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市场调查报告书
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1189866

无菌取样市场 - 增长、趋势、COVID-19 影响和预测 (2023-2028)

Aseptic Sampling Market - Growth, Trends, and Forecasts (2023 - 2028)
出版日期: | 出版商: Mordor Intelligence | 英文 120 Pages | 商品交期: 2-3个工作天内

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简介目录

预计在预测期内（2022-2027 年），无菌取样市场的复合年增长率约为 10.24%。

COVID-19 形势迫使许多公司专注于开发有效的疫苗、生物製剂和药物以预防/治疗疾病。 因此，对无菌检测的需求越来越大。 然而，由于其他药品和生物製品的开发和製造放缓，加上供应链中断，市场在 2020 年面临挑战。 关于大流行对市场增长的影响的各种研究已经发表。 例如，2021 年 6 月，发表了一项名为“Sampling Methods and Assays Applied in SARS-CoV-2 Exposure Assessment”的研究报告，其中主动采样方法使用多种采样设备来评估病毒。 但是，可能需要更长的主动采样时间，以确保收集到足够的空气传播病毒以供分子技术检测。 因此，市场受到大流行的影响。 然而，市场预计将长期增长。

无菌取样市场的增长主要受生物製药需求增加的推动，从而导致越来越多地采用一次性无菌取样产品。 另一方面，由于世界各地的公司和政府在医疗保健和药物开发方面的支出不断增加，无菌取样预计在此期间将出现显着增长。 根据美国食品和药物管理局的数据，2021 年 1 月，2020 年大约有 53 种新药获得批准，高于 2019 年的 48 种。 此外，2021年3月，美国又有12款新药获批。 此外，由于医疗保健支出增加、确保药物安全的政府法规以及全球该领域研发活动的增加，预计无菌取样市场将在预测期内增长。

此外，增加对新药开发和药物滥用研究的投资预计会增加对无菌取样产品的需求，这被认为会推动市场增长。 例如，根据美国国立卫生研究院 (NIH) 2022 年 5 月的一份报告，药物滥用研发支出将从 2015 年的 10.16 亿美元增加到 2021 年的 14.76 亿美元。 同样，2022 年 6 月，SK Pharma 的子公司 SK Farmteco 将投资约 3500 万美元，包括一座新建筑，用于扩建 SK 在爱尔兰都柏林郊区 Swords 的製药厂。我来了。 因此，此类投资和扩张预计将对无菌取样市场的增长产生重大影响。 然而，由于采用高温，采样过程中可浸出和可提取塑料材料的问题以及生物製药过程中出现的未知杂质预计会阻碍市场增长。

无菌取样市场趋势

预计在预测期内，生物技术和製药製造商细分市场将占据重要份额

由于研发支出的增加和生物製药管道的增加，预计无菌取样市场将见证生物技术和製药製造商的显着增长。 例如，一家名为安进公司的生物製药公司的研发支出逐年增加，根据安进公司2021年年报，研发支出将在2020年达到42.07亿美元，到2021年达到48.19亿美元。 此外，产品技术的进步以及製药和生物技术公司的采用预计将推动该领域的增长。 例如，2020 年 5 月，Aventor Inc 推出了 OmniTop Sample Tubes 可调节采样系统，专门设计用于降低生物工艺操作中的污染风险和常规采样。

COVID-19 疫情还导致大多数欧洲和亚洲国家的基本药物生产量大幅增加。 收购是市场增长的主要驱动力之一。 例如，2020 年 12 月，Spartek 通过收购 Tufpak, Inc. 扩大了市场地位，Tufpak, Inc. 是一家医疗级工程薄膜和塑料製造商，包括生物製药无菌采样袋。 同样，扩张也是细分市场增长的一个因素。 例如，2020 年 6 月，生物製药行业采样安全快速传输系统 (RTS) 製造商 ABC Transfer 在 A 轮融资中筹集了 300 万欧元。 因此，上述因素有望在预测期内促进市场增长。

