Monoclonal Antibodies: 2009 update

Table of Contents

ABOUT THIS SECTOR REPORT

• PharmaVitae Explorer database
• Chapter structure
  • mAb technology overview
  • Market analysis
  • Pipeline analysis
  • Key products

• Data sourcing

EXECUTIVE SUMMARY

• Key findings
  • Monoclonal antibody market outlook

• Introduction to the PharmaVitae company universe
• The prescription pharmaceutical market to 2014
  • Prescription pharmaceutical market performance, 2008-14
  • Introduction to molecule type analysis
  • Prescription pharmaceutical sales by molecule type, 2008-14

• The mAb market will deliver the largest and fastest sales growth across the industry
  • The mAb market is forecast to increase at a double-digit growth rate
  • The mAb market will deliver much-needed sales growth in order to offset US-centered small molecule sales collapse
  • Geographic sales growth: the US and 5EU lead the way
  • A raft of new mAbs expected to make it onto the market over 2008-14.....
  • .....but still only a few mAbs command the highest revenues
  • Big 5 dominance will remain, although their share will decline
  • Product analysis (size)
  • Product analysis (growth)
  • Company analysis

• Big Pharma' s hold on the mAb market
  • Recent M&A deals underline pharma' s ‘bankable view' of mAbs
  • The mAb landscape: innovation driven by collaboration and M&A

• Long-term opportunities and threats
  • (Untitled sub-section)
  • The price of mAb therapies is a major resistor to growth, but the collapse of the US branded small molecule market could ‘free-up' payer resource
  • Drive for personalized medicine: the role of companion diagnostics, an opportunity for diagnostic and mAb players

MAB TECHNOLOGY OVERVIEW

• Key findings
• Introduction
  • The immune system
  • B lymphocytes and antibodies
  • Antibody structure
  • Hybridoma technique - the production of mAbs

• Monoclonal antibodies as therapeutic agents
  • Targets
  • Production of mAbs
  • Mode of action

• Evolution of mAbs
  • Limitations associated with immunization
  • Murine
  • Chimeric and humanized antibodies
  • Fully human
  • Fragments
  • Conjugated
  • Naked mAbs still dominate

• Systematic naming of mAbs
• The mAb timeline - technology evolution
• Manufacturing
  • Mammalian cell culture - still the most widely-used system

MARKET ANALYSIS

• Key findings
• Introduction
  • The mAb market - overview of the fastest growing sector across the pharmaceutical industry
  • Key global mAb products over 2002-14

• mAb market product analysis, 2002-14
  • Historical product analysis, 2002-08
  • Forecast product analysis, 2008-14

• mAb market company analysis, 2002-14
  • Historical product analysis, 2002-08
  • Forecast company analysis, 2008-14

• mAb market therapy area analysis, 2002-14
  • Historical therapy area analysis, 2002-08
  • Forecast therapy area analysis, 2008-14

• mAb market geographic analysis, 2002-14
  • Historical geographic analysis, 2002-08
  • Forecast geographic analysis, 2008-14

• mAb market technology analysis, 2002-14
  • Historical technology analysis, 2002-08
  • Forecast technology analysis, 2008-14

• mAb market target analysis, 2002-14
  • Historical target analysis, 2002-08
  • Forecast target analysis, 2008-14

PIPELINE ANALYSIS

• Key findings
• Introduction
• mAb pipeline overview
• Company pipeline analysis
  • Late-stage company pipeline analysis
  • Early-stage company pipeline analysis
  • Change of direction driven by acquisition

• Technology pipeline analysis
• Therapy area pipeline analysis
• Target pipeline analysis
  • Target crowding evident with the late-stage mAbs; lifecycle management strategies being employed
  • Novel target early-stage candidates

KEY PRODUCTS

• Key findings
• Introduction
• Oncology
  • Avastin
  • Herceptin
  • MabThera/Rituxan
  • Erbitux
  • Prolia (oncology)
  • Vectibix
  • Arzerra

