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Monoclonal Antibodies: 2010

Datamonitor, October 2010, Pages: 201

Introduction
Across the branded prescription pharmaceutical market monoclonal antibodies (MAbs) are forecast to be the strongest performing molecule type, delivering a forecast six year compound annual growth rate of 9.5% over 2009-15, outpacing the growth rates of small molecules, therapeutic proteins and vaccines. As a result, there is a strong correlation between a strong MAbs portfolio and overall company

Features and benefits
- Strategic dynamics within the sector are broken down by product, company, geography, therapy area, technology type and target.
- The outlook for the sector is compared with other sectors of the pharmaceutical industry: small molecules, therapeutic proteins and vaccines.
- The impact of biosimilars on future MAb sales growth is evaluated and compared with small molecule brand sales following genericization

Highlights
While it is believed that biosimilar MAbs will make it onto the major markets, the rate of sales erosion of such a biosimilar MAb will be far less than that experienced by a small molecule upon generic entry.

Your key questions answered
- Assess the outlook for the monoclonal antibodies sector through to 2015
- Evaluate the impact of monoclonal antibody on company performances across the PharmaVitae universe
- Appraise the technological developments being made in the sector and see where monoclonal antibody pipelines are being focussed



Chapter 1 About this Sector Report
PharmaVitae Explorer database

Chapter structure
Data sourcing

Chapter 2 Executive Summary
Key findings
Introduction to the PharmaVitae company universe
The prescription pharmaceutical market to 2015
The MAb market will deliver the largest and fastest sales growth across the industry
The MAb sector will remain the fastest growing across the pharmaceutical industry
Historical market analysis
Forecast market analysis

Chapter 3 MAb Technology Overview
Key findings
Introduction
Monoclonal antibodies as therapeutic agents
Evolution of MAbs
Antibody drug conjugates – an alternative ‘combination therapy’
Bispecific antibodies – is now the time for commercial success?
Trifunctional antibodies – successful innovation in a niche indication
Ablynx’s nanobodies
GSK’s acquisition of Domantis gives it ownership of DAbs – will the leading Big Pharma player in inhalable drug delivery echo this into the antibody market?
Systematic naming of MAbs
The MAb timeline—technology evolution

Chapter 4 Market Analysis
Key findings
Introduction
MAb market product analysis, 2003–15
MAb market company analysis, 2003–15
MAb market therapy area analysis, 2003–15
MAb market geographic analysis, 2003–15
MAb market technology analysis, 2003–15
MAb market target analysis, 2003–15

Chapter 5 Pipeline Analysis
Key findings
Introduction
MAb pipeline overview
Company pipeline analysis
Technology pipeline analysis
Therapy area pipeline analysis
Target pipeline analysis

Chapter 6 Key Products
Introduction
Oncology
Immunology & inflammation
Central nervous system
Infectious diseases
Musculoskeletal
Other

Chapter 7 Appendix
References
Abbreviations
Exchange rates
About Datamonitor
Datamonitor consulting
Disclaimer

TABLE OF TABLES
Table 1: PharmaVitae company coverage by peer set
Table 2: Molecule type definitions
Table 3: General characteristics of small molecule drugs vs. biologics
Table 4: Prescription pharmaceutical sales by molecule type ($m), 2009–15
Table 5: Overview of a selection of marketed MAbs: technology type and immunogenicity
Table 6: Infix nomenclature for MAbs
Table 7: Global top five MAb sales ($m), 2002, 2008 and 2014
Table 8: Annual revenues of the Big 5 ($m), 2009 and 2015
Table 9: Historical MAb product sales ($m), 2003–09
Table 10: Forecast MAb product sales ($m), 2009–15
Table 11: Historical MAb sales by company ($m), 2003–09
Table 12: Forecast MAb sales by company ($m), 2009–15
Table 13: Historical MAb sales by therapy area ($m), 2003–09
Table 14: Forecast MAb sales by therapy area ($m), 2009–15
Table 15: Historical MAb sales by geography ($m), 2003–09
Table 16: Forecast MAb sales by geography ($m), 2009–15
Table 17: Historical MAb sales by technology ($m), 2003–09
Table 18: Forecast MAb sales by technology ($m), 2009–15
Table 19: Historical MAb sales by target ($m), 2003–09
Table 20: Forecast MAb sales by target ($m), 2009–15
Table 21: MAb pipeline overview, 20010
Table 22: Count of marketed mAbs by company, 2010
Table 23: Count of Phase III-registration MAb players, 2010
Table 24: Count of companies with multiple Phase I–II mAb candidates, 2010
Table 25: MAb count split by technology type, 2010
Table 26: MAb count split by therapy area, 2010
Table 27: Detailed product/target analysis of MAbs in late-stage development, 2010
Table 28: Novel late-stage MAb targets, 2010
Table 29: Novel early-stage MAb targets, 2010
Table 30: MAb market key products overview
Table 31: Avastin: overview
Table 32: Avastin: sales forecast ($m), 2009–15
Table 33: MabThera/Rituxan: overview
Table 34: MabThera/Rituxan: sales forecast ($m), 2009–15
Table 35: Herceptin: overview
Table 36: Herceptin: sales forecast ($m), 2009–15
Table 37: Erbitux: overview
Table 38: Erbitux: sales forecast ($m), 2009–15
Table 39: Prolia (oncology): overview
Table 40: Prolia (onco): sales forecast ($m), 2009–15
Table 41: Vectibix: overview
Table 42: Vectibix : sales forecast ($m), 2009–15
Table 43: Arzerra: overview
Table 44: Humira: overview
Table 45: Humira: sales forecast ($m), 2009–15
Table 46: Remicade: overview
Table 47: Remicade: sales forecast ($m), 2009–15
Table 48: Simponi: overview
Table 49: Simponi: sales forecast ($m), 2009–15
Table 50: Actemra: overview
Table 51: Actemra: sales forecast ($m), 2009–15
Table 52: Benlysta: overview
Table 53: Benlysta: sales forecast ($m), 2009–15
Table 54: Stelara: overview
Table 55: Stelara: sales forecast ($m), 2009–15
Table 56: Tysabri: overview
Table 57: Tysabri: sales forecast ($m), 2009–15
Table 58: Bapineuzumab: overview
Table 59: Bapineuzumab: sales forecast ($m), 2009–15
Table 60: Synagis: overview
Table 61: Synagis: sales forecast ($m), 2009–15
Table 62: Numax: overview
Table 63: Numax: sales forecast ($m), 2009–15
Table 64: Prolia: overview
Table 65: Prolia (musc): sales forecast ($m), 2009–15
Table 66: Lucentis: overview
Table 67: Lucentis: sales forecast ($m), 2009–15
Table 68: Exchange rates, 2010

