Commercial Insight: Autoimmune Overview

Market Continues to Prosper

Publication Date	December 2007
Publisher	Datamonitor
Product Type	Report
Pages	285
ISBN Number	not applicable
Product Code	DAT09487

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Summary

Introduction

The autoimmune disease market will be rapidly growing due to a high number of competitive brands currently on the market and a full pipeline. Company strategies include expanding the treatment algorithm by pursuing approval for 'early' disease stages, launching easy-to-use devices to make up for downsides of injectable drugs, and developing fully human monoclonal antibodies as follow-on products.

Scope

Indication based forecasts for the top autoimmune brands and significant pipeline drugs
Assessment of indication-specific drivers and resistors likely to impact the market
Future market outlook for individual products taking into account key market events, and competitor launch dates
Market overview by indication, mechanism of action and geographical area with value analysis of clinical and commercial factors underlying performance

Highlights

In 2006, the TNF-inhibitors were by far the highest selling mechanism of action in the autoimmune market, across all seven major markets. This group of products was very popular in the US especially, with sales of $6.5 billion accounting for 66% of the market.

In the US, rheumatoid arthritis and multiple sclerosis both had a large share of the sales, 44% ($4.4 billion) and 32% (almost $3.2 billion), respectively. Psoriasis/psoriatic arthritis sales and Crohn's disease sales were lower compared to the top two indications, with sales of $1.2 billion (12%) and $722m (7%), respectively.

Remicade was the second highest-selling drug in the seven major markets of the brands evaluated in this report with sales of $3,130m in 2006. Datamonitor expects this to decrease over the next 10 years mainly due to the launch of follow-on humanized TNF-inhibitor golimumab, which is forecast to take the majority of its share from Remicade.

Reasons to Purchase

Identify key opportunities and threats that will impact the use and uptake of new and existing products
Quantify the future size and scope of the autoimmune market and predict the future performance of key compounds
Understand and capitalize on clinical unmet needs in the market, either through lifecycle management of marketed drugs or new product development

