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欧州のGMP試験サービス市場の2028年までの予測-地域分析- サービスタイプ別、エンドユーザー別

Europe GMP Testing Service Market Forecast to 2028 - COVID-19 Impact and Regional Analysis - by Service Type and End User
出版日: | 発行: The Insight Partners | ページ情報: 英文 117 Pages | 納期: 即納可能 即納可能とは

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欧州のGMP試験サービス市場の2028年までの予測-地域分析- サービスタイプ別、エンドユーザー別
出版日: 2023年01月10日
発行: The Insight Partners
ページ情報: 英文 117 Pages
納期: 即納可能 即納可能とは
  • 全表示
  • 概要
  • 図表
  • 目次
概要

欧州GMP試験サービス市場は、2022年の6億1,677万米ドルから2028年には8億9,722万米ドルに成長すると予測され、2022年から2028年までのCAGRは6.4%と推定されています。

GMP試験サービスに関する拡大が欧州のGMP試験サービス市場の成長を押し上げる

多くのライフサイエンス企業は、ロボティクスとコグニティブオートメーション（R&CA）の採用という概念に初めて触れることになります。USFDA規則21の要件がR&CAの不確実性につながり、人間の安全性に影響を与える可能性があるため、GMP試験業界の進歩が減速しています。技術導入の遅れにもかかわらず、製薬、医療機器、バイオテクノロジー企業では、特に臨床試験や規制遵守のさまざまな段階で、自動化の利用が徐々に一般的になってきています。インダストリー4.0は、接続性、高度な分析、ロボット、自動化を可能にし、今後5～10年の間に医薬品製造のあらゆる側面に革命をもたらす可能性があります。医薬品製造におけるインダストリー4.0の初期使用事例では、成熟した効率的なラボ環境において、生産性が30～40%向上することが実証されており、さらなる改善により、品質管理コスト全体を50%以上削減することができます。デジタル化と自動化は、手作業によるエラーやばらつきを減らすことで品質とコンプライアンスを向上させ、同時に問題への迅速かつ効果的な対処を可能にします。ロボティック・プロセス・オートメーションやコグニティブ・オートメーション、バリデーションは、GMPの一部として、以下のプロセスに貢献する可能性があります：

製品の品質や流通に関するデータを処理するツールや機能を提供することで、面倒な製品表示プロセスを合理化し、ファーマコビジランスの進歩をサポートします。新薬申請用の試験プロトコルなど、FDAの要件で検査対象となるプレディケートルールで必要とされる公式記録の維持トレーニングや学習管理システム（LMS）の効果を高める。トレーニング課題の自動化、ギャップ特定、担当者とのコミュニケーション促進を通じ、放射線レポートなどの画像にあるリスクの高い異常の同定臨床試験のデータの大規模解釈や処理を通じて。

欧州GMP試験サービス市場の概要

欧州のGMP試験サービス市場は、ドイツ、英国、フランス、イタリア、スペイン、その他欧州に細分化されます。その他欧州は、ポーランド、オーストリア、スイス、スウェーデン、ノルウェー、アイルランド、デンマーク、ベルギー、オランダなどの国々で構成されています。欧州は、世界のGMP試験サービス市場で大きなシェアを占めており、市場推計・予測期間中に顕著なCAGRを記録すると推定されています。同地域の市場成長は、医薬品、バイオ医薬品、バイオテクノロジー、医療機器産業の普及、市場関係者による製品イノベーション、慢性疾患の有病率の上昇に起因しています。

欧州GMP試験サービス市場の収益と2028年までの予測（百万米ドル）

欧州GMP試験サービス市場のセグメンテーション

欧州GMP試験サービス市場は、サービスタイプ、エンドユーザー、国別に区分されます。サービスタイプに基づき、欧州GMP試験サービス市場は、製品バリデーション試験、バイオ分析サービス、包装・貯蔵寿命試験、その他のサービスタイプに区分されます。2022年には、製品バリデーション試験分野が最大の市場シェアを占めています。

エンドユーザーに基づき、欧州GMP試験サービス市場は、製薬・バイオ医薬品企業と医療機器企業に二分されます。2022年には製薬・バイオ製薬会社セグメントがより大きな市場シェアを占めています。

欧州GMP試験サービス市場は、国別に、ドイツ、英国、スペイン、イタリア、フランス、その他欧州に区分されます。2022年はその他欧州が市場シェアを独占しました。

Eurofins Scientific;Almac Group;INTERTEK GROUP PLC;WuXi AppTec;Sartorius AG;North American Science Associates, Inc.;Nelson Laboratories, LLC;and Thermo Fisher Scientific Inc.（PPD Inc.）は、欧州GMP試験サービス市場で事業を展開している主要企業です。

