Non-Small-Cell Lung Cancer

Pharmacor -- June 2007

  Introduction:

Non-small-cell lung cancer (NSCLC) is characterized by high incidence, poor survival, and therefore high clinical unmet need. Despite the launch of bevacizumab (Genentech/Roche/Chugai’s Avastin) at the end of 2006 in the United States, and its imminent launch in Europe, significant unmet clinical need still exists for a treatment to improve further the prognosis of patients. Many other industry players are attempting to follow the footsteps of Genentech/Roche and capture a share of the lucrative NSCLC market.

  Questions Answered in This Report:

Bevacizumab, a monoclonal antibody against VEGF, was recently approved in the United States for the first-line treatment of advanced NSCLC. Launch in Europe and Japan is highly likely. How will its approval affect market dynamics and medical practice? What is bevacizumab’s peak-year sales potential for NSCLC?

Unmet clinical need for NSCLC is high because it is the leading cause of cancer-related deaths in the world, despite best attempt at treatment. Improvements in survival of advanced stage disease patients have been incremental and counted in weeks rather than months over the past decade. Will unmet need remain high during the forecast period? How much opportunity remains to fulfill this unmet need on approval of bevacizumab? Will prognosis incrementally improve, will a new treatment evolve that will lead to a more significant clinical benefit?

Research and development (R&D) investment in NSCLC is high because of the large incidence and high clinical unmet need; there are currently 13 drugs in Phase III NSCLC clinical trials. What are the most promising classes of agents in clinical development? Which of these agents are likely to launch? What will their impact be on the NSCLC market during the 2006-2016 forecast period?

Thought-leading physicians tell us that one of the most important challenges in NSCLC treatment is to understand further the mechanisms of action of targeted agents so that they can tailor therapy specifically to each patient. Much research is ongoing on this issue, in the hope of releasing the true potential of targeted agents. What is the likely clinical impact of ongoing research on gene expression and predictive factor analysis on the 2006-2016? Will tailored therapy be widely adopted among the medical community?

  Scope:

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

Primary research: 26 country-specific interviews with experts.

Epidemiology: Incidence of NSCLC by TNM stage; prevalence of NSCLC by TNM stage.

Population segments in market forecast: TNM IB/II; TNM IIIA, TNM IIIB without pleural effusion; TNM IIIB with pleural effusion + TNM IV; second-line; third-line.

Emerging therapies: Phase II: 73 drugs; Phase III: 13 drugs.

Market forecast features: Using a proprietary patient-flow model incorporating mortality, we forecast population sizes and drug sales for treatment-naive and nonresponder patient segments through 2016.

Alternative market scenarios: Bevacizumab is approved for treatment of early-stage disease; Bevacizumab use more wide scale; Cetuximab is approved for first-line treatment of advanced-stage disease; One or more emerging agents not approved; Spiral CT screening shows significant benefit.