Celgene, BMS, Novartis expected to top 2022 orphan drug market worth $209B: report

Celgene is expected to top the world in 2022 orphan drug sales, according to a report from life science commercial intelligence firm Evaluate.

Even as orphan drug laws get scrutiny in Congress, a new report outlines just how much sales for the meds are expected to take off in the coming years. The short of it? Orphan drug growth is set to far outpace the larger pharma industry through 2022.

Between 2017 and 2022, orphan drug sales are forecast to balloon 11% annually to $209 billion, according to a report from life science commercial intelligence firm Evaluate. That’s about double the growth the analysts expect from the overall prescription drug market, and it will be some of the largest drug companies, like Novartis, Roche and Johnson & Johnson, that will be selling them.

“The image of the plucky small biotech striving to develop treatments for the rare diseases largely ignored by big pharma is long gone,” EP Vantage editor and report contributor Lisa Urquhart said in a release accompanying the report. “Instead, this year we again find big pharma dominating the sector.”

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At the end of the period, Celgene is set to top all competitors in orphan drug sales as blood cancer drug Revlimid makes its climb from nearly $7 billion in 2016 sales to more than $13.5 billion by 2022, according to the analysts. Back in 2005, that drug won its orphan approval to treat myelodysplastic syndrome. Since then, it’s picked up orphan indications to treat non-Hodgkin lymphoma and multiple myeloma.

Bristol-Myers Squibb, Novartis, Roche and Johnson & Johnson are expected to trail Celgene in that order at the end of the period. EvaluatePharma’s Orphan Drug Report 2017 pegs checkpoint inhibitor Opdivo as Europe’s top orphan drug in 2022.

On average last year, orphan drugs cost $140,443 per patient, compared to $27,756 for nonorphan meds. Using median prices, EP analysts found that orphan drugs were 5.5 times more expensive per patient in 2016 than nonorphan drugs.

The analysis comes on the heels of Sen. Charles Grassley’s recent commitment to look into the United States’ orphan drug laws. Enacted in 1983, the Orphan Drug Act provides development incentives and exclusivity for drugmakers willing to chase rare diseases, but Iowa Republican Grassley said “unanticipated uses” from the law could be costing taxpayers.

RELATED: Senator says drugmakers may be misusing FDA orphan drug rules—and costing taxpayers money

According to a recent Kaiser Health News report, drugmakers have legally racked up millions in incentives, tax breaks and patent-protected profits, in some cases through monopoly pricing, by winning orphan indications for meds that are also widely marketed.

RELATED: Drugmakers 'hijacked' the FDA's orphan system to score premium pricing on mass-market meds: report

Grassley said that report triggered his interest in the issue. His staff is “meeting with interested groups and other Senate staff to get their views on the extent of the problem and how we might fix it,” he said.