目次

第1章 イントロダクション

  • 調査範囲
  • 洞察パートナーズの調査報告書ガイダンス
  • 市場セグメンテーション
    • 欧州のGMP試験サービス市場：サービスタイプ別
    • 欧州のGMP試験サービス市場：エンドユーザー別
    • 欧州のGMP試験サービス市場：国別

第2章 主要なポイント

第3章 調査手法

  • カバレッジ
  • 2次調査（セカンダリーリサーチ
  • 1次調査

第4章 欧州GMP試験サービス市場- 市場情勢

  • PEST分析
    • 欧州のPEST分析
  • 専門家の見解

第5章 欧州GMP試験サービス市場-主要市場力学

  • 市場促進要因
    • 製薬業界の継続的な発展
    • 医療機器製造業の発展
  • 市場抑制要因
    • GMP試験サービスに関する統一された規制の不在
  • 市場機会
    • 研究開発におけるGMP試験サービスの受容性
  • 今後の動向
    • GMP試験サービス製品に関連する拡張性
  • 影響度分析

第6章 GMP試験サービス市場-欧州の分析

  • 欧州GMP試験サービス市場の収益と予測・分析

第7章 欧州のGMP試験サービス市場-サービスタイプ別

  • GMPテスティングサービス市場のサービスタイプ別収益シェア（2021年、2028年）
  • 製品バリデーション試験
  • バイオアナリティカルサービス
  • 包装・賞味期限試験
  • その他のサービスタイプ

第8章 欧州GMP試験サービス市場：エンドユーザー別

  • GMP試験サービス市場、エンドユーザー別、2021年、2028年（%）
  • 製薬会社、バイオ医薬品会社
  • 医療機器メーカー

第9章 欧州のGMP試験サービス市場：国別分析

  • 欧州

第10章 GMP試験サービス市場-業界情勢

  • 市場参入企業が行った成長戦略（%）
  • 有機的な展開
  • インオーガニックの展開

第11章 企業プロファイル

  • Eurofins Scientific
  • Almac Group
  • INTERTEK GROUP PLC
  • WuXi AppTec
  • Sartorius AG
  • North American Science Associates, Inc.
  • Nelson Laboratories, LLC
  • Thermo Fisher Scientific Inc.（PPD Inc.）

第12章 付録

  • The Insight Partners について
  • GMP試験サービス市場の用語集
図表

List Of Tables

  • Table 1. Germany GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 2. Germany GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 3. UK GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 4. UK GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 5. France GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 6. France GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 7. Italy GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 8. Italy GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 9. Spain GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 10. Spain GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 11. Rest of Europe GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 12. Rest of Europe GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 13. Organic Developments Done By Companies
  • Table 14. Inorganic Developments Done By Companies
  • Table 15. Glossary of Terms

List Of Figures

  • Figure 1. Europe GMP Testing Service Market Segmentation
  • Figure 2. Europe GMP Testing Service Market, By Country
  • Figure 3. Europe GMP Testing Service Market Overview
  • Figure 4. Product Validation Testing Segment Held Largest Share of Surgery Type Segment in GMP Testing Service Market
  • Figure 5. Rest of Europe is Expected to Show Remarkable Growth During the Forecast Period
  • Figure 6. Europe: PEST Analysis
  • Figure 7. Europe Experts Opinion
  • Figure 8. Europe Impact Analysis
  • Figure 9. Europe GMP Testing Service Market - Revenue Forecasts and Analysis - 2020- 2028
  • Figure 10. Europe GMP Testing Services Market Revenue Share, by Service Type (2021 and 2028)
  • Figure 11. Europe Product Validation Testing: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 12. Europe Bioanalytical Services: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 13. Europe Packaging and Shelf-Life Testing: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 14. Europe Other Service Types: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 15. Europe GMP Testing Services Market, by End User, 2021 and 2028 (%)
  • Figure 16. Europe Pharmaceutical and Biopharmaceutical Companies: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 17. Europe Medical Devices Companies: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 18. Europe: GMP Testing Services Market, by Key Country - Revenue (2021) (US$ Million)
  • Figure 19. Europe: GMP Testing Services Market, by Country, 2021 & 2028 (%)
  • Figure 20. Germany: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 21. UK: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 22. France: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 23. Italy: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 24. Spain: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 25. Rest of Europe: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 26. Growth Strategies Done by the Companies in the Market, (%)
目次
Product Code: BMIRE00027762

The Europe GMP testing service market is expected to grow from US$ 616.77 million in 2022 to US$ 897.22 million by 2028; it is estimated to grow at a CAGR of 6.4% from 2022 to 2028.

