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Published by: Business Insights
Published: Jul. 1, 2006 - 180 Pages
Table of Contents
- Executive Summary
- Introduction
- Antibody engineering and innovation in the market
- The current monoclonal antibody market
- The antibody pipeline and forecasts to 2011
- Competitive landscape and future growth strategies
- Chapter 1 Introduction
- Summary
- Introduction
- History of monoclonal antibodies
- Monoclonal antibody approval process
- Current approval process
- Biogeneric regulations
- Key trends in the market
- Advancements in innovation
- Diversification of therapy areas
- Big Pharma entering the mAb market
- Chapter 2 Antibody engineering and innovation in the market
- Summary
- Introduction
- The move from murine to fully human mAbs
- Whole IgG monoclonal antibodies
- Murine
- Chimeric
- Humanized
- Human
- Innovations in antibody structures
- Fab fragments
- Single chain variable fragments
- Extended release formulations
- Innovation in antibody conjugation
- Types of conjugation
- Direct arming: antibody conjugation
- Indirect arming: Bispecific monoclonal antibodies
- Pre-targeting
- Marketed conjugated monoclonal antibodies
- Conjugation technology
- Seattle Genetics antibody technology
- ImmunoGen mAb technology
- Peregrine mAb technology
- Enhancing monoclonal antibody potency
- Drug discovery
- Cambridge Antibody Technology
- Dyax
- Morphosys
- Innovation in drug delivery
- Drug delivery devices
- Inhaled monoclonal antibodies
- Oral monoclonal antibodies
- Chapter 3 The current monoclonal antibody market
- Summary
- Introduction
- Strategic analysis
- Drivers
- Pipeline drugs
- Immature market
- Big Pharma entering the mAb market
- High level of innovation
- Approval of new indications
- Combination therapies
- Resistors
- Publicized side effects
- Drugs suspended from market
- Competition from small molecule drugs
- Pricing and reimbursement schemes
- Analysis of launched drugs
- Oncology
- Rituxan
- Herceptin
- Avastin
- Erbitux
- Campath
- Zevalin
- MyloTarg
- Bexxar
- AIID
- Remicade
- Humira
- Raptiva
- Simulect
- Zenapax
- OrthoClone OKT3
- Hemostasis
- ReoPro
- Anti-infectives
- Synagis
- Respiratory
- Xolair
- Marketed monoclonal antibody forecasts
- Chapter 4 The antibody pipeline and forecasts to 2011
- Summary
- Introduction
- Strategic analysis
- Opportunities
- Clinical trials
- Erbitux and Avastin
- Simulect, Zenapax and Campath
- Campath
- Others
- Innovation in antibody engineering
- New indications
- Challenges
- Generic biologics
- Adverse reactions in clinical trials, side effects and termination of development
- High attrition rates
- Analysis of pipeline drugs
- AIID
- Cimzia
- MRA/Actemra
- Eculizumab
- AMG-162
- Cardiovascular
- Pexelizumab
- Infectious diseases
- Numax
- Oncology
- ABX-EGF
- MDX-010+MDX-1379
- Humax
- Ophthalmology
- Lucentis
- Late stage pipeline forecasts
- The antibody market in 2011
- Chapter 5 Competitive landscape and future growth strategies
- Summary
- Introduction
- Key players in the monoclonal antibody market
- M&A and licensing activity
- Big Pharma acquiring biotechs and antibody companies
- AstraZeneca and CAT
- Novartis and NeuTec
- Amgen and Abgenix
- Roche and GlycArt
- MedImmune and Cellective Therapeutics
- Pfizer and Bioren
- Company profiles
- Big Pharma
- Roche
- Company overview
- Strategic and growth analysis
- Marketed products
- Pipeline
- Novartis
- Company overview
- Strategic and growth analysis
- Marketed products
- Pipeline
- Pfizer
- Company overview
- Strategic and growth analysis
- Pipeline
- Large biotech
- Genentech
- Company overview
- Strategic and growth analysis
- Marketed products
- Pipeline
- MedImmune
- Company Profile
- Strategic and growth analysis
- Marketed products
- Pipeline products
- Biogen Idec
- Company overview
- Strategic analysis
- Marketed products
- Pipeline products
- UCB-Celltech
- Company overview
- Strategic and growth analysis
- Marketed products
- Pipeline products
- Small biotech/antibody companies
- Medarex
- Company overview
- Strategic and growth analysis
- Marketed products
- Pipeline products
- XOMA
- Company overview
- Strategic and growth analysis
- Marketed products
- Pipeline products
- Technology companies
- BioWa
- Company overview
- Strategic and growth analysis
- Pipeline products
- Crucell
- Company overview
- Strategic and growth analysis
- Pipeline products
- Chapter 6 Appendix
- Sales data
- Index
- List of Figures
- Figure 1.1: History of monoclonal antibodies
- Figure 2.2: Current marketed monoclonal antibodies, 2006
- Figure 2.3: Therapeutic mAbs entering clinical study, 1980-2004
- Figure 2.4: Whole antibody and fragment structures
- Figure 3.5: Drivers and resistors to growth in the monoclonal antibody market
- Figure 3.6: Market dynamics of current marketed drugs, 2004-5
- Figure 3.7: Marketed monoclonal antibodies by therapy area, 2006
- Figure 4.8: Opportunities and challenges in the mAb market
- Figure 4.9: Antibody structure analysis of forecasted monoclonal antibody sales ($m), 2004-11106
- Figure 4.10: Therapy area analysis in monoclonal antibody drug development, 2006
- Figure 4.11: Therapy area analysis of forecasted monoclonal antibody sales ($m), 2004-11
- Figure 5.12: Key growth strategies in the monoclonal antibody market, 2005-6
- Figure 5.13: Roche’s SWOT analysis in the mAb market
- Figure 5.14: Novartis’ SWOT analysis in the mAb market
- Figure 5.15: Pfizer’s SWOT analysis in the mAb market
