Stigma and other factors limit anti-obesity market growth
By Mia Burns (firstname.lastname@example.org)
The off-patent orlistat, also known as Roche’s Xenical, dominates the anti-obesity drug market, and the market is expected to grow from $750 million in 2012 to $2.6 billion in 2019, at a compound annual growth rate of 20.7 percent. According to business intelligence provider GBI Research, the small number of therapeutics in late-stage development will limit the market growth well below its potential.
The company has issued a new report forecasting that growth can be attributed to the anticipated performance of the recently approved Qsymia from Vivus, which has proven to be superior in terms of efficacy for the long-term treatment of obesity. However, the successful sales of Qsymia will depend on the drug proving its safety in the long-term and remaining on the market — a trend not historically seen with obesity drugs.
“For all companies with either marketed or late stage pipeline drugs, the slow growth is bad news as products aren’t reaching even a fraction of the potential market population,” says Katie Noon, life science analyst for GBI Research. “As previously mentioned, for growth to increase to nearer its full potential obesity drugs will have to prove they are safe in the long term, and that no serious side effects of the drug are found with long-term post-marketing use. This is mostly beyond the companies’ control as it will take time for clinicians and patients opinions to change, given the historic safety issues surrounding anti-obesity drugs. A strong marketing campaign may help to increase awareness of anti-obesity drugs and improve their sales.”
Only three percent of the obesity drug pipeline is currently in the late stages of development, with just one drug candidate in the pre-registration level and two in Phase III, according to GBI Research. This limits the number of drugs with the potential to be approved, as well as market growth. At this time, the obesity drug market consists of very few effective drugs, with limited availability in different regions. Only orlistat is available in both the European Union and the United States. Following its patent expiry in 2009, competitive generics are expected to drive down the market revenues of branded Orlistat, or Xenical, within the forecast period.
Noon told Med Ad News Daily, “The FDA and EMEA have established guidelines regarding the mandatory efficacy/safety and trial design requirements for anti-obesity drugs to be considered for approval, which include the following: a minimum one year study must be carried out; efficacy: the difference in mean weight loss between the drug and placebo groups must be at least 5 percent and statistically significant; the proportion of subjects who lose greater than or equal to 5 percent of baseline body weight in the active product group must be at least 35 percent; the proportion of patients who lose greater than or equal to five percent of their baseline body weight must be approximately double the proportion in the placebo-treated group, and the difference between groups must be statistically significant; a placebo controlled trial must be carried out.”
In addition, Noon says, “The FDA may require additional long-term studies to be carried out for a drug in relation to a particular endpoint, if the use of that drug or a previously approved drug with a similar mechanism presents or presented with data for a particular endpoint with long-term use that represents a cause for concern. For example, the manufacturers of Belviq are required to conduct post-marketing studies regarding the cardiovascular safety of the long-term use of this drug. Although it is more costly, it may be beneficial for manufacturers to perform long-term studies at earlier clinical phases or throughout the development of the drug in order to highlight any long-term safety concerns earlier on in drug development. Furthermore, a novel drug may present with a side effect not common to any recently or historically approved drug, which governing bodies aren’t aware of, and for which investigation is therefore not required in clinical trials. Subsequently, this side effect may only present with long-term use of the drug post-marketing, as is the historic trend. In order to avoid the removal of a product from the market post-marketing, robust side effect studies may be required at an earlier phase of development. In addition, longer term initial studies may be required in order to highlight any side effects not identified in the one-year studies that are currently required by the FDA.”
The anti-obesity drug market is considered immature, and the report covers its drivers and barriers. “The market is referred to immature as, although anti-obesity drugs have been marketed since the 1970s, the market is deemed to be significantly below its potential given its large target market, with few drugs available and a low treatment population,” Noon told Med Ad News Daily. As for the market drivers, she says, “Obesity is a very prevalent disease with large potential target populations globally; the recent approval of Qsymia is expected to drive market growth, providing the long-term safety of the product is proven in post-marketing studies; and the diversification of molecular targets has the potential to result in renewed interest in and growth of the market in future.” Noon explains that the barriers are, “Low treatment rate: Products must prove they are safe in the long term and overcome the stigma attached to them in terms of safety concerns; reimbursement issues: drugs aren’t currently widely reimbursed, which results in their limited use.”
GBI Research believes that for anti-obesity drugs to maximize their market potential and revenues, products will have to prove that they adhere to the efficacy requirements of governing bodies and that they demonstrate their long-term safety. It might take many years for the stigma attached to anti-obesity drugs to change among patients and healthcare professionals. “We are referring to the side effects and the fact that many anti-obesity drugs have been removed from the market because of these issues,” Noon told Med Ad News Daily.
Posted: September 2013