無菌サンプリングの世界市場規模、シェア、成長分析、タイプ別、手法別、用途別、エンドユーザー別-産業予測、2024～2031年

世界の無菌サンプリング市場規模は、2022年に3億3,353万米ドルと評価され、2023年の3億7,489万米ドルから2031年には9億5,506万米ドルに成長し、予測期間（2024～2031年）のCAGRは12.40%になる展望です。

バイオ医薬品の需要拡大により、シングルユースの無菌サンプリング製品の利用が増加しており、無菌サンプリング市場の成長を牽引しています。米国疾病管理予防センターによると、米国だけでも国民医療に3兆6,500億米ドル以上を費やしています。さらに、医薬品の安全性と品質を確保するための政府規制の増加、このセグメントにおける研究開発活動の増加、医療に対する政府支出の増加が、市場拡大をさらに促進すると予想されます。無菌サンプリング製品は通常、加工されたプラスチックポリマーで作られており、溶媒から物質を溶出・抽出する可能性があるため、汚染のリスクがあります。単回使用品からの溶出性物質や抽出性物質に対する懸念は、世界の無菌サンプリング市場の成長を制限する主要要因の一つです。さらに、多くのバイオ医薬品プロセスは高温を必要とし、その結果、最終製品を汚染する可能性のある不必要で未確認の化合物が生成されます。これは、シングルユース・バイオプロセシングシステムの採用に対するもう一つの重大な制約となっています。

目次

エグゼクティブサマリー

• 市場概要
• 繁栄と衰退

調査手法

• 情報調達
• 二次データソースと一次データソース
• 市場規模の推定
• 市場の危機と限界

親市場の分析

• 市場概要
• 市場規模
• 市場力学
  • 促進要因
  • 機会
  • 抑制要因
  • 課題

主要市場の考察

• 技術分析
• 価格分析
• サプライチェーン分析
• バリューチェーン分析
• 市場のエコシステム
• IP分析
• 貿易分析
• スタートアップ分析
• 原材料の分析
• イノベーションマトリクス
• パイプライン製品の分析
• マクロ経済指標
• 主要投資の分析
• 主要成功要因
• 競合の程度

市場力学と展望

• 市場力学
  • 促進要因
  • 機会
  • 抑制要因
  • 課題
• 規制情勢
• ポーターの分析
• 将来の混乱についての特別な考察

無菌サンプリングの世界市場：タイプ別

• 市場概要
• 手動無菌サンプリング
• 自動無菌サンプリング

無菌サンプリングの世界市場：手法別

• 市場概要
• オフラインサンプリング技術
• アットラインサンプリング技術
• オンラインサンプリング技術

無菌サンプリングの世界市場：用途別

• 市場概要
• 上流プロセス
• 下流プロセス

無菌サンプリングの世界市場：エンドユーザー別

• 市場概要
• バイオテクノロジーと製薬メーカー
• 委託研究製造組織
• 研究開発セグメント
• その他

無菌サンプリングの世界市場規模：地域別

• 市場概要
• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • その他の欧州地域
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他のアジア太平洋
• ラテンアメリカ
  • ブラジル
  • その他のラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ地域

競合情勢

• 上位5社の比較
• 主要企業の市場ポジショニング（2021年）
• 主要市場企業が採用した戦略
• 主要成功戦略
• 市場における最近の活動
• 主要企業の市場シェア（2021年）

主要企業プロファイル

• QualiTru Sampling Systems（米国）
• GemA1/4 Group（米国）
• Flownamics（米国）
• Sartorius AG（ドイツ）
• Merck KGaA（ドイツ）
• Danaher（米国）
• Thermo Fisher Scientific Inc.（米国）
• Saint-Gobain（フランス）
• GEA Group Aktiengesellschaft（ドイツ）
• Avantor, Inc.（米国）
• Keofitt A/S（デンマーク）
• W. L. Gore & Associates（米国）
• Lonza（スイス）
• Trace Analytics（米国）

Global aseptic sampling market size was valued at USD 333.53 million in 2022 and is poised to grow from USD 374.89 million in 2023 to USD 955.06 million by 2031, at a CAGR of 12.40% during the forecast period (2024-2031).

The growing demand for biopharmaceuticals has led to increased utilization of single-use aseptic sampling products, driving the growth of the aseptic sampling market. According to the Centres for Disease Control and Prevention, the United States alone spent over USD 3.65 trillion on national healthcare. Additionally, the rise in government regulations to ensure drug safety and quality, along with increased research and development activities in the sector and higher government spending on healthcare, are expected to further propel market expansion. Aseptic sampling products are typically made of processed plastic polymers that have the potential to leach and extract substances from solvents, posing contamination risks. Concerns about leachable and extractable substances from single-use items are among the key factors limiting the global aseptic sampling market's growth. Moreover, many biopharmaceutical processes require high temperatures, resulting in the production of unnecessary and unidentified compounds that could contaminate the final product. This presents another significant constraint on the adoption of single-use bioprocessing systems.

