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1542859

フォンヒッペルリンドウ病の世界市場：2024年～2031年

Global Von Hippel-Lindau Disease Market - 2024-2031
出版日: | 発行: DataM Intelligence | ページ情報: 英文 183 Pages | 納期: 即日から翌営業日

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フォンヒッペルリンドウ病の世界市場：2024年～2031年
出版日: 2024年08月26日
発行: DataM Intelligence
ページ情報: 英文 183 Pages
納期: 即日から翌営業日
ご注意事項 :
本レポートは最新情報反映のため適宜更新し、内容構成変更を行う場合があります。ご検討の際はお問い合わせください。
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  • 概要
  • 目次
概要

概要

世界のフォンヒッペルリンドウ病市場は、2023年に2億9,347万米ドルに達し、2024年から2031年の予測期間中にCAGR 6.92％で成長し、2031年には5億124万米ドルに達すると予測されています。

フォンヒッペルリンドウ症候群（VHL）は、脳、脊髄、目、内耳、副腎、膵臓、腎臓、生殖器系など、身体の様々な部位に腫瘍や嚢胞を発生させる稀な遺伝子疾患です。

VHLに関連する腫瘍のほとんどは良性（非がん性）であるが、悪性（がん性）腫瘍、特に腎細胞がんおよび膵神経内分泌腫瘍のリスクがあります。症状は通常、若年成人期に発現するが、どの年齢でも発現する可能性があります。この疾患は、細胞の成長と分裂を制御するのに重要なVHL遺伝子の突然変異によって引き起こされます。

市場力学：

促進要因

VHL関連腫瘍および血管芽腫の有病率の上昇

世界のフォンヒッペルリンドウ病市場の需要は、複数の要因によって牽引されています。主な要因の1つは、VHL関連腫瘍および血管芽細胞腫の有病率の上昇です。

フォン・ヒッペル-リンダウ病は身体の様々な部位に腫瘍を発生させるが、臨床試験参加者の多くは腎臓がんと並んで他のがん種も患っていました。2021年10月のMDアンダーソンがんセンターの統計によると、まれな膵臓がんである膵神経内分泌腫瘍の91％、脳や脊椎にある進行の遅い腫瘍である血管芽腫の30％が、少なくとも30％縮小しました。

2024年6月の国立がん研究センターのデータによると、フォンヒッペルリンドウ（VHL）病は、一般集団では出生27,000人に1人から43,000人に1人と推定されています。また、様々な調査研究によると、VHLは平均して新生児約35,000人に1人の割合で発症するとされています。

さらに同じ情報源から、VHL疾患の有病率は、ある時点での集団における症例総数を指し、31,000人に1人から91,000人に1人と推定されています。これは、VHLが一般人口10万人中1人から3人に発症することを意味します。

制約

高額な治療開発費、限られた治療オプションしか利用できないこと、個人の認識・診断不足、規制上の課題などが市場を阻害すると予想されます。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

  • 影響要因
    • 促進要因
      • VHL関連腫瘍および血管芽腫の有病率の上昇
    • 抑制要因
      • 治療開発コストの高さ
    • 機会
    • 影響分析

第5章 産業分析

  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • 価格分析
  • 規制分析

第6章 腫瘍部位別

  • 脳
  • 脊髄
  • 目
  • 内耳
  • 生殖管
  • 腎臓
  • その他

第7章 治療別

  • 薬剤タイプ
    • HIF-2a阻害薬
      • ベルズチファン
    • VEGF阻害薬
      • ベバシズマブ
      • ラニビズマブ
  • 外科手術
    • マイクロ外科的切除
    • ネフロン温存手術（NSS）
    • 早期根治切除術
  • その他

第8章 エンドユーザー別

  • 病院および専門クリニック
  • 外来手術センター
  • その他

第9章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • スペイン
    • イタリア
    • その他欧州
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • 韓国
    • その他アジア太平洋地域
  • 中東・アフリカ

第10章 競合情勢

  • 競合シナリオ
  • 市況/シェア分析
  • M&A分析

第11章 企業プロファイル

  • Merck & Co., Inc.
    • 会社概要
    • 製品ポートフォリオと説明
    • 財務概要
    • 主な発展
  • F. Hoffmann-La Roche Ltd
  • Genentech, Inc.
  • Amgen Inc
  • Betta Pharmaceuticals Co., Ltd
  • Amneal Pharmaceuticals, Inc.
  • Reliance Life Sciences
  • Lupin
  • Sandoz, Inc.
  • Biogen

第12章 付録

目次
Product Code: PH8586

Overview

The global von Hippel-Lindau disease market reached US$ 293.47 million in 2023 and is expected to reach US$ 501.24 million by 2031 growing with a CAGR of 6.92% during the forecast period 2024-2031.

Von Hippel-Lindau syndrome (VHL) is a rare genetic disorder that leads to the development of tumors and cysts in various parts of the body, including the brain, spinal cord, eyes, inner ear, adrenal glands, pancreas, kidneys, and reproductive system.

