Report: Market Share Of Orphan Drugs Could Top 20 Percent Of Global Market By 2022

A new industry report shows that the average prices for orphan drugs are increasing and are projected to comprise more than 20 percent of the patented pharmaceutical sales market by 2022.

EvaluatePharma, a company headquartered in London which provides consensus forecasting to the pharmaceutical and biotechnology industries, has released its Orphan Drug Report 2017.

Orphan drugs are those which treat rare diseases. The determination of which diseases are “rare” is made based upon disease prevalence in the population. In the United States, a disease is considered rare if it affects fewer than 200,000 people in the country, while Japan uses a less than 50,000 patient limit, and the European Union refers to a disease affecting less than 5 per 10,000 people.

As the diseases are rare and the potential patient pool small, rare diseases are sometimes referred to as “orphan” diseases, as their low potentiality for profit “orphaned” them from the pharmaceutical industry.

In the United States, the Orphan Drug Act of 1983 incentivised research and development into treatments for rare diseases, by offering 7 years of data exclusivity from approval time, R&D grants to fund portions of phase 1 to phase 3 clinical trials, and a 50 percent tax credit on research and development costs.

EvaluatePharma has found that the sales growth forecast for orphan drugs is 11 percent per year, more than twice the predicted rate for conventional drugs. While pharmaceutical companies receive financial incentives in the form of lowered research and development costs, prices for drugs for patients remain expensive.

EvaluatePharma found that in the United States, the average price per patient per year for an orphan drug was US$140,443, compared to the average cost for a non-orphan drug at US$27,756.

While the patient population is relatively small, EvaluatePharma has forecast that by 2022, patented orphan drugs will comprise 21.4 percent of worldwide prescription drug sales. The report estimates that Revlimid (lenalidomide), a drug which treats some forms of cancer, will lead Celgene to become the world’s top orphan drug company in 2022. The drug comprises 80 percent of Celgene’s sales, and costs roughly US$17,773 for a month’s supply in the United States.

In Europe, Opdivo (nivolumab), which treats a type of lung cancer, is predicted by EvaluatePharma to become the top selling orphan drug.

Kim Treanor is an intern at Intellectual Property Watch and a student in the graduate program of International Affairs at the New School in New York, where she studies development, trade and public health.