No Silver Bullet Cure for Obesity Epidemic
Total sales in the US anti-obesity drug market declined significantly in the period from 2002 to 2005.
Because of the high risk and large number of co-morbidities related with obesity, such as heart disease, stroke and diabetes, a population with a high rate of obesity represents a huge financial burden for governmental health services. Obesity is defined in most countries as someone with a body mass index (BMI) of 30 or more. The World Health Organization (WHO) estimates there to be at least 400 million clinically obese people worldwide and the rapidly expanding epidemic shows no signs of slowing. The most rapid increase has been observed in England, where obesity rates have risen three-fold from 1980 to 2001.
Lack of Reimbursement a Key Factor
However, the biggest barrier to widespread up-take is the lack of reimbursement. With the exception of the UK and Spain, obesity drug sales in Europe have declined in recent years, despite there being more obese people now than ever before. Despite the massive patient potential for the treatment of obesity across Europe, the size of the markets have been restricted by the lack of reimbursement and the failure to categorize obesity as a disease rather than a lifestyle condition. Conversely, the UK anti-obesity market has expanded significantly over the period of the last four years, representing 17% of the total global market. This steady growth is due to the reimbursement practices in the UK, where the patient only needs to pay the standard prescription charge for obesity medication.
Total sales in the US anti-obesity drug market declined significantly in the period from 2002 to 2005, in part due to the bad publicity surrounding Meridia in 2002 (which was withdrawn temporarily from the Italian market over long-term concerns regarding its cardiovascular safety) which had a knock-on effect on other drugs. The drop in sales can also be attributed to the high discontinuation rates that characterize obesity treatment, an issue further compounded by the fact that patients are paying for the expensive medication themselves, and therefore are a lot more likely to quit in the absence of dramatic weight loss.
Thus, the most critical issue for the rapid medical acceptance and commercial success of approved obesity products is reimbursement by payers, as patients are unwilling to pay out of their own pocket for therapy. Of current US health plans, 85% or more do not reimburse obesity products, but the US still accounts for 52% of anti-obesity drug sales in the seven major markets (US, Japan, France, Germany, Italy, Spain and the UK). While the medical community's view of obesity is evolving to where obesity is viewed as more than a lifestyle disease, payers may be less willing to change their views and reimburse for a product that will be chronically used.
Simply speaking, the huge rise in obesity is due to the over consumption of calories and inadequate physical activity. In practice, this is due to the increasingly sedentary nature of life in western societies combined with an increase in fast food and convenience food consumption. This is especially obvious in Japan, as the increasing westernization of diet has led to a sharp increase in the prevalence of obesity.
However, while there are drugs on the market designed to combat obesity, the use of these drugs has not increased in line with the rise in prevalence of the disease. This is in some measure because those currently on the market are associated with unpleasant side effects. It is also due to a perceived lack of efficacy, in some part at least due to inflated expectations of weight loss on the part of the patients and unwillingness to change their lifestyle. Patients that are motivated to lose weight usually comply with treatment. However, problems commonly occur in maintaining the weight loss and behavior modification essential to keep the excess weight off.
Lack of Reimbursement a Key Factor
However, the biggest barrier to widespread up-take is the lack of reimbursement. With the exception of the UK and Spain, obesity drug sales in Europe have declined in recent years, despite there being more obese people now than ever before. Despite the massive patient potential for the treatment of obesity across Europe, the size of the markets have been restricted by the lack of reimbursement and the failure to categorize obesity as a disease rather than a lifestyle condition. Conversely, the UK anti-obesity market has expanded significantly over the period of the last four years, representing 17% of the total global market. This steady growth is due to the reimbursement practices in the UK, where the patient only needs to pay the standard prescription charge for obesity medication.
Total sales in the US anti-obesity drug market declined significantly in the period from 2002 to 2005, in part due to the bad publicity surrounding Meridia in 2002 (which was withdrawn temporarily from the Italian market over long-term concerns regarding its cardiovascular safety) which had a knock-on effect on other drugs. The drop in sales can also be attributed to the high discontinuation rates that characterize obesity treatment, an issue further compounded by the fact that patients are paying for the expensive medication themselves, and therefore are a lot more likely to quit in the absence of dramatic weight loss.
Thus, the most critical issue for the rapid medical acceptance and commercial success of approved obesity products is reimbursement by payers, as patients are unwilling to pay out of their own pocket for therapy. Of current US health plans, 85% or more do not reimburse obesity products, but the US still accounts for 52% of anti-obesity drug sales in the seven major markets (US, Japan, France, Germany, Italy, Spain and the UK). While the medical community's view of obesity is evolving to where obesity is viewed as more than a lifestyle disease, payers may be less willing to change their views and reimburse for a product that will be chronically used.
Roche and Abbott Currently Lead the Way
Currently, the leading anti-obesity drugs are Roche's Xenical and Abbott's Meridia/Reductil, which Datamonitor forecast will earn $228 million and $124 million, respectively in the seven major markets in 2007. New drugs coming to market will have to show superior efficacy to those currently available, most likely to the point of having a demonstrable impact on other cardiovascular risk factors and co-morbidities such as diabetes, to have a chance at reimbursement, which must be viewed as the 'holy grail' for anti-obesity drug producers.
To this end, Sanofi-Aventis has put in a lot of effort into proving that Acomplia (rimonabant) combats multiple risk factors of cardiovascular disease and ameliorates existing conditions. Sanofi-Aventis aims to submit Acomplia for worldwide approval in 2009 as a treatment for type 2 diabetes. If approval is granted, Acomplia may also be granted reimbursement, at least in diabetic obese patients.
Compounding the issues with the currently marketed anti-obesity medications, the anti-obesity drug development pipeline does not hold any outstanding candidates either. Of the 42 different products in development in 2006, only nine were in Phase III clinical trials. Highlighting the difficulties manufacturers of marketed drugs and those still in development face finding safe, tolerable and efficacious obesity treatments, there are 38 different mechanisms of action amongst the 42 drugs in development. The pipeline is rich in Phase I and II candidates, but only 12% are in Phase III development.
Datamonitor has not identified any products in development that will provide a significant improvement on those currently available. In the absence of a highly effective pharmacological cure, and barring a huge sea change in society's attitude towards diet and physical activity, governmental and societal initiatives seem to be the only thing standing in the way of the continual expansion of the first great epidemic of the 21st century. An especially worrying trend is that prior to the current generation, obesity has been something that largely developed in adult life. However, we are now seeing children that are essentially growing up obese, promising a huge burden for national health services and tax payers for years to come, with no immediate prospect of a 'silver bullet' cure.
Related Research:
Commercial and Pipeline Perspectives: Obesity - Lack of Reimbursement Limits Market Potential priced $ 11,400 DMHC2236. http://datamonitor-market-research.com/Merchant2/merchant.mvc?Store_Code=RESEARCH&AFFIL=pbi2121&Screen=PROD&Product_Code=DMHC2236
Obesity, Dieting, Exercise And The Future Of Food And Drink priced $5,695
DMCM4603. http://datamonitor-market-research.com/Merchant2/merchant.mvc?Store_Code=RESEARCH&AFFIL=pbi2121&Screen=PROD&Product_Code=DMCM4603
Roche: PharmaVitae Profile priced $5,700. CSHC1296. http://datamonitor-market-research.com/Merchant2/merchant.mvc?Store_Code=RESEARCH&AFFIL=pbi2121&Screen=PROD&Product_Code=CSHC1296
