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Feature

Hormonal Cancers: Key drivers in a market of chang

Posted on: 03 Feb 03
Hormonal Cancers: Key drivers in a market of chang

Summary

Four major brands, TAP’s Lupron, AstraZeneca’s Zoladex, Nolvadex and Casodex, account for 49% of the total value of the anti-hormonals market at present. The loss of patent protection for these compou
Four major brands, TAP’s Lupron, AstraZeneca’s Zoladex, Nolvadex and Casodex, account for 49% of the total value of the anti-hormonals market at present. The loss of patent protection for these compounds will lead to an increase in generic drugs and therefore influence the rate of expansion of the market. Datamonitor examines how the major drug companies will attempt to maintain their market position.

In the broadest sense, hormonal cancers can be defined as tumors whose growth is facilitated by hormones. In Market Dynamics: Anti-hormonal Therapies Datamonitor provides key insights into the hormonal therapy market. The report focuses solely on breast cancer and prostate cancer, since these together account for almost all of the sales generated by anti-hormonal drug classes.

Generic impact

In addition to the market leading drugs, the patents held by AstraZeneca and Pharmacia , for products that will become key to the expansion of the anti-hormonals market over the next five years, such as Arimidex, are also set to expire in the foreseeable future. With few pipeline products approaching launch, there will be an increased shift toward the use of generic versions of anti-hormonal products during this period.

For pharmaceutical manufacturers, novel anti-hormonal drugs will need to be well- distinguished from impending generic versions of existing therapies. They will have to use various methods to maintain their leadership.

They could, for example, reformulate existing products and in-license compounds from outside of their own R&D programs. Recent history also suggests that the major players will employ a long-term strategy of supporting, instead of acquiring, biotechnology companies, thereby enabling innovation to continue in the right environment.

Though patent expiries will exert downward pressure, the epidemiology of hormonal cancers and the premium pricing acceptable for novel agents with advantages over standard products will drive the market forward. The potential patient pool is expected to rise by 2010.

Demand to drive R&D

Since such a sizable patient volume receives anti-hormonal drugs, and most for prolonged periods of time, this market will continue to be an attractive area for the
pharmaceutical industry in which to develop new agents. The template for companies that wish to either enter or sustain a lucrative position within the anti-hormonals market is the "Arimidex story."


Datamonitor believes that this agent will be a blockbuster within the next few years, and yet the accomplishment of this third generation anti-aromatase agent, and indeed the class as a whole, was unimaginable 10 years ago. Moreover, the launch of Faslodex, the first of a new class of selective estrogen receptor downregulators (SERDs), in May 2002 is a very exciting development.

Clinical data comparing Faslodex, developed by AstraZeneca, to anti-aromatase agents suggest that it possesses similar and possibly superior efficacy in the treatment of tamoxifen-resistant breast tumors. Faslodex looks set to achieve significant revenue in the near future. This should create a great deal of confidence for pharmaceutical companies to develop subsequent SERDs.

Novartis' Femara is hoping to follow the template that AstraZeneca has engineered with Arimidex with hopes of an early-stage breast cancer indication once phase III clinical trials have been completed. If this indication is achieved for Femara, then AstraZeneca’s dominance will begin to be challenged.

Arimidex in control

Between 2002 and 2010, the growth of the anti-hormonals market will come from anti-androgens and anti-aromatase agents. The organizations leading this field, namely AstraZeneca and Novartis, will profit as a result and continue to drive further developments.

Third-generation anti-aromatase agents, and AstraZeneca’s Arimidex in particular, will usurp tamoxifen’s role as the standard first-line hormonal therapy in the treatment of breast cancer. This is being facilitated by data characterizing the survival benefits of these agents over tamoxifen (e.g. AstraZeneca’s ATAC trial), and the assumption that anti-aromatase agents’ mechanism of action results in fewer side effects.

Arimidex, like Casodex, is by far the leading agent of its class, partly by virtue of its first-to-market status, but also as a result of AstraZeneca’s marketing prowess and comprehensive knowledge of the anti-cancer hormonals market. However, emerging data describing the use of anti-aromatase agents in earlier lines of therapy indicate that there is an opportunity for other agents to make an impact.

Arimidex will nevertheless, be able to achieve a market-leading position providing it can resist the challenge from new competitors such as Novartis’ Femara and Pharmacia’s Aromasin.

If you found this week's Expert View useful, you may be interested in Datamonitor's reports, all available from www.datamonitor.com/healthcare:

  • · Market Dynamics: Anti-hormonal Therapies - Positioning for a Changing Paradigm priced $6,400


  • · Drugs of Tomorrow: Cancer Overview - The Synergistic Advance - Innovatives Complement Traditional Chemotherapies priced $6,100



  • · Breast Cancer Insight: Defining Drug Decisions - How Can Companies Influence the Treatment of Breast Cancer? priced $75,000


  • For a free Datamonitor healthcare report please click here.

    For more information on Datamonitor products please visit www.datamonitor.com or email inpharm@datamonitor.com

    Michael Randle

    Last updated on: 27/08/2010 11:40:18

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