유럽의 의약품 용출 시장 - 분석 및 예측(2024-2033년)

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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.

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