Monoclonal Therapeutics and Companion Diagnostic Products

SUMMARY

Abstract

INTRODUCTION

Our key objective was to present a comprehensive analysis of the current monoclonal antibody market and its future direction.

SCOPE OF STUDY

This report contains:

• Descriptions of various types of monoclonal therapeutic and diagnostic antibodies in terms of their history in medicine, their types and technology categories
• The current market status for monoclonal therapeutic and diagnostic antibodies, trends and forecasts for growth over the next 5 years
• Technological issues including the latest trends and a thorough patent analysis
• Analysis of the monoclonal therapeutic and diagnostic antibodies industry on a worldwide basis, both from a market and application perspective
• Discussion of government support in major regions of the world

TABLE OF CONTENTS

Table of Contents

• Monoclonal Therapeutics and Companion Diagnostic Products
• Chapter 1 - EXECUTIVE SUMMARY
  • Summary Table: WORLDWIDE SALES OF MONOCLONAL THERAPEUTIC AND COMPANION DIAGNOSTICS, THROUGH 2012 ($ BILLIONS)
  • Summary Figure: WORLDWIDE SALES OF MONOCLONAL THERAPEUTIC AND COMPANION DIAGNOSTICS, 2005-2012 ($ BILLIONS)
    • MAB GROWTH IN THERAPEUTICS
      • PHARMA MOVES IN
  • MAB GROWTH IN DIAGNOSTICS
    • KEY DRIVERS AND CHALLENGES
    • SIGNIFICANT TRENDS
• Chapter 2 - OVERVIEW
  • Table 1 BIOPHARMACEUTICAL CATEGORIES
  • Table 2MONOCLONAL ANTIBODIES APPROVED FOR DISEASE THERAPY*
  • Table 2 (CONTINUED)
  • Figure 1 COMPOSITION OF COMMERCIALIZED ANTIBODIES BY TYPE, 2007 AND 2012 (%)
    • OVERVIEWC(CONTINUED)
  • Figure 2 ANTIBODY ILLUSTRATED
    • MAB TECHNOLOGY: BEGINNINGS AND MOVEMENTS
  • Table 3TIMELINE FOR MAB DEVELOPMENT
    • MOVING TOWARDS HUMANIZATION
  • ANTIBODY TECHNOLOGY TYPES
    • HUMANIZATION
  • Table 4 WORLDWIDE FORECAST OF THERAPEUTIC MONOCLONAL ANTIBODIES, BY TYPE, THROUGH 2012 ($ BILLIONS)
    • SUPERHUMANIZATION
    • SMART TECHNOLOGY
  • Table 5 SMART TECHNOLOGY ROYALTIES BY LICENSEE AND PRODUCT AS A PERCENTAGE OF TOTAL ROYALTY REVENUE:EXAMPLE OF TECHNOLOGY ROYALTY POTENTIAL (%)
    • FULLY HUMAN TECHNOLOGY
    • PHAGE DISPLAY
      • Phage Display (Continued)
  • CRUCELL'S PER.C6 AND MABSTRACT
  • TRANSGENIC MICE
  • Table 6TRANSGENIC TECHNOLOGIES
  • Table 6 (CONTINUED)
    • EMERGING ANTIBODY TECHNOLOGY TYPES
      • Fragments
      • Single Chain Antibodies
      • Bispecific Antibodies
      • Conjugation
  • Table 7 LEADING CONJUGATION TECHNOLOGIES
    • TECHNOLOGY RELATED ISSUES AND CHALLENGES
      • Optimization
      • Adjusting Glycosylation
  • Table 8ANTIBODY TECHNOLOGY BEHIND COMMERCIALIZED MABS
    • MANUFACTURING
    • LEGALITY AND INTELLECTUAL PROPERTY
      • Legality and Intellectual Property (Continued)
