Monoclonal Gammopathy of Undetermined Significance (MGUS) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Monoclonal Gammopathy of Undetermined Significance (MGUS) Market Outlook

Thelansis’s “Monoclonal Gammopathy of Undetermined Significance (MGUS) 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 Monoclonal Gammopathy of Undetermined Significance (MGUS) treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Monoclonal Gammopathy of Undetermined Significance (MGUS) Overview

Monoclonal gammopathies are a group of disorders characterized by a monoclonal protein in circulation. These disorders encompass a range of entities, from the highly prevalent and asymptomatic monoclonal gammopathy of undetermined significance (MGUS) to more advanced and less frequent conditions such as multiple myeloma. These disorders are classified based on the involved immunoglobulin (M-protein), including non-immunoglobulin M (IgM), IgM, and light chain. The progression rate to multiple myeloma (MM), a lymphoproliferative disorder, amyloidosis, or light-chain deposition disease is 1% per year. Patients with IgM MGUS have an increased risk of developing non-Hodgkin lymphoma, chronic lymphocytic leukemia, light-chain amyloidosis, and Waldenström macroglobulinemia (WM) at a rate of 1.5% per year. The most common heavy-chain subtype in MGUS is IgG, found in approximately 70% of patients, followed by IgM (15%), IgA (12%), and biclonal gammopathy (3%). MGUS is biologically and clinically heterogeneous, with a spectrum of patients who eventually progress and others who have a durably indolent course. The disorder is associated with various complications such as infections, fractures, peripheral neuropathy, thromboembolism, and monoclonal gammopathy of renal significance.

• In the USA, the incidence of MGUS increases with age, with a prevalence of 3.2% in individuals ≥50 years of age, 5.3% in persons ≥70 years, and 8.9% in men ≥85 years old. MGUS is detected twice as frequently in men than women and three times more often in patients of African descent.

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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