Novartis is expected to remain market leader with sales of $11.8bn
The worldwide orphan drug market is set to reach US$127bn by 2018, accounting for nearly 16% of total prescription drug sales, reveals a new report by sector analyst EvaluatePharma.
The 2013 Orphan Drug Report projects that sales will experience a compound annual growth rate of 7.4% between 2012 and 2018, nearly double that of the prescription drug market, excluding generics, which is set to grow at 3.7%.
For pharmaceutical companies, the findings confirm that orphan drugs offer a greater return on investment than non-orphan drugs. Orphan drugs that have been filed for regulatory review or are in Phase III trials provide a 1.7 times greater return on investment than non-orphan drugs, the report finds. EvaluatePharma’s analysis also shows that Phase III development costs for orphan drugs are half of those of non-orphan drugs.
Pharma has shifted efforts to more niche indications which, as our analysis demonstrates, offer a greater return on investment
‘Pharma has traditionally been focused on developing drugs for large disease populations,’ said Anthony Raeside, Evaluate’s Head of Research. ‘However, with R&D costs rising into the billions, pharma has shifted efforts to more niche indications which, as our analysis demonstrates, offer a greater return on investment.’
Other findings of the report are that orphan drug sales increased 7.1% to $83bn in 2012 compared with the previous year. This compares with a 2.1% decline in overall prescription drug sales (excluding generics), which fell to $645bn.
Novartis will maintain its position as the world’s No. 1 orphan drug company in 2018, with expected sales of $11.8bn, and Rituxan (rituximab) will be the leading orphan drug.
Kyprolis, a drug from Onyx Pharmaceuticals for multiple myeloma, was the most promising new orphan drug in 2012, with US sales expected to reach $897m in 2017.
The number of orphan drug designations in the US fell 7% in 2012, marking the first decline since 2007. In Europe, they increased 44%, reversing a decline in 2011.
Of the 43 new drugs approved by the FDA in 2012, 15 were orphan drugs, representing 35% of the industry’s new drug output.