查看购物车
  • Traditional Chinese
  • English
  • Japanese
  • Korean
欧洲药物溶离度测试市场－分析与预测（2024-2033）
市场调查报告书
商品编码
1876450

欧洲药物溶离度测试市场－分析与预测（2024-2033）

Europe Pharmaceutical Dissolution Market: Analysis and Forecast, 2024-2033
出版日期: | 出版商: BIS Research | 英文 58 Pages | 商品交期: 1-5个工作天内

价格

欧洲药物溶离度测试市场预计将从 2024 年的 2.086 亿美元成长到 2033 年的 4.095 亿美元，2024 年至 2033 年的复合年增长率为 7.78%。

药物溶离度测试是指药物製剂（如片剂、胶囊和粉末）在液体介质（通常模拟生理体液）中溶解并释放其活性药物​​成分 (API) 的过程。这个过程对于了解药物在人体内的行为至关重要，因为它直接影响生物利用度，并决定活性成分进入血液的速率和程度。溶出度测试是欧洲药物研发和品管的基础，确保药物符合欧洲药品管理局 (EMA) 和各国监管机构要求的严格的安全性、有效性和均一性标准。它对于口服剂型的特性分析和优化至关重要，同时也为上市核准申请和持续的欧洲市场监管合规性提供关键数据。

关键市场统计数据
预测期 2024-2033
2024年评估 2.086亿美元
2033年的预测 4.095亿美元
复合年增长率 7.78%

市场概览

欧洲药物溶离度测试市场在药物品管和药物研发中发挥至关重要的作用，确保了全部区域医疗产品的安全性、有效性和合规性。药物溶离度测试透过测量活性药物成分（API）在模拟生理环境的条件下，以片剂、胶囊和粉剂等剂型溶解的情况，提供预测药物体内性能和生物利用度的重要资讯。

欧洲先进的製药产业，以欧洲药品管理局 (EMA) 和各国监管机构健全的法规结构为特征，推动了对精密溶离度测试设备和服务的需求。该地区聚集了许多跨国製药公司、学名药生产商、受託研究机构和学术研究机构，它们在药物生命週期的各个阶段，从初始製剂研发到商业化生产和品管，都高度依赖溶离度测试。

市场涵盖种类繁多的溶离度测试设备，包括自动化系统、手动设备和专用生物溶离度设备，以及相关的介质、配件和分析服务。德国、法国、英国、义大利和瑞士是重要的市场，对欧洲的製药生产和研发做出了重大贡献。

由于严格的监管、学名药研发的扩张、製药业研发投入的增加以及技术进步，欧洲的药物溶离度测试产业正经历持续的变化。随着品质源于设计（QbD）理念的引入、自动化技术的应用以及生物基方法的广泛普及，溶出度测试正迅速成为欧洲药物创新和品质保证的重要工具。

市场区隔:

细分 1：按区域

  • 欧洲
    • 德国
    • 英国
    • 法国
    • 义大利
    • 西班牙
    • 其他的

欧洲药物溶离度测试市场趋势、驱动因素与挑战

主要市场趋势

  • 为提高效率、减少人为误差并确保药品品管符合法规要求，自动化溶离度测试系统的应用日益广泛。
  • 为了预测药物在体内的行为，人们开始转向生物相关溶离度测试，这种测试能更紧密地模拟生理条件。
  • 人工智慧 (AI) 和机器学习正越来越多地被整合到溶离度测试中，用于资料分析、方法开发和预测建模。
  • 随着製药公司将品管职能外包，提供专业溶离度测试服务的受託研究机构（CRO）正在不断扩张。
  • 在製剂开发中，对品质源于设计 (QbD) 原则的日益重视使得溶离度测试成为药物开发的关键组成部分。
  • 市场对可同时测试多个样品以提高通量的多容器溶离度测试系统的需求日益增长。

主要市场驱动因素

  • 欧洲药品管理局 (EMA) 和各国监管机构的严格监管要求，规定药物核准和批次放行必须进行全面的溶离度测试。
  • 欧洲学名药产量增加，需要进行广泛的溶离度测试，以证明其与品牌药具有生物等效性。
  • 欧洲各地对製药研发投入的增加，推动了製剂开发阶段对溶离度测试设备和服务的需求。
  • 随着药物缓释性变得越来越复杂，例如缓释製剂、缓释製剂和组合製剂，需要更先进的溶离度测试方法。
  • 不断发展的生物製药产业需要针对复杂的生物製药和生物相似药采用专门的溶离度测试方法。
  • 随着欧洲人口老化，药品消费量不断增加，而需要品管的药品生产也不断增加。

