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The Pharmaceutical Market: USA

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Date: May 15, 2012
Pages: 178
Price:
US$ 1,085.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: PB69D0286E2EN

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THE PHARMACEUTICAL MARKET: USA - REVIEW

Espicom projects that the US pharmaceutical market will grow by a moderate CAGR between 2011 and 2016. The effect of recent legislation is difficult to measure. Pharmaceutical companies face a number of costs initially, depressing sales growth. However, pharmaceutical sales are expected to be boosted in the long-term as at least an additional 32.0 million Americans, equal to about a tenth of the population, should receive insurance from 2014 onwards. Not all of this additional population will require drugs, as many will be young people or those already consuming drugs, but further consumption should rise overall. Biologic companies will gain with the new 12-year data exclusivity provided by the new healthcare regulation. In 2011, major competitive strategies included Novo Nordisk’s agreement to set up a new US headquarters; Pfizer’s sale of Capsugel to KKR; Allergan’s agreement to acquire all of the outstanding assets of Vicept; Valeant’s agreement to acquire the assets of Janssen’s Ortho Dermatologics division; Valeant’s agreement to acquire Dermik from Sanofi; Merck & Co’s acquisition of Inspire; Baxter’s agreement to acquire Prism Pharmaceuticals; Forest’s acquisition of Clinical Data (CD); Sanofi’s acquisition of Genzyme; Daiichi Sankyo’s acquisition of Plexxikon; AstraZeneca’s US$1.1 billion payment to resolve tax matters; and Pfizer’s acquisition of King Pharmaceuticals.

The US generic sector is expected to rise by a higher CAGR between 2011 and 2016. According to the GPhA, there are around 50 manufacturers. Major US generic players include Mylan, Watson and Hospira. Other important US generic companies include Greenstone (Pfizer), Qualitest Products and Mallinckrodt. Overseas companies have a major stake in the market, including Teva, Sandoz (Novartis), Apotex, Actavis, Lupin and Dr Reddy’s. A number of other Indian companies are attempting to break into the retail market. In 2011, major competitive strategies included KV’s divestidure of Nesher Pharmaceuticals; Perrigo’s acquisition of Paddock Laboratories; Cephalon shareholders’ approval for Teva to acquire the company; Watson’s announcement to expand its Salt Lake City site; the merger of Caraco and Sun; Apotex’s resumed shipments to the USA; Hikma’s acquisition of Baxter's Generic Injectables Business; Sagent’s IPO launch; Texas Jury’s order for Actavis to pay US$170.3 million in damages; and Elite’s generic agreement with Hi-Tech Pharmacal.

In May 2011, the FDA published details of its proposed user fee structure for the regulation of biosimilar products in the USA. This would run for five years, from 2013 to 2017. Under the Biologics Price Competition and Innovation Act (BCPIA), the FDA has been given the task of developing such a user fee programme in order to support its activities in the area. The BCPIA creates a new category of approval – a 351(k) – for biosimilars under the Public Health Service Act (PHS). To date, all existing biologics are approved under the 351(a) procedure, for which user fees are already collected under the Prescription Drug User Fee Act (PDUFA), first enacted in 1993. Fees are currently collected for all original drug and biologic applications, but not for ANDA generic applications. In 2011, major competitive strategies included Gilead’s agreement to purchase one of Genentech's manufacturing facilities; Omni Bio’s stake acquisition in BioMimetix; Grifols’ acquisition of Talecris Biotherapeutics; Astellas’ acquisition of Perseid from Maxygen; Sanofi’s acquisition of Genzyme; Boehringer Ingelheim’s acquisition of Amgen's Fremont facility; Amgen’s acquisition of BioVex; Gilead’s acquisition of Calistoga Pharmaceuticals; the alliance between Merck and Parexel to form a biosimilar strategic alliance; Alexion’s acquisition of Taligen; and Eli Lilly’s agreement to acquire Alnara Pharmaceuticals.

ENHANCED STRATEGIC INTELLIGENCE

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.

HEALTHCARE STATISTICS

A comprehensive tabula review, comprising demographics, epidemiology, health expenditure, hospital and primary care infrastructure & services and healthcare personnel, is additionally included.

