The future of the pharmaceutical market will be determined by biologics - drugs produced by natural organisms or recombinant techniques consisting of proteins and other products derived from living organisms for the treatment or management of diseases or injuries. What are the products that lead the market now and what can we expect to see in the coming years?

This Company report, What's Next in Biologics? represents our latest research into the market for non-vaccine biological drugs and the companies who compete in the market. The following are among the data points in this report:

• Biopharmaceutical Pipeline for Significant Companies

• Market Size of Biopharmaceuticals

  • Monoclonal Antibodies (mAbs)

  • Recombinant Hormones and Proteins (rDNA)

  • Interferons and

  • Other Biologics

• Biopharmaceutical Market Forecast to 2015

• Products in Development: New Compound vs. Additional Indications

• Competitor Market Shares for Biopharmaceuticals

• Autoimmune, Cancer, Cardiovascular and Hormone Treatments Market Sizes and Competitor Shares

• Drug Development Cost Progression

• Leading Biotech Therapies by 2010 Revenues

• Population and Healthcare Spending Trends

• Select Biotechnology Drugs Approved for Marketing

The biologics industry encompasses a wide range of products including monoclonal antibodies, blood products, vaccines, and some diagnostics and devices. For the purpose of this study, Company has focuses on those biologics that are used in conjunction with or as a replacement to traditional pharmaceutical treatment. For example, treatments for cancer, growth disorders, autoimmune diseases and blood disorders. This study excludes products such as vaccines—including prophylactic vaccines—which are covered in-depth in separate Kalorama studies. The following is among the qualitative analysis found in this report:

• The Role Government Incentives Will Play in the Future Biotech Market

• Pharmaceutical Regulatory Exclusivity

• Biosimilars: Where They Stand and What We Can Expect

• The Largest Areas of Research for Biopharmaceuticals

• Improvements in the Next Generation of Biologics

• The Impact of Aging Populations on Biotechnology Market Development

• Health Care Reform: What it Means

• Recent Mergers, Acquisitions, and Collaborations

• Contributors to R&D Success

• Targeted Cancer Therapy

• Genome Sequencing for Personalized Healthcare

• The Role of Contract Research Organizations

In the traditional pharmaceutical market, the pipeline is struggling to produce strong therapies and the growing number of drugs losing patent protection will more than offset revenues generated from new developments. For now, the biotechnology market is spared the impact of this setback as the path to generic or biosimilar development is more involved and the number of biotechnology drugs facing generic competition remains limited. Many companies are capitalizing on this trend, and among those discussed in the report include the following:

• Abbott Laboratories

• Amgen

• Biogen Idec

• Johnson & Johnson

• Merck & Co.

• Merck Serono

• Novo Nordisk

• Pfizer

• Roche/Genentech

• Sanofi-Aventis/Genzyme

CHAPTER ONE: EXECUTIVE SUMMARY

• Introduction
• Scope and Methodology
• Biopharmaceutical Market Overview
• Issues and Trends Affecting Market
• Leading Companies

CHAPTER TWO: INTRODUCTION

• Overview of Biopharmaceutical
• General Biotech Terms
• Expanded Options in Treating Diseases
• Disease Descriptions
  • Autoimmune Diseases
  • Cardiovascular and Blood Disorders
  • Cancer
  • Hormone Disorders
  • Infectious Diseases
  • Neurological Disorders
• Research & Development Overview

CHAPTER THREE: BIOLOGIC PRODUCTS ON THE MARKET

• Product Segments
  • Monoclonal Antibodies
  • Recombinant Hormones and Proteins
  • Gene Therapy
  • Interferons/Interleukins
  • Cell Therapy
  • Antisense Therapy
  • Growth Factors
• Current Products

