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全球丁香综合症市场 - 2023-2030

Global CLOVES Syndrome Market - 2023-2030

出版日期: 2023年10月18日 | 出版商:

DataM Intelligence | 英文 160 Pages | 商品交期: 约2个工作天内

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简介目录

概述

全球丁香症候群市场将于 2022 年达到 10 亿美元，预计到 2030 年将达到 10 亿美元，在 2023-2030 年预测期间复合年增长率为 YY%。

先天性脂肪瘤过度生长、血管畸形、表皮痣、脊柱/骨骼异常/脊柱侧弯(CLOVES) 综合征是一种非常罕见的先天性（出生时出现）疾病，其特征是血管（涉及血管）、皮肤、脊椎和骨骼的组合或关节异常。

迄今为止，全世界已发现的丁香症候群病例不到 200 例。丁香是由 PIK3CA 基因突变引起的。患有丁香的孩子的长期前景将取决于他们的年龄和症状的严重程度。

诊断丁香综合症可能很困难，因为这种综合征很罕见，而且症状也各不相同。临床评估、基因检测、医学影像和对各种特征的仔细评估经常结合起来做出结论性的诊断。治疗 CLOVES 综合征需要采用多学科方法，其中可能涉及解决身体异常的手术、治疗血管畸形的干预措施以及解决相关併发症的支持疗法。定期医疗追踪对于监测病情进展并解决任何新出现的问题至关重要。

此外，丁香症候群研究资金的增加，以及医疗专业人员和公众对罕见遗传性疾病的认识不断提高，预计将在预测期内推动市场发展。

动力学

增加对丁香综合症斑马鱼模型的资助预计将推动市场成长

丁香是一种导致脂肪细胞过度生长、血管畸形和其他身体异常的遗传性疾病，投资开发丁香斑马鱼模型是这种罕见疾病的研究和潜在治疗的重大进展。

2022 年 10 月 20 日，爱丁堡大学巴顿实验室获得 10 万美元的研究捐赠，用于创建丁香症候群的斑马鱼模型。该计画的主要目标是在斑马鱼的帮助下建立一个新鲜且具有临床意义的丁香综合征动物模型。

斑马鱼已被广泛接受作为研究人类疾病的模型。至少 70% 的导致人类疾病的基因在斑马鱼中有对应的基因。为了进一步进行这项研究，科学家打算利用 CRISPR-Cas9 技术将导致 CLOVES 症候群的主要突变以及正常基因引入斑马鱼 Pik3ca。使用萤光标记，科学家将观察 Pik3ca 突变细胞的行为以及它们如何与周围的正常细胞相互作用。

此外，研究人员相信，与先前使用的其他动物模型相比，这种方法将使他们能够创建更详细的丁香综合征模型。此模型可作为筛选丁香症候群新疗法的基础。 Liz Patton 博士领导了该项目，并利用斑马鱼模型作为识别和靶向黑色素瘤细胞群的主要工具。

因此，由于上述因素，预计市场在预测期内将继续成长。

大众对丁香症候群的认识不断提高预计将推动市场成长

每年 8 月 3 日是丁香症候群意识日，旨在提高人们对这种影响身体许多不同部位发育的罕见遗传性疾病的认识。这一天的目的是促进对受丁香症候群影响的个人和家庭的理解、支持和团结。

社区联合起来交流有关丁香病的资讯和资源，并教育个人识别早期症状。讲习班也讨论社会包容和社会在帮助有受影响成员的家庭方面的责任。由于它是一种罕见疾病，仅有略多于 200 例的记录病例，因此没有足够的资金和研究分配给它。因此，受影响的家庭无法获得有效的治疗，如果不提高意识，他们可能无法获得所需的支持。

因此，丁香症候群意识日提供了一个传播有关丁香症候群及其对人们生活影响的资讯和资源的机会。这一天是社区汇集知识和资源来对抗这种疾病的一天。因此，由于上述因素，预计市场在预测期内将继续成长。

