Abstract
The 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.
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
- Anti-infectives
- Respiratory
- 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
- Infectious diseases
- Oncology
- ABX-EGF
- MDX-010+MDX-1379
- Humax
- Ophthalmology
- 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
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