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07.08.2025 - 18:06:39Idiopathic Inflammatory Myositis Market Predicted to Show Positive Growth at a Tremendous CAGR of 21.1% by 2034 | DelveInsight
Key Takeaways from the Idiopathic Inflammatory Myositis Market Report
According to DelveInsight's analysis, the market size for idiopathic inflammatory myositis was found to be USD 447 million in the 7MM in 2023.As per the estimates, among the therapies currently in use, immunoglobulins held the largest market share, generating approximately USD 270.3 million in revenue in 2023 across the 7MM.The total diagnosed prevalent cases of idiopathic inflammatory myositis in the 7MM were approximately 191K cases in 2023, which are expected to increase during the forecast period (2020–2034).Leading idiopathic inflammatory myositis companies such as Pfizer, Argenx, AstraZeneca, Priovant Therapeutics, CSL Behring, Abcuro, Inc., Amgen, Janssen, Galapagos NV, Immunoforge, Merck KGaA (EMD Serono Research & Development Institute), Cabaletta Bio, Restem, and others are developing novel idiopathic inflammatory myositis drugs that can be available in the idiopathic inflammatory myositis market in the coming years.The promising idiopathic inflammatory myositis therapies in the pipeline include Dazukibart, Efgartigimod, SAPHNELO (Anifrolumab), Brepocitinib, HIZENTRA, Empasiprubart, Ulviprubart (ABC008), Daxdilimab, Nipocalimab, Froniglutide (PF1801), GLPG3667, Enpatoran (M5049), CABA-201, Umbilical Cord Lining Stem Cells (ULSC), and others.In November 2024, argenx decided to continue developing efgartigimod SC (efgartigimod alfa and hyaluronidase-qvfc) in the ongoing Phase 2/3 ALKIVIA study for adults with idiopathic inflammatory myopathies. The decision was based on topline results from the Phase 2 portion, which met the primary endpoint by demonstrating a statistically significant treatment effect in the mean total improvement score (TIS) at Week 24. Additionally, improvements were observed across all six core set measures of the TIS, favoring efgartigimod SC over placebo.Discover which therapies are expected to grab the major idiopathic inflammatory myositis market share @ Idiopathic Inflammatory Myositis Market Report
Idiopathic Inflammatory Myositis Overview
Idiopathic inflammatory myositis (IIM) is a rare autoimmune disorder that leads to muscle inflammation, causing muscle weakness, and in some cases, skin rashes. It encompasses several conditions, including polymyositis, dermatomyositis, inclusion body myositis, and necrotizing autoimmune myopathy. The exact cause of IIM is unknown, but it is thought to be triggered by an autoimmune response where the body's immune system mistakenly attacks its own muscle tissues. Genetic, environmental, and infectious factors may contribute to the development of the condition.
Symptoms of IIM typically include progressive muscle weakness, especially in the upper arms, thighs, neck, and shoulders. Patients may also experience fatigue, difficulty swallowing (dysphagia), joint pain, and in the case of dermatomyositis, a characteristic rash. The rash can appear as red or purple discoloration over the eyelids (heliotrope rash) or a raised, scaly rash on the knuckles (Gottron's papules).
Diagnosis involves a combination of clinical examination, blood tests, muscle biopsy, and imaging studies. Blood tests often reveal elevated levels of muscle enzymes, such as creatine kinase (CK), which indicate muscle damage. Electromyography (EMG) can assess muscle electrical activity, while MRI may show muscle inflammation. In certain cases, a muscle biopsy is required to confirm the diagnosis by evaluating tissue samples for signs of inflammation and muscle damage. Identifying specific autoantibodies can also assist in diagnosis and help determine the subtype of IIM.
Idiopathic Inflammatory Myositis Epidemiology Segmentation
The idiopathic inflammatory myositis epidemiology section provides insights into the historical and current idiopathic inflammatory myositis patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The idiopathic inflammatory myositis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory MyositisIdiopathic Inflammatory Myositis Treatment Market
Idiopathic inflammatory myositis, while classified as a rare disease, has become more widely recognized in recent years, thanks to advancements in diagnostic methods, increased awareness among healthcare professionals, and a deeper understanding of the disease. This growing recognition, along with the rising number of diagnosed cases, could fuel the IIM market growth as more patients seek treatment. The management of this condition generally involves a combination of pharmacological treatments and supportive therapies, with the main goals being to reduce inflammation, control symptoms, preserve muscle function, and prevent complications.
