|
||
| |||||||
|
A wider awareness regarding urinary incontinence has developed since the aggressive marketing policy employed by Pharmacia for the market launch of Detrol in 1998. But with the two market leading drugs both suffering from poor side-effect profiles, and significant scope for improved efficacy, there is still considerable unmet need in the market. The Market Brief 'Urinary Incontinence: a market update', Datamonitor focuses on the latest developments in the urinary incontinence drug treatment pipeline, analyzing the effects the drugs in late-stage development will have on the current market leaders and urinary incontinence drug treatment as a whole. Increased awareness In 1998, Pharmacia (now Pfizer) launched Detrol (tolterodine) into the urinary incontinence (UI) market. Prior to the launch of this drug, the sector had been relatively small, dominated by various generic versions of oxybutynin. However, to accompany the drug’s launch, Pharmacia invested heavily in campaigns to promote awareness of UI. This tactic caused the market to swell considerably, with the UI population currently numbering 35 million people in the seven major markets, helping Detrol achieve sales of $757m in 2002. Hot on the heels of Pharmacia, Alza (a Johnson & Johnson company) developed Ditropan XL, an extended-release version of oxybutynin. Though this has failed to reach Detrol’s heights, plagued by a poor side-effect profile that causes many patients to stop using the drug quickly, it achieved sales of $296m in 2002, firmly establishing itself as the second-biggest drug in the market. Competition Over the next two years, Detrol and Ditropan XL will be exposed to a new batch of competition, in the shape of Yamanouchi’s Vesicare (solifenacin succinate) and Novartis’s Enablex (darifenacin). Of these two drugs, Vesicare, backed by favorable results from a head-to-head trial with Detrol, will offer the stiffest competition to the market leader while Enablex will offer an attractive alternative to patients currently on Ditropan XL. An improved efficacy and side-effect profile for urge urinary incontinence drug therapies is a key priority for future R&D activities. Although existing agents are associated with reasonable efficacy, the side effects associated with immediate-release oxybutynin and, albeit to a lesser degree, its extended-release counterpart and Detrol, mean that a significant proportion of women withdraw from treatment. Early withdrawal not only has implications for the efficacy of urinary incontinence therapies, but also overall cost-effectiveness, potentially discouraging the use of more expensive, branded agents. Consequently, agents that, whether as a result of their mechanism of action, dosing levels or delivery methods, offered significantly lower levels of side effects than existing drug therapies are bound to experience considerable success. Key market entry The stress urinary incontinence (SUI) market, which accounts for roughly half of the UI patient population, is yet to see the launch of any drug specifically indicated for this indication. This should change by 2005, however, as Eli Lilly nears final approval for its SUI drug, duloxetine. Similarly to Pharmacia’s tactic when launching Detrol, Eli Lilly is expected to accompany duloxetine’s launch with high-profile campaigns to raise the awareness of SUI. This will expand the drug’s potential market through encouraging both more patients suffering from SUI symptoms to present to their physician and more physicians to diagnose the disease. As the SUI-diagnosed population grows, swelling to 11.41 million people in 2011, in the US, EU and Japan, Lilly will reap the rewards of its investment. Datamonitor expects duloxetine’s sales to grow to $488m by 2011, after US, EU and Japanese launches in 2005, 2006 and 2007 respectively. A novel opportunity Despite the drugs in line to enter this market, Pfizer’s Detrol is expected to maintain its position as urinary incontinence market leader. Of the two drugs expected to launch in 2004, Vesicare is expected to prove more popular than Enablex, backed by favorable results from a head-to-head study with Detrol. Meanwhile, in the stress urinary incontinence sub-indication, Eli Lilly’s duloxetine will enjoy considerable success as the market expands. Clearly, in urinary incontinence, as elsewhere, there is a considerable difference between demonstrating a statistically significant level of efficacy and one that has meaning for patients, physicians and payors. It is critical, therefore, that companies developing novel agents for urinary incontinence ensure that measures of patients’ quality of life before, during and after treatment are included as a standard component of clinical trials. Ultimately, however, pharmaceutical companies should look to develop drugs that can achieve clinically meaningful reductions in incontinence, while maintaining reasonable tolerability. If you found this week's Expert
View useful, you may be interested in the following reports:
To order these reports contact peter.barfoot@bioportfolio.com or telephone +44 1300 321501 or +1 415 680 2472 and a representative will get back to you. You can also order on line at: http://www.bioportfolio.com/cgi-bin/acatalog/search.html |
|
| ||||||||