Singapore, Mar 10, 2010: According to the forecast of independent business analyst, the anti-diabetics market will be worth $37 billion by 2018 up from $20 billion in 2008. This rapid market expansion presents significant opportunities for pharmaceutical companies that are able to develop new therapies to address the unmet clinical needs in type 2 diabetes. In contrast, Datamonitor expects the opportunities in the obesity market to be extremely limited.

“Safety scares, such as that with Avandia (rosgiltazone from GlaxoSmithKline) in 2007, coupled with re-evaluation of known side-effects and the risk of hypoglycemia associated with sulfonylurea use have all combined to highlight the need for new therapies with clean side-effect profiles for type 2 diabetes” says Dr Nick Karachalias, lead healthcare analyst, Datamonitor.

Drugs which target the incretin system are set to be the big new mechanism and dipeptidyl peptidase-IV (DPP-IV) inhibitors are likely to account for the largest percentage of the growing market. Glucagon-like-1 (GLP-1) agonists will have a smaller but still significant impact on the diabetes market than DPP-IV inhibitors, despite greater efficacy and associated weight loss due to their injection based dosing.

“Having benefited from a significant time period as the only DPP-IV on the market, Januvia (sitagliptin from Merck & Co) will continue to be the market leader despite having little clinical differentiation from other molecules in the class. With the additional revenues from the existing fixed dose combination, Janumet (sitagliptin + metformin) and anticipated success of the fixed dose combination of sitagliptin or pioglitazone, which is currently in phase III development, we expect the franchise to generate $6 billion by 2018 in the seven major markets,” comments Dr Karachalias based in London.

Whilst type 2 diabetes is viewed as a legitimate condition which can be treated by drug therapy, obesity is still regarded by physicians and healthcare providers as the result of lifestyle choices and should therefore be managed through diet and exercise.

“Despite obesity being a large driver for the type 2 diabetes market growth, our research only forecasts the value of this sector to reach $600 million by 2018. The sector continues to be plagued by low efficacy, significant side-effect profiles and lack of reimbursement by healthcare providers,” adds Dr Karachalias.

The two leading drugs in the market Acomplia (rimonabant from Sanofi-aventis) and Reductil (sibutramine from Abbott) have both been pulled from the European markets due to side-effects with Acomplia never having received regulatory approval in the US.

New agents in the development pipeline are expected to be hindered by low efficacy and poor side effect profiles, with many of the agents having profiles which would only be acceptable in small niche populations where the benefits of the drug would outweigh the detrimental side-effects. Regulatory authorities have stated that poor risk benefit profiles would preclude the chronic use of the drugs in large patient populations. Segmentation of the obesity market could offer a profitable niche for the right candidate, however, considerably greater efficacy must be shown than that displayed by the current pipeline.