BMI's Executive Summary

[TOP]

Although slowing in the short-term, BMI expects the US drug market to pick up towards the end of the forecast period when it should reach a value of US$364.7bn. The best performing segment should be generics, due to a wave of patent expiries and the fact that cost-containment remians a priority throughout the health sector. The biggest threat to generics remains downward price pressure, sparked by stiff competition. For this reson we see growth declining from over 15% in 2008 to just 6% by 2012.

Patented drugs will not fare as well, with growth hovering around the 4% mark. However, the recent quarter has seen a spate of product approvals, which should help the long term prospects of the sector. In October 2007, Bristol Myers-Squibb (BMS) received US FDA approval for its breast cancer drug Ixempra (ixabepilone), which is forecast to generate US$500mn in sales by 2011. In the same month the US FDA also approved Merck & Co's revolutionary new HIV/AIDS medication Isentress (raltegravir) for patients who have formed resistance to existing treatment, while in August, Pfizer's breakthrough HIV/AIDS treatment Selzentry (maraviroc) also received the greenlight.

On the downside, Pfizer had recently pulled its inhaled insulin product Exubera – hailed as a major advance when it was approved in 2006 – after poor sales. This demonstates the danger that many potenital blockbusters face. In terms of regulatory developments, the biggest news has involved direct-toconsumer (DTC) advertising, with a new bill passing through Congress protecting the right of drugmakers to advertise products that carry serious safety warnings. However, the US FDA will be given the power to review TV advertisements before they air. Also, the agency will be given leeway to levy fines for adverts considered false and misleading.

In BMI's new methodology for Business Environemt Rankings - which give stronger emphasis to the regulatory environment, and also factor in country-specific economic and political indicators - the US ranks in No.1 position, both in the Americas region and globally. This is primarilly because of its worldleading Intellectual Property (IP) povisions, the sheer size of the pharmaceutical market, and the generally positive structure of the US economy.

Contents

[TOP]

Executive Summary

US Pharmaceuticals & Healthcare Industry SWOT

United States Political SWOT

United States Economic SWOT

Chapter 1 - US Pharmaceutical Business Environment Ratings

Table: Americas Pharmaceutical Business Environment Rankings

Limits To Potential Returns

Chapter 2 - United States - Market Summary

Chapter 3 - Regulatory Regime

Intellectual Property Developments

Pricing And Reimbursement Issues

Chapter 4 - Industry Developments

Healthcare Sector

Universal Healthcare

Table: US Health Insurance Key States, 2005

Part D

Democrats Controlling Congress

Biotechnology Sector

Table: Biotechnology Medicines Under Development, 2006

Table: Top 10 Biotech IPOs, 2006

Statins

Advertising Sector

Product Approvals

Merck Settles Over Vioxx

Mergers And Acquisitions

Marketing Sector

Research And Development Sector

Generics Sector

Wal-Mart Enters The Fray

Authorised Generics

Biogenerics

Canadian Imports

Pharmacy Sector

Manufacturing Sector

Vaccine-preventable Diseases

Chapter 5 - Industry Forecast Scenario

Overall Market Forecast

Table: US Pharmaceuticals And Healthcare Sector - Historical Data and Forecasts

Key Growth Factors - Industry

Key Growth Factors - Macroeconomic

Table: United States - Macroeconomic Forecasts

Patented Market Forecast

Table: Patented Market Indicators

OTC Market Forecast

Table: OTC Market Indicators (US$mn unless otherwise stated)

Generics Market Forecast

Table: Generics And Patented Market Indicators

Export/Import Forecasts

Table: US Pharmaceuticals And Healthcare Sector (US$mn)

Other Healthcare Data

Table: US Pharmaceuticals And Healthcare Sector

Table: US Pharmaceuticals And Healthcare Sector

Chapter 6 - Competitive Landscape

Overview

Chapter 7 - Market Data

Table: Leading 10 Therapeutic Classes By US Sales, 2006

Table: Leading 10 Products By US Sales, 2006

Table: 10 Leading Corporations By US Sales, 2006

Table: 10 Leading Corporations By Total US Dispensed Prescriptions, 2006

Table: Channel Distribution By US Dispensed Prescription, 2006

Table: Channel Distribution By US Sales, 2006

Table: Leading 10 Products By Total US Dispensed Prescriptions, 2006

Table: HMG-COA Reductase Inhibitors (statins) – Total US Sales (US$’000)

Table: Proton Pump Inhibitors – Total US Sales (US$’000)

Table: Antidepressants (includes SSRI, SNRI and newer generation) – Total US Sales (US$’000)

Table: Antiarthitics, COX-2 Inhibitors – Total US Sales (US$’000)

Table: Sexual Function Disorder – Total US Sales (US$’000)

Chapter 8 - Company Profiles

Pfizer

GlaxoSmithKline (GSK)

Novartis

Merck & Co

Eli Lilly

Bristol-Myers Squibb (BMS)

Amgen

Genentech

Chapter 9 - BMI Forecast Modelling

How We Generate Our Industry Forecasts

Pharmaceutical Industry

Pharmaceutical Business Environment Ratings Methodology

Ratings Overview

Table: Pharmaceutical Business Environment Indicators

Sources

Competitive Landscape for Americas Pharmaceuticals and Healthcare: Sample of Companies Ranked

[TOP]

Cross-border analysis of regulatory systems comparing the patenting environment, summarising regional pricing and reimbursement factors and monitoring the growth of the Pharmaceuticals sector across the region. Company SWOTs cover leading multinational and national drug companies operating in each market.

Network of American Pharmaceuticals & Healthcare Sources

[TOP]

BMI's American Pharmaceuticals & Healthcare Reports are based on an extensive network of multilateral organisations, government departments, pharmaceuticals industry associations, chambers of commerce and company reports. Information sources include: