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Lipodystrophy - Market Insight, Epidemiology And Market Forecast - 2032

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    Report

  • 107 Pages
  • February 2023
  • Region: Global
  • DelveInsight
  • ID: 5524245
UP TO OFF until Dec 31st 2024
This ‘Lipodystrophy - Market Insights, Epidemiology, and Market Forecast-2032' report delivers an in-depth understanding of Lipodystrophy historical and forecasted epidemiology as well as the Lipodystrophy market trends in the United States, EU4 (Germany, France, Italy and Spain), the UK, and Japan.

The Lipodystrophy market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Lipodystrophy market size. The report also covers Lipodystrophy procedure, SWOT analysis, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

  • The United States
  • EU4 (Germany, France, Italy, Spain) and the UK
  • Japan
Study Period: 2019-2032

Lipodystrophy Understanding

Lipodystrophy Overview

Lipodystrophy is a medical condition characterized by complete or partial loss of adipose tissue. Not infrequently, lipodystrophy occurs in combination with the pathological accumulation of adipose tissue at distinct anatomical sites. Patients with lipodystrophy exhibit numerous metabolic complications, which indicate the importance of adipose tissue as an active endocrine organ. The total amount and the appropriate distribution of adipose tissue depots contribute to the metabolic state. Genetic and molecular research has improved our understanding of the mechanisms underlying lipodystrophy. Circulating hormones secreted by the adipose tissue, such as leptin and adiponectin, are greatly reduced in distinct subpopulations of patients with lipodystrophy. This finding rationalizes the use of these adipokines or agents that increase their circulating levels, such as peroxisome proliferator-activated receptor ? (PPAR?) agonists, for therapeutic purposes. Other novel therapeutic approaches, including growth hormone and growth hormone-releasing factors, are also being studied as potential additions to the therapeutic armamentarium. New insights gained from research and clinical trials could potentially revolutionize the management of this difficult-to-treat condition.

Types of Lipodystrophy

Lipodystrophies are categorized according to both the etiology (congenital or acquired) and the pattern of adipose tissue loss, which can be either generalized (affecting the whole body) or partial (affecting specific body regions).

Generalized lipodystrophy

Congenital generalized lipodystrophy (CGL), or Berardinelli¬-Seip syndrome, is a rare autosomal recessive disorder that is characterized by a near total lack of body adipose tissue. Approximately 250 cases of CGL have been described in the literature. This syndrome is ubiquitous in all geographic regions, with the highest frequency reported in Brazil.

CGL occurs most frequently in instances of parental consanguinity and is diagnosed soon after birth. Despite voracious appetites and accelerated linear growth rates, children with cGl demonstrate markedly reduced subcutaneous adiposity. CGL is also associated with diabetes mellitus, hypertriglyceridemia, hepatic steatosis, cirrhosis, acromegaloid features, and acanthosis nigricans. Cardiomyopathy, mild mental retardation, advanced bone age, cervical spine instability, and muscular weakness have also been reported. Reproductive function is severely impaired in women but usually unaffected in men. Females are commonly present with clitoromegaly, hirsutism, amenorrhea or irregular menstrual cycles, and ovarian cysts. Finally, levels of leptin and adiponectin, hormones produced in adipose tissue, are low in both sexes.

Acquired generalized lipodystrophy

Acquired generalized lipodystrophy, or Lawrence-Seip syndrome, shares many features with CGL, including severely reduced subcutaneous adiposity, insulin resistance or diabetes mellitus, acanthosis nigricans, hypertriglyceridemia, hepatic steatosis, hypoleptinemia, and hypoadiponectinemia. In addition to reduced subcutaneous adiposity, adipose tissue is reduced in the palms, soles, and intra-abdominal areas.

Lipodystrophy Epidemiology

The epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Cases of Lipodystrophy, Subtype-specific Cases of Lipodystrophy, Gender-specific Cases of Lipodystrophy covering the United States, the EU4 (Germany, France, Italy, Spain), UK and Japan from 2019 to 2032.

Key Findings

  • In 2021, the total incident cases of Lipodystrophy in the US were ~1,050 cases, which are anticipated to increase in 2032.
  • EU4 and the UK, in 2021, accounted for ~1,850 cases of Lipodystrophy, which are anticipated to increase by the year 2032.
  • Among the EU4 countries, the highest number of cases of Lipodystrophy were found in France, i.e., ~760 cases in the year 2021, which are estimated to increase by the year 2032.
  • In 2021, the gender-specific cases of Lipodystrophy in the US were ~210 and ~840, for males and females, respectively. These cases are expected to increase during the forecast period.

