TABLE OF CONTENTS EXECUTIVE SUMMARY Introduction Disclaimer Certification Understanding Biopharmaceuticals Market Segmentation Biopharma Classes Market Summary Biopharmaceuticals Market 1 INTRODUCTION 1.1 Key Take-Aways 1.2 Report Description 1.3 Markets Covered 1.4 Stakeholders 1.5 Research Methodology 2 MARKET OVERVIEW 2.1 Summary 2.2 Segmentation 3 INDUSTRY PROFILE 3.1 Introduction 3.2 Market Age 3.3 Base Year Revenues 3.4 Potential Revenues 3.5 Base Year Market Growth Rate 3.6 Forecast Period Market Growth Rate 3.7 Growth of Active Market Competitors 3.8 Base Year Number of Major Therapeutic Areas 3.9 Number of Products in Phase III Trials 3.1 Price Sensitivity 3.11 Top Biopharmaceutical Companies and Products In 2009 3.12 Biopharmaceutical Drug Classifications 3.12.1 Antisense Therapies 3.12.2 Cytokines 3.12.3 Proteins, Enzymes, and Hormones 3.12.4 Gene and Cell Therapies 3.12.5 Monoclonal Antibodies 3.12.6 Vaccines 3.12.7 Others 3.13 FDA Full Biopharmaceutical Approvals in 2009 3.14 Details of Key Approved Products 4 ANALYST INSIGHTS 4.1 Current Focus and Trends 4.2 Incentives for Orphan Drug 4.3 Industry Challenges 4.4 Biopharmaceutical Drugs are The Last Choice Amongst Prescription Medications 4.4.1 Highly Price-Sensitive: Determines Profitability 4.4.2 Intense Competition Amongst New Drugs on Clinical Efficacy 4.5 Market Drivers 4.6 Unmet Medical Needs Encourage Growth 4.6.1 Increase in FDA-Approved Biopharma Products in 2008 and 2009 4.6.2 Strong Biopharmaceuticals Pipeline Encourages Future Growth 4.6.3 Expansion of Indications 4.6.4 Less Number of Marketed Generics 4.6.5 Fewer Patent Expirations 4.6.6 High Lobby Power of Biopharma Companies And Benefit Managers 4.6.7 Increase in The Elderly Population 4.6.8 Market Restraints 4.7 High Cost of Biopharmaceuticals Discourages Their Use 4.7.1 Competition from Alternative Pharmaceuticals Product Choices 4.7.2 Black Box Labeling and Safety Warnings 4.7.3 High Technology Complexity, R&D Investment, and Time Lag For Product Development 4.7.4 Increased Competition Among Biopharmaceuticals 4.7.5 Follow-on Proteins 4.7.6 Regularizations and Possible Amendments to Medicare Part D 4.7.7 BCG Matrix: Evaluation of Top 5 Companies By Their Products 4.8 Analytical Hierarchy Process 4.9 Metrics’ and Calculations 4.1 Key Trends of The Health Reform Bill (2009) and The Medicare And Medicaid 4.11 Product Pipeline and Recalls 5 MARKET ANALYSIS 5.1 Total Market Forecasts 5.1.1 Revenue Forecasts 5.1.2 Sub-Market Forecast by Revenue 5.2 Market Forecast for P.E.H 5.2.1 Market Forecast for Mabs 5.3 Market Forecast for Vaccines 5.4 Market Forecast for Cytokines 5.5 Market Forecast for Gene and Cell Therapies 5.6 Market Split of Biopharmaceutical Drugs by Class and Revenue (U.S.) 6 PATENT ANALYSIS 6.1 Introduction 6.2 Analysis 6.3 Patents Published 7 COMPETITIVE LANDSCAPE 7.1 Biopharmaceuticals