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Therapeutic Monoclonal Antibodies Markets

Published by: Trimark Publications

Published: Jun. 1, 2009 - 112 Pages


Table of Contents


1. Introduction

1.1 Statement of Report

1.2 Objectives of this Report

1.3 Scope of the Report

1.4 Methodology

1.5 Executive Summary

2. Introduction: The State of Therapeutic Monoclonal Antibody Technology

2.1 State of the Pharmaceutical Industry

2.2 Antibodies as an Alternative Pharmaceutical Agent

2.3 Current Status of Antibody Therapeutics

2.4 Demands of Antibody Therapeutics Development

3. Recent Technology Trends

3.1 Classic Design of Antibodies

3.1.1 Chimeric Monoclonal Antibodies

3.1.2 Humanized Monoclonal Antibodies

3.1.3 Totally Human Antibodies

3.1.4 Monoclonal Antibody Processing

3.2 Monoclonal Antibodies Therapeutics

3.2.1 Naked Monoclonal Antibodies

3.2.2 Conjugated Monoclonal Antibodies

3.3 Synthetic Antibodies, Unique Scaffolds

3.4 Screening and Selection of Antibodies

3.5 Novel Antibody Modifications: Glycosylation, Pegylation, Polymer Conjugations

3.5.1 Miniaturizing and Delivering Antibody Drugs

3.5.2 Recombinant Polyclonals

3.6 Monoclonal Antibody Purification

4. Industry Challenges

4.1 Introduction: Challenges Affecting the U.S. Therapeutic Monoclonal Antibodies Market

4.2 Increasing Costs and Complexities of Clinical Trials

4.3 Long-term Safety and Efficacy

4.3.1 Post-marketing Surveillance of Monoclonal Antibodies

4.4 High Cost of Monoclonal Antibodies

4.5 Restricted Government Healthcare Spending

4.6 Intellectual Property Thicket

4.7 Government Regulation

4.8 Third-party Reimbursement Environment

5. Pipeline Analysis

5.1 Overview of the Monoclonal Antibodies Pipeline

5.1.1 Anti-Cancer Antibodies

5.1.2 Profiles of Important Monoclonal Antibodies in Oncology

5.1.2.1 Avastin

5.1.2.2 Phase I Trials of Anti-EpCAM Antibody Adecatumumab (MT201) in Combination with Chemotherapy

5.1.2.3 Adecatumumab (MT201) in Combination with Chemotherapy

5.1.2.4 Herceptin

5.1.2.5 Pertuzumab, a HER2 Dimerization Inhibitor

5.1.2.6 Cetuximab

5.1.2.7 Prostate Cancer: Will Vaccines Lead the Way?

5.1.2.8 Recent Trial of an Anti-prostate Cancer Monoclonal Antibody

5.1.2.9 Anti-melanoma Antibodies

5.1.2.10 Other Anti-cancer Monoclonal Antibodies

5.1.3 Monoclonal Antibodies in Autoimmune and Inflammatory Disorders

5.1.3.1 Type 1 Diabetes

5.1.3.2 Rheumatoid Arthritis

5.1.4 Monoclonal Antibodies in Organ Transplants

5.1.5 Monoclonal Antibodies in Cardiovascular Disorders

5.1.5.1 Ablynx

5.1.5.2 ThromboGenics/BioInvent International

5.1.5.3 Pexelizumab: A Recombinant Humanized Single Chain Monoclonal Antibody

5.1.6 Monoclonal Antibodies in Infectious Diseases

5.1.7 Monoclonal Antibodies in Miscellaneous Indications

5.1.7.1 Alzheimer’s Disease

5.1.7.2 Parkinson’s Antibody Therapy

5.2 U.S. Therapeutic Monoclonal Antibodies Market

5.2.1 Market Dimensions

6. Short-term Market Predictions

6.1 Total Revenue Forecasts

6.2 Segment Revenue Forecast

6.2.1 Oncology, Arthritis, Immune and Inflammatory Disorders (AIID)

6.3 Competitive Analysis Forecast

6.3.1 Competition between Similar Products

6.3.2 Competitive Factors

6.4 Conclusions

6.4.1 A Rocky Road

6.4.2 The Only Solution to High Medical Costs is Research

7. Antibody Technology Companies: Profiles

7.1 Abbott Laboratories

7.2 Abgenix

7.3 Ablynx

7.4 Aeres

7.5 Affimed Therapeutics AG

7.6 Affitech AS

7.7 Agensys

7.8 Alexion Pharmaceuticals

7.9 Amgen

7.10 Antisoma

7.11 ApoLife, Inc.

7.12 Applied Molecular Evolution, Inc.

7.13 Arana Therapeutics

7.14 Astellas Pharma

7.15 AstraZeneca plc

7.16 Biogen Idec, Inc.

7.17 BioInvent International AB

7.18 Biosite Discovery

7.19 Biovation Ltd.

7.20 BioWa

7.21 Boehringer Ingelheim

7.22 Cambridge Antibody Technology Group

7.23 Celltech

7.24 Corixa

7.25 Crucell NV

7.26 Cytogen

7.27 Dyax

7.28 Eisai Co., Ltd.

7.29 Elan Corporation

7.30 Eli Lilly

7.31 Elusys Therapeutics

7.32 Enzon Pharmaceuticals

7.33 Genentech

7.34 Genmab A/S

7.35 Genovac GmbH

7.36 Genzyme Corporation

7.37 GlaxoSmithKline plc

7.38 GlycArt

7.39 ILEX Oncology

7.40 ImClone Systems

7.41 ImmunoGen

7.42 Immunomedics

7.43 InNexus Biotechnology, Inc.

7.44 Johnson & Johnson

7.45 Lexigen

7.46 Medarex

7.47 MedImmune

7.48 Merus BV

7.49 Micromet

7.50 Millegen

7.51 Millennium Pharmaceuticals

7.52 MorphoSys AG

7.53 Novartis

7.54 Peregrine Pharmaceuticals, Inc.

7.55 PDL BioPharma

7.56 Philogen

7.57 Philotec

7.58 Phylos

7.59 Roche

