Twelve new game-changing drugs are predicted to achieve blockbuster status by 2022, according to the newly released 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics.
More blockbusters — drugs projected to achieve $1 billion in sales within five years — have been predicted to launch in 2018 than in any other year since the Drugs to Watch report began in 2013. This year we’ve identified four biologicals, one RNAi-based drug, one vaccine and six small molecules that have blockbuster potential.
This record number of projected blockbusters reflects the continued innovation within the pharmaceutical industry, which has been spurred by strategies such as stratifying patients for clinical trials and harnessing the use of biomarkers for targeting treatments. Progress has also been fuelled by partnerships between sharply focused biotech firms and deep-pocketed pharma companies.
More than half of the projected blockbusters have been granted priority review, breakthrough therapy or fast-track designations by the US FDA. Five of the 12 drugs we identified are first-in-class and four are indicated for orphan diseases. Streamlining of regulatory channels has helped to reduce the time it takes to get a drug to market, which has contributed to our record blockbuster forecasts for 2018.
In stark contrast to 2017, where more than half of the drugs on our blockbuster list were cancer treatments, only one blockbuster expected to launch in 2018 is for cancer – Erleada (apalutamide).
Our projections for the Drugs to Watch report were derived from Cortellis – a comprehensive biopharma database that brings together information gathered from diverse industry sources such as annual filings, drug pipelines, patents, clinical trial read-outs, deal documents, company announcements and conference presentations.
Following an advanced analysis of the database, a shortlist of drugs were manually researched and evaluated by life-science experts at Clarivate, who reviewed each drug in its individual context and assessed clinical trial results, regulatory data, market data and regulatory designations for each drug.
The blockbuster drugs that we have identified in our report cover a wide range of therapeutic areas, including type 2 diabetes, endometriosis, childhood epilepsy, hemophilia, HIV, migraine, opioid addiction and shingles.
Here is as closer look at a few of the projected blockbusters:
Aimovig (erenumab) from Amgen and Novartis: After little movement for many years, the migraine prevention market is about to undergo transformation with several novel calcitonin gene-related peptide (CGRP) receptor inhibitors poised to enter the market from 2018 onwards. A first-to-market advantage will be crucial for Aimovig since competition from two other subcutaneously administered monoclonal antibodies targeting CGRP is not very far behind.
Biktarvy (tenofovir alafenamide + emtricitabine + bictegravir) from Gilead: Gilead's HIV triplet comprising the nucleoside reverse transcriptase inhibitor tenofovir alafenamide, the nucleoside reverse transcriptase inhibitor emtricitabine and the novel integrase inhibitor bictegravir offers an effective and simple treatment option for patients with HIV. It is forecast to achieve sales in excess of $3 billion and will help Gilead cement its leading position in the HIV market.
Ozempic (semaglutide) from Novo Nordisk: As we predicted in our 2017 report, Novo Nordisk's weekly GLP1 analog was approved for use in patients with type 2 diabetes in the same year based on positive data from the SUSTAIN clinical trial program. However, the late approval in December 2017 delayed the expected year-end launch to February 2018. Despite competing in the crowded type 2 diabetes market, Ozempic is forecast to perform well due to its superior efficacy and safety versus competitor products.
Shingrix (Zoster vaccine recombinant, adjuvanted) from GlaxoSmithKline: The only vaccine to make the list and the first new shingles vaccine in more than a decade, GSK’s Shingrix is projected to become the market leading shingles vaccine.
Sublocade (buprenorphine) from Indivior: Sublocade could disrupt the market for medication-assisted treatment options to overcome opioid use. It is administered via subcutaneous injection once a month by a healthcare provider and does not require a detox period, thereby addressing the limitations of other treatment options.
2018 is also expected to see the launch of the first FDA-approved cannabidiol-based drug, Epidiolex from GW Pharmaceuticals, potentially opening up a new market for cannabidiol-based medicines. Epidiolex has been filed for two rare forms of childhood-onset epilepsy, Dravet syndrome and Lennox-Gestaut syndrome, and efficacy data have been compelling in both indications, supporting approval.
Richard Harrison is chief scientific officer, Clarivate Analytics