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市场调查报告书
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1557325

伴同性诊断 (CDx) 市场 – 2024 年至 2029 年预测

Companion Diagnostics (CDx) Market - Forecasts from 2024 to 2029
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 121 Pages | 商品交期: 最快1-2个工作天内

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简介目录

伴同性诊断 (CDx) 市场预计将以 11.54% 的复合年增长率成长，从 2024 年的 71.2 亿美元增至 2029 年的 122.93 亿美元。

伴同性诊断（CDx）设备是为使用者提供有关相应药物和生物製药使用的重要资讯的医疗设备。推动市场成长的主要原因是癌症和其他慢性疾病盛行率的上升，导致市场越来越多地引入伴同性诊断。此外，癌症治疗领域不断增加的创新和可用技术，以及对精准医疗的需求，为伴同性诊断带来了巨大的机会。

从地区来看，伴同性诊断市场分为北美、南美、欧洲、中东和非洲以及亚太地区。由于医疗旅游的快速成长和医疗领域的进步，预计亚太地区将占据很大的市场占有率。此外，由于医疗保健支出不断增加，预计北美和欧洲地区将占据最大的市场占有率。

伴同性诊断 (CDx) 市场驱动因素：

  • 癌症发生率的上升正在推动伴同性诊断市场的成长。

伴同性诊断在癌症诊断和治疗中特别有用，因为它们有助于根据个人的癌症概况确定特定的治疗解决方案。 CDx 建立了具体参数，帮助分析治疗效果和对患者健康的副作用。全球癌症发生率的迅速增加预计将推动对伴同性诊断设备的巨大需求。

根据世界卫生组织（WHO）的资料，2022年全球报告了近2,000万新发癌症病例和970万人死亡。据同一资讯来源称，到 2050 年，新发癌症病例的频率将达到 3,500 万，与 2022 年相比大幅增加 77%。癌症患者数量的增加预计将急剧增加对诊断和治疗的需求，从而支持伴同性诊断市场。

  • CDx技术不断创新以增强癌症治疗效果，为市场带来了新的成长前景。

癌症是全世界死亡的主要原因之一。随着新病例数的不断增加，对更精准、更有效治疗的需求也在增加，这为现代方法和技术创新带来了新的可能性。

因此，CDx 提供了一种识别此类创新并衡量其在癌症治疗中的有效性的工具。许多公司正在观察这些趋势，并投资于创新、策略联盟和市场启动。

例如，2024 年 7 月，Foundation Medicine Inc. 的 FoundationOne® Liquid CDx 获得食品药物管理局的核准，用于治疗 BRCA 突变的去势抗性前列腺癌患者。同样，2024 年 3 月，拜耳和赛默飞世尔科技将合作开发基于次世代定序的CDx 检测方法，以帮助确定癌症的精准治疗方法。

伴同性诊断 (CDx) 细分市场分析

  • 次世代定序仪的伴同性诊断预计将占据显着的市场占有率

基于技术，伴同性诊断市场分为聚合酵素链锁反应、免疫组织化学、原位杂合反应和次世代定序。由于其技术功效和良好的市场前景，使用次世代定序仪的伴同性诊断预计将占据大量市场占有率。

  • 肺癌和乳癌适应症预计将主导伴同性诊断​​市场。

伴同性诊断市场依适应症分为肺癌、乳癌及大肠癌。由于肺癌病例数量庞大，预计它将主导伴同性诊断​​市场。根据世界卫生组织（WHO）的资料，2022年，肺癌占全球新报告癌症病例的12.4%，也是导致死亡的主要原因。

乳癌和大肠癌预计在特定时期内呈正增长。据同一消息来源称，2022年将有230万新发乳癌相关病例，占所有新发病例的11.6%。同样，大肠直肠癌占新病例的 9.6%。

预计北美将占据重要的市场占有率。

从地区来看，由于主要地区经济体美国的癌症盛行率不断上升，预计北美市场将占据重要的市场占有率。例如，根据美国癌症协会估计，2023年美国新增癌症病例数为1,958,310例，新增病例数增加2.1%，死亡病例数达到60万例，达到9,820例。乳癌作为主要癌症，与 2022 年报告的新病例数相比增长了 3.4%。

同样，治疗疗法和精准医学的不断开拓伴随着市场参与者的建立。例如，雅培（Abbott）、Illumina和赛默飞世尔科技（Thermo Fisher Scientific）积极参与伴随诊断开发，也正在推动区域市场扩张。

