Breast Cancer

Pharmacor -- June 2007

  Introduction:

Breast cancer (CaB) is the most common cancer in women worldwide. In 2016--the end of our study period--nearly 500,000 new cases of CaB will be diagnosed in the major pharmaceutical markets under study. The incorporation of trastuzumab (Genentech/Roche/Chugai’s Herceptin) for HER2-overexpressing patients into the adjuvant population, along with the launch of a second HER2-targeted agent, lapatinib (GlaxoSmithKline’s Tykerb), is driving the robust growth of the CaB market. Although uptake of bevacizumab (Genentech/Roche/Chugai’s Avastin) may be restricted to a minority of patients, the agent, along with a second VEGF inhibitor, sunitinib (Pfizer’s Sutent), will also expand the CaB market. Conversely, despite widespread uptake of the aromatase inhibitors in the adjuvant treatment of postmenopausal patients with hormone-receptor-positive CaB, patent expiries, which will trigger aggressive price erosion, and a sparse late-stage drug pipeline will cause the CaB market for endocrine drugs to contract.

  Questions Answered in This Report:

Following positive Phase III data, trastuzumab is being incorporated into adjuvant treatment of patients with high-risk CaB that overexpresses HER2. How will the market dynamics change as a result of the increasing use of trastuzumab in the adjuvant population?

Lapatinib, a small-molecule HER2 tyrosine kinase inhibitor, has become a second treatment option for patients overexpressing HER2. How will lapatinib be incorporated into medical practice? Will lapatinib steal market share from trastuzumab?

Data on paclitaxel plus the VEGF monoclonal antibody bevacizumab show a twofold increase in progression-free survival in first-line metastatic CaB. Based on these data, bevacizumab gained regulatory approval in Europe in 2007. How will VEGF-directed agents fare in the clinic and the marketplace? Will the improvement in efficacy be sufficient to justify the high price of bevacizumab or will cost be a barrier to its uptake? Will experts expect to see gains in overall survival to justify its use?

The use of gene expression profiling has moved closer to the mainstream of clinical practice in the United States. Which two genetic profiling technologies has the FDA approved, and how do they work? How will these technologies affect the treatment of CaB?

CaB remains an attractive area for research and drug development. What new targets are attracting interest? Which drugs do CaB experts believe hold the most promise? What commercial opportunity remains during our forecast period?

Upfront use of aromatase inhibitors has dramatically increased in the adjuvant setting. How will the market dynamics change as a result of the increasing competition among the three aromatase inhibitors: letrozole, anastrozole, and exemestane?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.

36 country-specific interviews with CaB specialists.

Epidemiology: Incidence of stage I CaB; incidence of stage II CaB; incidence of stage III CaB; incidence of stage IV CaB; prevalence of stage I CaB; prevalence of stage II CaB; prevalence of stage III CaB; prevalence of stage IV CaB; incidence of premenopausal estrogen-receptor-negative CaB; incidence of premenopausal estrogen-receptor-positive CaB; incidence of postmenopausal estrogen-receptor-negative CaB; incidence of postmenopausal estrogen-receptor-positive CaB.

Patient segments in market forecast: Nonendocrine therapy  market patient segments: operable low-risk; operable medium-/high-risk, recurrent/metastatic first-line, recurrent/metastatic second-line, recurrent/metastatic third-line; recurrent/metastatic fourth- and subsequent lines. Endocrine therapy market patient segments: premenopausal adjuvant and neoadjuvant, postmenopausal adjuvant and neoadjuvant, recurrent/metastatic first-line, recurrent/metastatic second- and subsequent lines.

Emerging therapies: Phase II: 66 drugs; Phase III: 7 drugs.

Market: Using a proprietary patient-flow model incorporating mortality and treatment rates, we forecast population sizes and drug sales for all patient segments in the CaB market through 2016.

Alternative market scenarios: (1) Approval of biogeneric versions of trastuzumab following loss of patent protection for the branded drug in 2014, (2) reduced duration of adjuvant trastuzumab, (3) failure of sunitinib in the adjuvant setting, and (4) treatment with adjuvant aromatase inhibitors for ten rather than five years.