PharmaPoint: Rheumatoid Arthritis – Global Drug Forecast and Market Analysis to 2025

  • Pages: 403
  • Published: February 2017
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  • Report Code: GDHC143PIDR
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Rheumatoid arthritis (RA) is a chronic autoimmune disease which causes inflammation and deformity of the joints . It affects over six million individuals in the 8MM covered in this report (US, France, Germany, Italy, Spain, UK, Japan, and Australia) and this prevalence is expected to grow to just shy of 7 million individuals by 2025. The anti-TNFs have been effective in treating the signs and symptoms of RA and inhibiting progression to erosive bone disease. However, the landscape is quickly changing with the introduction of biosimilars, novel biologics, and a class of oral therapies known as JAK inhibitors, all of which will change the market dynamics between 2015 and 2025. With the anti-TNFs as extremely effective for RA, the market is extremely competitive for new entrants and will undergo further pressure as biosimilars launch across the 8MM and begin to gain traction in these markets.

Scope

Overview of rheumatoid arthritis (RA), including etiology, pathophysiology, and country-specific diagnosis and treatment recommendations.

Annualized RA market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications for the RA biologics and biosimilars markets.

Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically JAK inhibitors (such as Eli Lilly/Incyte’s Olumiant (baricitinib), novel biologics (such as AstraZeneca-MedImmune’s mavrilimumab), and biosimilars (such as Celltrion/Hospira/Pfizer’s Inflectra/Remsima, Samsung Bioepis/Biogen/Merck’s Flixabi and Benepali, Sandoz’s Erelzi, and Amgen’s Amjevita).

Analysis of the current and future market competition in the global RA market. Insightful review of the key industry and governmental drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the RA market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global RA market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Track drug sales in the eight major RA markets from 2015-2025.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Companies mentioned

AbbVie

Pfizer

Amgen

Johnson & Johnson

Eli Lilly

Bristol-Myers Squibb

UCB

Roche

GlaxoSmithKline

Novartis

Sanofi

AstraZeneca-MedImmune

Astellas

Daiichi Sankyo

Samsung Bioepis

Sandoz

AbbVie

Pfizer

Amgen

Johnson & Johnson

Eli Lilly

Bristol-Myers Squibb

UCB

Roche

GlaxoSmithKline

Novartis

Sanofi

AstraZeneca-MedImmune

Astellas

Daiichi Sankyo

Samsung Bioepis

Sandoz

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Catalyst

2.2 Related Reports

2.3 ...

