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Extending Shelf Life--Additional Indications Drive Product Growth
Decision Resources, Inc, Nov 2005, Pages: 19
The last ten years have been particularly challenging for the pharmaceutical industry: R&D costs continue to rise, new drug approvals have dwindled, competition from generic drugs has increased, and few new drugs are in the pipelines. Prolonging and maximizing the life cycles of existing products by expanding into new markets is becoming a key priority for the pharmaceutical industry and will be a core capability for success in the future.
In this report, we focus on extending shelf life by winning additional indication approvals. We examine three drug classes that have been particularly successful in executing this strategy: antidepressants (the SSRIs and SNRIs), anti-TNF-alpha agents for inflammatory diseases, and angiotensin II antagonists used in cardiovascular indications. We explore each class in detail, focusing on brand name drugs within each class and the activities of the pharmaceutical companies involved, and we conclude with our projections for the future of these three drug classes.
Business Implications
- With many blockbusters facing patent expiry, fewer blockbusters in the pipeline, and rising R&D costs, the pharmaceutical industry
confronts a serious financial challenge. To succeed in this difficult environment, companies must increasingly invest in product life-cycle management to protect revenue streams. Maximizing a product's life cycle through expansion into new markets is a vital marketing and sales practice that is becoming a key priority for the pharmaceutical industry and is set to become a core capability for future success.
- Biological agents and agents in select therapeutic categories appear to have the best chance of winning additional indication approvals. Some inflammatory diseases, cardiovascular conditions, and central nervous system disorders share common pathways; agents that impact these systems can provide benefit in more than one indication.
- The anti-TNF agents inhibit cytokine pathways involved in rheumatoid arthritis (RA), psoriasis, and Crohn's disease (CD) and have been successful in gaining approvals in all these diseases. Significant sales growth, even reaching blockbuster status, has resulted from the continued expansion of use into new patient populations.
- Antidepressant agents have proved beneficial in the highly comorbid conditions of major depression and anxiety disorders. Differentiation of drugs and approvals in multiple indications are factors critical to success in this crowded treatment market. Antidepressants coming late to the market are seeking new indications outside depression and anxiety to distinguish themselves from competitors.
- Angiotensin II antagonists compete in the extremely competitive and saturated market for treatment of hypertension. Approvals for use in chronic heart failure and renal conditions have expanded their use and provide opportunity for continued growth before patent expiry.
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