Strategic Analysis & Forecast of US Biopharmaceutical Industry

Strategic Analysis & Forecast of US Biopharmaceutical Industry – (2009-2016): Impact of Healthcare Reform, Technological Innovation & Market

Report Code: PH 1538 Feb, 2011, by marketsandmarkets.com

The U.S. biopharmaceuticals market is expected to increase to $144 billion by 2016. The growth is expected as a result of the launch of new products, approval of new indications for existing therapies and drugs, and increase in population aged 65 years and above. From 2009 to 2016 the U.S. market revenues are forecasted to grow at a compound annual growth rate (CAGR) of 11.2%.

This research report analyzes the U.S. biopharmaceuticals market and its growth factors, with special emphasis on the top companies in the field and their product pipeline. While it looks at the overall market size and presents forecast till 2016, a key focus of the report is the increasing role of biopharmaceutical products. The growing interest in biotechnology development has led to the metamorphosis of the pharmaceutical industry, resulting in the subset industry of biopharmaceuticals. The big players in the pharma industry, including Pfizer, Merck, and Novartis, have been the first few to reap the benefits of investing in biotechnology through both organic as well as inorganic growth mechanisms.

Market forecasts include the biopharmaceuticals currently in the market as well as those projected to enter the market by the end of the forecast period in 2016. Market challenges, drivers, and restraints have also been identified and assessed. Selected late stage pipeline analysis is also included.

This report analyzes the biopharmaceutical industry’s products, features, companies, market size and potential, and patent portfolios. The impact of the Medicare and Medicaid policies and individual plan behaviors on the biopharmaceutical industry is also discussed.

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Scope of the Report

Market Overview

This section discusses the market definition of U.S. biopharmaceutical market. This section also discusses the way market is segmented and the methodology as well as the assumptions considered for forecasting the revenues for the all the individual product/drug class segments.

Market segmentation

This research service covers biopharmaceuticals and their impact on the U.S. healthcare market.

Products included in this study by their market segmentation:
  • Gene and Cell therapies, including “Antisense Therapies”
  • Cytokines
  • PEH: Proteins, Enzymes, and Hormones
  • Monoclonal Antibodies
  • Vaccines
  • Others: Blood and Allergenic components and others.

Products not included:

  • Biosurgical products like tissue grafts and sealants
  • Biologics used for diagnostic purposes
  • Bionanotechnology drugs

Analysis Insights

This section discusses the current trends and focus of the U.S. biopharmaceutical market and the challenges faced by the industry. Other sections include market analysis, patent analysis and competitive landscape.

Company Profiles

This section provides the company profiles of major companies participating in the U.S. biopharmaceutical market. Company profiles include a brief overview of the company, primary business, strategies followed and developments.

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The U.S. biopharmaceuticals market is expected to increase to $144 billion by 2016. The growth is expected as a result of the launch of new products, approval of new indications for existing therapies and drugs, and increase in population aged 65 years and above. From 2009 to 2016 the U.S. market revenues are forecasted to grow at a compound annual growth rate (CAGR) of 11.2%.

This research report analyzes the U.S. biopharmaceuticals market and its growth factors, with special emphasis on the top companies in the field and their product pipeline. While it looks at the overall market size and presents forecast till 2016, a key focus of the report is the increasing role of biopharmaceutical products. The growing interest in biotechnology development has led to the metamorphosis of the pharmaceutical industry, resulting in the subset industry of biopharmaceuticals. The big players in the pharma industry, including Pfizer, Merck, and Novartis, have been the first few to reap the benefits of investing in biotechnology through both organic as well as inorganic growth mechanisms.

Market forecasts include the biopharmaceuticals currently in the market as well as those projected to enter the market by the end of the forecast period in 2016. Market challenges, drivers, and restraints have also been identified and assessed. Selected late stage pipeline analysis is also included.

This report analyzes the biopharmaceutical industry’s products, features, companies, market size and potential and patent portfolios The impact of the Medicare and Medicaid policies and individual plan behaviors on the biopharmaceutical industry is also discussed.

The main purpose of this report is to analyze the U.S. biopharmaceuticals market and its growth factors, with special emphasis on the top companies in the field and their product pipeline. The report also focuses upon the increasing role of biopharmaceutical products in the U.S. Healthcare market.

The report also analyzes the U.S. biopharmaceuticals market and its growth factors, with special emphasis on the top companies in the field and their product pipeline. The report also analyses the current trends and focus of the U.S. biopharmaceutical market and the challenges faced by the industry. It provides the company profiles of major companies participating in the United States market.

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 
  3.10 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 
  4.10 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
  8.1 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
  8.2 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

    
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)  


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