Inclusion Body Myositis - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• IBM remains one of the most underrepresented subtypes within idiopathic inflammatory myopathies (IIMs), with rheumatologists citing it as particularly underserved amid increasing calls for faster, safer, and steroid-sparing treatments.
• There are currently no FDA-approved therapies for IBM; however, various off-label drugs such as glucocorticoids, methotrexate, cyclophosphamide, azathioprine, intravenous immunoglobulin (IVIG), and alemtuzumab are used in clinical practice.
• Off-label drugs offer limited or inconsistent benefit, leading to an unmet need for effective disease-modifying therapies.
• Several late-stage IBM drug programs have been discontinued, including bimagrumab (Novartis) for lack of functional benefit, arimoclomol (Orphazyme) for failing key endpoints, and sirolimus for limited efficacy and substantial side effects in some patients. These setbacks have substantially reduced IBM's pipeline, leaving only a limited number of candidates in development.
• The pipeline for IBM remains sparse, with few investigational drugs like ulviprubart currently in mid-to-late-stage clinical trials.
• Current innovation in IBM is focused on targeted immunotherapies like ulviprubart, which aim to slow disease progression, enhance muscle function, and address the limited effectiveness of conventional off-label treatments.

DelveInsight's "Inclusion Body Myositis (IBM) - Market Insight, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of IBM, historical and forecasted epidemiology, as well as the IBM market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The IBM market report provides current treatment practices, emerging drugs, IBM's share of individual therapies, and current and forecasted IBM market size from 2020 to 2034, segmented by seven major markets. The report also covers current IBM treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Inclusion Body Myositis (IBM) Disease Understanding and Treatment Algorithm

Inclusion Body Myositis (IBM) Overview

IBM is a rare, progressive muscle disease that typically affects men over 50, causing slow-onset, asymmetric weakness of the quadriceps and finger flexors, along with frequent falls and swallowing difficulties. It involves both autoimmune muscle fiber injury and degenerative protein accumulation, confirmed by a muscle biopsy showing rimmed vacuoles and inclusion bodies. Blood tests may show normal or mildly elevated creatine kinase, and the condition responds poorly to immunosuppressive therapy. Management is supportive, focusing on rehabilitation and symptom relief, as the disease gradually leads to significant disability.

Inclusion Body Myositis (IBM) Diagnosis

Diagnosis of IBM is based on a combination of clinical, laboratory, and histopathological findings. Clinically, the hallmark is slowly progressive, asymmetric muscle weakness affecting the quadriceps and finger flexors. Laboratory tests often show normal or mildly elevated creatine kinase levels. Electromyography typically reveals a mix of myopathic and neurogenic changes. The definitive diagnosis is made through muscle biopsy, which demonstrates characteristic features such as endomysial inflammation, rimmed vacuoles, and inclusion bodies containing abnormal protein aggregates. In some cases, MRI of the muscles can aid in detecting selective patterns of muscle involvement to guide biopsy.

Inclusion Body Myositis (IBM) Treatment

Treatment is primarily supportive, as there is currently no curative therapy, and the condition responds poorly to immunosuppressive drugs used in other inflammatory myopathies. Management focuses on maintaining mobility and function through physical and occupational therapy, preventing falls, and addressing complications such as dysphagia with dietary modifications or swallowing therapy. Assistive devices (e.g., braces, canes, wheelchairs) may be needed as the disease progresses. Experimental approaches, including novel immunotherapies, anti-inflammatory agents, and strategies targeting protein aggregation, are under investigation, but none have shown definitive long-term benefit to date.

Inclusion Body Myositis (IBM) Epidemiology

The IBM epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total prevalent cases of IBM, age-specific cases of IBM, and gender-specific cases of IBM in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• The prevalence of IBM is about 5 to 9 cases per million adults, and it varies with factors like geographic area, ethnicity, and age.
• In the US, the estimated number of IBM cases is approximately 20,000 to 25,000.
• IBM usually develops after the age of 50 and is more likely to affect men than women.
• The mean age at symptom onset for patients grouped by presenting symptom was 64.8 years for quadriceps weakness, 62.2 years for finger flexor weakness, and 67.7 years for swallowing difficulties, respectively.

Inclusion Body Myositis (IBM) Drug Chapters

Emerging Drugs

Ulviprubart (ABC008): Abcuro

Ulviprubart is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing naive, regulatory, and central memory T cells. Ulviprubart has been designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM). It is being evaluated in Phase II/III of development for the treatment of IBM.

