Monoclonal Therapeutics and Companion Diagnostic Products

Published by: BCC Research

Published: Jan. 1, 2008

Table of Contents

INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THIS STUDY

SCOPE OF REPORT

INTENDED AUDIENCE

METHODOLOGY

INFORMATION SOURCES

ABOUT THE AUTHOR

RELATED BCC WORK CREDENTIALS

BCC ONLINE SERVICES

DISCLAIMER

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

OVERVIEW

TABLE 1 BIOPHARMACEUTICAL CATEGORIES

TABLE 2 MONOCLONAL 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 3 TIMELINE 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 6 TRANSGENIC 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 8 ANTIBODY 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 10 PHARMA’S MAB-RELATED ACQUISITIONS

FIGURE 3 THE SYNERGY OF PHARMA AND BIOTECH

TABLE 11 GLOBAL SNAPSHOT: BIOTECHNOLOGY INDUSTRY*

Pharmaceutical and Biotechnology … (Continued)

MABS IN THERAPEUTICS

FIGURE 4 SHARE 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 14 GROWTH OF COMMERCIALIZED MONOCLONAL ANTIBODIES BY THERAPEUTIC AREA, THROUGH 2012 (NUMBER OF COMMERCIALIZED ANTIBODIES EACH YEAR)

TABLE 15 BIOPHARMACEUTICAL MARKET VALUE OF VARIOUS DISEASES/CONDITIONS, THROUGH 2012 ($ BILLIONS)

THERAPEUTIC AREAS DETAILED

ONCOLOGY

Oncology (Continued)

ONCOLOGY MARKET AS A WHOLE

TABLE 16 CANCER’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 18 CNS GLOBAL MARKET VALUES ($ BILLIONS)

CARDIOVASCULAR (CV)

INFECTIOUS DISEASE

OPHTHALMOLOGY

BLOOD DISORDERS

WOMEN’S HEALTH/OSTEOPOROSIS

FREQUENT MAB THERAPEUTIC TARGETS

TABLE 19 COMMON ANTIGEN TARGETS EXPLAINED

TABLE 19 (CONTINUED)

FIGURE 5 MAJOR MAB ANTIGEN TARGETS COMMERCIALIZED

THERAPEUTIC MABS IN THE PIPELINE

TABLE 20 THERAPEUTIC 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)

MABS IN DIAGNOSTICS

MABS IN DIAGNOSTICS

TABLE 21 WORLDWIDE 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 23 MAB-BASED DIAGNOSTIC RADIOPHARMACEUTICALS: CURRENT AND EMERGING

FUTURE GROWTH EXPECTED

PATHWAYS FORWARD

MABS IN IMMUNOASSAYS

FIGURE 6 WORLDWIDE 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 24 A NEW PARADIGM: MULTIFUNCTIONAL MAB DEVELOPMENT PIPELINE

TABLE 24 (CONTINUED)

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

LIST OF TABLES

SUMMARY TABLE WORLDWIDE SALES OF MONOCLONAL THERAPEUTIC AND COMPANION DIAGNOSTICS, THROUGH 2012 ($ BILLIONS)

TABLE 1 BIOPHARMACEUTICAL CATEGORIES

TABLE 2 MONOCLONAL ANTIBODIES APPROVED FOR DISEASE THERAPY*

TABLE 3 TIMELINE FOR MAB DEVELOPMENT

TABLE 4 WORLDWIDE FORECAST OF THERAPEUTIC MONOCLONAL ANTIBODIES, BY TYPE, THROUGH 2012 ($ BILLIONS)

TABLE 5 SMART TECHNOLOGY ROYALTIES BY LICENSEE AND PRODUCT AS A PERCENTAGE OF TOTAL ROYALTY REVENUE: EXAMPLE OF TECHNOLOGY ROYALTY POTENTIAL (%)

TABLE 6 TRANSGENIC TECHNOLOGIES

TABLE 7 LEADING CONJUGATION TECHNOLOGIES

TABLE 8 ANTIBODY TECHNOLOGY BEHIND COMMERCIALIZED MABS

TABLE 9 CAT’S PHAGE AND RIBOSOME DISPLAY PATENTS

TABLE 10 PHARMA’S MAB-RELATED ACQUISITIONS

TABLE 11 GLOBAL SNAPSHOT: BIOTECHNOLOGY INDUSTRY*

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 14 GROWTH OF COMMERCIALIZED MONOCLONAL ANTIBODIES BY THERAPEUTIC AREA, THROUGH 2012 (NUMBER OF COMMERCIALIZED ANTIBODIES EACH YEAR)