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Catalyst

2.2 Related Reports

2.3 Upcoming Related Reports

3 Disease Overview

3.1 Etiology and Pathophysiology

3.1.1 Etiology

3.1.2 Pathophysiology

3.2 Symptoms

3.3 Prognosis

3.4 Quality of Life

4 Epidemiology

4.1 Disease Background

4.2 Risk Factors and Comorbidities

4.3 Global Trends

4.3.1 Diagnosed Incidence

4.3.2 Prevalence

4.4 Forecast Methodology

4.4.1 Sources Used

4.4.2 Forecast Assumptions and Methods

4.4.3 Sources Not Used

4.5 Epidemiological Forecast for RA (2015–2025)

4.5.1 Diagnosed Incident Cases

4.5.2 Diagnosed Prevalent Cases

4.5.3 Total Prevalent Cases

4.6 Discussion

4.6.1 Epidemiological Forecast Insight

4.6.2 Limitations of the Analysis

4.6.3 Strengths of the Analysis

5 Disease Management

5.1 Diagnosis and Treatment Overview

5.1.1 Diagnosis

5.1.2 Treatment Guidelines

5.1.3 Leading Prescribed Drugs for the Treatment of RA

5.1.4 Clinical Practice

5.2 US

5.3 France

5.4 Germany

5.5 Italy

5.6 Spain

5.7 UK

5.8 Japan

5.9 Australia

6 Competitive Assessment

6.1 Overview

6.2 Product Profiles – Major Brands

6.2.1 Enbrel (etanercept)

6.2.2 Humira (adalimumab)

6.2.3 Remicade (infliximab)

6.2.4 Simponi (golimumab)

6.2.5 Cimzia (certolizumab pegol)

6.2.6 Orencia (abatacept)

6.2.7 Actemra/RoActemra (tocilizumab)

6.2.8 Rituxan/MabThera (rituximab)

6.2.9 Inflectra/Remsima (infliximab biosimilar)

6.2.10 Flixabi (infliximab biosimilar)

6.2.11 Benepali (etanercept biosimilar)

6.2.12 Erelzi (etanercept biosimilar)

6.2.13 Amjevita (adalimumab biosimilar)

6.2.14 Xeljanz (tofacitinib)

6.2.15 Iguratimod/T-614

6.2.16 Methotrexate (Numerous Brands)

6.3 Biosimilars Assessment

6.3.1 Introduction

6.3.2 Biosimilars in the Immunology Community

6.3.3 By the Numbers: Biosimilars in Development

6.3.4 The Impact of Biosimilars Is Being Felt Throughout the Pharmaceutical Industry

6.3.5 Uptake of Biosimilars for RA Is Expected to Vary by Market

6.4 Other Therapies

7 Unmet Needs and Opportunities

7.1 Overview

7.2 Development of Cost-Effective Therapies

7.2.1 Unmet Need

7.2.2 Gap Analysis

7.2.3 Opportunity

7.3 Biomarkers to Predict Responsiveness to Therapy

7.3.1 Unmet Need

7.3.2 Gap Analysis

7.3.3 Opportunity

7.4 Early Diagnosis of RA

7.4.1 Unmet Need

7.4.2 Gap Analysis

7.4.3 Opportunity

7.5 Personalized Treatment Approach

7.5.1 Unmet Need

7.5.2 Gap Analysis

7.5.3 Opportunity

8 Pipeline Assessment

8.1 Overview

8.2 Clinical Trial Mapping

8.2.1 Clinical Trials by Class

8.3 Promising Drugs in Clinical Development

8.3.1 Sarilumab

8.3.2 Sirukumab

8.3.3 Clazakizumab

8.3.4 Vobarilizumab (ALX-0016)

8.3.5 Mavrilimumab

8.3.6 Pralia (denosumab)

8.3.7 Olumiant (baricitinib)

8.3.8 Peficitinib

8.3.9 Filgotinib

8.3.10 Upadacitinib

8.3.11 Piclidenoson

8.4 Other Drugs in Development

9 Current and Future Players

9.1 Trends in Corporate Strategy

9.2 Company Profiles

9.2.1 AbbVie

9.2.2 Pfizer

9.2.3 Amgen

9.2.4 Johnson & Johnson

9.2.5 Eli Lilly

9.2.6 Bristol-Myers Squibb

9.2.7 UCB

9.2.8 Roche

9.2.9 GlaxoSmithKline

9.2.10 Sanofi

9.2.11 AstraZeneca- MedImmune

9.2.12 Astellas

9.2.13 Daiichi Sankyo

9.2.14 Samsung Bioepis

9.2.15 Sandoz

10 Market Outlook

10.1 Global Markets

10.1.1 Forecast

10.1.2 Drivers and Barriers – Global Issues

10.2 US

10.2.1 Forecast

10.2.2 Key Events

10.2.3 Drivers and Barriers

10.3 5EU

10.3.1 Forecast

10.3.2 Key Events

