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全球丁香綜合症市場 - 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: 約2個工作天內

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簡介目錄

概述

全球丁香症候群市場將於 2022 年達到 10 億美元，預計到 2030 年將達到 10 億美元，在 2023-2030 年預測期間年複合成長率為 YY%。

先天性脂肪瘤過度生長、血管畸形、表皮痣、脊柱/骨骼異常/脊柱側彎(CLOVES) 症候群是一種非常罕見的先天性（出生時出現）疾病，其特徵是血管（涉及血管）、皮膚、脊椎和骨骼的組合或關節異常。

迄今為止，全世界已發現的丁香症候群病例不到 200 例。丁香是由 PIK3CA 基因突變引起的。患有丁香的孩子的長期前景將取決於他們的年齡和症狀的嚴重程度。

診斷丁香綜合症可能很困難，因為這種症候群很罕見，而且症狀也各不相同。臨床評估、基因檢測、醫學影像和對各種特徵的仔細評估經常結合起來做出結論性的診斷。治療 CLOVES 症候群需要採用多學科方法，其中可能涉及解決身體異常的手術、治療血管畸形的干涉措施以及解決相關併發症的支持療法。定期醫療追蹤對於監測病情進展並解決任何新出現的問題至關重要。

此外，丁香症候群研究資金的增加，以及醫療專業人員和公眾對罕見遺傳性疾病的認知不斷提高，預計將在預測期內推動市場發展。

動力學

增加對丁香綜合症斑馬魚模型的資助預計將推動市場成長

丁香是一種導致脂肪細胞過度生長、血管畸形和其他身體異常的遺傳性疾病，投資開發丁香斑馬魚模型是這種罕見疾病的研究和潛在治療的重大進展。

2022 年 10 月 20 日，愛丁堡大學巴頓實驗室獲得 10 萬美元的研究捐贈，用於創建丁香症候群的斑馬魚模型。該計畫的主要目標是在斑馬魚的幫助下建立一個新鮮且具有臨床意義的丁香症候群動物模型。

斑馬魚已被廣泛接受作為研究人類疾病的模型。至少 70% 的導致人類疾病的基因在斑馬魚中有對應的基因。為了進一步進行這項研究，科學家打算利用 CRISPR-Cas9 技術將導致 CLOVES 症候群的主要突變以及正常基因引入斑馬魚 Pik3ca。使用螢光標記，科學家將觀察 Pik3ca 突變細胞的行為以及它們如何與周圍的正常細胞相互作用。

此外，研究人員相信，與先前使用的其他動物模型相比，這種方法將使他們能夠創建更詳細的丁香症候群模型。此模型可作為篩選丁香症候群新療法的基礎。 Liz Patton 博士領導了該項目，並利用斑馬魚模型作為識別和靶向黑色素瘤細胞群的主要工具。

因此，由於上述因素，預計市場在預測期內將繼續成長。

大眾對丁香症候群的認知不斷提高預計將推動市場成長

每年 8 月 3 日是丁香症候群意識日，旨在提高人們對這種影響身體許多不同部位發育的罕見遺傳性疾病的認知。這一天的目的是促進對受丁香症候群影響的個人和家庭的理解、支持和團結。

社區聯合起來交流有關丁香病的資訊和資源，並教育個人識別早期症狀。講習班也討論社會包容和社會在幫助有受影響成員的家庭方面的責任。由於它是一種罕見疾病，僅有略多於 200 例的記錄病例，因此沒有足夠的資金和研究分配給它。因此，受影響的家庭無法獲得有效的治療，如果不提高意識，他們可能無法獲得所需的支持。

因此，丁香症候群意識日提供了一個傳播有關丁香症候群及其對人們生活影響的資訊和資源的機會。這一天是社區匯集知識和資源來對抗這種疾病的一天。因此，由於上述因素，預計市場在預測期內將繼續成長。

與管理丁香症候群相關的挑戰預計將阻礙市場成長

根據國家罕見疾病組織的說法，治療丁香症候群非常具有挑戰性，需要一支由在過度生長性疾病和血管異常方面具有豐富經驗的跨科醫生團隊組成。

例如，CLOVES 症候群的症狀差異很大，可能包括脂肪組織腫塊、腳和手部問題、靜脈擴張、胎記、脊椎彎曲和脊髓栓系。控制這些症狀並預防血栓等併發症需要持續的醫療和手術介入。因此，由於與丁香症候群管理相關的挑戰，預計將阻礙預測期內的市場成長。

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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