乳がんリキッドバイオプシーの世界市場：2024年～2031年

レポート概要

乳がんリキッドバイオプシーの世界市場は、2023年に16億米ドルに達し、2031年には79億8,000万米ドルに達し、予測期間2024年～2031年にCAGR 23.2％で成長すると予測されています。

リキッドバイオプシー（液体生検）とは、血液、尿、その他の体液サンプルから、腫瘍のがん細胞や、腫瘍細胞から体液中に放出されたDNA、RNA、その他の分子の小片を探す検査です。リキッドバイオプシーでは、時間をかけて複数のサンプルを採取することができるため、医師は腫瘍でどのような遺伝子や分子の変化が起こっているかを理解するのに役立つ可能性があります。リキッドバイオプシーは、がんを早期に発見するのに役立ちます。また、治療計画を立てるのに役立てたり、治療がどの程度効いているのか、あるいはがんが再発したのかを調べるのにも使用されます。

リキッドバイオプシーは、循環腫瘍細胞（CTC）、無細胞核酸、エクソソーム、腫瘍"教育化血小板"など、さまざまな生物学的マトリックスから構成されます。最近の技術的、分子学的進歩は、多くの場合マイクロ流体工学の使用によって大いに促進され、リキッドバイオプシー成分の精製能力と分析能力の両面で大きな進歩を可能にしています。

市場力学：

促進要因

乳がんの有病率の増加

乳がんリキッドバイオプシー市場の需要は複数の要因によって牽引されています。乳がんの有病率の上昇が市場成長を促進します。

さらに、治療に対する需要は、人々の意識の高まりと技術の進歩によって促進されます。例えば、uicc.orgによると、乳がんは世界中の女性の間で最も診断されているがんであり、157カ国の女性で最も診断されているがんであり、がん症例の4人に1人を占めています。男女ともに2番目に多いがんであり、女性のがんによる死亡原因の第1位です。2022年に新たに乳がんと診断される症例は230万人と推定され、全世界で診断される男女のがんのおよそ9人に1人が乳がんです。2022年、乳がんによる死亡者数は推定669,418人で、このうち不釣り合いな数が低リソース環境で発生しています。

さらに、breastcancer.orgによると、乳がん患者の約66％は、治療が最も容易な乳房外にがんが広がる前の限局期で診断されています。米国には現在、乳がんの既往歴がある女性が400万人以上います。

さらに、WHOが2023年2月に投稿した記事によると、乳がんは毎年230万人以上の患者が発生しており、成人の間で最も多いがんとなっています。95％の国で、乳がんは女性のがん死亡原因の1位または2位を占めています。しかし、乳がんによる生存率は、国によって、また国内においても大きく不平等であり、乳がんおよび子宮頸がんによる死亡の80％近くは、低・中所得国で発生しています。

阻害要因

リキッドバイオプシーに関連する高コスト、熟練した専門家の不足、新しい治療法の承認に対する厳しい規制要件などの要因が市場の妨げになると予想されます。

市場セグメンテーション

世界の乳がんリキッドバイオプシー市場は、製品タイプ、循環バイオマーカー、用途、エンドユーザー、地域によって区分されます。

循環腫瘍細胞（CTC）セグメントは、世界の乳がんリキッドバイオプシー市場シェアの約47.9％を占めています。

循環腫瘍細胞セグメントは予測期間中最大の市場シェアを占めると予想されます。この分野では、技術的進歩、民間メーカーの研究資金の増加がこの市場を牽引するであろう。

リキッドバイオプシーとしての循環腫瘍細胞（CTC）は、臨床応用や基礎がん研究において大きな可能性を秘めています。低侵襲技術であるリキッドバイオプシーは、体液から直接がんバイオマーカーを検出することを可能にします。これらのバイオマーカーのうち、CTC、無細胞DNA（cfDNA）、RNAは腫瘍の遺伝的状況をダイナミックに垣間見ることができます。この画期的なアプローチは、がんの早期発見、病勢進行のモニタリング、個別化治療戦略への有望な手段を提供します。