10.3.3 Drivers and Barriers

10.4 Japan

10.4.1 Forecast

10.4.2 Key Events

10.4.3 Drivers and Barriers

10.5 Australia

10.5.1 Forecast

10.5.2 Key Events

10.5.3 Drivers and Barriers

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.4 Forecasting Methodology

11.4.1 Diagnosed RA Patients

11.4.2 Percentage of Drug-Treated Patients

11.4.3 Drugs Included in Each Therapeutic Class

11.4.4 Launch and Patent Expiry Dates

11.4.5 General Pricing Assumptions

11.4.6 Individual Drug Assumptions

11.4.7 Generic and Biosimilar Erosion

11.4.8 Pricing of Pipeline Agents

11.5 Primary Research – KOLs Interviewed for This Report

11.6 Primary Research – Prescriber Survey

11.7 About the Authors

11.7.1 Analyst

11.7.2 Therapy Area Director

11.7.3 Epidemiologist

11.7.4 Global Director of Therapy Analysis and Epidemiology

11.8 About GlobalData

11.9 Contact Us

11.10 Disclaimer

List of tables

Table 1: Symptoms of RA

Table 2: Risk Factors and Comorbidities of RA

Table 3: 1987 ACR Diagnostic Criteria for RA

Table 4: 8MM, Sources ...

Table 1: Symptoms of RA

Table 2: Risk Factors and Comorbidities of RA

Table 3: 1987 ACR Diagnostic Criteria for RA

Table 4: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of RA

Table 5: 8MM, Sources Used to Forecast the Total Prevalent Cases of RA

Table 6: 8MM, Sources Used to Forecast the Diagnosed Prevalent Cases of RA

Table 7: 8MM, Sources Used to Forecast Severity Segmentation of the Diagnosed Prevalent Cases of RA

Table 8: 8MM, Sources Not Used in the Epidemiological Analysis of RA

Table 9: 8MM, Diagnosed Incident Cases of RA, Ages ≥18 Years, Both Sexes, N, Selected Years 2015–2025

Table 10: 8MM, Age-Specific Diagnosed Incident Cases of RA, Both Sexes, N (Row %), 2015

Table 11: 8MM, Sex-Specific Diagnosed Incident Cases of RA, Ages ≥18 Years, N (Row %), 2015

Table 12: 8MM, Diagnosed Prevalent Cases of RA, Ages ≥18 Years, Both Sexes, N, Selected Years 2015–2025

Table 13: 8MM, Age-Specific Diagnosed Prevalent Cases of RA, Both Sexes, N (Row %), 2015

Table 14: 8MM, Sex-Specific Diagnosed Prevalent Cases of RA, Ages ≥18 Years, N (Row %), 2015

Table 15: 8MM, Total Prevalent Cases of RA, Ages ≥18 Years, Both Sexes, N, Selected Years 2015–2025

Table 16: 8MM, Age-Specific Total Prevalent Cases of RA, Both Sexes, N (Row %), 2015

Table 17: 8MM, Sex-Specific Total Prevalent Cases of RA, Ages ≥18 Years, N (Row %), 2015

Table 18: 1987 ACR Diagnostic Criteria for RA

Table 19: 2010 ACR/EULAR Diagnostic Criteria for RA

Table 20: Treatment Guidelines for RA Used by Each Country in the 8MM

Table 21: ACR 2015 Criteria for RA Remission and Low/Moderate/High Disease Activity

Table 22: EULAR 2013 Criteria for RA Remission

Table 23: Most-Prescribed Biologics for RA (After csDMARDs) in the Global Markets, 2015

Table 24: RA Treatment Country Profile – US

Table 25: RA Treatment Country Profile – France

Table 26: RA Treatment Country Profile – Germany

Table 27: RA Treatment Country Profile – Italy

Table 28: RA Treatment Country Profile – Spain

Table 29: RA Treatment Country Profile – UK

Table 30: RA Treatment Country Profile – Japan

Table 31: RA Treatment Country Profile – Australia

Table 32: Leading Branded Treatments for RA, 2016

Table 33: Product Profile – Enbrel

Table 34: 10-Year, Open-Label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 Years for Completers

Table 35: 10-Year, Open-Label Safety and Efficacy Trial of Enbrel: Overall Safety Results

