Rheumatoid Arthritis – Global Drug Forecast and Market Analysis to 2029

The rheumatoid arthritis (RA) market is expected to grow from $26.2bn in 2019 to $29.1bn in 2029 across the eight major markets (8MM*) at a compound annual growth rate (CAGR) of 1.0%. This report discusses that although the RA market is expected to grow during the forecast period, this growth will be stymied by erosion from biosimilars.

Rose Joachim, PhD, Senior Immunology Analyst at GlobalData, explains: “Between 2019 and 2029, there will be modest growth in the RA market. Growth will mainly be driven by the continued uptake of new marketed products in the Janus kinase (JAK) inhibitor class, as well as the anticipated approval and launch of four pipeline therapies.

GlobalData’s report highlights four late-stage pipeline therapies for RA. Three are biologics, including Taisho’s tumor necrosis factor inhibitor, ozoralizumab, R-Pharm’s interleukin 6 inhibitor, olokizumab, and GlaxoSmithKline’s granulocyte-macrophage colony-stimulating factor inhibitor, otilimab. The fourth drug, Roche/Genentech’s fenebrutinib, is an oral Bruton’s tyrosine kinase inhibitor. Together, these four pipeline agents are expected to represent less than 5% of the RA market in 2029, equivalent to about $1.1bn.

Despite numerous sources of growth and development in the RA market, GlobalData expects market size to be severely impacted by biologic patent expiries, and the subsequent influx of discounted biosimilar products.

Rolling launches of new biosimilars will ratchet up the competition in an already dense, complex market. However, KOLs interviewed by GlobalData have emphasized that despite all the available drugs, there is still room for the standard of care in RA to improve. In particular, they highlighted the need for therapeutic strategies targeting patients with early and preclinical RA, novel pharmaceutical options for treatment-refractory patients, as well as more personalized treatment algorithms for patients with active disease.

*8MM = US, France, Germany, Italy, Spain, the UK, Japan, and Australia; 4EU = France, Germany, Italy, and Spain

Scope

  • Overview of RA including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Topline RA therapeutics market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
  • Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting RA therapeutics sales in the 8MM.
  • Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global RA therapeutics market.
  • Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The greatest drivers of growth in the global RA market will be the continued uptake of new products in the IL-6 and JAK inhibitor classes, the anticipated approval and launch of four pipeline therapies, a steadily climbing diagnosed prevalence rate, and a high overall treatment rate.

The main barriers to growth in the RA market will be significant market share erosion from biosimilars and tofacitinib generics as well as a challenging environment for new product launches due to intense competition in the market.

KOLs expressed measured enthusiasm for the four pipeline agents in development. Of these agents, KOLs were most interested in the two with new mechanisms of action: GSK’s GM-CSF inhibitor, otilimab, and Roche/Genentech’s BTK inhibitor, fenebrutinib. Although they were dubious that these agents’ efficacy would be comparable to that of JAK inhibitors, they believed they would expand available options for patients and could potentially be useful in future combination regimens.

The most important unmet needs in RA are those for earlier diagnosis and treatment, more cost-effective medications, personalized strategies for treatment of active disease, a better-defined approach to de-escalation of DMARDs during remission, as well as new options for patients with treatment-refractory disease.

Reasons to buy

The report will enable you to:

  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
  • Develop business strategies by understanding the trends shaping and driving the global RA therapeutics 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 global RA therapeutics market from 2019-2029.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

 

 

KEY QUESTIONS ANSWERED

  • With the increased entry of biosimilars into the RA marketplace, sales growth has begun to slacken and will likely continue to slow over the next 10 years. How will biosimilar uptake differ across the 8MM? What companies and drugs will be most affected by sales erosion from biosimilars?
  • What are the main R&D trends in the RA market and which companies are leading the way?
  • Are there major differences in the mechanisms of action used by therapies in late-stage versus early-stage clinical development?
  • KOLs interviewed by GlobalData have indicated that there are still many remaining unmet needs within the RA indication. What are the main unmet needs in the RA market? How can the pharmaceutical industry address these needs? To what degree will the therapies under development fulfill these unmet needs?