Market: Competitive Structure (U.S.) 7.2 Description 8 COMPANY PROFILES 8.1 ABBOTT 8.1.1 Overview 8.1.2 Primary Business 8.1.3 Strategy 8.1.4 Developments 8.2 AMGEN INC. 8.2.1 Overview 8.2.2 Primary Business 8.2.3 Strategy 8.2.4 Developments 8.3 ASTELLAS PHARMA INC. 8.3.1 Overview 8.3.2 Primary Business 8.3.3 Strategy 8.3.4 Developments 8.4 ASTRAZENECA PLC 8.4.1 Overview 8.4.2 Primary Business 8.4.3 Strategy 8.4.4 Developments 8.5 BAXTER INTERNATIONAL INC. 8.5.1 Overview 8.5.2 Primary Business 8.5.3 Strategy 8.5.4 Developments 8.6 BIOGEN IDEC INC. 8.6.1 Overview 8.6.2 Primary Business 8.6.3 Strategy 8.6.4 Developments 8.7 BRISTOL-MYERS SQUIBB 8.7.1 Overview 8.7.2 Primary Business 8.7.3 Strategy 8.7.4 Developments 8.8 CSL LTD. 8.8.1 Overview 8.8.2 Primary Business 8.8.3 Strategy 8.8.4 Developments 8.9 DAIICHI SANKYO CO., LTD. 8.9.1 Overview 8.9.2 Primary Business 8.9.3 Strategy 8.9.4 Developments 8.10 ELI LILLY AND CO. 8.10.1 Overview 8.10.2 Primary Business 8.10.3 Strategy 8.10.4 Developments 8.11 ENDO PHARMACEUTICALS HOLDINGS INC. 8.11.1 Overview 8.11.2 Primary Business 8.11.3 Strategy 8.11.4 Developments 8.12 GENZYME CORP. 8.12.1 Overview 8.12.2 Primary Business 8.12.3 Strategy 8.12.4 Developments 8.13 GLAXOSMITHKLINE PLC 8.13.1 Overview 8.13.2 Primary Business 8.13.3 Strategy 8.13.4 Developments 8.14 H LUNDBECK A/S 8.14.1 Overview 8.14.2 Primary Business 8.14.3 Strategy 8.14.4 Developments 8.15 JOHNSON & JOHNSON 8.15.1 Overview 8.15.2 Primary Business 8.15.3 Strategy 8.15.4 Developments 8.16 NOVARTIS AG 8.16.1 Overview 8.16.2 Primary Business 8.16.3 Strategy 8.16.4 Developments 8.17 NOVO NORDISK A/S 8.17.1 Overview 8.17.2 Primary Business 8.17.3 Strategy 8.17.4 Developments 8.18 PFIZER INC. 8.18.1 Overview 8.18.2 Primary Business 8.18.3 Strategy 8.18.4 Developments 8.19 ROCHE HOLDINGS LTD. 8.19.1 Overview 8.19.2 Primary Business 8.19.3 Strategy 8.19.4 Developments 8.20 TEVA PHARMACEUTICALS INDUSTRIES LTD. 8.20.1 Overview 8.20.2 Primary Business 8.20.3 Strategy 8.20.4 Developments APPENDIX U.S. Patents Eurpoe Patents WIPO Patents ROW Patents LIST OF TABLES 1 THE TOP 15 BIOPHARMACEUTICALS PRODUCTS BY SALES IN THE U.S. BIOPHARMACEUTICALS MARKET IN 2009 2 TOP 20 BIOPHARMACEUTICAL COMPANIES BY THEIR ANNUAL PRODUCT SALES IN 2009 IN THE U.S. MARKET 3 LIST OF 2009 FULL BIOPHARMACEUTICAL APPROVALS BY FDA 4 DETAILS OF KEY APPROVED PRODUCTS 5 CURRENT CHALLENGES FOR THE U.S. BIOPHARMA INDUSTRY (2009 TO 2016) 6 DRIVERS FOR THE U.S. BIOPHARMA MARKET (2009 TO 2016) 7 RESTRAINTS FOR THE U.S. BIOPHARMACEUTICALS MARKET (2009 TO 2016) 8 PAIR WISE COMPARISON OF LEVEL 0 CRITERIA FROM GOAL NODE 9 PAIR WISE COMPARISON OF LEVEL 1 CRITERIA’S FROM LEVEL 0 NODE 10 PAIR WISE COMPARISON OF LEVEL 1 CRITERIA FROM MARKET 11 PAIR WISE COMPARISON OF LEVEL1 CRITERIA FROM TECH MATURITY 12 PAIR WISE COMPARISON OF LEVEL 1 CRITERIA FROM CFA (COST