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Chronic Lymphocytic Leukemia: Monoclonal Antibodies Will Drive Steady Growth
Decision Resources, Inc., June 2006, Pages: 24
Chronic lymphocytic leukemia (CLL) is the most common leukemia in the Western world. Current research is focusing on the urgent unmet need for agents that improve survival. Improved responses from treatment regimens that combine targeted biological agents with established chemotherapy, as well as increased drug therapy for early-stage patients who are likely to progress based on potential prognostic markers, have already begun and will continue to create market opportunities and propel steady growth of the CLL market.
In this report, we provide an overview of CLL, including its staging, epidemiology, and biological markers. We discuss the current treatments and promising late-stage agents in development for CLL, as well as the market outlook though 2010.
Business Implications
- Chronic lymphocytic leukemia is the most common leukemia in the Western world, with more than 160,000 people affected in the seven major markets we cover. Although the American Cancer Society (ACS) estimates that the U.S. incidence of CLL has decreased by 1.9% per year since 1992, there were still an estimated 9,100 new cases of CLL in the United States in 2005; the ACS also estimates that CLL caused 4,600 deaths in 2005. While CLL is considered incurable, recent advances in combination chemoimmunotherapy (monoclonal antibodies [MAbs] in combination with chemotherapy) have produced the best responses to date in all lines of CLL treatment.
- Currently, the only MAb approved for use in CLL patients is alemtuzumab (Schering AG’s MabCampath, Berlex’s Campath), which has achieved significant success when used in combination with fludarabine (Schering AG/Berlex’s Fludara, generics) in refractory patients. Off-label use of rituximab (Biogen Idec/Genentech’s Rituxan), currently in Phase III for CLL, has had significant success in combination with fludarabine and cyclophosphamide (Bristol-Myers Squibb’s Cytoxan, Baxter’s Endoxan/Endoxana, Pfizer’s Neosar/Cyclostin, generics) in previously untreated patients, and we expect its adoption to increase when rituximab is approved.
- Currently, the greatest unmet need in the CLL market is for an agent that will prolong survival. Several new agents in development seek to achieve this goal, including immune system modulators (such as MAbs and immunotoxins), cell-cycle inhibitors, proteasome inhibitors, apoptosis inducers, and angiogenesis inhibitors. Stem cell transplantation (SCT) offers the only chance for a cure for CLL. Although mortality and morbidity rates with this developmental procedure are high, new nonmyeloablative procedures have significantly improved its safety, and we expect its use to increase.
- In 2005, the CLL market in the United States was approximately $153 million, with MAbs making up 77% of the market. We expect the market to continue to grow steadily over the next five years, driven by the continued dominance of MAbs, the approval of rituximab, and the identification of prognostic markers for patients at risk of progression, which will result in increased drug therapy in early-stage patients.
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