This article is part of an ongoing blog series profiling the twelve new, game-changing drugs predicted to achieve blockbuster status by 2022 in the 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics. Read the full Drugs to Watch report here or follow the series for latest updates.
The 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics, predicted the market entry of GlaxoSmithKline (GSK)’s potential blockbuster Shingrix, a vaccine for herpes zoster (shingles) infection. Shingrix is now available nationwide in the U.S.1,2,3 and was also approved in the EU and Japan in late March 2018.4
One in three people in the U.S. will develop shingles in their lifetime and there are an estimated 1 million cases of shingles in the U.S. each year.5,6 In Europe and Japan, shingles annually affects approximately 1.7 million and 600,000 people, respectively.4 Shingles is caused by the varicella zoster virus, the same virus that causes chickenpox. After a person recovers from chickenpox, the virus stays dormant in the body and it remains unclear why the virus can reactivate years later, causing shingles.5
One in three people in the U.S. will develop shingles in their lifetime and there are an estimated 1 million cases of shingles in the U.S. each year.
FDA approval in October 2017 made Shingrix (Zoster vaccine recombinant, adjuvanted) the first new shingles vaccine in more than a decade.6 Shingrix is the only shingles vaccine to achieve >/=90% efficacy across all age groups studied and is anticipated to quickly take market share from Zostavax (shingles vaccine [live]; Merck), previously the only FDA-approved shingles vaccine.
In the phase 3 ZOE-50 trial in adults aged >/= 50 years old and the ZOE-70 trial in adults aged >/= 70 years old, Shingrix reduced the risk of shingles by 97.2% and 89.8%, respectively, compared with placebo.7,8 In contrast to Zostavax, for which protection wanes over time, GSK’s vaccine offers lasting protection, and it can provide protection for those who have previously received Zostavax. Although Zostavax is more convenient, requiring one dose versus two for Shingrix, the U.S. Centers for Disease Control and Prevention made a formal recommendation in January 2018 to use Shingrix over Zostavax in adults aged 50 years and older due to Shingrix’s superior efficacy.9
Following launch throughout the U.S. and approvals in the EU and Japan, Cortellis Consensus Forecast data (source Thomson Reuters I/B/E/S) are now even higher than at the time of writing the Drug to Watch report. Shingrix is still expected to replace Zostavax as the market-leading shingles vaccine within two years of its launch, with 2019 forecasts of $595 million (up from $537 million as forecast in March 2018) for Shingrix and $492 million for Zostavax (decreasing from a peak of $765 million in 2014). However, Shingrix sales are forecast to hit the $1 billion mark from 2020, rather than 2021, onwards, and 2022 sales of $1.564 billion are now forecast (up from $1.368 billion).