Table 36: Enbrel SWOT Analysis, 2016

Table 37: Product Profile – Humira

Table 38: Humira SWOT Analysis, 2016

Table 39: Product Profile – Remicade

Table 40: Remicade SWOT Analysis, 2016

Table 41: Product Profile – Simponi

Table 42: Simponi SWOT Analysis, 2016

Table 43: Product Profile – Cimzia

Table 44: Cimzia SWOT Analysis, 2016

Table 45: Product Profile – Orencia

Table 46: Orencia SWOT Analysis, 2016

Table 47: Product Profile – Actemra

Table 48: Actemra SWOT Analysis, 2016

Table 49: Product Profile – Rituxan

Table 50: Rituxan SWOT Analysis, 2016

Table 51: Product Profile – Inflectra/Remsima

Table 52: Inflectra/Remsima SWOT Analysis, 2016

Table 53: Product Profile – Flixabi

Table 54: Flixabi SWOT Analysis, 2016

Table 55: Product Profile – Benepali

Table 56: Benepali SWOT Analysis, 2016

Table 57: Product Profile – Erelzi

Table 58: Erelzi SWOT Analysis, 2016

Table 59: Product Profile – Amjevita

Table 60: Amjevita SWOT Analysis, 2016

Table 61: Product Profile – Xeljanz

Table 62: ORAL Standard ACR20 Responses for Tofacitinib vs. Humira and Placebo at Month 6

Table 63: ORAL Step ACR20, 50, and 70 Responses for Xeljanz vs. Placebo at Month 6

Table 64: Xeljanz SWOT Analysis, 2016

Table 65: Product Profile – Iguratimod

Table 66: Iguratimod SWOT Analysis, 2016

Table 67: Product Profile – MTX

Table 68: MTX SWOT Analysis, 2016

Table 69: Marketed and Pipeline Biosimilars for RA, 2016

Table 70: Biosimilar Legislations Across the 8MM

Table 71: Physician Uptake of Biosimilar Products for RA Across the 8MM, 2016

Table 72: Summary of Minor Therapeutic Drug Classes Used to Treat RA, 2016

Table 73: Unmet Needs and Opportunities in RA, 2016

Table 74: Comparison of Therapeutic Drug Classes in Development for RA, 2016

Table 75: Product Profile – Sarilumab

Table 76: MOBILITY Study Part, A, Results for Sarilumab at Week 12

Table 77: MOBILITY Study Part B, Results for Sarilumab at Week 52

Table 78: Safety Results of the Sarilumab Phase III SARIL-RA-ASCERTAIN Trial

Table 79: Laboratory Results of Sarilumab Phase III SARIL-RA-ASCERTAIN Trial

Table 80: Sarilumab SWOT Analysis, 2016

Table 81: Product Profile – Sirukumab

Table 82: SIRROUND-D Study Results for Sirukumab

Table 83: Sirukumab SWOT Analysis, 2016

Table 84: Product Profile – Clazakizumab

Table 85: Phase IIb Study of Clazakizumab: ACR Responses After 12 Weeks

Table 86: Phase IIb Study of Clazakizumab: ACR Responses After 24 Weeks

Table 87: Clazakizumab SWOT Analysis, 2016

Table 88: Product Profile – Vobarilizumab

Table 89: Phase IIb Study of Vobarilizumab: Efficacy Results for ITT Population at Week 12

Table 90: Vobarilizumab SWOT Analysis, 2016

Table 91: Product Profile – Mavrilimumab

Table 92: EARTH-EXPLORER 2 Results for Mavrilimumab at 24 Weeks

Table 93: EARTH-EXPLORER 2 Results for Mavrilimumab at 24 Weeks

Table 94: Mavrilimumab SWOT Analysis, 2016

Table 95: Product Profile – Denosumab

Table 96: Denosumab SWOT Analysis, 2016

Table 97: Product Profile – Baricitinib

Table 98: Phase III RA-BEAM Study Results for Baricitinib at Week 12

Table 99: Phase III RA-BEAM Study Results for Baricitinib at Week 24

Table 100: Phase III RA-BEACON Study Results for Baricitinib at Week 12 and Week 24

