공지 : 도쿄증권거래소 JASDAQ 스탠다드 시장 신규 상장 관련 안내

Global Information
회사소개 | 문의 | 비교리스트

바이오버든 시험 시장 : 성장, 동향, COVID-19의 영향, 예측(2021-2026년)

Bioburden Testing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

리서치사 Mordor Intelligence Pvt Ltd
발행일 2021년 03월 상품 코드 871416
페이지 정보 영문
가격
US $ 4,250 ₩ 4,788,000 PDF (Single User License)
US $ 4,750 ₩ 5,352,000 PDF (Team License: Up to 7 Users)
US $ 6,000 ₩ 6,760,000 PDF (Site License)
US $ 7,500 ₩ 8,451,000 PDF (Corporate License)


바이오버든 시험 시장 : 성장, 동향, COVID-19의 영향, 예측(2021-2026년) Bioburden Testing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)
발행일 : 2021년 03월 페이지 정보 : 영문

본 상품은 영문 자료로 한글과 영문목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

세계의 바이오버든 시험(Bioburden Testing) 시장에 대해 조사했으며, 시장 개요와 성장 촉진요인·저해요인, 제품·열거법·용도·지역별 시장 분석, 경쟁 상황, 주요 기업 개요 등의 정보를 정리했습니다.

목차

제1장 서론

  • 연구 성과
  • 조사 가정
  • 조사 범위

제2장 조사 방법

제3장 주요 요약

제4장 시장 역학

  • 시장 개요
  • 시장 성장 촉진요인
    • 미생물 오염에 의한 고빈도 제품 회수
    • 생명과학에 대한 연구 개발 투자 증가
    • 의료기기 및 소모품에 대한 엄격한 공정내 시험 요구
  • 시장 성장 저해요인
    • 고비용의 미생물 계수 장비
    • 숙련된 인원의 부족
  • Porter’s Five Forces 분석
    • 신규 참여업체의 위협
    • 바이어/소비자의 협상력
    • 공급업체의 협상력
    • 대체 제품의 위협
    • 업계의 경쟁

제5장 시장 세분화

  • 제품별
    • 소모품
    • 장비
  • 열거법별
    • 막여과
    • 플레이트 카운트법
    • 최확수(MPN)
    • 기타 방법
  • 용도별
    • 원료 검사
    • 의료기기 검사
    • 공정내 검사
    • 기기 세정 검증
    • 기타 용도
  • 지역별
    • 북미
    • 유럽
    • 아시아태평양
    • 중동 및 아프리카
    • 남미

제6장 경쟁 상황

  • 기업 개요
    • Becton, Dickinson and Company
    • Charles River Laboratories Inc.
    • Merck KGaA
    • Nelson Laboratories Inc.
    • Pacific BioLabs Inc.
    • SGS SA
    • Thermo Fisher Scientific Inc.
    • WuXi AppTec Co. Ltd

제7장 시장 기회 및 향후 동향

KSM 19.07.02

The bioburden testing market is expected to register a CAGR of nearly 9.2% during the forecast period. The major factors that are found boosting the market growth are the high frequency of product recall due to microbial contamination and increasing R&D investments in life sciences.

With the rising of the COVID-19, there are many regulatory bodies like the United States Food and Drug Administration (FDA) that have deemed it necessary to maintain adequate sterilization that can facilitate the rapid turnaround of sterilized or disinfected medical devices, raw materials, and packaging and that help reduce the contamination, to ensure the safety of the novel diagnostic tests and drugs that are being developed for the treatment and management of COVID-19.

There are also increasing researches taking place for instance, in May 2020, The Department of Biotechnology (DBT) in India had undertaken a project to sequence 1,000 SARS-CoV-2 genomes from samples to understand the evolving behaviour of the virus that causes the coronavirus disease (COVID-19). The samples were being collected across India to study the emerging mutations in the virus and how they change the symptoms of the disease. Therefore all these increasing researches have helped in boosting the bioburden testing. Hence all these factors are expected to increase the demand for proper sterilization, which is expected to boost the market growth of bioburden testing.

Bioburden testing is a process that is used for the assessment of cleaning processes, and packaging of products to ensure safety. One of the major factors that have a direct impact on the market studied is the rising R&D investments by companies, institutes, and other academia in life sciences. There is an increasing demand for biopharmaceuticals that has also led to the significant need for ensuring validation of the process of manufacturing it. The biopharmaceuticals research for rare diseases, supported by R&D spending, offers a great opportunity.​

Also, as per Pharmaprojects 2019, the United States was the largest producer of pharma R&D, contributing 46%, followed by Europe. Therefore, the increased investments by the companies and other organizations in R&D activities is expected to fuel the market studied.​

Furthermore, the growth in the medical devices, pharmaceutical, and rising product recalls, due to microbial contamination are also the major factors that drive the growth of the bioburden testing market. In biotechnology and food and beverage industries, safety concerns supplement the overall growth. The increasing advancements are made in membrane filtration production and module designs, capital and operating costs that are likely to continuously increase that helps in boosting the overall market growth.

Key Market Trends

Polymerase Chain Reaction Systems is Expected to Hold the Large Share of the Market

The molecular methods of identifying pathogens are becoming progressively popular, as they offer precise detection at a fraction of the time and effort invested in traditional, culture-based methods. Both the real-time and end-point PCR delivers the rapid, sensitive, and highly specific detection of nucleic acids from bacteria, viruses, fungi, and other microbial organisms.

