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1463412

医薬品無菌試験の世界市場規模、シェア、成長分析、タイプ別、サンプル別 - 産業予測、2024~2031年

Global Pharmaceutical Sterility Testing Market Size, Share, Growth Analysis, By Type(In-house, and Outsourcing), By Sample(Pharmaceuticals, Medical Devices) - Industry Forecast 2024-2031

出版日: | 発行: SkyQuest | ページ情報: 英文 219 Pages | 納期: 3~5営業日

価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=154.36円
医薬品無菌試験の世界市場規模、シェア、成長分析、タイプ別、サンプル別 - 産業予測、2024~2031年
出版日: 2024年04月06日
発行: SkyQuest
ページ情報: 英文 219 Pages
納期: 3~5営業日
  • 全表示
  • 概要
  • 目次
概要

世界の医薬品無菌試験の市場規模は、2022年に14億8,000万米ドルとなり、2023年の16億6,000万米ドルから、2031年までには41億米ドルに成長し、予測期間(2024~2031年)のCAGRは12%で成長する見通しです。

高品質の医薬品へのニーズ、医薬品の安全性と有効性の重視の高まり、無菌試験に対する規制要件が、世界の医薬品無菌試験市場を牽引する主要な要因です。生きた微生物の存在を確認することで、医薬品無菌試験は医薬品やその他の医薬品の有効性と安全性を保証します。規制機関は、医薬品やその他の医療用品に微生物汚染がないことを保証するために無菌試験を義務付けており、これは患者に重大な悪影響を及ぼす可能性があります。医薬品無菌試験市場は、主に3つの要因によって牽引されています。高品質の医薬品に対するニーズ、医薬品の安全性と有効性の重視の高まり、そして無菌試験に対する規制要件です。安全性と有効性を保証するため、米国食品医薬品局(FDA)や欧州医薬品庁(EMA)などの規制機関は、すべての医薬品や医療製品に無菌試験を実施することを義務付けています。その結果、医薬品無菌試験のニーズはここ数年で顕著に急増しています。医薬品無菌試験業界の成長を妨げている主要な要因は、商品やサービスの試験に関連する法外な費用です。無菌試験のプロセスは複雑で時間がかかり、熟練した作業員と高度な機器を必要とします。そのため、この業界への参入を阻み、業界の拡大を制限している企業もあります。医薬品の複雑化は、医薬品無菌試験分野が直面する主要な障害のひとつです。

目次

エグゼクティブサマリー

  • 市場概要
  • 運命の輪

調査手法

  • 情報調達
  • 二次・一次情報源
  • 市場規模の推定
  • 市場の前提条件と制限

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

主要な市場の考察

  • 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
  • 主要な投資の分析
  • 主要な成功要因
  • 競合の程度

市場力学と見通し

  • 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

医薬品無菌試験の世界市場:タイプ別

  • 市場概要
  • 社内
  • アウトソーシング

医薬品無菌試験の世界市場:サンプル別

  • 市場概要
  • 医薬品
  • 医療機器
  • バイオ医薬品

医薬品無菌試験の世界市場規模: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
    • その他欧州地域
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • 韓国
    • その他アジア太平洋
  • ラテンアメリカ
    • ブラジル
    • その他ラテンアメリカ地域
  • 中東・アフリカ(MEA)
    • 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)
  • 主要な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

  • Charles River Laboratories International, Inc.(US)
  • Eurofins Scientific(Luxembourg)
  • Merck KGaA(Germany)
  • Thermo Fisher Scientific Inc.(US)
  • SGS SA(Switzerland)
  • WuXi AppTec(China)
  • bioMA(C)rieux SA(France)
  • Nelson Laboratories, LLC(US)
  • Pace Analytical Services, LLC(US)
  • Toxikon Corporation(US)
  • Sartorius AG(Germany)
  • STERIS plc(US)
  • Microbac Laboratories, Inc.(US)
  • North American Science Associates, Inc.(US)
  • Gibraltar Laboratories(US)
  • Boston Analytical, Inc.(US)
  • Analytical Lab Group(US)
  • Becton, Dickinson and Company(US)
  • Pacific Biolabs(US)
  • Dynatec Labs(US)
目次
Product Code: SQMIG35I2168

Global Pharmaceutical Sterility Testing Market size was valued at USD 1.48 billion in 2022 and is poised to grow from USD 1.66 billion in 2023 to USD 4.10 billion by 2031, growing at a CAGR of 12% during the forecast period (2024-2031).

