查看购物车
  • Traditional Chinese
  • English
  • Japanese
  • Korean
病毒清除市场：2023 年至 2028 年预测
市场调查报告书
商品编码
1410034

病毒清除市场：2023 年至 2028 年预测

Viral Clearance Market - Forecasts from 2023 to 2028
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 146 Pages | 商品交期: 最快1-2个工作天内

价格
简介目录

预计病毒清除市场在预测期内将以 6.75% 的复合年增长率成长。

病毒清除旨在透过有效去除样本中的病毒（完全去除或使其无传染性）来防止所需产品的污染。病毒清除应用涵盖多个领域，包括血液製品、重组蛋白、细胞和基因治疗产品、疫苗和其他相关领域。病毒清除产业的主要成长动力包括製药和生物技术产业以及学术研究机构的出现和成长。

製药业的崛起正在推动病毒清除市场的成长。

病毒清除用于製药行业，以确保生物製药的安全性和效率，并且随着生技药品需求的增加以及政府投资和积极倡议的增加，该行业显着增长，病毒清除的需求变得更加明显。例如，印度于2022年3月宣布了製药业集约化（SPI）计划，预计2021-22年至2025-26年财政支出为500亿卢比。这些措施预计将为病毒清除的市场需求带来积极的前景，并促进整体市场成长。

新的研究和开发正在推动病毒清除市场的扩大。

病毒清除用于研发 (R&D)，以确保生物製药的安全性和效率。对创新生技药品不断增长的需求和生物技术的进步正在推动製药业的研发活动。此外，研发投资的增加也增加了对病毒清除技术的需求，以满足监管要求并降低病毒污染的风险。作为医疗保健领域的领导者，罗氏将其研发 (R&D) 投资大幅增加至 2022 年的 147 亿美元，而前一年为 133 亿美元。

技术进步正在推动病毒清除市场的成长。

病毒清除技术的不断进步，如层析法、过滤和病毒灭活方法，显着提高了病毒清除过程的效率和效果。因此，这些进展将有助于生物製药公司透过更有效率、更可靠的病毒清除程序确保产品安全和纯度，满足严格的监管要求，并解决人们日益增长的病毒污染风险担忧，在推动市场成长方面发挥着至关重要的作用。例如，2022 年 6 月，Bio-Rad Laboratories, Inc. 推出了 EconoFit 低压预载色谱管柱包，以支援蛋白质精製工作流程开发和树脂筛检实验。

预计北美将成为市场领导。

北美地区预计将占据病毒清除市场的很大份额，因为以领先公司、广泛的研发活动和先进的基础设施为特征的强大的製药和生物技术行业将有助于全部区域。此外，由于对生技药品的需求不断增长、监管指南更加严格以及确保患者安全的需要，该地区正在对製药和生物技术行业进行大量投资。例如，2022 年 9 月，美国卫生与公众服务部宣布拨款 4000 万美元，以扩大生物製造在活性药物成分 (API)、抗生素和关键药物成分生产中的作用，并加强美国应对大流行病的能力国。我们宣布将以美元进行投资。

高成本限制了病毒清除市场的成长

由于专业设备的高成本、对熟练人员的需求以及广泛测试的需要，病毒清除行业面临障碍。这些成本对财力有限的中小型企业造成了障碍，限制了他们投资清除病毒的能力。因此，市场成长可能会受到阻碍，因为中小企业可能难以满足进行有效病毒清除的财务要求，从而限制市场进入。

