Therapeutic Monoclonal Antibodies Report 2008-2023

Therapeutic Monoclonal Antibodies Report 2008-2023

This brand new report investigates the global market for therapeutic monoclonal antibodies. While the pharmaceutical industry as a whole is suffering from single digit growth, thinner pipelines than before and pressure from an ever-aggressive generics industry, the segment of monoclonal antibodies therapeutics is thriving and growing at a double-digit rate. Therapeutic Monoclonal Antibodies 2008-2023 shows how monoclonal antibodies are a leading product of biotechnology, being increasingly used in therapy. Currently, monoclonal antibodies are playing an important role in the treatment of cancer, autoimmune and inflammatory disorders. Therapeutic monoclonal antibodies boast one of the most active and promising pipelines in the pharmaceutical industry.

Ten years ago, there were only two monoclonal antibody drugs on the world market, now there are 21 FDA approved therapies - including eight blockbuster drugs. In 2007, the market was worth $21.9bn, but what will it be in 5 years time? This report will tell you and tell you today. Visiongain believes that some of the greatest opportunities ever available for biopharmaceutical companies are now there to be seized, with important sales, licensing agreements and collaborative partnerships from the present onwards in monoclonal antibodies and other biologicals.

Our new Therapeutic Monoclonal Antibodies 2008-2023 report examines the market for monoclonal antibodies critically, through comprehensive primary and secondary research. In addition to consultation with experts in industry - including full interview transcripts - this research involved a detailed study of relevant documents, industrial reports and current developments. Visiongain discusses the monoclonal antibody market in the context of the biotechnological platforms and therapeutic areas.  Importantly, visiongain applied techniques such as financial forecasting and analysis of drivers and restraints. The result is a comprehensive market-based report with detailed analyses and informed opinion.

In particular, Therapeutic Monoclonal Antibodies 2008-2023 concentrates on the following essential aspects of the monoclonal antibodies sector:

•  Technologies that drive the MAb sector
  
  
•  Therapy areas that drive the MAb sector
  
  
•  Sales forecasts of the global therapeutic MAb market from 2008-2023 - including those of principal market segments, both by disease area and technology
  
  
•  Sales forecasts for leading products worldwide in this sector
  
  
•  Sales forecasts for therapeutic MAb sales in leading national markets, including China and India
  
  
•  Key industrial players in the therapeutic monoclonal antibody sector - both established and emerging - including partnerships
  
  
•  Drivers and opportunities in the MAb sector
  
  
•  Restraints and threats in the MAb sector
  
  
•  Assessments of relevant business models, technological solutions and associated issues
  
  
•  Coverage of future trends in MAbs, especially pipeline developments
  
  
•  Insight from interviews with relevant experts

• To receive a comprehensive analysis of the prospects for the therapeutic monoclonal antibodies industry from 2008-2023, including sales forecasts, major growth areas and pipeline products
  
  
•  To discover predicted revenues, growth rates and other key metrics in the therapeutic monoclonal antibodies market from 2008-2023, especially for leading brands

•  Drivers and restraints on market
  
  
•  Competition
  
  
•  Strengths, weaknesses, opportunities and threats.
  
  
•  To find out where the therapeutic monoclonal antibodies market is heading from 2008 onwards - both technologically and commercially

