Breast cancer is one of the most common cancers among women, with an estimate of about 500,000 mortalities in 2011 according to the World Health Organization (WHO). Although Breast cancer is considered as a disease of developed countries, its prevalence is rising rapidly in the developing countries owing to urbanization and adoption of sedentary and stressful lifestyle. According to WHO, in 2012 an estimated of 70,000 females in India died due to Breast cancer, while in China about 48,000 deaths were recorded and in the U.S. 44,000 deaths were recorded for Breast cancer. The survival rate varies across the globe based on diagnosis time and rate along with the availability and affordability of services, with about 80% in North America and 60% in middle income countries. High prevalence globally has led doctors and scientists to take serious measures for early detection for the cancer so that proper care and treatment can be given to the patient.

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Developing technology is adding various innovative devices which have helped in early diagnosis of cancers. Digital Breast tomosynthesis also referred to as 3D mammography, is one of the technologies being developed for detection and characterization of Breast lesions. The technique involves multiple projection images which allow visualization of thin Breast sections which reveals cancers buried within normal tissue, allowing better diagnosis of Breast cancer. FDA approval of digital Breast tomosynthesis, Selenia Dimensions System by Hologic, Inc. in 2011 has boosted the market. Quick adoption, fewer recalls and simultaneous market penetration supported the market growth. In 2013, GE received CE mark for SenoClaire, and entered the European market.

The company also plans for regulatory approval in the U.S. Currently the digital Breast tomosynthesis market has been more inclined towards North America and Europe where expensive devices can be afforded by medical institutes. An article published by The Boston Globe in 2012 mentions that by 2012 the device was sold to about 300 institutes in the U.S. According to the U.S. FDA, each year about 40 million mammography procedures are performed in the U.S. alone. These procedures may be replaced with digital Breast tomosynthesis as it is a better alternative and delivers better results.

As the demand for better Breast cancer diagnosis increases, the market will hold grounds in Japan, China, India and Brazil, which are considered to be the most profitable opportunities in the future. High cost of the device is the major restraining force for the market growth in Asia-Pacific and Rest of the World. Majority of the buying of expensive medical devices is supported by funding from investors and government. Hence these intermediaries will decide the fate of digital Breast tomosynthesis in the developing economies. Rising incidences of Breast cancer will also contribute to the market expansion in the future. Thus entry in this lucrative market is also easier, if the device has been successful in the U.S. market. Increasing trend for medical tourism in these regions will also pressurize medical institutes to upgrade to newer technology to deliver better medical services. Countries in Latin America such as Brazil, Mexico, Venezuela and Colombia are developing rapidly.

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Regulatory scenario in these regions is also favorable, where most of the countries taking support of U.S. FDA and CE approvals. In Mexico, New Health Accord came into effect in the year 2010 which stated that medical devices approved in the U.S. or Canada will receive quicker approval in the country. Chile also demands no additional regulatory and accepts devices approved in the U.S. Key players in the market include Hologic, Inc., GE Healthcare, Siemens, and Dexela Ltd. (subsidiary of Perkin Elmer).

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