Companies mentioned

Abbvie Inc

Ablynx NV

Amgen Inc

Asahi Kasei Pharma Corp

Astellas Pharma Inc

AstraZeneca Plc

Biogen Inc

Bristol-Myers Squibb Co

Celltrion Inc

Chugai Pharmaceutical Co Ltd

Daiichi Sankyo Co Ltd

Eisai Co Ltd

Eli Lilly and Co

F Hoffman-La Roche Ltd

Galapagos NV

Genentech Ltd

Gilead Science Inc

GlaxoSmithKline Plc

Johnson & Johnson/Janssen

Merck & Co Inc/Merck Sharp & Dohme

Mitsubishi Tanabe Pharma Corp

Ono Pharmaceutical Co Ltd

Pfizer Inc

Regeneron Pharmaceuticals Inc

R-Pharm

Samsung Bioepis Co Ltd

Sandoz Inc

Sanofi

Taisho Pharmaceutical Holdings Co Ltd

Takeda Pharmaceutical Co Ltd

UCB SA

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Rheumatoid Arthritis: Executive Summary

2.1 Biosimilar and Generic Erosion Will Stymie Sales Growth in the RA Market from 2019–2029

2.2 Development of Novel Oral Agents and Biosimilars Are Popular R&D Strategies

2.3 Opportunities Remain for More Rapid, Targeted, and Cost-Effective Treatment for RA Patients

2.4 Late-Stage RA Pipeline Holds Promise But Likely Won’t Match the Utility of JAK Inhibitors

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology

4.2 Pathophysiology

4.2.1 Preclinical RA

4.2.2 Early and Established RA

4.2.3 Therapeutic Mechanisms in RA

4.3 Symptoms and Severity Classifications

5 Epidemiology

5.1 Risk Factors and Comorbidities

5.2 Global and Historical Trends

5.3 Forecast Methodology

5.3.1 Sources

5.3.2 Forecast Assumptions and Methods

5.4 Epidemiological Forecast for RA (2019–2029)

5.4.1 Diagnosed Incident Cases of RA

5.4.2 Sex-Specific Diagnosed Incident Cases of RA

5.4.3 Age-Specific Diagnosed Incident Cases of RA

5.4.4 Diagnosed Prevalent Cases of RA

5.4.5 Sex-Specific Diagnosed Prevalent Cases of RA

5.4.6 Age-Specific Diagnosed Prevalent Cases of RA

5.4.7 Diagnosed Prevalent Cases of RA by Severity

5.4.8 Total Prevalent Cases of RA

5.4.9 Sex-Specific Total Prevalent Cases of RA

5.4.10 Age-Specific Total Prevalent Cases of RA

5.4.11 Total Prevalent Cases of RA by Severity

5.5 Discussion

5.5.1 Epidemiological Forecast Insight

5.5.2 Limitations of the Analysis

5.5.3 Strengths of the Analysis

6 Disease Management

6.1 Diagnosis and Treatment Overview

6.1.1 Diagnosis

6.1.2 Treatment

6.2 US

6.3 5EU

6.4 Japan

6.5 Australia

7 Competitive Assessment

7.1 Overview

7.2 Biosimilars in the RA Market

7.2.1 Marketed Biosimilars

7.2.2 Pipeline Biosimilars

7.2.3 Pricing of Biosimilars across the 8MM

7.2.4 Uptake of Biosimilars across the 8MM

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Earlier Diagnosis and Treatment

8.2.1 Improved Access to Rheumatologists

8.2.2 Diagnosis and Treatment of Early, Undifferentiated, and Preclinical RA

8.3 Cost-Effective Therapies

8.3.1 Biosimilars

8.3.2 Tofacitinib Generics

8.4 Personalized Treatment Strategies

8.5 Improved Guidance on Treating RA Patients in Remission

8.6 New Treatment Options for Patients with Refractory RA

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

9.2.1 TNF Inhibitors

9.2.2 IL-6 Inhibitors

9.2.3 GM-CSF Inhibitors

9.2.4 Kinase Inhibitors

9.3 Other Drugs in Development – Kinase Inhibitors

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Company Portfolio Assessments