企业产品

  • ClearancePlus： Charles River Laboratories 提供 ClearancePlus，这是一项综合性病毒清除研究，其中包含基于风险的评估。该服务包括对与产品相关的所有样品进行大容量电镀的标准做法，这强化了对数减少值 (LRV) 声明并有效确保病毒减少。这已经得到证实。这些技术彻底评估病毒清除的有效性，并为客户提供有关其病毒减少策略有效性的可靠资料。
  • USP 病毒清除和调查方法： Nelson Labs 提供 USP 病毒清除和调查方法，旨在对生物製药製造中使用的各种动物性材料和加工试剂进行品管测试。我是。这些调查方法评估病毒污染物污染的可能性，并确保最终产品的安全性和完整性。透过采用 USP 建议的病毒清除方法，Nelson Labs 帮助维持高品质标准并降低製造过程中与病毒污染相关的风险。
  • MockV RVLP套件(M230)： MockV RVLP套件由 Cygnus 开发，使用 BSL-1 相容储备液，其中含有源自 CHO 细胞培养物的非感染性类病毒颗粒(RVLP)。该解决方案可作为病毒清除测试的加标剂，确保测试过程的准确性和可靠性。套件包括 RVLP 库存溶液、用于样品分析的96孔盘孔板、RNA 萃取和 qPCR 试剂以及精心控制的 RNA 标准品等基本组件，以实现准确可靠的 RVLP 定量。

目录

第一章简介

  • 市场概况
  • 市场定义
  • 调查范围
  • 市场区隔
  • 货币
  • 先决条件
  • 基准年和预测年时间表

第二章调查方法

  • 调查资料
  • 先决条件

第三章执行摘要

  • 研究亮点

第四章市场动态

  • 市场驱动因素
  • 市场抑制因素
  • 波特五力分析
  • 产业价值链分析

第五章病毒清除市场：依方法

  • 介绍
  • 病毒清除方法
  • 病毒灭活方法
  • 如何检测病毒

第六章病毒清除市场：依应用分类

  • 介绍
  • 血液和血液製品
  • 重组蛋白
  • 细胞和基因疗法产品
  • 疫苗
  • 其他的

第七章病毒清除市场：依最终用户划分

  • 介绍
  • 製药和生物技术产业
  • 学术研究所
  • CRO
  • 其他的

第八章病毒清除市场：按地区

  • 介绍
  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他的
  • 欧洲
    • 英国
    • 德国
    • 法国
    • 西班牙
    • 其他的
  • 中东/非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 以色列
    • 其他的
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 韩国
    • 印尼
    • 泰国
    • 其他的

第九章竞争环境及分析

  • 主要企业及策略分析
  • 市场占有率分析
  • 合併、收购、协议和合作

第十章 公司简介

  • Charles River Laboratories, Inc.
  • Merck KGaA
  • Texcell SA
  • WuXi AppTec
  • Sartorius AG
  • Nelson Labs
  • Vironova
  • Sigma-Aldrich
  • Eurofins
  • Cynus Technologies
简介目录
Product Code: KSI061615693

The viral clearance market is estimated to grow at a CAGR of 6.75% during the forecast period.

Viral clearance aims to prevent the contamination of the desired product by effectively eliminating viruses from the sample, either through complete removal or by rendering them non-infectious. The applications of viral clearance encompass various areas including blood products, recombinant proteins, cellular and gene therapy products, vaccines, as well as other relevant fields. The significant growth drivers for the viral clearance industry include the emergence and growth of the pharmaceutical and biotech industry, as well as academic research institutes.

Rising pharmaceuticals sector bolsters the viral clearance market growth.

Viral clearance is used in the pharmaceuticals industry to ensure the safety and efficiency of biopharmaceutical products and as the industry experiences significant growth due to the increasing demand for biologics coupled with the increased government investments and proactive initiatives the need for viral clearance becomes more prominent. For instance, in March 2022, in India, the Strengthening of Pharmaceutical Industry (SPI) Scheme unveiled a financial outlay of Rs. 500 crores for the duration of FY 2021-22 to FY 2025-26. Such initiatives are expected to provide a positive outlook to the market demand for viral clearance thereby augmenting the overall market growth.

Emerging research and development drive the viral clearance market expansion.

Viral clearance is used in research and development (R&D) to ensure the safety and efficiency of biopharmaceutical products. The growing demand for innovative biologics and advancements in biotechnology is promoting R&D activities in the pharmaceutical industry. Moreover, due to an increase in R&D investments, the need for viral clearance techniques to address regulatory requirements and mitigate viral contamination risks rises. Roche, a renowned healthcare leader, significantly increased its investment in research and development (R&D) to $14.7 billion in 2022, marking a notable rise from $13.3 billion in the previous year.

Technological advancements are driving viral clearance market growth.

