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表紙：バイオ分析試験サービスの世界市場-2023年～2030年
市場調査レポート
商品コード
1352191

バイオ分析試験サービスの世界市場-2023年～2030年

Global Bioanalytical Testing Services Market - 2023-2030
出版日: | 発行: DataM Intelligence | ページ情報: 英文 185 Pages | 納期: 約2営業日

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本日の銀行送金レート: 1USD=156.76円
バイオ分析試験サービスの世界市場-2023年～2030年
出版日: 2023年09月27日
発行: DataM Intelligence
ページ情報: 英文 185 Pages
納期: 約2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。
  • 全表示
  • 概要
  • 目次
概要

概要

バイオ分析試験サービスは、創薬・薬剤開発において、また生体液中の薬剤およびその代謝物や関連バイオマーカーの定量において重要な役割を果たします。バイオ分析法は、薬物動態学および毒性動態学研究の評価に使用され、これらの方法はヒトの臨床薬理学および毒性学の研究に応用することができます。

バイオ分析試験は、血液、血漿、血清、脳脊髄液、唾液、尿などの様々な生物学的マトリックス内の薬物を同定し、定量するプロセスを含みます。一般的なバイオ分析試験の種類には、薬物動態試験、薬力学試験、ADME試験などがあります。

市場力学

バイオ分析サービスへの支出の増加

バイオ分析試験には、与えられた生物学的マトリックス中の分析物の定量的評価のために、検証されたバイオ分析法を使用することが含まれます。バイオ分析試験サービスへの支出の増加は、市場成長の重要な促進要因として作用します。また、多くの主要企業が新しいバイオ分析試験サービスを開設することで、市場の進歩に大きな役割を果たしています。

例えば、2022年9月、ユーロフィンズ・サイエンティフィックは、デジタル試験事業をスターリング・スクエア・キャピタル・パートナーズに現金・無借金ベースで2億2,000万ユーロで投資することで合意したと発表しました。これは、研究所の設備投資、デジタル化、バイオ分析試験やその他のライフサイエンス分野でのリーダーシップをさらに強化するための買収など、グループの資本配分の優先順位をサポートするものです。

また、2021年11月、バイオアジリティックスは、シンヴェンによるさらなる資本増強の合意を宣言しました。Cinvenによる投資により、BioAgilytixは、新規治療薬の開発と商業化をサポートするための科学的な高い評価と主要な専門知識により、その高品質なバイオ分析サービスに対する需要の高まりに対応するための資金とリソースの増加を得ることができます。

さらに2021年4月、Vitruvian PartnersはKCAS Bioanalytical and Biomarker Servicesへの戦略的成長投資を報告しました。同社は、生物学的（高分子）および合成（低分子）治療見込みの専門知識を提供し、早期発見のサポートから登録まで、バイオ分析サービスの全領域を提供します。

さらに、バイオ分析サービスの需要拡大、研究開発、サービス買収などの大きな市場促進要因が、予測期間中の市場を牽引すると予想されます。

バイオ分析の開発手法における課題

バイオ分析開発における様々な課題は、市場の成長を妨げる可能性があります。バイオ分析法の開発と検証は、機敏なアプローチが要求される複雑なプロセスです。研究者はこの点で、計算エラー、抽出技術の欠陥、FDAの審査官が概説する分析上の問題など、数多くの課題に遭遇します。

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
      • バイオ分析サービスへの支出の増加
    • 抑制要因
      • バイオ分析の開発手法における課題
    • 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
  • DMIの見解

第6章 COVID-19分析

第7章 試験タイプ別

  • 薬物動態（PK）試験
  • 薬力学（PD）試験
  • ADME試験
    • In-Vito (生体内) ADME
    • In-Vitro (生体外) ADME
  • バイオアベイラビリティ試験
  • 生物学的同等性試験
  • その他

第8章 分子タイプ別

  • 低分子
  • 高分子
    • 免疫測定
    • LC-MS試験
    • その他

第9章 エンドユーザー別

  • バイオ製薬企業
  • CRO（医薬品開発業務受託機関）
  • CDMO（医薬品開発製造受託機関）
  • 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
    • オーストラリア
    • その他アジア太平洋
  • 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

  • Syneous Health
    • 企業概要
    • 診断技術のポートフォリオと説明
    • 財務概要
    • 主な動向
  • SGS S.A
  • ICON Plc
  • Charles River Laboratories Inc.
  • Laboratory Corporation of America Holdings
  • Intertek Group Plc.
  • Q2 Solutions
  • Pace Analytical Services LLC
  • Prolytix
  • Frontage Laboratories

第13章 付録

目次
Product Code: HCIT2264

Overview

Bioanalytical testing services play an important role in drug discovery and development and in quantifying drugs and their metabolites or related biomarkers in biological fluids. Bioanalytical methods are used to evaluate pharmacokinetics and toxic kinetic studies and these methods can be applied to study human clinical pharmacology and toxicology.

