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表紙：バイオマーカーの世界市場-2023年～2030年
市場調査レポート
商品コード
1374836

バイオマーカーの世界市場-2023年～2030年

Global Biomarkers Market - 2023-2030

出版日
ページ情報
英文 187 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=146.82円
バイオマーカーの世界市場-2023年～2030年
出版日: 2023年11月01日
発行: DataM Intelligence
ページ情報: 英文 187 Pages
納期: 即日から翌営業日
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  • 概要
  • 目次
概要

概要

バイオマーカーは、生物学的マーカーとも呼ばれ、正常な生物学的プロセス、病原性プロセス、または治療介入に対する薬理学的反応の指標として客観的に測定・評価される特性です。バイオマーカーは個人の健康状態の診断に用いられます。医学用語では、測定可能なバイオマーカーは、疾患の存在と重症度を反映する化学成分です。

さらに、バイオマーカーは、血圧やコレステロール値などの臨床評価に使用される指標であり、適切な治療介入を計画できるように、個人または集団全体の健康状態をモニタリングおよび予測するために使用されます。バイオマーカーは、個々人の健康状態や疾患状態を評価するために単独で、または組み合わせて使用されます。あらゆる生物学的システムには固有のバイオマーカーが存在します。これらのバイオマーカーの多くは測定が比較的容易であり、日常診療の一部を構成しています。

市場力学：促進要因

がんの診断における新規アプローチの増加と採用の増加

がん症例における新規アプローチの増加とバイオマーカー採用の増加は、予測期間を通じて市場を牽引するとみられます。バイオマーカーは、がん、特に卵巣がんの検出において最も一般的に使用されています。卵巣がんの有病率の増加は、バイオマーカーの採用増加につながっています。例えば、Global Cancer Statistics, 2020によると、卵巣がんは世界の女性で7番目に頻度の高いがんで、年間約31万4,000人の新規症例（女性の新規がん症例全体の3.4％）を占めています。

さらに、卵巣がんの診断には、がん抗原125（CA-125）と経膣画像が一般的に用いられています。最も一般的に使用されている血清バイオマーカーはCA-125ですが、スクリーニング検査として単独で使用するには感度と特異度が不足しています。また、CA-125の発現レベルは正確な検出には低すぎるため、早期診断には効果がありません。

例えば、2022年11月7日、アコヤバイオサイエンス社は、PhenoImagerプラットフォーム上でのハイスループット空間バイオマーカー探索と検証のためのPhenoCode Signature Panelsを発売しました。カスタマイズ可能なマルチプレックスパネルには、腫瘍微小環境（TME）と免疫状態を表現するための主要なマーカーが含まれています。PhenoImagerプラットフォームの高速かつ堅牢なイメージングと組み合わせることで、迅速かつ定量的なエンドツーエンドの空間的表現型解析ワークフローが実現します。このワークフローは、免疫腫瘍学アプリケーションのための予測シグネチャーと予後バイオマーカーの開発と検証を加速します。

さらに、バイオマーカーの分野では多くの新しいアプローチが進んでいます。例えば、2021年4月19日、アムジェンは、より多くの転移性（ステージIV）非小細胞肺がん（NSCLC）患者がバイオマーカー検査を受けられるよう、Biomarker Assistを開始しました。診断時のバイオマーカー検査は、患者さんが適切な治療を受けるための重要な第一歩です。Biomarker Assistを通じて、対象となる患者はバイオマーカー検査の費用を節約することができます。

バイオマーカーの技術的進歩は、バイオマーカーの採用を増加させます。例えば、2021年1月11日、Biogen Inc.はAppleと共同で、Apple WatchとiPhoneが認知機能のモニタリングと軽度認知障害（MCI）を含む認知機能の低下のスクリーニングに果たしうる役割を調査する新しい仮想調査を発表しました。この調査の主な目的は、認知能力を長期的にモニタリングし、MCIの早期兆候を特定するのに役立つデジタルバイオマーカーを開発することです。

さらに、がんの有病率の増加、FDA承認の増加、臨床試験の増加、認知度の向上、技術の進歩は、予測期間にわたって市場を牽引すると予想される要因です。

阻害要因

バイオマーカーに関連する合併症、高い投資コスト、サンプルの保管や収集などの問題、不利な償還シナリオなどの要因が、予測期間中の市場成長の妨げになると予想されます。

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
      • がんの診断における新規アプローチの増加と採用の増加
    • 抑制要因
      • 高い投資コスト
    • 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
  • パイプライン分析
  • アンメットニーズ
  • 特許分析
  • DMIの見解

第6章 COVID-19分析

第7章 製品タイプ別

  • 診断用バイオマーカー
  • モニタリング用バイオマーカー
  • 予測用バイオマーカー
  • 感受性/リスクバイオマーカー
  • 予後予測バイオマーカー
  • 薬力学的/反応性バイオマーカー
  • 安全性バイオマーカー
  • その他

第8章 用途別

  • 創薬・医薬品開発
  • 疾病診断
  • 疾患リスク評価
  • 個別化医療
  • その他

第9章 エンドユーザー別

  • 製薬企業
  • バイオテクノロジー企業
  • 研究センター・研究所
  • 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
    • オーストラリア
    • 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

  • Bio-Rad Laboratories 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
  • Merck KGaA
  • QIAGEN N.V.
  • Siemens Healthcare Private Limited
  • Enzo Biochem Inc.
  • PerkinElmer Inc.
  • BRUKER CORPORATION
  • Epigenomics AG
  • Signosis, Inc.
  • Thermo Fisher Scientific Inc.

第13章 付録

目次
Product Code: PH1794

Overview

Biomarkers also known as biological markers, is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacological responses to a therapeutic intervention. Biomarkers are used for the diagnosis health status of an individual. In medical terms, a measurable biomarker is a chemical component that reflects the presence as well as the severity of the disease.

Moreover, biomarkers are the measures used to perform a clinical assessment such as blood pressure or cholesterol level and are used to monitor and predict health states in individuals or across populations so that appropriate therapeutic intervention can be planned. Biomarkers may be used alone or in combination to assess the health or disease state of an individual. Every biological system has its own specific biomarkers. Many of these biomarkers are relatively easy to measure and form part of routine medical examinations.

Market Dynamics: Drivers

Increasing novel approaches and increasing adoption in the diagnosis of cancer

The increasing novel approaches and increasing adoption of biomarker in cancer cases is expected to drive the market over the forecast period. The biomarkers are most commonly used in the detection of cancer, especially ovarian cancer. The increasing prevalence of ovarian cancer leads to the increasing adoption of the biomarkers. For instance, according to Global Cancer Statistics, 2020, Ovarian cancer is the seventh most frequent cancer in women worldwide, accounting for around 314,000 new cases (3.4% of all new cancer cases in females) per year.

Moreover, cancer Antigen-125 (CA-125) and transvaginal imaging are commonly used to diagnose ovarian cancer. The most commonly used serum biomarker is CA-125, although it lacks the sensitivity and specificity to be utilized alone as a screening test. It is also ineffective for early diagnosis since CA-125 expression levels are too low for accurate detection.

For instance, on November 07, 2022, Akoya Biosciences, Inc. launched the PhenoCode Signature Panels for high-throughput spatial biomarker discovery and validation on the PhenoImager platforms. Each of the customizable multiplex panels includes key markers for phenotyping the tumor microenvironment (TME) and immune status. When combined with the high-speed and robust imaging of the PhenoImager platforms, a rapid, quantitative, end-to-end spatial phenotyping workflow is enabled. The workflow accelerates the development and validation of predictive signatures and prognostic biomarkers for immuno-oncology applications.

