The Pharmaceutical Market: USA

NEW YORK, Dec. 4, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

The Pharmaceutical Market: USA

http://www.reportlinker.com/p0203098/The-Pharmaceutical-Market-USA.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pharmaceutical

Espicom's highly regarded world pharmaceutical market reports have been redesigned to provide enhanced strategic intelligence in a user-friendly format. Each report provides in-depth information, setting the pharmaceutical market in context. The reports provide:

Five-year projections for economic, demographic, health expenditure, health workforce and pharmaceutical market indicators. Specialised intelligence on OTCs, generics, biologics and biosimilars. Exclusive economic and demographic data for each market in the series. A separate statistical health file, comprising health expenditure, health infrastructure, health services and health personnel. The reports are updated quarterly, providing you with the latest information for a full year. In addition, the service will keep you up to date with market and industry news on a regular basis.

TABLE OF CONTENTS EXECUTIVE SUMMARY 1

A patent reform is in discussion to strengthen IPR protection 1

Snapshot: Strategic Espicom Analysis 2

Snapshot: Key Data Projections 3

MACROENVIRONMENT 4

POLITICAL 4

ECONOMIC5

Projections 5

LEGAL6

Intellectual Property Rights6

2011 Patent Law Reform 6

Hatch-Waxman Reform 6

Hatch-Waxman 7

Bolar Amendment 7

DEMOGRAPHIC 8

Projections 8

Demographic Indicators9

Birth Rate 9

Death Rate 9

Infant Mortality 9

Life Expectancy at Birth 9

EPIDEMIOLOGY 10

DISEASE BURDEN 10

DISEASE PREVALENCE11

Communicable Diseases 11

HIV/AIDS 11

Non-Communicable Diseases 11

HEALTHCARE - ACCOMPANYING HEALTH STATISTICS 12

ORGANISATION 12

Passage of the Healthcare Reform 12

Centres for Medicare & Medicaid Services 13

Medicare 13

Medicaid 14

CHIP 15

Health Insurance Portability and Accountability Act of 1996 15

Private Health Provision 15

Blue Cross and Blue Shield Association (BCBSA) 15

Managed Care 15

EXPENDITURE 16

Projections 16

INFRASTRUCTURE 18

Hospital Resources 18

SERVICES 18

Inpatient Activity Analysis18

Outpatient Activity Analysis18

WORKFORCE 19

Projections 19

REGULATORY AFFAIRS 20

NATIONAL AUTHORITY 20

FDA Amendments Act (FDAAA) 21

FDA Modernization Act21

DRUG APPROVAL PROCESS 22

Preclinical Assessment 22

Clinical Trials 22

FDA Review 23

Post-Marketing Surveillance 26

Drug Recalls 26

GOOD MANUFACTURING PRACTICE ENFORCEMENT 27

MARKETING 27

Direct-to-Consumer Promotion 27

FDAAA Modifications to DTC Promotion 27

INTERNATIONAL CO-OPERATION 28

Information-Sharing Agreements28

European Medicines Agency 28

Japan and Australia 28

Mexico and Canada28

Switzerland 28

Harmonisation 29

PRICING & REIMBURSEMENT 30

PUBLIC DRUG PROCUREMENT 31

Medicaid31

Average Wholesale Price (AWP) 31

Medicare32

Bill H R 1 32

STATE PRICING/REIMBURSEMENT MOVES 33

DISTRIBUTION CHANNELS 34

WHOLESALING 34

Trade Association34

HDMA 34

Leading Wholesalers 34

AmerisourceBergen 34

Cardinal Health 35

McKessons Corporation 36

RETAILING 38

Trade Association38

NACDS 38

Leading Drug Store Chains38

CVS Caremark 38

Walgreens 38

MARKET ANALYSIS 39

SIZE 39

Projections 39

Historical Figures 42

Current Structure 43

Prescription Drug Sales by Source 43

Retail Prescription Drug Sales by Retail Type45

Retail Drug Store Sales46

Research-Based Pharmaceutical Sales 47

PRODUCT DEVELOPMENT 49

MANUFACTURING 51

TRADE51

Exports 51

Imports 56

Parallel Imports60

Balance of Trade 61

COMPETITION 62

TRADE ASSOCIATION 62

PhRMA 62

Competitive Strategies63

GLOBAL COMPANY INTELLIGENCE66

Abbott67

Company Overview 67

Financial Performance 67

Product Portfolio 69

R&D Strategy 71

Manufacturing Capabilities 73

Outlook 73

Allergan 74

Company Overview 74

Financial Performance 74