FOR ALTERNATIVES) 13 PAIR WISE COMPARISON OF ALTERNATIVES FROM FUNDING 14 PAIR WISE COMPARISON OF ALTERNATIVES FROM COST OF DEVELOPMENT 15 PAIR WISE COMPARISON OF ALTERNATIVES FROM CAGR 16 PAIR WISE COMPARISON OF ALTERNATIVES FROM SIZE 17 PAIR WISE COMPARISON OF ALTERNATIVES FROM PI 18 PAIR WISE COMPARISON OF ALTERNATIVES FROM PII 19 PAIR WISE COMPARISON OF ALTERNATIVES FROM PIII 20 PAIR WISE COMPARISON OF ALTERNATIVES FROM SMALL MOLECULES 21 PAIR WISE COMPARISON OF ALTERNATIVES FROM NEED FOR BIOSIMILARS 22 PAIR WISE COMPARISON OF ALTERNATIVES FROM PATENTS 23 PAIR WISE COMPARISON OF ALTERNATIVES FROM FDAA 24 KEY BIOPHARMACEUTICAL PRODUCTS IN PIPELINE BY THEIR COMPANY U.S. (2009–2010) 25 NUMBER OF BIOPHARMACEUTICALS IN THE PIPELINE BY THERAPEUTIC CLASS, U.S. (2009) 26 KEY BIOPHARMACEUTICAL PRODUCT RECALLS BY THEIR COMPANY (U.S., 2008–2010) 27 U.S. BIOPHARMACEUTICALS MARKET FOR THE PERIOD 2009 – 2016 28 U.S. P.E.H (PROTEIN THERAPEUTICS) MARKET FOR THE PERIOD 2009 – 2016 29 U.S. MABS (MONOCLONAL ANTIBODY) MARKET FOR THE PERIOD 2009 – 2016 30 U.S. VACCINES MARKET FOR THE PERIOD 2009-2016 31 U.S. CYTOKINES MARKET FOR THE PERIOD 2009-2016 32 U.S. GENE AND CELL THERAPIES MARKET FOR THE PERIOD 2009 – 2016 33 2010 COMPANIES AND PATENTS (USPTO) 34 COMPREHENSIVE MERGERS & ACQUISITIONS CHECKLIST (JANUARY 2009 – OCTOBER 2010) LIST OF FIGURES 1 GLOBAL BIOPHARMACEUTICALS MARKET (2006 – 2016) 2 MARKET SEGMENTATION FOR THE U.S. BIOPHARMACEUTICALS MARKET (2009) 3 BCG MATRIX EVALUATION ON THE PRODUCTS AT PFIZER U.S. IN 2009 4 BCG MATRIX EVALUATION ON THE PRODUCTS AT BRISTOL-MYERS SQUIBB U.S. IN 2009 5 BCG MATRIX EVALUATION ON THE PRODUCTS AT AMGEN U.S. IN 2009 6 BCG MATRIX EVALUATION ON THE PRODUCTS AT ELI LILY U.S. IN 2009 7 BCG MATRIX EVALUATION ON THE PRODUCTS AT ROCHE U.S. IN 2009 8 AHP-BASED PRIORITIZATION OF DISRUPTIVE POTENTIAL OF BIOPHARMA TECHNOLOGIES U.S. (2009 – 2016) 9 DISRUPTIVE PRODUCT-CLASS POTENTIAL INDEX (U.S.) 2009 – 2016 10 IMPLICATIONS OF THE HEALTH CARE REFORM BILL ON THE BIOPHARMACEUTICAL INDUSTRY 11 PERCENTAGE SHARE OF BIOPHARMACEUTICALS IN THE PIPELINE, BY THERAPEUTIC CLASS, U.S. (2009) 12 U.S. BIOPHARMACEUTICALS MARKET FOR THE PERIOD 2009 TO 2016 13 U.S. PEH (PROTEIN THERAPEUTICS) MARKET FOR THE PERIOD 2009 TO 2016 14 U.S. MONOCLONAL ANTIBODIES (MABS) MARKET FOR THE PERIOD 2009 TO 2016 15 U.S. VACCINES MARKET FOR THE PERIOD 2009 TO 2016 16 U.S. CYTOKINES MARKET FOR THE PERIOD 2009 TO 2016 17 U.S. GENE AND CELL THERAPIES MARKET FOR THE PERIOD 2009 TO 2016 18 U.S. BIOPHARMACEUTICALS MARKET SPLIT BY REVENUE OF EACH DRUG CLASS (2009–2016) 19 PIE DISTRIBUTION OF BIOPHARMACEUTICAL RESEARCH CLUSTERS/HUBS WITHIN THE U.S. (2010) (USPTO) 20 PATENTS PUBLISHED AT USPTO (2008 TO 2010) 21 ANALYSIS OF BIOPHARMACEUTICALS MARKET: COMPETITIVE STRUCTURE (U.S.), 2009 22 BARGAINING POTENTIAL IN THE U.S. BIOPHARMACEUTICALS MARKET (2009)