Table 101: Phase III RA-BUILD Study Results for Baricitnib at Week 12 and Week 24

Table 102: Baricitinib SWOT Analysis, 2016

Table 103: Product Profile – Peficitinib

Table 104: Peficitinib SWOT Analysis, 2016

Table 105: Product Profile – Filgotinib

Table 106: DARWIN I Study Results for Filgotinib at Week 12

Table 107: DARWIN I Study Results for Filgotinib at Week 24

Table 108: DARWIN II Study Results for Filgotinib at Week 12

Table 109: DARWIN II Study Results for Filgotinib at Week 24

Table 110: Filgotinib SWOT Analysis, 2016

Table 111: Product Profile – Upadacitinib

Table 112: Upadacitinib Phase IIb BALANCE-I Trial, ACR Responses at Week 12

Table 113: Upadacitinib Phase IIb BALANCE-II Trial, ACR Responses at Week 12

Table 114: Upadacitinib SWOT Analysis, 2016

Table 115: Product Profile – Piclidenoson

Table 116: Piclidenoson SWOT Analysis, 2016

Table 117: Drugs in Phase II of Development for RA, 2016

Table 118: Key Companies in the RA Market, 2016

Table 119: AbbVie’s RA Portfolio Assessment, 2016

Table 120: AbbVie SWOT Analysis in RA, 2015–2025

Table 121: Pfizer’s RA Portfolio Assessment, 2016

Table 122: Pfizer SWOT Analysis in RA, 2015–2025

Table 123: Amgen’s RA Portfolio Assessment, 2016

Table 124: Amgen SWOT Analysis in RA, 2015–2025

Table 125: J&J’s RA Portfolio Assessment, 2016

Table 126: J&J SWOT Analysis in RA, 2015–2025

Table 127: Eli Lilly’s RA Portfolio Assessment, 2016

Table 128: Eli Lilly SWOT Analysis in RA, 2015–2025

Table 129: BMS’ RA Portfolio Assessment, 2016

Table 130: BMS SWOT Analysis in RA, 2015–2025

Table 131: UCB’s RA Portfolio Assessment, 2016

Table 132: UCB SWOT Analysis in RA, 2015–2025

Table 133: Roche’s RA Portfolio Assessment, 2016

Table 134: Roche SWOT Analysis in RA, 2015–2025

Table 135: GSK’s RA Portfolio Assessment, 2016

Table 136: GSK SWOT Analysis in RA, 2015–2025

Table 137: Sanofi’s RA Portfolio Assessment, 2016

Table 138: Sanofi SWOT Analysis in RA, 2015–2025

Table 139: AstraZeneca/MedImmune’s RA Portfolio Assessment, 2016

Table 140: AstraZeneca/MedImmune SWOT Analysis in RA, 2015–2025

Table 141: Astellas’ RA Portfolio Assessment, 2016

Table 142: Astellas SWOT Analysis in RA, 2015–2025

Table 143: Daiichi Sankyo’s RA Portfolio Assessment, 2016

Table 144: Daiichi Sankyo SWOT Analysis in RA, 2015–2025

Table 145: Samsung Bioepis’ RA Portfolio Assessment, 2016

Table 146: Samsung Bioepis’ SWOT Analysis in RA, 2015–2025

Table 147: Sandoz’s RA Portfolio Assessment, 2016

Table 148: Sandoz’s SWOT Analysis in RA, 2015–2025

Table 149: Global RA Market – Drivers and Barriers, 2015–2025

Table 150: Key Events Impacting Sales for RA in the US, 2015–2025

Table 151: RA Market in the US – Drivers and Barriers, 2015–2025

Table 152: Key Events Impacting Sales for RA in the 5EU, 2015–2025

Table 153: RA Market in 5EU – Drivers and Barriers, 2015–2025

Table 154: Key Events Impacting Sales for RA in Japan, 2015–2025

Table 155: RA Market in Japan – Drivers and Barriers, 2013–2023

Table 156: Key Events Impacting Sales for RA in Australia, 2015–2025

Table 157: RA Market in Australia – Drivers and Barriers, 2013–2023

Table 158: 8MM, Key Launch Dates of RA Products

Table 159: 8MM, Key Patent Expiries of RA Products

Table 160: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of figures

Figure 1: Normal Synovial Joint and Synovial Joint with RA

Figure 2: Cellular and Cytokine Targets for the Current RA Drugs

Figure 3: 8MM, Diagnosed ...

