Orphan Drugs: Rescue From the Patent Cliff
Description: This reports looks at big pharma and how it has been affected by the patent cliff and the patent-loss of many of its biggest-selling blockbuster drugs and examines how the development of orphan drugs may help return companies to growth.
Published Date: 03/12/2013
Category: Drug Discovery & Development
Research Report Decription
drugs treat diseases that affect fewer than 1 in 2,000 Europeans & fewer
than 200,000 Americans. Research into orphan drugs benefits from incentives
provided by the 1983 Orphan Drug Act, such as tax breaks, faster regulatory
reviews and assistance from FDA reviewers. Orphan drugs are less likely to face
competition and provide a high return on investment. Cinryze costs $487,000
- This reports looks at big pharma and how it has been
affected by the patent cliff and the patent-loss of many of its biggest-selling
- Orphan drugs are granted certain incentives at the
development stage, which encourages Big Pharma to invest in them.
- Orphan drugs can be very lucrative as companies can charge a
large amount for them. Much of the costs are covered by governments/insurance
Key Questions Answered:
What drugs have lost their patents/are due to lose their
patents, and what are they worth?
Why is the orphan drug market attractive to pharmaceuticals
How have companies attempted to enter this market?
Are the high prices of orphan drugs sustainable?
Global orphan drug sales increased at a rate of 7.1% to be
worth $83bn in 2012 compared to the previous year. Orphan drugs are expected to
bring in revenues of $127bn by 2018 and will account for almost 16% of total
prescription drug sales, compared to 12.9% in 2012.
The most expensive drug in the world in 2013, Cinryze, is
used by patients with hereditary angioedema, and is sold by ViroPharma. The
drug\'s annual cost per patient is $487,000 per year. The second most expensive
drug, Soliris, is sold by Alexion Pharmaceuticals, treats patients with
paroxysmal nocturnal hemoglobinuria, & costs $486,000 annually.
According to patient advocacy group, Eurodis, around one
third of EU patients can\'t get access to, or have difficulty accessing, the
orphan drug they need.