The Pharmaceutical Market: USA

NEW YORK, Nov. 28, 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 from the Economist Intelligence Unit (EIU) 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 2

Key Data Projections, 2011-2016 3

Political Landscape, 2011 4

Regional Ranking of Projected Economies, 2016 (US$ Billion) 5

Projected Economy, 2011-2016 (US$ Billion) 5

Regional Ranking of Projected Demographics, 2016 (Million) 8

Projected Demographics, 2011-2016 (Million) 8 Selected Demographic Indicators, 1990-2009 9

Causes of Death, 2000-2009 (000s) 10

Regional Ranking of Projected Health Expenditure, 2016 16

Projected Health Expenditure, 2011-2016 16

Projected Health Expenditure by Funding Source, 2010-2020 (US$ Billion) 17

Regional Ranking of Projected Physicians, 2016 (000) 19

Projected Physicians, 2011-2016 (000) 19

Organisation of CDER, 2010 20

FDA Standard & Priority NDAs and BLAs Approvals, 1997-2010 23

FDA Standard & Priority NMEs and New BLAs Approvals, 1997-2010 24

FDA Standard & Priority New or Expanded Use Approvals of Drugs and Biologics, 1997-2007 25

Drug Recalls by Type, 1997-2007 27

Average Retail Prescription Price, 2007-2009 (US$) 30

Average Retail Prescription Price by Income Distribution, 2008-2009 30

AmerisourceBergen's Selected Financial Data, 2006-2010 (US$ Million) 35

Cardinal Health's Selected Financial Data, 2006-2010 (US$ Million) 36

McKesson Corporation's Selected Financial Data, 2007-2011 (US$ Million) 37

Community Pharmacy Retail Outlets, 2005-2009 38

Regional Ranking of Projected Pharmaceutical Markets, 2016 (US$ Million) 39

Projected Pharmaceutical Market at Retail Prices, 2011-2016 (US$ Million) 41

Projected Pharmaceutical Market at Retail Prices by Sector, 2011-2016 (US$ Million) 41

Projected Pharmaceutical Market at Retail Prices by Sector, 2011-2016 (%) 41

Historical Pharmaceutical Market at Retail Prices, 1995-2010 (US$ Million) 42

Projected Prescription Drug Expenditure by Funding Source, 2010-2020 (US$ Million) 43

Annual Retail Prescription Drug Sales by Retail Type, 2005-2009 (US$ Billion) 45

Annual Retail Prescription Drug Sales by Retail Type, 2005-2009 (Million Scripts Dispensed) 45

Monthly Retail Drug Store Sales, 1992-May 2011 (US$ Million) 46

Annual Research-Based Pharmaceutical Manufacturers' Sales, 1990-2010 (US$ Million) 47

R&D Expenditure, 1990-2010 (US$ Million) 49 R&D Expenditure by Type, 2006-2009 (US$ Million) 50

R&D Expenditure by Phase, 2005-2009 (US$ Million) 50

R&D Personnel by Phase, 2005-2009 50

Pharmaceutical Exports by Category, 1995-2010 (US$ Millions) 51

Exports of Raw Materials by Country/Region, 2006-2010 (US$ Millions) 52

Exports of Antisera & Vaccines by Country/Region, 2006-2010 (US$ Millions) 53

Exports of Semi-finished Medicaments by Country/Region, 2006-2010 (US$ Millions) 54

Exports of Retail Medicaments by Country/Region, 2006-2010 (US$ Millions) 55

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

Imports of Raw Materials by Country/Region, 2006-2010 (US$ Million) 57

Imports of Antisera & Vaccines by Country/Region, 2006-2010 (US$ Million) 58

Imports of Semi-finished Medicaments by Country/Region, 2006-2010 (US$ Million) 59

Imports of Retail Medicaments by Country/Region, 2006-2010 (US$ Million) 60

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

Members of PhRMA, 2011 62

Selected US Pharmaceutical Manufacturers by Pharmaceutical Sales, 2006-2010 (US$ Million) 66

Abbott's Principal Operating Results, 2007-2011 (US$ Million) 68

Abbott's Revenue by Business Area, 2007-2011 (US$ Million) 68

Abbott's Revenue by Geographic Area, 2007-2011 (US$ Million) 68

Abbott's Pharmaceutical Sales by Leading Products, 2006-2010 (US$ Million) 69

Abbott's Recent Product Approvals, 2011-2012 70

Abbott's Principal Pharmaceutical Manufacturing Facilities by Location, 2011 73

Allergan's Revenue by Business Area, 2007-2011 (US$ Million) 75

Allergan's Revenue by Geographic Area, 2007-2011 (US$ Million) 76

Allergan's Revenue by Leading Products, 2007-2011 (US$ Million) 77

Allergan's Recent Product Approvals, 2011-2012 77

Amgen's Principal Operating Results, 2007-2011 (US$ Million) 80

Amgen's Revenue by Geographic Area, 2007-2011 (US$ Million) 80

Amgen's Pharmaceutical Sales by Leading Products, 2007-2011 (US$ Million) 81

Amgen's Recent Product Approvals, 2011-2012 82

Amgen's Major Manufacturing Facilities by Location, 2012 83

Biogen Idec's Principal Operating Results, 2007-2011 (US$ Million)86

Biogen Idec's Revenue by Business Area, 2007-2011 (US$ Million) 86

Biogen Idec's Revenue by Geographic Area, 2007-2011 (US$ Million) 86

Biogen Idec's Pharmaceutical Sales by Leading Products, 2007-2011 (US$ Million) 87

