From afar, the obesity market looks like the perfect untapped resource for Big Pharma; a disease with a high prevalence, constantly in the public eye due to its recognition as a major health issue, with little competition throughout the major markets. However, look closer and it quickly becomes apparent that the obesity market is littered with a multitude of past failures and numerous hurdles. A complex pathophysiology, a sluggish reimbursement environment, several high-profile withdrawals, and the lingering view that obesity is a lifestyle issue, rather than a disease, have continued to hamper development and uptake of novel therapies. However, with the continued investment in this space, is there hope on the horizon?
Once bitten, twice shy
Between 1997-2010, several high-profile withdrawals shook the obesity market, having huge financial implications for the companies involved. The specter of these withdrawals still haunts the development landscape; both regulatory agencies and physicians are generally still skittish about the approval and prescription of novel obesity therapies. As of 2017, only a handful of branded anti-obesity therapies remain on the market across the major markets, none of which have yet come close to blockbuster status. Despite the launches of Novo Nordisk’s Saxenda and Orexigen’s Contrave/Mysimba throughout the EU5, drug treatment options outside of the United States remain sparse (and indeed, almost non-existent in Japan). The reimbursement environment remains difficult throughout all the major markets. Although there are a greater number of treatment options, and physicians have a more positive attitude towards the use of pharmacotherapy, insurance cover for obesity therapies is overwhelmingly poor in the United States and regularly results in high out-of-pocket costs for patients, leading to yet further decreases in treatment rates. Unfortunately, these reimbursement issues look likely to remain across all the major markets for some time to come, according to thought leaders interviewed by DRG.
"The reason I don't regularly use any of the current therapies is because the efficacy (or lack of) doesn't warrant the cost or the risk to patients. In my experience, the best you really get is 5% weight loss."
Thought Leader – United States
A bigger slice of the pie for Novo Nordisk?
Although the gloom of the past still lingers over the obesity space, there does seem to be some light breaking through the darkness. Given the lack of treatment options and the common overlap between obesity and diabetes, antidiabetic drugs, especially GLP-1 receptor agonists, are increasingly being repurposed for the treatment of obesity. Thought leaders frequently state that their familiarity with these drugs, in addition to their good safety profile and positive effect on cardiovascular outcomes, is helping to drive uptake. Novo Nordisk is leading the way with Saxenda (liraglutide 3mg), launched for the treatment of obesity in 2015, and its follow-up, semaglutide, expected to enter Phase III for obesity in early 2018. Semaglutide could be the first therapy to consistently offer >15% weight loss, closing the gap between pharmacotherapy and bariatric surgery. DRG forecasts these two therapies alone will be the major drivers behind the total growth of the obesity market, from $1 billion in 2016 to over $4 billion in 2026. Furthermore, the early-phase pipeline continues to be bolstered by several new compounds, many of those targeting novel pathways not utilized in current treatment, and continued investment from industry.
“In my opinion, semaglutide is going to be the gamechanger. If we can get 15% weight loss AND positive CVOTs, I think we are likely to see the whole landscape change.”
Thought Leader – United States
The proof of the pudding is in the eating
Despite some of the disasters of the past, progress is being made towards producing safer, more efficacious treatments for the treatment of obesity. Whilst the reimbursement environment remains stagnant, it is possible that with increasingly efficacious drugs providing benefits beyond that of just weight loss, this may ease. There is still work to do however, both in terms of drug development and the acceptance of obesity as a serious and tangible disease.
An in-depth analysis of obesity, with accompanying epidemiology driven sales forecast models, is presented in Decision Resources Group’s Obesity/Overweight Insights, available here.