CTCは現在、転移プロセスにおける重要な役割を担っていると認識されています。その検出と解析は、従来の組織生検に代わる低侵襲のリキッドバイオプシー技術の開発に道を開いた。この革新的なアプローチは腫瘍動態の理解に革命をもたらし、リアルタイムのモニタリングを可能にし、腫瘍の不均一性、治療反応、疾患の進行に関する洞察を提供しています。

地域別市場分析

北米は乳がんリキッドバイオプシー世界市場シェアの約42.8%を占める

北米地域が予測期間中最大の市場シェアを占めると予想されます。同地域における乳がん罹患率の上昇と人々の意識の高まりが、同市場の推進力となっています。

例えば、breastcancer.orgによると、米国女性の約13％（約8人に1人）が生涯のうちに浸潤性乳がんを発症するといいます。近年、罹患率は年間0.5％ずつわずかに増加しています。乳がんは依然として米国女性のがん関連死の主要原因の一つであり、肺がんに次いで2番目です。乳がんは、皮膚がんに次いで米国女性の間で最も多く診断されるがんです。毎年、新たに診断される女性のがんの約30％が乳がんです。現在、米国には乳がんの既往歴のある女性が400万人以上います。

さらに2023年6月、ラボコープはがんに関連するバイオマーカーを検出するリキッドバイオプシーを発売しました。プラズマフォーカスのリキッドバイオプシーは、通常の採血だけで実施できます。腫瘍細胞から血流に放出される無細胞DNA（cfDNA）の断片を検体から探し出し、特定の患者に最も効果的に作用するがん治療法についての洞察を得ることができます。

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
    • 乳がんの有病率の増加
    • 人々の意識の高まり
    • 技術の進歩
• 抑制要因
  • リキッドバイオプシーに伴う高コスト
  • 熟練した専門家の不足
  • 厳しい規制要件
• 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
• アンメットニーズ
• PESTEL分析
• 特許分析
• SWOT分析

第6章 製品タイプ別

• 試薬・キット
• 機器

第7章 循環バイオマーカー別

• 循環腫瘍細胞（CTC）
• 循環無細胞DNA（cfDNA）
• 細胞外小胞
• その他

第8章 用途別

• 早期スクリーニング
• 治療選択

第9章 エンドユーザー別

• 病院
• 診断センター
• 研究・教育機関
• その他

第10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
  • イタリア
  • スペイン
  • 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11章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第12章 企業プロファイル

• F. Hoffmann-La Roche Ltd.
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Thermo Fisher Scientific Inc.
• Abbott
• Agilent Technologies Inc.
• Merck KGaA
• Cell Signaling Technology Inc.
• Medtronic
• Bio-Rad Laboratories Inc.
• ExoDx
• Biocept Inc.

第13章 付録

Report Overview

The Global Breast Cancer Liquid Biopsy Market reached US$ 1.6 billion in 2023 and is expected to reach US$ 7.98 billion by 2031, growing at a CAGR of 23.2% during the forecast period 2024-2031.

A liquid biopsy is a laboratory test done on a sample of blood, urine, or other body fluid to look for cancer cells from a tumor or small pieces of DNA, RNA, or other molecules released by tumor cells into a person's body fluids. Liquid biopsy allows multiple samples to be taken over time, which may help doctors understand what kind of genetic or molecular changes are taking place in a tumor. A liquid biopsy may be used to help find cancer at an early stage. It may also be used to help plan treatment or to find out how well treatment is working or if cancer has come back.

It is composed of different biological matrices such as circulating tumor cells (CTCs), cell-free nucleic acids, exosomes or tumors "educated platelets." Recent technological and molecular advances, greatly facilitated by the use of microfluidics in many cases, have permitted large progress in both the ability to purify and analyze liquid biopsy components.

Market Dynamics: Drivers

Increasing prevalence of breast cancer

The demand for the breast cancer liquid biopsy market is driven by multiple factors. The rising prevalence of breast cancer propels the market growth.

Furthermore, the demand for treatment will be fueled by the increase in awareness among people and technological advancements. For instance, according to uicc.org, Breast cancer is the most diagnosed cancer among women worldwide and is the most diagnosed cancer in women in 157 countries, accounting for 1 in 4 cancer cases. It is the second most frequent cancer amongst both sexes and is the leading cause of death from cancer in women. With the estimated 2.3 million new cases of breast cancer in 2022, roughly one in every 9 cancers for both sexes diagnosed globally was breast cancer. In 2022, there were an estimated 669,418 deaths from breast cancer, with a disproportionate number of these deaths occurring in low-resource settings.

Moreover, according to breastcancer.org, About 66% of breast cancer cases are diagnosed at a localized stage before cancer has spread outside of the breast when it is easiest to treat. There are currently more than four million women with a history of breast cancer in the US.

Moreover, according to an article posted by WHO in February 2023, there are more than 2.3 million cases of breast cancer that occur each year, which makes it the most common cancer among adults. In 95% of countries, breast cancer is the first or second leading cause of female cancer deaths. Yet, survival from breast cancer is widely inequitable between and within countries nearly 80% of deaths from breast and cervical cancer occur in low- and middle-income countries.

Restraints

Factors such as high costs associated with liquid biopsy, the shortage of skilled professionals, and stringent regulatory requirements for the approval of new treatments are expected to hamper the market.

Market Segment Analysis

The global breast cancer liquid biopsy market is segmented based on product type, circulating biomarkers, application, end-user, and region.

The segment circulating tumor cells (CTCs) accounted for approximately 47.9% of the global breast cancer liquid biopsy market share

The circulating tumor cells segment is expected to hold the largest market share over the forecast period. In this segment, the technological advancements, and rising funds for private manufacturers for research work would drive this market.

Circulating tumor cells (CTCs) as a liquid biopsy have great potential in clinical applications and basic cancer research. Liquid biopsy, a minimally invasive technique, allows for the detection of cancer biomarkers directly from bodily fluids. Among these biomarkers, CTCs, cell-free DNA (cfDNA), and RNA provide a dynamic glimpse into the tumor's genetic landscape. This revolutionary approach offers promising avenues for early cancer detection, monitoring disease progression, and tailoring personalized treatment strategies.

CTCs are now recognized as crucial players in the metastatic process. Their detection and analysis have paved the way for the development of liquid biopsy techniques, offering a minimally invasive alternative to traditional tissue biopsies. This innovative approach has revolutionized our understanding of tumor dynamics, enabling real-time monitoring and providing insights into tumor heterogeneity, treatment response, and disease progression.

Market Geographical Analysis

North America accounted for approximately 42.8% of the global breast cancer liquid biopsy market share

North America region is expected to hold the largest market share over the forecast period. The rising incidence of breast cancer, and growing awareness among people, in this region, help to propel the market.

For instance, according to breastcancer.org, approximately 13% (about one in eight) of U.S. women will develop invasive breast cancer in the course of their life. In recent years, incidence rates have increased slightly by 0.5% per year. Breast cancer is still one of the leading causes of cancer-related death in U.S. women, second only to lung cancer. Breast cancer is the most commonly diagnosed cancer among U.S. women after skin cancers. Each year, about 30% of all newly diagnosed cancers in women are breast cancer. There are currently more than four million women with a history of breast cancer in the US.

Moreover in June 2023, Labcorp launched liquid biopsy to detect cancer-related biomarkers. The Plasma Focus liquid biopsy requires only a standard blood draw to run. It looks through the sample for bits of cell-free DNA (cfDNA) that are released by tumor cells into the bloodstream and that may offer insights into the cancer treatments that'll work most effectively for a specific patient.

