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Biologics (US Market & Forecast)

US demand to exceed $100 billion by 2015

Demand for biologics will exceed $100 billion in 2015, experiencing continuing strong growth following a decade of double-digit annual increases. Continued growth will be driven by dramatic shifts in production technology and expansion of targeted diseases, and challenged by the introduction of biosimilar products following patent expiry of major biologic products.

Monoclonal antibodies to benefit from biotech boom

Biologics such as insulin and red blood cell stimulants have been available for many years, but since the introduction of recombinant DNA technology, manufacturers have developed a wide range of new products with very specific applications. Monoclonal antibodies are a prime example of this important shift. Proteins that destroy targeted antigens can now be purified, cloned and introduced into patients to instigate immune responses. These products have quickly established themselves as effective therapies for many forms of cancer, rheumatoid arthritis, macular degeneration and other conditions. New antibodies are under intensive investigation, and will be introduced to market within the forecast period.

Routine immunizations to boost vaccines demand

Biologics are also being targeted for a wider range of diseases and population segments. Biologics are complex materials that must be produced by living cells, and their producers have targeted small, niche populations with rare or difficult to treat conditions. However, as the market has grown and matured, many new applications are being found for these products. Vaccines, for example, were once focused on a small number of infectious diseases of early childhood. The number of recommended immunizations has grown significantly over the past decade, however, and since 2006, the Centers for Disease Control has encouraged adolescent and adult boosters and new immunizations, including one against the human papilloma virus associated with cervical cancer. Influenza shots are now recommended not only for the immunocompromised, but for all adults and young children, and investigation is well underway for vaccines that can protect against several core strains, effectively offering herd immunity against widespread pandemic infection. Several new vaccines are available or in late-stage clinical trials for use both as preventives and as therapies against several forms of cancer.

Biosimilar products offer good opportunities

Impending expiry of patents for a number of biopharmaceuticals and consumer demand to reduce treatment costs are encouraging a global market for biosimilar products. Biosimilars are made by new sponsors innovating biopharmaceuticals that reference the original drug. Manufacturers will have access to the original, commercialized products, but not to the original molecular clones and cell banks, fermentation and purification processes, or active drug substances. Biosimilars are subject to careful regulation. Europe has led the global regulatory process, requiring a strict demonstration that the “similar” product is highly comparable to the original. In the US, the FDA has allowed only a few biosimilars for sale following procedures for small molecule generics, but new regulations are under development and biosimilars are expected to become a dominant force by 2020.

Study coverage

Details on these and other findings are contained in a new Freedonia industry study, “Biologics”, which presents historical demand data (2000, 2005, 2010) plus forecasts for 2015 and 2020 by product and application. This study also considers market environment factors, evaluates company market share and profiles US industry competitors.

This study can help you:

  • Determine your market & sales potential
  • Learn more about industry competitors
  • Assess new products & technologies
  • Identify firms to merge with or acquire
  • Complement your research & planning
  • Gather data for presentations
  • Confirm your own internal data
  • Make better business decisions

Table of Contents

INTRODUCTION

I. EXECUTIVE SUMMARY

II. MARKET ENVIRONMENT

  • General
  • Demographic Patterns
  • Macroeconomic Outlook
  • Healthcare Trends
    • National Health Expenditures
    • Pharmaceutical Supply & Demand
    • Pharmaceutical Shipments by Therapeutic Class
  • Patient Activity
  • Medical Conditions
    • Acute Conditions
    • Chronic Conditions
  • Animal Health Industry Outlook
  • Technological Overview of Biologics
    • Recombinant DNA Biologics
    • Biosimilars
  • Regulation
    • Regulation of Human Biologic Therapies
    • Regulation of Biosimilar Products
    • Regulation of Biologics Research & Testing Products
    • Regulation of Animal Biologics

III. PRODUCTS

  • General
  • Demand by Type
  • Monoclonal Antibodies
    • Cancer Treatment
    • Rheumatoid Arthritis
    • Macular Degeneration
    • Psoriasis
    • Infectious Disease
    • Other Applications
  • Vaccines & Toxoids
    • Vaccines for Human Health
      • Routine Immunizations
      • Influenza
      • Therapeutic Vaccines
      • Other Vaccines
    • Animal Vaccines
  • Hormones
    • Insulin
    • Human Growth Hormone
    • Teriparatide
    • Follicle-Stimulating Hormone
    • Estrogen
    • Calcitonin
    • Thyrotropin
    • Corticotropin
    • Other Hormones
  • Growth Factors
    • Erythropoietins
    • Colony-Stimulating Factors
    • Bone Morphogenetic Proteins
    • Other Growth Factors
  • Immunomodulators
    • Immunosuppressing Agents
    • Interferons
    • Other Immunomodulators
  • Blood & Blood Products
    • Plasma & Plasma Fractions
    • Whole Blood
    • Cellular Components
  • Enzymes
    • Enzyme Replacement Therapies
    • Neuromodulators
    • Digestive Enzymes
    • Thrombolytics
    • Diagnostics
  • Other Enzymes
  • Coagulation Factors
    • Antihemophilics
    • Other Coagulation Factors
  • Other Biologics

IV. APPLICATIONS

  • General
  • Human Healthcare
    • Cancer
    • Autoimmune Diseases
    • Infectious Diseases
    • Blood Disorders
    • Diabetes
    • Other Conditions
  • Biologics for Other Uses
    • Animal Health
    • Research & All Other Applications

