Commercial Insight: Autoimmune Overview - Market continues to prosper

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 (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