预计在预测期内北美将占据主要市场份额

北美预计将在无菌取样市场占有重要份额，并有望在预测期内这样做。 此外，主要市场参与者增加产品发布和扩展以及政府对各种药品安全和质量的严格规定预计将推动北美无菌取样市场。 由于主要市场参与者的存在以及政府对製药和生物技术产品的生产和质量的支持不断增加，预计美国将占据很大份额。 该地区的主要参与者已推出各种战略来保持其市场份额并扩展到更新的产品线。 2022 年 2 月，Labcorp 将在印第安纳州南本德开设一个新的诊断实验室，使其能够提高服务水平并向南本德和整个地区的患者和医生提供服务。

公司通过收购、合作和合併来增强其製造能力、产品组合併创造竞争优势。 例如，2021 年 11 月，Pace Analytical Services 收购了位于北加州的全方位环境分析测试公司 Basic Laboratory, Inc.。 同样，2020 年 8 月，总部位于多伦多的 BioPharma Services, Inc. 从生物分析实验室服务 (BLS) 获得了一份经过验证的检测清单。 BLS 的资产将与 BioPharma 现有的生物分析实验室整合，以进一步扩展和改进其分析产品，使其成为临床研究领域的世界领导者。 因此，上述因素可能会在预测期内促进该地区的市场增长。

其他好处

  • Excel 格式的市场预测 (ME) 表
  • 3 个月的分析师支持

内容

第一章介绍

  • 研究假设和市场定义
  • 调查范围

第二章研究方法论

第 3 章执行摘要

第四章市场动态

  • 市场概览
  • 市场驱动力
    • 严格的政府法规确保药物安全
    • 对生物製药的需求增加以消除污染风险
  • 市场製约因素
    • 采样过程中塑料材料的可浸出物和可提取物问题
    • 在生物製药过程中使用高温产生的未知杂质
  • 波特的五力分析
    • 新进入者的威胁
    • 买方/消费者议价能力
    • 供应商的议价能力
    • 替代品的威胁
    • 竞争公司之间的敌对关係

第 5 章市场细分（基于价值的市场规模：百万美元）

  • 按采样类型
    • 手动无菌取样
      • 包
      • 瓶子
      • 其他
    • 自动无菌取样
  • 通过申请
    • 上游过程
    • 下游过程
  • 最终用户
    • 生物技术和製药製造商
    • 合同研发/製造组织
    • 其他
  • 按地区
    • 北美
      • 美国
      • 加拿大
      • 墨西哥
    • 欧洲
      • 德国
      • 英国
      • 法国
      • 意大利
      • 西班牙
      • 其他欧洲地区
    • 亚太地区
      • 中国
      • 日本
      • 印度
      • 澳大利亚
      • 韩国
      • 其他亚太地区
    • 中东和非洲
      • 海湾合作委员会
      • 南非
      • 其他中东地区
    • 南美洲地区
      • 巴西
      • 阿根廷
      • 其他南美洲

第六章竞争格局

  • 公司简介
    • Merck KGaA
    • Sartorius Stedim Biotech
    • Keofitt A/S
    • Saint Gobain
    • GEA Group
    • Qualitru Sampling Systems
    • Thermo Fisher Scientific
    • Gemu Group
    • Gore & Associates
    • Lonza Group
    • Bbi-Biotech Gmbh
    • Advanced Microdevices Pvt. Ltd

第7章 市场机会今后动向

简介目录
Product Code: 67406

The aseptic sampling market registered a CAGR of nearly 10.24% during the forecast period (2022-2027).

