, threats and opportunities that are expected to play a role in this market are evaluated in detail.

The scope of the report excludes the in vitro diagnostic products and their regulatory aspects. Also excluded are the nucleic acid-based tests in general, focusing solely on the companion diagnostics that meet the FDA definition.

Report Includes:
- 53 data tables and 44 additional tables
- An overview of the global market for companion diagnostic (CDx) technologies
- Analyses of the global market trends, with data from 2019-2020, estimates for 2021 and projections of compound annual growth rates (CAGRs) through 2026
- Evaluation of current market size, market forecast, and technological advancements within the industry and discussion on technical issues related to biomarker stability and storage
- Market share analysis of global CDx market by solution and type of test, technology, application, and geographic region
- Information on biomarkers, their role in precision medicine and discussion on potential use of biomarkers in the development of companion diagnostics (CDx)
- Insights into CDx approvals and FDA guidelines for new drugs and description of predictive genomic biomarkers for immunotherapy including microsatellite instability (MSI) and tumor mutational burden (TMB)
- Coverage of new CDx product developments, clinical trials, patents issued, mergers and acquisitions, partnerships, collaborations and other effective market development strategies
- Comprehensive company profiles of major industry players, including Adaptive Biotechnologies, Exact Sciences Corp., Exosome Diagnostics Inc., Foundation Medicine Inc., Myriad Genetic Laboratories Inc., Roche Molecular Systems Inc., Prometheus Biosciences, Qiagen and Thermo Fisher Scientific Inc.

Summary:
Pharmacotherapy, as we know it, is undergoing a dramatic transition.The growing knowledge that pharmacotherapy can be highly variable from one patient to another, largely driven by the patient’s genetic and phenotypic heterogeneity, has given rise to the concept of personalized or precision therapy.

Further, advances in the research and development of novel molecular biomarkers that point to single gene variations responsible for disease identification and prognosis have aided in the development of companion diagnostics (CDx) tests. A particular application of CDx is in the treatment decision process—that is, to guide the use of targeted drugs.

The employment of CDx has seen extensive adoption in the field of cancer. The development of targeted therapies that rely on specific genetic biomarkers have given a boost to the use of CDx tests that are being increasingly employed to identify the likely responders and non-responders of those therapies.This is exemplified by the 45 FDA-approved CDx and thousands of other lab-developed tests (LDTs) that are available from small- to medium-sized diagnostic laboratories. In fact, many leading specialized laboratories—namely, LabCorp, Quest Diagnostics, Myriad Genetics, Foundation Medicine, ARUP Laboratories, NeoGenomics and many others—are working towards the development of precision
medicine-directed CDx assays.

Since they benefit patients directly, CDx are proving to be efficient cost-saving tools for drug developers, healthcare systems and payers alike.Several studies and industry expert reviews have highlighted the billions of dollars’ worth of savings that are possible due to the use of CDx in medical systems.

Driven by their potential applications in clinical studies and benefits for patient populations, the CDx are gaining adoption in other disease areas as well, including neurological diseases and cardiovascular diseases, as well as potential decision-making tools for novel therapies like gene and cell therapies, among others.

A leading driver of the global CDx market is the strong collaboration and partnership environment witnessed within pharma and diagnostic developers.Several mergers and acquisitions in recent years have been focused on expanding technical expertise in the precision diagnostics sector, next-generation sequencing (NGS) assays and liquid biopsy, all of them offering opportunities in the CDx development sector.

The U.S. has been on the forefront of this market with strong support from the FDA, which encourages the adoption of state-of-the-art diagnostic methods and has extended support for codevelopment of drugs with their CDx. Other countries, including some in Europe and several in the Asia-
Pacific region, are also updating or establishing their in vitro diagnostics (IVD) regulations to adopt CDx. The reimbursement situation has also seen a positive trend in this market, with many public systems providing coverage for CDx, including NGS multiplex assays.

However, certain challenges for this market remain.The lack of coordination and misaligned financial motivations for pharma and diagnostic developers have led to a slower-than-expected development in the CDx sector.

High costs of development, need for regulatory approvals and strong competition from the LDTs have been the major challenges.