Global Lipodystrophy Market - 2023-2030

Overview

Lipodystrophy is a medical condition that is rare and complex. It is characterized by an abnormal distribution or absence of body fat. This disorder can either be inherited (congenital) or acquired. In the latter case, it is often associated with conditions such as HIV/AIDS or long-term use of specific medications, particularly antiretroviral drugs. The primary symptoms of lipodystrophy include the loss of fat from certain parts of the body like the face, arms, and legs, and an accumulation of fat in other areas, particularly around the abdomen and neck.

Additionally, individuals with lipodystrophy experience metabolic abnormalities such as insulin resistance, hypertriglyceridemia, and fatty liver disease. These conditions increase the risk of developing diabetes and cardiovascular complications.

The treatment methods for lipodystrophy are personalized according to the root cause and frequently involve adjustments to one's lifestyle, such as changes in diet and exercise, as well as medication to address metabolic problems.

Market Dynamics: Drivers and Restraints

Increasing research for the novel treatment of acquired lipodystrophy is expected to drive market growth

On October 18, 2022, Researchers from the University of California, San Francisco made an important discovery about acquired lipodystrophy. This condition is characterized by the loss of fat tissue and metabolic issues, and the researchers have found an autoantibody biomarker, which is a type of immune response marker, that could potentially lead to new treatment options for this complex condition.

The biomarker enables individuals with acquired lipodystrophy to be tested, along with those who are at risk of developing the condition. These autoantibodies have been found to appear before patients become severely ill, and identifying them could eventually lead to new therapeutic approaches.

The UCSF team used an unbiased method to screen the entire proteome or set of proteins and discovered autoantibodies targeting a protein called perilipin 1 (PLIN1), which is specific to fat cells' lipid droplets. This discovery was made in a mouse model of autoimmune polyendocrine syndrome type 1 (APS1). The researchers then tested patients with acquired lipodystrophy, as well as those with immune tolerance issues, and found PLIN1 autoantibodies.

The research began with a collaboration between experts in biochemistry, biophysics, and medical investigation. They developed a comprehensive screening method to identify antibodies in patient's blood that were associated with autoimmune diseases. The first patient to participate in the study, who had APS1, acquired lipodystrophy, and autoantibodies to PLIN1, was identified through this innovative screening process.

Therefore, this discovery can pave the way for potential treatments and offers a way to test both affected and at-risk individuals. The presence of autoantibodies that target a fat cell protein indicates autoimmune lipodystrophies and immune tolerance disruption. This breakthrough was achieved through an advanced screening method, marking a significant step forward in understanding and addressing this complex condition. Hence, owing to the above factors, the market is expected to drive over the forecast period.

Furthermore, the increasing prevalence of disease, increased support from the government, and surge in R&D expenditure from key players are the factors expected to drive the market growth over the forecast period.

Restraint:

The market for lipodystrophy is expected to be hampered by high costs, limited FDA-approved treatments, and drug side effects.

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Segment Analysis

The global lipodystrophy market is segmented based on type, treatment type, distribution channel, and region.

The diabetes and insulin resistance treatment from the treatment type segment accounted for approximately 38.2% of the lipodystrophy market share

Managing diabetes and insulin resistance in the presence of lipodystrophy has many benefits. It helps to maintain optimal blood sugar levels, preventing the harmful effects of high glucose such as diabetic issues and cardiovascular complications. Effective management decreases the risk of related complications like vision loss, neuropathy, circulation disorders, and kidney problems.

Moreover, it increases energy levels by regulating blood sugar, reduces cardiovascular risks by addressing contributing factors like abnormal lipid profiles and hypertension, and improves the body's sensitivity to insulin, enabling efficient glucose utilization.

In addition, addressing insulin resistance promotes healthier weight management, reduces chronic inflammation commonly associated with diabetes, enhances overall quality of life by minimizing symptoms and limitations, and protects long-term well-being by preventing gradual complications. Healthcare providers customize treatments, taking into account individual factors, promoting psychological well-being by stabilizing blood sugar, and potentially reducing medication dependency, thereby alleviating the burden of multiple drugs and their side effects.

For instance, Metformin is a biguanide drug commonly prescribed to manage insulin sensitivity and blood sugar levels in individuals with lipodystrophy and insulin resistance. It is a crucial part of treating type 2 diabetes, often associated with lipodystrophy. Hence, owing to the above factors, the market segment is expected to hold the largest market share over the forecast period.