The treatment landscape for idiopathic inflammatory myositis has evolved to include a comprehensive approach, combining medications, physical therapy, and supportive care. First-line treatments often include high-dose corticosteroids like prednisone or ACTHAR GEL to control inflammation and immune responses. Immunosuppressants, such as methotrexate, azathioprine, and tacrolimus, are commonly used to minimize long-term steroid use.
When response to initial therapies is inadequate, biologics like rituximab may be used for targeted immune suppression. Physical therapy remains a crucial component for maintaining muscle strength and function, while additional supportive treatments like NSAIDs and sun protection help alleviate symptoms. Intravenous Immunoglobulin (IVIG) therapy, with OCTAGAM 10% approved in the US and Europe and VENOGLOBULIN-IH 5% available in Japan, is another option.
For severe, treatment-resistant cases, IV cyclophosphamide may be considered, although its use is limited due to potentially severe side effects. Treatment plans are individualized based on disease severity and patient response, striving to balance efficacy with minimizing adverse effects. There is a significant unmet need for new treatments for idiopathic inflammatory myositis, as current therapies often do not fully manage the condition.
To know more about idiopathic inflammatory myositis treatment guidelines, visit @ Idiopathic Inflammatory Myositis Management
Idiopathic Inflammatory Myositis Pipeline Therapies and Key Companies
Dazukibart PF-06823859 (anti-beta interferon): PfizerEfgartigimod: ArgenxSAPHNELO (Anifrolumab): AstraZenecaBrepocitinib: Priovant Therapeutics/PfizerHIZENTRA: CSL BehringEmpasiprubart: ArgenxUlviprubart (ABC008): Abcuro, Inc.Daxdilimab: AmgenNipocalimab: JanssenFroniglutide (PF1801): ImmunoforgeGLPG3667: Galapagos NVEnpatoran (M5049): Merck KGaA (EMD Serono Research & Development Institute)CABA-201: Cabaletta BioUmbilical Cord Lining Stem Cells (ULSC): RestemDiscover more about idiopathic inflammatory myositis drugs in development @ Idiopathic Inflammatory Myositis Clinical Trials
Idiopathic Inflammatory Myositis Market Dynamics
The idiopathic inflammatory myositis market is driven by several key factors, including the increasing prevalence of autoimmune diseases and advancements in diagnostic technologies. As awareness of IIM rises, early detection and accurate diagnosis are becoming more feasible, leading to timely interventions and better patient outcomes. Additionally, the growing understanding of the underlying pathophysiology of IIM is propelling the development of targeted therapies, such as biologics and immune-modulating drugs. The demand for personalized treatments tailored to individual genetic profiles is also pushing innovation in the market.
Furthermore, the rising healthcare expenditure and improved access to specialized care contribute to the market's growth, particularly in developed regions. Finally, ongoing clinical trials and research into novel treatment options continue to fuel optimism for better management and potential cures for IIM, further accelerating the market's expansion.
Potential therapies are being investigated for the treatment of idiopathic inflammatory myositis, and it is safe to predict that the treatment space will significantly impact the idiopathic inflammatory myositis market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the idiopathic inflammatory myositis market in the 7MM.
However several factors may impede the growth of the idiopathic inflammatory myositis market. One of the primary challenges is the rarity and heterogeneous nature of IIM, which makes it difficult to diagnose and classify accurately. This complicates the development of targeted therapies and slows the recruitment of patients for clinical trials, limiting the scope for market expansion. Additionally, the lack of standardized diagnostic criteria and the complexity of managing the disease, which often involves multidisciplinary care, create barriers to effective treatment and patient outcomes.
High costs associated with specialized treatments, coupled with reimbursement issues in many regions, further restrict access to therapies. Moreover, the limited understanding of the disease pathophysiology and the lack of robust biomarkers for monitoring disease progression present additional hurdles for both research and treatment optimization. As a result, these factors collectively impede the growth potential of the IIM market, requiring ongoing innovation and policy support to overcome.
