Early-Stage Anticancer Drugs

Pharmacor -- November 2006

  Introduction:

Advances in technology have facilitated the detailed molecular characterization of cancer and have revealed a plethora of potential new targets, which has fueled pharmaceutical R&D. More than 500 candidate drugs are reported to be in early (Phase I and II) clinical evaluation, and countless more are in the preclinical stages of development. We identify some of the most promising cancer targets and explore the market opportunity for new drugs in 2016 and 2021 in five cancer indications.

  Questions Answered in This Report:

A vast number of drugs are in early-stage clinical evaluation for the treatment of cancer. What factors are used to determine which agents will progress from Phase I clinical trials? What regulatory hurdles will be encountered along the development pathway? How can clinical evaluation be expedited?

We forecast that in 2016 the cancer market will be dominated by targeted therapies. What targets are attracting the most development interest? What will be their market potential? Will physicians use these novel agents in combination with chemotherapy or other targeted agents?

Thought-leading physicians tell us they believe that patients increasingly will be preselected for treatment based on the molecular characteristics of their disease. How extensive is this trend, how will it affect drug sales over the study period, and how will regulatory authorities respond to these changes?

  Scope:

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

Primary research: 99 interviews with thought leaders.

Epidemiology: 2016 and 2021 staged incidence of breast cancer, colon cancer, rectal cancer, non-small-cell lung cancer, pancreatic cancer, and multiple myeloma.

Treatable pool segments in market potential: 

- Breast cancer: early stage (operable); recurrent and stage IV first-line; recurrent and stage IV second-line; recurrent and stage IV third-line.

- Non-small-cell lung cancer: stage IA; stages IB and II; stage IIIA and IIIB without pleural effusion; stages IIIB with pleural effusion and stage IV first-line; stages IIIB with pleural effusion and stage IV second-line; stages IIIB with pleural effusion and stage IV third-line.

- Colorectal cancer: early stage (operable); recurrent and stage IV first-line; recurrent and stage IV second-line; recurrent and stage IV third-line.

- Pancreatic cancer: localized; regional; distant and recurrent first-line; distant and recurrent second-line.

- Multiple myeloma: stage I; stages II+III initial induction and maintenance; stages II+III first relapse; stages II+III second and subsequent relapse.

Emerging therapies: Phase I: 20 drugs; Phase II: 20 drugs; Phase III: 3 drugs; preregistration: 2 drugs; registered: 9 drugs.

Market forecast features: Using a proprietary patient-flow model incorporating mortality, we forecast population sizes and drug sales for adjuvant and metastatic patient segments in breast cancer, colon cancer, rectal cancer, non-small cell lung cancer, pancreatic cancer, and multiple myeloma through 2021.