Market Report Source

Overview

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.

Table of Contents

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 (adalimuma)
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