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Disease Analysis: Rheumatoid Arthritis

  • ID: 4944299
  • Report
  • May 2021
  • Region: Global
  • 94 Pages
  • Pharma Intelligence
Definition

The rheumatoid arthritis (RA) market will decline slightly over the 2020-29 forecast period, with sales in the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK) ending at $19.2bn in 2029, and decreasing at an overall compound annual growth rate (CAGR) of -0.6%. Revenues in this market will peak at $22.3bn in 2025 due to increasing disease prevalence, uptake of new targeted drugs, and the anticipated launch of pipeline drugs, before decreasing as a whole due to biosimilar and generic erosion.

Latest Key Takeaways

  • The rheumatoid arthritis (RA) market is set to experience increasing attrition due to biosimilar competition. The EU market has taken the brunt of biosimilar erosion, with earlier launches and more acceptance of biosimilars compared to other countries. Over time, biosimilar penetration is anticipated to gain more momentum as international real-world evidence builds, with long-term data supporting biosimilar efficacy and safety. This should allow physicians and patients to grow their confidence and familiarity with biosimilars and encourage uptake.
  • Nevertheless, as the RA caseload enlarges and several pipeline drugs launch, this will provide impetus for market growth. The publisher estimates that in 2018, there were 25.9 million prevalent cases of RA worldwide, and expects that number to increase to 28.6 million prevalent cases by 2027.
  • As multi-billion-dollar products, Humira and Enbrel represent the best-selling brands in the market, and their stronghold will continue. In the US, biosimilars will face challenges in usurping branded anti-TNF drugs, with adalimumab biosimilars not expected to enter until 2023, etanercept biosimilars held in patent litigation, substantial originator rebates, and exclusive contracting with payers.
  • Gilead’s Jyseleca is the latest addition to the oral JAK inhibitor class, following Rinvoq’s US launch in September 2019. AbbVie is positioning Rinvoq as a follow-on product from Humira, supported by an extensive global pivotal trial program, and AbbVie has demonstrated Rinvoq’s superiority in head-to-head trials with gold-standard Humira. AbbVie’s experience and presence in the RA market will foster success for the drug, despite its third-to-market status.
  • Although the JAK inhibitors are differentiated by their convenient oral administration, the class has been associated with venous thromboembolic event (VTE) concerns, and this stigma may fuel hesitancies towards using these products. Despite AbbVie releasing data showing that the rate of VTEs associated with Rinvoq treatment was in line with the background rate for RA patients, the FDA included a black box warning for the safety issue. Furthermore, the drugs are premium-priced, and the entry of generic tofacitinib will not only erode market share from Xeljanz, but also from Olumiant, Rinvoq, and Jyseleca.
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OVERVIEW
  • Latest key takeaways

DISEASE BACKGROUND
  • Definition
  • Patient segmentation

TREATMENT
  • ACR treatment guidelines
  • EULAR treatment guidelines

EPIDEMIOLOGY
  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS
  • No To Five, Yes To Three: NICE Decides On Funding For Drugs In England
  • Alberta Expands Biosimilar Switching With Adalimumab
  • Celltrion’s Remsima SC Will No Longer Need IV Loading
  • Jyseleca European Launches Could Lift Gloom At Galapagos
  • Sandoz Confirms Launch Of Humira Rival In Canada
  • Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
  • Viatris And FKB Introduce First Japanese Adalimumab Biosimilar
  • Pfizer’s Xeljanz Could See Narrower Label And New REMS Due To CV And Malignancy Risks
  • Canada Approves Celltrion’s Remsima SC Biosimilar
  • Henlius Seeks To Add RA Indication To Chinese Rituximab
  • Celltrion Wins Race For High-Concentration Adalimumab
  • Henlius Gets Green Light For Adalimumab In China
  • Shaking Off US Rebuff, Gilead And Galapagos Get Filgotinib Green Lights In EU And Japan
  • Cadila Pharma Adds To Indian Biosimilars With Adalimumab
  • Lupin And Mylan Launch Etanercept In Germany
  • Gilead’s RA Hopeful Filgotinib Hit By Complete Response Letter
  • Cadila Pharma Launches Rituximab And Teriparatide Biosimilars In India
  • FDA Approves Mylan’s Humira Biosimilar
  • Japan Approves First Humira Biosimilar
  • Sandoz’ Ziextenzo And Riximyo Cleared In Canada
  • Teva And Celltrion Gain Arthritis Advantage On Rituximab

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Labcorp Buys Myriad Genetics’ Vectra Autoimmune Test Business
  • Micro Labs And Zydus Deal Quickly From Tofacitinib Action
  • Biogen Delves Deeper Into Biosimilars With Tocilizumab Partnership
  • Sorrento Acquires Abivertinib Partner ACEA
  • Aptevo Offloads Ruxience Biosimilar Rights In $67.5m Deal
  • Pfizer Buys Into Promise Of Imcyse Imotopes
  • Gilead Gives Up On Galapagos’s Filgotinib In RA
  • Jubilant Obtains Americas Rights To Navidea’s RA Diagnostic Agent

CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent Events

DRUG ASSESSMENT MODEL
  • Biologic DMARDs
  • Non-biologic DMARDs

MARKET DYNAMICS

FUTURE TRENDS
  • Brands will face headwinds as the RA market is penetrated by more biosimilars
  • Spearheaded by Humira and Enbrel, the anti-TNF class will remain dominant, despite pressure from biosimilars
  • Expansion of the JAK inhibitor class will be dampened by the entry of generic tofacitinib and safety concerns
  • New pipeline products will be relegated to later lines of therapy

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION
  • Jyseleca for Rheumatoid Arthritis (March 4, 2021)
  • Xeljanz/Xeljanz XR for Rheumatoid Arthritis (January 27, 2021)
  • ATI-450 for Rheumatoid Arthritis (January 19, 2021)
  • Piclidenoson for Rheumatoid Arthritis (October 6, 2020)
  • Jyseleca for Rheumatoid Arthritis (August 18, 2020)
  • ABBV-3373 for Rheumatoid Arthritis (June 10, 2020)
  • Rinvoq for Rheumatoid Arthritis (June 6, 2020)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS
  • Therapies are clinically comparable
  • Pricing and insurance coverage drive prescribing

UNMET NEEDS
  • There is critical unmet need for effective drugs that achieve remission
  • Unmet need exists for targeted treatments applied with a stratified medicine approach
  • With RA patients being treated with costly specialty drugs, more affordable treatments are needed
  • Better tolerated, safer drugs are desired

BIBLIOGRAPHY

APPENDIX

LIST OF FIGURES
Figure 1: 2015 ACR treatment algorithm for patients with symptomatic early RA
Figure 2: 2015 ACR treatment algorithm for patients with established RA
Figure 3: 2015 ACR recommendations for patients with single TNFi failure in established RA
Figure 4: 2015 ACR recommendations for patients with single non-TNF biologic failure in established RA
Figure 5: Trends in prevalent cases of rheumatoid arthritis, 2018–27
Figure 6: Overview of pipeline drugs for rheumatoid arthritis in the US
Figure 7: Pipeline drugs for rheumatoid arthritis, by company
Figure 8: Pipeline drugs for rheumatoid arthritis, by drug type
Figure 9: Pipeline drugs for rheumatoid arthritis, by classification
Figure 10: Probability of success in the rheumatoid arthritis pipeline
Figure 11: Clinical trials in rheumatoid arthritis
Figure 12: Top 10 drugs for clinical trials in rheumatoid arthritis
Figure 13: Top 10 companies for clinical trials in rheumatoid arthritis
Figure 14: Trial locations in rheumatoid arthritis
Figure 15: Rheumatoid arthritis trials status
Figure 16: Rheumatoid arthritis trials sponsors, by phase
Figure 17: The publisher’s drug assessment summary for rheumatoid arthritis
Figure 18: Market dynamics in rheumatoid arthritis
Figure 19: Future trends in rheumatoid arthritis
Figure 20: Jyseleca for Rheumatoid Arthritis (March 4, 2021): Phase II - MANTA-RAy
Figure 21: Xeljanz/Xeljanz XR for Rheumatoid Arthritis (January 27, 2021): Phase IIIb/IV - ORAL Surveillance (A3921133)
Figure 22: ATI-450 for Rheumatoid Arthritis (January 19, 2021): Phase IIa - POC
Figure 23: ABBV-3373 for Rheumatoid Arthritis (June 10, 2020): Phase II - M16-560
Figure 24: Rinvoq for Rheumatoid Arthritis (June 6, 2020): Phase III - SELECT-CHOICE
Figure 25: Key upcoming events in rheumatoid arthritis

LIST OF TABLES
Table 1: 2015 ACR recommendations for patients with symptomatic early RA
Table 2: 2015 ACR recommendations for patients with established RA
Table 3: 2016 EULAR recommendations for the management of RA
Table 4: Prevalent cases of rheumatoid arthritis, 2018–27
Table 5: Marketed drugs for rheumatoid arthritis
Table 6: Pipeline drugs for rheumatoid arthritis in the US
Table 7: Historical global sales, by drug ($m), 2016–20
Table 8: Forecasted global sales, by drug ($m), 2021–25
Table 9: Jyseleca for Rheumatoid Arthritis (March 4, 2021)
Table 10: Xeljanz/Xeljanz XR for Rheumatoid Arthritis (January 27, 2021)
Table 11: ATI-450 for Rheumatoid Arthritis (January 19, 2021)
Table 12: Piclidenoson for Rheumatoid Arthritis (October 6, 2020)
Table 13: Jyseleca for Rheumatoid Arthritis (August 18, 2020)
Table 14: ABBV-3373 for Rheumatoid Arthritis (June 10, 2020)
Table 15: Rinvoq for Rheumatoid Arthritis (June 6, 2020)
Note: Product cover images may vary from those shown