1 Executive Summary

1.1 Aims of This Report

1.2 A Brief Overview of the Chapters

2 Introduction

2.1 What is a Monoclonal Antibody?

2.1.1 Structure of Antibodies

2.1.2 Function of Antibodies

2.2 History of Therapeutic Monoclonal Antibody Development

2.2.1 Different Types of Therapeutic Antibody

2.2.2 Timeline for Monoclonal Antibodies in Therapy

2.3 There are 21 FDA Approved Therapeutic Monoclonals

2.4 Monoclonal Antibodies are a Thriving Part of the Biotech Market

2.4.1 MAbs Lead the Market

2.5 The Monoclonal Antibody Market is Taking Off

3 World Market for Therapeutic Monoclonal Antibodies

3.1 Summary of Key Findings

3.2 Therapeutic Monoclonal Antibodies Generated Over $21bn in 2007

3.3 World Therapeutic Monoclonal Antibodies Market Forecast 2008-2023

3.4 Market Analysis of the Leading Products - the 'Big 5'

3.4.1 Remicade is Leading the Pack, but Will it Last?

3.5 Market Forecast by Therapeutic Analysis

3.5.1 Oncology Drugs Dominate in the Monoclonal Antibody Market

3.5.1.1 Over Half of Monoclonal Antibody Revenues are from Oncology Products

3.5.1.2 Cancer Drugs will Drive the Market

3.5.2 AIID is Second in Line

3.5.2.1 AIID Narrows the Gap

3.5.3 Other Therapeutic Areas are also Growing Quickly

3.5.3.1 Other Therapeutic Areas Represent 10% of the Market

3.6 Market Forecast by Technology Analysis

3.6.1 Chimeric Antibodies Retiring from the Spotlight

3.6.2 Humanised Antibodies Moving to Centre Stage

3.6.3 Fully Human Antibodies Set to Become the Next Star

3.6.4 A Change of Guard in Technology Forerunners

4 Forces Affecting the Therapeutic Monoclonal Antibodies Market

4.1 SWOT Analysis of the Therapeutic Monoclonal  Antibodies Market

4.2 Monoclonal Drugs Constitute a Thriving Market

4.2.1 Monoclonal Technology Allows a Wide Range of Targets

4.2.2 Cancer Drugs Lead the Monoclonal Market

4.2.3 Chronic and Niche Diseases Generate High Revenues

4.2.4 There is a Lower Risk of Adverse Events for Monoclonals

4.2.5 Monoclonal Antibodies Avoid Biogeneric Competition

4.2.6 Rising Expenditures of Prescription Drugs Stimulate Market Growth

4.3 Pipeline Developments in Monoclonal Antibody Therapies are Very Promising

4.3.1 New Production Methods Will Reduce Costs

4.3.2 Flexible Formats to Fill Unmet Needs in Oncology

4.3.3 Innovative Combination Uses of Existing Products

4.4 Weaknesses and Threats Will Hold Back the Monoclonal Market to Some Degree

4.4.1 Big and Expensive: Developmental Costs Limit Growth

4.4.2 Injections are the Main Mode of Administration

4.4.3 The Challenge of Immunogenicity Looms Large

4.4.4 High Profile Safety Cases Increase Regulatory Concerns

4.4.5 Competition is Fierce for Many Prime Targets

5 Leading Marketed and Pipeline Products for Therapeutic Monoclonal Antibodies

5.1 The 'Big 5' Will Continue to Dominate the Market

5.1.1 Remicade (Johnson and Johnson)

5.1.1.1 Doubts Linger Around Remicade

5.1.2 Rituxan/MabThera (Roche/Genentech)

5.1.2.1 Rituxan Grows to $6.4bn by 2013

5.1.3 Herceptin (Roche/Genentech)

5.1.3.1 Herceptin Faces Tough Competition

5.1.4 Avastin (Roche/Genentech)

5.1.4.1 Avastin to Drive the Growth and Innovation of Therapeutic Antibodies

5.1.5 Humira (Abbott)

5.1.5.1 Humira Has Immense Opportunities

5.2 Market Analysis of the Emerging Products - The Three Other Blockbusters

5.2.1 Erbitux (Merck/ImClone)

5.2.1.1 Erbitux Does Not Have Enough to Overtake Avastin

5.2.2 Lucentis (Roche/Genentech)

5.2.2.1 Growth Flattens for Lucentis

5.2.3 Synagis (AstraZeneca)

5.2.3.1 Pessimism Surrounds Synagis

5.3 Top Seven Products to Watch

5.3.1 Cimzia (UCB)

5.3.2 Golimumab (Johnson and Johnson)

5.3.3 Denosumab (Amgen)

5.3.4 Numax (AstraZeneca/MedImmune/Applied Molecular Evolution)

5.3.5 Bapineuzumab (Elan/Wyeth)

5.3.6 ABT-874 (Abbott)

5.3.7 Ustekinumab (Johnson and Johnson)

6 Therapeutic Monoclonal Antibodies Market Dynamics

6.1 Therapeutic Monoclonal Antibodies Market Finds Success Outside of the Traditional Blockbuster Model

6.2 Therapeutic Monoclonal Antibodies - a High-Value Market with a High Barrier of Entry

6.3 Big Pharma is Moving into the Market

6.4 Strategic Alliances Help to Accelerate Market Growth

6.5 Roche and Genentech's Partnership Follows a Winning Business Blueprint

6.6 A Market Monopolised by Three Giants

6.6.1 Roche/Genentech Has Absolute Control in the Market

6.6.1.1 Marketed Monoclonal Antibody Therapies

6.6.1.2 Pipeline Analysis

6.6.1.3 Strategic Analysis

6.6.2 Johnson and Johnson Looking to Secure Leadership in Autoimmune Antibodies