Lipodystrophy Drug Chapters

Lipodystrophy Emerging Drugs

WAYLIVRA (volanesorsen): Ionis Pharmaceuticals

WAYLIVRA (volanesorsen), an antisense oligonucleotide inhibitor of apolipoprotein CIII (apoCIII) mRNA, is being developed by Ionis Pharmaceuticals through its subsidiary company, Akcea Therapeutics to treat familial partial lipodystrophy (FPL). Familial partial lipodystrophy (FPL) is a rare genetic disorder characterized by selective, progressive body fat loss (adipose tissue) from various body areas. Individuals with FPL often have reduced subcutaneous fat in the arms and legs, and the head and trunk regions may or may not have fat loss.

Mibavademab: Regeneron Pharmaceuticals

Mibavademab (REGN 4461) is a leptin receptor (LEPR) agonist antibody developed by Regeneron pharmaceuticals to treat generalized lipodystrophy. The drug is currently in Phase II clinical trials conducted on patients with generalized lipodystrophy and familial partial lipodystrophy.

Empagliflozin: Boehringer Ingelheim

Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for glucose reabsorption in the kidney. It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies, for managing type 2 diabetes mellitus. Upon oral administration, empagliflozin selectively and potently inhibits SGLT2 in the kidneys, suppressing glucose reabsorption in the proximal tubule. Inhibition of SGLT2 increases urinary glucose excretion by the kidneys, resulting in a reduction of plasma glucose levels in an insulin-independent manner.

Lipodystrophy Market Outlook

Lipodystrophy includes a heterogeneous group of rare diseases characterized by different amounts of adipose tissue loss and several metabolic complications, including hypertriglyceridemia, steatohepatitis, and insulin resistance that may lead to severe morbidity and, sometimes, mortality. Therefore, therapy for lipodystrophy primarily consists of a conventional approach that involves standard treatments of metabolic abnormalities. Because lipodystrophy is heterogeneous, various therapeutic approaches are available, each of which has a different efficacy based on the type of illness and the patient's unique appearance. Lipodystrophy treatment aims to improve both the metabolic issues and pathological alterations in adipose tissue distribution.

The standard clinical treatment of lipodystrophy include lifestyle modification, the use of oral and injectable diabetes medications and insulin (also includes concentrated formulations), lipid-lowering drugs, and other medications to treat complications of lipodystrophy.

Lipodystrophy syndromes are characterized by various and severe metabolic complications, treatment of which is challenging. Since standard therapies often lack sufficient metabolic regulation - leptin replacement therapy with metreleptin, a recombinant leptin analog - is needed. Metreleptin therapy has been approved by the FDA and EMA, respectively, for patients with GL and both GL and PL. Patients with GL commonly benefit from therapy with metreleptin, which is generally used as an adjunct to diet, physical activity, and other standard treatments for metabolic abnormalities. For a subgroup of patients with PL, metreleptin may be a suitable treatment option, while it might not represent an adequate therapy for others. Additional studies on metabolic pathways are necessary for these patients to develop novel therapeutic strategies.

Key Findings

  • In 2021, the US had the largest Lipodystrophy market size of ~USD 77 million among the 7MM countries.
  • Among the EU4 countries, France had the highest market size for Lipodystrophy in 2021, i.e., ~USD 26 million.
  • The lowest market size among EU4 countries was estimated in Italy with ~USD 9 million in 2021.
  • The market size of Lipodystrophy in the UK was observed to be ~USD 8 million in 2021.

The United States Market Outlook

This section provides the total Lipodystrophy market size and market size by therapies in the United States.

EU4 and the UK Market Outlook

The total Lipodystrophy market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Lipodystrophy market size and market size by therapies in Japan are provided.

Lipodystrophy Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Lipodystrophy market or expected to get launched in the market during the study period 2019-2032. The analysis covers the Lipodystrophy market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, and reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Lipodystrophy Development Activities

The report provides insights into different therapeutic candidates in Phase II and Phase III stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions, merger, licensing, and patent details for Lipodystrophy emerging therapies.

