Global CLOVES Syndrome Market - 2023-2030

Overview

Congenital Lipomatous Overgrowth, Vascular Malformations, Epidermal Nevis, Spinal/Skeletal Anomalies/Scoliosis (CLOVES) syndrome is a very rare congenital (present at birth) disorder characterized by a combination of vascular (involving the blood vessels), skin, spinal, and bone or joint abnormalities.

Fewer than 200 cases of CLOVES syndrome have been identified worldwide to date. CLOVES are caused by mutations in a gene called PIK3CA. The long-term outlook for a child with CLOVES will depend on their age and the severity of their symptoms.

Diagnosing CLOVES syndrome can be difficult as it is rare and symptoms can vary. Clinical assessment, genetic testing, medical imaging, and careful assessment of the various features are frequently combined to make a conclusive diagnosis. Managing CLOVES syndrome requires a multidisciplinary approach, which may involve surgery to address physical abnormalities, interventions to manage vascular malformations, and supportive therapies to address associated complications. Regular medical follow-ups are essential to monitor the progression of the condition and address any emerging issues.

Furthermore, the increasing funding in the research of CLOVES Syndrome, and increasing awareness among medical professionals and the general public about rare genetic disorders are the factors expected to drive the market over the forecast period.

Dynamics

Increasing Funding in Zebrafish Models of CLOVES Syndrome is Expected to Drive the Market Growth

Investing in the development of zebrafish models for CLOVES, a genetic disorder that causes overgrowth of fat cells, vascular malformations, and other physical anomalies, is a major advancement in the research and potential treatment of this rare condition.

On October 20, 2022, the Patton Lab at the University of Edinburgh was granted a research donation of $100,000 to create zebrafish models of CLOVES syndrome. The main objective of this project is to establish a fresh and clinically significant animal model of CLOVES syndrome with the help of zebrafish.

Zebrafish have been widely accepted as models for studying human diseases. At least 70% of genes that cause human diseases have counterparts in zebrafish. To further this research, scientists intend to employ CRISPR-Cas9 technology to introduce the primary mutation responsible for CLOVES syndrome, along with the normal gene, into zebrafish Pik3ca. Using fluorescent markers, the scientists will observe the actions of Pik3ca-mutant cells and how they interact with the surrounding normal cells.

In addition, researchers are confident that this method will enable them to create a more detailed model of CLOVES syndrome compared to other animal models used previously. This model can be used as a foundation for screening new treatments for CLOVES syndrome. Dr. Liz Patton leads this project and utilizes zebrafish models as her primary tool for identifying and targeting melanoma cell populations.

Thus, owing to the above factors, the market is expected to drive over the forecast period.

Increasing Awareness of CLOVE Syndrome among the General Public is Expected to Drive the Market Growth

Cloves Syndrome Awareness Day is observed on August 3 every year to spread awareness about the rare genetic disorder that affects the development of many different parts of the body. The day aims to foster understanding and extend support, and solidarity for individuals and families affected by CLOVES syndrome.

Communities unite to exchange information and resources regarding CLOVES disease and educate individuals on identifying early symptoms. Workshops also address social inclusion and society's responsibility in assisting families with afflicted members. As it is a rare disease with only slightly over 200 documented cases, there is insufficient funding and research allocated towards it. As a result, affected families lack access to effective treatments and may not receive the support they require without increased awareness.

Therefore, Cloves Syndrome Awareness Day provides an opportunity to spread information and resources about CLOVES syndrome and its impact on people's lives. It is a day for communities to pool their knowledge and resources to combat the disease. Thus, owing to the above factors, the market is expected to drive over the forecast period.

Challenges Associated with Managing CLOVES Syndrome is Expected to Hamper the Market Growth

According to National Organization for Rare Disorders, Inc., managing CLOVES syndrome can be very challenging and requires an interdisciplinary team of physicians with experience in overgrowth disorders and vascular anomalies.

For instance, the symptoms of CLOVES syndrome can vary widely and may include fatty tissue masses, problems with feet and hands, dilated veins, birthmarks, spinal curvature, and tethered cord. Managing these symptoms and preventing complications such as blood clots requires ongoing medical and surgical interventions. Thus, owing to the challenges associated with the management of CLOVE syndrome is expected to hamper the market growth over the forecast period.

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Segment Analysis

The global CLOVES syndrome market is segmented based on treatment type, sales channel and region.