HIGHLY DETAILED REPORT CONTENT

EXECUTIVE SUMMARY

Including Espicom's at a glance strategic analysis and key data projections

MACROENVIRONMENT

Political, economic, legal and demographic analysis

EPIDEMIOLOGY

Disease burden and prevalence

HEALTHCARE

Organisation, expenditure, infrastructure, services and workforce

REGULATORY AFFAIRS

Regulatory developments and marketing registration/authorisation

PRICING & REIMBURSEMENT

DISTRIBUTION CHANNELS

MARKET ANALYSIS

Projections, product development, manufacturing and trade

COMPETITION

Trade associations, trade fairs, company intelligence and competitive strategies

GLOBAL COMPANY INTELLIGENCE

OTC PHARMACEUTICALS

GENERIC PHARMACEUTICALS

BIOLOGICS & BIOSIMILARS

OPPORTUNITIES & CHALLENGES

Espicom's unique strategic analysis

DIRECTORY

METHODOLOGY & SOURCES

Contents

EXECUTIVE SUMMARY

A patent reform is in discussion to strengthen IPR protection. 1
Snapshot: Strategic Espicom Analysis
Snapshot: Key Data Projections

MACROENVIRONMENT

POLITICAL
ECONOMIC
  Projections
LEGAL
  Intellectual Property Rights
  2011 Patent Law Reform
  Hatch-Waxman Reform
  Hatch-Waxman
  Bolar Amendment
DEMOGRAPHIC
  Projections
  Demographic Indicators
    Birth Rate
    Death Rate
    Infant Mortality
    Life Expectancy at Birth

EPIDEMIOLOGY

DISEASE BURDEN
DISEASE PREVALENCE
  Communicable Diseases
    HIV/AIDS
  Non-Communicable Diseases

HEALTHCARE - ACCOMPANYING HEALTH STATISTICS

ORGANISATION
  Passage of the Healthcare Reform
  Centres for Medicare & Medicaid Services
  Medicare
  Medicaid
CHIP
  Health Insurance Portability and Accountability Act of 1996
  Private Health Provision
  Blue Cross and Blue Shield Association (BCBSA)
  Managed Care
EXPENDITURE
  Projections
INFRASTRUCTURE
  Hospital Resources
SERVICES
  Inpatient Activity Analysis
  Outpatient Activity Analysis
WORKFORCE
  Projections

REGULATORY AFFAIRS

NATIONAL AUTHORITY
  FDA Amendments Act (FDAAA)
  FDA Modernization Act
  DRUG APPROVAL PROCESS
  Preclinical Assessment
  Clinical Trials
  FDA Review
  Post-Marketing Surveillance
  Drug Recalls
GOOD MANUFACTURING PRACTICE ENFORCEMENT
MARKETING
  Direct-to-Consumer Promotion
  FDAAA Modifications to DTC Promotion
INTERNATIONAL CO-OPERATION
  Information-Sharing Agreements
  European Medicines Agency
  Japan and Australia
  Mexico and Canada
  Switzerland
  Harmonisation

PRICING & REIMBURSEMENT

PUBLIC DRUG PROCUREMENT
  Medicaid
  Average Wholesale Price (AWP)
  Medicare
  Bill H.R.1
STATE PRICING/REIMBURSEMENT MOVES

DISTRIBUTION CHANNELS

WHOLESALING
  Trade Association
    HDMA
  Leading Wholesalers
    AmerisourceBergen
    Cardinal Health
    McKessons Corporation
RETAILING
  Trade Association
    NACDS
    Leading Drug Store Chains
    CVS Caremark
    Walgreens

MARKET ANALYSIS

SIZE
  Projections
  Historical Figures
  Current Structure
  Prescription Drug Sales by Source
  Retail Prescription Drug Sales by Retail Type
  Retail Drug Store Sales
  Research-Based Pharmaceutical Sales
PRODUCT DEVELOPMENT
MANUFACTURING
TRADE
  Exports
  Imports
  Parallel Imports
  Balance of Trade

COMPETITION

TRADE ASSOCIATION
  PhRMA
  Competitive Strategies
GLOBAL COMPANY INTELLIGENCE
  Abbott
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Allergan
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Amgen
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Biogen Idec
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Bristol-Myers Squibb
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Eli Lilly
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Forest Laboratories
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Gilead Sciences
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Hospira
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Johnson & Johnson
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Merck & Co
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Mylan
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Pfizer
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook
  Watson Pharmaceuticals
    Company Overview
    Financial Performance
    Product Portfolio
    R&D Strategy
    Manufacturing Capabilities
    Outlook

REGULATORY AFFAIRS

OTC Drug Review
MARKET SIZE
COMPETITION
  Trade Association
    CHPA
  Competitive Strategies

