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市場調查報告書
商品編碼
1189866

無菌取樣市場 - 增長、趨勢、COVID-19 影響和預測 (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個工作天內

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簡介目錄

預計在預測期內（2022-2027 年），無菌取樣市場的複合年增長率約為 10.24%。

COVID-19 形勢迫使許多公司專注於開發有效的疫苗、生物製劑和藥物以預防/治療疾病。 因此，對無菌檢測的需求越來越大。 然而，由於其他藥品和生物製品的開發和製造放緩，加上供應鏈中斷，市場在 2020 年面臨挑戰。 關於大流行對市場增長的影響的各種研究已經發表。 例如，2021 年 6 月，發表了一項名為“Sampling Methods and Assays Applied in SARS-CoV-2 Exposure Assessment”的研究報告，其中主動採樣方法使用多種採樣設備來評估病毒。 但是，可能需要更長的主動採樣時間，以確保收集到足夠的空氣傳播病毒以供分子技術檢測。 因此，市場受到大流行的影響。 然而，市場預計將長期增長。

無菌取樣市場的增長主要受生物製藥需求增加的推動，從而導致越來越多地採用一次性無菌取樣產品。 另一方面，由於世界各地的公司和政府在醫療保健和藥物開發方面的支出不斷增加，無菌取樣預計在此期間將出現顯著增長。 根據美國食品和藥物管理局的數據，2021 年 1 月，2020 年大約有 53 種新藥獲得批准，高於 2019 年的 48 種。 此外，2021年3月，美國又有12款新藥獲批。 此外，由於醫療保健支出增加、確保藥物安全的政府法規以及全球該領域研發活動的增加，預計無菌取樣市場將在預測期內增長。

此外，增加對新藥開發和藥物濫用研究的投資預計會增加對無菌取樣產品的需求，這被認為會推動市場增長。 例如，根據美國國立衛生研究院 (NIH) 2022 年 5 月的一份報告，藥物濫用研發支出將從 2015 年的 10.16 億美元增加到 2021 年的 14.76 億美元。 同樣，2022 年 6 月，SK Pharma 的子公司 SK Farmteco 將投資約 3500 萬美元，包括一座新建築，用於擴建 SK 在愛爾蘭都柏林郊區 Swords 的製藥廠。我來了。 因此，此類投資和擴張預計將對無菌取樣市場的增長產生重大影響。 然而，由於採用高溫，採樣過程中可浸出和可提取塑料材料的問題以及生物製藥過程中出現的未知雜質預計會阻礙市場增長。

無菌取樣市場趨勢

預計在預測期內，生物技術和製藥製造商細分市場將佔據重要份額

由於研發支出的增加和生物製藥管道的增加，預計無菌取樣市場將見證生物技術和製藥製造商的顯著增長。 例如，一家名為安進公司的生物製藥公司的研發支出逐年增加，根據安進公司2021年年報，研發支出將在2020年達到42.07億美元，到2021年達到48.19億美元。 此外，產品技術的進步以及製藥和生物技術公司的採用預計將推動該領域的增長。 例如，2020 年 5 月，Aventor Inc 推出了 OmniTop Sample Tubes 可調節採樣系統，專門設計用於降低生物工藝操作中的污染風險和常規採樣。

COVID-19 疫情還導致大多數歐洲和亞洲國家的基本藥物生產量大幅增加。 收購是市場增長的主要驅動力之一。 例如，2020 年 12 月，Spartek 通過收購 Tufpak, Inc. 擴大了市場地位，Tufpak, Inc. 是一家醫療級工程薄膜和塑料製造商，包括生物製藥無菌採樣袋。 同樣，擴張也是細分市場增長的一個因素。 例如，2020 年 6 月，生物製藥行業採樣安全快速傳輸系統 (RTS) 製造商 ABC Transfer 在 A 輪融資中籌集了 300 萬歐元。 因此，上述因素有望在預測期內促進市場增長。

預計在預測期內北美將佔據主要市場份額

北美預計將在無菌取樣市場佔有重要份額，並有望在預測期內這樣做。 此外，主要市場參與者增加產品發布和擴展以及政府對各種藥品安全和質量的嚴格規定預計將推動北美無菌取樣市場。 由於主要市場參與者的存在以及政府對製藥和生物技術產品的生產和質量的支持不斷增加，預計美國將佔據很大份額。 該地區的主要參與者已推出各種戰略來保持其市場份額並擴展到更新的產品線。 2022 年 2 月，Labcorp 將在印第安納州南本德開設一個新的診斷實驗室，使其能夠提高服務水平並向南本德和整個地區的患者和醫生提供服務。

公司通過收購、合作和合併來增強其製造能力、產品組合併創造競爭優勢。 例如，2021 年 11 月，Pace Analytical Services 收購了位於北加州的全方位環境分析測試公司 Basic Laboratory, Inc.。 同樣，2020 年 8 月，總部位於多倫多的 BioPharma Services, Inc. 從生物分析實驗室服務 (BLS) 獲得了一份經過驗證的檢測清單。 BLS 的資產將與 BioPharma 現有的生物分析實驗室整合，以進一步擴展和改進其分析產品，使其成為臨床研究領域的世界領導者。 因此，上述因素可能會在預測期內促進該地區的市場增長。

其他好處

  • Excel 格式的市場預測 (ME) 表
  • 3 個月的分析師支持

內容

第一章介紹

  • 研究假設和市場定義
  • 調查範圍

第二章研究方法論

第 3 章執行摘要

第四章市場動態

  • 市場概覽
  • 市場驅動力
    • 嚴格的政府法規確保藥物安全
    • 對生物製藥的需求增加以消除污染風險
  • 市場製約因素
    • 採樣過程中塑料材料的可浸出物和可提取物問題
    • 在生物製藥過程中使用高溫產生的未知雜質
  • 波特的五力分析
    • 新進入者的威脅
    • 買方/消費者議價能力
    • 供應商的議價能力
    • 替代品的威脅
    • 競爭公司之間的敵對關係

第 5 章市場細分（基於價值的市場規模：百萬美元）

  • 按採樣類型
    • 手動無菌取樣
      • 包
      • 瓶子
      • 其他
    • 自動無菌取樣
  • 通過申請
    • 上游過程
    • 下游過程
  • 最終用戶
    • 生物技術和製藥製造商
    • 合同研發/製造組織
    • 其他
  • 按地區
    • 北美
      • 美國
      • 加拿大
      • 墨西哥
    • 歐洲
      • 德國
      • 英國
      • 法國
      • 意大利
      • 西班牙
      • 其他歐洲地區
    • 亞太地區
      • 中國
      • 日本
      • 印度
      • 澳大利亞
      • 韓國
      • 其他亞太地區
    • 中東和非洲
      • 海灣合作委員會
      • 南非
      • 其他中東地區
    • 南美洲地區
      • 巴西
      • 阿根廷
      • 其他南美洲

第六章競爭格局

  • 公司簡介
    • 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 市場機會今後動向

簡介目錄
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