Biogen Idec's Recent Product Approvals, 2011-2012 88

Biogen Idec's Major Manufacturing Facilities, 2012 89

BMS' Principal Operating Results, 2007-2011 (US$ Million) 91

BMS' Revenue by Geographic Area, 2008-2011 (US$ Million) 91

BMS's Pharmaceutical Sales by Leading Products, 2007-2011 (US$ Million) 92

BMS' Recent Product Approvals, 2011-2012 93 Eli Lilly's Principal Operating Results, 2007-2011 (US$ Million) 96

Eli Lilly's Revenue by Geographic Area, 2007-2011 (US$ Million)96

Eli Lilly's Revenue by Leading Products, 2007-2011 (US$ Million) 97

Eli Lilly's Recent Product Approvals, 2011-2012 98

Eli Lilly's Major Manufacturing Plants, 2011 99

Forest's Principal Operating Results, 2006-2010 (US$ Million) 101

Forest's Revenue by Business Area, 2006-2010 (US$ Million) 101

Forest's Pharmaceutical Sales by Geographic Area, 2006-2010 (US$ Million) 101

Forest's Pharmaceutical Sales by Leading Products, 2006-2010 (US$ Million) 102

Forest's Recent Product Approvals, 2010-2011 102

Forest's Major Manufacturing Facilities by Location, 2011 103

Gilead's Principal Operating Results, 2006-2010 (US$ Million) 105

Gilead's Revenue by Geographic Area, 2006-2010 (US$ Million) 105

Gilead's Pharmaceutical Revenue by Leading Products, 2006-2010 (US$ Million) 106

Gilead's Recent Product Approvals, 2010-2011 107

Gilead's Major Manufacturing Facilities by Location, 2011108

Hospira's Principal Operating Results, 2006-2010 (US$ Million) 110

Hospira's Revenue by Business Area, 2006-2010 (US$ Million) 110

Hospira's Revenue by Geographic Area & Business Area, 2006-2010 (US$ Million) 111

Hospira's Major Recent Product Approvals, 2010-2011 112

Hospira's Major Manufacturing Facilities by Location, 2011 113

Johnson & Johnson's Principal Operating Results, 2006-2010 (US$ Million) 116

Johnson & Johnson's Revenue by Business Area, 2006-2010 (US$ Million) 116

Johnson & Johnson's Revenue by Geographic Area, 2006-2010 (US$ Million) 116

Johnson & Johnson's Pharmaceutical Revenue by Leading Products, 2006-2010 (US$ Million) 117

Johnson & Johnson's Recent Product Approvals, 2010-2011 118

Johnson & Johnson's Major Manufacturing Facilities by Location, 2011 120

Merck & Co's Principal Operating Results, 2007-2011 (US$ Million) 122

Merck & Co's Revenue by Business Area, 2007-2011 (US$ Million) 122

Merck & Co's Revenue by Geographic Area, 2007-2011 (US$ Million) 123

Merck & Co's Revenue by Leading Products, 2007-2011 (US$ Million) 124

Merck & Co's Recent Product Approvals, 2011-2012 124

Mylan's Principal Operating Results, 2008-2010 (US$ Million) 128

Mylan's Revenue by Business Area, 2008-2010 (US$ Million) 128

Mylan's Sales by Geographic Area, 2008-2010 (US$ Million) 128

Mylan's Pharmaceutical Sales by Leading Therapeutic Area, 2008-2010 (US$ Million) 129

Mylan's Manufacturing Facilities by Location, 2011 130

Pfizer's Principal Operating Results, 2007-2011 (US$ Million) 132

Pfizer's Sales by Business Area, 2008-2011 (US$ Million) 132

Pfizer's Sales by Geographic Area, 2008-2011 (US$ Million) 132

Pfizer's Sales by Leading Products, 2007-2011 (US$ Million) 133

Pfizer's Recent Product Approvals, 2011-2012 134

Pfizer's Manufacturing Facilities by Location, 2012 136

Watson's Principal Operating Results, 2006-2010 (US$ Million) 138

Watson's Revenue by Business Area, 2006-2010 (US$ Million) 139

Watson's Pharmaceutical Revenue by Geographic Area, 2008-2010 (US$ Million) 139

Watson's Recent Branded Product Approvals, 2010-2011 140

Watson's Major Manufacturing Facilities by Location, 2011 142

OTC Drug Review, 2006-2010 143

OTC Sales by Category, 2006-2010 (US$ Million) 143

Members of CHPA, 2011 145

Generic Drug Review, 2006-2010 147

Leading Companies by ANDAs Approved, 2010148

Leading First Time Generic Product Approvals, 2010 148

Major Generic Product Approvals, 2001-2009 149

SWOT Analysis of the Generic Sector, 2011 151

Biologic Therapeutic Review, 2006-2010 157

New BLAs Approvals, 2004-2010 158

Biologic R&D Expenditure by Type, 2006-2009 (US$ Million) 165

Espicom Analysis of the Pharmaceutical Market, 2011 175

SWOT 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

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

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