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全球生物分析测试服务市场 - 2023-2030

Global Bioanalytical Testing Services Market - 2023-2030

出版日期: 2023年09月27日 | 出版商:

DataM Intelligence | 英文 185 Pages | 商品交期: 约2个工作天内

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简介目录

概述

生物分析测试服务在药物发现和开发以及生物体液中药物及其代谢物或相关生物标记的定量方面发挥着重要作用。生物分析方法用于评估药物动力学和毒性动力学研究，这些方法可用于研究人类临床药理学和毒理学。

生物分析测试涉及对各种生物基质（例如血液、血浆、血清、脑脊髓液、唾液和尿液）中的药物进行识别和定量的过程。常见的生物分析测试类型包括药物动力学测试、药效学测试和ADME测试。

市场动态

生物分析服务支出增加

生物分析测试涉及使用经过验证的生物分析方法对给定生物基质中的分析物进行定量评估。生物分析测试服务支出的增加是市场成长的重要动力。此外，许多关键参与者透过开放新的生物分析测试服务在市场的进步中发挥重要作用。

例如，2022 年 9 月，Eurofins Scientific 宣布达成协议，以现金和无债务的方式，以 2.2 亿欧元向 Stirling Square Capital Partners 投资其数位测试业务。它支持集团的资本分配优先事项，包括实验室的资本支出、数位化和收购，以进一步增强其在生物分析测试和其他生命科学领域的领导地位。

此外，2021 年 11 月，BioAgilytix 宣布达成一项由 Cinven 进一步资本化的协议。 Cinven 的投资为BioAgilytix 提供了更多的资金和资源，以满足对其高品质生物分析服务不断增长的需求，这得益于其强大的科学声誉和支持新型疗法的开发和商业化的领先专业知识。

此外，2021 年 4 月，Vitruvian Partners 报告了对 KCAS 生物分析和生物标记服务的策略性成长投资。该公司提供生物（大分子）和合成（小分子）治疗前景的专业知识，并提供从早期发现支援到註册的全方位生物分析服务。

此外，生物分析服务、研发和服务收购需求不断增长等重要成长动力预计将在预测期内推动市场发展。

生物分析开发方法的挑战

生物分析开发中的各种挑战可能会阻碍市场成长。开发和验证生物分析方法是一个复杂的过程，需要灵活的方法。正如 FDA 审查人员所概述的，研究人员在这方面遇到了许多挑战，包括计算错误、提取技术有缺陷和分析问题。

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

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