Product Portfolio 76

R&D Strategy 78

Manufacturing Capabilities 78

Outlook 78

Amgen79

Company Overview 79

Financial Performance80

Product Portfolio 81

R&D Strategy 83

Manufacturing Capabilities 83

Outlook 84

Biogen Idec 84

Company Overview 84

Financial Performance85

Product Portfolio 87

R&D Strategy 88

Manufacturing Capabilities 89

Outlook 89

Bristol-Myers Squibb90

Company Overview 90

Financial Performance 91

Product Portfolio 92

R&D Strategy 94

Manufacturing Capabilities 95

Outlook 95

Eli Lilly 95

Company Overview 95

Financial Performance96

Product Portfolio 96

R&D Strategy 98

Manufacturing Capabilities 99

Outlook 99

Forest Laboratories 100

Company Overview100

Financial Performance 100

Product Portfolio 101

R&D Strategy103

Manufacturing Capabilities 103

Outlook104

Gilead Sciences 104

Company Overview104

Financial Performance 105

Product Portfolio 106

R&D Strategy107

Manufacturing Capabilities 108

Outlook108

Hospira 109

Company Overview109

Financial Performance 110

Product Portfolio 111

R&D Strategy 112

Manufacturing Capabilities 113

Outlook 114

Johnson & Johnson 114

Company Overview 114

Financial Performance 115

Product Portfolio 117

R&D Strategy 119

Manufacturing Capabilities 120

Outlook120

Merck & Co 121

Company Overview 121

Financial Performance 122

Product Portfolio 123

R&D Strategy125

Manufacturing Capabilities 126

Outlook 126

Mylan127

Company Overview 127

Financial Performance 127

Product Portfolio 129

R&D Strategy130

Manufacturing Capabilities 130

Outlook 131

Pfizer 131

Company Overview 131

Financial Performance 132

Product Portfolio 133

R&D Strategy 135

Manufacturing Capabilities 136

Outlook 137

Watson Pharmaceuticals 137

Company Overview 137

Financial Performance 138

Product Portfolio 139

R&D Strategy 141

Manufacturing Capabilities 142

Outlook142

REGULATORY AFFAIRS 143

OTC Drug Review 143

MARKET SIZE 143

COMPETITION 145

Trade Association 145

CHPA 145

Competitive Strategies 146

GENERIC PHARMACEUTICALS 147

REGULATORY AFFAIRS147

Generic Drug Review 147

Ruling regarding Labelling 150

Push for Generic Drug User Fees 150

MARKET SIZE 151

COMPETITION153

Trade Association 154

GPhA 154

Competitive Strategies 154

BIOLOGICS & BIOSIMILARS 157

REGULATION 157

Biologic Therapeutic Review 157

Proposed Biosimilar User Fee Structure 159

Call for Shorter Data Exclusivity Period for Biologics160

Biosimilar Hearing 160

Work on Biosimilar Pathway 161

Biosimilar Pathway Provisions 162

PRODUCT DEVELOPMENT 165

PhRMA Expenditure on Biologics 165

Qualifying Therapeutic Discovery Project165

COMPETITION 166

Trade Associations166

BIO166

PPTA166

Competitive Strategies 167

CONCLUSIONS: OPPORTUNITIES & CHALLENGES 170

Strategic Espicom Analysis 170

MACROENVIRONMENT 170

EPIDEMIOLOGY 170

HEALTHCARE171

REGULATORY AFFAIRS171

PRICING & REIMBURSEMENT 172

DISTRIBUTION CHANNELS 172

MARKET 172

COMPETITION 173

OTC PHARMACEUTICALS 173

GENERIC PHARMACEUTICALS173

BIOLOGICS & BIOSIMILARS 174

Radar Analysis 176

SWOT Analysis 176

DIRECTORY 177

COMPANY INTELLIGENCE 177

GOVERNMENT ORGANISATIONS 177

TRADE ORGANISATIONS177

METHODOLOGY & SOURCES 178

List of Tables

Espicom Analysis of the Pharmaceutical Market, 2011 2Key Data Projections, 2011-2016 3Political Landscape, 2011 4Regional Ranking of Projected Economies, 2016 (US$ Billion) 5Projected Economy, 2011-2016 (US$ Billion) 5Regional Ranking of Projected Demographics, 2016 (Million) 8Projected Demographics, 2011-2016 (Million) 8 Selected Demographic Indicators, 1990-2009 9Causes of Death, 2000-2009 (000s) 10Regional Ranking of Projected Health Expenditure, 2016 16Projected Health Expenditure, 2011-2016 16Projected Health Expenditure by Funding Source, 2010-2020 (US$ Billion) 17Regional Ranking of Projected Physicians, 2016 (000) 19Projected Physicians, 2011-2016 (000) 