CHAPTER FOUR: BIOPHARMACEUTICAL PIPELINES

• Overview
• Biopharmaceutical Development Outlook
• Company R&D Profiles
  • Abbott
  • Amgen
  • Biogen Idec
  • Bristol-Myers Squibb
  • Eli Lilly
  • GlaxoSmithKline
  • Merck KGaA
  • Novartis
  • Novo Nordisk
  • Pfizer
  • Roche

CHAPTER FIVE: ISSUES AND TRENDS

• Overview of the Industry
• The Next Generation of Biologics
  • Technology for Drug Adherence, Targeted Delivery and Monitoring
• Government Incentives for Biologic Development
• Biopharmaceutical and Biosimilar Drug Development
• Clinical Trial Costs
• Orphan Drugs
• Pharmaceutical Regulatory Exclusivity
  • Pediatric Extensions
  • Biopharmaceutical Industry—Biosimilar (Biogeneric) Development and Exclusivity
• Aging Population
• Healthcare Expenditures Growth
  • Health Care Reform's Impact on Biopharmaceutical Companies
• Mergers, Acquisitions, and Collaborations
• Contributors To R&D Success
• R&D Spending
• Cancer Drugs in Development 2011
• The Impact of Targeted Therapy in Oncology
• Genome Sequencing for Personalized Healthcare
• The Role of Contract Research Organizations
• Global Expansion

CHAPTER SIX: MARKET SUMMARY

• Market Overview
• Biopharmaceutical Product Analysis
• Market Forecast
• Geographical Analysis
• Competitor Analysis
  • Company Analysis by Therapeutic Segment

CHAPTER SEVEN: COMPANY PROFILES

• Introduction
• Abbott Laboratories, Inc
• Amgen, Inc.
• Biogen Idec
• Johnson & Johnson
• Merck & Co., Inc.
• Merck Serono
• Novo Nordisk
• Pfizer
• Roche/Genentech
• Sanofi-Aventis/Genzyme

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-1 Global Biopharmaceutical Treatments (non-vaccine)Market, 2008-2015 Compound Annual Growth Rate
• Figure 1-1 Global Biopharmaceutical Treatments (non-vaccine)Market, 2008-2015

CHAPTER TWO: INTRODUCTION

• Table 2-1 World Cancer Incidence by Selected Types of Cancer, 2010 and 2020, all races, both sexes
• Table 2-2 Total Cancer Incidence by Sex and Country, 2010 Estimates
• Table 2-3 Phases of Clinical Drug Development in the United States

CHAPTER THREE: PRODUCT OVERVIEW

• Table 3-1 Monoclonal Antibody Source Identifiers
• Figure 3-1 Biopharmaceutical Approvals by Year Range (FDA)
• Table 3-2 Select Biopharmaceutical Drugs Approved for Marketing
• Table 3-2 (continued) Select Biopharmaceutical Drugs Approved for Marketing
• Table 3-2 (continued) Select Biopharmaceutical Drugs Approved for Marketing
• Table 3-2 (continued) Select Biopharmaceutical Drugs Approved for Marketing
• Table 3-2 (continued) Select Biopharmaceutical Drugs Approved for Marketing