While most tumors associated with VHL are benign (non-cancerous), there is a risk of malignant (cancerous) tumors, particularly renal cell carcinoma and pancreatic neuroendocrine tumors. Symptoms typically emerge in young adulthood, although they can manifest at any age. The condition is caused by mutations in the VHL gene, which is crucial for regulating cell growth and division.

Market Dynamics: Drivers

Rising prevalence of VHL-related tumors and hemangioblastomas

The demand for the global von Hippel-Lindau disease market is driven by multiple factors. One of the primary factors is the rising prevalence of VHL-related tumors and hemangioblastomas.

Von Hippel-Lindau's disease leads to the development of tumors in various parts of the body, and many of the clinical trial participants also had other cancer types alongside kidney cancer. As per MD Anderson Cancer Center stats in October 2021, 91% of pancreatic neuroendocrine tumors, which are a rare form of pancreatic cancer, and 30% of hemangioblastomas, which are slow-growing tumors located in the brain or spine, reduced in size by at least 30%.

According to National Cancer Institute data in June 2024, Von Hippel-Lindau (VHL) disease is estimated to range from 1 case per 27,000 to 1 case per 43,000 live births in the general population. Also, various research studies stated that on average, VHL affects approximately 1 in every 35,000 newborns.

Furthermore, from the same source, the prevalence of VHL disease, which refers to the total number of cases in a population at a given time, is estimated to be between 1 in 31,000 to 1 in 91,000 individuals. This means that VHL affects somewhere between 1 and 3 people out of every 100,000 individuals in the general population.

Restraints

Factors such as the high cost of treatment development, the limited availability of treatment options, lack of awareness & diagnosis among individuals, and regulatory challenges are expected to hamper the market.

Segment Analysis

The global von Hippel-Lindau disease market is segmented based on tumor site, treatment, end-user, and region.

The Belzutifan segment accounted for approximately 62.8% of the global von Hippel-Lindau disease market share.

The Belzutifan segment is expected to hold the largest market share over the forecast period. Belzutifan is approved for treating adult patients with von Hippel-Lindau (VHL) disease who need therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET) that do not require immediate surgical intervention.

In addition, Belzutifan is indicated for adult patients with advanced renal cell carcinoma (RCC) after they have received treatment with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, as well as a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Moreover, key players in the industry product launches & approvals, and key developments help to drive this segment growth of the market. For instance, in August 2021, the U.S. Food and Drug Administration (FDA) approved Belzutifan (WELIREG, Merck), a first-in-class hypoxia-inducible factor (HIF) inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), but do not require immediate surgery.

According to the New England Journal of Medicine research article in November 2021, individuals with von Hippel-Lindau (VHL) disease experience a high rate of renal cell carcinoma due to the inactivation of the VHL gene, which leads to the continuous activation of the transcription factor hypoxia-inducible factor 2a (HIF-2a). Belzutifan was linked to primarily grade 1 and 2 adverse events and demonstrated effectiveness in patients with renal cell carcinomas as well as other neoplasms associated with von Hippel-Lindau (VHL) disease.

In addition, key player's ongoing R&D studies would propel this market growth. As per the Ocular Oncology and Pathology research publication in November 2024, Belzutifan demonstrates significant potential in preventing vision-threatening complications in patients with VHL-associated retinal hemangioblastomas (RHs). While the optimal dosing for treating ocular tumors requires additional research, patients receiving treatment for RHs could likely be maintained on a lower daily dose of 80 mg.

However, further studies are needed to address the long-term efficacy of Belzutifan and to determine the best approach for incorporating its use into the treatment and surveillance protocols for patients with VHL-associated RHs. Ongoing research and clinical trials will help refine the dosing and treatment strategies for this patient population.

Geographical Analysis

North America accounted for approximately 44.4% of the global von Hippel-Lindau disease market share.

North America region is expected to hold the largest market share over the forecast period owing to the rising prevalence of VHL-related tumors, raising awareness of cancer, and increasing demand for advanced therapies driving this market growth in the region.

As per ACS publication in March 2021, the VHL tumor suppressor gene is responsible for the persistent expression of angiogenic and growth factors. In the United States, von Hippel-Lindau (VHL) disease occurs in roughly 1 out of every 36,000 newborns. The average age at which VHL is diagnosed is around 26 years old. By the time patients reach 65 years of age, the disease has penetrated and manifested in over 90% of cases.

Moreover, key players in the industry more focus on the treatment for VHL disease research studies, government initiatives, and the rising number of clinical trials that would propel this market growth. For instance, in November 2023, International Kidney Cancer Symposium, Dr. Jaleh Fallah, a medical oncologist at the FDA, reviewed the agency's assessment of data from the phase 2 LITESPARK-004 trial (NCT03401788).

This evaluation was pivotal in the approval of Belzutifan (Welireg) for adult patients with von Hippel-Lindau (VHL) disease who need treatment for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNETs) that do not require immediate surgical intervention.