Expansions Concerning GMP Testing Services Boost Europe GMP Testing Service Market Growth

Many life sciences companies are new to the concept of adopting robotics and cognitive automation (R&CA). The USFDA Regulation 21 requirements have led to uncertainties about R&CA, and their potential impact on human safety has decelerated the progress of the GMP testing industry. Despite the lag in technology adoption, the use of automation is gradually becoming commonplace across pharmaceutical, medical device, and biotechnology companies, especially in various stages of clinical trials and regulatory compliance. Industry 4.0-enabling connectivity, advanced analytics, robotics, and automation-can revolutionize every aspect of pharmaceutical manufacturing in the next 5-10 years. The initial use cases of Industry 4.0 in pharmaceutical manufacturing have been demonstrated to deliver a 30-40% surge in productivity in mature and efficient lab environments; further improvements could lead to more than 50% reductions in the overall quality-control costs. Digitization and automation ensure better quality and compliance by reducing manual errors and variability, simultaneously enabling the faster and more effective addressal of problems. Robotic process automation and cognitive automation, and validation are likely to contribute to the following processes, as a part of GMPs:

Streamlining the tedious product labeling process, supporting advancements in pharmacovigilance by providing tools and ability to process product quality and distribution data Maintaining official records required by predicate rules that are subject to inspection under FDA requirements, such as study protocols for new drug applications Enhancing the effectiveness of training and learning management systems (LMS) by automating training assignments, identifying gaps, and facilitating communications with respective personnel Identifying high-risk abnormalities in images, such as radiology reports, through large-scale interpretation and processing of the data of clinical trials.

Europe GMP Testing Service Market Overview

The Europe GMP testing service market is subsegmented into Germany, the UK, France, Italy, Spain, and the Rest of Europe. The Rest of Europe consists of countries such as Poland, Austria, Switzerland, Sweden, Norway, Ireland, Denmark, Belgium, and the Netherlands. Europe holds a significant share of the global GMP testing services market and is estimated to record a notable CAGR during the forecast period. The market growth in the region is attributed to the proliferation of the pharmaceuticals, biopharmaceuticals, biotechnology, and medical device industries; product innovations by the market players; and the rising prevalence of chronic diseases.

Europe GMP testing service Market Revenue and Forecast to 2028 (US$ Million)

Europe GMP testing service Market Segmentation

The Europe GMP testing service market is segmented on the basis of service type, end user, and country. Based on service type, the Europe GMP testing service market is segmented into product validation testing, bioanalytical services, packaging & shelf-life testing, and other services type. The product validation testing segment held the largest market share in 2022.

Based on end user, the Europe GMP testing service market is bifurcated into pharmaceutical and biopharmaceutical companies and medical device companies. The pharmaceutical and biopharmaceutical companies segment held a larger market share in 2022.

The Europe GMP testing service market, by country, is segmented into the Germany, the UK, Spain, Italy, France, and Rest of Europe. The Rest of Europe dominated the market share in 2022.

Eurofins Scientific; Almac Group; INTERTEK GROUP PLC; WuXi AppTec; Sartorius AG; North American Science Associates, Inc.; Nelson Laboratories, LLC.; and Thermo Fisher Scientific Inc. (PPD Inc.) are among the leading companies operating in the Europe GMP testing service market.

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Table Of Contents

1. Introduction

  • 1.1 Study Scope
  • 1.2 The Insight Partners Research Report Guidance
  • 1.3 Market Segmentation
    • 1.3.1 Europe GMP Testing Service Market - By Service Type
    • 1.3.2 Europe GMP Testing Service Market - By End User
    • 1.3.3 Europe GMP Testing Service Market - By Country

2. Key Takeaways

3. Research Methodology

  • 3.1 Coverage
  • 3.2 Secondary Research
  • 3.3 Primary Research

4. Europe GMP Testing Service Market - Market Landscape

  • 4.1 Overview
  • 4.2 PEST Analysis
    • 4.2.1 Europe PEST Analysis
  • 4.3 Experts Opinion

5. Europe GMP Testing Service Market- Key Market Dynamics

  • 5.1 Market Drivers
    • 5.1.1 Continuous Propagation of Pharmaceuticals Industry
    • 5.1.2 Flourishment of Medical Device Manufacturing
  • 5.2 Market Restraints
    • 5.2.1 Absence of Uniform Regulatory Framework Related to GMP Testing Services
  • 5.3 Market Opportunities
    • 5.3.1 Acceptance of GMP Testing Services in R&D
  • 5.4 Future Trends
    • 5.4.1 Expansions Related to GMP Testing Services Products
  • 5.5 Impact Analysis

6. GMP Testing Service Market- Europe Analysis

  • 6.1 Europe GMP Testing Service Market Revenue Forecasts and Analysis
    • 6.1.1 Overview

7. Europe GMP Testing Service Market - by Service Type

  • 7.1 Overview
  • 7.2 GMP Testing Services Market Revenue Share, by Service Type (2021 and 2028)
  • 7.3 Product Validation Testing
    • 7.3.1 Overview
    • 7.3.2 Product Validation Testing: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • 7.4 Bioanalytical Services
    • 7.4.1 Overview
    • 7.4.2 Bioanalytical Services: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • 7.5 Packaging and Shelf-Life Testing
    • 7.5.1 Overview
    • 7.5.2 Packaging and Shelf-Life Testing: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • 7.6 Other Service Types
    • 7.6.1 Overview
    • 7.6.2 Other Service Types: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)