Top-down and bottom-up approaches were used to estimate and validate the size of the global Aseptic Sampling market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Aseptic Sampling Market Segmental Analysis

Global aseptic sampling market is segmented based on the type, technique, application, end user, and region. By type, the market is segmented into manual aseptic sampling, and automated aseptic sampling. By technique, the market is segmented into off-line sampling technique, at-line sampling technique, on-line sampling technique. By application, the market is segmented into upstream processes, and downstream processes. By End-users, the market is segmented into biotechnology and pharmaceutical manufacturers, contract research and manufacturing organizations, R&D departments, and others. By region, the market is segmented into North America, Europe, Asia-Pacific, Latin America, and MEA.

Drivers of the Global Aseptic Sampling Market

The growth of the aseptic sampling market will primarily be fueled by several key factors. These include the uptick in research and development activities, the surge in investments in healthcare infrastructure in developing nations, the growing demand for pharmaceuticals, the expanding government regulations aimed at ensuring drug safety and quality, and the establishment of biotechnology-based companies.

Restraints in the Global Aseptic Sampling Market

Issues concerning extractables and leachables could indeed hinder the expansion of the market. Additionally, the sluggish adoption of advanced technologies in both the production and disposal of biopharmaceuticals may pose further obstacles to the market's growth during the projection period.

Market Trends of the Global Aseptic Sampling Market

The aseptic sample market is poised for significant growth within the biotechnology and pharmaceutical sectors, driven by increasing research and development expenditures and a burgeoning pipeline of biological and pharmaceutical products. As an example, Amgen Inc., a prominent biopharmaceutical company, has witnessed a steady increase in its research and development spending over the years. According to Amgen Inc.'s 2022 annual report, this spending escalated from USD 4,207 million in 2021 to USD 4,819 million in 2022. Furthermore, advancements in product technology and their adoption by pharmaceutical and biotechnology firms are expected to further fuel market growth.

Table of Contents

Executive Summary

• Market Overview
• Wheel of Fortune

Research Methodology

• Information Procurement
• Secondary & Primary Data Sources
• Market Size Estimation
• Market Assumptions & Limitations

Parent Market Analysis

• Market Overview
• Market Size
• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges

Key Market Insights

• Technology Analysis
• Pricing Analysis
• Supply Chain Analysis
• Value Chain Analysis
• Ecosystem of the Market
• IP Analysis
• Trade Analysis
• Startup Analysis
• Raw Material Analysis
• Innovation Matrix
• Pipeline Product Analysis
• Macroeconomic Indicators
• Top Investment Analysis
• Key Success Factor
• Degree of Competition

Market Dynamics & Outlook

• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges
• Regulatory Landscape
• Porters Analysis
  • Competitive rivalry
  • Threat of Substitute Products
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers
• Skyquest Special Insights on Future Disruptions
  • Political Impact
  • Economic Impact
  • Social Impact
  • Technical Impact
  • Environmental Impact
  • Legal Impact

Global Aseptic Sampling Market by Type

• Market Overview
• Manual Aseptic Sampling
• and Automated Aseptic Sampling

Global Aseptic Sampling Market by Technique

• Market Overview
• Off-Line Sampling Technique
• At-Line Sampling Technique
• On-Line Sampling Technique

Global Aseptic Sampling Market by Application

• Market Overview
• Upstream Processes
• and Downstream Processes

Global Aseptic Sampling Market by End User

• Market Overview
• Biotechnology and Pharmaceutical Manufacturers
• Contract Research and Manufacturing Organizations
• R&D Departments
• and Others

Global Aseptic Sampling Market Size by Region

• Market Overview
• North America
  • USA
  • Canada
• Europe
  • Germany
  • Spain
  • France
  • UK
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC Countries
  • South Africa
  • Rest of MEA

Competitive Landscape

• Top 5 Player Comparison
• Market Positioning of Key Players, 2021
• Strategies Adopted by Key Market Players
• Top Winning Strategies
  • By Development
  • By Company
  • By Year
• Recent Activities in the Market
• Key Companies Market Share (%), 2021

Key Company Profiles

• QualiTru Sampling Systems (U.S.)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GemA1/4 Group (U.S.)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Flownamics (U.S.)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sartorius AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Merck KGaA (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Danaher (U.S.)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc. (U.S.)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Saint-Gobain (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GEA Group Aktiengesellschaft (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Avantor, Inc. (U.S.)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Keofitt A/S (Denmark)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• W. L. Gore & Associates (U.S.)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lonza (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Trace Analytics (U.S.)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments