United States Pharmaceuticals and Healthcare Q4 2012
Business Monitor International, October 2012, Pages: 98
The United States Pharmaceuticals and Healthcare Report provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on United States's pharmaceuticals and healthcare industry.
BMI View:
Regardless of who emerges victorious in the US presidential election in November 2012, the country's healthcare system is set for further changes. Bloated spending on medical services is widely acknowledged and will receive further attention during the 'fiscal cliff', when taxes will rise and government spending will decrease, to reduce the trillion-dollar deficit. Any significant amendment to healthcare in the world's largest economy will have far-reaching effects on pharmaceutical companies,
medical device companies, hospital chains and managed care firms/health insurers.
Headline Expenditure Projections:
- Pharmaceuticals: US$337.1bn in 2011 to US$343.1bn in 2012; +1.8% growth in local currency terms. Forecast unchanged from Q312.
- Healthcare: US$2,708bn in 2011 to US$2,864bn in 2012; +5.8% growth in local currency terms. Forecast unchanged from Q312.
- Medical devices: US$133bn in 2011 to US$139bn in 2012; +4.6% growth in local currency terms. Forecast unchanged from Q312.
Risk/Reward Rating:
The US pharmaceutical risk/reward ratings (RRR) score has increased from 79.1 out of 100 in Q312 to 80.6 in Q412. This was due to an upwards revision to the medium-term pharmaceutical market growth rate. This in turn boosted the industry rewards component of the proprietary ratings systems. Scores for the other components – country rewards, industry risks and country risks – remain unchanged this quarter.
Key Trends And Developments:
- In August 2012, Aetna acquired Coventry Health Care for US$7.3bn, including the assumption of Coventry debt. The purchase gives Aetna increased presence in the two main US government-run health insurance schemes: Medicaid for those on low incomes and Medicare for the elderly. Both plans will see growth over the medium term, due to President Obama's healthcare reforms and the country's ageing population.
- In June 2012, the US Senate passed legislation that will ensure new medicines continue to reach the market soon after the successful completion of clinical trials. This benefits pharmaceutical companies and patients. Under the fifth reauthorisation of the Prescription Drug User Fee Act
(PDUFA), the government also benefits, since generic drugs will be introduced in a shorter timeframe, consequentially lowering spending on Medicare.
- The June 2012 decision by the US Supreme Court to uphold President Barack Obama's healthcare law primarily benefits the millions of people currently unable to pay for health insurance and therefore denied access to medical services. It also helps hospital chains, which have lost money after treating people without the ability to pay. The outcome is neutral for multinational pharmaceutical companies.
BMI Economic View:
We maintain our 2.0% real GDP growth forecast for 2012 and our 2.1%
projection for 2013. The economy is running dangerously close to 'stall speed', by which we mean that any major unanticipated headwind would be enough to push the economy into recession.
BMI Political View: A victory for Mitt Romney in the US presidential election in November 2012 would be a positive outcome for innovative pharmaceutical companies and medical device manufacturers. He has expressed support for the industry in the past and the Republican Party has traditionally aligned itself with the free-pricing model preferred by drugmakers. We caution that the composition of Congress is the key risk to this outlook. A Romney victory could be accompanied by a Democrat-dominated Senate,
which could inhibit any pro-industry legislation. It is also important to note that re-election of Barack Obama would not be negative for pharmaceutical companies and medical device manufacturers,
primarily because we expect continuation of existing policies that have generally been favourable.
Executive Summary 5
SWOT Analysis 7
US Pharmaceuticals And Healthcare Industry SWOT 7
United States Political SWOT 8
United States Economic SWOT 9
United States Business Environment SWOT 9
Pharmaceutical Risk/Reward Ratings 10
Table: Americas Pharmaceutical Risk/Reward Ratings, Q412 10
Rewards 11
Risks 12
US – Market Summary 13
Regulatory Regime 15
Innovative Drug Regulations 16
Prescription Drug User Fee Act (PDUFA) 18
Generic Drug Regulations 18
Biosimilar Regulations 21
OTC Medicine Regulations 23
Medical Device Regulations 24
Promotion Regulations 25
Intellectual Property Regulations 27
Pricing And Reimbursement Environment 28
Part D 30
Industry Developments 32
Epidemiology 32
Healthcare Sector 33
Research & Development Sector 35
Clinical Trials 36
Contract/Clinical Research Organisations 37
Medical Device Industry 38
Industry Forecast Scenario 39
Pharmaceutical Market Forecast 39
Table: Pharmaceutical Sales Indicators 2008-2016 41
Key Growth Factors – Industry 42
Table: Healthcare Expenditure Indicators 2008-2016 44
Table: Healthcare Governmental Indicators 2008-2016 44
Table: Healthcare Private Indicators 2008-2016 44
Key Growth Factors – Macroeconomic 45
Table: US Macro Indicators 51
Prescription Drug Market Forecast 52
Table: Prescription Drug Sales Indicators 2008-2016 53
Table: Top 10 Therapeutic Classes By Sales (US$bn) 54
Table: Top 10 Therapeutic Classes By Dispensed Prescriptions (mn) 54
United States Pharmaceuticals & Healthcare Report Q4 2012
© Business Monitor International Ltd
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Patented Drug Market Forecast 55
Table: Patented Drug Market Indicators 2008-2016 55
Generic Drug Market Forecast 56
Table: Generic Drug Sales Indicators 2008-2016 57
OTC Medicine Market Forecast 58
Table: OTC Medicine Sales Indicators 2008-2016 59
Medical Device Market Forecast 60
Table: Medical Devices Sales Indicators 2008-2016 61
Pharmaceutical Trade Forecast 62
Table: Exports and Imports Indicators 2008-2016 63
Key Risks To our Forecast Scenario 64
Competitive Landscape 65
Research-Based Industry 65
Table: Top 10 Companies By US Prescription Sales (US$bn) 66
Table: Top 10 Drugs By US Sales (US$bn) 66
Research-Based Industry – Key Developments 67
Generic Drugmakers 68
Table: Top 10 Companies By US Dispensed Prescriptions (mn) 68
Drug Distribution Sector 69
Pharmacy Retail Sector 70
Table: US Dispensed Prescription Drug Distribution By Channel Distribution Volume (mn) 71
Company Profiles 72
US Companies 72
Pfizer 72
Merck & Co 75
Eli Lilly 77
Amgen 80
Watson Pharmaceuticals 82
Foreign Companies 84
GlaxoSmithKline 84
AstraZeneca 86
Demographic Outlook 88
Table: Population By Age Group, 1990-2020 (‘000) 89
Table: Population By Age Group, 1990-2020 (% of total) 90
Table: Key Population Ratios, 1990-2020 91
Table: Rural And Urban Population, 1990-2020 91
Glossary 92
BMI Methodology 94
How We Generate Our Pharmaceutical Industry Forecasts 94
Pharmaceuticals Business Environment Ratings 95
Risk/Reward Ratings Methodology 95
Ratings Overview 95
Table: Pharmaceutical Business Environment Indicators 96
Weighting 97
Table: Weighting Of Components 97
Sources 97
Historical Data & Forecasts 97
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