在癌症检测和治疗方面持续投资的推动下，欧洲和亚太地区预计将实现稳定成长。因此，领先的政府机构和癌症研究机构正在该领域合作，为该地区市场带来新的成长前景。

伴同性诊断 (CDx) 市场的主要发展：

  • 2024 年 1 月，Labcorp 的伴同性诊断 nAbCyte(TM) Anti-AAVRh74var HB-FE Assay 获得美国食品药物管理局的核准。这是为了确定患者合格接受辉瑞 FDA核准的B型血友病基因治疗产品 BEQVEZ 治疗。
  • 2024 年 1 月，安捷伦科技将利用前者的技术专长和全球监管部门的核准，支持西方市场肿瘤学和血液学伴同性诊断 (CDx) 的开发和商业化。
  • 2023 年 11 月，Foundation Medicine Inc. 获得 FDA核准FoundationOne (R) CDx 与 Truqap (TM) 一起用于治疗荷尔蒙受体阳性乳癌患者。
  • 2022年5月，Illumina公司推出了新的泛癌CDx，可侦测多种肿瘤基因。这使我们能够识别 NTRK（神经营养性酪胺酸受体激酶）基因融合呈阳性的患者，包括 NTRK1、NTRK2 和 NTRK3。

伴同性诊断 (CDx) 市场区隔与分析如下：

依技术

  • Polymerase Chain Reaction（PCR）
  • Immunohistochemistry（HC）
  • In-Situ Hybridization（ISH）
  • Next Generation Sequencing（NGS）

按指示

  • 肺癌
  • 乳癌
  • 大肠直肠癌
  • 其他的

按地区

  • 北美洲
  • 美国
  • 加拿大
  • 墨西哥
  • 南美洲
  • 巴西
  • 阿根廷
  • 其他的
  • 欧洲
  • 德国
  • 法国
  • 美国英国
  • 义大利
  • 其他的
  • 中东/非洲
  • 沙乌地阿拉伯
  • 以色列
  • 其他的
  • 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 其他的

目录

第一章简介

  • 市场概况
  • 市场定义
  • 调查范围
  • 市场区隔
  • 货币
  • 先决条件
  • 基准年和预测年时间表
  • 相关利益者的主要利益

第二章调查方法

  • 研究设计
  • 调查过程

第三章执行摘要

  • 主要发现

第四章市场动态

  • 市场驱动因素
  • 市场限制因素
  • 波特五力分析
  • 产业价值链分析
  • 分析师观点

第五章伴同性诊断 (CDx) 市场：依技术分类

  • 介绍
  • 聚合酵素链锁反应(PCR)
  • 免疫组织化学 (IHC)
  • 原位杂交（ISH）
  • 次世代定序（NGS）

第六章伴同性诊断 (CDx) 市场：依适应症分类

  • 介绍
  • 肺癌
  • 乳癌
  • 大肠直肠癌
  • 其他的

第七章伴同性诊断 (CDx) 市场：按地区

  • 介绍
  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他的
  • 欧洲
    • 德国
    • 法国
    • 英国
    • 义大利
    • 其他的
  • 中东/非洲
    • 沙乌地阿拉伯
    • 以色列
    • 其他的
  • 亚太地区
    • 中国
    • 印度
    • 日本
    • 韩国
    • 其他的

第八章竞争环境及分析

  • 主要企业及策略分析
  • 市场占有率分析
  • 合併、收购、协议和合作
  • 竞争对手仪表板

第九章 公司简介

  • Abbott
  • Aglient Technologies Inc.
  • Arup Laboratories
  • F. Hoffmann-La Roche Ltd
  • Illumina, Inc.
  • Invivoscribe, Inc
  • Myriad Genetics, Inc.
  • QIAGEN
  • Thermo Fisher Scientific Inc.
简介目录
Product Code: KSI061611889

The companion diagnostics (CDx) market is predicted to grow at a CAGR of 11.54%, increasing from US$7.120 billion in 2024 to US$12.293 billion in 2029.

A companion diagnostic (CDx) device is a medical device that enables the user to receive crucial information regarding the use of corresponding drugs or biological products. The prime reason driving the market growth is the rising prevalence of cancer and other chronic diseases, which is increasing the market adoption of companion diagnostics. Furthermore, increasing innovations in cancer treatment therapies and available technology, coupled with the demand for precision medicine, have created notable opportunities for companion diagnostic devices.

