New Drug Futures: Products that could change the pharma market to 2013 and beyond :: Espicom

Arrhythmia
Despite the unmet need in the arrhythmia market, there are relatively few agents under active investigation for this indication (although there are several for use in prevention of stroke associated with atrial fibrillation – which are covered under thrombosis). sanofi-aventis’ new class III anti-arrhythmic agent Multaq (dronedarone) is the closest to market and could generate sales of US$860 million by 2013.

Dyslipidaemia
The sheer size of the cholesterol-lowering market has made it an attractive one for drug companies to target, and a number of approaches are under investigation. Following the success of Zetia (ezetimibe)/Vytorin (ezetimibe+ simvastatin) (Merck & Co/Schering-Plough), a number of other cholesterol absorption inhibitors have been studied. These compounds work in combination with statins to give an additional LDL-lowering effect. sanofi-aventis expects to launch its competing agent in 2011. One approach that continues to receive R&D investment is the cholesteryl ester transfer protein inhibitors, even though this class of agents suffered a setback when Pfizer’s torceptrapib was discontinued from development.

Thrombosis
The development of new agents for use in the treatment of disorders involving blood-clotting is probably the most dynamic in the CV market at present. The development of several late-stage agents is making this an increasingly interesting and competitive arena as the treatment of thrombosis remains an area of considerable unmet medical need. A number of approaches are under investigation. Schering-Plough is developing an orally-active thrombin receptor antagonist, while other approaches include the potentially important oral direct Factor Xa inhibitors.

Alzheimer’s disease
On a 2007 market value of US$5.4 billion, the report forecasts a 2008-13 CAGR for the Alzheimer’s disease market of -2%. There are several competing trends in this market. We expect an increase in the number of patients suffering from the disease, as the population ages. In addition, drugs are to be used earlier in therapy (although healthcare payers in some markets, such as the UK, are resisting this).

However, these two positive trends are insufficient to outweigh the loss of patent protection on two market leading products: Pfizer/Eisai’s Aricept (donepezil) and Forest Labs’ Namenda (memantine). The loss of sales may be offset partially by the launch of Wyeth/Elan’s novel therapy bapineuzumab, which we believe has the potential to be a top-selling product with peak sales potential in the order of US$5 billion.

ADHD
A 2008-13 CAGR of 1% is forecast for the ADHD market, representing a considerable slowdown in growth rates to those seen in recent years as the market - which has seen huge increases in patient numbers - starts to mature.

The decline in growth is also partly the result of the maturing of products such as Johnson & Johnson’s Concerta (methylphenidate) and Eli Lilly’s Strattera (atomoxetine), but also the loss of exclusivity on Shire’s Adderall XR (mixed amphetamine salts). The launch of new products such as Shire’s Vyvanse (lisdexamphetamine dimesylate) goes some way to offsetting this.

Depression & anxiety
The depression market is set to experience a continuation of the long-term decline. We anticipate a 2008-13 CAGR of -7%, primarily as the result of some major patent expiries. Several major products, including Wyeth’s Effexor (venlafaxine), Forest Labs’ Lexapro (escitaprolam) and Lilly’s Cymbalta (duloxetine) are all set to experience generic competition within the forecast timeframe.

Although new antidepressants such as sanofi-aventis’ saredutent and Novartis/Serviers’ Valdoxan (agomelatine) are in late-stage development, we are cautious on their likelihood of reaching the market in time to have a significant impact on market growth rates. This is due, in part, to the increasingly safety conscious regulatory stance that has delayed launches in this indication.

Insulin
The insulin market has demonstrated double-digit growth in recent years. This breaks down roughly 50:50 into volume growth (a combined result of the trend towards more intensive therapy and greater patient numbers) and value uplift, as patients switch to new devices and new rapid, long-acting insulin analogues. These trends are expected to continue, albeit at a lower level, over the coming 5 years, and we forecast high single-digit 2008-13 CAGR of 7%. The switch to insulin analogues will continue until about 2011, by which time most suitable patients will have switched and growth will revert to its underlying annual trend of 5-6%.

From a company perspective, we expect the main drivers of growth in the insulin market to be the European players sanofi-aventis and Novo Nordisk, with forecast 2008-13 CAGR for insulin product sales of 11 and 7% respectively, powered by the launch of new insulin analogue products. Eli Lilly, by contrast, after initial market success from the introduction of Humalog, has failed to build on its position.

Non-insulin diabetes agents
Solid growth for non-insulin therapies for the treatment of diabetes is expected, despite the negative impact of generic competition to both Avandia (rosiglitazone) and Actos (pioglitazone) from 2011. Added to this is the adverse impact of the new FDA guidelines for the approval of new agents for the treatment of Type II diabetes (which can add at least 3 years to potential US launch dates). We therefore expect a 2008-13 CAGR of 5% for this market.

From a company perspective, the big losers in the diabetes market are those with agents set to lose patent protection: GlaxoSmithKline and Takeda (though Takeda’s declining position in the diabetes market may be offset by the launch of the DPP IV inhibitor alogliptin). Winners are companies such as Merck & Co which has a potential blockbuster on its hands (the DPP IV inhibitor Januvia (sitagliptin)).

Obesity
Despite the growing prevalence of obesity and the unmet need for effective agents, the forecast for 2008-13 CAGR is only 2%. Both Roche’s Xenical and Abbott’s Meridia have failed to achieve expected sales despite considerable investment, including (in the case of Xenical) the inclusion of data in the label demonstrating a reduction in risk of developing Type II diabetes. New agents in development include Arena’s lorcaserin and Shionogi’s velneperit.

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