Market Research Forecasts a Rise in the US Generic Drug Market Between 2012 and 2016

ROCKVILLE, MD -- (Marketwire) -- 06/18/12 -- MarketResearch.com has announced the addition of the new report "The Pharmaceutical Market: USA," to their collection of Pharmaceuticals market reports. For more information, visit: http://www.marketresearch.com/Espicom-Healthcare-Intelligence-v1129/Pharmaceutical-USA-6977019/

Espicom projects that the US pharmaceutical market will grow by a moderate CAGR between 2011 and 2016. The effect of recent legislation is difficult to measure. Pharmaceutical companies face a number of costs initially, depressing sales growth. However, pharmaceutical sales are expected to be boosted in the long-term as at least an additional 32.0 million Americans, equal to about a tenth of the population, should receive insurance from 2014 onwards. Not all of this additional population will require drugs, as many will be young people or those already consuming drugs, but further consumption should rise overall. Biologic companies will gain with the new 12-year data exclusivity provided by the new healthcare regulation. In 2011, major competitive strategies included Novo Nordisk's agreement to set up a new US headquarters; Pfizer's sale of Capsugel to KKR; Allergan's agreement to acquire all of the outstanding assets of Vicept; Valeant's agreement to acquire the assets of Janssen's Ortho Dermatologics division; Valeant's agreement to acquire Dermik from Sanofi; Merck & Co's acquisition of Inspire; Baxter's agreement to acquire Prism Pharmaceuticals; Forest's acquisition of Clinical Data (CD); Sanofi's acquisition of Genzyme; Daiichi Sankyo's acquisition of Plexxikon; AstraZeneca's US$1.1 billion payment to resolve tax matters; and Pfizer's acquisition of King Pharmaceuticals.

The US generic sector is expected to rise by a higher CAGR between 2011 and 2016. According to the GPhA, there are around 50 manufacturers. Major US generic players include Mylan, Watson and Hospira. Other important US generic companies include Greenstone (Pfizer), Qualitest Products and Mallinckrodt. Overseas companies have a major stake in the market, including Teva, Sandoz (Novartis), Apotex, Actavis, Lupin and Dr Reddy's. A number of other Indian companies are attempting to break into the retail market. In 2011, major competitive strategies included KV's divestidure of Nesher Pharmaceuticals; Perrigo's acquisition of Paddock Laboratories; Cephalon shareholders' approval for Teva to acquire the company; Watson's announcement to expand its Salt Lake City site; the merger of Caraco and Sun; Apotex's resumed shipments to the USA; Hikma's acquisition of Baxter's Generic Injectables Business; Sagent's IPO launch; Texas Jury's order for Actavis to pay US$170.3 million in damages; and Elite's generic agreement with Hi-Tech Pharmacal.

In May 2011, the FDA published details of its proposed user fee structure for the regulation of biosimilar products in the USA. This would run for five years, from 2013 to 2017. Under the Biologics Price Competition and Innovation Act (BCPIA), the FDA has been given the task of developing such a user fee programme in order to support its activities in the area. The BCPIA creates a new category of approval -- a 351(k) -- for biosimilars under the Public Health Service Act (PHS). To date, all existing biologics are approved under the 351(a) procedure, for which user fees are already collected under the Prescription Drug User Fee Act (PDUFA), first enacted in 1993. Fees are currently collected for all original drug and biologic applications, but not for ANDA generic applications. In 2011, major competitive strategies included Gilead's agreement to purchase one of Genentech's manufacturing facilities; Omni Bio's stake acquisition in BioMimetix; Grifols' acquisition of Talecris Biotherapeutics; Astellas' acquisition of Perseid from Maxygen; Sanofi's acquisition of Genzyme; Boehringer Ingelheim's acquisition of Amgen's Fremont facility; Amgen's acquisition of BioVex; Gilead's acquisition of Calistoga Pharmaceuticals; the alliance between Merck and Parexel to form a biosimilar strategic alliance; Alexion's acquisition of Taligen; and Eli Lilly's agreement to acquire Alnara Pharmaceuticals.

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