Refractory Generalised Myasthenia Gravis (gMG) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Refractory Generalised Myasthenia Gravis (gMG) Market Outlook

Thelansis’s “Refractory Generalised Myasthenia Gravis (gMG) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" 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 Refractory generalised myasthenia gravis treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Refractory Generalised Myasthenia Gravis (gMG) Overview

Myasthenia gravis (MG) is a clinically heterogeneous autoimmune disorder affecting the neuromuscular junction. It is characterized by fatigable weakness of voluntary muscles. The onset of MG can occur at any age, but in the adult-onset form, there is a bimodal peak. Generalized MG, which commonly affects women under the age of 40, has a higher prevalence than in men. Men, on the other hand, are more likely to develop MG after the age of 60. The underlying cause of MG is autoimmune in nature. Self-reactive antibodies target acetylcholine receptors, which are crucial for facilitating muscle contraction and movement. However, approximately 15% of individuals with generalized MG do not have antibodies against acetylcholine receptors. Instead, these patients possess self-reactive antibodies against other important molecules involved in nerve-muscle communication, such as muscle-specific kinase (MuSK). Nearly all patients who develop generalized MG do so within two or three years after the initial display of symptoms. The exact pathogenesis of MG remains unknown. However, it is associated with circulating antibodies against various muscle receptors, including acetylcholine receptor (AChR) and muscle-specific receptor tyrosine kinase (MuSK). Another targeted molecule, the low-density lipoprotein receptor-related protein 4 (LRP4), has also been identified. The thymus is believed to trigger the production of antibodies against AChR in certain forms of the disease. These antibodies are known to have a pathogenic role in all forms of MG. Drug-induced MG can occur due to the use of medications such as D-penicillamine, interferon alpha, or as a result of bone marrow transplantation. In some cases, an initial infection (EBV) may be responsible for the development of MG. Muscle weakness is the primary manifestation of MG. Approximately 85% of patients experience generalized myasthenia gravis, which affects the proximal muscles of the extremities and trunk. Generalized MG (gMG) treatments include thymectomy, immunosuppressive therapies, intravenous immunoglobulins, and plasmapheresis.

• The estimated prevalence of MG in the United States is 14 to 20 cases per 100,000 individuals.

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: 2022-2032

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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