19Organisation of CDER, 2010 20FDA Standard & Priority NDAs and BLAs Approvals, 1997-2010 23FDA Standard & Priority NMEs and New BLAs Approvals, 1997-2010 24FDA Standard & Priority New or Expanded Use Approvals of Drugs and Biologics, 1997-2007 25Drug Recalls by Type, 1997-2007 27Average Retail Prescription Price, 2007-2009 (US$) 30Average Retail Prescription Price by Income Distribution, 2008-2009 30AmerisourceBergen's Selected Financial Data, 2006-2010 (US$ Million) 35Cardinal Health's Selected Financial Data, 2006-2010 (US$ Million) 36McKesson Corporation's Selected Financial Data, 2007-2011 (US$ Million) 37Community Pharmacy Retail Outlets, 2005-2009 38Regional Ranking of Projected Pharmaceutical Markets, 2016 (US$ Million) 39Projected Pharmaceutical Market at Retail Prices, 2011-2016 (US$ Million) 41Projected Pharmaceutical Market at Retail Prices by Sector, 2011-2016 (US$ Million) 41Projected Pharmaceutical Market at Retail Prices by Sector, 2011-2016 (%) 41Historical Pharmaceutical Market at Retail Prices, 1995-2010 (US$ Million) 42Projected Prescription Drug Expenditure by Funding Source, 2010-2020 (US$ Million) 43Annual Retail Prescription Drug Sales by Retail Type, 2005-2009 (US$ Billion) 45Annual Retail Prescription Drug Sales by Retail Type, 2005-2009 (Million Scripts Dispensed) 45Monthly Retail Drug Store Sales, 1992-May 2011 (US$ Million) 46Annual Research-Based Pharmaceutical Manufacturers' Sales, 1990-2010 (US$ Million) 47R&D Expenditure, 1990-2010 (US$ Million) 49 R&D Expenditure by Type, 2006-2009 (US$ Million) 50R&D Expenditure by Phase, 2005-2009 (US$ Million) 50R&D Personnel by Phase, 2005-2009 50Pharmaceutical Exports by Category, 1995-2010 (US$ Millions) 51Exports of Raw Materials by Country/Region, 2006-2010 (US$ Millions) 52Exports of Antisera & Vaccines by Country/Region, 2006-2010 (US$ Millions) 53Exports of Semi-finished Medicaments by Country/Region, 2006-2010 (US$ Millions) 54Exports of Retail Medicaments by Country/Region, 2006-2010 (US$ Millions) 55Pharmaceutical Imports by Category, 1995-2010 (US$ Millions) 56Imports of Raw Materials by Country/Region, 2006-2010 (US$ Million) 57Imports of Antisera & Vaccines by Country/Region, 2006-2010 (US$ Million) 58Imports of Semi-finished Medicaments by Country/Region, 2006-2010 (US$ Million) 59Imports of Retail Medicaments by Country/Region, 2006-2010 (US$ Million) 60Balance of Pharmaceutical Trade, 1995-2010 (US$ Millions) 61Members of PhRMA, 2011 62Selected US Pharmaceutical Manufacturers by Pharmaceutical Sales, 2006-2010 (US$ Million) 66Abbott's Principal Operating Results, 2007-2011 (US$ Million) 68Abbott's Revenue by Business Area, 2007-2011 (US$ Million) 68Abbott's Revenue by Geographic Area, 2007-2011 (US$ Million) 68Abbott's Pharmaceutical Sales by Leading Products, 2006-2010 (US$ Million) 69Abbott's Recent Product Approvals, 2011-2012 70Abbott's Principal Pharmaceutical Manufacturing Facilities by Location, 2011 73Allergan's Revenue by Business Area, 2007-2011 (US$ Million) 75Allergan's Revenue by Geographic Area, 2007-2011 (US$ Million) 76Allergan's Revenue by Leading Products, 2007-2011 (US$ Million) 77Allergan's Recent Product Approvals, 2011-2012 77Amgen's Principal Operating Results, 2007-2011 (US$ Million) 80Amgen's Revenue by Geographic Area, 2007-2011 (US$ Million) 80Amgen's Pharmaceutical Sales by Leading Products, 2007-2011 (US$ Million) 81Amgen's Recent Product Approvals, 2011-2012 82Amgen's Major Manufacturing Facilities by Location, 2012 83Biogen Idec's Principal Operating Results, 2007-2011 (US$ Million)86Biogen Idec's Revenue by Business Area, 2007-2011 (US$ Million) 86Biogen Idec's Revenue by Geographic Area, 2007-2011 (US$ Million) 86Biogen Idec's Pharmaceutical Sales by Leading Products, 2007-2011 (US$ Million) 87Biogen Idec's Recent Product Approvals, 2011-2012 88Biogen Idec's Major Manufacturing Facilities, 2012 89BMS' Principal