主要挑战

  • 安装复杂的自动化溶离度测试设备需要大量的资金投入，这对中小型製药公司和研究实验室来说是一个障碍。
  • 缺乏奈米颗粒、脂质体和经皮吸收贴片新型药物递送系统的标准化方法，使得溶离度测试通讯协定变得复杂。
  • 欧洲市场普遍缺乏接受过先进溶离度测试技术和法规要求培训的熟练人员
  • 开发能够准确预测体内性能并同时满足监管要求的生物相关溶出方法的复杂性
  • 儘管欧洲各国努力协调统一，但各国对监管规定的解读存在差异，这给跨国公司带来了合规的挑战。
  • 溶离度测试设备的维护和校准要求既耗时又昂贵，会影响运作效率。
  • 建立体外-体内相关性（IVIVC）面临许多挑战，尤其对于复杂製剂和难溶性药物而言。

产品与创新策略：本报告深入分析了药物溶离度测试领域的最新技术进展，使企业能够推动创新并开发符合市场需求的尖端产品。

成长与行销策略：透过全面的市场分析与关键成长机会的识别，我们为企业提供製定有针对性的行销策略并有效扩大市场份额所需的知识。

竞争策略：该报告对竞争格局进行了全面分析，以帮助企业了解其竞争对手在药物溶离度测试领域的优势和劣势，并制定有效的策略以获得市场竞争优势。

监管与合规策略：提供有关不断变化的法规结构、核准情况以及药物溶出度测试行业指南的最新信息，确保您的组织保持合规，并加速新药物溶出度测试产品的市场准入。

投资和业务扩大策略：透过分析市场趋势、资金筹措模式和合作机会，我们帮助企业做出明智的投资决策，并识别潜在的併购机会以促进业务成长。

主要市场参与者及竞争摘要

我们根据对公司覆盖范围、产品系列和市场渗透率的分析，并结合从行业领先专家那里收集的信息，来选择对其中进行介绍的公司。

该市场的主要企业包括：

  • Merck KGaA
  • Almac Group
  • Sotax

目录

执行摘要

第一章调查方法

第二章：药物溶离度测试市场概述

第三章 市场产业展望

  • 市场概览与生态系统
  • 市场机会评估
  • 产品基准测试
  • 监管状态/合规性
    • 欧盟

4. 2023-2033年按地区分類的药物溶离度测试市场规模（百万美元）

  • 区域摘要
  • 成长占有率矩阵
  • 欧洲
    • 区域概览
    • 司机
    • 抑制因素
    • 德国
    • 英国
    • 法国
    • 义大利
    • 西班牙
    • 其他的

第五章 市场竞争情势

  • 竞争基准化分析
  • 竞争格局
    • 併购
    • 资金筹措活动
    • 关键发展分析
    • 企业市场占有率分析，2023年
  • 公司简介（主要製造商）
    • Merck KGaA
    • Sotax
    • Almac Group
  • 服务供应商
    • Eurofins Scientific
    • Intertek Group plc
    • Avivia BV

This report can be delivered in 2 working days.

Introduction to Europe Pharmaceutical Dissolution Market

The Europe pharmaceutical dissolution market is projected to reach $409.5 million by 2033 from $208.6 million in 2024, growing at a CAGR of 7.78% during the forecast period 2024-2033. Pharmaceutical dissolution is the process by which a medicinal product, typically in tablet, capsule, or powder form, dissolves in a liquid medium-usually simulating physiological fluids-to release its active pharmaceutical ingredient (API). This process is fundamental to understanding drug performance within the human body, as it directly impacts bioavailability and determines the rate and extent to which the active substance enters the bloodstream. Dissolution testing serves as a cornerstone of pharmaceutical development and quality control throughout Europe, ensuring medicinal products meet stringent safety, efficacy, and consistency standards required by the European Medicines Agency (EMA) and national regulatory authorities. It is indispensable for characterising and optimising oral dosage forms whilst generating essential data for marketing authorisation applications and ongoing regulatory compliance across European markets.

