A new study by the international market consultancy Frost & Sullivan (http://pharma.frost.com), analyses the breast cancer pharmaceutical market in Germany, France, Italy, the UK, Spain, Benelux and Scandinavia. Across this region, approximately 2,10,000 women are diagnosed with cancer each year, representing 20 to 25 per cent of all malignancies in female patients.

Fortunately, as rates of breast cancer have grown, so has awareness of the condition. Promotional campaigns by organisations and research institutes, such as high-profile events and fund-raising initiatives, have improved rates of early detection as a growing proportion of women are being routinely screened for breast cancer.

The charity and cancer research organisation Imperial Cancer Research Fund, for example, is spearheading force in cancer research and was responsible for the initial development of the monoclonal antibody, Herceptin.

Health governments have come under increased pressure to commit to increased uptake of breast screening programmes, especially for elderly women, and to make more substantial investments into screening equipment.

Although the drugs available to early-stage breast cancer patients are increasingly efficacious in attacking the cancer, a notable reduction in the numbers of metastatic cases could not be achieved. For those with advanced forms of the disease, the benefits provided by anti-cancer drugs include improved comfort and quality of life, pain management and better chance of longer survival.

The growing number of treatment lines these women are receiving to slow tumour growth, coupled with the longer duration of treatment, energise the market for breast cancer pharmaceuticals. Amassing revenues worth $1.33 billion in 2002, the growth rate is set to remain stable over the next few years. This is due to the advancing maturity of the market and the deepening market penetration in both cytotoxic and hormonal segments.

In 2005, the market will achieve substantial growth rates triggered by the anticipated launch of Faslodex (AstraZeneca) and stronger uptake of Arimidex (AstraZeneca) in early-stage breast cancer. However, Frost & Sullivan's study cautions that the arrival of generic paclitaxel will have an adverse impact on overall market growth.

The launch of new products, including Novartis' Epothilone B and Lilly's Gemzar, as well as licence extensions to the remaining aromatase inhibitors and taxanes, are expected to provide further impetus for growth.

Changing demographics and Europe's ageing population, along with the general trend towards combination therapy and the launch of novel therapies, will help sustain momentum behind sales in Europe's breast cancer pharmaceuticals market.

The main thrust of market growth originates form the hormonals segment, which is poised for heightened popularity as side-effects of alternative therapies, such as cytotoxics, have come under a higher level of scrutiny. As a result, most patients who are deemed suitable for treatment give preference to hormonals.

The high unmet patient need for prevention of cancer development continues to present huge commercial opportunities for drug companies. With the options that are available today, and given the sheer volume of potential drugs in research and development as well as clinical trials, oncologists are nearing that goal in early-stage breast cancer. However, the market is still waiting for a highly successful drug with a favourable safety profile and low toxicity, which can be administered to end-stage patients.

Across Europe, a general trend towards the use of anti-cancer drugs in the adjuvant setting can be observed. Adjuvant systemic therapy uses chemotherapy drugs or hormone therapy to help destroy any cancer cells that were not removed during surgery, minimising the risk of the cancer recurring.

The use of adjuvant therapy will result in an increase in the number of patients receiving both cytotoxic and hormonal treatment, thus, prompting growth in the overall breast cancer pharmaceuticals market.

The squeeze on hospital budgets and the general cost-containment strategies in the healthcare sector are giving rise to a growing number of tendering arrangements between hospitals and pharmaceutical companies, reducing drug prices in the process.

Sarah Mott, Research Analyst at Frost & Sullivan, points out that this trend could result in a reluctance amongst physicians to prescribe premium-priced therapies which do not offer significant survival benefit, or to use adjuvant therapy. "These policies force pharmaceutical companies to keep their prices at a low level. Parallel imports represent another problem for these players, and this issue will rise in eminence once generics begin to compete with branded products. Consequently, pricing policies must be given careful consideration," she notes.

In light of European oncologists' varying methods of treating their patients, the formulation of cancer guidelines are an attempt to standardise care. "However, " Mott remarks, "due to the heterogeneous nature of the disease, endeavours often do not result in uniform regimes. Whether it is possible to define the best treatment regime remains to be seen. The identification of target populations and personalised medicine may well prove to be effective in defining the best treatment for a particular tumour in the future."

Frost & Sullivan's study cites product efficacy as the key competitive factor in the European breast cancer pharmaceuticals market. The success of the drug also depends on the line of treatment for which it receives approval. Thus, companies will increasingly compete to achieving better indications and early-stage treatment. Although drugs in this market are not entirely price-sensitive, cost-effectiveness is perceived as a major competitive differentiator. Frost & Sullivan expects market participants to contend on product development and cost-effectiveness during the forecast period.

Thriving on the strength of its cytotoxic product Taxol (paclitaxel), Bristol-Myers Squibb is the most potent force in the European breast cancer pharmaceutical market, accounting for a 22.2 per cent share of the total market. Taxol's patent expires at the end of 2003, and generic companies are expected to enter the market in 2005. This will impact the market negatively, especially in countries where generics enjoy greater uptake.

Ranking in second place is Aventis with its rival drug taxane, Taxotere (docetaxel), representing 17.4 per cent of the market. This patent is likely to be safe until the end of the forecast period. Generic paclitaxel may affect the sales of this product, but the large proportion of oncologists already using Taxotere is expected to remain loyal to Aventis, even if the price of Taxol should decline.