• Immunology & inflammation
  • Humira
  • Remicade
  • Simponi
  • Cimzia
  • Actemra
  • Stelara

• Central nervous system
  • Tysabri
  • Bapineuzumab
  • Campath (CNS)

• Infectious diseases
  • Numax
  • Synagis

• Respiratory
  • Xolair

• Musculoskeletal
  • Prolia

• Cardiovascular
  • ReoPro

• Other
  • Lucentis

APPENDIX

• References
  • External references

• Abbreviations
• Exchange rates

TABLES

• Table: PharmaVitae company coverage by peer set
• Table: Molecule type definitions
• Table: General characteristics of small molecule drugs vs. biologics
• Table: Prescription pharmaceutical sales by molecule type ($m), 2008-14
• Table: The global small molecule market ($m), 2008-14
• Table: The global mAb market ($m), 2008-14
• Table: Annual revenues of the Big 5 ($m), 2008 and 2014
• Table: Overview of a selection of marketed mAbs: technology type and immunogenicity
• Table: Infix nomenclature for mAbs
• Table: Manufacturing cell lines for marketed mAbs
• Table: Global top five mAb sales ($m), 2002, 2008 and 2014
• Table: Annual revenues of the Big 5 ($m), 2008 and 2014
• Table: Historical mAb product sales ($m), 2002-08
• Table: Forecast mAb product sales ($m), 2008-14
• Table: Historical mAb sales by company ($m), 2002-08
• Table: Forecast mAb sales by company ($m), 2008-14
• Table: Historical mAb sales by therapy area ($m), 2002-08
• Table: Forecast mAb sales by therapy area ($m), 2008-14
• Table: Historical mAb sales by geography ($m), 2002-08
• Table: Forecast mAb sales by geography ($m), 2008-14
• Table: Historical mAb sales by technology ($m), 2002-08
• Table: Forecast mAb sales by technology ($m), 2008-14
• Table: Historical mAb sales by target ($m), 2002-08
• Table: Forecast mAb sales by target ($m), 2008-14
• Table: mAb pipeline overview, 2009
• Table: Count of marketed mAbs by company, 2009
• Table: Count of Phase III mAb players, 2009
• Table: Count of companies with multiple Phase I-II mAb candidates, 2009
• Table: mAb count split by technology type, 2009
• Table: mAb count split by technology type, 2009
• Table: Detailed product/target analysis of mAbs in late-stage development, 2009
• Table: Novel late-stage mAb targets, 2009
• Table: Novel early-stage mAb targets, 2009
• Table: Avastin: overview
• Table: Avastin: sales forecast ($m), 2008-14
• Table: Herceptin: overview
• Table: Herceptin: sales forecast ($m), 2008-14
• Table: MabThera/Rituxan: overview
• Table: MabThera/Rituxan: sales forecast ($m), 2008-14
• Table: Erbitux: overview
• Table: Erbitux: sales forecast ($m), 2008-14
• Table: Prolia (oncology): overview
• Table: Prolia (oncology): sales forecast ($m), 2008-14
• Table: Vectibix: overview
• Table: Vectibix: sales forecast ($m), 2008-14
• Table: Arzerra: overview
• Table: Arzerra: sales forecast ($m), 2008-14
• Table: Humira: overview
• Table: Humira: sales forecast ($m), 2008-14
• Table: Remicade: overview
• Table: Remicade: sales forecast ($m), 2008-14
• Table: Simponi: overview
• Table: Simponi: sales forecast ($m), 2008-14
• Table: Comparison of the route of administration and dosing frequency of the anti-TNFs in rheumatoid arthritis
• Table: Cimzia: overview
• Table: Cimzia: sales forecast ($m), 2008-14
• Table: Actemra: overview
• Table: Actemra: sales forecast ($m), 2008-14
• Table: Stelara: overview
• Table: Stelara: sales forecast ($m), 2008-14
• Table: Tysabri: overview
• Table: Tysabri: sales forecast ($m), 2008-14
• Table: Bapineuzumab: overview
• Table: Bapineuzumab: sales forecast ($m), 2008-14
• Table: Campath (CNS): overview
• Table: Campath (CNS): sales forecast ($m), 2008-14
• Table: Numax: overview
• Table: Numax: sales forecast ($m), 2008-14
• Table: Synagis: overview
• Table: Synagis: sales forecast ($m), 2008-14
• Table: Xolair: overview
• Table: Xolair: sales forecast ($m), 2008-14
• Table: Prolia: overview
• Table: Prolia: sales forecast ($m), 2008-14
• Table: ReoPro: overview
• Table: ReoPro: sales forecast ($m), 2008-14
• Table: Lucentis: overview
• Table: Lucentis: sales forecast ($m), 2008-14
• Table: Exchange rates, 2009

