Idiopathic Inflammatory Myopathies (IIMs) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Idiopathic Inflammatory Myopathies (IIMs) Market Outlook and Forecast

Idiopathic Inflammatory Myopathies (IIMs) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Published Date : 2023-03-09

Updated On : 2024-01-04

Pages : 157

Idiopathic Inflammatory Myopathies (IIMs) Market Outlook

Thelansis’s “Idiopathic Inflammatory Myopathies (IIMs) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Idiopathic inflammatory myopathies treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Idiopathic Inflammatory Myopathies (IIMs) Overview

Idiopathic inflammatory myopathies (IIMs) represent a cluster of autoimmune disorders marked by muscle inflammation (myositis) and involvement of other organs, leading to broad organ dysfunction, heightened morbidity, and premature mortality. Presently, IIMs are categorized into distinct subtypes:

  1. Dermatomyositis (DM) includes classic dermatomyositis, juvenile dermatomyositis, and clinical amyopathic dermatomyositis. These may be linked with connective tissue disorders (CTDs) and malignancies
  2. Polymyositis (PM), comprising classical PM and nonspecific or overlap myositis, is often associated with CTDs
  3. Autoimmune necrotizing myopathy, connected with malignancies, statin use, and CTDs
  4. Sporadic IBM is occasionally associated with CTDs

These conditions arise due to prolonged immune activity triggered by exposure to environmental risk factors in individuals with a genetic predisposition. Diagnosing IIM can be straightforward when patients display typical muscle weakness, evident multisystem involvement, and a consistent serological profile. However, in clinical settings, many patients present with nonspecific symptoms such as fever, fatigue, myalgia, and arthralgia. Typically, IIM manifests acute or subacute symmetrical muscle weakness in proximal and leg muscles. This weakness may manifest as difficulty in simple tasks like combing hair or rising from a chair, and in severe cases, it may affect functions like speech or swallowing. Corticosteroids are the cornerstone of treatment for polymyositis and dermatomyositis (PM/DM), with prednisone usually starting at 1 to 2 mg/kg/day. In severe cases, intravenous methylprednisolone at 1 mg/kg/day for three consecutive days may be administered. Steroid-sparing therapies like methotrexate and azathioprine are options for those experiencing adverse effects or difficulties tapering off steroids, especially in individuals with normal thiopurine methyltransferase (TPMT) activity.

  • The estimated prevalence of IIM ranges from 14.0 to 21.4 cases per 100,000 population in the United States.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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Idiopathic Inflammatory Myopathies (IIMs) Competitive Landscape

S. no Asset Company Stage
1 CAB-201 Cabaletta Bio Phase 2
2 ABC008 Abcuro, Inc. Phase 3
3 Froniglutide Immunoforge Co. Ltd. Phase 2
4 Daxdilimab Horizon Therapeutics Phase 2
5 EFG PH20 SC argenx Phase 3
6 Arimoclomol ZevraDenmark Phase 2
7 Palovarotene Ipsen Phase 2
8 Octagam Octapharma Phase 3
9 KYV-101 Kyverna Therapeutics Phase 1
10 KZR-616 Kezar Life Sciences, Inc. Phase 2

Continued...

KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.

COUNTRY No. Of KOLs
USA 17
GERMANY 4
UK 4
SPAIN 3
FRANCE 2
ITALY 3
JAPAN 3
CHINA 4

Idiopathic Inflammatory Myopathies (IIMs) Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.

Idiopathic Inflammatory Myopathies (IIMs) Market Forecast

1.  Idiopathic Inflammatory Myopathies (IIMs) – Key Findings Summary

         1.1.    Clinical findings
                     1.1.1. Disease overview
                     1.1.2. Therapeutic practices
                     1.1.3. Future outlook
         1.2.    Commercial findings
                     1.2.1. Idiopathic Inflammatory Myopathies (IIMs) market scenario 2023
                     1.2.2. Idiopathic Inflammatory Myopathies (IIMs) market scenario 2028
                     1.2.3. Idiopathic Inflammatory Myopathies (IIMs) market scenario 2033

