Idiopathic Inflammatory Myopathies Market Assessment: Epidemiology, Treatment Landscape, Unmet Needs, Emerging Therapies, and Value & Access

Table of Contents

• A heterogenous group of chronic, autoimmune disorders marked by inflammation and weakness of the skeletal muscle
• Figure 1.1. Immune system involvement and druggable therapeutic targets in IIM
• There are no standardized classification criteria for IIMs
• Figure 1.2. Clinical manifestations in the IIM sub-types

• Disease definition
• Figure 2.1. Diagnosed prevalent cases of DM, ASyS, and IMNM by region
• Table 2.1. Diagnosed prevalent and drug-treated patients in the US and EU5

• Overview
• Figure 3.1. Referral and diagnostic pathway for IIM patients
• Autoantibody testing is useful in predicting the severity and disease course of IIM patients
• Table 3.1. Clinical presentation of IIM subtypes and associated antibodies
• All IIM patients need to be on drug therapy during the course of their disease
• Table 3.2. Treatment goals for DM, ASyS, and IMNM patients
• Figure 3.2. Physician-reported percentage of IIM patients receiving some form of drug therapy
• Treatment flow for DM, ASyS, and IMNM
• Immune suppression is the current backbone of IIM treatment
• Figure 3.3. Current treatment share for DM, IMNM, and ASyS patients
• Figure 3.4. Physician-reported rating of current therapy effectiveness in DM, IMNM, and ASyS
• Upsides and downsides of current IIM treatments
• Physicians’ perspectives on current treatment use in DM, ASyS, and IMNM
• Octagam 10% is the only FDA-approved treatment for DM; there are no approved therapies for other subtypes
• Table 3.3. Summary of the PRODERM trial results
• IIMs are characterized by frequent occurrences of remission and relapse
• Key treatment dynamics that will shape disease management and drug use in DM, ASyS, and IMNM
• Figure 3.5. Important dynamics of IIM market evolution

• Overview
• Figure 4.1. Top unmet needs in DM, IMNM, and ASyS
• Figure 4.2. Physician-reported unmet needs in DM, IMNM, and ASyS
• There is a high unmet need for FDA-approved treatments with fewer insurance barriers
• Figure 4.3. Neurologist-reported proportion of DM, IMNM, and ASyS who are not well-managed with current therapy options
• Figure 4.4. Physician-reported proportion of DM, IMNM, and ASyS patients who encounter these barriers to receiving drug therapy
• Physician perspectives on unmet needs in the diagnosis and treatment of IIM

• Overview
• Figure 5.1. Percentage of rheumatologists and neurologists (n=26) rating target as “promising” for DM, IMNM, and ASyS (score of 6 or 7)
• The pipeline for IIM is limited with three treatments in Phase 2/3 clinical development
• Table 5.1. Comparison of ongoing Phase 3 and Phase 2/3 trials of therapies for IIM
• The pipeline for DM is active; currently there are no industry-funded Phase 1 trials for IIM
• Table 5.2. Comparison of ongoing Phase 2 therapies for IIM
• Physician perspectives on novel, upcoming therapies are largely positive

• Overview
• Table 6.1. Current IIM therapy pricing, U.S.
• Table 6.2. Typical U.S. commercial payer coverage of Octagam 10%
• Key market access dynamics that will continue to shape treatment use
• Table 6.1. IIM patients by insurance type

• Primary market research approach
• Epidemiology methodology

Samples

Companies Mentioned

• Priovant
• CSL Behring
• Janssen
• argenx
• Alexion/AstraZeneca
• Pfizer
• Horizon Therapeutics
• Paean Biotechnology
• EMD Serono