FIGURES

• Figure: The PharmaVitae Explorer
• Figure: The total pharmaceutical market outlook, sales ($m) and year-on-year growth rate (%), 2002-14
• Figure: Change in annual sales of PharmaVitae universe by molecule type ($m), 2008-14
• Figure: CAGR of PharmaVitae universe by molecule type, 2008-14
• Figure: Total sales of the mAb market ($m), 2002-14
• Figure: The US versus ex-US small molecule market sales growth ($m and %), 2002-14
• Figure: The US versus ex-US mAb market sales growth ($m and %), 2002-14
• Figure: mAb market geographic analysis, total sales ($m), 2002-14
• Figure: Total number of mAbs versus total mAb market sales ($m), 2002-14
• Figure: Total mAb sales versus average price per mAb ($m), 2002-14
• Figure: Sales proportion of the Big 5 vs. the rest of the mAb market (%), 2002-14
• Figure: mAb product sales ($m), 2002-14
• Figure: Growth driver/resistor products of forecast revenue performance ($m), 2008-14
• Figure: mAb company sales ($m), 2002-14
• Figure: mAb ownership sales by peer set ($m and %), 2002-14
• Figure: Big Pharma' s $74 billion worth of key mAb acquisitions over the past five years
• Figure: The collaborative landscape of the mAb market key players
• Figure: The structure of an antibody
• Figure: Types of antibodies
• Figure: Immunogenicity ranges
• Figure: Number of marketed mAb technologies, 2008
• Figure: Schematic illustration of antibody fragments
• Figure: mAb timeline - technology shift
• Figure: Total sales of the mAb market ($m and %), 2002-14
• Figure: mAb product sales ($m), 2002-14
• Figure: Growth driver/resistor products of historical revenue performance ($m), 2002-08
• Figure: Growth driver/resistor products of forecast revenue performance ($m), 2008-14
• Figure: mAb sales by company ($m), 2002-14
• Figure: Growth driver/resistor companies of historical revenue performance ($m), 2002-08
• Figure: Growth driver/resistor companies of forecast revenue performance ($m), 2008-14
• Figure: mAb sales by therapy area ($m), 2002-14
• Figure: Growth driver/resistor therapy areas of historical revenue performance ($m), 2002-08
• Figure: Growth driver/resistor therapy areas of forecast revenue performance ($m), 2008-14
• Figure: mAb sales by geography ($m), 2002-14
• Figure: Growth driver/resistor geographies of forecast revenue performance ($m), 2008-14
• Figure: mAb sales by technology ($m), 2002-14
• Figure: Growth driver/resistor technologies of forecast revenue performance ($m), 2008-14
• Figure: mAb sales by target ($m), 2002-14
• Figure: Growth driver/resistor targets of forecast revenue performance ($m), 2008-14
• Figure: Count of marketed mAb players, 2009
• Figure: Count of Phase III pipeline mAb players, 2009
• Figure: Count of companies with multiple Phase I-II mAb candidates, 2009
• Figure: Phase I-III mAb pipeline count split by technology, 2009
• Figure: The stepwise evolution of naked mAb technology
• Figure: Overview of pipeline technology type
• Figure: Phase I-pre-registration mAb count split by therapy area, 2009
• Figure: Count of the most popular targets in early-stage development, 2009