Owing to the Increasing FDA Approvals and Rising Acceleration of Treatment Options, the Treatment Type Segment Accounted for Approximately 39.4% of the CLOVE Syndrome Market Share

CLOVES syndrome is a condition that is present from birth, and it is characterized by excessive growth of tissue and the presence of complicated vascular irregularities. When the FDA approves treatment for this condition, it represents a significant milestone in the development of therapies for CLOVES Syndrome. This approval not only confirms that the treatment is safe and effective, but it also has far-reaching effects on patient access, market growth, investment, and research initiatives.

For instance, on April 6, 2022, Novartis announced the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vijoice (alpelisib) for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million. Following the Accelerated Approval Program, continued approval may be contingent upon verification and description of clinical benefit from confirmatory evidence.

Hence, owing to the above factors, the market segment is expected to hold the largest market share over the forecast period.

Geographical Penetration

North America Accounted for Approximately 39.2% of the Market Share in 2022, Owing to the Increasing Funding, and Availability of Targeted Treatments

North America is expected to hold the largest market share owing to the increasing funding, availability of targeted treatments, and increasing prevalence of spinal problems.

For instance, in May 2022, Dr. Wen Yih Aw of The University of North Carolina/Chapel Hill has been awarded a $50,000 grant by the Scientific and Medical Advisory Board and Board of Directors of the CLOVES Syndrome Community for her project titled Non-canonical Signaling and therapeutic targets for vascular anomalies in CLOVES.

The objective of this project is to gain a better understanding of the formation of vascular malformations and identify the genes and proteins that could potentially be targeted to reverse them and promote healthy vasculature. Dr. Aw has created a micro-physiological model using human cells to investigate vascular malformations. Her research has demonstrated that this model can replicate the development of vascular malformations when using cells expressing a mutated version of the PIK3CA gene, which is associated with CLOVES.

Dr. Aw's project involves testing two drugs that have been effective in treating other types of vascular malformations and certain cancers. Each drug targets a specific protein, and by testing them in her micro-physiological model, she can observe how inhibiting each protein affects individual cells and blood vessel formation.

The results of her work not only have the potential to explore the use of these drugs as treatments for CLOVES-related vascular malformations but also to enhance our understanding of how these malformations develop. This could ultimately lead to the development of new drugs and interventions. Thus, owing to the above factors, the North American region is expected to hold the largest market share over the forecast period.

Competitive Landscape

The major global players in the market include: Pfizer Inc., Novartis AG, Glenmark Pharmaceuticals U.S. Inc., USA, Methapharm, Inc., Apotex Inc., AngioDynamics, ENDO-FLEX GmbH, C.R. Bard, Inc, Cook Medical LLC, and Cordis among others.

Key Developments

• On April 6, 2022, Novartis announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vijoice (alpelisib) for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million.

COVID-19 Impact Analysis

The COVID-19 pandemic has significantly affected the healthcare industry, including the market for CLOVES Syndrome. Many regions experienced disruptions in healthcare services due to lockdowns, restrictions, and healthcare system strain, which may have caused delays in diagnosis and care for individuals with CLOVES Syndrome, especially those seeking specialized medical attention.

Clinical trials for rare diseases, including CLOVES Syndrome, were also affected by the pandemic. Trials may have been postponed, suspended, or faced challenges in recruiting participants and conducting in-person assessments. The COVID-19-related research redirection could have impacted the funding availability for rare disease studies, potentially affecting the ongoing and planned research efforts for CLOVES Syndrome.

In addition, advocacy organizations and patient support groups may have faced challenges in organizing events, fundraising, and raising awareness due to restrictions on gatherings and reduced attention to non-COVID-19 health issues.

Furthermore, remote work became more prevalent, which could have caused challenges for researchers and clinicians in conducting collaborative research, accessing labs, and performing hands-on experiments for understanding and treating CLOVES Syndrome. Thus, owing to the above factors, the global market for CLOVES Syndrome is anticipated to have a negative impact on the market.

By Treatment Type

• Sclerotherapy
• Embolization
• Debulking Surgery
• Medications
• Rehabilitation Therapies
• Others

By Sales Channel

• End User
  • Hospitals
  • Ambulatory Surgical Center
  • Occupational Therapy Centers
  • Others

• Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

By Region

• North America
  • U.S.
  • Canada
  • Mexico

• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Rest of Europe

• South America
  • Brazil
  • Argentina
  • Rest of South America

• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific

• Middle East and Africa

Why Purchase the Report?

• To visualize the global CLOVES syndrome market segmentation based on treatment type, sales channel and region as well as understand key commercial assets and players
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of global CLOVES syndrome market-level with all segments
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study
• Product mapping available as Excel consisting of key products of all the major players

The global CLOVES syndrome market report would provide approximately 53 tables, 49 figures, and 160 Pages.

Target Audience 2023

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