Based on geography, the companion diagnostics market is segmented into North America, South America, Europe, the Middle East and Africa, and the Asia Pacific. The Asia Pacific region is forecasted to hold a substantial market share owing to a surge in medical tourism and advancement in the medical sector. The North American and European regions are also projected to hold the largest market share with increased healthcare spending.

Companion Diagnostics (CDx) Market Drivers:

  • Rising cancer prevalence has propelled the companion diagnostics market growth.

Companion diagnosis notably helps in cancer diagnosis and treatment as the device facilitates identifying a specific therapeutic solution for an individual based on his/her cancer profile. CDx establishes certain parameters that assist in analyzing treatment efficacy and its side effects on the patient's health. The booming cancer prevalence globally is expected to drive notable demand for companion diagnostic devices.

According to the World Health Organization's data, in 2022, nearly 20 million new cancer cases were reported globally, with death cases reaching up to 9.7 million. The same sources specified that by 2050, the frequency of new cancer cases will reach up to 35 million, thereby showcasing a massive 77% jump in comparison to 2022. The rise in cancer cases is expected to surge the demand for diagnosis and treatment, supporting the companion diagnostics market.

  • Ongoing innovations in CDx to bolster cancer treatment have provided new growth prospects for the market.

Cancer has become one of the major causes of death globally. With the constant rise in the strength of new cases, the demand for more precise and effective treatment is also growing, providing new scope for modern approaches and technological innovations.

Hence, CDx provides the medium for identifying such innovations and measuring their effectiveness in cancer treatment. Various companies are observing such ongoing trends and investing in innovations, strategic collaborations, and launches.

For instance, in July 2024, Foundation Medicine Inc. received the Food and Drug Administration's approval for its "FoundationOne(R)Liquid CDx," which would be used for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer patients. Likewise, in March 2024, Bayer AG and Thermo Fisher Scientific collaborated to develop next-generation sequencing-based CDx assays, which would assist in identifying precision cancer therapies.

Companion Diagnostics (CDx) Market Segment Analysis

  • A next-generation sequencing companion diagnostic is expected to hold a notable market share.

Based on technology, the companion diagnostic market can be distinguished into polymerase chain reaction, immunohistochemistry, in-situ hybridization, and next-generation sequencing. A next-generation sequencing companion diagnostic is expected to hold a significant market share, owing to its technological effectiveness and better market prospects.

  • Lung and Breast Cancer indication is expected to dominate the market for companion diagnostics.

By indication, the companion diagnostic market can be segmented into lung, breast, and colorectal cancer. Lung cancer indication is expected to dominate the companion diagnostic market owing to a higher number of cases. As per the data provided by the World Health Organization, in 2022, lung cancer accounted for 12.4% of the new cancer cases reported globally and was also the leading cause of death.

Breast cancer and colorectal cancer are expected to show positive growth during the given timeframe. As per the same source, in 2022, breast cancer-related new cases stood at 2.3 million, which accounted for 11.6% of the total new cases. Likewise, colorectal cancer constituted 9.6% of new cases.

North America is anticipated to account for a considerable market share.

Geography-wise, the North American market is projected to constitute a considerable market share fueled by the growing prevalence of cancer in major regional economies, namely the United States. For instance, according to the American Cancer Society, in 2023, the estimated number of new cancer cases in the USA stood at 1,958,310, which signified a 2.1% increase in new cases, and the number of deaths reached 609,820. Major cancer breast cancer witnessed a 3.4% growth in comparison to new cases reported in 2022.

Likewise, the ongoing development in therapeutic therapies and precision medicine followed by the well-established presence of market players. For instance, Abbott, Illumina Inc., and Thermofisher Scientific, which have actively participated in CDx development, are also driving the regional market expansion.

The European and Asia Pacific regions are poised for steady growth, which is attributable to ongoing investments in cancer detection and treatment. Hence, major governing authorities and cancer research institutes are collaborating on this front, which has provided new growth prospects for the regional markets.

Companion Diagnostics (CDx) Key Market Development:

  • In January 2024, Labcorp received approval from the U.S. Food and Drug Administration for the company's companion diagnostics product, "nAbCyte(TM) Anti-AAVRh74var HB-FE Assay". It is designed to determine the patient's eligibility for treatment with Pfizer's FDA-approved hemophilia B gene therapy product "BEQVEZ."
  • In January 2024, Agilent Technologies formed an agreement with Incyte to leverage the former's technical expertise and global regulatory approvals to support the development and commercialization of companion diagnostics (CDx) for oncology and Hematology in the European and US markets. The collaboration has furthered the development of precision medicine products.
  • In November 2023, Foundation Medicine Inc. received FDA approval for its "FoundationOne(R)CDx," which would be used along with "Truqap(TM)" to treat hormone receptor-positive breast cancer patients. The approval has supported the development of new targeted treatment options for these specific cancer patients.
  • In May 2022, Illumina Inc. launched its new pan-cancer CDx that detects multiple tumor genes, thereby identifying patients who are positive for the NTRK (Neurotrophic Tyrosine Receptor Kinase) gene fusion, which includes NTRK1, NTRK2, and NTRK3.