GENERIC PHARMACEUTICALS

REGULATORY AFFAIRS

Generic Drug Review
Ruling regarding Labelling
Push for Generic Drug User Fees
MARKET SIZE
COMPETITION
  Trade Association
    GPhA
  Competitive Strategies

BIOLOGICS & BIOSIMILARS

REGULATION
  Biologic Therapeutic Review
  Proposed Biosimilar User Fee Structure
  Call for Shorter Data Exclusivity Period for Biologics
  Biosimilar Hearing
  Work on Biosimilar Pathway
  Biosimilar Pathway Provisions
PRODUCT DEVELOPMENT
  PhRMA Expenditure on Biologics
  Qualifying Therapeutic Discovery Project

COMPETITION

  Trade Associations
    BIO
    PPTA
  Competitive Strategies

CONCLUSIONS: OPPORTUNITIES & CHALLENGES

Strategic Espicom Analysis
  MACROENVIRONMENT
  EPIDEMIOLOGY
  HEALTHCARE
  REGULATORY AFFAIRS
  PRICING & REIMBURSEMENT
  DISTRIBUTION CHANNELS
  MARKET
  COMPETITION
  OTC PHARMACEUTICALS
  GENERIC PHARMACEUTICALS
  BIOLOGICS & BIOSIMILARS
Radar Analysis
SWOT Analysis
DIRECTORY
COMPANY INTELLIGENCE
GOVERNMENT ORGANISATIONS
TRADE ORGANISATIONS