  • Table 9 CAT'S PHAGE AND RIBOSOME DISPLAY PATENTS
    • PHARMACEUTICAL AND BIOTECHNOLOGY LANDSCAPE
  • Table 10PHARMA'S MAB-RELATED ACQUISITIONS
  • Figure 3THE SYNERGY OF PHARMA AND BIOTECH
  • Table 11GLOBAL SNAPSHOT: BIOTECHNOLOGY INDUSTRY*
    • Pharmaceutical and Biotechnology ý (Continued)
• Chapter 3 - MABS IN THERAPEUTICS
  • Figure 4SHARE OF MONOCLONAL ANTIBODY THERAPY MARKET BY THERAPEUTIC AREA, 2007 AND 2012 (%)
  • Figure 4 (CONTINUED)
    • SIGNIFICANT TRENDS
    • EXPANDING INDICATIONS
    • NOVEL MECHANISMS OF ACTION
    • NOVEL APPLICATIONS
    • GROUPS OR COMBINATIONS OF ANTIBODIES AND OTHER AGENTS
    • FRAGMENTS OF ANTIBODIES (FABS)
    • COMPANION DIAGNOSTICS
    • MARKETS FOR THERAPEUTIC MABS COMPARED
  • Table 12 MARKET VALUE OF BIOPHARMACEUTICAL THERAPEUTIC AREAS, THROUGH 2012 ($ BILLIONS)
  • Table 13 WORLDWIDE SALES OF THERAPEUTIC MONOCLONAL ANTIBODIES, BY THERAPEUTIC AREA, THROUGH 2012 ($ BILLIONS)
  • Table 14GROWTH OF COMMERCIALIZED MONOCLONAL ANTIBODIES BY THERAPEUTIC AREA, THROUGH 2012 (NUMBER OF COMMERCIALIZED ANTIBODIES EACH YEAR)
  • Table 15BIOPHARMACEUTICAL MARKET VALUE OF VARIOUS DISEASES/CONDITIONS, THROUGH 2012 ($ BILLIONS)
    • THERAPEUTIC AREAS DETAILED
    • ONCOLOGY
      • Oncology (Continued)
  • ONCOLOGY MARKET AS A WHOLE
  • Table 16CANCER'S GLOBAL ANNUAL DEATH TOLL
  • Table 17 ESTIMATED NEW CASES OF CANCER IN THE U.S., 2007
    • AIID
    • RESPIRATORY
      • TRANSPLANTATION
      • CENTRAL NERVOUS SYSTEM (CNS)
  • Table 18CNS GLOBAL MARKET VALUES ($ BILLIONS)
    • CARDIOVASCULAR (CV)
    • INFECTIOUS DISEASE
    • OPHTHALMOLOGY
    • BLOOD DISORDERS
    • WOMEN'S HEALTH/OSTEOPOROSIS
    • FREQUENT MAB THERAPEUTIC TARGETS
  • Table 19COMMON ANTIGEN TARGETS EXPLAINED
  • Table 19 (CONTINUED)
  • Figure 5MAJOR MAB ANTIGEN TARGETS COMMERCIALIZED
    • THERAPEUTIC MABS IN THE PIPELINE
  • Table 20THERAPEUTIC PIPELINE: SELECTED MABS IN DEVELOPMENT
  • Table 20 (CONTINUED)
  • Table 20 (CONTINUED)
  • Table 20 (CONTINUED)
  • Table 20 (CONTINUED)
  • Table 20 (CONTINUED)
  • Table 20 (CONTINUED)
  • Table 20 (CONTINUED)
  • Table 20 (CONTINUED)
• Chapter 4 - MABS IN DIAGNOSTICS
  • MABS IN DIAGNOSTICS
  • Table 21WORLDWIDE VALUE OF MAB-ASSOCIATED DIAGNOSTICS, BY TECHNOLOGY TYPE, THROUGH 2012 ($ BILLIONS)
    • KEY DRIVERS
      • MABS IN DIAGNOSTIC RADIOPHARMACEUTICALS
        • MAbs in Diagnostic Radiopharmaceuticals (Continued)
  • Table 22 SCANNING TECHNOLOGIES THAT ARE USED WITH DIAGNOSTIC RADIOPHARMACEUTICALS
  • CHALLENGES FOR MAB DIAGNOSTIC RADIOPHARMACEUTICALS
    • MARKET STATUS
  • Table 23MAB-BASED DIAGNOSTIC RADIOPHARMACEUTICALS: CURRENT AND EMERGING
    • FUTURE GROWTH EXPECTED
    • PATHWAYS FORWARD
  • MABS IN IMMUNOASSAYS