Content

About Datamonitor Healthcare
- About The Immune Disorders And Inflammation (Idi) Pharmaceutical Analysis Team
Chapter 1 Executive Summary
- Scope of The Analysis
- Datamonitor Insight Into The Autoimmune Market
- Contributing Experts
- Related Reports
Chapter 2 Background And Epidemiology
- Overview of Autoimmune Diseases
- The Commonality of Autoimmune Diseases
- Rheumatoid Arthritis Market Potential
- Definition of Rheumatoid Arthritis
- Epidemiology of Rheumatoid Arthritis
- Segmentation of Rheumatoid Arthritis
- Ankylosing Spondylitis Market Potential
- Definition of Ankylosing Spondylitis
- Epidemiology of Ankylosing Spondylitis
- Segmentation of Ankylosing Spondylitis
- Psoriasis Market Potential
- Definition of Psoriasis
- Epidemiology of Psoriasis
- Segmentation of Psoriasis
- Psoriatic Arthritis Market Potential
- Definition of Psoriatic Arthritis
- Epidemiology of Psoriatic Arthritis
- Multiple Sclerosis Market Potential
- Definition of Multiple Sclerosis
- Epidemiology of Multiple Sclerosis
- Segmentation of Multiple Sclerosis
- Crohn's Disease And Ulcerative Colitis Market Potential
- Definition of Crohn's Disease And Ulcerative Colitis
- Epidemiology of Crohn's Disease And Ulcerative Colitis
- Systemic Lupus Erythematosus (Sle) Market Potential
- Definition of Systemic Lupus Erythematosus
- Epidemiology of Systemic Lupus Erythematosus
- Segmentation of Systemic Lupus Erythematosus
Chapter 3 Market Overview
- Market Definition For This Report
- Tnf-Inhibitors
- B And T Cell Inhibitors
- Interleukins
- Immunosuppressants
- Beta-Interferons
- Other
- The Autoimmune Market By Mechanism of Action
- Tnf-Inhibitors
- Beta-Interferons
- Other
- T-Cell Inhibitors
- Interleukin Inhibitors
- B-Cell Inhibitors
- The Autoimmune Market By Indication
- Rheumatoid Arthritis
- Psoriasis/Psoriatic Arthritis
- Multiple Sclerosis
- Crohn's Disease
- The Autoimmune Market By Country
- Seven Major Markets
- Five Major European Markets
- Us
- Japan
Chapter 4 Product Profiles And Forecast Analysis
- Tnf-Inhibitors
- Enbrel (Etanercept)
- Strategic Analysis
- Indications
- Forecast
- Remicade (Infliximab)
- Strategic Analysis
- Indications
- Forecast
- Humira (Adalimumab)
- Strategic Analysis
- Indications
- Forecast
- Cimzia (Certolizumab)
- Strategic Analysis
- Indications
- Forecast
- Golimumab (Cnto-148)
- Indications
- Forecast
- B-Cell Inhibitors
- Rituxan/Mabthera (Rituximab)
- Strategic Analysis
- Indications
- Forecast
- Ocrelizumab
- Indications
- Forecast
- ofatumumab
- Indications
- Forecast
- Beta Interferons
- Avonex (Interferon Beta-1a)
- Strategic Analysis
- Indications
- Forecast
- Rebif (Interferon Beta-1a)
- Strategic Analysis
- Indications
- Forecast
- Betaseron/Betaferon (Interferon Beta-1b)
- Strategic Analysis
- Indications
- Forecast
- T-Cell Inhibitors
- Orencia (Abatacept)
- Strategic Analysis
- Indications
- Forecast
- Other T-Cell Inhibitors
- Raptiva (Efalizumab)
- Amevive (Alefacept)
- Interleukin Inhibitors
- Actemra (Tocilizumab)
- Indications
- Forecast
- Ustekinumab (Cnto-1275)
- Indications
- Forecast
- Other Interleukin Inhibitors
- Kineret (Anakinra)
- Abt-874
- Zenapax (Daclizumab)
- Other Mechanisms of Action
- Copaxone (Glatiramer Acetate)
- Strategic Analysis
- Indications
- Forecast
- Tysabri (Natalizumab)
- Strategic Analysis
- Indications
- Forecast
- Bg-12
- Fingolimod
- Other
- Arava (Leflunomide)
- Teriflunomide (Hmr-1726)
- Cellcept (Mycophenolate Mofetil)
- Data Definitions, Limitations And Assumptions
- Standard Units
- Japanese Market Data
- Derivation of Sales Forecasts And Pricing Trends
