The breast cancer therapeutics market is expected to show sustained growth and opportunity for new market participants as greater efficacy and reduced toxicity of innovative breast cancer therapies increase their uptake.
That is the opinion of the latest research report, which predicts that the emergence of personalised medicine will propel the effectiveness of breast cancer treatments that suffer from harsh side effects prolonging the patient life rather than offer a cure.
Backed by these forecasts, the breast cancer therapeutics market is anticipated to grow from its current size of $5.9 million (€5 million) to $11.5 million by 2011, with a compound annual growth rate (CAGR) of 9.8 per cent.
Like numerous forms of cancer, breast tumour growth is a multifactor disease with no standardised medication available for patients.
Currently Herceptin, a humanised antibody approved in ErbB2 positive breast cancers is the only product that is approved by the Food and Drug Administration (FDA) available on the market.
Besides, mastectomy and radiotherapy, the administration of hormonal, cytotoxic or biologic therapeutics is carried out to improve the long-term outlook of the treatment.
Lack of treatments is compounded by lack of efficacy and high toxicity of existing products, along with disagreements among physicians with the best course of treatment, means that there remains a significant area of unmet medical need.
This lack of consensus among physicians is attributable to several factors, including the merits of products in the market with efficacy relative to toxicity, the reimbursement provided by the government of each individual state and the size of the sales and marketing force in each geographical region.
Another challenge requires that companies must not only bring a drug successfully through the development process, but also persuade payers that the high price of such novel therapies is justified due to their increased survival periods, reduced hospital stay and their ability to reduce therapy costs.
Anti-hormonal therapies used to treat breast cancer in women and prostate cancer in men currently totals $4.8 billion a year and will rise to $5.5 billion by 2014, an annual growth rate of 0.9 per cent as key drugs in the class are coming off patent, and new ones emerge in the pipeline.
The competitive landscape is set to change with the entry of generic companies. "As blockbuster breast cancer therapeutic patents begin to expire and products get launched from new competitors, the market is anticipated to diversify, making defensive tactics essential to ensure sustainable profits," commented Frost & Sullivan Healthcare manager Alex Wong.
"This will encourage entrants to introduce low-cost therapies," he added.
The report said that in order to remain competitive the efforts of manufacturers to convince government and healthcare providers of the efficacy of their products, in the hope that the inflexible reimbursement schemes will be eased, will be critical.
Against the backdrop of continuing efforts to ensure medication safety, an increase in clinical efficiency as well as reduction in toxicity and side effects during drug development holds the key to market growth and development.
Cancer therapeutics cost to market will pose a challenge for smaller companies to compete with the larger, better-established market leaders.
Currently cytotoxics will remain standard treatment until 2008, when several key products face patent expiry.
GlaxoSmithKline's lapatinib is currently the forerunner of the new drug classes, forecast to achieve blockbuster sales by 2012.
Lapatinib is a dual kinase inhibitor that is following in Genentech/Roche's Herceptin's (trastuzumab) footsteps. Conferring significant advantages, patient convenience and likely competitive pricing, uptake is predicted to be significant.
The problems associated with cytotoxics will also be eased with targeted therapies. Much needed therapy will be in the form of American BioScience's Abraxane, a reformulated paclitaxel currently in preregistration.
With significant advantages over Bristol-Myers Squibb's Taxol, Abraxane is set to become a key cytotoxic.
The recent FDA approval of Eli Lilly's Gemzar in combination with Taxol for the first-line treatment of metastatic breast cancer will see the company become a major player in the breast cancer market.
For more details of Frost and Sullivan's report: "World Breast Cancer Therapeutics Market (B612-52)," visit the company's website here.