表紙:無菌試験の世界市場(2021年~2028年)
市場調査レポート
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1063093

無菌試験の世界市場(2021年~2028年)

Global Sterility Testing Market - 2021-2028

出版日: | 発行: DataM Intelligence | ページ情報: 英文 165 Pages | 納期: 約2営業日

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無菌試験の世界市場(2021年~2028年)
出版日: 2022年02月18日
発行: DataM Intelligence
ページ情報: 英文 165 Pages
納期: 約2営業日
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本レポートは最新情報反映のため適宜更新し、内容構成変更を行う場合があります。ご検討の際はお問い合わせください。
  • 全表示
  • 概要
  • 目次
概要

当レポートでは、世界の無菌試験市場について調査分析し、市場力学、業界分析、市場分析、競合情勢など、体系的な情報を提供しています。

目次

第1章 世界の滅菌試験市場の調査手法と範囲

  • 調査手法
  • 調査の目的と調査範囲

第2章 世界の滅菌試験市場-市場の定義と概要

第3章 世界の滅菌試験市場-エグゼクティブサマリー

  • 市場の内訳:製品タイプ別
  • 市場の内訳:テストタイプ別
  • 市場の内訳:アプリケーション市場
  • 市場の内訳:地域別

第4章 世界の滅菌試験市場-市場力学

  • 市場に影響を与える要因
    • 促進要因
    • 抑制要因
    • 市場機会
    • 影響分析

第5章 世界の滅菌試験市場-業界分析

  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • 価格分析
  • 規制分析
  • アンメットニーズ

第6章 世界の無菌試験市場-COVID-19分析

  • 市場のCOVID-19分析
    • COVID-19以前の市場シナリオ
    • 現在のCOVID-19の市場シナリオ
    • COVID-19以後の市場シナリオ/将来の市場シナリオ
  • COVID-19における価格の力学
  • 需要と供給のスペクトル
  • パンデミック時の市場に関連する政府のイニシアチブ
  • メーカーの戦略的イニシアチブ
  • 結論

第7章 世界の滅菌試験市場:製品タイプ別

  • イントロダクション
  • 市場規模分析、および前年比成長分析(%):製品タイプ別
  • 市場魅力指数:製品タイプ別
    • 装置
    • キットと試薬
    • サービス

第8章 世界の滅菌試験市場:試験タイプ別

  • イントロダクション
  • 市場規模分析、および前年比成長分析(%):試験タイプ別
  • 市場魅力指数:試験タイプ別
    • 膜ろ過
    • 直接接種
    • その他

第9章 世界の滅菌試験市場:アプリケーション別

  • イントロダクション
    • 市場規模分析、および前年比成長分析(%):アプリケーション別
    • 市場魅力指数:アプリケーション別
  • 製薬および生物学的製造*
    • イントロダクション
    • 市場規模分析、100万米ドル(2019年~2028年)、および前年比成長分析(%)(2020年~2028年)
  • 医療機器製造
  • その他

第10章 世界の滅菌試験市場:地域別

  • イントロダクション
    • 市場規模分析、100万米ドル(2019年~2028年)、および前年比成長分析(%)(2020年~2028年):地域別
    • 市場魅力指数:地域別
  • 北米
  • 欧州
  • 南米
  • アジア太平洋
  • 中東とアフリカ

第11章 世界の滅菌試験市場-競合情勢

  • 主な開発と戦略
  • 企業シェア分析
  • 製品のベンチマーク

第12章 世界の滅菌試験市場-企業プロファイル概要

  • Redberry*
    • 企業概要
    • 製品ポートフォリオおよび説明
    • 主要ハイライト
    • 財務概要
  • BioMerieux
  • Charles River Laboratories, Inc.
  • Merck KGaA
  • Sartorius AG
  • SGS S.A.
  • Sotera Health LLC
  • Thermo Fisher Scientific
  • Alcami Corporation
  • Lucideon

第13章 世界の滅菌試験市場-DataM

  • 付録
  • 当社・サービスについて
  • お問い合わせ
目次
Product Code: DMOT4707

Market Overview

The global sterility testing market size was valued at US$ XX million in 2020 and is estimated to reach US$ XX million by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).

Sterility testing is a GMP (Good Manufacturing Process) microbiology testing requirement to ensure that sterile products are free of viable microorganisms before release and patient administration.

Market Dynamics

The major factors contributing to the growth of the global sterility testing market are the increasing R&D, and the increasing number of drug approvals is expected to drive the market growth.

The increasing number of drug approvals is expected to drive the market growth in the forecast period

The development or validation of product-specific methods and reliable sterility testing are critical steps in drug development. Sterility testing is required to ensure no viable contaminating microorganisms in a product. This testing is done in an isolator or cleanroom environment using direct inoculation or membrane filtration methods. Pharmaceutical articles must be sterile tested during the sterilization validation process and routine release testing. USP requirements use sterility testing as an official test to determine the suitability of a lot.

