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1557325

伴同性診斷 (CDx) 市場 – 2024 年至 2029 年預測

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個工作天內

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簡介目錄

伴同性診斷 (CDx) 市場預計將以 11.54% 的複合年成長率成長，從 2024 年的 71.2 億美元增至 2029 年的 122.93 億美元。

伴同性診斷（CDx）設備是為使用者提供有關相應藥物和生物製藥使用的重要資訊的醫療設備。推動市場成長的主要原因是癌症和其他慢性疾病盛行率的上升，導致市場擴大引入伴同性診斷。此外，癌症治療領域不斷增加的創新和可用技術，以及對精準醫療的需求，為伴同性診斷帶來了巨大的機會。

從地區來看，伴同性診斷市場分為北美、南美、歐洲、中東和非洲以及亞太地區。由於醫療旅遊的快速成長和醫療領域的進步，預計亞太地區將佔據很大的市場佔有率。此外，由於醫療保健支出不斷增加，預計北美和歐洲地區將佔據最大的市場佔有率。

伴同性診斷 (CDx) 市場促進因素：

  • 癌症發生率的上升正在推動伴同性診斷市場的成長。

伴同性診斷在癌症診斷和治療中特別有用，因為它們有助於根據個人的癌症概況確定特定的治療解決方案。 CDx 建立了具體參數，幫助分析治療效果和對患者健康的副作用。全球癌症發生率的迅速增加預計將推動對伴同性診斷設備的巨大需求。

根據世界衛生組織（WHO）的資料，2022年全球報告了近2,000萬新發癌症病例和970萬人死亡。據同一資訊來源稱，到 2050 年，新發癌症病例的頻率將達到 3,500 萬，與 2022 年相比大幅增加 77%。癌症患者數量的增加預計將急劇增加對診斷和治療的需求，從而支持伴同性診斷市場。

  • CDx技術不斷創新以增強癌症治療效果，為市場帶來了新的成長前景。

癌症是全世界死亡的主要原因之一。隨著新病例數的不斷增加，對更精準、更有效治療的需求也在增加，這為現代方法和技術創新帶來了新的可能性。

因此，CDx 提供了一種識別此類創新並衡量其在癌症治療中的有效性的工具。許多公司正在觀察這些趨勢，並投資於創新、策略聯盟和市場啟動。

例如，2024 年 7 月，Foundation Medicine Inc. 的 FoundationOne® Liquid CDx 獲得食品藥物管理局的核准，用於治療 BRCA 突變的去勢抗性前列腺癌患者。同樣，2024 年 3 月，拜耳和賽默飛世爾科技將合作開發基於次世代定序的CDx 檢測方法，以幫助確定癌症的精準治療方法。

伴同性診斷 (CDx) 細分市場分析

  • 次世代定序儀的伴同性診斷預計將佔據顯著的市場佔有率

基於技術，伴同性診斷市場分為聚合酵素鏈鎖反應、免疫組織化學、原位雜合反應和次世代定序。由於其技術功效和良好的市場前景，使用次世代定序儀的伴同性診斷預計將佔據大量市場佔有率。

  • 肺癌和乳癌適應症預計將主導伴同性診斷​​市場。

伴同性診斷市場依適應症分為肺癌、乳癌及大腸癌。由於肺癌病例數量龐大，預計它將主導伴同性診斷​​市場。根據世界衛生組織（WHO）的資料，2022年，肺癌佔全球新報告癌症病例的12.4%，也是導致死亡的主要原因。

乳癌和大腸癌預計在特定時期內呈正成長。據同一消息來源稱，2022年將有230萬新發乳癌相關病例，佔所有新發病例的11.6%。同樣，大腸直腸癌佔新病例的 9.6%。

預計北美將佔據重要的市場佔有率。

從地區來看，由於主要地區經濟體美國的癌症盛行率不斷上升，預計北美市場將佔據重要的市場佔有率。例如，根據美國癌症協會估計，2023年美國新增癌症病例數為1,958,310例，新增病例數增加2.1%，死亡病例數達到60萬例，達到9,820例。乳癌作為主要癌症，與 2022 年報告的新病例數相比成長了 3.4%。

