Boston, MA -- (ReleaseWire) -- 04/14/2014 -- Pharmaceutical companies are facing far greater opportunities and challenges than the Affordable Care Act (ACA). Healthcare reform in the US could have sought significant monetary contributions from drugmakers, but this did not materialise in a meaningful sense, primarily due to industry cooperation when the legislation was being drafted. Of greater near-term concern to pharmaceutical companies is the shifting pricing and reimbursement landscape globally.
Headline Expenditure Projections
- Pharmaceuticals: US$341.2bn in 2013 to US$342.7bn in 2014; 0.4% growth in local currency terms. Forecast slightly up from Q114 due to industry factors. ? Healthcare: US$2,978bn in 2013 to US$3,157bn in 2014; +6.0% growth in local currency terms. Forecast slightly down from Q114 due to industry factors.
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Risk/Reward Rating (RRR): The US has a Pharmaceutical RRR score of 78.5 out of 100 for Q214. This is unchanged from Q114 and Q413 but slightly down from the 80.9 score recorded in Q313, which was due to a downgrade in BMI's forecasts for pharmaceutical expenditure over the next ten years. Despite this negative development, the market remains highly attractive to all multinational drugmakers.
Key Trends And Developments
- In February 2014, the FDA was considering significant changes to OTC medicine regulations, making it easier to react to new information on a product's safety or recommended use. Current rules are over 40 years old and do not require manufacturers to get approval as long as the main ingredient had previously been deemed safe and effective for that entire category of medicines. A public hearing on the matter will take place in late March 2014.
- In January 2014, the FDA acted to prohibit Ranbaxy Laboratories from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The agency noted that the Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012. The decree contains, amongst other things, provisions to ensure compliance with cGMP requirements at Ranbaxy facilities in Paonta Sahib and Dewas, India, as well as provisions to address data integrity issues at those facilities. In September 2013, the FDA added Ranbaxy's Mohali facility to the cGMP provisions of the decree.
- By January 2014, approximately 2.1mn people in the US had enrolled in private health insurance plans through new federal and state websites since October 2013, under President Barack Obama's healthcare plan, according to US officials. In October and November 2013 about 3.9mn people in the US were deemed eligible for Medicaid or the Children's Health Insurance Program, according to Health and Human Services Secretary Kathleen Sebelius. However, 2014 is expected to bring new challenges as those enrolled begin to use their medical coverage from January 1.
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