Operating Results, 2007-2011 (US$ Million) 91BMS' Revenue by Geographic Area, 2008-2011 (US$ Million) 91BMS's Pharmaceutical Sales by Leading Products, 2007-2011 (US$ Million) 92BMS' Recent Product Approvals, 2011-2012 93 Eli Lilly's Principal Operating Results, 2007-2011 (US$ Million) 96Eli Lilly's Revenue by Geographic Area, 2007-2011 (US$ Million)96Eli Lilly's Revenue by Leading Products, 2007-2011 (US$ Million) 97Eli Lilly's Recent Product Approvals, 2011-2012 98Eli Lilly's Major Manufacturing Plants, 2011 99Forest's Principal Operating Results, 2006-2010 (US$ Million) 101Forest's Revenue by Business Area, 2006-2010 (US$ Million) 101Forest's Pharmaceutical Sales by Geographic Area, 2006-2010 (US$ Million) 101Forest's Pharmaceutical Sales by Leading Products, 2006-2010 (US$ Million) 102Forest's Recent Product Approvals, 2010-2011 102Forest's Major Manufacturing Facilities by Location, 2011 103Gilead's Principal Operating Results, 2006-2010 (US$ Million) 105Gilead's Revenue by Geographic Area, 2006-2010 (US$ Million) 105Gilead's Pharmaceutical Revenue by Leading Products, 2006-2010 (US$ Million) 106Gilead's Recent Product Approvals, 2010-2011 107Gilead's Major Manufacturing Facilities by Location, 2011108Hospira's Principal Operating Results, 2006-2010 (US$ Million) 110Hospira's Revenue by Business Area, 2006-2010 (US$ Million) 110Hospira's Revenue by Geographic Area & Business Area, 2006-2010 (US$ Million) 111Hospira's Major Recent Product Approvals, 2010-2011 112Hospira's Major Manufacturing Facilities by Location, 2011 113Johnson & Johnson's Principal Operating Results, 2006-2010 (US$ Million) 116Johnson & Johnson's Revenue by Business Area, 2006-2010 (US$ Million) 116Johnson & Johnson's Revenue by Geographic Area, 2006-2010 (US$ Million) 116Johnson & Johnson's Pharmaceutical Revenue by Leading Products, 2006-2010 (US$ Million) 117Johnson & Johnson's Recent Product Approvals, 2010-2011 118Johnson & Johnson's Major Manufacturing Facilities by Location, 2011 120Merck & Co's Principal Operating Results, 2007-2011 (US$ Million) 122Merck & Co's Revenue by Business Area, 2007-2011 (US$ Million) 122Merck & Co's Revenue by Geographic Area, 2007-2011 (US$ Million) 123Merck & Co's Revenue by Leading Products, 2007-2011 (US$ Million) 124Merck & Co's Recent Product Approvals, 2011-2012 124Mylan's Principal Operating Results, 2008-2010 (US$ Million) 128Mylan's Revenue by Business Area, 2008-2010 (US$ Million) 128Mylan's Sales by Geographic Area, 2008-2010 (US$ Million) 128Mylan's Pharmaceutical Sales by Leading Therapeutic Area, 2008-2010 (US$ Million) 129Mylan's Manufacturing Facilities by Location, 2011 130Pfizer's Principal Operating Results, 2007-2011 (US$ Million) 132Pfizer's Sales by Business Area, 2008-2011 (US$ Million) 132Pfizer's Sales by Geographic Area, 2008-2011 (US$ Million) 132Pfizer's Sales by Leading Products, 2007-2011 (US$ Million) 133Pfizer's Recent Product Approvals, 2011-2012 134Pfizer's Manufacturing Facilities by Location, 2012 136Watson's Principal Operating Results, 2006-2010 (US$ Million) 138Watson's Revenue by Business Area, 2006-2010 (US$ Million) 139Watson's Pharmaceutical Revenue by Geographic Area, 2008-2010 (US$ Million) 139Watson's Recent Branded Product Approvals, 2010-2011 140Watson's Major Manufacturing Facilities by Location, 2011 142OTC Drug Review, 2006-2010 143OTC Sales by Category, 2006-2010 (US$ Million) 143Members of CHPA, 2011 145Generic Drug Review, 2006-2010 147Leading Companies by ANDAs Approved, 2010148Leading First Time Generic Product Approvals, 2010 148Major Generic Product Approvals, 2001-2009 149SWOT Analysis of the Generic Sector, 2011 151Biologic Therapeutic Review, 2006-2010 157New BLAs Approvals, 2004-2010 158Biologic R&D Expenditure by Type, 2006-2009 (US$ Million) 165Espicom Analysis of the Pharmaceutical Market, 2011 175SWOT Analysis of the Pharmaceutical Market, 2011 176