Reimbursement Scenario in Lipodystrophy

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

The publisher performs competitive market Intelligence analysis of the Lipodystrophy market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

  • The report covers a descriptive overview of Lipodystrophy, explaining its procedure, types, indications, and currently available therapies.
  • Comprehensive insight has been provided into Lipodystrophy epidemiology and treatment.
  • Additionally, an all-inclusive account of both the current and emerging therapies for Lipodystrophy is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
  • A detailed review of the Lipodystrophy 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 Lipodystrophy market.

Report Highlights

  • The robust pipeline with novel MOA and oral ROA, increasing prevalence, and effectiveness of drugs will positively drive the Lipodystrophy market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Lipodystrophy R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition using Lipodystrophy.
  • Major players are involved in developing therapies for Lipodystrophy. The launch of emerging therapies will significantly impact the Lipodystrophy market.
  • Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Lipodystrophy Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Lipodystrophy Pipeline Analysis
  • Lipodystrophy Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

Lipodystrophy Report Key Strengths

  • 11-Year Forecast
  • The US, EU4, the UK, and Japan Coverage
  • Lipodystrophy Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market

Lipodystrophy Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • SWOT analysis

Key Questions Answered

Market Insights:

  • What was the Lipodystrophy market share (%) distribution in 2019 and how it would look like in 2032?
  • What would be the Lipodystrophy total market size as well as market size by therapies across the 7MM during the forecast period (2022-2032)?
  • What are the key findings pertaining to the market across the 7MM Coverage and which country will have the largest Lipodystrophy market size during the forecast period (2022-2032)?
  • At what CAGR, the Lipodystrophy market is expected to grow at the 7MM Coverage level during the forecast period (2022-2032)?
  • What would be the Lipodystrophy market outlook across the 7MM Coverage during the forecast period (2022-2032)?
  • What would be the Lipodystrophy market growth till 2032 and what will be the resultant market size in the year 2032?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

  • What are the risk, burdens, and unmet needs of Lipodystrophy?
  • What is the historical Lipodystrophy patient pool in the United States, EU4 (Germany, France, Italy, Spain), the UK and Japan?
  • What would be the forecasted patient pool of Lipodystrophy at the 7MM Coverage level?
  • What will be the growth opportunities across the 7MM Coverage with respect to the patient population pertaining to Lipodystrophy?
  • Out of the above-mentioned countries, which country would have the highest cases of Lipodystrophy during the forecast period (2022-2032)?
  • At what CAGR are these cases expected to grow across the 7MM Coverage during the forecast period (2022-2032)?

Epidemiology Insights:

  • What are the current treatment practices in Lipodystrophy along with the approved therapy?
  • What are the current treatment guidelines for Lipodystrophy?
  • What are the Lipodystrophy marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
  • How many companies are developing therapies for Lipodystrophy?
  • How many emerging therapies are in the mid-stage and late stages of development for Lipodystrophy?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Lipodystrophy therapies?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Lipodystrophy and their status?
  • What are the key designations that have been granted for the emerging therapies for Lipodystrophy?
  • What are the 7MM Coverage historical and forecasted market of Lipodystrophy?

Reasons to Buy

  • The report will help in developing business strategies by understanding trends shaping and driving Lipodystrophy.
  • To understand the future market competition in the Lipodystrophy market and an insightful review of the market.
  • Organize sales and marketing efforts by identifying the best opportunities for Lipodystrophy in the 7MM Coverage.
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
  • Organize sales and marketing efforts by identifying the best opportunities for the Lipodystrophy market.
  • To understand the future market competition in the Lipodystrophy market.

Table of Contents

1. Key Insights

2. Report Introduction

3. Lipodystrophy Market Overview at a Glance
3.1. Market Share (%) Distribution of Lipodystrophy by Therapies in 2019
3.2. Market Share (%) Distribution of Lipodystrophy by Therapies in 2032

4. Executive Summary of Lipodystrophy

5. Key events

6. Disease Background and Overview
6.1. Introduction
6.2. Types of lipodystrophy
6.2.1. Generalized lipodystrophy
6.2.2. Partial lipodystrophy
6.2.3. Pathophysiology
6.3. Diagnosis
6.3.1. Identification and differential diagnosis of lipodystrophy
6.4. Diagnosis of Lipodystrophy: Multi-society Practice Guideline (2016)
6.5. Establishing the presence of lipodystrophy