- Indication Calculations
- Assumptions And Caveats For Diagnosis Value Estimates
- Forecasts
- Forecast Methodology
Chapter 5 Case Studies
- Biosimilars
- Europe Has Some Guidelines, But The Us Stays Behind
- Opposition From The Innovators
- Multiple Stakeholders Need To Be Targeted
- Physician And Patient View On Biosimilars Will Be Important
- Patent Expiries In Autoimmune Diseases
- Biosimilars In Multiple Sclerosis
- Biomarkers
- B Cell Biomarkers
- T Cell Biomarkers
- Cytokine And Antibody Biomarkers
- The Future of Biomarkers
- Indication Specific Clinical Trial Issues
- Established Products Have Strong Position
- Quality of Life Questionnaires
- Pasi May Not Be Best Endpoint For Psoriasis
- The Issue of Remission In Rheumatoid Arthritis
- The Revised Mcdonald Criteria Allows Trials To Include Early Ms Patients
- Standardized Ulcerative Colitis And Sle Endpoints Are Lacking
- Placebo-Controlled Ms Trials May Be Considered Unethical
- Clinical Trial Design In Sle Is A Notoriously Difficult Task
- Non-Responder Trials
Bibliography
- Conferences
- Datamonitor Reports
- Prescribing Information
- Press Releases
- Websites
Appendix A - Market Forecast Data
- Seven Major Markets
- Us
- Five Major European Markets
- Japan
Appendix B Brand Overviews
- Amevive
- Arava
- Avonex
- Betaseron/Betaferon
- Copaxone
- Enbrel
- Humira
- Kineret
- Orencia
- Raptiva
- Rebif
- Remicade
- Rituxan/Mabthera
- Tysabri
Appendix C
- Contributing Experts
- Report Methodology
- About Datamonitor
- About Datamonitor Healthcare
- Disclaimer
List of Tables
- Table 1: Overview of Studies Investigating Relationships Between Autoimmune Diseases
- Table 2: Prevalence of Several Autoimmune Diseases In The Seven Major Markets, 2007
- Table 3: Prevalence of Rheumatoid Arthritis In The Seven Major Markets, 2007
- Table 4: Rheumatoid Arthritis Disease Severity As A Percentage of Total Diagnosed Ra Population In The Seven Major Markets, 2006
- Table 5: Physician-Estimated Proportion of Patients Defined As Having Early Active Rheumatoid Arthritis In The Seven Major Markets, 2006
- Table 6: Prevalence of Ankylosing Spondylitis In The Seven Major Markets, 2007
- Table 7: Prevalence of Psoriasis In The Seven Major Markets, 2007
- Table 8: Overview of Different Forms of Psoriasis
- Table 9: Prevalence of Psoriatic Arthritis In The Seven Major Markets, 2007
- Table 10: Prevalence of Multiple Sclerosis In The Seven Major Markets, 2007
- Table 11: Multiple Sclerosis Disease Types As A Percentage of Total Diagnosed Ms Population In The Seven Major Markets, 2006
- Table 12: Prevalence of Crohn's Disease In The Seven Major Markets, 2007
- Table 13: Prevalence of Ulcerative Colitis In The Seven Major Markets, 2007
- Table 14: Prevalence of Systemic Lupus Erythematosus (Sle) In The Seven Major Markets, 2007
- Table 15: Overview of Leading Molecules Used In The Treatment of Autoimmune Diseases
- Table 16: Sales Per Mechanism of Action In Different Geographical Areas, 2006 ($Millions)
- Table 17: Sales Per Indication In Different Geographical Areas, 2006-2016 ($Millions)
- Table 18: Overview of The Indications of Approved Rheumatoid Arthritis Products
- Table 19: Overview of The Indications of Approved Psoriasis Products
- Table 20: Overview of The Indications of Approved Psoriatic Arthritis Products
- Table 21: Overview of The Indications of Approved Multiple Sclerosis Products
- Table 22: Overview of The Indications of Approved Multiple Sclerosis Products
- Table 23: Sales of Autoimmune Disease Market Per Geographical Area ($Millions)
- Table 24: Enbrel's Approved Indications And Date of First Approval In The Us, Europe And Japan For Each Major Indication