与管理丁香症候群相关的挑战预计将阻碍市场成长

根据国家罕见疾病组织的说法，治疗丁香症候群非常具有挑战性，需要一支由在过度生长性疾病和血管异常方面具有丰富经验的跨科医生团队组成。

例如，CLOVES 症候群的症状差异很大，可能包括脂肪组织肿块、脚和手部问题、静脉扩张、胎记、脊椎弯曲和脊髓栓系。控制这些症状并预防血栓等併发症需要持续的医疗和手术介入。因此，由于与丁香综合征管理相关的挑战，预计将阻碍预测期内的市场成长。

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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

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Treatment Type
3.2. Snippet by Sales Channel
3.3. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Increasing Funding in Zebrafish Models of CLOVES Syndrome
  - 4.1.1.2. Increasing Awareness of CLOVE Syndrome among the General Public
- 4.1.2. Restraints
  - 4.1.2.1. Challenges Associated with Managing CLOVES Syndrome
- 4.1.3. Opportunity
  - 4.1.3.1. Advancements in Genomics and Genetic Sequencing Technologies
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's 5 Forces Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Pipeline Analysis
5.6. Unmet Needs
5.7. DMI Opinion

6. COVID-19 Analysis

6.1. Analysis of COVID-19
- 6.1.1. Scenario Before COVID-19
- 6.1.2. Scenario During COVID-19
- 6.1.3. Scenario Post COVID-19
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During the Pandemic
6.5. Manufacturers' Strategic Initiatives
6.6. Conclusion

7. By Treatment Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
- 7.1.2. Market Attractiveness Index, By Treatment Type
7.2. Sclerotherapy*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%
7.3. Embolization
7.4. Debulking Surgery
7.5. Medication
7.6. Rehabilitation Therapies
7.7. Others

8. By Sales Channel

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel
- 8.1.2. Market Attractiveness Index, By Sales Channel
8.2. End User*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  - 8.2.2.1. Hospitals
  - 8.2.2.2. Ambulatory Surgical Centers
  - 8.2.2.3. Occupational Therapy Centers
  - 8.2.2.4. Others
8.3. Distribution Channel

9. By Region

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 9.1.2. Market Attractiveness Index, By Region
9.2. North America
- 9.2.1. Introduction
- 9.2.2. Key Region-Specific Dynamics
- 9.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Treatment Type
- 9.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Sales Channel
- 9.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 9.2.5.1. U.S.
  - 9.2.5.2. Canada
  - 9.2.5.3. Mexico
9.3. Europe
- 9.3.1. Introduction
- 9.3.2. Key Region-Specific Dynamics
- 9.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Treatment Type
- 9.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Sales Channel
- 9.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 9.3.5.1. Germany
  - 9.3.5.2. U.K.
  - 9.3.5.3. France
  - 9.3.5.4. Italy
  - 9.3.5.5. Spain
  - 9.3.5.6. Rest of Europe
9.4. South America
- 9.4.1. Introduction
- 9.4.2. Key Region-Specific Dynamics
- 9.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Treatment Type
- 9.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Sales Channel Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 9.4.4.1. Brazil
  - 9.4.4.2. Argentina
  - 9.4.4.3. Rest of South America
9.5. Asia Pacific
- 9.5.1. Introduction
- 9.5.2. Key Region-Specific Dynamics
- 9.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Treatment Type
- 9.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Sales Channel
- 9.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 9.5.5.1. China
  - 9.5.5.2. India
  - 9.5.5.3. Japan
  - 9.5.5.4. Australia
  - 9.5.5.5. Rest of Asia Pacific
9.6. Middle East and Africa
- 9.6.1. Introduction
- 9.6.2. Key Region-Specific Dynamics
- 9.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Treatment Type
- 9.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Sales Channel

10. Competitive Landscape

10.1. Competitive Scenario
10.2. Product Benchmarking
10.3. Company Share Analysis
10.4. Key Developments and Strategies

11. Company Profiles

11.1. Pfizer Inc.*
- 11.1.1. Company Overview
- 11.1.2. Product Portfolio and Description
- 11.1.3. Financial Overview
- 11.1.4. Key Developments
11.2. Novartis AG
11.3. Glenmark Pharmaceuticals U.S. Inc., USA
11.4. Methapharm, Inc.
11.5. Apotex Inc.
11.6. AngioDynamics
11.7. ENDO-FLEX GmbH
11.8. C.R. Bard, Inc
11.9. Cook Medical LLC
11.10. Cordis

LIST NOT EXHAUSTIVE