For instance, according to the Congressional Budget Office's April 2021 report on "Research and Development in Pharmaceutical Industry," there was a 60% increase in the number of new drugs approved for sale in the United States between 2010 and 2019, with 59 new drugs approved in the country in 2018. Hence, with increasing drug approvals and launches, the global sterility testing market is expected to grow in the forecast period.

The problems associated with sterility testing is expected to hamper the market growth

In addition to the significant limitation of testing sterilized products, there is also the uncertainty associated with sterility testing execution. Contamination of the test by non-product-related microorganisms is one of the issues with sterility testing. The USP describes a typical contamination rate for sterility testing of 0.1 percent or 1 per 1,000 samples. This level is likely to rise as test article size, complexity, and manipulation increase. Thus, even if one attempted to test the fully sterilized product with the massive sample size required to verify a typical SAL of 106, the test method would almost certainly fall short of the required precision. In addition to the significant limitation of testing sterilized products, there is also the uncertainty associated with sterility testing execution.

COVID-19 Impact Analysis

The COVID-19 pandemic forced most pharmaceutical and biotechnological companies to focus on research and development to identify leads that can diagnose and treat the SARS-CoV-2 infection, as well as forcing them to look beyond just conventional medicine and therapy, resulting in massive investment in research and development activities by private and government entities all over the world, significantly increasing the growth of sterility testing market.

Segment Analysis

Based on application, the pharmaceutical and biological manufacturing segment is expected to drive the market growth

Sterility testing is performed at all pharmaceutical and biological product manufacturing levels to reduce the risk of product contamination. The rapid growth of the pharmaceutical and biological industries will significantly increase the overall use of sterility testing, resulting in high demand for sterility testing products and solutions. Sterility testing is performed in the manufacturing process of any pharmaceutical or biological product for raw materials, finished product, and even before the final product is released to ensure the absence of microorganisms as per the mandated regulations of the regulatory authority or institutions, and as the demand for pharmaceutical and medical products for various health conditions increases, so does the frequency of sterility testing in the industries. Furthermore, rising investment in research and development and increasing regulatory approvals for drugs and other biologics are propelling new drugs and products, which is expected to fuel the market in the coming years.

For instance, on 22nd November 2019, Reading Scientific Services Ltd. launched a fast, responsive, and flexible sterility testing service for pharmaceutical companies.

Geographical Analysis

North America region is expected to hold the largest market share in the global sterility testing market

The increased research and innovation in the biotechnology and pharmaceutical industries in the regions increased investment in research and development activities in the life sciences and medical technology, and favorable government initiatives are expected to drive the market growth. For instance, according to Statistics Canada's May 2021 report "The Canadian Research and Development Pharmaceutical Sector," in 2018, the pharmaceutical sector added nearly USD 15 billion in value-added to the Canadian economy while spending approximately USD 1.5 billion to USD 2 billion on research and development.

Furthermore, high-end research activities in academics and research institutes will drive the growth of the country's sterility testing market over the forecast period.

Global Sterility Testing Market- Competitive Landscape

The global sterility testing market is highly competitive with mergers, collaborations, and product launches. Some of the major key players in the market are BioMerieux, Charles River Laboratories, Inc., Merck KGaA, Sartorius AG, SGS S.A., Sotera Health LLC, Thermo Fisher Scientific, Alcami Corporation, Redberry, Lucideon

Redberry

Overview: Redberry company creates new platforms to avoid the culture phase of microorganisms in industrial microbiology and thus provide immediate results at previously unheard-of costs, performance, and ease-of-use. It was founded in 2017.

Product Portfolio: Red One, a fully automated rapid microbial detection. Red One detects viable active microorganisms (bacteria, yeasts, and moulds) and eukaryotic cells. It can count samples with concentrations ranging from 10 to 5 10e5 microorganisms per cap (linear range).

Key Developments: On December 14th, 2020, Redberry launched Red One, a fully automated rapid microbial detection platform for in-process control and the release of industrial products.

Why Purchase the Report?

  • Visualize the composition of the global sterility testing market segmentation by product type, by test type, and application highlighting the key commercial assets and players.
  • Identify commercial opportunities in global sterility testing market by analyzing trends and co-development deals.
  • Excel data sheet with thousands of data points of global sterility testing market- level 4/5 segmentation.
  • PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study.
  • Product mapping in excel for the key product of all major market players

The global sterility testing market report would provide an access to an approx. 45+market data table, 40+figures and 180 pages.