There is a positive impact on the segment due to the increasing demand for the COVID testing. The RT-PCR is found to be one of the most widely used laboratory methods for detecting the COVID-19 virus. While many countries have used real time RT-PCR for diagnosing other diseases therefore this has boosted the adoption of these PCR systems in the COVID-19 testing.

Polymerase chain reaction testing is therefore found to be one of the well-established method for the detection, quantification of different types of the microbial agents in the areas of clinical diagnostics and food safety. The PCR-based pathogen detection requires the use of appropriate controls, which aid in result interpretation by identifying adverse factors such as contamination, inhibition of the amplification reaction.

Moreover, the market players are also adopting various growth strategies, such as frequent product launches, partnerships, and merger and acquisition activities, to gain a competitive edge in the market. For instance in June 2018, QIAGEN (ThermoFisher) had launched the QIAseq 16S/ITS Panels and UCP Multiplex PCR Kit. The new QIAGEN kits avoid external bias in PCR and NGS library preparation with inhibitor-resistant PCR and low bioburden reagents tested for bacterial and fungal DNA contamination. Hence all these factors has majorly impacted the overall market growth.

North America Region Holds the Largest Market Share of Bioburden Testing Market

North America hold the largest regional market in terms of revenue due to the increasing R&D expenditures, increased number of product recalls, and the government initiatives related to the accuracy of the safety process of drugs and devices.

The recent outbreak of COVID -19 has also created a huge demand for drug discovery and medical devices that has raised the demand for bioburden testing. Many companies have launched new products​ to reduce the infection rate from the drugs and devices

According to the Pharmaceutical Research and Manufacturers Association (PhRMA), 2018, the United States firms conducted over half the world's R&D in pharmaceuticals. Approximately 79.6 billion had been invested in biopharmaceutical research and development in the United States in the year 2018. Due to the increasing number of drugs and devices recalled, there is an emerging need for validation of drugs and devices process of manufacturing that is expected to boost the demand in the market studied.

Increasing R&D investments by prominent companies and research costs are expected to encourage companies to adopt highly efficient biological testing tools to counter the possible losses caused by contamination. For example, Bristol-Myers Squibb had invested in the production of investigational medicine to support clinical trials. Furthermore, regulatory bodies, such as the U.S. FDA requires sterilization validation that helps in creating a need for bioburden testing for medical devices.

According to the United States Food & Drug Administration (FDA), the United States had approximately 4,676 manufacturing sites for drugs. The government has also taken various measures to ensure the safety of the products. For instance, the government of the United States has developed a code of federal regulation under Title 21. This regulation checks upon the microbial limit testing, which is used for medical devices.

Hence, the increasing investments in research and development activities in the United States are expected to fuel the growth of the market studied over the forecast period.

Competitive Landscape

The bioburden testing market consists of several major players. The companies are implementing certain strategic initiatives, such as a merger, new product launch, acquisition, and partnerships that help them in strengthening their market position. For instance, Charles River Laboratories is adopting an innovative technology platform for helping in streamline bioburden testing. Additionally, one of the players, Merck KGaA., developed the product for testing of bioburden and others, called EZ Fluo Rapid Detection, Ready-to-Use Culture Media.

Reasons to Purchase this report:

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

TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 Study Deliverables
  • 1.2 Study Assumptions
  • 1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 High Frequency of Product Recall Due to Microbial Contamination
    • 4.2.2 Increasing R&D Investments in Life Sciences
  • 4.3 Market Restraints
    • 4.3.1 High Costs of Microbial Enumeration Instruments
    • 4.3.2 Lack of Skilled Personnel
  • 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

  • 5.1 By Product
    • 5.1.1 Consumables
      • 5.1.1.1 Culture Media and Reagents
      • 5.1.1.2 Other Consumables
    • 5.1.2 Instruments
      • 5.1.2.1 Automated Microbial Identification Systems
      • 5.1.2.2 Polymerase Chain Reaction (PCR) Systems
      • 5.1.2.3 Microscopes
      • 5.1.2.4 Other Instruments
  • 5.2 By Enumeration Method
    • 5.2.1 Membrane Filtration
    • 5.2.2 Plate Count Method
    • 5.2.3 Most Probable Number (MPN)
    • 5.2.4 Other Enumeration Methods
  • 5.3 By Application
    • 5.3.1 Raw Material Testing
    • 5.3.2 Medical Devices Testing
    • 5.3.3 In-process Testing
    • 5.3.4 Equipment Cleaning Validation
    • 5.3.5 Other Applications
  • 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 Becton, Dickinson and Company
    • 6.1.2 Charles River Laboratories Inc.
    • 6.1.3 Merck KGaA
    • 6.1.4 Nelson Laboratories Inc.
    • 6.1.5 Pacific BioLabs Inc.
    • 6.1.6 SGS SA
    • 6.1.7 Thermo Fisher Scientific Inc.
    • 6.1.8 WuXi AppTec Co. Ltd
    • 6.1.9 North American Science Associates Inc.
    • 6.1.10 Biomerieux SA
    • 6.1.11 STERIS Laboratories
    • 6.1.12 Sartorius AG

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

Back to Top
전화 문의
F A Q