Geographical Analysis

North America accounted for approximately 40.2% of the market share in 2022

North America region is expected to hold the largest market share over the forecast period owing to the increasing research for acquired generalized lipodystrophy and increasing clinical trials of drugs.

For instance, a clinical study conducted by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) focuses on evaluating the safety and effectiveness of metreleptin, a drug used to treat patients with generalized lipodystrophy. Generalized lipodystrophy is a rare condition characterized by low levels of the hormone leptin, leading to metabolic complications such as severe insulin resistance, diabetes, hypertriglyceridemia, and more.

Metreleptin, a recombinant human leptin analog, has shown promise in improving metabolic and endocrine abnormalities in patients with lipodystrophy. The study aims to provide access to metreleptin for patients who cannot obtain it through approved mechanisms in their home country or have received it in previous NIH studies.

The patients will receive regular doses of metreleptin and undergo evaluations at the NIH to assess improvements in various metabolic markers. The study intends to collect data on the long-term efficacy of metreleptin in ameliorating the complications of lipodystrophy. It involves about 30 participants and is an open-label, interventional trial. The primary outcomes include improvements in serum triglycerides and hemoglobin A1c levels, while secondary outcomes encompass measures of various metabolic parameters, body composition, bone health, and reproductive function. The study started on October 9, 2014, and is estimated to be completed by July 31, 2025.

Therefore, the study's contribution can raise awareness, interest, and investment in addressing lipodystrophy, promoting innovation, and improving diagnostic tools and therapeutic options. Hence, owing to the above factors, the North American region is expected to hold the largest market share over the forecast period.

COVID-19 Impact Analysis:

The COVID-19 pandemic has had significant implications for the lipodystrophy market. Individuals who have underlying cardiovascular disease and/or cardiovascular risk factors are at a higher risk of developing severe COVID-19, as these are some of the most significant negative prognostic factors for the disease. Lipodystrophic syndromes, which are rare disorders that result in the loss of subcutaneous fat without any nutritional deprivation or catabolic state, also put individuals at a higher risk of severe COVID-19. For this reason, those with lipodystrophy, particularly those with underlying comorbidities, should receive the SARS-CoV-2 vaccine to minimize the risk of infection.

Moreover, a recently published case report in Frontiers outlines a precision COVID-19 immunization approach that was used to address individual frailty in a patient with generalized lipodystrophy type 4. Despite receiving two doses of the BNT162b2 vaccine, which uses lipid nanoparticle-encapsulated mRNA, the patient did not respond. Since this disease results from biallelic variants of the CAVIN1 molecule, which is essential for lipid endocytosis and regulation, the vaccination regimen was supplemented with a single dose of the Ad26.COV2 vaccine. The report suggests that using a precision Covid-19 immunization strategy could prove beneficial in overcoming individual frailty for those with lipodystrophy.

In contrast, during the pandemic, healthcare systems faced immense pressure, leading to the postponement of non-essential medical services. Lipodystrophy patients were among those who experienced disrupted diagnosis and treatment.

Furthermore, clinical trials for new treatments were also delayed or put on hold, hindering the development and approval of new drugs and therapies. The impact of these effects could be felt for years to come as the healthcare system recovers and adjusts to new challenges.

Competitive Landscape

The major global players in the lipodystrophy market include: Amryt Pharma plc, Theratechnologies Inc., Takeda Pharmaceutical Company Limited, AstraZeneca, Camber Pharmaceuticals, Inc., Merck KGaA, Bristol-Myers Squibb Company, GlaxoSmithKline, and Viatris Inc. among others.

Key Developments

• On March 23, 2021, Amryt, a global, commercial-stage biopharmaceutical company focused on acquiring, developing, and commercializing novel treatments for rare diseases, provides an update on its engagement with the FDA on Myalept and its proposed development plan and study design to support an indication for patients with partial lipodystrophy (PL).
• On December 1, 2022, PTC Therapeutics, Inc. disclosed that the Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria), has given its approval for Waylivra (volanesorsen) to be used as the first treatment for familial partial lipodystrophy (FPL) in Brazil. This is the first time that Waylivra has been approved globally for the FPL indication. Additionally, Waylivra has also been approved in Brazil for the treatment of Familial Chylomicronemia Syndrome (FCS).

Why Purchase the Report?

• To visualize the global lipodystrophy market segmentation based on type, treatment type, distribution channel and region as well as understand key commercial assets and players.
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• Excel data sheet with numerous data points of lipodystrophy market-level with all segments.
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The global lipodystrophy market report would provide approximately 58 tables, 56 figures, and 186 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies