Kinase Inhibitors in Oncology

Pharmacor -- April 2008

  Introduction:

Kinase inhibitors (KIs) have the potential to dramatically boost oncology market growth and revolutionize medical practice. Currently marketed KIs offer limited clinical benefits over conventional treatments, but opportunities exist for marketed KIs to be used more effectively and for investigational KIs to offer improved clinical benefits. To overcome the scientific and commercial challenges facing KI developers, a vast stakeholder endeavor--involving both funding and willingness to collaborate with academia and other members of industry--will be required.

  Questions Answered in This Report:

The prognosis for patients who are in advanced stages of cancer remains dismal. Furthermore, the incidence of solid cancers and, therefore, mortality rates are increasing. How does incidence and prognosis differ relative to each solid cancer? How does currently available KI treatment affect the prognosis for various solid cancers?

During the 2006-2016 forecast period, several KIs will launch for solid cancer and significantly alter medical practice. Which KIs will launch and for what indications, and in which new indications will currently available KIs receive additional approvals?

The KI market is poised to experience dramatic growth over the 2006-2016 period, driven by new entrants as well as label extensions for currently available KIs. What are the dynamics of the KI drug market over the next decade? Which KIs will have the highest sales, and what are the peak-year sales for each drug? Which patient segments will be commercially lucrative for KIs?

Significant challenges face the drug development industry, but KI developers that are innovative can overcome these challenges and prosper in a commercially rewarding drug market. What steps can KI developers take to overcome challenges in pricing and reimbursement issues, the regulatory environment, and competition? Which attributes are required for KIs to be commercially successful?

  Scope:

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

Primary research: 83 country-specific interviews with physicians and thought leaders.

Epidemiology: Incidence of breast cancer, colorectal cancer, gastrointestinal stromal tumor, hepatocellular carcinoma, malignant melanoma, non-small-cell lung cancer, pancreatic cancer, renal cell carcinoma, and squamous cell carcinomas of the head and neck.

Population segments in market forecast: Early-stage versus advanced-stage versus recurrent/refractory lines for breast cancer, colorectal cancer, gastrointestinal stromal tumor, hepatocellular carcinoma, malignant melanoma, non-small-cell lung cancer, pancreatic cancer, renal cell carcinoma, and squamous cell carcinomas of the head and neck.

Emerging therapies: Phase II: 19 drugs; Phase III: 10 drugs. Coverage of 33 select early-phase products.

Market forecast features: Using proprietary patient-flow modeling incorporating mortality and outcomes to treatment, we forecast KI-treatable and -treated populations and KI sales for 27 patient segments through 2016.

Alternative market scenarios: (1) Erlotinib and/or lapatinib is approved for squamous cell carcinoma of the head and neck; (2) erlotinib receives expanded approval for early-stage non-small-cell lung cancer and/or expanded approval for early-stage pancreatic cancer; (3) lapatinib proves superior to trastuzumab in breast cancer; (4) sorafenib receives approval for malignant melanoma and/or expanded approval for early-stage hepatocellular carcinoma; (5) everolimus is approved for neuroendocrine pancreatic cancer; (6) imatinib is approved for three-year treatment of gastrointestinal stromal tumor; (7) sunitinib is shown to cause a significantly high rate of heart failure; (8) fewer KIs are approved for renal cell carcinoma; (9) additional KIs are approved for non-small-cell lung cancer; and (10) the United Kingdom’s National Health Service denies funding/access to second- or later-to-market KIs.