- Table 25: Overview of Clinical Trials of Enbrel In Rheumatoid Arthritis And Juvenile Rheumatoid Arthritis
- Table 26: Overview of Clinical Trials of Enbrel In Rheumatoid Arthritis In Japan
- Table 27: Overview of Clinical Trials of Enbrel In Psoriasis And Psoriatric Arthritis
- Table 28: Overview of Clinical Trials of Enbrel In Ankylosing Spondylitis (As)
- Table 29: Remicade's Approved Indications And Date of First Approval In The Us, Europe And Japan For Each Major Indication
- Table 30: Overview of Clinical Trials of Remicade In Crohn's Disease
- Table 31: Overview of Clinical Trials of Remicade In Rheumatoid Arthritis
- Table 32: Overview of Clinical Trials of Remicade In Psoriasis
- Table 33: Overview of Clinical Trials of Remicade In Ulcerative Colitis
- Table 34: Humira's Approved Indications And Date of First Approval In The Us, Europe And Japan For Each Major Indication
- Table 35: Overview of Clinical Trials of Humira In Rheumatoid Arthritis
- Table 36: Overview of Clinical Trials of Humira In Psoriasis
- Table 37: Overview of Clinical Trials of Humira In Crohn's Disease
- Table 38: Overview of Clinical Trials of Humira In Ulcerative Colitis
- Table 39: Overview of Cimzia's Development
- Table 40: Overview of Golimumab's Development
- Table 41: Rituxan/Mabthera's Approved Autoimmune Indications And Date of First Approval In The Us, Europe And Japan For Each Major Indication
- Table 42: Overview of Clinical Trials of Rituxan/Mabthera In Rheumatoid Arthritis
- Table 43: Overview of Clinical Trials of Rituxan/Mabthera In Multiple Sclerosis
- Table 44: Overview of Clinical Trials of Rituxan/Mabthera In Psoriasis, Psoriatic Arthritis, Ulcerative Colitis And Ankylosing Spondylitis
- Table 45: Overview of Ocrelizumab's Development
- Table 46: Overview of ofatumumab's Development
- Table 47: Overview of Clinical Trials of Avonex In Multiple Sclerosis
- Table 48: Overview of Clinical Trials of Rebif In Multiple Sclerosis
- Table 49: Overview of Clinical Trials of Betaseron/Betaferon In Multiple Sclerosis
- Table 50: Orencia's Approved Indications And Date of First Approval In The Us, Europe And Japan For Each Major Indication
- Table 51: Overview of Clinical Trials of Orencia In Rheumatoid Arthritis
- Table 52: Overview of Clinical Trials of Orencia In Psoriatic Arthritis And Crohn's Disease
- Table 53: Overview of Clinical Trials of Raptiva In Psoriasis
- Table 54: Overview of Actemra's Development
- Table 55: Overview of Ustekinumab's Development
- Table 56: Overview of Clinical Trials of Copaxone In Multiple Sclerosis
- Table 57: Tysabri's Approved Indications And Date of First Approval In The Us, Europe And Japan For Each Major Indication
- Table 58: Overview of Clinical Trials of Tysabri In Multiple Sclerosis
- Table 59: Overview of Bg-12's Development
- Table 60: Overview of Fingolimod's Development
- Table 61: Ims Prescribing Insights Sample Size For Dermatologists, Rheumatologists And Gastroenterologists
- Table 62: Patent Expiry Dates And Expected Risk of Currently Marketed Biologic Brands
- Table 63: Emerging Biomarkers In Autoimmune Diseases
- Table 64: Overview of Clinical Trials Endpoints In Autoimmune Diseases
- Table 65: Forecast of Sales In The Seven Major Markets, 2006-2016
- Table 66: Forecast of Sales In The Us, 2006-2016
- Table 67: Forecast of Sales In The 5 Major European Markets, 2006-2016
- Table 68: Forecast of Sales In Japan, 2006-2016
- Table 69: Amevive: Key Facts
- Table 70: Arava: Key Facts
- Table 71: Avonex: Key Facts
- Table 72: Betaseron/Betaferon: Key Facts
