Antibody Therapies in Oncology

Pharmacor -- June 2008

  Introduction:

Monoclonal antibodies (MAbs) have experienced impressive commercial success in cancer treatment, and they have the potential to further boost sales and revolutionize medical practice. Marketed MAbs already offer clinical benefits over conventional treatments, but considerable opportunity remains for these MAbs to be used more effectively in cancer treatment and for investigational MAbs to offer even greater clinical benefits. We forecast that, over the 2006-2016 forecast period, the MAb market will more than double in size, making MAbs the most lucrative drug class in cancer treatment.

  Questions Answered in This Report:

The prognosis for patients with solid or hematological malignancies who are in advanced stages of the disease remains dismal. Furthermore, the incidence of cancers is increasing, emphasizing the need for efficacious therapies to combat high mortality rates. How do incidence and prognosis differ relative to each solid and hematological malignancy? How do currently available MAbs affect the prognosis for various solid and hematological malignancies?

During the forecast period covered in this report (2006-2016), a variety of MAbs will launch onto the solid and hematological cancer drug market and will significantly alter medical practice. Which MAbs will launch and for which indications? For what new indications will currently available MAbs receive additional approvals?

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

Significant challenges face the drug development industry, but innovative MAb developers will overcome these challenges and prosper in a commercially rewarding drug market. How can companies overcome challenges such as the need to better understand the science, pricing and reimbursement issues, the regulatory environment, and the competition? Which attributes must MAbs have to be commercially successful?

  Scope:

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

Primary research: 143 country-specific interviews with thought leaders, experts, and scientists.

Epidemiology: Incident cases of breast cancer, colorectal cancer, malignant melanoma, non-small-cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, prostate cancer, ovarian cancer, non-Hodgkin’s lymphomas, chronic lymphocytic leukemia, acute myeloid leukemia, and acute lymphoblastic leukemia.

Population segments in market forecast: Early stage versus advanced stage versus relapsed/refractory lines for breast cancer, colorectal cancer, malignant melanoma, non-small-cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, prostate cancer, and ovarian cancer. First-line versus relapsed/refractory for non-Hodgkin’s lymphomas, chronic lymphocytic leukemia, acute myeloid leukemia, and acute lymphoblastic leukemia.

Emerging therapies: Phase II: 57 drugs; Phase III: 11 drugs.

Market forecast features: Using proprietary patient-flow modeling incorporating mortality and outcomes to treatment, we forecast MAb-treatable and -treated populations and MAb sales for 40 patient segments through 2016.

Alternative market scenarios: 1) biosimilar MAbs do not enter the market during the 2006-2016 forecast period; 2) lapatinib proves superior to trastuzumab in breast cancer; 3) bevacizumab proves unsuccessful in the adjuvant setting; and 4) ofatumumab proves more efficacious than rituximab and replaces it in all NHL subtypes.