Bioanalytical testing involves the process of identifying and quantifying drugs within various biological matrices, such as blood, plasma, serum, cerebrospinal fluid, saliva, and urine. Common bioanalytical testing types include pharmacokinetic testing, pharmacodynamics testing, and ADME testing.

Market Dynamics

Increasing expenditure on bioanalytical services

Bioanalytical testing involves using a validated bioanalytical method for the quantitative evaluation of analytes in the given biological matrix. The increasing expenditures for bioanalytical testing services act as a significant driver for market growth. Also, many key players play a major role in the advancements of the market by opening new bioanalytical testing services.

For instance, in September 2022, Eurofins Scientific declared an agreement to invest its Digital Testing business to Stirling Square Capital Partners for €220m on a cash and debt-free basis. It supports the Group's capital allocation priorities, including capital expenditure in laboratories, digitalization, and acquisitions to further enhance its leadership in bioanalytical testing and other life science areas.

Also, in November 2021, BioAgilytix declared an agreement to be further capitalized by Cinven. The investment by Cinven provides BioAgilytix with increased funding and resources to meet the growing demand for its high-quality bioanalytical services, driven by its strong scientific reputation and leading expertise in supporting the development and commercialization of novel therapeutics.

Additionally, in April 2021, Vitruvian Partners reported the strategic growth investment in KCAS Bioanalytical and Biomarker Services. The company provides expertise in biological (big molecule) and synthetic (small molecule) therapeutic prospects and provides a full spectrum of bioanalytical services from early discovery support through registration.

Furthermore, significant growth drivers such as the growing demand for bioanalytical services, research and developments, and service acquisitions are expected to drive the market in the forecast period.

Challenges in bioanalytical development method

Various challenges in bioanalytical development can hamper market growth. Developing and validating bioanalytical methods is a complex process that demands an agile approach. Researchers encounter numerous challenges in this regard, including calculation errors, flawed extraction techniques, and analytical issues, as outlined by FDA reviewers.

Segment Analysis

The global bioanalytical testing services market is segmented based on test type, molecule type, end users, and region.

The small molecule segment accounted for approximately 37.2% of the market share

Small molecule bioanalysis is the chemical analysis of compounds within a biological matrix. Small molecules are traditional pharmaceuticals and have a low molecular weight of less than 900 Daltons and regulate a biological process. Small molecule testing is expected to hold the largest market share over the period forecast owing to increasing developments and advancements of small molecule testing services.

For instance, in August 2023, Metrion Biosciences Limited decided to offer GLP-compliant hERG ion channel screening services to the global life sciences community. GLP hERG screening is a crucial part of the process when transitioning from preclinical research to Phase 1 clinical trials in humans. Additionally, it's an important step in the Investigational New Drug (IND) application process for potential small molecule therapeutics.

Additionally in August 2022, BioDuro Sundia launched the DNA Encoded Compound Library (DEL) technology services in China to help more innovative pharmaceutical companies quickly discover small molecule drugs.

Geographical Analysis

North America is expected to hold a significant position in the global bioanalytical testing services market share

The global bioanalytical testing services market is segmented into North America, Europe, Asia Pacific, South America, Middle East, and Africa. North America has maintained a significant market proportion due to factors such as the rising demand for bioanalytical services, and service acquisitions, and this trend is anticipated to continue throughout the forecast period.

For instance, in July 2022, U.S. Alliance Pharma acquired U.K.-based LGC's Drug Development Solutions (DDS) Business. This acquisition broadens the bioanalytical, analytical material testing, and laboratory capabilities for the biopharma and pharma businesses internationally.

In October 2022, Thermo Fisher Scientific extended its clinical research operations with the development of a cutting-edge bioanalytical lab in Richmond, Virginia in the United States. The new facility helps meet the rising demand for dependable, top-notch laboratory services needed to accelerate the development of new drugs in the biopharmaceutical industry.