The Companion Diagnostics (CDx) market is segmented and analyzed as follows:

By Technology

  • Polymerase Chain Reaction (PCR)
  • Immunohistochemistry (HC)
  • In-Situ Hybridization (ISH)
  • Next Generation Sequencing (NGS)

By Indication

  • Lung Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Others

By Geography

  • North America
  • United States
  • Canada
  • Mexico
  • South America
  • Brazil
  • Argentina
  • Others
  • Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Others
  • Middle East and Africa
  • Saudi Arabia
  • Israel
  • Others
  • Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Others

TABLE OF CONTENTS

1. INTRODUCTION

  • 1.1. Market Overview
  • 1.2. Market Definition
  • 1.3. Scope of the Study
  • 1.4. Market Segmentation
  • 1.5. Currency
  • 1.6. Assumptions
  • 1.7. Base and Forecast Years Timeline
  • 1.8. Key Benefits for the Stakeholder

2. RESEARCH METHODOLOGY

  • 2.1. Research Design
  • 2.2. Research Processes

3. EXECUTIVE SUMMARY

  • 3.1. Key Findings

4. MARKET DYNAMICS

  • 4.1. Market Drivers
  • 4.2. Market Restraints
  • 4.3. Porter's Five Forces Analysis
    • 4.3.1. Bargaining Power of Suppliers
    • 4.3.2. Bargaining Power of Buyers
    • 4.3.3. Threat of New Entrants
    • 4.3.4. Threat of Substitutes
    • 4.3.5. Competitive Rivalry in the Industry
  • 4.4. Industry Value Chain Analysis
  • 4.5. Analyst View

5. COMPANION DIAGNOSTICS (CDX) MARKET BY TECHNOLOGY

  • 5.1. Introduction
  • 5.2. Polymerase Chian Reaction (PCR)
  • 5.3. Immunohistochemistry (IHC)
  • 5.4. In-Situ Hybridization (ISH)
  • 5.5. Next-Generation Sequencing (NGS)

6. COMPANION DIAGNOSTICS (CDX) MARKET BY INDICATION

  • 6.1. Introduction
  • 6.2. Lung Cancer
  • 6.3. Breast Cancer
  • 6.4. Colorectal Cancer
  • 6.5. Others

7. COMPANION DIAGNOSTICS (CDX) MARKET BY GEOGRAPHY

  • 7.1. Introduction
  • 7.2. North America
    • 7.2.1. United States
    • 7.2.2. Canada
    • 7.2.3. Mexico
  • 7.3. South America
    • 7.3.1. Brazil
    • 7.3.2. Argentina
    • 7.3.3. Others
  • 7.4. Europe
    • 7.4.1. Germany
    • 7.4.2. France
    • 7.4.3. United Kingdom
    • 7.4.4. Italy
    • 7.4.5. Others
  • 7.5. Middle East and Africa
    • 7.5.1. Saudi Arabia
    • 7.5.2. Israel
    • 7.5.3. Others
  • 7.6. Asia Pacific
    • 7.6.1. China
    • 7.6.2. India
    • 7.6.3. Japan
    • 7.6.4. South Korea
    • 7.6.5. Others

8. COMPETITIVE ENVIRONMENT AND ANALYSIS

  • 8.1. Major Players and Strategy Analysis
  • 8.2. Market Share Analysis
  • 8.3. Mergers, Acquisitions, Agreements, and Collaborations
  • 8.4. Competitive Dashboard

9. COMPANY PROFILES

  • 9.1. Abbott
  • 9.2. Aglient Technologies Inc.
  • 9.3. Arup Laboratories
  • 9.4. F. Hoffmann-La Roche Ltd
  • 9.5. Illumina, Inc.
  • 9.6. Invivoscribe, Inc
  • 9.7. Myriad Genetics, Inc.
  • 9.8. QIAGEN
  • 9.9. Thermo Fisher Scientific Inc.