Melanoma is a form of skin cancer. Some of the major risk factors for melanoma are high levels of exposure to ultraviolet (UV) light leading to blistering sunburns, especially among population groups who are either in countries, which are in proximity to the equator or at very high altitudes.
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According to the American Academy of Dermatology, the prevalence of melanoma is gradually increasing and rapidly spreads to other parts of the body. However, if melanoma is detected at an early stage i.e. in situ or stage 0. In this stage, the cure rate with surgical removal is nearly 100i% without any delays in seeking treatment; the survival rates from the disease are nearly 100 percent. When melanoma has spread to other body parts or has penetrated deeper into the skin or spreads, the treatment often becomes more complex. Hence, the systemic drug therapy for melanoma largely depends on the properties and stage at which melanoma is detected.
Since, 2011 various drugs have received FDA approval for treatment of melanoma. The melanoma drugs market has been segmented based on type of drug therapy into chemotherapy, immunotherapy and, targeted therapy. Immunotherapy works on the mechanism of stimulating persons own immune system response to distinguish cancer cells from normal cells more efficiently. A number of types of immunotherapy treatments can be used to treat melanoma. During the past few years, many new immunotherapy drugs for melanoma have entered the market. Immunotherapy drugs for melanoma include Keytruda(pembrolizumab) and Opdivo (nivolumab) which got FDA approval in 2014. Above mentioned drugs target PD-1, a protein on immune system cells called T cells. By blocking PD-1 protein, these drugs increase the immune response of the body against melanoma cells. Recently, the FDA approval of Yervoy (ipilimumab) in October 2015 has opened new market opportunities for market expansion of immunotherapy drugs in melanoma drugs market. Ipilimumab (Yervoy) is also another type of drug that upsurges immune response. However, it blocks CTLA-4, another protein on T cells.
These drugs are given as an intravenous (IV) infusion every 2 or 3 weeks. This results in shrinking of tumor. This treatment can help number of people with stage IV melanoma to live longer. However, it’s not yet clear if these drugs can completely cure melanoma.
These drugs act as checkpoint inhibitors to fight against melanoma cancer. In addition, there is a strong pipeline for melanoma treatment drugs under development by major key players and other new entrants in this market. Thus, taking into consideration the strategic new product launches after FDA approval the melanoma drugs market is expected to grow exponentially.
Similarly the Cytokines are proteins in the body that increase the immune system. Artificial cytokines, such as interferon-alfa and interleukin-2 (IL-2), are occasionally used in patients with melanoma.
When chemotherapy drugs fail to deliver positive results in melanoma patients, targeted therapy drugs are administered to them. The targeted therapy drugs include BRAF inhibitors such as Zelboraf (vemurafenib) and Tafinlar (dabrafenib). The BRAF drugs work on the mechanism of shrinking tumors among those metastatic melanoma patients who have undergone genetic mutation. They are found to increase the progression free survival rate of patients. The MEK inhibitors such as trametinib (Mekinist) and cobimetinib (Cotellic) block the MEK proteins. In November 2015, Cotellic (cobimetinib) of Genentech Inc. received approval from FDA for the treatment of BRAF V600E or V600K melanoma. Generally Cotellic is used in combination with vemurafenib, a BRAF inhibitor, to treat melanoma.
On October 27th 2015, Amgen Inc.’s Oncolytic virus therapy for a deadly form of skin cancer/ melanoma was approved by U.S. FDA. The drug is known as talimogene laherparepvec, or T-vec, was cleared as a treatment for melanoma lesions in the skin and lymph nodes that can’t be removed completely by surgery. According to FDA brand-name of the drug is Imlygic. It uses adapted version of the herpes simplex virus to attack cancerous cells. After being injected into the tumor, the virus replicates until it causes the cells to breach and it results in provoking an immune system response that communicates the body to recognize the cancer.
Targeted therapy drugs have lower severity of side effects compared to other melanoma cancer drugs. However, despite of the new market opportunities created as a result of recent FDA approvals, some of the major restraints in the market are attributed to the lack of innovative and successful therapies in the market to reduce the risk of mortality of advanced metastatic melanoma patients. Thus, targeted therapy and their combinations could lead the melanoma drugs market and play a potential role in driving in melanoma drug market.
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Some of the major players in this market include Amgen, Inc., Bristol-Myers Squibb, Eisai Co. Ltd., F. Hoffmann-La Roche Ltd., Genentech Inc. Janssen Biotech, Inc., and Novartis International AG. Pfizer, Vical and ZIOPHARM.
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