With FDA approval of Tivicay, the HIV drug development partnership of GlaxoSmithKline ($GSK), Pfizer ($PFE) and Shionogi brings its first drug to market. As drug data researcher EvaluatePharma (EP) sees it, the debut of Tivicay marks another very significant turning point--the beginning of the end in the growth of the branded HIV drug market.
According to EvaluatePharma, that market will grow from $17.5 billion in 2012 to $20.6 billion in 2016, where it will peak. It then sees it tapering off to about $18 billion in 2018.
The researcher says the market has become a victim of its own successes. A lot of new blockbuster treatments have made a big leaps in treating the disease and its attendant symptoms. The early drugs lost patent protection in the middle of the last decade, but innovation has brought some new blockbusters like Prezista from Johnson & Johnson ($JNJ) and Reyataz from Bristol-Myers Squibb ($BMY). But as those drugs lose their patents in the next few years, branded drug sales will start to lose momentum and generics will dominate.
That is not to say that some branded drugs will not see growth. The report says in 2016, it sees four of the top 10 selling branded HIV drugs still expanding sales. Those are the newcomer Tivicay from the ViiV Healthcare partnership, Intelence from J&J and two Gilead Sciences ($GILD) drugs, the four-in-one combo Stribild and its three-drug combo Complera. In fact, Gilead and its combo drugs, which have made compliance easier, will dominate the market. It is forecast to hold half the branded business in 2016, with $10.5 billion in sales, leaving 5 others to scrap for the rest. But even Gilead is expected to see HIV drug sales fading to about $9.6 billion in 2018.
That is not to say that innovation can't change the outlook. There is work on vaccines and Gilead, AbbVie ($ABBV) and Biogen Idec ($BIIB) all have projects that could pan out. So that could lead to an impressive leap in innovation and sales. EvaluatePharma says, "(G)iven the improvements in pharmaceutical treatments for HIV patients, what is probably necessary to steal serious market share in this space is a vast improvement in efficacy--in short, a cure or something very close to one--or a way to reduce the dosing burden or side effects even more."
- here's the EvaluatePharma report