Due to the COVID-19 situation, there were many companies focused on the development of effective vaccines, biologics, and drugs to prevent/cure the disease. This is increased demand for aseptic testing. However, due to the slowdown of development and manufacturing of other pharmaceuticals or biologics coupled with supply chain disruption, the market has witnessed difficulties in 2020. Various research studies have been published on the impact of the pandemic on market growth. For instance, in June 2021, a research study was published titled "Sampling methods and assays applied in SARS-CoV-2 exposure assessment" stated that among the active sampling methods, several sampling devices can be used to assess the airborne virus. However, longer active sampling times may be required to ensure the collection of sufficient airborne viruses for detection by molecular techniques. Hence, the market is adversely affected by the pandemic. However, the market will grow in the long term.

The major factors attributing to the growth of the aseptic sampling market are the rise in the demand for biopharmaceuticals which resulted in the increased adoption of single-use aseptic sampling products. On the other hand, with growing spending on healthcare and drug development by companies and governments all over the world, aseptic sampling is projected to grow notably over the period. In January 2021, according to United States Food and Drug Administration, there were about 53 novel drugs approved in 2020 compared to 48 in 2019. Moreover, in March 2021, there were additional 12 novel drugs approved in United States. In addition, as a result of the increase in expenditure on healthcare, government regulations to ensure drug safety, and R&D activities in the segment increase globally, the aseptic sampling market is expected to grow over the forecast period.

Further, with the growing investment in the development of new drugs and drug abuse research, the demand for aseptic sampling products is expected to increase which is expected to boost the market growth. For instance, as per the May 2022 report of the National Institute of Health (NIH) of United States, the research and development expenditure for drug abuse has increased over the years from USD 1,016 million in 2015 to USD 1,476 million in 2021. Similarly, in June 2022, SK Pharmteco, a subsidiary of SK Pharmaceuticals is investing about USD 35 million in the expansion of SK's pharmaceutical manufacturing plant in the Dublin suburb of Swords, Ireland, including a new building. Hence, such investments and expansions are expected to have a significant impact on the growth of the aseptic sampling market. However, issues related to leachable and extractable plastic materials in the sampling procedure coupled with the unknown impurities generated during the biopharmaceutical processes due to the employment of high temperatures are expected to hinder the market growth.

Aseptic Sampling Market Trends

Biotechnology and Pharmaceutical Manufacturers Segment is Expected to Have a Significant Share Over the Forecast Period

In the aseptic sampling market, biotechnology and pharmaceutical manufacturers are expected to have notable growth owing to the growing research and development spending and growing biological and pharmaceutical pipeline. For instance, the research and development expenditure of one of the biopharmaceutical companies known as Amgen Inc. is increasing over the years and as per the 2021 annual report of Amgen Inc., the research and development expenditure increased from USD 4,207 million in 2020 to USD 4,819 million in 2021. Also, advancements in product technologies and adoption by pharma and biotech companies are expected to fuel segment growth. For instance, in May 2020, Aventor Inc launched OmniTop Sample Tubes Adjustable sampling system explicitly designed for lower contamination risk and routine sampling in bioprocessing operations.

Also, with the COVID-19 situation, the manufacturing of essential drugs has increased tremendously in most of the countries in Europe and Asia. The acquisition is one of the key factors in market growth. For instance, in December 2020, Spartech acquired Tufpak, Inc., a manufacturer of medical-grade engineered films and plastics including biopharmaceutical aseptic sampling bags to expand its market position. Similarly, expansion is another factor in segmental growth. For instance, in June 2020, ABC Transfer, a manufacturer of secure Rapid Transfer Systems (RTS) for sampling in the biopharmaceutical industry, raised EUR 3 million in a Series A financing round. Hence, the above-mentioned factors are expected to increase market growth over the forecast period.

North America Region is Expected Occupy Major Share in the Market Over the Forecast Period

North America is projected to have a notable share of the aseptic sampling market and is expected to do the same in the forecast period. Also, the increase in product launches and expansions by key market players and stringent government regulations regarding the safety and quality of various drugs will drive the North American aseptic sampling market. United States is expected to have a significant share owing to the presence of key market players and the rising support of the government for the production and quality of pharma and biotech products. Key players in the region have been initiating various strategies to retain market share and expand into newer product lines. In February 2022, Labcorp opened a new diagnostics laboratory in South Bend, Indiana, allowing the company to enhance service levels and offerings to patients and physicians in South Bend and throughout the region.