Idiopathic Inflammatory Myositis Market Report Metrics
Details
Study Period
2020–2034
Coverage
7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Idiopathic Inflammatory Myositis Market CAGR
21.1 %
Idiopathic Inflammatory Myositis Market Size in 2023
USD 447 Million
Key Idiopathic Inflammatory Myositis Companies
Pfizer, Argenx, AstraZeneca, Priovant Therapeutics, CSL Behring, Abcuro, Inc., Amgen, Janssen, Galapagos NV, Immunoforge, Merck KGaA (EMD Serono Research & Development Institute), Cabaletta Bio, Restem, and others
Key Pipeline Idiopathic Inflammatory Myositis Therapies
Dazukibart, Efgartigimod, SAPHNELO (Anifrolumab), Brepocitinib, HIZENTRA, Empasiprubart, Ulviprubart (ABC008), Daxdilimab, Nipocalimab, Froniglutide (PF1801), GLPG3667, Enpatoran (M5049), CABA-201, Umbilical Cord Lining Stem Cells (ULSC), and others
Scope of the Idiopathic Inflammatory Myositis Market Report
Therapeutic Assessment: Idiopathic Inflammatory Myositis current marketed and emerging therapiesIdiopathic Inflammatory Myositis Market Dynamics: Key Market Forecast Assumptions of Emerging Idiopathic Inflammatory Myositis Drugs and Market OutlookCompetitive Intelligence Analysis: SWOT analysis and Market entry strategiesUnmet Needs, KOL's views, Analyst's views, Idiopathic Inflammatory Myositis Market Access and ReimbursementDownload the report to understand which factors are driving idiopathic inflammatory myositis market trends @ Idiopathic Inflammatory Myositis Market Trends
Table of Contents
1
Key Insights
2
Report Introduction
3
Market Overview at a Glance
3.1
Market Share (%) Distribution of Idiopathic Inflammatory Myositis in 2020
3.2
Market Share (%) Distribution of Idiopathic Inflammatory Myositis in 2034
4
Epidemiology and Market Forecast Methodology
5
Executive Summary
6
Key Events
7
Disease Background and Overview
7.1
Introduction
7.2
Clinical Manifestations
7.3
Etiology and Risk Factors
7.4
Pathophysiology
7.5
Diagnosis
7.5.1
Differential Diagnosis
7.5.2
Diagnostic Criteria
7.5.2.1
Bohan and Peter's Diagnostic Criteria for Polymyositis and Dermatomyositis
7.5.3
Diagnostic Algorithm
7.5.4
Diagnostic Guidelines
7.5.4.1
The European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile IIM: 2017
7.6
Treatment
7.6.1
Treatment Algorithm
7.6.2
Treatment Guidelines
7.6.2.1
British Society for Rheumatology Guideline on Management of Pediatric, Adolescent, and Adult Patients with IIM
8
Patient Journey
9
Epidemiology and Patient Population
9.1
Key Findings
9.2
Assumptions and Rationale: The 7MM
9.3
Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the 7MM
9.4
The US
9.4.1
Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US
9.4.2
Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US
9.4.3
Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US
9.4.4
Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in the US
9.5
EU4 and the UK
9.5.1
Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK
9.5.2
Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK
9.5.3
Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK
9.5.4
Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in EU4 and the UK
9.6
Japan
9.6.1
Total Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan
9.6.2
Type-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan
9.6.3
Gender-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan
9.6.4
Age-specific Diagnosed Prevalent Cases of Idiopathic Inflammatory Myositis in Japan
10
Marketed Drugs
10.1
Key Cross Competition
10.2
OCTAGAM 10% (Intravenous Immune Globulin [Human]): Octapharma/Pfizer
10.2.1
Product Description
10.2.2
Product Profile
10.2.3
Regulatory Milestone
10.2.4
Other Developmental Activities
10.2.5
Clinical Trials Information
10.2.6
Safety and Efficacy
10.3
VENOGLOBULIN-IH 5% IV (Human Immunoglobulin G): Mitsubishi Tanabe Pharma
10.3.1
Product Description
10.3.2
Product Profile
10.3.3
Regulatory Milestone
10.3.4
Other Developmental Activities
10.3.5
Clinical Trials Information
10.3.6
Safety and Efficacy
11
Emerging Drugs
11.1
Key Cross Competition
11.2
Dazukibart PF-06823859 (anti-beta interferon): Pfizer
11.2.1
Drug Description
11.2.2
Drug Profile
11.2.3
Other Developmental Activities
11.2.4
Clinical Trials Information
11.2.5
Safety and Efficacy
11.2.6
Analyst Views
11.3
Efgartigimod: Argenx
11.3.1
Drug Description
11.3.2
Drug Profile
11.3.3
Clinical Trials Information
11.4
SAPHNELO (Anifrolumab): AstraZeneca
11.4.1
Drug Description
11.4.2
Drug Profile
11.4.3
Other Developmental Activities
11.4.4
Clinical Trials Information
11.4.5
Analyst Views
11.5
Brepocitinib: Priovant Therapeutics/Pfizer
11.5.1
Drug Description
11.5.2
Drug Profile
11.5.3
Other Developmental Activities
11.5.4
Clinical Trials Information
11.5.5
Safety and Efficacy
11.5.6
Analyst Views
11.6
HIZENTRA: CSL Behring
11.6.1
Drug Description
11.6.2
Drug Profile
11.6.3
Other Developmental Activities
11.6.4
Clinical Trials Information
11.6.5
Analysts' View
11.7
Empasiprubart: Argenx
11.7.1
Drug Description
11.7.2
Drug Profile
11.7.3
Clinical Trials Information
11.8
Ulviprubart (ABC008): Abcuro, Inc.
11.8.1
Drug Description
11.8.2
Drug Profile
11.8.3
Other Development Activities
11.8.4
Clinical Trial Information
11.8.5
Safety and Efficacy
11.8.6
Analyst Views
11.9
Daxdilimab: Amgen
11.9.1
Drug Description
11.9.2
Drug Profile
11.9.3
Other Developmental Activities
11.9.4
Clinical Trials Information
11.10
Nipocalimab: Janssen
11.10.1
Drug Description
11.10.2
Drug Profile
11.10.3
Other Development Activities
11.10.4
Clinical Trials Information
11.11
Froniglutide (PF1801): Immunoforge
11.11.1
Drug Description
11.11.2
Drug Profile
11.11.3
Other Developmental Activities
11.11.4
Clinical Trials Information
11.12
GLPG3667: Galapagos NV
11.12.1
Drug Description
11.12.2
Drug Profile
11.12.3
Clinical Trials Information
11.12.4
Safety and Efficacy
11.13
Enpatoran (M5049): Merck KGaA (EMD Serono Research & Development Institute)
11.13.1
Drug Description
11.13.2
Drug Profile
11.13.3
Clinical Trials Information
11.14
CABA-201: Cabaletta Bio
11.14.1
Drug Description
11.14.2
Drug Profile
11.14.3
Other Developmental Activities
11.14.4
Clinical Trials Information
11.14.5
Safety and Efficacy
11.14.6
Analyst Views
11.15
Umbilical Cord Lining Stem Cells (ULSC): Restem
11.15.1
Drug Description
11.15.2
Drug Profile
11.15.3
Clinical Trials Information
11.15.4
Safety and Efficacy
12
Idiopathic Inflammatory Myositis: Market Analysis
12.1
Key Findings
12.2
Key Market Forecast Assumptions
12.2.1
Cost Assumptions and Rebates
12.2.2
Pricing Trends
12.2.3
Analogue Assessment
12.2.4
Launch Year and Therapy Uptake
12.3
Market Outlook
12.4
Attribute Analysis
12.5
Total Market Size of Idiopathic Inflammatory Myositis in the 7MM
12.6
Total Market Size of Idiopathic Inflammatory Myositis by Therapies in the 7MM
12.7
Total Market Size of Idiopathic Inflammatory Myositis in the US
12.7.1
Total Market Size of Idiopathic Inflammatory Myositis
12.7.2
The Market Size of Idiopathic Inflammatory Myositis by Therapies in the US
12.8
Market Size of Idiopathic Inflammatory Myositis in EU4 and the UK
12.8.1
Total Market Size of Idiopathic Inflammatory Myositis in EU4 and the UK
12.8.2
The Market Size of Idiopathic Inflammatory Myositis by Therapies in EU4 and the UK
12.9
Market Size of Idiopathic Inflammatory Myositis in Japan
12.9.1
Total Market Size of Idiopathic Inflammatory Myositis in Japan
12.9.2
The Market Size of Idiopathic Inflammatory Myositis by Therapies in Japan
13
Key Opinion Leaders' Views
14
SWOT Analysis
15
Unmet Needs
16
Market Access and Reimbursement
16.1
The United States
16.1.1
Centre for Medicare & Medicaid Services (CMS)
16.2
In EU4 and the UK
16.2.1
Germany
16.2.2
France
16.2.3
Italy
16.2.4
Spain
16.2.5
The United Kingdom
16.3
Japan
16.3.1
MHLW
17
Appendix
17.1
Bibliography
17.2
Acronyms and Abbreviations
17.3
Report Methodology
18
DelveInsight Capabilities
19
Disclaimer
20
About DelveInsight
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