In March 2025, Abcuro announced that they had presented safety, pharmacokinetic, and pharmacodynamics data from the Phase I clinical trial evaluating ulviprubart for the treatment of IBM at the American Academy of Neurology (AAN) Annual Meeting, taking place in California.

In June 2024, Abcuro announced the completion of enrollment of the registrational Phase II/III MUSCLE clinical trial evaluating ulviprubart for the treatment of IBM.

Drug Class Insight

In the emerging class of drugs, the cornerstone of therapy includes antibody-dependent cellular cytotoxicity, such as ulviprubart.

Antibody-dependent cellular cytotoxicity

Antibody-dependent cellular cytotoxicity is an immune mechanism in which antibodies bind to specific antigens on the surface of target cells, effectively "tagging" them for destruction. Once bound, the Fc region of the antibody is recognized by Fc gamma receptors (FcYR) on effector immune cells, primarily natural killer cells. This interaction activates the natural killer cells, prompting them to release cytotoxic molecules such as perforin, which creates pores in the target cell membrane, and granzymes, which enter the cell to trigger apoptosis. Through this process, the tagged harmful cells are selectively eliminated, allowing the immune system to clear them without broadly affecting healthy tissue.

Inclusion Body Myositis (IBM) Market Outlook

The therapeutic landscape for IBM remains largely supportive, with no FDA-approved drug currently available for the condition. Management often relies on off-label use of immunosuppressant's, intravenous immunoglobulin (IVIG), corticosteroids, and other agents, though these have shown limited or inconsistent benefit. Symptom-focused strategies, including physical therapy, assistive devices, and interventions to preserve mobility, remain central to care. The emerging pipeline is led by ulviprubart, a monoclonal antibody targeting KLRG1-positive cytotoxic T cells via antibody-dependent cellular cytotoxicity (ADCC), aiming to selectively deplete pathogenic immune cells while sparing beneficial populations. Other investigational approaches, like agents modulating protein homeostasis or inflammation, and others have been discontinued after failing to demonstrate meaningful efficacy or due to safety limitations. These setbacks have considerably reduced the therapeutic pipeline for the condition, leaving only a small number of early-stage candidates currently in development. Overall, IBM research is at a pivotal stage, with ulviprubart representing the most advanced targeted candidate, while development efforts continue to focus on immune-targeted and muscle-protective therapies.

Inclusion Body Myositis (IBM) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry.

Inclusion Body Myositis (IBM) Pipeline Development Activities

The report provides insights into different therapeutic candidates in late and mid stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for IBM's emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair of the Department of Medicine and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or IBM market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Delveinsight's analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as the Washington University School of Medicine, University Medical Center Hamburg-Eppendorf, and University Graduate School of Medicine, etc., were contacted. Their opinion helps understand and validate IBM epidemiology and market trends.

Qualitative Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT and Conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial's primary and secondary outcome measures are evaluated.

Further, the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a descriptive overview of IBM, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into IBM epidemiology and treatment.
• Additionally, an all-inclusive account of the current therapies for IBM is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the IBM market, historical and forecasted, is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM IBM market.

Inclusion Body Myositis (IBM) Report Insights

Inclusion Body Myositis (IBM) Report Insights

• Patient Population
• Therapeutic Approaches
• IBM Pipeline Analysis
• IBM Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

Inclusion Body Myositis (IBM) Report Key Strengths

• Ten-Year Forecast
• 7MM Coverage
• IBM Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Inclusion Body Myositis (IBM) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Analyst Views
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

• What was the IBM market share (%) distribution in 2020, and what would it look like in 2034?
• What would be the IBM total market size, as well as market size by therapies across the 7MM during the study period (2020-2034)?
• What are the key findings about the market across the 7MM, and which country will have the largest IBM market size during the study period (2020-2034)?
• At what CAGR, the IBM market expected to grow at the 7MM level during the study period (2020-2034)?
• What would be the IBM market growth till 2034?
• What are the disease risks, burdens, and unmet needs of IBM?
• What is the historical IBM patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• What will be the growth opportunities across the 7MM concerning the patient population of IBM?
• Among the 7MM, which country would have the most prevalent cases of IBM?
• At what CAGR is the population expected to grow across the 7MM during the study period (2020-2034)?
• How many companies are developing therapies for the treatment of IBM?
• What are the key collaborations (industry-industry, industry-academia), mergers and acquisitions, and licensing activities related to IBM therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the 7MM historical and forecasted market of IBM?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving the IBM market.
• To understand the future market competition in the IBM market and insightful review of the SWOT analysis of IBM.
• Organize sales and marketing efforts by identifying the best opportunities for IBM in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• To understand the future market competition in the IBM industry.