COVID-19 Impact Analysis

The COVID-19 pandemic has had a significant impact on the bioanalytical testing services market. The bioanalytical laboratory has modified its routine lab procedures and clinical trial procedures due to travel and personnel constraints. The reduction in the availability of lab supplies, reagents, personal protective equipment (PPE), and biological matrices is the outcome of logistical supply chain issues. Therefore, the bioanalytical testing services market is expected to be moderately affected over the forecast period.

Market Segmentation

By Test Type

  • Pharmacokinetic (PK) Testing
  • Pharmacodynamics (PD) Testing
  • ADME Testing
    • In-Vivo ADME
    • In-Vitro ADME
  • Bioavailability Testing
  • Bioequivalence Testing
  • Others

By Molecule Type

  • Small Molecule
  • Large Molecule
    • Immunoassays
    • LC-MS Studies
    • Others

By End Users

  • Biopharmaceutical Companies
  • Clinical Research Organizations
  • Contract Development and Manufacturing Organization (CDMO)
  • 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

Competitive Landscape

The major global players in the market include: Syneous Health, SGS S.A, ICON Plc, Charles River Laboratories Inc., Laboratory Corporation of America Holdings, Intertek Group Plc., Q2 Solutions, Pace Analytical Services LLC, Prolytix, Frontage Laboratories among others.

Key Developments

  • In September 2023, Cerba HealthCare acquired CIRION Biopharma Research Inc (CIRION). The goal is to enhance our bioanalytical capabilities and reduce the time required to launch intricate clinical trials.
  • In December 2022, Alliance Pharma opened its new 20,000-square-foot bioanalytical laboratory, Alliance Pharma Pty, Ltd., in Brisbane, Australia.
  • In Jan 2021, Nexelis acquired the GSK vaccines clinical bioanalytical laboratory located in Marburg Germany, and entered into a 5-year strategic agreement with GSK.

Why Purchase the Report?

  • To visualize the global bioanalytical testing services market segmentation based on test type, molecule type, end users, 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 bioanalytical testing services 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 bioanalytical testing services market report would provide approximately 61 tables, 60 figures, and 185 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 Test Type
  • 3.2. Snippet by Molecule Type
  • 3.3. Snippet by End Users
  • 3.4. Snippet by Region

4. Market Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Increasing expenditure on bioanalytical services
    • 4.1.2. Restraints
      • 4.1.2.1. Challenges in the bioanalytical development method
    • 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. 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 Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. By Test Type

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
    • 7.1.2. Market Attractiveness Index, By Test Type
  • 7.2. Pharmacokinetic (PK) Testing *
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Pharmacodynamics (PD) Testing
  • 7.4. ADME Testing
    • 7.4.1. In-Vivo ADME
    • 7.4.2. In-Vitro ADME
  • 7.5. Bioavailability Testing
  • 7.6. Bioequivalence Testing
  • 7.7. Others

8. By Molecule Type

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
    • 8.1.2. Market Attractiveness Index, By Molecule Type
  • 8.2. Small Molecule*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Large Molecule
    • 8.3.1. Immunoassays
    • 8.3.2. LC-MS Studies
    • 8.3.3. Others

9. By End Users

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End Users
    • 9.1.2. Market Attractiveness Index, By End Users
  • 9.2. Biopharmaceutical Companies *
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Clinical Research Organizations
  • 9.4. Contract Development and Manufacturing Organization (CDMO)
  • 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 Test Type
    • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
    • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End Users
    • 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. Introduction
    • 10.3.3. Key Region-Specific Dynamics
    • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
    • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
    • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End Users
    • 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 Test Type
    • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
    • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End Users
    • 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 Test Type
    • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
    • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End Users
    • 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 Test Type
    • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
    • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End Users

11. Competitive Landscape

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

12. Company Profiles

  • 12.1. Syneous Health
    • 12.1.1. Company Overview
    • 12.1.2. Diagnostic technique Portfolio and Description
    • 12.1.3. Financial Overview
    • 12.1.4. Key Developments
  • 12.2. SGS S.A
  • 12.3. ICON Plc
  • 12.4. Charles River Laboratories Inc.
  • 12.5. Laboratory Corporation of America Holdings
  • 12.6. Intertek Group Plc.
  • 12.7. Q2 Solutions
  • 12.8. Pace Analytical Services LLC
  • 12.9. Prolytix
  • 12.10. Frontage Laboratories

LIST NOT EXHAUSTIVE

13. Appendix

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