The need for high-quality pharmaceutical goods, the growing emphasis on drug safety and efficacy, and the regulatory requirements for sterility testing are the main factors driving the global pharmaceutical sterility testing market. By checking for the presence of live microorganisms, pharmaceutical sterility testing ensures the efficacy and safety of medications and other pharmaceutical items. Regulatory bodies mandate sterility testing to guarantee that medications and other medical supplies are free of microbiological contamination, which can have grave negative consequences on patients. The market for pharmaceutical sterility testing is primarily driven by three factors: the need for high-quality pharmaceutical goods, the growing emphasis on drug safety and efficacy, and the regulatory requirements for sterility testing. To guarantee its safety and effectiveness, regulatory bodies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandate that all medications and medical products undergo sterility testing. Consequently, there has been a notable surge in the need for pharmaceutical sterility testing in recent times. The primary impediment to the growth of the pharmaceutical sterility testing industry is the exorbitant expenses associated with testing goods and services. The process of sterility testing is intricate and time-consuming, requiring skilled workers and sophisticated equipment. This can prevent some businesses from entering the industry and restrict its expansion. The growing complexity of pharmaceutical goods is one of the main obstacles facing the pharmaceutical sterility testing sector.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Pharmaceutical Sterility Testing 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 Pharmaceutical Sterility Testing Market Segmental Analysis

The global pharmaceutical sterility testing market is segmented on the basis of type, application, and region. Based on type, the market is segmented into in-house, and outsourcing. In terms of sample, the market is grouped into pharmaceuticals, medical devices, and biopharmaceuticals. By region, the market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.

Drivers of the Global Pharmaceutical Sterility Testing Market

Because biologics and biosimilar medications are so successful in treating critical illnesses including cancer, neurological conditions, and infectious diseases, there has been a surge in demand for these medications in recent years. As a result, there is a growing need for pharmaceutical sterility testing to guarantee the security and effectiveness of these goods. The market for pharmaceutical sterility testing has expanded as a result of the approval of multiple biosimilar medications in recent years, including Adalimumab, Rituximab, and Trastuzumab.

Restraints in the Global Pharmaceutical Sterility Testing Market

Many clients may find the high expense of pharmaceutical sterility testing services to be a major deterrent, particularly in developing nations or environments with limited resources. In order to meet FDA standards, small and medium-sized pharmaceutical and medical device firms prefer to outsource sterility testing because they may not have the resources to perform high-quality tests.

Market Trends of the Global Pharmaceutical Sterility Testing Market

The pharmaceutical industry is seeing an increase in the use of quick microbial detection technologies due to their ability to expedite results and reduce testing durations. It is expected that this trend will continue in the years to come.

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 Pharmaceutical Sterility Testing Market by Type

  • Market Overview
  • In-house
  • and Outsourcing

Global Pharmaceutical Sterility Testing Market by Sample

  • Market Overview
  • Pharmaceuticals
  • Medical Devices
  • and Biopharmaceuticals

Global Pharmaceutical Sterility Testing 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

  • Charles River Laboratories International, Inc. (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Eurofins Scientific (Luxembourg)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Merck KGaA (Germany)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Thermo Fisher Scientific Inc. (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • SGS SA (Switzerland)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • WuXi AppTec (China)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • bioMA(C)rieux SA (France)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Nelson Laboratories, LLC (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Pace Analytical Services, LLC (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Toxikon Corporation (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Sartorius AG (Germany)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • STERIS plc (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Microbac Laboratories, Inc. (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • North American Science Associates, Inc. (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Gibraltar Laboratories (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Boston Analytical, Inc. (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Analytical Lab Group (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Becton, Dickinson and Company (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Pacific Biolabs (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Dynatec Labs (US)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments