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What's Next in Biopharmaceuticals? (mAbs, rDNA, Interferons, and Other Upcoming Biologic Drugs) 2011-2015

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?

Find out in Kalorama Information's report, What's Next in Biologics?, which 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, Kalorama Information focuses on those biologics that are used in conjunction with, or as a replacement to, traditional pharmaceutical treatments. 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 topics are 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

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For Kalorama's take on the healthcare news of the week, based on our analysis of healthcare markets, follow Kalorama Information's Key Point Blog at http://kaloramakeypoint.blogspot.com/


A full biologics pipeline will lead to continued growth in the biopharmaceutical market, according to Kalorama Information. The healthcare market research firm expects annual growth of 7.1% through 2015, given the nearly 200 products in late-stage development. According to their latest report, What's Next in Biologics (mAbs, rDNA, Interferons, and Other Biologics) 2011-2015, the top five biopharmaceutical companies continue to dominate this market landscape.

A majority of the 200 biologics currently in the development pipeline are aimed at the treatment of cancers, followed by cardiovascular diseases and autoimmune and hormone disorders. According to the report, monoclonal antibodies account for the largest share of the innovation with nearly thirty new antibody compounds in development. Multiple companies expecting to profit from the products currently in late-stage development, each of which can cost $1-2 billion to develop, are driving the market's growth through 2015, when Kalorama expects it to reach just under $150 billion.

"The Phase III pipelines are heavy in this area and that will keep growth up," said Bruce Carlson, publisher of Kalorama Information. "The beneficiaries will be a number of companies, though especially the top five. Although a number of smaller companies are operating in this market, difficulties remain in overcoming the high cost of development."

The report details several companies, but indicates that the biologics market is still dominated by the top five pharmaceutical companies--Amgen, GlaxoSmithKline, Novartis, Pfizer and Roche--which combined hold over a quarter of the late-stage products.

"The big players have a steady flow of new products and extensions coming through the pipeline, with over 100 projects in development," added Carlson. "The strongest pipeline is still held by Roche's Genetech."

Kalorama Information's What's Next in Biologics (mAbs, rDNA, Interferons, and Other Biologics) 2011-2015 looks at the market for non-vaccine biological drugs and the companies that compete in the market. The report discusses the biopharmaceutical pipeline for major companies and provides market size estimates and forecasts for monoclonal antibodies, recombinant hormones and proteins, interferons and other biologics.

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

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