CHAPTER FOUR: DEVELOPMENTS

• Figure 4-1 Biopharmaceutical Development by General Indication and Development Activity (Phase III through Registration)
• Table 4-1 New Developments in Biopharmaceutical, Phase III and Beyond
• Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond
• Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond
• Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond
• Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond
• Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond
• Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond
• Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond
• Figure 4-2 Pipeline Snapshot: Biopharmaceutical Pipelines for New Compounds and Product Extensions by Type
• Figure 4-3 Select Company Biopharmaceutical Pipelines by Development Status
• Table 4-2 Abbott’s Biopharmaceutical Pipeline
• Table 4-3 Amgen’s Biopharmaceutical Pipeline
• Table 4-3 (continued) Amgen’s Biopharmaceutical Pipeline
• Table 4-4 Biogen Idec’s Biopharmaceutical Pipeline
• Table 4-5 Bristol-Myers Squibb’s Late Stage Biopharmaceutical Pipeline
• Table 4-6 Eli Lilly’s Biopharmaceutical Pipeline
• Table 4-7 GlaxoSmithKline’s Biopharmaceutical Pipeline
• Table 4-7 (continued) GlaxoSmithKline’s Biopharmaceutical Pipeline
• Table 4-8 Merck KGaA’s Biopharmaceutical Pipeline
• Table 4-9 Novartis’ Biopharmaceutical Pipeline
• Table 4-10 Novo Nordisk’s Biopharmaceutical Pipeline
• Table 4-11 Pfizer’s Biopharmaceutical Pipeline
• Table 4-11 (continued) Pfizer’s Biopharmaceutical Pipeline
• Table 4-12 Roche’s Biopharmaceutical Pipeline (including Genentech)
• Table 4-12 (continued) Roche’s Biopharmaceutical Pipeline (including Genentech)
• Table 4-12 (continued) Roche’s Biopharmaceutical Pipeline (including Genentech)

CHAPTER FIVE: ISSUES AND TRENDS

• Table 5-1 International Population Trend Age 65+ International Population Trend Age 65+
• Table 5-2 United States Population Trend Age 65+ United States Population Trend Age 65+
• Table 5-3 Recent Biopharmaceutical Business Mergers and Acquisitions
• Table 5-4 Pharmaceutical/Biopharmaceutical R&D Statistics
• Table 5-5 Total Industry R&D Spending 2004-2010
• Table 5-6 Pharmaceutical and Biopharmaceutical Cancer Drugs in Development 2011 CHAPTER SIX: MARKET SUMMARY
• Table 6-1 Global Biopharmaceutical Treatments (non-vaccine)Market, 2008-2015 Compound Annual Growth Rate
• Figure 6-1 Global Biopharmaceutical Treatments (non-vaccine)Market, 2008-2015
• Table 6-2 Global Biopharmaceutical Treatments (non-vaccine)Market by Product Category
• Figure 6-2 Global Biopharmaceutical Treatments (non-vaccine)Market by Product Category
• Table 6-3 Leading Biotech Therapies by 2010 Revenues
• Table 6-4 Global Biopharmaceutical Treatments (non-vaccine)Market Forecast by Product Category, 2010 and 2015—based on late stage development
• Figure 6-3 Global Biopharmaceutical Treatments (non-vaccine)Market Forecast by Product Category, 2010 and 2015—based on late stage development
• Table 6-5 Biopharmaceutical Treatments (non-vaccine)Sales by Region, 2008-2010 and Forecast through 2015
• Figure 6-4 Biopharmaceutical Treatments (non-vaccine)Sales by Region, 2008-2010 and Forecast through 2015
• Figure 6-5 Estimated Biopharmaceutical Treatments (non-vaccine)Sales by Broad Region, 2010
• Table 6-6 Competitor Market Shares and Revenues for Biopharmaceutical Therapies, 2010
• Figure 6-6 Biopharmaceutical Sales by Company, 2008-2010
• Figure 6-7 Competitor Market Shares for Biopharmaceutical Therapies, 2010
• Table 6-7 Top Three Competitors for Autoimmune Biopharmaceutical Treatments, 2010
• Figure 6-8 Competitor Market Shares: Autoimmune Biopharmaceutical Therapies, 2010
• Table 6-8 Top Three Competitors for Cancer Biopharmaceutical Treatments, 2010
• Figure 6-9 Competitor Market Shares: Cancer Biopharmaceutical Treatments, 2010
• Table 6-9 Top Three Competitors for Cardiovascular/Blood Disorder Biopharmaceutical Treatments, 2010
• Figure 6-10 Competitor Market Shares: Cardiovascular/Blood Disorder Biopharmaceutical Treatments, 2010
• Table 6-10 Top Three Competitors for Hormone Biopharmaceutical Treatments, 2010
• Figure 6-11 Competitor Market Shares: Hormone Biopharmaceutical Treatments, 2010