  • Figure 6WORLDWIDE IN-VITRO DIAGNOSTIC MARKET SHARE BY THERAPEUTIC AREA, 2006 (%)
    • IHC AND COMPANION DIAGNOSTICS
    • COMPANY MOVEMENTS
      • Company Movements (Continued)
  • REGULATORY PATHMAKING
  • EMERGING COMPANION DIAGNOSTIC PRESENCE
• A NEW PARADIGM: MULTIFUNCTIONAL MABS IN DEVELOPMENT
  • Table 24A NEW PARADIGM: MULTIFUNCTIONAL MAB DEVELOPMENT PIPELINE
  • Table 24 (CONTINUED)
• Chapter 5 - COMPANY PROFILES
  • ABGENIX, INC. (NOW AMGEN)
  • ABBOTT LABORATORIES
  • Table 25 ABBOTT PRODUCT CATEGORIES
  • Table 26 HUMIRA'S LIFECYCLE TO DATE
    • AERES BIOMEDICAL, LTD.
    • ALEXION PHARMACEUTICALS, INC.
      • ALEXION PHARMACEUTICALS, INC. (CONTINUED)
  • AMGEN, INC.
  • Table 27 AMGEN'S PRODUCTS IN PHASE II OR LATER DEVELOPMENT
    • ARIUS RESEARCH, INC.
    • ASTRAZENECA
  • Table 28 ASTRAZENECA'S KEY BIOLOGICALS IN CLINICAL TRIALS
  • Table 29 ASTRAZENECA'S KEY BIOLOGICALS IN PRECLINICALS
    • BECKMAN COULTER
    • BIOGEN IDEC, INC.
      • BIOGEN IDEC, INC. (CONTINUED)
      • BIOGEN IDEC, INC. (CONTINUED)
  • CAMBRIDGE ANTIBODY TECHNOLOGY, LTD.
  • CENTOCOR
    • CHUGAI PHARMACEUTICAL
  • Table 30 CHUGAI'S ANTIBODY-BASED PIPELINE
  • Table 30 (CONTINUED)
    • CRUCELL
    • CURAGEN CORPORATION
  • Table 31 CURAGEN'S ANTIBODY-BASED DRUG CANDIDATES
  • Table 31 (CONTINUED)
    • CYTOGEN CORPORATION
    • DYAX CORPORATION
    • ELAN CORPORATION
    • ELAN CORPORATION (CONTINUED)
  • EISAI CO., LTD.
  • Table 32 EISAI'S (MORPHOTECK ACQUISITION) MONOCLONAL PIPELINE
    • GENENTECH, INC.
      • GENENTECH, INC. (CONTINUD)
  • Table 33 SELECTED PRODUCTS FROM WHICH GENENTECH RECEIVES ROYALTIES
  • Table 34 SELECTED ADDITIONAL PRODUCTS FROM WHICH GENENTECH RECEIVES ROYALTIES
    • GENMAB A/S
    • GENZYME CORPORATION
    • GLAXOSMITHKLINE, PLC
      • GLAXOSMITHKLINE, PLC (CONTINUD)
  • IMCLONE SYSTEMS
  • IMMUNOGEN
  • IMMUNOMEDICS, INC.
  • Table 35 IMMUNOMEDICS' THERAPEUTIC PRODUCT PIPELINE
    • LONZA BIOLOGICS
    • MEDAREX, INC.
  • Table 36 MEDAREX'S PRODUCT PIPELINE
    • MERCK SERONO
    • MICROMET
  • Table 37 MICROMET'S PIPELINE
    • MILLENNIUM PHARMACEUTICALS, INC.
  • Table 38 MILLENNIUM'S PRODUCTS IN PHASE II OR LATER DEVELOPMENT
    • MORPHOSYS AG
  • Table 39 MORPHOSYS HUCAL-BASED ANTIBODY PRODUCTS
  • Table 40 MORPHOSYS' PATENT PORTFOLIO
    • NABI PHARMACEUTICALS
    • NOVARTIS PHARMACEUTICALS CORPORATION
    • ORTHO BIOTECH PRODUCTS
    • ONYVAX
    • PDL BIOPHARMA
  • Table 41 PDL BIOPHARMA'S PRODUCTS IN PHASE II OR LATER
    • PROGENICS PHARMACEUTICALS
    • REGENERON PHARMACEUTICALS, INC.
    • ROCHE
    • SEATTLE GENETICS
    • TANABE SEIYAKU CO., LTD.
  • Table 42 TANABE SEIYAKU'S ANTIBODY-BASED PIPELINE
    • UCB S.A.
    • VIVALIS
    • VIVENTIA BIOTECH, INC.
    • WYETH PHARMACEUTICALS, INC.
    • XOMA, LTD.