KEY MARKET STATISTICS
Forecast Period2024 - 2033
2024 Evaluation$208.6 Million
2033 Forecast$409.5 Million
CAGR7.78%

Market Introduction

The European pharmaceutical dissolution market is an important part of the pharmaceutical quality control and drug development sector, assuring the safety, efficacy, and regulatory compliance of medical goods throughout the region. Pharmaceutical dissolution testing provides crucial information that forecasts in vivo medication performance and bioavailability by measuring how drug formulations, such as tablets, capsules, and powders, dissolve their active pharmaceutical ingredients (API) under physiologically simulated settings.

Sophisticated dissolution testing equipment and services are in high demand due to Europe's developed pharmaceutical industry, which is defined by strong regulatory frameworks overseen by the European Medicines Agency (EMA) and national competent authorities. Throughout the drug lifecycle, from early formulation development to commercial manufacturing and quality control, the region is home to a large number of multinational pharmaceutical companies, generic drug manufacturers, contract research organizations, and academic research institutions that heavily rely on dissolution testing.

Along with related media, accessories, and analytical services, the market includes a variety of dissolving testing equipment types, such as automated systems, manual testers, and specialized biorelevant dissolution instruments. Germany, France, the United Kingdom, Italy, and Switzerland are important European markets that make substantial contributions to regional pharmaceutical production and research.

The European pharmaceutical dissolution industry is constantly changing due to strict regulations, growing generic medication development, increased pharmaceutical R&D investments, and technical developments in testing procedures. Dissolution testing is becoming an essential tool for pharmaceutical innovation and quality assurance throughout Europe as a result of the implementation of Quality by Design (QbD) concepts, automation technology, and biorelevant testing methodologies.

Market Segmentation:

Segmentation 1: By Region

  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Rest-of-Europe

Europe Pharmaceutical Dissolution Market Trends, Drivers and Challenges

Key Market Trends

  • Growing adoption of automated dissolution testing systems to improve efficiency, reduce human error, and ensure regulatory compliance in pharmaceutical quality control
  • Increasing shift toward biorelevant dissolution testing that better mimics physiological conditions to predict in vivo drug performance
  • Rising integration of artificial intelligence and machine learning in dissolution testing for data analysis, method development, and predictive modeling
  • Expansion of contract research organizations (CROs) offering specialized dissolution testing services as pharmaceutical companies outsource quality control activities
  • Growing focus on Quality by Design (QbD) principles in formulation development, making dissolution testing a critical component of drug development
  • Increasing demand for multi-vessel dissolution testing systems that allow simultaneous testing of multiple samples to increase throughput

Primary Market Drivers

  • Stringent regulatory requirements from the European Medicines Agency (EMA) and national regulatory bodies mandating comprehensive dissolution testing for drug approval and batch release
  • Rising generic drug production in Europe requiring extensive dissolution testing to demonstrate bioequivalence with branded products
  • Increasing pharmaceutical R&D investments across Europe driving demand for dissolution testing equipment and services during formulation development
  • Growing complexity of drug formulations including modified-release, extended-release, and combination products requiring sophisticated dissolution testing methods
  • Expanding biopharmaceutical sector necessitating specialized dissolution testing approaches for complex biologics and biosimilars
  • Aging European population leading to higher medication consumption and increased pharmaceutical manufacturing requiring quality control testing

Major Challenges

  • High capital investment costs for advanced automated dissolution testing equipment creating barriers for smaller pharmaceutical companies and laboratories
  • Lack of standardized methods for novel drug delivery systems such as nanoparticles, liposomes, and transdermal patches complicating dissolution testing protocols
  • Shortage of skilled personnel trained in advanced dissolution testing techniques and regulatory requirements across European markets
  • Complexity in developing biorelevant dissolution methods that accurately predict in vivo performance while maintaining regulatory acceptance
  • Variability in regulatory interpretations across different European countries despite harmonization efforts, creating compliance challenges for multinational operations
  • Maintenance and calibration requirements for dissolution testing equipment being time-consuming and costly, impacting operational efficiency
  • Challenges in establishing in vitro-in vivo correlations (IVIVC) particularly for complex formulations and poorly soluble drugs

How can this report add value to an organization?

Product/Innovation Strategy: The report offers in-depth insights into the latest technological advancements in pharmaceutical dissolution, enabling organizations to drive innovation and develop cutting-edge products tailored to market needs.