- Figure 5.16: Genentech’s SWOT analysis in the mAb market
- Figure 5.17: MedImmune’s SWOT analysis in the mAb market
- Figure 5.18: Biogen Idec’s SWOT analysis in the mAb market
- Figure 5.19: UCB Celltech’s SWOT analysis in the mAb market
- Figure 5.20: Medarex’s SWOT analysis in the mAb market
- Figure 5.21: XOMA’s SWOT analysis in the mAb market
- Figure 5.22: BioWa’s SWOT analysis in the mAb market
- Figure 5.23: Crucell’s SWOT analysis in the mAb market
- List of Tables
- Table 1.1: Current marketed drugs, 2006
- Table 1.2: Key players in the monoclonal antibody market, 2006
- Table 2.3: Marketed therapeutic monoclonal antibodies, 1986-2006
- Table 2.4: Antibody fragment pipeline, 2006
- Table 2.5: Conjugated antibody engineering technology
- Table 2.6: Drug development technology
- Table 2.7: Monoclonal antibody drug discovery technology
- Table 3.8: Marketed therapeutic monoclonal antibodies, 2004-5
- Table 3.9: Marketed monoclonal antibody sales forecasts, 2005-11
- Table 4.10: Other post-marketing clinical trials, 2005-6
- Table 4.11: Late stage monoclonal antibody pipeline, 2006
- Table 4.12: Late stage monoclonal antibody pipeline sales forecast to 2011
- Table 5.13: Key players in the monoclonal antibody market, 2006
- Table 5.14: Monoclonal antibody collaborations, manufacturing, development and supply agreements, 2005-6
- Table 5.15: Key acquisitions in the monoclonal antibody market, 2005-6
- Table 5.16: Roche’s marketed monoclonal antibodies, 2006
- Table 5.17: Roche’s monoclonal antibody pipeline, 2006
- Table 5.18: Novartis’ marketed monoclonal antibodies, 2006
- Table 5.19: Novartis’ monoclonal antibody pipeline, 2006
- Table 5.20: Pfizer’s monoclonal antibody pipeline, 2006
- Table 5.21: Genentech’s marketed monoclonal antibodies, 2006
- Table 5.22: Genentech’s monoclonal antibody pipeline, 2006
- Table 5.23: MedImmune’s marketed monoclonal antibodies, 2006
- Table 5.24: MedImmune’s monoclonal antibody pipeline, 2006
- Table 5.25: Biogen Idec’s marketed monoclonal antibodies, 2006
- Table 5.26: Biogen Idec’s monoclonal antibody pipeline, 2006
- Table 5.27: UCB-Celltech monoclonal antibody pipeline, 2006
- Table 5.28: Medarex’s monoclonal antibody pipeline, 2006
- Table 5.29: XOMA’s monoclonal antibody pipeline, 2006
- Table 5.30: BioWa’s monoclonal antibody pipeline, 2006
- Table 5.31: Crucell’s monoclonal antibody pipeline, 2006
AbstractThe monoclonal antibody (mAb) market has grown rapidly in recent years, reaching sales of $14bn in 2005, an increase of 36.5% from 2004 sales of $10.3bn. Köhler and Milstein developed the hybridoma method of murine antibody production in 1975, which allowed the production of the first mAb to market; Johnson & Johnson’s Orthoclone OKT3 (muromonab) in 1986. The mAb market is highly innovative and a key trend has been the move from murine to humanized and fully human antibodies. As technology has progressed these humanized mAbs have prevented immune responses (HAMA), thus having a larger market potential. The traditional therapy areas in the mAb market are oncology and autoimmune and inflammatory disorders (AIID), however this is forecast to change with the emergence of other therapy areas including infectious disease and ophthalmology. The clear leader in the mAb market is Genentech with 5 marketed drugs, with sales totaling $4,116.4m in 2005. A key theme of this report is the high level of innovation, as demonstrated by advancements in antibody engineering with the introduction of chimeric, humanized and fully human mAbs. Other innovation in antibody technology include advancements in non-invasive drug delivery technology, which is predicted to lead to a huge boost in sales in the long-term once drugs that utilize this technology come to market.
Key findings of the report:
- The antibody market is set to more than double in value over the next 5 years to $29.7bn, continuing the rapid growth witnessed in the past 2 years.
- During the next 5 years antibodies for oncology and arthritis, immune and inflammatory disorders (AIID) are forecast to continue to lead the market, with sales of $14bn and $11bn, respectively in 2011.
- With the predicted launch of 2 pipeline antibodies in the next 5 years, the infectious disease area is set to grow in importance. Antibodies are also being developed in respiratory, cardiovascular and ophthalmology indications.
- Analysis of early and late stage pipelines show development focus is shifting away from murine and chimeric mAbs to humanized and fully human antibodies. Abbott/CAT’s Humira, launched in the US in 2003, was the first fully human antibody on the market.
- Genentech and Roche held a combined 48.7% share of the antibodies market in 2005, primarily due to the success of their collaborative oncology drugs, Rituxan, Herceptin and Avastin.
Key questions answered in this report:
- What were the key events in the global mAb market in 2005-06?
- What are the opportunities and threats to key players in this market?
- Which companies are innovators in the mAb market and who have they formed collaborations with?
- What is the sales forecast in each therapy area of the mAb market over the period 2005-11?
- What are current and future leading brands in the global mAb market?
- What strategies are the leading companies implementing to maximize sales and boost market share?
- Which new product launches are forecast to gain blockbuster status?
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