GlobalData, a leading global research and consulting firm, reports that the US will remain the leading market for cancer companion diagnostics, with its value expanding from $262.4 million in 2014 to an estimated $365.4 million by 2020, when it will account for just over 54% of the projected global share.

The company’s report states that the regulatory landscape in the US will be a key market driver throughout the forecast period, as the US Food and Drug Administration (FDA) requires the development of a companion diagnostic test before any new therapeutic drug is approved.

According to Andrew S. Thompson,  GlobalData’s senior analyst covering In vitro Diagnostics, a drug manufacturer must develop a diagnostic test that meets the FDA’s requirements for an approved in vitro diagnostic product before the therapeutic product can gain approval.

Thompson explains: “The diagnostic test must satisfy FDA criteria in efficacy, quality and manufacture, as it is an intrinsic part of the treatment process, not just something to be used within a clinical trial.

“Generally, non-FDA-approved diagnostic tests have greater difficulty in receiving reimbursement than FDA-approved tests. However, FDA approval does not necessarily mean the test is reimbursed, neither does a lack of FDA approval necessarily preclude reimbursement.”

Other significant drivers of cancer companion diagnostics market growth include increasing disease incidence, accelerating demand for targeted therapies and economic pressures to develop maximally efficient treatments.



GlobalData’s report also states that of the ten major countries, namely the US, France, Germany, Italy, Spain, the UK, Japan, India, Brazil, and China, the fastest growth will be seen in China, with its market value expanding at a Compound Annual Growth Rate (CAGR) of 17.3% to reach $33.3 million by 2020.

Thompson continues: “In China, breast cancer companion diagnostic tests will continue to contribute more than half the market share throughout the forecast period, bucking the global trend of dominance by non-small cell lung cancer testing.

“It is anticipated that virtually all urban women diagnosed with breast cancer in China will receive a HER2 immunohistochemistry test within a decade, as a result of efforts by Chinese professional societies and Roche to improve and standardize HER2 testing,” the analyst concludes.