2. Idiopathic Inflammatory Myopathies (IIMs) Overview

         2.1.    Disease Introduction
         2.2.    Pathophysiology
         2.3.    Signs and Symptoms
         2.4.    Risk Factors
         2.5.    Etiology
         2.6.    Classification
         2.7.    Pathogenesis
         2.8.    Diagnosis
         2.9.    Complications
         2.10. Treatment Algorithm
                     2.10.1.    Treatment in US (guidelines)
                     2.10.2.    Treatment in EU-5 (guidelines)
                     2.10.3.    Treatment in Japan (guidelines)
                     2.10.4.    Treatment in China (guidelines)
         2.11. Treatment Goals for Idiopathic Inflammatory Myopathies (IIMs)
         2.12. Referral Patterns
                     2.12.1.    Referral Scenario in US
                     2.12.2.    Referral Scenario in EU-5
                     2.12.3.    Referral Scenario in Japan
                     2.12.4.    Referral Scenario in China
         2.13. Idiopathic Inflammatory Myopathies (IIMs) Prognosis
         2.14. Healthcare burden
                     2.14.1.    Healthcare burden in US
                     2.14.2.    Healthcare burden in EU-5
                     2.14.3.    Healthcare burden in Japan
                     2.14.4.    Healthcare burden in China
         2.15.  Unmet Needs in Idiopathic Inflammatory Myopathies (IIMs) management
         2.16.  Market Opportunity for Idiopathic Inflammatory Myopathies (IIMs)
         2.17. KOL Comments on current and upcoming/expected treatment practices in Idiopathic Inflammatory Myopathies (IIMs)

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1. Idiopathic Inflammatory Myopathies (IIMs) Epidemiology in US (2023-2033)
                             3.2.1.1.              Incidence of Idiopathic Inflammatory Myopathies (IIMs)
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2. Idiopathic Inflammatory Myopathies (IIMs) Epidemiology in EU-5 (2023-2033)
                             3.2.2.1.              Incidence of Idiopathic Inflammatory Myopathies (IIMs)
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3. Idiopathic Inflammatory Myopathies (IIMs) Epidemiology in Japan (2023-2033)
                             3.2.3.1.              Incidence of Idiopathic Inflammatory Myopathies (IIMs)
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4. Idiopathic Inflammatory Myopathies (IIMs) Epidemiology in China (2023-2033)
                             3.2.4.1.              Incidence of Idiopathic Inflammatory Myopathies (IIMs)
                             3.2.4.2.              Diagnosed cases
                             3.2.4.3.              Treatable Patient Pool
                             3.2.4.4.              Epidemiology Trends
         3.3.    Epidemiology Trends (World-wide)

4.       Market Outlook

         4.1.    US Idiopathic Inflammatory Myopathies (IIMs) Market Forecast 2023-2033
                     4.1.1. Market Progression (Futuristic)
                     4.1.2. Market Trends and Expectations
                             4.1.2.1.              Worst case scenario
                             4.1.2.2.              Base Case Scenario
                             4.1.2.3.              Best Case Scenario
                     4.1.3. Drivers and Barriers
         4.2.    UK Idiopathic Inflammatory Myopathies (IIMs) Market Forecast 2023-2033
                     4.2.1. Market Progression (Futuristic)
                     4.2.2. Market Trends and Expectations
                             4.2.2.1.              Worst case scenario
                             4.2.2.2.              Base Case Scenario
                             4.2.2.3.              Best Case Scenario
                     4.2.3. Drivers and Barriers
         4.3.    France Idiopathic Inflammatory Myopathies (IIMs) Market Forecast 2023-2033
                     4.3.1. Market Progression (Futuristic)
                     4.3.2. Market Trends and Expectations
                             4.3.2.1.              Worst case scenario
                             4.3.2.2.              Base Case Scenario
                             4.3.2.3.              Best Case Scenario
                     4.3.3. Drivers and Barriers
         4.4.    Germany Idiopathic Inflammatory Myopathies (IIMs) Market Forecast 2023-2033
                     4.4.1. Market Progression (Futuristic)
                     4.4.2. Market Trends and Expectations
                             4.4.2.1.              Worst case scenario
                             4.4.2.2.              Base Case Scenario
                             4.4.2.3.              Best Case Scenario
                     4.4.3. Drivers and Barriers
         4.5.    Italy Idiopathic Inflammatory Myopathies (IIMs) Market Forecast 2023-2033
                     4.5.1. Market Progression (Futuristic)
                     4.5.2. Market Trends and Expectations
                             4.5.2.1.              Worst case scenario
                             4.5.2.2.              Base Case Scenario
                             4.5.2.3.              Best Case Scenario
                     4.5.3. Drivers and Barriers
         4.6.    Spain Idiopathic Inflammatory Myopathies (IIMs) Market Forecast 2023-2033
                     4.6.1. Market Progression (Futuristic)
                     4.6.2. Market Trends and Expectations
                             4.6.2.1.              Worst case scenario
                             4.6.2.2.              Base Case Scenario
                             4.6.2.3.              Best Case Scenario
                     4.6.3. Drivers and Barriers
         4.7.    Japan Idiopathic Inflammatory Myopathies (IIMs) Market Forecast 2023-2033
                     4.7.1. Market Progression (Futuristic)
                     4.7.2. Market Trends and Expectations
                             4.7.2.1.              Worst case scenario
                             4.7.2.2.              Base Case Scenario
                             4.7.2.3.              Best Case Scenario
                     4.7.3. Drivers and Barriers
         4.8.    China Idiopathic Inflammatory Myopathies (IIMs) Market Forecast 2023-2033
                     4.8.1. Market Progression (Futuristic)
                     4.8.2. Market Trends and Expectations
                             4.8.2.1.              Worst case scenario
                             4.8.2.2.              Base Case Scenario
                             4.8.2.3.              Best Case Scenario
                     4.8.3. Drivers and Barriers
         4.9.    Key Expected Milestones (world-wide) Impacting the Market