Additionally, many novel approaches are going on in the field of biomarkers. For instance, on April 19, 2021, Amgen launched the Biomarker Assist to help more patients with metastatic (stage IV) non-small cell lung cancer (NSCLC) gain access to biomarker testing. Biomarker testing at the time of diagnosis is a critical first step in getting patients on the right treatment. Through Biomarker Assist, eligible patients may save on biomarker testing.

The technological advancements in biomarkers increase the adoption of biomarkers. For instance, on January 11, 2021, Biogen Inc. released a new virtual research study, in collaboration with Apple, to investigate the role Apple Watch and iPhone could play in monitoring cognitive performance and screening for decline in cognitive health including mild cognitive impairment (MCI). The study's primary objectives are to develop digital biomarkers to help monitor cognitive performance over time and identify early signs of MCI.

Further, the increasing prevalence of cancers, rising FDA approvals, increasing clinical trials, increasing awareness and technological advancements are the factors expected to drive the market over the forecast period.

Restraints

Factors such as complications associated with the biomarkers, high investment costs, problems such as sample storage and collection, and unfavorable reimbursement scenarios are expected to hamper the market growth during the forecast period.

Segment Analysis

The global biomarkers market is segmented based on product type, application, end-user and region.

The diagnostic biomarkers segment accounted for approximately 43.2% of the biomarkers market share

The diagnostic biomarkers segment is expected to hold the largest market share over the forecast period. The diagnostic biomarkers play a crucial role in the disease diagnosis. Diagnostic biomarkers may be used not only to identify people with a disease but also to redefine the classification of the disease. Diagnostic biomarkers identify disease subtypes and thus often play critical roles when the results of diagnostic classification can be used as prognostic biomarkers and predictive biomarkers.

For instance, on July 13, 2023, Quest Diagnostics, the leading provider of diagnostic information services, launched a novel prostate cancer biomarker test through its subspecialty pathology business, AmeriPath, in collaboration with Envision Sciences. Envision Sciences Pty Ltd. Is an Australian-based clinical diagnostics company developing a pipeline of biomarker-based cancer diagnostic and prognostic tests in tissue and blood.

In addition on September 08, 2023, Ibex Medical Analytics launched Galen Breast HER2, a novel breast cancer AI-powered biomarker scoring solution developed in collaboration with AstraZeneca and Daiichi Sankyo, to support improved patient outcomes. Galen Breast HER2 allows clinicians to rapidly and accurately identify patients with HER2-low who would benefit from targeted therapies.

Geographical Analysis

North America accounted for approximately 39.2% of the market share

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and increasing adoption. North America especially the United States is known for its strong presence of major players such as pharmaceutical companies and biotechnology companies. The presence of major players actively adopting the biomarkers drug discovery and development of personalized medicines.

Moreover, the increasing prevalence of cancer in the region leads to the increasing adoption of biomarkers. For instance, according to the American Cancer Society, in 2020, an estimated 1.8 million new cancer cases and 606,520 cancer deaths in the United States will be diagnosed. In contrast, in 2021, an estimated 1.9 million new cancer cases will be diagnosed and 608,570 cancer deaths in the United States. Therefore, it has increased the adoption of biomarkers for cancer.

Competitive Landscape

The major global players in the biomarkers market include: Bio-Rad Laboratories Inc., Merck KGaA, QIAGEN N.V., Siemens Healthcare Private Limited, Enzo Biochem Inc., PerkinElmer Inc., BRUKER CORPORATION, Epigenomics AG, Signosis, Inc. and Thermo Fisher Scientific Inc. among others.

Key Developments

  • On May 17, 2023, Chordia Therapeutics, Inc. released the beginning of field trials leveraging Fujitsu's AI causal discovery technology to shed light on biomarkers that increase the probability of success or shorten the duration of clinical trials in the development of new cancer drugs.
  • On October 25, 2022, Koneksa, a healthcare technology company developing evidence-based validated digital biomarkers, launched its clinical pipeline featuring biomarkers across neuroscience, oncology, respiratory, and other therapeutic areas. With 15 digital biomarker programs in development, the company will also be launching several upcoming clinical studies.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global biomarkers market. The pandemic led to disruptions in ongoing clinical trials, delays in the initiation of new trials, and difficulties in patient recruitment. This impacted the development and validation of biomarkers.