TABLE OF FIGURES
Figure 1: The PharmaVitae Explorer
Figure 2: The total pharmaceutical market outlook, sales ($m) and year-on-year growth rate (%), 2003–15
Figure 3: Total sales of the prescription pharmaceutical market ($m), 2003–15
Figure 4: Change in annual sales of PharmaVitae universe by molecule type ($m), 2009–15
Figure 5: CAGR of PharmaVitae universe by molecule type, 2003-15
Figure 6: Launch, core, expiry configuration of small molecules and MAbs, 2009-15 ($m)
Figure 7: Volume analysis: small molecule generics versus MAb biosimilars
Figure 8: Total sales of the MAb market ($m and %), 2003–15
Figure 9: Growth driver/resistor products of historical revenue performance ($m), 2003–09
Figure 10: Growth driver/resistor companies of historical revenue performance ($m), 2009–15
Figure 11: Total sales of the MAb market ($m), 2003–15
Figure 12: Growth driver/resistor products of forecast revenue performance ($m), 2009–15
Figure 13: Growth driver/resistor companies of forecast revenue performance ($m), 2009–15
Figure 14: Big Pharma peer set net sales growth performance, 2009-15 ($m)
Figure 15: The structure of an antibody
Figure 16: Types of antibodies
Figure 17: Immunogenicity ranges
Figure 18: Schematic illustration of antibody fragments
Figure 19: MAb timeline – technology shift
Figure 20: Total sales of the MAb market ($m and %), 2003–15
Figure 21: MAb product sales ($m), 2003–15
Figure 22: Growth driver/resistor products of historical revenue performance ($m), 2003–09
Figure 23: Growth driver/resistor products of forecast revenue performance ($m), 2009–15
Figure 24: MAb sales by company ($m), 2003–15
Figure 25: Growth driver/resistor companies of historical revenue performance ($m), 2003–09
Figure 26: Growth driver/resistor companies of forecast revenue performance ($m), 2009–15
Figure 27: MAb sales by therapy area ($m), 2003–15
Figure 28: Growth driver/resistor therapy areas of historical revenue performance ($m), 2003–09
Figure 29: Growth driver/resistor therapy areas of forecast revenue performance ($m), 2009–15
Figure 30: MAb sales by geography ($m), 2003–15
Figure 31: Growth driver/resistor geographies of forecast revenue performance ($m), 2009–15
Figure 32: MAb sales by technology ($m), 2003–15
Figure 33: Growth driver/resistor technologies of forecast revenue performance ($m), 2009–15
Figure 34: MAb sales by target ($m), 2003–15
Figure 35: Growth driver/resistor targets of forecast revenue performance ($m), 2009–15
Figure 36: Count of marketed mAb players, 2010
Figure 37: Count of Phase III pipeline MAb players, 2010
Figure 38: Count of companies with multiple Phase I–II mAb candidates, 2010
Figure 39: Phase I–III MAb pipeline count split by technology, 2010
Figure 40: The stepwise evolution of naked MAb technology
Figure 41: Overview of pipeline technology type
Figure 42: Phase I–pre-registration mAb count split by therapy area, 2010
Figure 43: Count of the most popular novel targets in early-stage development, 2010

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