7. Current treatment of lipodystrophy
7.1. Lifestyle modification
7.2. Non-leptin based treatment
7.3. Leptin treatment
7.4. Additional treatments for specific comorbidities
7.5. Cosmetic treatment, counseling, and pain management
7.6. Treatment of Lipodystrophy Syndromes: Multi-society Practice Guideline (2016)

8. Methodology

9. Epidemiology and Patient Population
9.1. Key Findings
9.2. Assumptions and Rationale
9.3. Epidemiology Scenario: 7MM
9.3.1. Total Cases of Lipodystrophy in the 7MM
9.4. The United States
9.4.1. Total cases of Lipodystrophy in the United States
9.4.2. Subtype-specific Cases of Lipodystrophy in the United States
9.4.3. Gender-specific Cases of Lipodystrophy in the United States
9.5. EU4 and the UK
9.5.1. Total Cases of Lipodystrophy in EU4 and the UK
9.5.2. Subtype-specific Cases of Lipodystrophy in EU4 and the UK
9.5.3. Gender-specific cases of Lipodystrophy in EU4 and the UK
9.6. Japan
9.6.1. Total cases of Lipodystrophy in Japan
9.6.2. Subtype-specific Cases of Lipodystrophy in Japan
9.6.3. Gender-specific cases of Lipodystrophy in Japan

10. Patient Journey

11. Marketed Therapies
11.1. Key Cross Competition
11.2. MYALEPT (metreleptin): Amryt Pharma
11.2.1. Product description
11.2.2. Regulatory milestones
11.2.3. Other developmental activities
11.2.4. Clinical developmental activities
11.2.5. Safety and efficacy
11.3. EGRIFTA/EGRIFTA SV (tesamorelin): Thera Technologies
11.3.1. Product description
11.3.2. Regulatory milestones
11.3.3. Other developmental activities
11.3.4. Clinical developmental activities
11.3.5. Safety and efficacy

12. Emerging Therapies
12.1. Key Cross Competition
12.2. WAYLIVRA (volanesorsen): Ionis Pharmaceuticals
12.2.1. Product description
12.2.2. Other developmental activities
12.2.3. Clinical development
12.2.4. Safety and efficacy
12.3. Mibavademab: Regeneron Pharmaceuticals
12.3.1. Product Description
12.3.2. Clinical development
12.3.3. Safety and efficacy
12.4. Empagliflozin: Boehringer Ingelheim
12.4.1. Product description
12.4.2. Other developmental activities
12.4.3. Clinical development
12.4.4. Safety and efficacy

13. Lipodystrophy Market Analysis
13.1. Key Findings
13.2. Market Outlook
13.3. Key Market Forecast Assumptions
13.4. Attribute Analysis
13.5. 7MM Market Size
13.5.1. Total Market Size of Lipodystrophy in the 7MM
13.5.2. Market Size of Lipodystrophy by Current and Emerging Therapies in the 7MM
13.6. United States Market Size
13.6.1. Total Market Size of Lipodystrophy in the United States
13.6.2. Market Size of Lipodystrophy by Current and Emerging Therapies in the United States
13.7. EU4 and the UK Market Size
13.7.1. Total Market size of Lipodystrophy in EU4 and the UK
13.7.2. Market Size of Lipodystrophy by Current and Emerging Therapies in EU4 and the UK
13.8. Japan Market Size
13.8.1. Total Market Size of Lipodystrophy in Japan
13.8.2. Market Size of Lipodystrophy by Current and Emerging Therapies in Japan