With the focus on understanding and combating COVID-19, there may have been a shift in research priorities and funding away from other areas, including biomarker research for different diseases. Moreover, the pandemic likely influenced the development and use of biomarkers for diagnosing COVID-19 and monitoring its severity.

Market Segmentation

By Product Type

  • Diagnostic Biomarkers
  • Monitoring Biomarkers
  • Predictive Biomarkers
  • Susceptibility/Risk Biomarkers
  • Prognostic Biomarkers
  • Pharmacodynamic/Response Biomarkers
  • Safety Biomarkers
  • Others

By Application

  • Drug Discovery and Development
  • Disease Diagnostics
  • Disease Risk Assessment
  • Personalized Medicine
  • Others

By End-User

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Research Centers and Institutes
  • 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
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa

Why Purchase the Report?

  • To visualize the global biomarkers market segmentation based on product type, 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 biomarkers 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 biomarkers market report would provide approximately 61 tables, 65 figures, and 187 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 Product Type
  • 3.2. Snippet by Application
  • 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. Increasing Novel Approaches and Increasing Adoption in the Diagnosis of Cancer
    • 4.1.2. Restraints
      • 4.1.2.1. High Investment Costs
    • 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
  • 5.5. Pipeline Analysis
  • 5.6. Unmet Needs
  • 5.7. Patent Analysis
  • 5.8. DMI Opinion

6. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario Before COVID
    • 6.1.2. Scenario During COVID
    • 6.1.3. Scenario Post COVID
  • 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 Product Type

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 7.1.2. Market Attractiveness Index, By Product Type
  • 7.2. Diagnostic Biomarkers*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Monitoring Biomarkers
  • 7.4. Predictive Biomarkers
  • 7.5. Susceptibility/Risk Biomarkers
  • 7.6. Prognostic Biomarkers
  • 7.7. Pharmacodynamic/Response Biomarkers
  • 7.8. Safety Biomarkers
  • 7.9. 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. Drug Discovery and Development*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Disease Diagnostics
  • 8.4. Disease Risk Assessment
  • 8.5. Personalized Medicine
  • 8.6. Others

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. Pharmaceutical Companies*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Biotechnology Companies
  • 9.4. Research Centers and Institutes
  • 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 Application
    • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.2.6.1. U.S.
      • 10.2.6.2. Canada
      • 10.2.6.3. 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 Application
    • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.3.6.1. Germany
      • 10.3.6.2. UK
      • 10.3.6.3. France
      • 10.3.6.4. Italy
      • 10.3.6.5. Spain
      • 10.3.6.6. 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 Application
    • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.4.6.1. Brazil
      • 10.4.6.2. Argentina
      • 10.4.6.3. 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 Application
    • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.5.6.1. China
      • 10.5.6.2. India
      • 10.5.6.3. Japan
      • 10.5.6.4. Australia
      • 10.5.6.5. 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 Application
    • 10.6.5. 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. Bio-Rad Laboratories Inc.*
    • 12.1.1. Company Overview
    • 12.1.2. Product Portfolio and Description
    • 12.1.3. Financial Overview
    • 12.1.4. Key Developments
  • 12.2. Merck KGaA
  • 12.3. QIAGEN N.V.
  • 12.4. Siemens Healthcare Private Limited
  • 12.5. Enzo Biochem Inc.
  • 12.6. PerkinElmer Inc.
  • 12.7. BRUKER CORPORATION
  • 12.8. Epigenomics AG
  • 12.9. Signosis, Inc.
  • 12.10. Thermo Fisher Scientific Inc.

LIST NOT EXHAUSTIVE

13. Appendix

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