METHODOLOGY & SOURCES

LIST OF TABLES

Espicom Analysis of the Pharmaceutical Market, 2011
Key Data Projections, 2011-2016
Political Landscape, 2011
Regional Ranking of Projected Economies, 2016 (US$ Billion)
Projected Economy, 2011-2016 (US$ Billion)
Regional Ranking of Projected Demographics, 2016 (Million)
Projected Demographics, 2011-2016 (Million)
Selected Demographic Indicators, 1990-2009
Causes of Death, 2000-2009 (000s)
Regional Ranking of Projected Health Expenditure, 2016
Projected Health Expenditure, 2011-2016
Projected Health Expenditure by Funding Source, 2010-2020 (US$ Billion)
Regional Ranking of Projected Physicians, 2016 (000)
Projected Physicians, 2011-2016 (000)
Organisation of CDER, 2010
FDA Standard & Priority NDAs and BLAs Approvals, 1997-2010
FDA Standard & Priority NMEs and New BLAs Approvals, 1997-2010
FDA Standard & Priority New or Expanded Use Approvals of Drugs and Biologics, 1997-2007
Drug Recalls by Type, 1997-2007
Average Retail Prescription Price, 2007-2009 (US$)
Average Retail Prescription Price by Income Distribution, 2008-2009
AmerisourceBergen’s Selected Financial Data, 2006-2010 (US$ Million)
Cardinal Health’s Selected Financial Data, 2006-2010 (US$ Million)
McKesson Corporation’s Selected Financial Data, 2007-2011 (US$ Million)
Community Pharmacy Retail Outlets, 2005-2009
Regional Ranking of Projected Pharmaceutical Markets, 2016 (US$ Million)
Projected Pharmaceutical Market at Retail Prices, 2011-2016 (US$ Million)
Projected Pharmaceutical Market at Retail Prices by Sector, 2011-2016 (US$ Million)
Projected Pharmaceutical Market at Retail Prices by Sector, 2011-2016 (%)
Historical Pharmaceutical Market at Retail Prices, 1995-2010 (US$ Million)
Projected Prescription Drug Expenditure by Funding Source, 2010-2020 (US$ Million)
Annual Retail Prescription Drug Sales by Retail Type, 2005-2009 (US$ Billion)
Annual Retail Prescription Drug Sales by Retail Type, 2005-2009 (Million Scripts Dispensed)
Monthly Retail Drug Store Sales, 1992-May 2011 (US$ Million)
Annual Research-Based Pharmaceutical Manufacturers’ Sales, 1990-2010 (US$ Million)
R&D Expenditure, 1990-2010 (US$ Million)
R&D Expenditure by Type, 2006-2009 (US$ Million)
R&D Expenditure by Phase, 2005-2009 (US$ Million)
R&D Personnel by Phase, 2005-2009
Pharmaceutical Exports by Category, 1995-2010 (US$ Millions)
Exports of Raw Materials by Country/Region, 2006-2010 (US$ Millions)
Exports of Antisera & Vaccines by Country/Region, 2006-2010 (US$ Millions)
Exports of Semi-finished Medicaments by Country/Region, 2006-2010 (US$ Millions)
Exports of Retail Medicaments by Country/Region, 2006-2010 (US$ Millions)
Pharmaceutical Imports by Category, 1995-2010 (US$ Millions)
Imports of Raw Materials by Country/Region, 2006-2010 (US$ Million)
Imports of Antisera & Vaccines by Country/Region, 2006-2010 (US$ Million)
Imports of Semi-finished Medicaments by Country/Region, 2006-2010 (US$ Million)
Imports of Retail Medicaments by Country/Region, 2006-2010 (US$ Million)
Balance of Pharmaceutical Trade, 1995-2010 (US$ Millions)
Members of PhRMA, 2011
Selected US Pharmaceutical Manufacturers by Pharmaceutical Sales, 2006-2010 (US$ Million)
Abbott’s Principal Operating Results, 2007-2011 (US$ Million)
Abbott’s Revenue by Business Area, 2007-2011 (US$ Million)
Abbott’s Revenue by Geographic Area, 2007-2011 (US$ Million)
Abbott’s Pharmaceutical Sales by Leading Products, 2006-2010 (US$ Million)
Abbott’s Recent Product Approvals, 2011-2012
Abbott’s Principal Pharmaceutical Manufacturing Facilities by Location, 2011
Allergan’s Revenue by Business Area, 2007-2011 (US$ Million)
Allergan’s Revenue by Geographic Area, 2007-2011 (US$ Million)
Allergan’s Revenue by Leading Products, 2007-2011 (US$ Million)
Allergan’s Recent Product Approvals, 2011-2012
Amgen’s Principal Operating Results, 2007-2011 (US$ Million)
Amgen’s Revenue by Geographic Area, 2007-2011 (US$ Million)
Amgen’s Pharmaceutical Sales by Leading Products, 2007-2011 (US$ Million)
Amgen’s Recent Product Approvals, 2011-2012
Amgen’s Major Manufacturing Facilities by Location, 2012
Biogen Idec’s Principal Operating Results, 2007-2011 (US$ Million)
Biogen Idec’s Revenue by Business Area, 2007-2011 (US$ Million)
Biogen Idec’s Revenue by Geographic Area, 2007-2011 (US$ Million)
Biogen Idec’s Pharmaceutical Sales by Leading Products, 2007-2011 (US$ Million)
Biogen Idec’s Recent Product Approvals, 2011-2012
Biogen Idec’s Major Manufacturing Facilities, 2012
BMS’ Principal Operating Results, 2007-2011 (US$ Million)
BMS’ Revenue by Geographic Area, 2008-2011 (US$ Million)
BMS’s Pharmaceutical Sales by Leading Products, 2007-2011 (US$ Million)
BMS’ Recent Product Approvals, 2011-2012
Eli Lilly’s Principal Operating Results, 2007-2011 (US$ Million)
Eli Lilly’s Revenue by Geographic Area, 2007-2011 (US$ Million)
Eli Lilly’s Revenue by Leading Products, 2007-2011 (US$ Million)
Eli Lilly’s Recent Product Approvals, 2011-2012
Eli Lilly’s Major Manufacturing Plants, 2011
Forest’s Principal Operating Results, 2006-2010 (US$ Million)
Forest’s Revenue by Business Area, 2006-2010 (US$ Million)
Forest’s Pharmaceutical Sales by Geographic Area, 2006-2010 (US$ Million)
Forest’s Pharmaceutical Sales by Leading Products, 2006-2010 (US$ Million)
Forest’s Recent Product Approvals, 2010-2011
Forest’s Major Manufacturing Facilities by Location, 2011
Gilead’s Principal Operating Results, 2006-2010 (US$ Million)
Gilead’s Revenue by Geographic Area, 2006-2010 (US$ Million)
Gilead’s Pharmaceutical Revenue by Leading Products, 2006-2010 (US$ Million)
Gilead’s Recent Product Approvals, 2010-2011
Gilead’s Major Manufacturing Facilities by Location, 2011
Hospira’s Principal Operating Results, 2006-2010 (US$ Million)
Hospira’s Revenue by Business Area, 2006-2010 (US$ Million)
Hospira’s Revenue by Geographic Area & Business Area, 2006-2010 (US$ Million)
Hospira’s Major Recent Product Approvals, 2010-2011
Hospira’s Major Manufacturing Facilities by Location, 2011
Johnson & Johnson’s Principal Operating Results, 2006-2010 (US$ Million)
Johnson & Johnson’s Revenue by Business Area, 2006-2010 (US$ Million)
Johnson & Johnson’s Revenue by Geographic Area, 2006-2010 (US$ Million)
Johnson & Johnson’s Pharmaceutical Revenue by Leading Products, 2006-2010 (US$ Million)
Johnson & Johnson’s Recent Product Approvals, 2010-2011
Johnson & Johnson’s Major Manufacturing Facilities by Location, 2011
Merck & Co’s Principal Operating Results, 2007-2011 (US$ Million)
Merck & Co’s Revenue by Business Area, 2007-2011 (US$ Million)
Merck & Co’s Revenue by Geographic Area, 2007-2011 (US$ Million)
Merck & Co’s Revenue by Leading Products, 2007-2011 (US$ Million)
Merck & Co’s Recent Product Approvals, 2011-2012
Mylan’s Principal Operating Results, 2008-2010 (US$ Million)
Mylan’s Revenue by Business Area, 2008-2010 (US$ Million)
Mylan’s Sales by Geographic Area, 2008-2010 (US$ Million)
Mylan’s Pharmaceutical Sales by Leading Therapeutic Area, 2008-2010 (US$ Million)
Mylan’s Manufacturing Facilities by Location, 2011
Pfizer’s Principal Operating Results, 2007-2011 (US$ Million)
Pfizer’s Sales by Business Area, 2008-2011 (US$ Million)
Pfizer’s Sales by Geographic Area, 2008-2011 (US$ Million)
Pfizer’s Sales by Leading Products, 2007-2011 (US$ Million)
Pfizer’s Recent Product Approvals, 2011-2012
Pfizer’s Manufacturing Facilities by Location, 2012
Watson’s Principal Operating Results, 2006-2010 (US$ Million)
Watson’s Revenue by Business Area, 2006-2010 (US$ Million)
Watson’s Pharmaceutical Revenue by Geographic Area, 2008-2010 (US$ Million)
Watson’s Recent Branded Product Approvals, 2010-2011
Watson’s Major Manufacturing Facilities by Location, 2011
OTC Drug Review, 2006-2010
OTC Sales by Category, 2006-2010 (US$ Million)
Members of CHPA, 2011
Generic Drug Review, 2006-2010
Leading Companies by ANDAs Approved, 2010
Leading First Time Generic Product Approvals, 2010
Major Generic Product Approvals, 2001-2009
SWOT Analysis of the Generic Sector, 2011
Biologic Therapeutic Review, 2006-2010
New BLAs Approvals, 2004-2010
Biologic R&D Expenditure by Type, 2006-2009 (US$ Million)
Espicom Analysis of the Pharmaceutical Market, 2011
SWOT Analysis of the Pharmaceutical Market, 2011