- Table 73: Copaxone: Key Facts
- Table 74: Enbrel: Key Facts
- Table 75: Humira: Key Facts
- Table 76: Kineret: Key Facts
- Table 77: Orencia: Key Facts
- Table 78: Raptiva: Key Facts
- Table 79: Rebif: Key Facts
- Table 80: Remicade: Key Facts
- Table 81: Rituxan/Mabthera: Key Facts
- Table 82: Tysabri: Key Facts
List of Figures
- Figure 1: Overall Sales In The Autoimmune Disease Market, Per Geographical Area
- Figure 2: Share of Sales Per Mechanism of Action In Different Geographical Areas, 2006
- Figure 3: Share of Sales Per Mechanism of Action In Different Geographical Areas, 2016
- Figure 4: Sales of Tnf-Inhibitors In The Seven Major Markets, 2006-2016
- Figure 5: Sales of Beta-Interferons In The Seven Major Markets, 2006-2016
- Figure 6: Sales of The 'Other' Class In The Seven Major Markets, 2006-2016
- Figure 7: Sales of The T-Cell Inhibitors In The Seven Major Markets, 2006-2016
- Figure 8: Sales of The Interleukin Inhibitors In The Seven Major Markets, 2006-2016
- Figure 9: Sales of The B-Cell Inhibitors In The Seven Major Markets, 2006-2016
- Figure 10: Share of Sales Per Indication In Different Geographical Areas, 2006
- Figure 11: Share of Sales Per Indication In Different Geographical Areas, 2016
- Figure 12: Number of Products On The Market And In Development Per Indication
- Figure 13: Sales For Rheumatoid Arthritis Per Mechanism of Action In The Seven Major Markets, 2006-2016 ($Millions)
- Figure 14: Sales For Rheumatoid Arthritis Per Brand In The Seven Major Markets, 2006-2016 ($Millions)
- Figure 15: Sales For Psoriasis And Psoriatic Arthritis Per Mechanism of Action In The Seven Major Markets, 2006-2016 ($Millions)
- Figure 16: Sales For Psoriasis And Psoriatic Arthritis Per Brand In The Seven Major Markets, 2006-2016 ($Millions)
- Figure 17: Sales For Multiple Sclerosis Per Mechanism of Action In The Seven Major Markets, 2006-2016 ($Millions)
- Figure 18: Sales For Multiple Sclerosis Per Brand In The Seven Major Markets, 2006-2016 ($Millions)
- Figure 19: Sales For Crohn's Disease Per Mechanism of Action In The Seven Major Markets, 2006-2016 ($Millions)
- Figure 20: Sales For Crohn's Disease Per Brand In The Seven Major Markets, 2006-2016 ($Millions)
- Figure 21: Blockbuster Brands In The Seven Major Markets In 2006 And 2016
- Figure 22: Brands Selling More Than $400m In The Five Major European Markets In 2006 And 2016
- Figure 23: Brands Selling More Than $800m In The Us In 2006 And 2016
- Figure 24: Brands Selling More Than $50m In Japan In 2006 And 2016
- Figure 25: Enbrel Forecast, 2006-2016
- Figure 26: Remicade Forecast, 2006-2016
- Figure 27: Humira Forecast, 2006-2007
- Figure 28: Cimzia Forecast, 2006-2016
- Figure 29: Golimumab Forecast, 2006-2016
- Figure 30: Rituxan/Mabthera Forecast, 2006-2016
- Figure 31: Ocrelizumab Forecast, 2006-2016
- Figure 32: ofatumumab Forecast, 2006-2016
- Figure 33: Avonex Forecast, 2006-2016
- Figure 34: Rebif Forecast, 2006-2016
- Figure 35: Betaseron/Betaferon Forecast, 2006-2016
- Figure 36: Orencia Forecast, 2006-2016
- Figure 37: Raptiva Forecast, 2006-2016
- Figure 38: Amevive Forecast, 2006-2016
- Figure 39: Actemra Forecast, 2006-2016
- Figure 40: Ustekinumab Forecast, 2006-2016
- Figure 41: Kineret Forecast, 2006-2016
- Figure 42: Copaxone Forecast, 2006-2016
- Figure 43: Tysabri Forecast, 2006-2016
- Figure 44: Bg-12 Forecast, 2006-2016
- Figure 45: Fingolimod Forecast, 2006-2016
- Figure 46: Arava Forecast, 2006-2016
- Figure 47: Multiple Stakeholders
- Figure 48: The Process Biomarkers Are Part of
- Figure 49: New Products Have Several Opportunities Alongside The Established Drugs