Companion Diagnostics Market Intelligence

*This report was last updated in Q4 2018. Please click on request customization if you are looking for an updated version of this report

Report Coverage

  • Oncology Companion Diagnostic Partnerships
  • Companion Diagnostic Technologies

Market Size

Global Market Size

$5.8 Bn


22.7 Percent

Market Size North America

$2.03-2.32 Bn

Table of contents

  1. Executive Summary
  1. Companion Diagnostics Precision Medicine Trends
  1. Companion Diagnostic Technologies
  1. Companion Diagnostic Co-Development Models
  1. Oncology Companion Diagnostic Partnerships

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Global Market Outlook on Companion Diagnostics

Companion diagnostic market was $5.8 billion in 2017 and will grow at a CAGR of 22.7 percent during 2018–2023. North America holds the largest market share, accounting approximately 35–40 percent of the global market.Increasing demand for personalized medicines and growing awareness among the population coupled with rising cases of adverse drug reactions related to drugs has been driving the need for companion diagnostics. Oncology accounts for the maximum market share (70 percent), in terms of indications, and is followed by other indications, like neurology, infectious disease, and cardiovascular.

Over 30 percent of new drug approved in 2017 were personalized medicines. The therapies approved in 2017 targeted cancer (e.g., breast cancer, metastatic Merkel cell carcinoma, non-small cell lung cancer, and myeloid leukemia), orphan diseases (e.g., CLN2 batten disease and mucopolysaccharidosis type VII (Sly syndrome), and infectious disease, such as hepatitis C.

  • Next generation sequencing and liquid biopsy are the technology catalysts for companion diagnostics
  • All the major suppliers have competitive technology and compete with each other for partnership with biopharmaceutical clients
  • Partnership deals are common, and many biopharma have multiple partners for the development of companion diagnostics

Precision Medicine Trends

Precision medicine beyond oncology

  • Oncology currently dominate the precision medicine and companion biomarker research space for targeted therapeutics, However, there has been a shift in industry to other therapeutic areas, like diabetes, inflammatory diseases, neurosciences, and infectious diseases (HIV and hepatitis)
  • Recent study has suggested that 93 percent of the current phase 3 pipelines are diagnostic dependent (i.e., targeted therapeutics) and about two-thirds are focused on non-oncology areas

Precision medicine harnessing big data capabilities

  • Precision medicine holds the promise of looking beyond the intrinsic omics factors and incorporating exogenous endpoints by capturing critical data, such as family history, food habits, alcohol intake, smoking, weight, salt intake, activity, etc., utilizing big health platforms
  • E.g., there are many innovative digital health coaching platforms available and many alternative therapies for the prevention and management of acute chronic health conditions, like wellness programs with proven behavioral therapies, such as Omada (digital behavioral therapies for diabetes patients) and Zipongo (personalized nutrition solutions)

Precision medicine boosting healthcare consumerism

  • With digital healthcare solutions, people are becoming more receptive to healthcare information and want to actively participate in their healthcare decision-making process
  • Precision medicine provides a sense of accountability for patients and their caregivers through evolving consumer-centric care business models, such as direct-to-consumer (DTC) diagnostics, telehealth, and e-prescriptions, which promotes awareness and cost transparency for lab procedures, hospital visits, and medications.
  • This, in turn, will provides patients with greater clarity about the actual cost of care for their specific health condition, making them more conscious of their health, and therefore, reducing the overall cost burden


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