8. Europe GMP Testing Services Market - By End User

  • 8.1 Overview
  • 8.2 GMP Testing Services Market, by End User, 2021 and 2028 (%)
  • 8.3 Pharmaceutical and Biopharmaceutical Companies
    • 8.3.1 Overview
    • 8.3.2 Pharmaceutical and Biopharmaceutical Companies: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • 8.4 Medical Devices Companies
    • 8.4.1 Overview
    • 8.4.2 Medical Devices Companies: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)

9. Europe GMP Testing Service Market - By Country Analysis

  • 9.1 Europe: GMP Testing Services Market
    • 9.1.1 Overview
    • 9.1.2 Europe: GMP Testing Services Market, by Country, 2021 & 2028 (%)
      • 9.1.2.1 Germany: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.1.1 Overview
        • 9.1.2.1.2 Germany: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.1.3 Germany: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.1.2.1.4 Germany: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
      • 9.1.2.2 UK: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.2.1 Overview
        • 9.1.2.2.2 UK: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.2.3 UK: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.1.2.2.4 UK: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
      • 9.1.2.3 France: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.3.1 Overview
        • 9.1.2.3.2 France: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.3.3 France: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.1.2.3.4 France: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
      • 9.1.2.4 Italy: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.4.1 Overview
        • 9.1.2.4.2 Italy: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.4.3 Italy: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.1.2.4.4 Italy: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
      • 9.1.2.5 Spain: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.5.1 Overview
        • 9.1.2.5.2 Spain: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.5.3 Spain: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.1.2.5.4 Spain: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
      • 9.1.2.6 Rest of Europe: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.6.1 Overview
        • 9.1.2.6.2 Rest of Europe: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.2.6.3 Rest of Europe: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.1.2.6.4 Rest of Europe: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)

10. GMP Testing Service Market - Industry Landscape

  • 10.1 Overview
  • 10.2 Growth Strategies Done by the Companies in the Market, (%)
  • 10.3 Organic Developments
    • 10.3.1 Overview
  • 10.4 Inorganic Developments
    • 10.4.1 Overview

11. Company Profiles

  • 11.1 Eurofins Scientific
    • 11.1.1 Key Facts
    • 11.1.2 Business Description
    • 11.1.3 Products and Services
    • 11.1.4 Financial Overview
    • 11.1.5 SWOT Analysis
    • 11.1.6 Key Developments
  • 11.2 Almac Group
    • 11.2.1 Key Facts
    • 11.2.2 Business Description
    • 11.2.3 Products and Services
    • 11.2.4 Financial Overview
    • 11.2.5 SWOT Analysis
    • 11.2.6 Key Developments
  • 11.3 INTERTEK GROUP PLC
    • 11.3.1 Key Facts
    • 11.3.2 Business Description
    • 11.3.3 Products and Services
    • 11.3.4 Financial Overview
    • 11.3.5 SWOT Analysis
    • 11.3.6 Key Developments
  • 11.4 WuXi AppTec
    • 11.4.1 Key Facts
    • 11.4.2 Business Description
    • 11.4.3 Products and Services
    • 11.4.4 Financial Overview
    • 11.4.5 SWOT Analysis
    • 11.4.6 Key Developments
  • 11.5 Sartorius AG
    • 11.5.1 Key Facts
    • 11.5.2 Business Description
    • 11.5.3 Products and Services
    • 11.5.4 Financial Overview
    • 11.5.5 SWOT Analysis
    • 11.5.6 Key Developments
  • 11.6 North American Science Associates, Inc.
    • 11.6.1 Key Facts
    • 11.6.2 Business Description
    • 11.6.3 Products and Services
    • 11.6.4 Financial Overview
    • 11.6.5 SWOT Analysis
    • 11.6.6 Key Developments
  • 11.7 Nelson Laboratories, LLC
    • 11.7.1 Key Facts
    • 11.7.2 Business Description
    • 11.7.3 Products and Services
    • 11.7.4 Financial Overview
    • 11.7.5 SWOT Analysis
    • 11.7.6 Key Developments
  • 11.8 Thermo Fisher Scientific Inc. (PPD Inc.)
    • 11.8.1 Key Facts
    • 11.8.2 Business Description
    • 11.8.3 Products and Services
    • 11.8.4 Financial Overview
    • 11.8.5 SWOT Analysis
    • 11.8.6 Key Developments

12. Appendix

  • 12.1 About The Insight Partners
  • 12.2 Glossary of Terms for GMP Testing Services Market