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歐洲藥物溶離度測試市場－分析與預測（2024-2033）
市場調查報告書
商品編碼
1876450

歐洲藥物溶離度測試市場－分析與預測（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個工作天內

價格

歐洲藥物溶離度測試市場預計將從 2024 年的 2.086 億美元成長到 2033 年的 4.095 億美元，2024 年至 2033 年的複合年成長率為 7.78%。

藥物溶離度測試是指藥物製劑（如片劑、膠囊和粉末）在液體介質（通常模擬生理體液）中溶解並釋放其活性藥物​​成分 (API) 的過程。這個過程對於了解藥物在人體內的行為至關重要，因為它直接影響生物利用度，並決定活性成分進入血液的速率和程度。溶出度測試是歐洲藥物研發和品管的基礎，確保藥物符合歐洲藥品管理局 (EMA) 和各國監管機構要求的嚴格的安全性、有效性和均一性標準。它對於口服劑型的特性分析和最佳化至關重要，同時也為上市核准申請和持續的歐洲市場監管合規性提供關鍵數據。

關鍵市場統計數據
預測期 2024-2033
2024年評估 2.086億美元
2033年的預測 4.095億美元
複合年成長率 7.78%

市場概覽

歐洲藥物溶離度測試市場在藥物品管和藥物研發中發揮至關重要的作用，確保了全部區域醫療產品的安全性、有效性和合規性。藥物溶離度測試透過測量活性藥物成分（API）在模擬生理環境的條件下，以片劑、膠囊和粉劑等劑型溶解的情況，提供預測藥物體內性能和生物利用度的重要資訊。

歐洲先進的製藥產業，以歐洲藥品管理局 (EMA) 和各國監管機構健全的法規結構為特徵，推動了對精密溶離度測試設備和服務的需求。該地區聚集了許多跨國製藥公司、學名藥生產商、受託研究機構和學術研究機構，它們在藥物生命週期的各個階段，從初始製劑研發到商業化生產和品管，都高度依賴溶離度測試。

市場涵蓋種類繁多的溶離度測試設備，包括自動化系統、手動設備和專用生物溶離度設備，以及相關的介質、配件和分析服務。德國、法國、英國、義大利和瑞士是重要的市場，對歐洲的製藥生產和研發做出了重大貢獻。

由於嚴格的監管、學名藥研發的擴張、製藥業研發投入的增加以及技術進步，歐洲的藥物溶離度測試產業正經歷持續的變化。隨著品質源於設計（QbD）理念的引入、自動化技術的應用以及生物基方法的廣泛普及，溶出度測試正迅速成為歐洲藥物創新和品質保證的重要工具。

市場區隔:

區隔 1：依區域

  • 歐洲
    • 德國
    • 英國
    • 法國
    • 義大利
    • 西班牙
    • 其他

歐洲藥物溶離度測試市場趨勢、促進因素與課題

主要市場趨勢

  • 為提高效率、減少人為誤差並確保藥品品管符合法規要求，自動化溶離度測試系統的應用日益廣泛。
  • 為了預測藥物在體內的行為，人們開始轉向生物相關溶離度測試，這種測試能更緊密地模擬生理條件。
  • 人工智慧 (AI) 和機器學習正擴大被整合到溶離度測試中，用於資料分析、方法開發和預測建模。
  • 隨著製藥公司將品管職能外包，提供專業溶離度測試服務的受託研究機構（CRO）正在不斷擴張。
  • 在製劑開發中，對品質源於設計 (QbD) 原則的日益重視使得溶離度測試成為藥物開發的關鍵組成部分。
  • 市場對可同時測試多個樣品以提高通量的多容器溶離度測試系統的需求日益成長。

主要市場促進因素

  • 歐洲藥品管理局 (EMA) 和各國監管機構的嚴格監管要求，規定藥物核准和批次放行必須進行全面的溶離度測試。
  • 歐洲學名藥產量增加，需要進行廣泛的溶離度測試，以證明其與品牌藥具有生物等效性。
  • 歐洲各地對製藥研發投入的增加，推動了製劑開發階段對溶離度測試設備和服務的需求。
  • 隨著藥物緩釋性變得越來越複雜，例如緩釋製劑、緩釋製劑和組合製劑，需要更先進的溶離度測試方法。
  • 不斷發展的生物製藥產業需要針對複雜的生物製藥和生物相似藥採用專門的溶離度測試方法。
  • 隨著歐洲人口老化，藥品消費量不斷增加，而需要品管的藥品生產也不斷增加。

主要課題

  • 安裝複雜的自動化溶離度測試設備需要大量的資金投入，這對中小型製藥公司和研究實驗室來說是一個障礙。
  • 缺乏奈米顆粒、脂質體和經皮吸收貼片新型藥物遞送系統的標準化方法，使得溶離度測試通訊協定變得複雜。
  • 歐洲市場普遍缺乏接受過先進溶離度測試技術和法規要求培訓的熟練人員
  • 開發能夠準確預測體內性能並同時滿足監管要求的生物相關溶出方法的複雜性
  • 儘管歐洲各國努力協調統一，但各國對監管規定的解讀存在差異，這給跨國公司帶來了合規的課題。
  • 溶離度測試設備的維護和校準要求既耗時又昂貴，會影響運作效率。
  • 建立體外-體內相關性（IVIVC）面臨許多課題，尤其對於複雜製劑和難溶性藥物而言。

產品與創新策略：本報告深入分析了藥物溶離度測試領域的最新技術進展，使企業能夠推動創新並開發符合市場需求的尖端產品。

成長與行銷策略：透過全面的市場分析與關鍵成長機會的識別，我們為企業提供製定有針對性的行銷策略並有效擴大市場佔有率所需的知識。

競爭策略：該報告對競爭格局進行了全面分析，以幫助企業了解其競爭對手在藥物溶離度測試領域的優勢和劣勢，並制定有效的策略以獲得市場競爭優勢。

監管與合規策略：提供有關不斷變化的法規結構、核准情況以及藥物溶出度測試行業指南的最新資訊，確保您的組織保持合規，並加速新藥物溶出度測試產品的市場准入。

投資和業務擴大策略：透過分析市場趨勢、資金籌措模式和合作機會，我們幫助企業做出明智的投資決策，並識別潛在的併購機會以促進業務成長。

主要市場參與者及競爭摘要

我們根據對公司覆蓋範圍、產品系列和市場滲透率的分析，並結合從行業領先專家那裡收集的資訊，來選擇對其中進行介紹的公司。

該市場的主要企業包括：

  • Merck KGaA
  • Almac Group
  • Sotax

目錄

摘要整理

第1章調查方法

第2章：藥物溶離度測試市場概述

第3章 市場產業展望

  • 市場概覽與生態系統
  • 市場機會評估
  • 產品基準測試
  • 監管狀態/合規性
    • 歐盟

4. 2023-2033年依地區分類的藥物溶離度測試市場規模（百萬美元）

  • 區域摘要
  • 成長佔有率矩陣
  • 歐洲
    • 區域概覽
    • 促進要素
    • 阻礙因素
    • 德國
    • 英國
    • 法國
    • 義大利
    • 西班牙
    • 其他

第5章 市場競爭情勢

  • 競爭基準化分析
  • 競爭格局
    • 併購
    • 資金籌措活動
    • 關鍵發展分析
    • 企業市場占有率分析，2023年
  • 公司簡介（主要製造商）
    • Merck KGaA
    • Sotax
    • Almac Group
  • 服務供應商
    • Eurofins Scientific
    • Intertek Group plc
    • Avivia BV

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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.

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