14. Market Access and Reimbursement
14.1. Patient support program
14.2. HTA Decisions

15. KOL Views

16. Unmet Needs

17. SWOT Analysis

18. Appendix
18.1. Report Methodology
18.2. Bibliography

19. Publisher Capabilities

20. Disclaimer

21. About the Publisher

List of Tables
Table 1: Summary of Lipodystrophy Market, and Epidemiology (2019-2032)
Table 2: Key Events
Table 3: Prevalence of Lipodystrophy
Table 4: Gender-specific Cases of Lipodystrophy
Table 5: Cases of Lipodystrophy Based on Subtypes
Table 6: Total Cases of Lipodystrophy in the 7MM (2019-2032)
Table 7: Total Cases of Lipodystrophy in the United States (2019-2032)
Table 8: Subtype-specific Cases of Lipodystrophy in the US (2019-2032)
Table 9: Gender-specific Cases of Lipodystrophy in the United States (2019-2032)
Table 10: Total Cases of Lipodystrophy in EU4 and the UK (2019-2032)
Table 11: Subtype-specific Cases of Lipodystrophy in EU4 and the UK (2019-2032)
Table 12: Gender-specific Cases of Lipodystrophy in EU4 and the UK (2019-2032)
Table 13: Total Cases of Lipodystrophy in Japan (2019-2032)
Table 14: Subtype-specific Cases of Lipodystrophy in Japan (2019-2032)
Table 15:Gender-specific Cases of Lipodystrophy in Japan (2019-2032)
Table 16: Comparison of Marketed Drugs
Table 17: Patent Expiry Timeline
Table 18: MYALEPT (metreleptin) Clinical Trial Description, 2022
Table 19: EGRIFTA/EGRIFTA SV (tesamorelin) Clinical Trial Description, 2022
Table 20: Comparison of Emerging Drugs
Table 21: WAYLIVRA; Clinical Trial Description, 2022
Table 22: Mibavademab; Clinical Trial Description, 2022
Table 23: Empagliflozin; Clinical Trial Description, 2022
Table 24: Key Market Forecast Assumptions for WAYLIVRA (volanesorsen)
Table 25: Key Market Forecast Assumptions for Mibavademab (REGN 4461)
Table 26: Key Market Forecast Assumptions for Empagliflozin
Table 27: Market Size of Lipodystrophy in the 7MM in USD million (2019-2032)
Table 28: Market Size of Lipodystrophy by Current and Emerging Therapies in the 7MM, in USD million (2019-2032)
Table 29: Market Size of Lipodystrophy in the United States, USD million (2019-2032)
Table 30: Market Size of Lipodystrophy by Current and Emerging Therapies in the US, in USD million (2019-2032)
Table 31: Market Size of Lipodystrophy in EU4 and the UK, USD million (2019-2032)
Table 32: Market Size of Lipodystrophy by Current and Emerging Therapies in EU4 and the UK, in USD million (2019-2032)
Table 33: Market Size of Lipodystrophy in Japan , USD million (2019-2032)
Table 34: Market Size of Lipodystrophy by Current and Emerging Therapies in Japan, in USD million (2019-2032)

List of Figures
Figure 1: Lipodystrophy syndromes
Figure 2: Lipodystrophy versus obesity
Figure 3: Diagnostic Approach
Figure 4: Total Cases of Lipodystrophy in the 7MM (2019-2032)
Figure 5: Total Cases of Lipodystrophy in the United States (2019-2032)
Figure 6: Subtype-specific Cases of Lipodystrophy in the United States (2019-2032)
Figure 7: Gender-specific Cases of Lipodystrophy in the United States (2019-2032)
Figure 8: Total Cases of Lipodystrophy in EU4 and the UK (2019-2032)
Figure 9: Subtype-specific Cases of Lipodystrophy in EU4 and the UK (2019-2032)
Figure 10: Gender-specific Cases of Lipodystrophy in EU4 and the UK (2019-2032)
Figure 11: Total Cases of Lipodystrophy in Japan (2019-2032)
Figure 12: Subtype-specific Cases of Lipodystrophy in Japan (2019-2032)
Figure 13: Gender-specific Cases of Lipodystrophy in Japan (2019-2032)
Figure 14: Patient Journey
Figure 15: Market Size of Lipodystrophy in the 7MM in USD million (2019-2032)
Figure 16: Market Size of Lipodystrophy by Current and Emerging Therapies in the 7MM, in USD million (2019-2032)
Figure 17: Market Size of Lipodystrophy in the US, USD millions (2019-2032)
Figure 18: Market Size of Lipodystrophy by Current and Emerging Therapies in the US, USD million (2019-2032)
Figure 19: Market Size of Lipodystrophy in EU4 and the UK, USD million (2019-2032)
Figure 20: EU4 and the UK Market Size of Lipodystrophy by Current and Emerging Therapies, in USD million (2019-2032)
Figure 21: Market Size of Lipodystrophy in Japan, USD millions (2019-2032)
Figure 22: Market Size of Lipodystrophy by Current and Emerging Therapies in Japan, USD million (2019-2032)
Figure 23: Unmet Needs

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Ionis Pharmaceuticals
  • Regeneron Pharmaceuticals
  • Boehringer Ingelheim