Companies have been engaging in acquisitions, partnerships, and mergers, to strengthen their manufacturing capacities, and product portfolio, and to provide competitive differentiation. For instance, in November 2021, Pace Analytical Services acquired Basic Laboratory, Inc., a full-service environmental analytical testing company with locations in northern California. Similarly, in August 2020, Toronto-based BioPharma Services, Inc. acquired a list of validated assays from Bioanalytical Laboratory Services (BLS). BLS assets will be combined with BioPharma's existing Bioanalytical Lab to further expand and improve its analytical services and become a global leader in clinical research. Hence, the above-mentioned factors are likely to increase the market growth in the region over the forecast period

Aseptic Sampling Market Competitive Analysis

The aseptic sampling market is moderately competitive and consists of several major players. Some of the market players operating in the market include GEA Group, Gemu Group, Gore & Associates, Keofitt A/S, Lonza Group, Merck KGaA, Qualitru Sampling Systems, Saint Gobain, Sartorius Stedim Biotech and Thermo Fisher Scientific among others.

Additional Benefits:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Stringent Government Regulations for Ensuring Drug Safety
    • 4.2.2 Increasing Demand for Biopharmaceuticals to Eliminate the Risk of Contamination
  • 4.3 Market Restraints
    • 4.3.1 Issues Related to Leachable and Extractables With the Plastic Materials in Sampling Procedure
    • 4.3.2 Unknown Impurities Generated During the Biopharmaceutical Processes Due to Employment of High Temperatures
  • 4.4 Porter's Five Force Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Size by Value - USD million)

  • 5.1 By Type of Sampling
    • 5.1.1 Manual Aseptic Sampling
      • 5.1.1.1 Bags
      • 5.1.1.2 Bottles
      • 5.1.1.3 Others
    • 5.1.2 Automated Aseptic Sampling
  • 5.2 By Application
    • 5.2.1 Upstream Process
    • 5.2.2 Downstream Process
  • 5.3 By End-User
    • 5.3.1 Biotechnology and Pharmaceutical Manufacturers
    • 5.3.2 Contract Research and Manufacturing Organizations
    • 5.3.3 Others
  • 5.4 Geography
    • 5.4.1 North America
      • 5.4.1.1 United States
      • 5.4.1.2 Canada
      • 5.4.1.3 Mexico
    • 5.4.2 Europe
      • 5.4.2.1 Germany
      • 5.4.2.2 United Kingdom
      • 5.4.2.3 France
      • 5.4.2.4 Italy
      • 5.4.2.5 Spain
      • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
      • 5.4.3.1 China
      • 5.4.3.2 Japan
      • 5.4.3.3 India
      • 5.4.3.4 Australia
      • 5.4.3.5 South Korea
      • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East and Africa
      • 5.4.4.1 GCC
      • 5.4.4.2 South Africa
      • 5.4.4.3 Rest of Middle East and Africa
    • 5.4.5 South America
      • 5.4.5.1 Brazil
      • 5.4.5.2 Argentina
      • 5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Merck KGaA
    • 6.1.2 Sartorius Stedim Biotech
    • 6.1.3 Keofitt A/S
    • 6.1.4 Saint Gobain
    • 6.1.5 GEA Group
    • 6.1.6 Qualitru Sampling Systems
    • 6.1.7 Thermo Fisher Scientific
    • 6.1.8 Gemu Group
    • 6.1.9 Gore & Associates
    • 6.1.10 Lonza Group
    • 6.1.11 Bbi-Biotech Gmbh
    • 6.1.12 Advanced Microdevices Pvt. Ltd

7 MARKET OPPORTUNITIES AND FUTURE TRENDS