List of Charts

FDA Review Time of Standard & Priority NDAs and BLAs Approvals, 1997-2008 (Months) 24

FDA Review Time of Standard & Priority NMEs and New BLAs Approvals, 1997-2008 (Months) 25

FDA Review Time of Standard & Priority New or Expanded Use Approvals of Drugs and Biologics, 1997-2007 (Months) 26

Regional Comparison of Top 4 Projected Pharmaceutical Markets at Retail Prices, 2016 40

Regional Comparison of Projected Pharmaceutical Market Share, 2016 (%) 40

Historical Pharmaceutical Market at Retail Prices, 1995-2010 42

Historical & Projected Annual Prescription Drug Expenditure, 1965-2020 (%) 44

Historical & Projected Annual Prescription Drug Expenditure, 1965-2020 (US$ Billion) 44

Annual Retail Drug Store Sales, 1992-2010 (US$ Billion)46

Annual Domestic Research-Based Pharmaceutical Manufacturers' Sales, 1971-2010 (US$ Billion) 47

Change in Annual Domestic Research-Based Pharmaceutical Manufacturers' Sales, 1971-2010 (%)48

Pharmaceutical Exports, 1995-2010 (US$ Millions) 52

Pharmaceutical Imports, 1995-2010 (US$ Millions) 56

Balance of Pharmaceutical Trade, 1995-2010 (US$ Millions) 61

Allergan's Principal Operating Results, 2007-2011 (US$ Million) 75

OTC Sales, 1990-2010 (US$ Billion) 144

Radar Graph of the Pharmaceutical Market, 2011 176

To order this report:Pharmaceutical Industry: The Pharmaceutical Market: USA

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