6.6.2.1 Marketed Monoclonal Antibody Therapies

6.6.2.2 Pipeline Analysis

6.6.2.3 Strategic Analysis

6.6.3 Abbott Ties its Future to Humira

6.6.3.1 Marketed Monoclonal Antibody Therapies

6.6.3.2 Pipeline Analysis

6.6.3.3 Strategic Analysis

6.7 Emerging Player to Watch

6.7.1 Amgen Bets on Bone Diseases

6.7.1.1 Marketed Monoclonal Antibodies Therapies

6.7.1.2 Pipeline Analysis

6.7.1.3 Strategic Analysis

7 Therapeutic Monoclonal Antibodies in the Leading Pharmaceutical Markets

7.1 Sales of Therapeutic Monoclonal Antibodies in the US

7.1.1 Increasing Prevalence of Cancer Will Drive Sales in the US Market

7.1.2 High Economic Cost of Cancer and Autoimmune Diseases Will Drive Sales of Monoclonal Antibodies

7.2 The European Market for Monoclonal Antibodies Will Increase Moderately

7.3 Developing Countries are Thriving

7.4 China and India Rise Up

8 Interviews with Industry Experts: Therapeutic Monoclonal Antibodies - Current and Future Trends

8.1 Interview 1: Professor Joe Cummins, Professor Emeritus of Genetics, University of Western Ontario, Canada.

8.1.1 Safety Concerns for Therapeutic Monoclonal Antibodies

8.1.2 Excitement Surrounding Therapeutic Monoclonal Antibodies

8.1.3 Prospects of Fully Human Antibodies

8.1.4 Prospects of the Therapeutic Monoclonal Antibodies Market

8.2 Interview 2: Dr Martin Wiles, Vice President of Business Development, BioInvent, Sweden

8.2.1 Greatest Obstacles to Market Growth

8.2.2 Prospects of Fully Human Antibodies

8.2.3 Prospects of Therapeutic Monoclonal Antibodies Market

8.2.4 Most Promising Products

8.2.5 Long-Term Collaborative Partnership between BioInvent and ThromboGenics

9 Future Trends for Therapeutic Monoclonal Antibodies

9.1 Are Magic Bullets Back in Vogue?

9.1.1 Immunogen's TAP System Attracts Attention

9.1.2 Seattle Genetics ADC Technology Shows Promise

9.2 Nanobodies, BiTEs and TandAbs - New Takes on the Monoclonal

9.2.1 BiTEs Can Thwart CD8 Negative Tumours

9.2.2 TandAbs Specialise in Tumour Killing

9.2.3 NanoBodies - Heavy Chain Only Technology

9.3 Diagnostic Tests Will Be Integral to Future Success

9.3.1 Lack of Low Hanging Fruit Will Force Integration

10 Conclusion: the Monoclonal Antibodies Market is Growing Strongly and Will Become a Leading Therapeutic Technology

10.1 The Monoclonal Antibodies Market is One of the Strongest Areas in the Pharmaceutical Industry

10.2 Oncology is the Key Driver to Market Growth

10.3 Humanised Monoclonal Antibodies Will Dominate the Market in the Short-Term, but Fully Human Antibodies are the Focal Point of Research Interest

10.4 Monoclonal Antibody Therapies Will Reach More Countries

10.5 The Market Will Be Restrained by Competition and Price Restrictions

10.6 Monoclonal Antibodies Will Become the Mainstream Therapeutic Technology in the Industry

10.7 Outlook for the Future

List of Tables

Table 2.1 FDA-Approved Therapeutic Monoclonal Antibodies, 2008

Table 2.2 Leading Biotech Drugs Based on Monoclonal Antibodies, 2007

Table 3.1 Leading Therapeutic Monoclonal Antibodies, Sales ($m) and Market Share (%), 2007

Table 3.2 Global Sales ($bn) by Therapeutic Area, 2007

Table 3.3 Statistics of Key Oncology Indications and Their Monoclonal Antibody Therapies, 2007

Table 3.4 Prevalence of Key AIID Indications and Their Monoclonal Antibody Therapies, 2007

Table 4.1 SWOT Analysis of the Monoclonal Antibody Market, 2008

Table 4.2 Targets and Indications for Selected Approved Antibodies

Table 4.3 Modes of Administration for Leading Monoclonal Antibody Drugs

Table 5.1 Global Market for the Emerging Three, Sales ($bn) and Market Share (%), 2007-2013

Table 6.1 Key Mergers and Acquisitions of the Monoclonal Antibody Market

Table 6.2 Near-Term Opportunities in the Roche Group's Pipeline, 2008

Table 6.3 Near-Term Opportunities in Johnson and Johnson's Pipeline, 2008

Table 6.4 Near-Term Opportunities in Abbott's Pipeline, 2008

Table 6.5 Near-Term Opportunities in Amgen's Pipeline, 2008

Table 7.1 Leading Regions of the Therapeutic Monoclonal Antibodies Market, Sales ($m) and Market Share (%), 2007 and 2013

Table 9.1 Examples of Conjugated Monoclonal Drugs in the Pipeline, 2008

Table 9.2 Immunogen's Product Pipeline, 2008

Table 9.3 Other Monoclonal-based Drugs in Development Using the TAP System, 2008

Table 9.4 Seattle Genetics Pipeline, 2008

Table 10.1 Global Monoclonal Antibodies, Sales ($bn) and  Growth (%), 2007-2013

Table 10.2 Global Monoclonal Antibodies Market, Key Therapy Areas, Sales ($bn) and CAGR (%), 2007-2013