LIST OF CHARTS

FDA Review Time of Standard & Priority NDAs and BLAs Approvals, 1997-2008 (Months)
FDA Review Time of Standard & Priority NMEs and New BLAs Approvals, 1997-2008 (Months)
FDA Review Time of Standard & Priority New or Expanded Use Approvals of Drugs and Biologics, 1997-2007 (Months)
Regional Comparison of Top 4 Projected Pharmaceutical Markets at Retail Prices, 2016
Regional Comparison of Projected Pharmaceutical Market Share, 2016 (%)
Historical Pharmaceutical Market at Retail Prices, 1995-2010
Historical & Projected Annual Prescription Drug Expenditure, 1965-2020 (%)
Historical & Projected Annual Prescription Drug Expenditure, 1965-2020 (US$ Billion)
Annual Retail Drug Store Sales, 1992-2010 (US$ Billion)
Annual Domestic Research-Based Pharmaceutical Manufacturers’ Sales, 1971-2010 (US$ Billion)
Change in Annual Domestic Research-Based Pharmaceutical Manufacturers’ Sales, 1971-2010 (%)
Pharmaceutical Exports, 1995-2010 (US$ Millions)
Pharmaceutical Imports, 1995-2010 (US$ Millions)
Balance of Pharmaceutical Trade, 1995-2010 (US$ Millions)
Allergan’s Principal Operating Results, 2007-2011 (US$ Million)
OTC Sales, 1990-2010 (US$ Billion)
Radar Graph of the Pharmaceutical Market, 2011 Skip to top

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