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Description
Rational drug design has accelerated the development of new pharmacological entities, but finding them solid ground in a competitive marketplace remains a challenge. For many drugs, niche indications, where there are small numbers of patients and treatment options, could be the answer. This approach avoids large-population dynamics and established protocols, and the market can be entered through a side door that has not been locked by the competition.
Novartis' Gleevec for chronic myelogenous leukemia (CML) is one such success story: the CML population is relatively small, but maximizing penetration in a small market proved better than minimal exposure in a large one. Four years after launch Gleevec generates about $1.8 billion in sales, a figure that is expected to rise through 2008. Other niche indications potentially offer the same lucrative launch scenarios and drug developers are beginning to take note.
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There is currently tremendous growth potential in specialist markets like oncology, where many niche areas with unmet needs remain. One such up-and-coming niche is renal cell carcinoma (RCC) where quantum leaps in therapeutic options are taking place after years of limited alternatives. Accounting for about 3% of all cancers, RCC features 50% cure rates for patients with an early-stage diagnosis but only palliative therapy for the majority of patients who present with advanced stages of the disease.
Encouragingly for drug developers, RCC may have a genetic Achilles' heel. Just as CML patients have mutations in the Philadelphia chromosome targeted by Gleevec, RCC patients show mutations in the VEGFR2 pathway, through which a tumour recruits new blood vessels... |
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