同樣，治療療法和精準醫學的不斷開拓伴隨著市場參與者的建立。例如，雅培（Abbott）、Illumina和賽默飛世爾科技（Thermo Fisher Scientific）積極參與伴隨診斷開發，也正在推動區域市場擴張。

在癌症檢測和治療方面持續投資的推動下，歐洲和亞太地區預計將實現穩定成長。因此，領先的政府機構和癌症研究機構正在該領域合作，為該地區市場帶來新的成長前景。

伴同性診斷 (CDx) 市場的主要發展：

  • 2024 年 1 月，Labcorp 的伴同性診斷 nAbCyte(TM) Anti-AAVRh74var HB-FE Assay 獲得美國食品藥物管理局的核准。這是為了確定患者合格接受輝瑞 FDA核准的B型血友病基因治療產品 BEQVEZ 治療。
  • 2024 年 1 月，安捷倫科技將利用前者的技術專長和全球監管部門的核准，支持西方市場腫瘤學和血液學伴同性診斷 (CDx) 的開發和商業化。
  • 2023 年 11 月，Foundation Medicine Inc. 獲得 FDA核准FoundationOne (R) CDx 與 Truqap (TM) 一起用於治療荷爾蒙受體陽性乳癌患者。
  • 2022年5月，Illumina公司推出了新的泛癌CDx，可偵測多種腫瘤基因。這使我們能夠識別 NTRK（神經營養性酪胺酸受體激酶）基因融合呈陽性的患者，包括 NTRK1、NTRK2 和 NTRK3。

伴同性診斷 (CDx) 市場區隔與分析如下：

依技術

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

按指示

  • 肺癌
  • 乳癌
  • 大腸直腸癌
  • 其他

按地區

  • 北美洲
  • 美國
  • 加拿大
  • 墨西哥
  • 南美洲
  • 巴西
  • 阿根廷
  • 其他
  • 歐洲
  • 德國
  • 法國
  • 美國英國
  • 義大利
  • 其他
  • 中東/非洲
  • 沙烏地阿拉伯
  • 以色列
  • 其他
  • 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 其他

目錄

第1章簡介

  • 市場概況
  • 市場定義
  • 調查範圍
  • 市場區隔
  • 貨幣
  • 先決條件
  • 基準年和預測年時間表
  • 相關利益者的主要利益

第2章調查方法

  • 研究設計
  • 調查過程

第3章執行摘要

  • 主要發現

第4章市場動態

  • 市場促進因素
  • 市場限制因素
  • 波特五力分析
  • 產業價值鏈分析
  • 分析師觀點

第5章伴同性診斷 (CDx) 市場：依技術分類

  • 介紹
  • 聚合酵素鏈鎖反應(PCR)
  • 免疫組織化學 (IHC)
  • 原位雜合技術（ISH）
  • 次世代定序（NGS）

第6章伴同性診斷 (CDx) 市場：依適應症分類

  • 介紹
  • 肺癌
  • 乳癌
  • 大腸直腸癌
  • 其他

第7章伴同性診斷 (CDx) 市場：按地區

  • 介紹
  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他
  • 歐洲
    • 德國
    • 法國
    • 英國
    • 義大利
    • 其他
  • 中東/非洲
    • 沙烏地阿拉伯
    • 以色列
    • 其他
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 韓國
    • 其他

第8章競爭環境及分析

  • 主要企業及策略分析
  • 市場佔有率分析
  • 合併、收購、協議和合作
  • 競爭對手儀表板

第9章 公司簡介

  • Abbott
  • Aglient Technologies Inc.
  • Arup Laboratories
  • F. Hoffmann-La Roche Ltd
  • Illumina, Inc.
  • Invivoscribe, Inc
  • Myriad Genetics, Inc.
  • QIAGEN
  • Thermo Fisher Scientific Inc.
簡介目錄
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.