TABLE 15 BIOPHARMACEUTICAL MARKET VALUE OF VARIOUS DISEASES/CONDITIONS, THROUGH 2012 ($ BILLIONS)

TABLE 16 CANCER’S GLOBAL ANNUAL DEATH TOLL

TABLE 17 ESTIMATED NEW CASES OF CANCER IN THE U.S., 2007

TABLE 18 CNS GLOBAL MARKET VALUES ($ BILLIONS)

TABLE 19 COMMON ANTIGEN TARGETS EXPLAINED

TABLE 20 THERAPEUTIC PIPELINE: SELECTED MABS IN DEVELOPMENT

TABLE 21 WORLDWIDE VALUE OF MAB-ASSOCIATED DIAGNOSTICS, BY TECHNOLOGY TYPE, THROUGH 2012 ($ BILLIONS)

TABLE 22 SCANNING TECHNOLOGIES THAT ARE USED WITH DIAGNOSTIC RADIOPHARMACEUTICALS

TABLE 23 MAB-BASED DIAGNOSTIC RADIOPHARMACEUTICALS: CURRENT AND EMERGING

TABLE 24 A NEW PARADIGM: MULTIFUNCTIONAL MAB DEVELOPMENT PIPELINE

TABLE 25 ABBOTT PRODUCT CATEGORIES

TABLE 26 HUMIRA’S LIFECYCLE TO DATE

TABLE 27 AMGEN’S PRODUCTS IN PHASE II OR LATER DEVELOPMENT

TABLE 28 ASTRAZENECA’S KEY BIOLOGICALS IN CLINICAL TRIALS

TABLE 29 ASTRAZENECA’S KEY BIOLOGICALS IN PRECLINICALS

TABLE 30 CHUGAI’S ANTIBODY-BASED PIPELINE

TABLE 31 CURAGEN’S ANTIBODY-BASED DRUG CANDIDATES

TABLE 32 EISAI’S (MORPHOTECK ACQUISITION) MONOCLONAL PIPELINE

TABLE 33 SELECTED PRODUCTS FROM WHICH GENENTECH RECEIVES ROYALTIES

TABLE 34 SELECTED ADDITIONAL PRODUCTS FROM WHICH GENENTECH RECEIVES ROYALTIES

TABLE 35 IMMUNOMEDICS’ THERAPEUTIC PRODUCT PIPELINE

TABLE 36 MEDAREX’S PRODUCT PIPELINE

TABLE 37 MICROMET’S PIPELINE

TABLE 38 MILLENNIUM’S PRODUCTS IN PHASE II OR LATER DEVELOPMENT

TABLE 39 MORPHOSYS HUCAL-BASED ANTIBODY PRODUCTS

TABLE 40 MORPHOSYS’ PATENT PORTFOLIO

TABLE 41 PDL BIOPHARMA’S PRODUCTS IN PHASE II OR LATER

TABLE 42 TANABE SEIYAKU’S ANTIBODY-BASED PIPELINE

LIST OF FIGURES

SUMMARY FIGURE WORLDWIDE SALES OF MONOCLONAL THERAPEUTIC AND COMPANION DIAGNOSTICS, 2005-2012 ($ BILLIONS)

FIGURE 1 COMPOSITION OF COMMERCIALIZED ANTIBODIES BY TYPE, 2007 AND 2012 (%)

FIGURE 2 ANTIBODY ILLUSTRATED

FIGURE 3 THE SYNERGY OF PHARMA AND BIOTECH

FIGURE 4 SHARE OF MONOCLONAL ANTIBODY THERAPY MARKET BY THERAPEUTIC AREA, 2007 AND 2012 (%)

FIGURE 5 MAJOR MAB ANTIGEN TARGETS COMMERCIALIZED

FIGURE 6 WORLDWIDE IN-VITRO DIAGNOSTIC MARKET SHARE BY THERAPEUTIC AREA, 2006 (%)

Abstract

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