5.       Competitive Landscape

         5.1.    Pipeline Therapies Overview
                     5.1.1. Phase III Therapies
                                      5.1.1.1.                     Current Status
                                      5.1.1.2.                     Trial details, results
                                      5.1.1.3.                     Approval Timeline
                                      5.1.1.4.                     Likelihood of approval
                                      5.1.1.5.                     Expected Product Positioning
                             5.1.1.2.              All other Phase III Therapies …..
                             5.1.1.3.              Attribute Analysis of Phase III molecules
                     5.1.2.  Phase II and Phase I/II Therapies
                                      5.1.2.1.                     Current Status
                                      5.1.2.2.                     Trial details, results
                                      5.1.2.3.                     Approval Timelines
                     5.1.3. List of active Pre-clinical Therapies
                                      5.1.3.1.                     Status in Idiopathic Inflammatory Myopathies (IIMs)
                                      5.1.3.2.                     Company positioning
                             5.1.3.2.              All other pre-clinical therapies
                     5.1.4. List of Inactive/discontinued assets
                             5.1.4.1.              Business impact of discontinuations on current pipeline
                     5.1.5. Potential winners from Idiopathic Inflammatory Myopathies (IIMs) Pipeline
                             5.1.5.1.              Potential Blockbusters across the pipeline

6.       Regulatory/Approval Scenario

         6.1.    Regulatory/Approval Framework in US
                     6.1.1. Policy Framework
                     6.1.2. Payer Expectations
         6.2.    Regulatory/Approval Framework in UK
                     6.2.1. Policy Framework
                     6.2.2. Payer Expectations
         6.3.    Regulatory/Approval Framework in France
                     6.3.1. Policy Framework
                     6.3.2. Payer Expectations
         6.4.    Regulatory/Approval Framework in Germany
                     6.4.1. Policy Framework
                     6.4.2. Payer Expectations
         6.5.    Regulatory/Approval Framework in Italy
                     6.5.1. Policy Framework
                     6.5.2. Payer Expectations
         6.6.    Regulatory/Approval Framework in Spain
                     6.6.1. Policy Framework
                     6.6.2. Payer Expectations
         6.7.       Regulatory/Approval Framework in Japan
                     6.7.1. Policy Framework
                     6.7.2. Payer Expectations
         6.8.       Regulatory/Approval Framework in China
                     6.8.1. Policy Framework
                     6.8.2. Payer Expectations

7.       Clinical Trial Assessment – Current and Future Paradigm

         7.1.    Distribution of Primary Endpoints across trials
         7.2.    Distribution of Secondary Endpoints across trials
         7.3.    Evolution and acceptance of surrogate endpoints
         7.4.    Key Investigator initiated trials
         7.5.    Attrition analysis
                     7.5.1. Suspended/Discontinued Assets
                     7.5.2. Failed Trials, Reasons and Business Impact
                     7.5.3. Terminated Trials, Reasons and Business Impact
                     7.5.4. Withdrawn Trials, Reasons and Business Impact
         7.6.    Trial enrollment scenario and challenges
         7.7.    Clinical Trial Guidance (across geographies)

8.       Thelansis Commentary

         8.1.    Key Unmet needs in Idiopathic Inflammatory Myopathies (IIMs)
         8.2.    Possible Best-case Clinical Trial Strategies
         8.3.    Possible Best Case Targeted Product Profile (TPP)
         8.4.    Possible Best-case Market positioning strategies
         8.5.    Possible Best-case Market Access Strategies
         8.6.    Possible Best-case LCM Strategies
         8.7.    Overall View on Idiopathic Inflammatory Myopathies (IIMs) Market in Dollar Value

9.       Report Methodology

         9.1.    Secondary research
         9.2.    Primary research
         9.3.    Data collation
         9.4.    Insight Generation

10.   About Thelansis

         10.1.    Our Capabilities
         10.2.    Our Services
         10.3.    Our Contacts
         10.4.    Disclaimer