The continuous progress in technological advancements of viral clearance techniques, including chromatography, filtration, and viral inactivation methods, has led to notable enhancements in the efficiency and effectiveness of viral clearance processes. As a result, these advancements play a pivotal role in driving the growth of the market, as they enable biopharmaceutical companies to ensure the safety and purity of their products through more efficient and reliable viral clearance procedures, meeting stringent regulatory requirements, and addressing growing concerns regarding viral contamination risks. For instance, in June 2022, Bio-Rad Laboratories, Inc., introduced EconoFit Low-Pressure Prepacked Chromatography Column Packs to aid protein purification workflow development and resin screening experiments.

North America is anticipated to be the market leader.

The North-American region will hold a significant share of the viral clearance market due to the region's robust pharmaceutical and biotech industry, characterized by major players, extensive research and development activities, and advanced infrastructure, which has contributed to the overall regional market growth. Furthermore, the region has witnessed substantial investments in the pharmaceutical and biotech industry propelled by the increasing demand for biologics, stringent regulatory guidelines, and the need for ensuring patient safety. For instance, in September 2022, the Department of Health and Human Services announced a $40 million investment to expand biomanufacturing's role in producing active pharmaceutical ingredients (APIs), antibiotics, and critical medication components, enhancing pandemic response capabilities in the United States.

High cost restrains the viral clearance market growth.

The viral clearance industry faces hindrances due to the high costs associated with specialized equipment, the need for skilled personnel, and the requirement for extensive testing. These expenses can create barriers for smaller companies with limited financial resources, impeding their ability to invest in viral clearance procedures. Consequently, market growth may be hindered as smaller companies struggle to meet the financial requirements for implementing effective viral clearance practices, limiting their participation in the market.

Key Developments

  • November 2022: Cygnus Technologies introduced the MockV RVLP Kit which empowers bioprocess scientists to accurately measure the elimination of Retrovirus-Like Particles (RVLPs) that are naturally generated by Chinese Hamster Ovary (CHO) cell lines throughout the biopharmaceutical manufacturing process.
  • March 2022: Thermo Fisher Scientific introduced the InhibiSURE Viral Inactivation Medium, a groundbreaking formulation that prioritizes safety by being non-hazardous, setting it apart from other inactivation media which often pose potential risks. Unlike traditional inactivation media, which often contain guanidine-based chemicals that can release toxic cyanide gas if mixed with bleach or strong acids, the InhibiSURE Viral Inactivation Medium ensures safety without compromising efficiency. Furthermore, the use of this medium eliminates the requirement for additional inactivation steps, streamlining laboratory workflows and enhancing overall throughput.

Company Products

  • ClearancePlus: Charles River Laboratories offers ClearancePlus, a comprehensive viral clearance study that incorporates risk-based assessments. This service includes a standard practice of utilizing large-volume plating for all product-relevant samples, thereby enhancing claims of log reduction value (LRV) and effectively demonstrating robust virus reduction. The inclusion of these practices ensures a thorough evaluation of viral clearance efficacy, providing clients with reliable data on the effectiveness of their viral reduction strategies.
  • USP Viral Clearance and Test Methodologies: Nelson Labs offers USP Viral Clearance and Test Methodologies, which are designed for conducting quality control testing on a range of animal-derived raw materials and processing reagents used in the manufacturing of biological products. These test methodologies serve to evaluate the potential for introducing viral contaminants, ensuring the safety and integrity of the final products. By employing USP-recommended viral clearance methods, Nelson Labs assists in maintaining high-quality standards and mitigating the risks associated with viral contamination during the production process.
  • MockV RVLP Kit (M230): The MockV RVLP Kit, developed by Cygnus, utilizes a BSL-1 compatible stock solution containing non-infectious Retrovirus-like Particles (RVLP) derived from CHO cell culture. This solution serves as a spiking agent for viral clearance testing, ensuring the accuracy and reliability of the testing process. The kit includes essential components such as RVLP stock solution, a 96-well plate for sample analysis, RNA extraction and qPCR reagents, and a meticulously controlled RNA standard, enabling precise and dependable quantification of RVLP.

