Commercial Insight: Autoimmune Overview - Market continues to prosper

Published by: Datamonitor

Published: Dec. 26, 2007 - 285 Pages

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

Abstract

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