Shire Plc is a biopharmaceutical company that focuses largely on human genetic therapies (HGT), gastrointestinal (GI) diseases, and therapies for attention deficit hyperactivity disorders (ADHD). It also has products that treat rare diseases, and infectious diseases such as HIV and Hepatitis B. The company also develops therapies through its collaborations with companies such as GlaxoSmithKline, 3TC and Zeffix. Shire markets most of its products in the U.S., Europe, Latin America, and the Asia Pacific.
In 2010 Shire product sales grew by 16% fom 2009 to $3,128 million. It was due to strong growth in its core products driven by its lead product VYANSE.
Beginning in 2009, the FDA implemented a series of reforms that include stricter monitoring of drug adverse events, more funding for the agency, stronger ability to force product recalls, more scientific expertise within the agency, more transparency. Even before 2009 the result has been a much more conservative FDA, demanding more product information.
Like other global pharmaceutical companies, Shire faces constant pressure from governments and activist organizations to increase access to medications by either lowering prices substantially or removing patent restrictions so generics can be manufactured.
Medicare and Medicaid policies have an important impact on Shire's sales. Medicare is the federal government's health subsidy plan while Medicaid generally falls to the states. Policies allow the government to bargain for lower prices; essentially the government caps prices for a large number of plans. This lowers revenues while increasing the amount of medications sold. Additionally, the government often requires rebates be paid at the end of the year. Limits by Medicare, Medicaid, and other third party payors may reduce the demand for Shire's products.
Additionally, country specific price regulations must be dealt with. In Europe price applications must be conducted on a country-by-country basis. This slow process has delayed the launch of approved products in some countries by up to two years.
Shire’s largest revenue segment is its therapies for the treatment of ADHD. At the end of 2010 the company held 24.6% of the U.S. ADHD market.
Key competitors include: