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市場調查報告書

生物學的安全性實驗的全球市場(2021年∼2028年)

Global Biological Safety Testing Market - 2021-2028

出版商 DataM Intelligence 商品編碼 1023097
出版日期 內容資訊 英文 180 Pages
商品交期: 約2個工作天內
價格
生物學的安全性實驗的全球市場(2021年∼2028年) Global Biological Safety Testing Market - 2021-2028
出版日期: 2021年08月12日內容資訊: 英文 180 Pages
簡介

生物安全檢測是指為確保生物藥物和疫苗不受污染並符合相關法規而進行的檢測程序。這包括無菌測試、細胞系鑑定和表徵測試、生物負載測試、內毒素測試、外來因子檢測測試和殘留宿主污染檢測測試。生物安全檢測市場的成長是由製藥和生物技術行業的快速成長以及投資增加以及高疾病負擔導致的新生物製劑產量增加所推動。由於藥物批准數量不斷增加,加上領先生物製藥公司在研的大量藥物,生物安全檢測市場將預見未來需求強勁。

本報告提供全球生物學的安全性測試市場的相關調查,市場概要,市場區隔、各地區的市場規模及成長率的變化與預測,新型冠狀病毒感染疾病(COVID-19)的影響分析,市場成長的推動要素及阻礙因素分析,市場機會,競爭情形,主要企業簡介等彙整資訊。

目錄

第1章 調查手法和範圍

  • 調查手法
  • 調查的目的和調查範圍

第2章 市場定義和概要

第3章 摘要整理

  • 市場明細:各產品
  • 市場明細:各用途
  • 市場明細:各實驗
  • 市場明細:各地區

第4章 市場動態

  • 市場影響要素
    • 促進因素
    • 阻礙因素
    • 市場機會
    • 影響分析

第5章 全球生物學的安全性測試市場:產業分析

  • 波特的五力分析
  • PEST分析
  • 流行病學
  • 供應鏈分析
  • 價格分析
  • 法規分析
  • 償付分析
  • 未滿足需求

第6章 新型冠狀病毒感染疾病(COVID-19)的影響分析

  • 新型冠狀病毒感染疾病(COVID-19)對市場的影響
    • COVID-19前方案
    • 目前方案
    • COVID-19後方案
  • COVID-19中的價格動態
  • 需求與供給的頻譜
  • 大流行期間與市場相關的政府舉措
  • 製造商策略性舉措
  • 結論

第7章 全球生物學的安全性測試市場:各產品

  • 簡介
    • 市場規模、與前一年同期比較成長率分析:各產品
    • 市場魅力指數:各產品
  • 試劑、套件
  • 設備
  • 其他

第8章 全球生物學的安全性測試市場:各用途

  • 簡介
    • 市場規模、與前一年同期比較成長率分析:各用途
    • 市場魅力指數:各用途
  • 疫苗、治療藥
  • 細胞療法、遺傳基因療法
  • 血液、血液為基礎的療法
  • 其他

第9章 全球生物學的安全性測試市場:各實驗

  • 簡介
    • 市場規模、與前一年同期比較成長率分析:各實驗
    • 市場魅力指數:各實驗
  • 微生物附著量實驗
  • 殺菌實驗
  • 終局毒素實驗
  • 其他

第10章 全球生物學的安全性測試市場:各地區

  • 簡介
    • 市場規模、與前一年同期比較成長率分析:各地區
    • 市場魅力指數:各地區
  • 北美
    • 簡介
    • 市場動態
    • 市場規模、與前一年同期比較成長率分析:各產品
    • 市場規模、與前一年同期比較成長率分析:各用途
    • 市場規模、與前一年同期比較成長率分析:各實驗
    • 市場規模、與前一年同期比較成長率分析:各國
  • 歐洲
  • 南美
  • 亞太地區
  • 中東、非洲

第11章 競爭情形

  • 主要的發展趨勢、策略
  • 企業佔有率分析
  • 產品基準
  • 關注企業
  • 有顛覆性技術的企業
  • Start-Ups企業

第12章 企業簡介

  • Lonza
    • 企業概要
    • 產品系列和詳細內容
    • 主要亮點
    • 財務形勢
  • Avance Biosciences
  • Cytovance Biologics
  • Eurofins Scientific
  • Merck KGaA
  • Promega Corporation
  • Thermo Fisher Scientific
  • Toxikon
  • WuXi AppTec
  • Charles River Laboratories

第13章 關於DataM Intelligence

  • 附錄
  • 關於本公司、服務
  • 諮詢方式

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

目錄
Product Code: DMHC3878

Biological Safety Testing Market Overview

The global biological safety testing market size was valued US$ XX billion in 2019 and is estimated to reach US$ XX billion by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).

Biological safety testing refers to the testing procedures that are carried out to ensure non-contamination of biopharmaceuticals and vaccines and to comply with regulations regarding the same. This includes sterility tests, cell line authentication and characterization tests, bioburden tests, endotoxin tests, adventitious agent detection tests, and residual host contamination detection tests.

Biological Safety Testing Market Dynamics

The biological safety testing market growth is driven by the rapidly increasing pharmaceutical and biotechnology industries, along with increasing investments, and rising production of new biologics due to the high disease burden.

Rising drug approvals by the U.S. FDA will create huge demand for biological safety testing

The biological safety testing market will foresee robust demand in the future owing to the rising number of drug approvals coupled with numerous drugs in the pipeline by leading biopharmaceutical companies. The Center for Drug Evaluation and Research (CDER) approved more than 50 novel drugs and biologics in 2018. In addition, the number of new products approved in 2018 increased by two-fold than the average number of annual drug approvals. For instance, in 2019, biologics accounted for six of the top-eight drugs in terms of revenue. Humira (adalimumab), which was developed by AbbVie for the treatment of rheumatoid arthritis, psoriasis, Crohn's, and other autoimmune diseases, led to USD 19 billion sales, as per the Top 15 Best-selling Drugs of 2019 report. Humira was also the fastest-growing biological drug. Thus, with the growing need for pharmaceutical manufacturing companies to avoid disease transmission and maximize drug safety, the adoption of biological safety testing instruments and services will escalate over the coming years.

With the increasing burden of biological hazards, the need for biological safety testing is estimated to boost in the upcoming period significantly. Governmental associations and regulatory bodies have set standards and guidelines for laboratories and manufacturing facilities to ensure minimal contamination. Similarly, biosafety levels have been established for laboratory practices, facilities and equipment, including biological safety cabinets, to limit contamination. The biosafety levels range from one to four, with an increasing degree of specific controls for microbe containment. Hence, with the rising need for biopharmaceutical firms to be cGMP-compliant, the demand for biologics safety testing will significantly expand.

Lack of skilled professional is likely to hinder the market growth

However, lack of skilled professional for conducting biological safety testing procedure and the biological safety process is quite time consuming and complex which is expected to hinder the market growth.

COVID-19 Impact Analysis

With the emergence of COVID-19, most of the pharmaceutical and biotechnology companies began developing new treatments and vaccines against COVID-19. These increasing R&D activities impacted positively on the biological safety testing market studied. For example, in March 2020, Regeneron and Sanofi started the development of their biologic Kevzara to treat patients with COVID-19. Kevzara (Sarilumab), jointly developed by Regeneron and Sanofi, also inhibits the IL-6 pathway. Biological safety testing plays an important role in ensuring the purity of vaccines and other biological products. Thus, with the development of novel treatment for COVID-19, the demand for biological safety testing has also increased.

Biological Safety Testing Market Segment Analysis

The reagents and kits segment are expected to hold largest share in this market segment

Reagents are a major component in biological safety testing and are extensively used in research and clinical laboratories. These reagents are antibiotics, attachments & matrix factors, biological buffers, freezing & dissociation reagents, and various reagents. Rapid advancements and modifications in the formulation of reagents and kits are expected to increase their adoption by laboratory technicians, especially in toxicology assessment.

The vaccine and therapeutics segment are expected to hold largest share in this market segment

Vaccine and therapeutics held the largest share. Clearly defined guidelines ensuring the safety of developed vaccines with unaltered therapeutic value and reduced toxicity are among the factors responsible for the largest share held by this segment. Several guidelines and recommendations issued by regulatory authorities, such as the U.S. FDA, about the characterization and qualification of materials used in the production of vaccines for infectious disease indications, are expected to fuel segment growth.

The bioburden testing segment are expected to hold largest share in this market segment

Bioburden Testing Segment is expected to hold the largest share in the test segment of the market over the forecast period. Organizations like the World Health Organization have also released instructions for health managers and health workers on required infrastructures and standard procedures for effective sterilization and decontamination of medical devices. These factors are expected to raise the demand for proper sterilization, which is expected to boost the demand for Bioburden testing as it acts as an efficient tool in the validation of validation and revalidation of sterilization processes, assessment of the efficiency of cleaning processes, routine monitoring of manufacturing processes to ensure safety.

Bioburden testing is an integral part of validation and revalidation of sterilization processes, assessment of the efficiency of cleaning processes, routine monitoring of manufacturing processes, monitoring of raw materials, components, or packaging, and overall environmental monitoring programs-the high adoption rate, to determine bioburden limits in wide-ranging biologics and medical devices. Moreover, the development of new products in the market is expected to accelerate the market studied. For example, in December 2019, the company has launched the BD Kiestra IdentifA system in Europe and Canada, which is used for microbial identification. It has incorporated automated sample processing steps that ensure accuracy and minimal error.

Moreover, there are high bioburden and microbial contamination rates during pharmaceutical and biologics manufacturing, which is expected to drive government and private organizations to improve underlying biological safety practices. Thus, all these practices performed might drive the overall market.

Biological Safety Testing Market Geographical Analysis

North America region holds the largest market share of global biological safety testing market

North America dominates the Market and is expected to do the same in the forecast period. The United States is expected to contribute majorly to the market growth of this region. Due to the outbreak of COVID-19, the rising R&D activities related to the COVID-19 have impacted positively on the market growth.

The growth of the biological safety testing market in this region can be directly attributed to the growing biotechnology and pharmaceutical industries in the region. The high growth of these industries is further attributable to factors, such as innovative technologies and the presence of favorable government initiatives. Also, the emerging need for validation of drugs and devices process of manufacturing is expected to boost the demand for the market studied. According to the United States Food & Drug Administration (FDA) report, in 2019, the United States had about 4,676 manufacturing sites for drugs.

Additionally, the advanced healthcare infrastructure and rising R&D spending are expected to increase the revenue size further. According to the data of Pharmaceutical Research and Manufacturers of America (PhRMA), in the United States, about USD 83 billion were spent by the pharmaceutical industry on the R&D. Thus, this is expected to boost the market growth over the forecast period.

Biological Safety Testing Market Competitive Landscape

The global biological safety testing market is highly competitive with presence of global companies. Some of the key players which are contributing to the growth of the market include Avance Biosciences, Cytovance Biologics, Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation, Thermo Fisher Scientific, Toxikon, and WuXi AppTec, Charles River Laboratories among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the market globally. For instance, In December 2020, Redberry introduced a new product ''Red One Automated Bioburden Detection'' that enables instantaneous bioburden detection of microorganisms and has been designed for water and pharmaceutical testing.

Biological Safety Testing Market Key Companies to Watch

Lonza

Overview: Lonza is a leading global provider of integrated healthcare solutions. Lonza Group comprises two segments: Pharma, Biotech & Nutrition segment provides a wide range of services and products from early phase discovery to custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms for the pharma and consumer health and nutrition industries. Specialty Ingredients segment offer custom development and manufacturing of specialty chemicals and composites to support the electronics, aerospace, food and agrochemical industries. Lonza has entered into a definitive agreement with Bain Capital and Cinven to acquire Lonza's Specialty Ingredients business and operations for an enterprise value of $ 4.57 billion.

Product Portfolio: The Company's portfolio comprised of include Primary & Stem Cells, CellBioServices, Culture Media & Reagents, 3D Culture Products, ADME & Toxicology, Transfection, Cell Analysis, Electrophoresis, Endotoxin Detection.

Key developments: In April 2021, Lonza expanded its product ''PyroTec PRO Automated Robotic Solution'' for endotoxin testing. It is compatible with the company's product PYROGENT-5000 Turbidimetric LAL (Limulus Amebocyte Lysate) Assay, Kinetic-QCL Chromogenic LAL Assay, and the PyroGene rFC Assay.

Why Purchase the Report?

  • Visualize the composition of the biological safety testing market segmentation by product, application, test and region highlighting the key commercial assets and players.
  • Identify commercial opportunities in biological safety testing market by analysing trends and co-development deals.
  • Excel data sheet with thousands of data points of biological safety 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 biological safety testing market report would provide an access to an approx. 61 market data table, 54 figures and 200 pages.

Target Audience

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

Market Segmentation

Global Biological Safety Testing Market - By Product

  • Reagents and Kits
  • Instruments
  • Other Products

Global Biological Safety Testing Market - By Application

  • Vaccines and Therapeutics
  • Cellular and Gene Therapy
  • Blood and Blood-based Therapy
  • Other Applications

Global Biological Safety Testing Market - By Test

  • Sterility Tests
  • Bioburden Tests
  • Endotoxin Tests
  • Other Tests

Global Biological Safety Testing Market - By Region

  • North America
  • Europe
  • Asia-Pacific
  • Middle East & Africa
  • South America

Table of Contents

1. Global Biological Safety Testing Market Methodology and Scope

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

2. Global Biological Safety Testing Market - Market Definition and Overview

3. Global Biological Safety Testing Market - Executive Summary

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

4. Global Biological Safety Testing Market - Market Dynamics

  • 4.1. Market Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Rising drug approvals by the U.S. FDA
    • 4.1.2. Restraints:
      • 4.1.2.1. Lack of skilled professional
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Global Biological Safety Testing Market - Industry Analysis

  • 5.1. Porter's Five Forces Analysis
  • 5.2. PEST Analysis
  • 5.3. Epidemiology
  • 5.4. Supply Chain Analysis
  • 5.5. Pricing Analysis
  • 5.6. Regulatory Analysis
  • 5.7. Reimbursement Analysis
  • 5.8. Unmet Needs

6. Global Biological Safety 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 Biological Safety Testing Market - By Product

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
    • 7.1.2. Market Attractiveness Index, By Product
  • 7.2. Reagents and Kits*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis, US$ Million, 2018-2028 and Y-o-Y Growth Analysis (%), 2020-2028
  • 7.3. Instruments
  • 7.4. Other Products

8. Global Biological Safety Testing Market - By Application

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
    • 8.1.2. Market Attractiveness Index, By Application
  • 8.2. Vaccines and Therapeutics*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis, US$ Million, 2018-2028 and Y-o-Y Growth Analysis (%), 2020-2028
  • 8.3. Cellular and Gene Therapy
  • 8.4. Blood and Blood-based Therapy
  • 8.5. Other Applications

9. Global Biological Safety Testing Market - By Test

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Segment
    • 9.1.2. Market Attractiveness Index, By Test Segment
  • 9.2. Bioburden Tests*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis, US$ Million, 2018-2028 and Y-o-Y Growth Analysis (%), 2020-2028
  • 9.3. Sterility Tests
  • 9.4. Endotoxin Tests
  • 9.5. Other Tests

10. Global Biological Safety Testing Market - By Region

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis, US$ Million, 2018-2028 and Y-o-Y Growth Analysis (%), 2020-2028, By Region
    • 10.1.2. Market Attractiveness Index, By Region
  • 10.2. North America
    • 10.2.1. Introduction
    • 10.2.2. Key Region-Specific Dynamics
    • 10.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
    • 10.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
    • 10.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test
    • 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
    • 10.3.1. Introduction
    • 10.3.2. Key Region-Specific Dynamics
    • 10.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
    • 10.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
    • 10.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test
    • 10.3.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 10.3.6.1. Germany
      • 10.3.6.2. U.K.
      • 10.3.6.3. France
      • 10.3.6.4. Italy
      • 10.3.6.5. Spain
      • 10.3.6.6. Rest of Europe
  • 10.4. South America
    • 10.4.1. Introduction
    • 10.4.2. Key Region-Specific Dynamics
    • 10.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
    • 10.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
    • 10.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test
    • 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
    • 10.5.1. Introduction
    • 10.5.2. Key Region-Specific Dynamics
    • 10.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
    • 10.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
    • 10.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test
    • 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
    • 10.6.1. Introduction
    • 10.6.2. Key Region-Specific Dynamics
    • 10.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
    • 10.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
    • 10.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test

11. Global Biological Safety Testing Market - Competitive Landscape

  • 11.1. Key Developments and Strategies
  • 11.2. Company Share Analysis
  • 11.3. Product Benchmarking
  • 11.4. Key Companies to Watch
  • 11.5. Company with disruptive technology
  • 11.6. Start Up Companies

12. Global Biological Safety Testing Market- Company Profiles

  • 12.1. Lonza*
    • 12.1.1. Company Overview
    • 12.1.2. Product Portfolio and Description
    • 12.1.3. Key Highlights
    • 12.1.4. Financial Overview
  • 12.2. Avance Biosciences
  • 12.3. Cytovance Biologics
  • 12.4. Eurofins Scientific
  • 12.5. Merck KGaA
  • 12.6. Promega Corporation
  • 12.7. Thermo Fisher Scientific
  • 12.8. Toxikon
  • 12.9. WuXi AppTec
  • 12.10. Charles River Laboratories

LIST NOT EXHAUSTIVE

13. Global Biological Safety Testing Market - DataM

  • 13.1. Appendix
  • 13.2. About Us and Services
  • 13.3. Contact Us