Target Audience

  • Service Providers/ Buyers
  • Industry Investors/Investment Bankers
  • Education & Research Institutes
  • Research Professionals
  • Emerging Companies
  • Manufacturers

Market Segmentation

Global Sterility Testing Market- By Product Type

  • Instruments
  • Kits and Reagents
  • Services

Global Sterility Testing Market- By Test Type

  • Membrane Filtration
  • Direct Inoculation
  • Other

Global Sterility Testing Market- By Application

  • Pharmaceutical and Biological Manufacturing
  • Medical Devices Manufacturing
  • Other

Global Sterility Testing Market- By Region

  • North America
  • Europe
  • South America
  • Asia Pacific
  • Middle East and Africa

Table of Contents

1. Global Sterility Testing Market Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Global Sterility Testing Market- Market Definition and Overview

3. Global Sterility Testing Market- Executive Summary

  • 3.1. Market Snippet By Product Type
  • 3.2. Market Snippet By Test Type
  • 3.3. Market Snippet By Application
  • 3.4. Market Snippet By Region

4. Global Sterility Testing Market-Market Dynamics

  • 4.1. Market Impacting Factors
    • 4.1.1. Drivers:
      • 4.1.1.1. The increasing number of drug approvals
    • 4.1.2. Restraints:
      • 4.1.2.1. The problems associated with sterility testing
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Global Sterility Testing Market- Industry Analysis

  • 5.1. Porter's Five Forces Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis
  • 5.5. Unmet Needs

6. Global Sterility Testing Market- COVID-19 Analysis

  • 6.1. Analysis of Covid-19 on the Market
    • 6.1.1. Before COVID-19 Market Scenario
    • 6.1.2. Present COVID-19 Market Scenario
    • 6.1.3. After COVID-19 or Future Scenario
  • 6.2. Pricing Dynamics Amid Covid-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. Global Sterility Testing Market- By Product Type

  • 7.1. Introduction
  • 7.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
  • 7.3. Market Attractiveness Index, By Product Type
    • 7.3.1. Instruments
      • 7.3.1.1.1. Introduction
      • 7.3.1.1.2. Market Size Analysis, US$ Mn, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028
    • 7.2.2. Kits and Reagents
    • 7.2.3. Services

8. Global Sterility Testing Market- By Test Type

  • 8.1. Introduction
  • 8.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
  • 8.3. Market Attractiveness Index, By Test Type
    • 8.3.2. Membrane Filtration
      • 8.3.2.1.1. Introduction
      • 8.3.2.1.2. Market Size Analysis, US$ Mn, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028
    • 8.3.3. Direct Inoculation
    • 8.3.4. Other

9. Global Sterility Testing Market- By Application

  • 9.1. Introduction
    • 9.1.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
    • 9.1.3. Market Attractiveness Index, By Application
  • 9.2. Pharmaceutical and Biological Manufacturing*
    • 9.2.2. Introduction
    • 9.2.3. Market Size Analysis, US$ Million, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028
  • 9.3. Medical Devices Manufacturing
  • 9.4. Other

10. Global Sterility Testing Market- By Region

  • 10.1. Introduction
    • 10.1.2. Market Size Analysis, US$ Million, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028, By Region
    • 10.1.3. Market Attractiveness Index, By Region
  • 10.2. North America
    • 10.2.2. Introduction
    • 10.2.3. Key Region-Specific Dynamics Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
    • 10.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
    • 10.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
    • 10.2.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 10.2.6.1. U.S.
      • 10.2.6.2. Canada
      • 10.2.6.3. Mexico
  • 10.3. Europe
    • 10.3.2. Introduction
    • 10.3.3. Key Region-Specific Dynamics
    • 10.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
    • 10.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
    • 10.3.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
    • 10.3.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 10.3.7.1. Germany
      • 10.3.7.2. U.K.
      • 10.3.7.3. France
      • 10.3.7.4. Italy
      • 10.3.7.5. Spain
      • 10.3.7.6. Rest of Europe
  • 10.4. South America
    • 10.4.2. Introduction
    • 10.4.3. Key Region-Specific Dynamics Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
    • 10.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
    • 10.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
    • 10.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 10.4.6.1. Brazil
      • 10.4.6.2. Argentina
      • 10.4.6.3. Rest of South America
  • 10.5. Asia Pacific
    • 10.5.2. Introduction
    • 10.5.3. Key Region-Specific Dynamics Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
    • 10.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
    • 10.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
    • 10.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 10.5.6.1. China
      • 10.5.6.2. India
      • 10.5.6.3. Japan
      • 10.5.6.4. Australia
      • 10.5.6.5. Rest of Asia Pacific
  • 10.6. Middle East and Africa
    • 10.6.2. Introduction
    • 10.6.3. Key Region-Specific Dynamics Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
    • 10.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
    • 10.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application

11. Global Sterility Testing Market- Competitive Landscape

  • 11.1. Key Developments and Strategies
  • 11.2. Company Share Analysis
  • 11.3. Product Benchmarking

12. Global Sterility Testing Market- Company Profiles

  • 12.1. Redberry*
    • 12.1.2. Company Overview
    • 12.1.3. Product Portfolio and Description
    • 12.1.4. Key Highlights
    • 12.1.5. Financial Overview
  • 12.2. BioMerieux
  • 12.2. Charles River Laboratories, Inc.
  • 12.3. Merck KGaA
  • 12.4. Sartorius AG
  • 12.5. SGS S.A.
  • 12.6. Sotera Health LLC
  • 12.7. Thermo Fisher Scientific
  • 12.8. Alcami Corporation
  • 12.9. Lucideon

LIST NOT EXHAUSTIVE

13. Global Sterility Testing Market- DataM

    • 13.1.2. Appendix
    • 13.1.3. About Us and Services
    • 13.1.4. Contact Us