Product Code: GDHC209PIDR
Rheumatoid arthritis (RA) is an autoimmune disease that, due to the complex interplay of environmental, immunological, and genetic factors, causes chronic inflammation and progressive deformity of the joints over time. In 2019, the diagnosed prevalence of RA in the 8MM averaged 0.7% in adults 18 years of age and older and 1.4% in adults aged 60 and older. Early RA typically presents as a bilateral inflammatory joint condition, usually beginning in the smaller joints such as the fingers and toes and eventually progressing to the larger joints. Patients can experience flare-ups early in disease onset, which are typically worse in the morning. Over time, pain and swelling may become constant, ultimately leading to deformity.
GlobalData projects that the global RA marketplace - which, for the purposes of this report, comprises eight major pharmaceutical markets (8MM) (US, France, Germany, Italy, Spain, UK, Japan, and Australia) - will grow at a compound annual growth rate (CAGR) of 1.0% over the 10-year forecast. Global revenues from RA drug sales are expected to grow from $26.2B in 2019 to $29.1B in 2029. Global growth in the RA market will be driven by continued uptake of new products in the IL-6 and JAK inhibitor classes along with the anticipated approval and launch of four pipeline therapies. This growth will be slackened by sales erosion from biosimilars and generic tofacitinib. Over 70% of sales will come from the US; the US has a large population of RA patients (estimated 1.8M diagnosed prevalent cases in 2029) and high price tags for biologic and targeted synthetic disease modifying anti-rheumatic drugs (DMARDs).
Biosimilar erosion will temper the growth of the RA market during the forecast period; between 2019 and 2029, biosimilars sales will increase from 5% to 28% of global sales. Due to favorable local regulations and increased access, biosimilar uptake is expected to be the highest in the 5EU; by 2029, GlobalData projects that biosimilar sales in 5EU will represent over 45% of its total sales -60% of which will come from sales of adalimumab and etanercept biosimilars.
GlobalData expects that despite biosimilar erosion, Pfizer/Amgen's Enbrel and AbbVie's Humira will remain the global sales leaders during the forecast period, amassing combined sales of $12.6B in 2019 and $9.0B in 2029. Sales of Enbrel and Humira are more likely to be protected from biosimilar erosion than Remicade (negative CAGR of 6.8%) mainly due to a lack of biosimilar availability in the US, the largest RA market in the 8MM. Etanercept and adalimumab biosimilars will not be available in the US until 2028 and 2023, respectively.
Although biosimilars may temper the impact of blockbuster biologics, GlobalData expects that the growth of the small molecule Janus kinase (JAK) inhibitor class will powerfully shape the RA market of the future. GlobalData projects that the JAK inhibitor class will continue to grow significantly over the forecast period, increasing at a CAGR of 7.2%. This growth is expected to be strongest in the 5EU, where the first JAK inhibitors, Pfizer's Xeljanz and Eli Lilly's Olumiant, only became available starting in 2017. The recent global launch of AbbVie's JAK1 inhibitor, Rinvoq, is expected to significantly expand JAK inhibitor market share, bringing in $2.2B in sales by 2029.
The late-stage pipeline for RA consists of three subcutaneously delivered biologics (the TNF inhibitor ozoralizumab, the interleukin 6 [IL-6] inhibitor olokizumab, and the granulocyte-macrophage colony-stimulating factor [GM-CSF] inhibitor otilimab) and one oral kinase inhibitor (the BTK inhibitor fenebrutinib). Key opinion leaders (KOLs) expressed measured enthusiasm for these agents-they welcomed the potential availability of new mechanisms of action but did not think that any of them would be more or even equally effective as JAK inhibitors. Of these agents, KOLs were the most enthusiastic about GSK's GM-CSF inhibitor, otilimab, expected to achieve global sales of $626.8M by 2029. All together, these four pipeline agents are expected to claim less than 5% of the RA market in 2029, equivalent to about $1.1B.
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?
- Although biosimilars may slow the growth of the RA market, GlobalData expects that new agents in the JAK inhibitor class will powerfully shape the RA market going forward.
- 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?
- 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.
- 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.
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.
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?
- 3.1 Catalyst
- 3.2 Related Reports
- 3.3 Upcoming Related Reports
4 Disease Overview
- 4.1 Etiology
- 4.2 Pathophysiology
- 4.3 Symptoms and Severity Classifications
- 5.1 Risk Factors and Comorbidities
- 5.2 Global and Historical Trends
- 5.3 Forecast Methodology
- 5.4 Epidemiological Forecast for RA (2019-2029)
- 5.5 Discussion
6 Disease Management
- 6.1 Diagnosis and Treatment Overview
- 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
8 Unmet Needs and Opportunity Assessment
- 8.1 Overview
- 8.2 Earlier Diagnosis and Treatment
- 8.3 Cost-Effective Therapies
- 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
- 9.3 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
11 Market Outlook
- 11.1 Global Markets
- 11.2 US
- 11.3 5EU
- 11.4 Japan
- 11.5 Australia
- 12.1 Bibliography
- 12.2 Abbreviations
- 12.3 Methodology
- 12.4 Primary Research - KOLs and Payers Interviewed for This Report
- 12.5 Primary Research - Prescriber Survey
- 12.6 About the Authors
- 12.7 About GlobalData
- 12.8 Contact Us
- 12.9 Disclaimer
List of Tables
List of Tables
- Table 1: RA: Key Metrics in the 8MM
- Table 2: RA Disease Severity Classification
- Table 3: 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
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 6: 8MM, Diagnosed Incidence of RA (Cases per 100,000 Population), Both Sexes, Ages ≥18 Years, 2019
- Figure 7: 8MM, Diagnosed Prevalence (%) of RA, Both Sexes, Ages ≥18 Years, 2019
- Figure 8: 8MM, Total Prevalence (%) of RA, Both Sexes, Ages ≥18 Years, 2019
- Figure 9: 8MM, Sources Used and Not Used to Forecast the Diagnosed Incident Cases of RA
- Figure 10: 8MM, Sources Used and Not Used to Forecast the Diagnosed and Total Prevalent Cases of RA
- Figure 11: 8MM, Diagnosed Incident Cases of RA, N, Both Sexes, Ages ≥18 Years, 2019
- Figure 12: 8MM, Diagnosed Incident Cases of RA, N, by Sex, Ages ≥18 Years, 2019
- Figure 13: 8MM, Diagnosed Incident Cases of RA by Age, N, Both Sexes, 2019
- Figure 14: 8MM, Diagnosed Prevalent Cases of RA, N, Both Sexes, Ages ≥18 Years, 2019
- Figure 15: 8MM, Diagnosed Prevalent Cases of RA, N, by Sex, Ages ≥18 Years, 2019
- Figure 16: 8MM, Diagnosed Prevalent Cases of RA by Age, N, Both Sexes, 2019
- Figure 17: 8MM, Diagnosed Prevalent Cases of RA by Severity, N, Both Sexes, Ages ≥18 Years, 2019
- Figure 18: 8MM, Total Prevalent Cases of RA, N, Both Sexes, Ages ≥18 Years, 2019
- Figure 19: 8MM, Total Prevalent Cases of RA, N, by Sex, Ages ≥18 Years, 2019
- Figure 20: 8MM, Total Prevalent Cases of RA by Age, N, Both Sexes, 2019
- Figure 21: 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