Tamoxifen is a type of selective estrogen receptor modulator (SERM) indicated for the treatment of women with high risk of breast cancer. Since its approval in 1998, tamoxifen has been used to treat millions of patients diagnosed with hormone receptor positive, early stage of breast cancer after surgery to reduce the risk of recurrence. It is the first choice for treatment of premenopausal women. Tamoxifen is the generic name for Nolvadex. Tamoxifen has off-label usage for the treatment of infertility, gynecomastia, retroperitoneal fibrosis, and idiopathic sclerosing mesenteritis.
Tamoxifen is a type of selective estrogen receptor modulator. The main pharmacologic action of Tamoxifen is to block the growth-promoting effects of estrogens on breast cancer. In bone cells, selective estrogen modulators interact with receptors the way estrogen does and strengthens bones. Tamoxifen is available in various forms such as powder, capsules, oral solution, and tablets.
Tamoxifen Market Dynamics
Being a generic molecule, the growth of the market has slowed down with increased competition. However, emergence of combination therapies and additional therapeutic indications for tamoxifen is expected to fuel the market growth. For instance, 2018 Novartis received breakthrough therapy designation for Kisqali by FDA in Phase 3. Designation was based on the successful phase 3 MONALEESA-7 trials, which demonstrated significant prolonged-free survival (PFS) of Kisqali + tamoxifen (or an aromatase inhibitor). Moreover, increasing number of government and non-government organizations are investing to discover additional therapeutic applications of tamoxifen, which in turn, is expected to boost market growth. For instance, In 2017 Duchenne UK, E-Rare, Duchenne Parent Project, and Monaco Association jointly contributed US$ 766,338 for a clinical trial, which aims to study the effects of tamoxifen in treating duchenne muscular dystrophy.
However, 2017, survey from European Cancer Congress discovered that the cost of tamoxifen increased 10 times during the period 2011 - 2016, despite being generic. The research found that the cost of the drug was 20 times the price in India. Such disparity in prices, with no adequate reimbursement deters acceptance for the drug. Furthermore, adverse effects of tamoxifen therapy such as anxiety, vaginal discharge, and painful urination, is expected to hamper the tamoxifen market growth.
Furthermore, increasing prevalence of breast cancer among women, both in developed and emerging economies is a major factor driving growth of the tamoxifen market. According to 2012, World Cancer Research Fund International report, around 1.7 million new breast cancer cases were diagnosed in 2012, which reflected an increase by over 20% from 2008.
Tamoxifen Market – Regional Insights
On the basis of region, the global tamoxifen market is segmented into North America, Europe, Latin America, Asia Pacific, Middle East, and Africa. North America tamoxifen market holds the dominant position, owing to high acceptance and high price of the drug in treating breast cancer. For instance, according to GoodRx Inc. 2018 pricing detail, 30 tablets of tamoxifen 20mg cost around US$ 65.71 on an average. Moreover, increasing prevalence of breast cancer has propelled the tamoxifen market growth in the North America region. According to 2018, U.S. Breast Cancer Organization statistics, around 1 in 8 U.S. women are estimated to develop invasive breast cancer during the course of her life. Moreover, around 266,120 women are expected to be diagnosed with invasive breast cancer in the U.S. in 2018.
Asia Pacific is expected to witness significant growth in the market over the forecast period, owing to its increasing number of people vulnerable to various chronic diseases and increasing healthcare initiatives. For instance, according to published article in the Lancet Oncology 2014, breast cancer is expected to rise from less than 60 cases per 100,000 woman aged 55-69 years to over 100 cases per 100,000 woman by 2021, reaching 2.5 million cases overall by 2021.
Tamoxifen Market – Competitive Landscape
Key players operating in the global tamoxifen market include Teva Pharmaceutical Industries Ltd, AstraZeneca plc, Aegis pharmaceuticals, Watson laboratories, Inc., Allergan plc, Mylan N.V., and Apotex Inc. Market players are focusing on adopting strategies such as acquisition and mergers to provide advanced research products to sustain their presence in the market. For instance, 2018 Dare Bioscience Inc. announced merger with Pear Tree Pharmaceuticals to procure rights to develop PT-101, as a potential treatment for vaginal and vulvar atrophy for patients suffering from hormone-receptive positive breast cancer. PT-101 is a proprietary vaginal formulation being developed by Pear Tree Pharmaceuticals.
Tamoxifen Market Taxonomy
On the basis of dosage form, the global tamoxifen market is segmented into:
On the basis of indication, the global tamoxifen market is segmented into:
On the basis of region, the global tamoxifen market is segmented into:
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