United States Pharmaceuticals and Healthcare Q4 2012

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United States Pharmaceuticals and Healthcare Q4 2012




Includes 3 FREE quarterly updates.


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.

United States Pharmaceuticals & Healthcare Report Q4 2012


- 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 Page 4

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 BMI's 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




To order this report:

Prescription_Drug Industry: United States Pharmaceuticals and Healthcare Q4 2012

Nicolas Bombourg
Email: [email protected]
US: (805)652-2626
Intl: +1 805-652-2626


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