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Top 15 Therapeutic Areas 2010

UBM Canon, Nov 2010, Pages: 124


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Achieving approval for new therapies is becoming increasingly difficult. Within the past few months, the industry has experienced disappointments for several promising therapies in late-stage clinical development. Some already-approved drugs have raised concerns and are under after-market review with regulators and advisory panels. Thus, the onus is on researchers to harness advances in science and technology and to better assess discoveries in all phases of development. Drug makers are working on identifying appropriate biomarkers to more accurately predict how a patient will respond to a treatment, as well as how susceptible varied populations are to developing side effects. In order to reduce late-phase attrition rates, biomarkers for use in clinical trials are forecast to grow 37.6% by 2015. As many pharmaceutical companies are focused on oncology R&D, the pipeline is crowded with overlapping products. The segment is struggling with declining returns, a crowded competitive landscape, significant price competition, patient recruitment, and higher commercial costs.

To offset these issues, and propelled by the increased movement toward personalized therapy, drug developers are focusing on targeted products and smaller patient segments. One such emerging segment in oncology research is melanoma. Experts are predicting melanoma cases to nearly double from now until 2019. Ground breaking strides are being made in treating terminal melanoma patients based on tumour gene expression. One drug in late-stage development that offers particular hope in this area is Roche and Plexxikon Inc.'s PLX4032. Available cytotoxics and cytokines for the condition induce response rates between 10% and 20%, with no significant benefit to overall survival rates. PLX4032, however, was able to shrink tumours in 81% of patients in a Phase I trial, and the subjects stayed in remission for a median time of seven months.

Cancer is one of the most expensive diseases to treat, with projected costs during 2010 expected to approach $264 billion. On average, an oncologist spends $2.3 million annually on such products. The cancer arena continues to grow, and drug spending in this therapeutic field is forecast to increase 12-14% in 2010.

The amount of oncology drugs in the overall pharmaceutical/biotechnology product pipeline is more than twice the total of any other therapeutic area. Company developers as well as clinicians are searching for better approaches to target tumours. For instance, a new generation of cancer therapeutics are using the immune system. Many emerging cancer treatments have the potential to become blockbuster brands.

Pipelines from the top 15 therapeutic areas are presented in order determined by the total number of products awaiting approval and in clinical trials in the United States.

The lists for each therapeutic area detail:

-Product name
-Phase of development
-Disease/medical use
-Therapeutic category
-Developer/Marketer


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