7.60 Sanofi-Aventis

7.61 Scil Proteins

7.62 Seattle Genetics

7.63 Symphogen A/S

7.64 Tanox

7.65 ThromboGenics NV

7.66 Trion Pharma

7.67 Viventia Biotech, Inc.

7.68 Wyeth

7.69 Xcellerex

7.70 Xencor, Inc.

7.71 Xoma Ltd.

References

INDEX OF FIGURES

Figure 2.1: Worldwide Pharmaceutical Sales and R&D Expenditures, 2000-2013

Figure 2.2: International Per Capita Healthcare Spending by Country

Figure 2.3: Total Spending on Healthcare in the U.S., 1960-2007

Figure 2.4: Percentage Breakdown of U.S. Healthcare Spending, 2008

Figure 3.1: Basic Structure of the Antibody Molecule

Figure 5.1: Global Market for Protein Therapeutics, 2007-2013

Figure 6.1: Sales of the Five Leading Antibodies, 2008

INDEX OF TABLES

Table 2.1: Number of New Drug Applications to the FDA, 2000-2008

Table 2.2: New Drug Approvals from FDA, 2000-2008

Table 2.3: Percentage of GDP Healthcare Spending by Country, 2008

Table 2.4: Life Expectancy Rate by Country, 2008

Table 2.5: Development Time for Major Drugs for Top U.S. Pharmaceutical Companies

Table 2.6: Number of FDA “Black-box” Warnings, 2003-2007

Table 2.7: Collaboration and Mergers

Table 2.8: Worldwide Spending of Specialty Pharmaceuticals, 2003-2010

Table 2.9: New Drug Development from Existing Drugs

Table 3.1: Timeline of Immunological Discoveries

Table 3.2: Antibody Screening and Selection Technologies

Table 3.3: FDA-Approved Rapid HIV Antibody Screening Tests

Table 4.1: Currently Approved Therapeutic Antibodies

Table 5.1: Therapeutic Antibodies in the Development Pipeline

Table 5.2: Currently Approved Anti-Cancer Antibodies

Table 5.3: Status of Clinical Studies Involving Avastin

Table 5.4: Market for Avastin Therapeutic Antibodies, 2006-2012

Table 5.5: Rise in Herceptin Sales, 1998-2008

Table 5.6: Monoclonal Antibodies in Clinical Trials for Cardiovascular Diseases

Table 6.1: Projected World Market for Therapeutic Monoclonal Antibodies, 2008-2012

Table 6.2: Market Record and Outlook for Oncological Therapeutic Antibodies, 2006-2012

Table 6.3: Recorded and Anticipated Sales Growth for Anti-inflammatory Monoclonal Antibodies, 2006-2012

Table 7.1: Genentech’s Operating Revenue, 2004-2008

Table 7.2: Genentech’s Product Sales, 2006-2008

Table 7.3: Genentech’s Product Licensee Products

Table 7.4: Genentech’s Products in Development

Abstract

Antibodies are proteins in the immune system that help the body defend against foreign invasion, particularly from pathogens and toxins. As such, a human-engineered therapeutic monoclonal antibody (mAb) is protein derived from the immune system through recombinant DNA technology that has the ability to combine specifically with a target protein that plays a role in a disease process. With this unique ability to specifically target diseased cells while leaving healthy cells unaffected, monoclonal antibodies can serve to diagnose and treat a wide range of medical conditions. Areas such as breast cancer therapy have benefited greatly since the advent of drugs like Herceptin (trastuzumab) that interferes with the HER2/neu receptor. Indeed, the field of therapeutic monoclonal antibodies potentially has far-reaching and paradigm-shifting implications for biology, drug discovery, and medical treatment of disease. The discipline has already yielded discoveries that have been used for drug delivery and diagnostic purposes, and other exciting new therapeutic applications. This TriMark Publications report reviews the market for medical products based on emerging therapeutic monoclonal antibodies. It defines the dollar volume of sales in the U.S. and worldwide, and it analyzes the factors that influence the size and the growth of the market segments. The study goes on to discuss in detail the trends that have developed which have stimulated this market and surveys many of the companies marketing, manufacturing or developing monoclonal antibodies therapies. Monoclonal antibodies for non-therapeutic purposes--used primarily in life science and research applications--are not discussed in this review. Moreover, antibody process technology is not covered. Special effort was made to include mention of smaller companies that are or potentially could have an impact on their industry far in excess of their current size. Each company is discussed in depth with a section on the history of the company, the product line, business and marketing analysis, and a subjective commentary of the position of the company in its market.

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