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The Future of Monoclonal Antibodies Therapeutics: Innovation In Antibody Engineering, Key Growth Strategies And Forecasts To 2011

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

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.

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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