Table 10.3 Leading Geographical Markets for Monoclonal  Antibodies, 2007, 2013, 2018, and 2023

List of Figures

Figure 2.1 Structure of an Antibody

Figure 3.1 Leading Therapeutic Monoclonal Antibodies, Sales ($m), 2007

Figure 3.2 Leading Therapeutic Monoclonal Antibodies, Market Share (%), 2007

Figure 3.3 Leading Monoclonal Therapeutic Antibodies, Sales Growth (%), 2007

Figure 3.4 World Therapeutic Monoclonal Antibodies, Sales ($bn), 2007-2013

Figure 3.5 Global Therapeutic Monoclonal Antibodies, Sales Growth (%), 2008-2013

Figure 3.6 Leading Therapeutic Monoclonal Antibodies, Market Share (%), 2007 and 2013

Figure 3.7 Leading Monoclonal Antibody Therapies, Sales ($m), 2007-2013

Figure 3.8 Global Monoclonal Antibodies Market by Therapeutic Area, Sales ($bn), 2007

Figure 3.9 Global Monoclonal Antibodies Market by Therapeutic Area, Market Share (%), 2007

Figure 3.10 Global Monoclonal Antibodies Market by Therapeutic Area, Sales ($bn), 2007-2013

Figure 3.11 Leading Monoclonal Antibody Therapies for Oncology, Sales ($m), 2007

Figure 3.12 The Oncology Sector of Monoclonal Antibodies Market, Sales ($bn), 2007-2023

Figure 3.13 Leading Monoclonal Antibody Therapies for AIID, Sales ($m), 2007

Figure 3.14 The AIID Sector of Monoclonal Antibodies Market, Sales ($bn), 2007-2023

Figure 3.15 Other Leading Monoclonal Antibody Therapies, Sales ($m), 2007

Figure 3.16 Other Therapeutic Areas of Monoclonal Antibodies Market, Sales ($bn), 2007-2023

Figure 3.17 Global Monoclonal Antibodies Market by Technology, Sales ($bn), 2007

Figure 3.18 Global Monoclonal Antibodies Market by Technology, Market Share (%), 2007

Figure 3.19 Global Chimeric Monoclonal Antibodies Market, Market Share (%), 2007

Figure 3.20 Global Chimeric Monoclonal Antibodies Market, Sales ($bn), 2007-2023

Figure 3.21 Global Humanised Monoclonal Antibodies, Market Share (%), 2007

Figure 3.22 Global Humanised Monoclonal Antibodies, Sales ($bn), 2007-2023

Figure 3.23 Global Fully Human Monoclonal Antibodies Market, Market Share (%), 2007

Figure 3.24 Global Fully Human Monoclonal Antibodies Market, Sales ($bn), 2007-2023

Figure 3.25 Global Therapeutic Monoclonal Antibodies by Technology, Sales ($bn), 2007-2023

Figure 5.1 Sales of Global Monoclonal Antibodies and the Big Five ($bn), 2007-2013

Figure 5.2 Global Market Forecast for Remicade, Sales ($m), 2007-2023

Figure 5.3 Global Market Forecast for Rituxan/MabThera, Sales ($m), 2007-2023

Figure 5.4 Global Market Forecast for Herceptin, Sales ($m), 2007-2023

Figure 5.5 Global Market Forecast for Avastin, Sales ($m),  2007-2023

Figure 5.6 Global Market Forecast for Humira, Sales ($m),  2007-2023

Figure 5.7 Global Market Forecast for Erbitux, Sales ($m),  2007-2023

Figure 5.8 Global Market Forecast for Lucentis, Sales ($m), 2007-2023

Figure 5.9 Global Market Forecast for Synagis, Sales ($m), 2007-2023

Figure 6.1 Leading Companies, Total Market Share  in the World Monoclonal Antibodies Market (%), 2007

Figure 6.2 Leading Companies, Total Sales ($bn) in the World Monoclonal Antibodies Market, 2007

Figure 6.3 Roche/Genentech's Therapeutic Monoclonal Antibodies, Market Share (%) and Sales ($m), 2007

Figure 6.4 Johnson and Johnson's Marketed Portfolio, Market Share (%) and Sales ($bn), 2007

Figure 7.1 Leading Pharmaceutical Markets, Market Share (%), 2007, 2013, 2018 and 2023

Figure 7.2 Leading Pharmaceutical Markets, Sales ($m), 2007, 2013, 2018 and 2023

Figure 7.3 Leading Pharmaceutical Markets, Growth Rates (CAGR %), 2007-2013

Figure 9.1 Antibody Formats

Figure 10.1 Global Therapeutic Monoclonal Antibodies by Technology, Sales ($bn), 2007-2023