Segmentation

By Method

  • Viral Removal Method
  • Viral Inactivation Method
  • Viral Detection Method

By Application

  • Blood and Blood Products
  • Recombinant Proteins
  • Cellular & Gene Therapy Products
  • Vaccines
  • Others

By End-Users

  • Pharmaceuticals and Biotech Industry
  • Academic Research Institutes
  • CROs
  • Others

By Geography

  • North America
  • United States
  • Canada
  • Mexico
  • South America
  • Brazil
  • Argentina
  • Others
  • Europe
  • United Kingdom
  • Germany
  • France
  • Spain
  • Others
  • Middle East and Africa
  • Saudi Arabia
  • UAE
  • Israel
  • Others
  • Asia Pacific
  • Japan
  • China
  • India
  • South Korea
  • Indonesia
  • Thailand
  • Others

TABLE OF CONTENTS

1. INTRODUCTION

  • 1.1. Market Overview
  • 1.2. Market Definition
  • 1.3. Scope of the Study
  • 1.4. Market Segmentation
  • 1.5. Currency
  • 1.6. Assumptions
  • 1.7. Base, and Forecast Years Timeline

2. RESEARCH METHODOLOGY

  • 2.1. Research Data
  • 2.2. Assumptions

3. EXECUTIVE SUMMARY

  • 3.1. Research Highlights

4. MARKET DYNAMICS

  • 4.1. Market Drivers
  • 4.2. Market Restraints
  • 4.3. Porter's Five Force Analysis
    • 4.3.1. Bargaining Power of Suppliers
    • 4.3.2. Bargaining Power of Buyers
    • 4.3.3. Threat of New Entrants
    • 4.3.4. Threat of Substitutes
    • 4.3.5. Competitive Rivalry in the Industry
  • 4.4. Industry Value Chain Analysis

5. VIRAL CLEARANCE MARKET, BY METHOD

  • 5.1. Introduction
  • 5.2. Viral Removal Method
  • 5.3. Viral Inactivation Method
  • 5.4. Viral Detection Method

6. VIRAL CLEARANCE MARKET, BY APPLICATION

  • 6.1. Introduction
  • 6.2. Blood and Blood Products
  • 6.3. Recombinant Proteins
  • 6.4. Cellular & Gene Therapy Products
  • 6.5. Vaccines
  • 6.6. Others

7. VIRAL CLEARANCE MARKET, BY END-USERS

  • 7.1. Introduction
  • 7.2. Pharmaceutical and Biotech Industry
  • 7.3. Academic Research Institutes
  • 7.4. CROs
  • 7.5. Others

8. VIRAL CLEARANCE MARKET, BY GEOGRAPHY

  • 8.1. Introduction
  • 8.2. North America
    • 8.2.1. United States
    • 8.2.2. Canada
    • 8.2.3. Mexico
  • 8.3. South America
    • 8.3.1. Brazil
    • 8.3.2. Argentina
    • 8.3.3. Others
  • 8.4. Europe
    • 8.4.1. United Kingdom
    • 8.4.2. Germany
    • 8.4.3. France
    • 8.4.4. Spain
    • 8.4.5. Others
  • 8.5. The Middle East and Africa
    • 8.5.1. Saudi Arabia
    • 8.5.2. UAE
    • 8.5.3. Israel
    • 8.5.4. Others
  • 8.6. Asia Pacific
    • 8.6.1. Japan
    • 8.6.2. China
    • 8.6.3. India
    • 8.6.4. South Korea
    • 8.6.5. Indonesia
    • 8.6.6. Thailand
    • 8.6.7. Others

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

  • 9.1. Major Players and Strategy Analysis
  • 9.2. Market Share Analysis
  • 9.3. Mergers, Acquisitions, Agreements, and Collaborations

10. COMPANY PROFILES

  • 10.1. Charles River Laboratories, Inc.
  • 10.2. Merck KGaA
  • 10.3. Texcell SA
  • 10.4. WuXi AppTec
  • 10.5. Sartorius AG
  • 10.6. Nelson Labs
  • 10.7. Vironova
  • 10.8. Sigma-Aldrich
  • 10.9. Eurofins
  • 10.10. Cynus Technologies