Market Segmentation

By Tumor Site

  • Brain
  • Spinal Cord
  • Eyes
  • Inner Ear
  • Reproductive Tract
  • Kidney
  • Others

By Treatment

  • Drug Type
    • HIF-2a Inhibitors
  • Belzutifan
    • VEGF Inhibitors
  • Bevacizumab
  • Ranibizumab
  • Surgeries
    • Microsurgical Resection
    • Nephron-Sparing Surgery (NSS)
    • Early Radical Resection
  • Others

By End-User

  • Hospitals & Specialty Clinics
  • Ambulatory Surgical Centers
  • Others

By Region

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • U.K.
    • France
    • Spain
    • Italy
    • Rest of Europe
  • South America
    • Brazil
    • Argentina
    • The rest of South America
  • Asia-Pacific
    • China
    • India
    • Japan
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa

Competitive Landscape

The major global players in the von Hippel-Lindau disease market include Merck & Co., Inc., F. Hoffmann-La Roche Ltd, Genentech, Inc., Amgen Inc., Betta Pharmaceuticals Co., Ltd, Amneal Pharmaceuticals, Inc., Reliance Life Sciences, Lupin, Sandoz, Inc., and Biogen among others.

Key Developments

  • In December 2023, Merck announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor. This medication is intended for adult patients with advanced renal cell carcinoma (RCC) who have previously been treated with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, as well as a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
  • In August 2021, Merck acquired the rights to Belzutifan, a hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor, as part of a $1.2 billion deal to purchase the small molecule from Peloton Therapeutics.

Why Purchase the Report?

  • To visualize the global von Hippel-Lindau disease market segmentation based on tumor site, treatment, end-user, and region and understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development.
  • Excel data sheet with numerous data points of the von Hippel-Lindau disease market with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping is available in Excel consisting of key products of all the major players.

The global von Hippel-Lindau disease market report would provide approximately 62 tables, 64 figures, and 183 pages.

Target Audience 2023

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

Table of Contents

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 Tumor Site
  • 3.2. Snippet by Treatment
  • 3.3. Snippet by End-User
  • 3.4. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Rising Prevalence of VHL-Related Tumors and Hemangioblastoma
    • 4.1.2. Restraints
      • 4.1.2.1. High Cost of Treatment Development
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's Five Force Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis

6. By Tumor Site

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Tumor Site
    • 6.1.2. Market Attractiveness Index, By Tumor Site
  • 6.2. Brain *
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.3. Spinal Cord
  • 6.4. Eyes
  • 6.5. Inner Ear
  • 6.6. Reproductive Tract
  • 6.7. Kidney
  • 6.8. Others

7. By Treatment

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 7.1.2. Market Attractiveness Index, By Treatment
  • 7.2. Drug Type *
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
    • 7.2.3. HIF-2a Inhibitors
      • 7.2.3.1. Belzutifan
    • 7.2.4. VEGF Inhibitors
      • 7.2.4.1. Bevacizumab
      • 7.2.4.2. Ranibizumab
  • 7.3. Surgeries
    • 7.3.1. Microsurgical Resection
    • 7.3.2. Nephron-Sparing Surgery (NSS)
    • 7.3.3. Early Radical Resection
  • 7.4. Others

8. By End-User

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 8.1.2. Market Attractiveness Index, By End-User
  • 8.2. Hospitals & Specialty Clinics *
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Ambulatory Surgical Centers
  • 8.4. Others

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 Tumor Site
    • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.2.6.1. U.S.
      • 9.2.6.2. Canada
      • 9.2.6.3. 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 Tumor Site
    • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.3.6.1. Germany
      • 9.3.6.2. U.K.
      • 9.3.6.3. France
      • 9.3.6.4. Spain
      • 9.3.6.5. Italy
      • 9.3.6.6. 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 Tumor Site
    • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.4.6.1. Brazil
      • 9.4.6.2. Argentina
      • 9.4.6.3. 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 Tumor Site
    • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.5.6.1. China
      • 9.5.6.2. India
      • 9.5.6.3. Japan
      • 9.5.6.4. South Korea
      • 9.5.6.5. 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 Tumor Site
    • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

10. Competitive Landscape

  • 10.1. Competitive Scenario
  • 10.2. Market Positioning/Share Analysis
  • 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

  • 11.1. Merck & Co., 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. F. Hoffmann-La Roche Ltd
  • 11.3. Genentech, Inc.
  • 11.4. Amgen Inc
  • 11.5. Betta Pharmaceuticals Co., Ltd
  • 11.6. Amneal Pharmaceuticals, Inc.
  • 11.7. Reliance Life Sciences
  • 11.8. Lupin
  • 11.9. Sandoz, Inc.
  • 11.10. Biogen

LIST NOT EXHAUSTIVE

12. Appendix

  • 12.1. About Us and Services
  • 12.2. Contact Us