Figure 1: Normal Synovial Joint and Synovial Joint with RA

Figure 2: Cellular and Cytokine Targets for the Current RA Drugs

Figure 3: 8MM, Diagnosed Incident Cases of RA, Ages ≥18 Years, Both Sexes, N, 2015–2025

Figure 4: 8MM, Age-Specific Diagnosed Incident Cases of RA, Both Sexes, N, 2015

Figure 5: 8MM, Sex-Specific Diagnosed Incident Cases of RA, Ages ≥18 Years, N, 2015

Figure 6: 8MM, Age-Standardized Diagnosed Incidence of RA, Ages ≥18 Years, Cases per 100,000 Population, 2015

Figure 7: 8MM, Diagnosed Prevalent Cases of RA, Ages ≥18 Years, Both Sexes, N, Selected Years 2015–2025

Figure 8: 8MM, Age-Specific Diagnosed Prevalent Cases of RA, Both Sexes, N, 2015

Figure 9: 8MM, Sex-Specific Diagnosed Prevalent Cases of RA, Ages ≥18 Years, N, 2015

Figure 10: 8MM, Age-Standardized Diagnosed Prevalence of RA, Ages ≥18 Years, %, 2015

Figure 11: 8MM, Diagnosed Prevalent Cases of RA by Severity, Both Sexes, Ages ≥18 Years, N, 2015

Figure 12: 8MM, Total Prevalent Cases of RA, Ages ≥18 Years, Both Sexes, N, Selected Years 2015–2025

Figure 13: 8MM, Age-Specific Total Prevalent Cases of RA, Both Sexes, N, 2015

Figure 14: 8MM, Sex-Specific Total Prevalent Cases of RA, Ages ≥18 Years, N, 2015

Figure 15: 8MM, Age-Standardized Total Prevalence of RA, Ages ≥18 Years, N, 2015

Figure 16: Disease Management Flowchart for Early RA – ACR 2015

Figure 17: Disease Management Flowchart for Established RA – ACR 2015

Figure 18: Flowchart for the Management of RA – EULAR 2013

Figure 19: Biosimilar Prescribing Habits in RA Across the 8MM, 2016

Figure 20: RA Clinical Trials by Drug Class, 2016

Figure 21: RA Phase II–III Pipeline, 2016

Figure 22: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2015–2025

Figure 23: Clinical and Commercial Positioning of Sarilumab

Figure 24: Clinical and Commercial Positioning of Sirukumab

Figure 25: Clinical and Commercial Positioning of Clazakizumab

Figure 26: Clinical and Commercial Positioning of Vobarilizumab

Figure 27: Clinical and Commercial Positioning of Mavrilimumab

Figure 28: Clinical and Commercial Positioning of Denosumab in RA

Figure 29: Clinical and Commercial Positioning of Baricitinib

Figure 30: Clinical and Commercial Positioning of Peficitinib

Figure 31: Clinical and Commercial Positioning of Filgotinib

Figure 32: Clinical and Commercial Positioning of Upadacitinib

Figure 33: Clinical and Commercial Positioning of Piclidenoson

Figure 34: Company Portfolio Gap Analysis in RA, 2015–2025

Figure 35: Global Sales for RA by Region, 2015–2025

Figure 36: Sales for RA in the US by Drug Class, 2015–2025

Figure 37: Sales for RA in the 5EU by Drug Class, 2015–2025

Figure 38: Sales for RA in Japan by Drug Class, 2015–2025

Figure 39: Sales for RA in Australia by Drug Class, 2015–2025

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