On April 14, 2003, the $3 billion Human Genome Project, funded by the US Department of Energy (DoE) and the National Institutes of Health (NIH), was completed 13 years after it began. Determining the sequence of the 3 billion letters in the DNA of human beings has ushered in significant advances in medicine in the past 10 years. One of these advancements is companion diagnostics (CDx) tests or tests that match the right therapy to the patient. A recent Frost & Sullivan analysis has revealed there are fewer regulatory barriers in Europe when it comes to companion diagnostics, which greatly benefits this procedure.
According to the Food and Drug Administration (FDA), companion diagnostics are tests that provide information about a patient’s genetic and genomic characteristics, which are used to guide decisions about treatment with specific drugs.With the price of a fully sequenced human genome now available for $1,000 compared to the hundreds of millions of dollars it costs for the earliest genomes to be sequenced, it is now possible to find therapies designed specifically for each patient.
The Frost & Sullivan analysis has found companion diagnostics testing is expected to grow to $1.295 billion in 2018. Although the focus is currently in oncology, CDx can be applied towards any condition including central nervous system, infectious diseases, cardiovascular conditions and more.
The report indicates the Western European CDx market is expected to grow at CAGR of 23.2 percent until the forecast period. The study covers breast cancer, colorectal cancer, and lung cancer panel segments as well as non-oncology diseases for Western Europe, including the United Kingdom, Germany, Italy, France, Spain, Benelux and Scandinavia.
"Limited regulatory barriers for drug and diagnostic combination products, which the current in-vitro diagnostic directive classifies under the low-risk category, are easing market access. As nearly all diagnostic tests in Europe belong to the low risk category, they are exempt from pre-market evaluation. Consequently, manufacturers tend to self-assess conformity, self-certify CDx products, and CE mark them before sale in the European market," said Frost & Sullivan Healthcare Senior Industry Analyst Divyaa Ravishankar.
According to Ravishankar, this relaxed process is responsible for the high rate of approval of new CDx tests and products in this region. But he foresees competition from laboratory developed tests (LDT) manufacturers hampering market growth.
The potential for CDx is huge to say the least as it has proven highly effective by providing targeted and effective treatments. This has led to an increase in pharmaceutical companies partnering with diagnostic firms to develop and produce these diagnostics, because they are able to achieve the most likely and successful therapy.
Edited by
Allison Sansone