Growth/Marketing Strategy: By providing comprehensive market analysis and identifying key growth opportunities, the report equips organizations with the knowledge to craft targeted marketing strategies and expand their market presence effectively.

Competitive Strategy: The report includes a thorough competitive landscape analysis, helping organizations understand their competitors' strengths and weaknesses in pharmaceutical dissolution and allowing them to strategize effectively to gain a competitive edge in the market.

Regulatory and Compliance Strategy: It provides updates on evolving regulatory frameworks, approvals, and industry guidelines specific to Pharmaceutical Dissolution, ensuring organizations stay compliant and accelerate market entry for new Pharmaceutical Dissolution

Investment and Business Expansion Strategy: By analyzing market trends, funding patterns, and partnership opportunities, the report assists organizations in making informed investment decisions and identifying potential M&A opportunities for business growth.

Key Market Players and Competition Synopsis

Profiled companies have been selected based on inputs gathered from primary experts, as well as analyzing company coverage, product portfolio, and market penetration.

Some prominent names established in this market are:

  • Merck KGaA
  • Almac Group
  • Sotax

Table of Contents

Executive Summary

1 Research Methodology

  • 1.1 Data Sources
    • 1.1.1 Primary Data Sources
    • 1.1.2 Secondary Data Sources
    • 1.1.3 Data Triangulation
  • 1.2 Market Estimation and Forecast

2 Pharmaceutical Dissolution Market: Overview

  • 2.1 Definitions
    • 2.1.1 Product Definition
  • 2.2 Inclusion and Exclusion Criteria
  • 2.3 Key Findings

3 Market Industry Outlook

  • 3.1 Market Overview and Ecosystem
  • 3.2 Market Opportunities Assessment
  • 3.3 Product Benchmarking
  • 3.4 Regulatory Landscape/Compliances
    • 3.4.1 European Union (EU)

4 Pharmaceutical Dissolution Market (By Region), $Million, 2023-2033

  • 4.1 Regional Summary
  • 4.2 Growth Share Matrix
  • 4.3 Europe
    • 4.3.1 Regional Overview
    • 4.3.2 Drivers
      • 4.3.2.1 Stringent Regulatory Guidelines for Drug Approvals
      • 4.3.2.2 Growing Focus on Quality Assurance
      • 4.3.2.3 Technological Advancement in Dissolution Testing
    • 4.3.3 Restraints
      • 4.3.3.1 Discriminatory Power of Dissolution Methods
      • 4.3.3.2 Regulatory Complexity and Evolving Standards
    • 4.3.4 Germany
      • 4.3.4.1 Increasing Adoption of Generic Drugs
      • 4.3.4.2 Rising Interest in Biopharmaceuticals
      • 4.3.4.3 Growing Focus on Quality Assurance
      • 4.3.4.4 Shortage of Skilled Labor
      • 4.3.4.5 Rising Pressure on Cost Efficiency
    • 4.3.5 U.K.
      • 4.3.5.1 Shifting Trends toward Generic Drugs
      • 4.3.5.2 Innovation in Dissolution Testing Technologies
      • 4.3.5.3 Increasing Government Initiatives
      • 4.3.5.4 Challenges in Dissolution Testing
      • 4.3.5.5 Variability in Dissolution Tests Result
    • 4.3.6 France
      • 4.3.6.1 Increasing Demand for Generic Drugs
      • 4.3.6.2 High Emphasis on Quality Assurance
      • 4.3.6.3 Testing Complex Drug Formulations
      • 4.3.6.4 Technical Challenges in Biorelevant Dissolution Testing
    • 4.3.7 Italy
      • 4.3.7.1 Stringent Regulatory Guidelines for Drug Approvals
      • 4.3.7.2 Rising Focus on Complex Drug Formulation
      • 4.3.7.3 Long Approval Time
    • 4.3.8 Spain
      • 4.3.8.1 Rising Development in Biopharmaceutical Industry
      • 4.3.8.2 Focus on Regulatory Requirements
      • 4.3.8.3 Significant Vulnerabilities in the Pharmaceutical Dissolution Process
    • 4.3.9 Rest-of-Europe
      • 4.3.9.1 Government Funding and Support
      • 4.3.9.2 High Costs of Advanced Dissolution Testing Systems
      • 4.3.9.3 Technological Adoption in Emerging Markets

