U.S. and Worldwide Monoclonal Antibody Medicine: Current Status and Future Trends

U.S. and Worldwide Monoclonal Antibody Medicine: Current Status and Future Trends

Antibody drugs were a $24 billion business in 2007. Although most pharmaceuticals are chemically synthesized small molecules, antibodies are large and complex proteins (immunoglobulins) that act as the human body’s own weapons against infections, diseases and abnormal cancer cells. Monoclonal antibodies (MAbs) mimic the body’s immune system with the antibody working as the drug molecule; only MAbs are engineered artificially outside the body, in the laboratory, rather than by a person’s own immune system. Furthermore, MAbs are engineered to binding to one particular antigen only. MAbs are thus important tools for medicine as extremely targeted therapies for treating patients with severe diseases - especially autoimmune conditions and cancers.

This report analyzes the activities of the leading biopharmaceutical companies with antibody-based drug products currently on the market or scheduled for introduction soon. The focus is MAb therapeutics used for treating a disease or condition (as opposed to MAbs used as a diagnostic or for research). The report details the status of drug makers' antibody pipelines; their alliances, M&As and investments to develop and commercialize new MAb drugs; and their standing in the battle for market share and bringing a new best-selling drug to patients. Technological progression in the development of antibody and protein-based human therapies is overviewed. This report is part of Fuji-Keizai’s ongoing efforts to track the U.S. and global biopharmaceuticals marketplace.  
 

Research Objectives

Research Method and Sources

Key Characteristics of Monoclonal Antibodies

1. Market Overview

Timeline of FDA approval of therapeutic MAbs (drugs now on the U.S. market)

MAbs in Clinical Trial (as of March 2008)

Market Players

Key Players & Business Model

Large Pharmas

Biotechnology Companies

Technology/Platform Companies

VC-funded Start-ups

Contract Biopharma Manufacturers

2. Product Trends

2.1 Current Products

Company Name/Product Name/Introduction/Target Body/2007 Sales Amount ($M)

2.2 Company Pipelines

Company Name/Project Name/Current Stage/Target Body /Important Items

3. Technology Trends Overview: Current to Future

3.1 Antibody and Immune System Overview

3.1.1 Antibody Structure

Immunoglobulin classes

3.1.2 Antibody Targets

Important targets for anti-cancer MAbs

Target/Drug or Drug Candidate/Status

3.1.3 Mechanisms of Action

Variety of MAbs: different technologies, structures, targets, action mechanisms

Brand Name/Technology/Structure/Target/Mechanism of Action

3.2 Antibody Generation: Current and Emerging Technologies

Evolution of MAb technology

3.2.1 Hybridoma Technology

Platform players:

3.2.2 Genetically Engineered and Humanized MAbs

Transgenic Animal Technologies

Platform players:

Library Technologies (phage display)

Platform players:

Optimization and Protein Engineering

Platform players:

3.2.3 Human MAb Platforms

MabIgX

HuCAL

3.2.4 Alternatives to plain MAbs

Antibody Conjugates

Platform players:

Antibody Fragments and Hybrids

Platform players:

Bifunctional MAbs

Platform players:

Recombinant polyclonal technology

Platform players:

3.2.5 Manufacturing

Players:

4. Market Analysis

4.1 Monoclonal Antibody Market Forecast (Total) 2006-2012

Key Findings

Late-stage MAb drugs: anticipated timeline for approval: 2009-2011

Growth Drivers

Market Impediments/Challenges

4.2 Breakdown by Company

Key Findings

4.3 Breakdown by Therapy Segment

MAb product revenues, by therapy areas: 2006-2012

Monoclonal antibody share of total immunology drug market (by revenues): 2008 -2012

Therapy Market Growth Drivers: Immunology and Cancer

Monoclonal antibody share of total cancer drug market (by revenues): 2012

Therapy areas, by market share ( %): 2007 revenues of all MAbs

4.4 Breakdown by Therapies in the Pipeline (2012 Market Potential)

Percentage of MAb drugs in pipeline, by therapy area (post-2008 potential)

MAb drug candidates in development, by specific disease indication

Growth Driver: Alzheimer's MAb pipeline

Findings

Infectious disease MAb pipeline

Maker/Drug Name/Stage/Therapy Market Comment

Osteoporosis MAb pipeline

Maker/Drug/Stage/Therapy Market/Comment

Finding

4.5 Breakdown by Products

Top 5 monoclonal antibody drugs, by sales

DrugMaker /Product Revenues ($ Million): 2006-2012

Market share (%) of top 5 MAb drugs, 2007

Growth Drivers of the Top 5

Multiple Indications as Growth Driver for Best-selling MAbs

Revenue for dual-purpose cancer drug Avastin: 2008-2012

Premium Pricing as Growth Driver and Inhibitor

Drug/Unit Price/Monthly or Yearly Cost

Finding

MAb oncology products, by sales

Drug Maker/Product Revenues ($Million): 2006-2012

Growth Drivers for Cancer MAb Products

Immunology MAb products, by sales

Drug Maker/Product Revenues ($Million): 2006-2012

Growth Drivers for Autoimmune Disease MAb Products

Other MAb commercialized products, by sales

Drug Maker /Product Revenues ($ Million): 2006-2012

Growth Drivers and Impediments in Other Disease Markets

4.6 Breakdown by Technology

5. M&A, Alliance Map

5.1 MAb and related biologics M&A activity: 2005-2008 (YTD)

Year/Buyer/Company Acquired /Asset Acquired/$ Value

Key Findings

Top 12 Pharmaceuticals (by 2007 sales) and MAb acquisitions or alliances

6. Major Company Analysis

6.1 Abbott Laboratories

Profile of Monoclonal Antibody Business

Currently marketed MAb drugs

Drug Name/Target Therapy Area/Comment

Market Superiority

M&A Strategy

Company Pipeline Analysis

Technology pipeline analysis

Therapy area pipeline analysis

MAb and protein-based drugs in development

Target pipeline analysis

6.2 Amgen, Inc.

Same as above-mentioned research items

6.3 Biogen Idec, Inc.

Same as above-mentioned research items

6.4 Genentec/Roche

Same as above-mentioned research items

6.5 Johnson & Johnson/Centocor

Same as above-mentioned research items

6.6 Medimmune/Astrazeneca

Same as above-mentioned research items

6.7 Novartis Pharmaceuticals

Same as above-mentioned research items

6.8 UCB Biopharma

Same as above-mentioned research items

7. Venture Company Activity (Total 20 companies)

Common Research Item:

Location/URL

Profile

Development

8. Key Findings

Big Picture

Pipeline

Technology and Production