V. INDUSTRY STRUCTURE

  • General
  • Market Share
  • Competitive Strategies
  • Mergers & Acquisitions
  • Licensing & Related Agreements
  • Research & Development
  • Manufacturing
  • Marketing & Distribution

COMPANY PROFILES

  • Abbott Laboratories
  • Alere Incorporated
  • Alexion Pharmaceuticals Incorporated
  • Allergan Incorporated
  • Alnara Pharmaceuticals, see Eli Lilly
  • American Red Cross
  • Amgen Incorporated
  • Aptalis Pharma Incorporated
  • AstraZeneca plc
  • Axcan Intermediate Holdings, see Aptalis Pharma
  • Baxter International Incorporated
  • Bayer AG
  • BBI Enzymes, see Alere
  • Biogen Idec Incorporated
  • BioMarin Pharmaceutical Incorporated
  • BioVex Group, see Amgen
  • Blood Systems Incorporated
  • Bristol-Myers Squibb Company
  • Crucell, see Johnson & Johnson
  • CSL Limited
  • EKR Therapeutics Incorporated
  • Eli Lilly & Company
  • EMD Serono, see Merck KGaA
  • Emergent BioSolutions Incorporated
  • Enzon Pharmaceuticals, see sigma-tau Group
  • Eurand, see Aptalis Pharma
  • Facet Biotech, see Abbott Laboratories
  • Genentech, see Roche Holding
  • Genzyme, see Sanofi-Aventis
  • GlaxoSmithKline plc
  • GSK Biologicals, see GlaxoSmithKline
  • Halozyme Therapeutics Incorporated
  • Intercell AG
  • Inverness Medical Innovations, see Alere
  • Ipsen
  • Johnson & Johnson
  • Lonza Group Limited
  • Lundbeck (H.) A/S
  • Massachusetts Biologic Laboratories
  • Medarex, see Bristol-Myers Squibb
  • MedImmune, see AstraZeneca
  • Medtronic Incorporated
  • Mentor Worldwide, see Johnson & Johnson
  • Merck & Company Incorporated
  • Merck KGaA
  • Merial, see Sanofi-Aventis
  • New York Blood Center
  • Novartis AG
  • Novo Nordisk A/S
  • Organon Teknika, see Merck & Company
  • Ortho-McNeil-Janssen Pharmaceuticals, see Johnson Johnson
  • Ovation Pharmaceuticals, see H. Lundbeck A/S
  • Percivia, see Johnson & Johnson
  • Pfizer Incorporated
  • Questcor Pharmaceuticals Incorporated
  • ratiopharm, see Teva Pharmaceutical Industries
  • Roche Holding Limited
  • Sandoz International, see Novartis
  • Sanofi-Aventis
  • Shire plc
  • sigma-tau Group
  • Solstice Neurosciences, see US WorldMeds
  • Solvay SA
  • Stryker Corporation
  • Teva Pharmaceutical Industries Limited
  • Theravance, see GlaxoSmithKline
  • TL Biopharmaceutical, see Lonza Group & Teva
  • Pharmaceutical Industries
  • Trubion Pharmaceuticals, see Emergent BioSolutions
  • US WorldMeds LLC
  • Ventana Medical Systems, see Roche Holding
  • ViaCyte Incorporated
  • Vivante GMP Solutions, see Lonza Group
  • WiCell Research Institute
  • Wisconsin International Stem Cell Bank, see WiCell
  • Research Institute
  • Wyeth, see Pfizer
  • ZyStor Therapeutics, see BioMarin Pharmaceutical
  • Other Companies Mentioned in Study

LIST OF TABLES

SECTION I -- EXECUTIVE SUMMARY

  • Summary Table

SECTION II -- MARKET ENVIRONMENT

  • Population & Households
  • Macroeconomic Indicators
  • National Health Expenditures by Type & Source of Payment
  • Pharmaceutical Supply & Demand
  • Pharmaceutical Shipments by Therapeutic Class
  • Patient Activity
  • Medical Conditions
  • Animal Population & Veterinary Health Expenditures

SECTION III -- PRODUCTS

  • Biologics Demand by Type
  • Monoclonal Antibodies Demand
  • Vaccines Demand
  • Hormones Demand
  • Growth Factors Demand
  • Immunomodulators Demand
  • Blood & Blood Products Demand
  • Enzymes Demand
  • Coagulation Factors Demand
  • Other Biologics Demand

SECTION IV -- APPLICATIONS

  • Biologics Demand by Application
  • Biologics Demand for Human Healthcare by Condition & Use
  • Cancer Biologics Demand
  • Autoimmune Biologics Demand
  • Infectious Diseases Biologics Demand
  • Blood Disorders Biologics Demand
  • Diabetes Biologics Demand
  • Other Human Health Biologics Demand
  • by Condition & Product
  • Biologics Demand for Other Applications

SECTION V -- INDUSTRY STRUCTURE

  • US Biologics Sales by Company, 2010
  • Selected Acquisitions & Divestitures
  • Selected Cooperative Agreements

LIST OF CHARTS

SECTION III -- PRODUCTS

  • Biologics Demand by Product Type, 2010

SECTION IV -- APPLICATIONS

  • Human Healthcare Biologics Demand by Condition
  • & Use, 2010

SECTION V -- INDUSTRY STRUCTURE

  • US Biologicals Market Share, 2010
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