5 Markets - Competitive Landscape

  • 5.1 Competitive Benchmarking
  • 5.2 Competitive Landscape
    • 5.2.1 Mergers and Acquisitions
    • 5.2.2 Funding Activities
    • 5.2.3 Key Developments Analysis
    • 5.2.4 Company Share Analysis, 2023
      • 5.2.4.1 Dissolution System
      • 5.2.4.2 Dissolution Accessories
  • 5.3 Company Profiles (Major Manufacturers)
    • 5.3.1 Merck KGaA
      • 5.3.1.1 Overview
      • 5.3.1.2 Top Products
        • 5.3.1.2.1 Dissolution Accessories
      • 5.3.1.3 Top Competitors
      • 5.3.1.4 Target Customers/End Users
      • 5.3.1.5 Analyst View
    • 5.3.2 Sotax
      • 5.3.2.1 Overview
      • 5.3.2.2 Top Products
        • 5.3.2.2.1 Dissolution System
        • 5.3.2.2.2 Pharma Services
      • 5.3.2.3 Top Competitors
      • 5.3.2.4 Target Customers/End Users
      • 5.3.2.5 Analyst View
    • 5.3.3 Almac Group
      • 5.3.3.1 Overview
      • 5.3.3.2 Top Products
        • 5.3.3.2.1 Dissolution Testing Equipment
      • 5.3.3.3 Top Competitors
      • 5.3.3.4 Target Customers/End Users
      • 5.3.3.5 Analyst View
  • 5.4 Service Providers
    • 5.4.1 Eurofins Scientific
      • 5.4.1.1 Overview
      • 5.4.1.2 Services Offered
      • 5.4.1.3 Top Competitors
      • 5.4.1.4 Target Customers/End Users
      • 5.4.1.5 Analyst View
    • 5.4.2 Intertek Group plc
      • 5.4.2.1 Overview
      • 5.4.2.2 Services Offered
      • 5.4.2.3 Top Competitors
      • 5.4.2.4 Target Customers/End Users
      • 5.4.2.5 Analyst View
    • 5.4.3 Avivia BV
      • 5.4.3.1 Overview
      • 5.4.3.2 Services Offered
      • 5.4.3.3 Top Competitors
      • 5.4.3.4 Target Customers/End Users
      • 5.4.3.5 Analyst View

List of Figures

  • Figure 1: Market Snapshot in 2023, 2026, 2033
  • Figure 2: Pharmaceutical Dissolution Market (by Region), $Billion, 2023, 2026, and 2033
  • Figure 3: Data Triangulation
  • Figure 4: Top-Down and Bottom-Up Approach
  • Figure 5: Assumptions and Limitations
  • Figure 6: Inclusion and Exclusion of the Study
  • Figure 7: Europe Pharmaceutical Dissolution Market Size, $ Million, 2023-2033
  • Figure 8: Pharmaceutical Dissolution Market, Growth-Share Matrix (by Region), 2023-2033
  • Figure 9: Germany Pharmaceutical Dissolution Market, $Million, 2023-2033
  • Figure 10: U.K. Pharmaceutical Dissolution Market, $Million, 2023-2033
  • Figure 11: France Pharmaceutical Dissolution Market, $Million, 2023-2033
  • Figure 12: Italy Pharmaceutical Dissolution Market, $Million, 2023-2033
  • Figure 13: Spain Pharmaceutical Dissolution Market, $Million, 2032-2023
  • Figure 14: Rest-of-Europe Pharmaceutical Dissolution Market, $Million, 2023-2033
  • Figure 15: Key Areas of Development in Pharmaceutical Dissolution Market
  • Figure 16: Company Share Analysis, 2023
  • Figure 17: Company Share Analysis, 2023

List of Tables

  • Table 1: Market Snapshot Scenario
  • Table 2: Drug Release Conditions and Acceptance Criteria
  • Table 3: Pharmaceutical Dissolution Market (by Region), $Million, 2023-2033
  • Table 4: Europe Pharmaceutical Dissolution Market (by Country), $Million, 2023-2033
  • Table 5: Mergers and Acquisitions (by Company), January 2021-September 2024
  • Table 6: Funding and Investment Activities (by Company), January 2021-September 2024