10.3.1 AbbVie

10.3.2 Pfizer

10.3.3 Amgen

10.3.4 Johnson & Johnson

10.3.5 Bristol-Myers Squibb

10.3.6 Roche/Genentech

10.3.7 Eli Lilly

10.3.8 UCB

10.3.9 Sanofi

10.3.10 Regeneron

10.3.11 Astellas

10.3.12 Gilead

10.3.13 Galapagos

10.3.14 GSK

10.3.15 R-Pharm

10.3.16 Taisho

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Drivers and Barriers

11.2 US

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

11.5 Australia

11.5.1 Forecast

11.5.2 Key Events

11.5.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Patients

12.3.3 Percent Drug-Treated Patients

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic/Biosimilar Erosion

12.3.9 Pricing of Pipeline and Recently Approved Agents

12.4 Primary Research – KOLs and Payers Interviewed for This Report

12.4.1 KOLs

12.4.2 Payers

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Therapy Area Director

12.6.3 Epidemiologist

12.6.4 Epidemiology Reviewers

12.6.5 Global Director of Therapy Analysis and Epidemiology

12.6.6 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

List of Tables

Table 1: RA: Key Metrics in the 8MM

Table 2: RA Disease Severity Classification

Table 2: Risk Factors and Comorbidities for RA

Table 4: Classification Criteria for RA – ACR 1987

Table 5: Classification Criteria for RA – ACR/EULAR 2010

Table 6: Treatment Guidelines for RA, 2020

Table 7: ACR/EULAR Diagnostic Definitions of Remission in RA Clinical Trials

Table 8: Country Profile – US

Table 9: Regional Profile – 5EU

Table 10: Country Profile – Japan

Table 11: Country Profile – Australia

Table 12: Leading Branded Treatments for RA, 2020

Table 13: Marketed Biosimilars for RA, 2020

Table 14: Expected Adalimumab Biosimilar Launches in the US

Table 15: Pipeline Biosimilars for RA, 2020

Table 16: Average Percent Discount on Biosimilars Compared to Biologic Reference Products Across the 8MM, 2020

Table 17: AbbVie’s RA Portfolio Assessment, 2020

Table 18: Pfizer’s RA Portfolio Assessment, 2020

Table 19: Amgen’s RA Portfolio Assessment, 2020

Table 20: J&J’s RA Portfolio Assessment, 2020

Table 21: BMS’ RA Portfolio Assessment, 2020

Table 22: Roche/Genentech’s RA Portfolio Assessment, 2020

Table 23: Eli Lilly’s RA Portfolio Assessment, 2020

Table 24: UCB’s RA Portfolio Assessment, 2020

Table 25: Sanofi’s RA Portfolio Assessment, 2020

Table 26: Regeneron’s RA Portfolio Assessment, 2020

Table 27: Astellas’ RA Portfolio Assessment, 2020

Table 28: Gilead’s RA Portfolio Assessment, 2020

Table 29: Galapagos’ RA Portfolio Assessment, 2020

Table 30: GSK’s RA Portfolio Assessment, 2020

Table 31: R-Pharm’s RA Portfolio Assessment, 2020

Table 32: Taisho’s RA Portfolio Assessment, 2020

Table 33: RA Market – Global Drivers and Barriers, 2019–2029

Table 34: Key Events Impacting Sales for RA in the US, 2019–2029

Table 35: RA Market – Drivers and Barriers in the US, 2019–2029

Table 36: Key Events Impacting Sales for RA in the 5EU, 2019–2029

Table 37: RA Market – Drivers and Barriers in the 5EU, 2019–2029

Table 38: Key Events Impacting Sales for RA in Japan, 2019–2029

Table 39: RA Market – Global Drivers and Barriers in Japan, 2019–2029

Table 40: Key Events Impacting Sales for RA in Australia, 2019–2029

Table 41: RA Market – Global Drivers and Barriers in Australia, 2019–2029

Table 42: Key Historical and Projected Launch Dates for RA

Table 43: Key Historical and Projected Patent/Exclusivity Expiry Dates for RA

Table 44: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for RA in 2019 and 2029

