SPI Infoamtion

Table of Contents

Executive Summary

Introduction to biopharmaceuticals
Developments in technology and clinical applications
Market analysis
The biopharmaceutical industry

Chapter 1 Introduction to biopharmaceuticals

Summary
Introduction
Definition
Main product classes

Monoclonal antibodies (MAbs)
Therapeutic proteins

Hemopoietic growth factors
Cytokines
Blood factors

Vaccines

Traditional vaccines
Novel vaccine technologies

Current status: uses and markets

Monoclonal antibodies

Anti-cancer
Anti-TNF
Market status of mAbs

Therapeutic proteins

Insulin
Erythropoietin
Growth hormone
Cytokines
Blood factors
Market status of therapeutic proteins

Vaccines

Chapter 2 Developments in technology and clinical applications

Summary
Introduction
Monoclonal antibodies

Technology

Human antibodies
Antibody fragments
Conjugated antibodies

Antibodies in advanced development

Pipeline activity

Oncology

Abagovomab
Anyara
Humax EGFr
Rencarex
Ipilimumab
Others

Inflammation and immunology

Benlysta
Epratuzumab
Ocrelizumab
Reslizumab
Others

Other indications

Bapineuzumab
Otelixizumab
Pagibaximab
Tanezumab
Others

Therapeutic proteins

Technology

Multikine
Cintredekin Besudotox
Rilonacept (IL-1 Trap)
Prevascar
PRX302

Hemopoietic growth factors
Recent pipeline activity

Replagal
Joulferon
CYT107
Talactoferrin
Taspoglutide

Vaccines

Technology

Heterologous prime-boost schemes
New adjuvants
New vaccines against existing targets

Vaccines against new targets

HIV vaccines
Cancer vaccines
Malaria
Tuberculosis

Vaccines pipeline

Menveo
Cervarix
Ixiaro/Jespect
Stimuvax

Chapter 3 Market analysis

Summary
Introduction
Market status by product group

Monoclonal antibodies
Therapeutic proteins

Cytokines
Anti-hemophilia products
Growth hormones

Vaccines

Production issues
Opportunities in emerging markets
Adjuvant developments
Therapeutic vaccines
Influenza

Market by geographic region
The threat from biosimilars

Rationale for biosimilar development
Selected biosimilar developments and introductions

EPO
G-CSF
Interferons
HGH
Monoclonal antibodies

Chapter 4 The biopharmaceutical industry

Summary
Evolution

Amgen, Biogen and Genentech

Involvement of big pharma
Biopharma specialist companies
M&A activity

Key findings
Future M&A trends

Chapter 5 Company profiles

Introduction
Companies marketing/researching Monoclonal Antibodies:

Industry leaders

Abbott Laboratories
Bayer Schering Pharma Ag
Biogen Idec Inc.
Genzyme Corporation
Imclone Systems Inc.
UCB S.A.
F. Hoffmann-La Roche Ltd
Medarex Inc.

Other companies involved in MAb research

Amgen Inc
Apogenix GmbH
Bioinvent International AB
Celldex Therapeutics Inc
Debiopharm Group
Genmab A/S
Glycotope GmbH
ImmunoGen Inc
Innate Pharma
Pfizer Inc.
Seattle Genetics Inc.
Tolerx Inc.
Trubion Pharmaceuticals Inc.
Wilex AG

Companies involved in Therapeutic Proteins

Industry Leaders

CSL Behring
Eli Lilly & Co.
Ipsen
Merck Serono S.A.
Novartis AG
Novo Nordisk A/S
Baxter International Inc

Other companies involved in Therapeutic Protein research

Agennix AG
Akebia Therapeutics, Inc.
Biovitrum AB
Cytheris SA
Dyax Corp
ERYtech Pharma
Helix BioPharma Corp.
Human Genome Sciences Inc.
Immutep S.A.
H. Lundbeck A/S
Octapharma AG
Phosphagenics Limited
Proteon Therapeutics, Inc.
Shire plc
Teva Pharmaceutical Industries Ltd
ThromboGenics NV
ZymoGenetics, Inc.

Companies involved in Vaccines

Industry Leaders

Merck & Co Inc.
GlaxoSmithKline plc
Sanofi-Aventis

Other companies involved in Vaccine Research

Advaxis Inc
Hawaii Biotech, Inc.
ImmunoVaccine Technologies Inc.
Intercell AG
Soligenix, Inc.
Stallergenes
Tripep AB
Vical Inc
Xcellerex, Inc

Index

List of Figures
Figure 1.1: Global biopharmaceutical market ($bn), 2009
Figure 1.2: Diagram of typical antibody structure
Figure 1.3: MAb market 2009, market share by use
Figure 1.4: Therapeutic proteins market, 2009 market, sales by class, $bn
Figure 3.5: Evolution of the biologics market 2009-2015
Figure 3.6: Geographic breakdown of the global biopharmaceutical market

List of Tables
Table 1.1: Marketed Anti-TNF MAbs
Table 1.2: Global market forecast for mAbs, 2009-2015, $bn
Table 1.3: mAb market leaders, 2009
Table 1.4: Human growth hormone products
Table 1.5: Approved cytokines
Table 1.6: Blood factors for hemophilia treatment
Table 1.7: Global therapeutic proteins market and forecast, $bn
Table 1.8: Leading vaccine product sales, 2009; $bn
Table 1.9: Global vaccines market and forecast, 2009-2015, $bn
Table 2.10: MAbs near to market launch, 2010
Table 2.11: Anti-cancer monoclonal antibody products in Phase III trials
Table 2.12: Immune system related monoclonal antibody products in Phase III trials
Table 2.13: mAb products in clinical development for novel indications
Table 2.14: Therapeutic proteins in development
Table 2.15: Therapeutic proteins in development (continued)
Table 2.16: Vaccines in late stage development
Table 3.17: Biopharmaceutical market, estimated value and forecast 2009-2015; $bn
Table 3.18: Leading monoclonal antibody products in 2009
Table 3.19: Hemopoietic growth factors
Table 3.20: Cytokines sales. 2009
Table 3.21: Anti-hemophilia products sales, 2009
Table 3.22: Growth factor product sales, 2008
Table 3.23: Leading vaccine products, sales 2009, $bn
Table 3.24: Biologics facing the launch of biosimilars
Table 4.25: Company dependence on biopharmaceuticals
Table 4.26: Leading specialist biotech companies