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Targeted therapeutics and companion diagnostics are the pillars of personalised medicine. Personalised medicine is a genome-based therapeutic approach that aims to adopt customised treatment for each individual. It uses aspects of genetic testing for checking potential abnormalities and tailoring the treatment so as to make it as individualised as the disease itself.
Targeted drugs have been fast to overshadow the traditional drugs, which favour the concept of one-size-fits-all. This has primarily been due to their superior efficacy and safety profile. More recently, several targeted drugs are being developed in association with a companion diagnostic test, which aids the identification of target population most likely to benefit from the therapy. The biopharmaceutical industry has been sceptical and slow to adopt the concept of companion diagnostics, as it limits the target population for the drug. However, their use also allows the companies to command premium prices in the market for their targeted drugs. Several companion drugs have reached blockbuster status even after targeting a limited audience, including Herceptin and Glivec.
Both large and small biopharmaceutical companies are now actively developing drug-diagnostic combination products. The success of Herceptin and Glivec has proved that the benefits of use of companion diagnostics far outweigh the challenge of limited target population. In this report, we look at the extent of use of some popular companion diagnostic tests - Her-2/neu, KRAS, EGFR and c-kit - across some leading national markets.
The journey of a biomarker to a companion diagnostic is a long one, with the regulatory authorities favouring the co-development and approval of companion drug and diagnostic. Although complex, the pipeline for companion diagnostics is rich. In the future, the launch and success of drugs will also be governed by successful development of a commercial companion diagnostic test. The 2013-2023 period will see the launch of numerous new companion diagnostics. We have explored the opportunities for growth in this niche market for both pharmaceutical and diagnostic companies, presented case studies of some marketed drug-diagnostic combinations, analysed the rich pipeline and looked at the recent collaborations that will drive this market. Additionally, we have also analysed the current and future state of the molecular and tissue diagnostics market, to which all companion diagnostic tests belong.