Market Segmentation

By Product Type

Reagents & Kits

Instruments

By Circulating Biomarkers

Circulating Tumor Cells (CTCs)

Circulating Cell-free DNA (cfDNA)

Extracellular Vesicles (EVs)

Others

By Application

Early Screening

Treatment Selection

By End-User

Hospitals

Diagnostic Centers

Research and Educational Institutions

Others

By Region

North America

U.S.

Canada

Mexico

Europe

Germany

U.K.

France

Spain

Italy

Rest of Europe

South America

Brazil

Argentina

Rest of South America

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific

Middle East and Africa

Market Competitive Landscape

The major global players in the global breast cancer liquid biopsy market include F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Abbott, Agilent Technologies Inc., Merck KGaA, Cell Signaling Technology Inc., Medtronic, Bio-Rad Laboratories Inc., ExoDx, and Biocept Inc. among others.

Key Developments

On September 2023, nRichDX(R) launched its new RUO-labeled CTC enrichment kit that uniquely isolates Circulating Tumor Cells (CTCs) from up to 40mL of whole blood samples to help researchers advance liquid biopsy assay research and development.

Why Purchase the Report?

To visualize the global breast cancer liquid biopsy market segmentation based on product type, circulating biomarkers, application, end-user, 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 breast cancer liquid biopsy market level 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 breast cancer liquid biopsy market report would provide approximately 51 tables, 54 figures, and 181 Pages.

Target Audience 2024

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 Product Type
• 3.2. Snippet by Circulating Biomarkers
• 3.3. Snippet by Application
• 3.4. Snippet by End-User
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Prevalence of Breast Cancer
    • 4.1.1.2. Increasing Awareness Among People
    • 4.1.1.3. Technological Advancements
• 4.2. Restraints
  • 4.2.1. High Costs Associated with Liquid Biopsy
  • 4.2.2. Shortage of Skilled Professionals
  • 4.2.3. Stringent Regulatory Requirements
• 4.3. Opportunity
• 4.4. 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
• 5.5. Unmet Needs
• 5.6. PESTEL Analysis
• 5.7. Patent Analysis
• 5.8. SWOT Analysis

6. By Product Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 6.1.2. Market Attractiveness Index, By Product Type
• 6.2. Reagents and Kits*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Instruments

7. By Circulating Biomarkers

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulating Biomarkers
  • 7.1.2. Market Attractiveness Index, By Circulating Biomarkers
• 7.2. Circulating Tumor Cells (CTCs)*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Circulating Cell-free DNA (cfDNA)
• 7.4. Extracellular Vesicles
• 7.5. Others

8. By Application

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.1.2. Market Attractiveness Index, By Application
• 8.2. Early Screening*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Treatment Selection

9. By End-User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.1.2. Market Attractiveness Index, By End-User
• 9.2. Hospitals*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Diagnostic Centers
• 9.4. Research and Educational Institutions
• 9.5. Others

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulating Biomarkers
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.7.1. The U.S.
    • 10.2.7.2. Canada
    • 10.2.7.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulating Biomarkers
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.7.1. Germany
    • 10.3.7.2. UK
    • 10.3.7.3. France
    • 10.3.7.4. Italy
    • 10.3.7.5. Spain
    • 10.3.7.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulating Biomarkers
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.7.1. Brazil
    • 10.4.7.2. Argentina
    • 10.4.7.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulatory Biomarkers
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.7.1. China
    • 10.5.7.2. India
    • 10.5.7.3. Japan
    • 10.5.7.4. South Korea
    • 10.5.7.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulatory Biomarkers
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. F. Hoffmann-La Roche Ltd. *
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Thermo Fisher Scientific Inc.
• 12.3. Abbott
• 12.4. Agilent Technologies Inc.
• 12.5. Merck KGaA
• 12.6. Cell Signaling Technology Inc.
• 12.7. Medtronic
• 12.8. Bio-Rad Laboratories Inc.
• 12.9. ExoDx
• 12.10. Biocept Inc. (*LIST NOT EXHAUSTIVE)

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us