Figure 2: Analysis of the Company Portfolio Gap in RA During the Forecast Period, 2019–2029

Figure 3: Competitive Assessment of Recently Approved and Late-Stage Pipeline Agents for the Treatment of RA During the Forecast Period, 2019–2029

Figure 4: Overview of RA Pathogenesis and Pathophysiology

Figure 5: Cellular and Cytokine Targets for the Marketed and Late-Stage Pipeline RA Drugs, 2020

Figure 3: 8MM, Diagnosed Incidence of RA (Cases per 100,000 Population), Both Sexes, Ages ≥18 Years, 2019

Figure 4: 8MM, Diagnosed Prevalence (%) of RA, Both Sexes, Ages ≥18 Years, 2019

Figure 5: 8MM, Total Prevalence (%) of RA, Both Sexes, Ages ≥18 Years, 2019

Figure 6: 8MM, Sources Used and Not Used to Forecast the Diagnosed Incident Cases of RA

Figure 7: 8MM, Sources Used and Not Used to Forecast the Diagnosed and Total Prevalent Cases of RA

Figure 8: 8MM, Diagnosed Incident Cases of RA, N, Both Sexes, Ages ≥18 Years, 2019

Figure 9: 8MM, Diagnosed Incident Cases of RA, N, by Sex, Ages ≥18 Years, 2019

Figure 10: 8MM, Diagnosed Incident Cases of RA by Age, N, Both Sexes, 2019

Figure 11: 8MM, Diagnosed Prevalent Cases of RA, N, Both Sexes, Ages ≥18 Years, 2019

Figure 12: 8MM, Diagnosed Prevalent Cases of RA, N, by Sex, Ages ≥18 Years, 2019

Figure 13: 8MM, Diagnosed Prevalent Cases of RA by Age, N, Both Sexes, 2019

Figure 14: 8MM, Diagnosed Prevalent Cases of RA by Severity, N, Both Sexes, Ages ≥18 Years, 2019

Figure 15: 8MM, Total Prevalent Cases of RA, N, Both Sexes, Ages ≥18 Years, 2019

Figure 16: 8MM, Total Prevalent Cases of RA, N, by Sex, Ages ≥18 Years, 2019

Figure 17: 8MM, Total Prevalent Cases of RA by Age, N, Both Sexes, 2019

Figure 18: 8MM, Total Prevalent Cases of RA by Severity, N, Both Sexes, Ages ≥18 Years, 2019

Figure 22: General Treatment Algorithm for RA Patients, 2020

Figure 23: 8MM Physician-Reported Biosimilar Prescription Rates to RA Patients, 2020

Figure 24: 5EU Physician-Reported Biosimilar Prescription Rates to RA Patients, 2020

Figure 25: Unmet Needs and Opportunities in RA, 2020

Figure 26: Overview of the Development Pipeline in RA

Figure 27: Key Phase II/III Trials for the Promising Pipeline Agents That GlobalData Expects to Be Licensed for RA in the 8MM During the Forecast Period, 2019–2029

Figure 28: Competitive Assessment of Recently Approved and Late-Stage Pipeline Agents for the Treatment of RA During the Forecast Period, 2019–2029

Figure 29: Analysis of the Company Portfolio Gap in RA During the Forecast Period, 2019–2029

Figure 30: Global (8MM) Sales Forecast by Country for RA in 2019 and 2029

Figure 31: Global (8MM) Sales Forecast for RA, by Class, in 2019 and 2029

Figure 32: Sales Forecast by Class for RA in the US in 2019 and 2029

Figure 33: Sales Forecast by Class for RA in the 5EU in 2019 and 2029

Figure 34: Sales Forecast by Class for RA in Japan in 2019 and 2029

Figure 35: Sales Forecast by Class for RA in Australia in 2019 and 2029

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