Rheumatoid Arthritis | Landscape & Forecast | Disease Landscape & Forecast

Publish date: June 2019

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AbbVie’s JAK inhibitor, upadacitinib, is under regulatory review in both the United States and Europe for the treatment of adult moderate to severe RA. In December 2018, following positive results from its Phase III SELECT program, AbbVie submitted an NDA to the FDA and MAA to the EMA for its JAK inhibitor, upadacitinib. The application was accepted in the United States in February 2019 with a priority review designation (AbbVie used a priority review voucher to ensure an expedited review process); as such, the FDA will attempt to rule on the NDA within six months (as opposed to the more standard ten month review time), and we expect approval to follow in Q3 2019. Upadacitinib will be the third oral JAK inhibitor to enter the U.S. and EU markets for RA, and will face the challenge of competing with earlier to market agents within the drug class (i.e., Pfzer’s Xeljanz and Eli Lilly’s Olumiant) in both regions. However, the drug will also benefit from AbbVie’s extensive marketing experience in the rheumatology space. For more information on this drug’s clinical profile, together with KOL insight and future market potential, please see “Emerging Therapies” and “Market Outlook.” 

Additionally, Astellas’s JAK inhibitor, peficitinib, was approved—brand name Smyraf—in March 2019 by the MHLW in Japan for the treatment of RA (including prevention of structural joint damage) in patients who have an inadequate response to conventional therapies. Previously, Astellas and Janssen were collaborating on peficitinib’s development in the United States, Europe, and Japan, but Janssen terminated the collaboration in early 2015 following negative results from the drug’s Phase II program. Astellas continued the drug’s development in Japan, and after meeting the primary efficacy endpoints in two Phase III studies (based primarily in Japan), the company applied for marketing authorization in mid 2018. Given the lack of continued development in the United States and Europe, no approvals in these regions are expected. For more information on this drug’s clinical profile and market potential, please see “Emerging Therapies” and “Market Outlook.”

Table of contents

  • Disease Landscape & Forecast
    • Key Updates
      • June 2019
      • October 2018
      • September 2018
      • July 2018
    • Market Outlook
      • Key Findings
        • Market Overview
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for Rheumatoid Arthritis?
        • What Factors Are Constraining the Market for Rheumatoid Arthritis?
      • Drug-Class-Specific Trends
        • TNF-Alpha Inhibitors
        • Selective Costimulation Modulators
        • B-Cell-Targeted Therapies
        • Interleukin-6 Inhibitors
        • Jak Inhibitors
        • RANKL Inhibitors
        • Adenosine Receptor Agonists
        • Conventional DMARDs
    • Forecast
      • Market Forecast Assumptions
      • Market Forecast Dashboard
    • Etiology and Pathophysiology
      • Disease Overview
        • Disease Overview
      • Etiology
        • Genetic Factors
        • Environmental Risk Factors
      • Pathophysiology
        • Disease Progression
        • Adaptive and Innate Immune Responses in Disease Pathogenesis
      • Key Pathways and Drug Targets
    • Epidemiology Overview
      • Key Findings
      • Epidemiology Populations
        • Total Prevalent Cases
        • Severity
        • Diagnosed Prevalent Cases of Rheumatoid Arthritis
        • Drug-Treated Cases of Rheumatoid Arthritis
    • Current Treatment
      • Key Findings
      • Treatment Goals
      • Key Current Therapies
        • Overview
        • TNF-Alpha Inhibitors
        • Selective Costimulation Modulators
        • B-Cell-Targeted Therapies
        • Interleukin-6 Inhibitors
        • Janus Kinase Inhibitors
        • RANKL Inhibitors
      • Medical Practice
        • Overview
        • Treatment Guidelines
        • Country-Specific Treatment Practices
    • Unmet Need Overview
      • Current and Future Attainment of Unmet Needs in Rheumatoid Arthritis
    • Emerging Therapies
      • Key Findings
        • Expert Insight
      • Key Emerging Therapies
        • Notable Developments in the Late-Phase Pipeline for Rheumatoid Arthritis
        • Jak Inhibitors
        • Interleukin-6 Inhibitors
        • Adenosine Receptor Agonists
      • Early-Phase Pipeline Analysis
        • Notable Developments in the Early-Phase Pipeline for Rheumatoid Arthritis
      • Key Discontinuations and Failures in Rheumatoid Arthritis
    • Access & Reimbursement Overview
      • Region-Specific Reimbursement Practices
        • United States
        • EU5
        • Japan
      • Looking for More?
    • Methodology
      • Bottom-Up Forecasting Overview
        • Patient Populations
        • Drug-Specific Assumptions
      • Bottom-Up Forecast Assumptions
        • General Sources of Data
        • Agents Included in Our Market Analysis
        • General Statements About Pricing
        • Dosing, Days of Therapy, and Compliance
        • Generic Erosion
        • Biosimilar Erosion
        • Out-Year Forecasting
        • Emerging Therapy Prices
      • Primary Market Research
        • Experts Interviewed
    • Appendix
      • Rheumatoid Arthritis Bibliography

Author(s): Hailing Yang, PhD; Andrea Buurma Kravit

Hailing Yang, is an analyst on the Immune and Inflammatory research team at Decision Resources Group, focusing primarily on psoriasis and psoriatic arthritis. In this role, he conducts primary research via interviews/surveys with medical experts and write market analysis deliverables designed for key decision-makers within the biopharmaceutical industry. Prior to joining DRG, Dr. Yang worked at Selecta Biosciences and Bioss USA Antibodies as a consultant. He studied brain cancer and received a from Tufts University, where he held an executive role for Tufts New England Case Competition. Dr. Yang earned a from Wuhan University in China.

Andrea Kravit is a director in Decision Resources Group’s Immune and Inflammatory division, where she manages, and supports, a team of therapeutically-aligned analysts who conduct extensive primary and secondary market research in the gastrointestinal and respiratory space. Prior to this role, she was a principal analyst for Decision Resources Group's Central Nervous Systems and Ophthalmology division, where she provided expert insight into the commercial aspects of drug development and market sizing across Pain indications. Her project experience includes patient-based market forecasting, market opportunity assessments, early to late-stage pipeline analyses, and competitive analytics for the life-science ;