市场调查报告书
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1308641
2030 年病毒清除市场预测 - 按方法、应用、最终用户和地区进行的全球分析Viral Clearance Market Forecasts to 2030 - Global Analysis By Method, Application, End User and By Geography |
根据 Stratistics MRC 的数据,2023 年全球病毒清除市场规模将达到 7.6464 亿美元,预计到 2030 年将达到 19.3815 亿美元,预测期内復合年增长率为 14.21%。
重组蛋白、糖蛋白、组织和血液衍生产品、医疗器械和单克隆抗体的开发都依赖于病毒清除过程。动物和人类细胞都可以被病毒感染,但病毒具有自我复制的能力。它还具有在细菌宿主细胞内繁殖和传播的能力,造成损害和感染。病毒清除方法的一个关键组成部分是评估无风险生产产品并确保其人类使用安全的能力。原材料、下游工艺、细胞培养过程都会受到病毒感染的影响。这将有助于病毒安全实践的发展和病毒清除流程的实施。
据 BioSpace 称,2018 年有 386 种药物註册用于临床开发,而 2008 年仅为 178 种。开发过程中的药物数量不断增加,对病毒清除服务的需求也随之增加。
推动病毒灭活市场增长的因素包括慢性病毒感染和疾病患病率的上升以及对有效治疗的需求增加。由于生命科学行业投资的增加、新药引进的增加以及研发创新的增加,预计该市场还将增长。
阻碍市场发展的是产品和技术开发成本过高。此外,缓慢的药物开发过程以及与病毒清除相关的几个问题(例如蛋白质交联、蛋白质变性和蛋白质降解)限制了市场的扩张。
病毒安全评估是确保产品安全的重要一步。监管机构认真对待病毒安全性,并需要復杂的数据来支持它,特别是 IND 和 BLA 批准。了解监管要求、流程和流程关键领域对于有效的战略规划至关重要。药物开发中的此类病毒安全法规正在增加对使试验更加成功的服务的需求。
作为病毒清除服务提供商,与製药公司、生物技术公司、医疗器械公司以及研究和学术机构竞争有才华和经验丰富的科学家,招聘和留住高技能专业人员是我面临的挑战。为了在竞争中保持领先地位,公司必须提供更高的薪酬和其他激励措施,这反过来又会影响尤其是规模较小的分析测试提供商的财务和财务绩效。熟练专业人员的短缺阻碍了新技术和工艺的采用,并可能限制未来几年的市场增长。
市场受到 COVID-19 大流行的负面影响。劳动力和人员短缺、感染传播的风险以及生物製药和生物技术领域的生产停滞是市场面临的挑战。然而,2021年,市场增长急剧加速。这种增长归因于临床试验的增加。为了开发针对SARS-CoV-2病毒的疫苗和药物,许多製药和生物製药公司增加了研发和製造流程。此外,自 COVID-19 爆发以来,与製药公司和学术机构就 COVID-19 疫苗开发建立了许多新的全球伙伴关係和合作。
预计重组蛋白领域将在预测期内占据最大的市场份额。影响该领域增长的主要因素之一是对治疗牛皮癣、多发性硬化症、风湿病和炎症性肠病等炎症性疾病的生物製药的需求不断增长。随着重组蛋白的引入,生物製药的生产和开发已经彻底改变。随着许多由重组蛋白製成的生物製剂和疫苗正在研发中并预计将获得 FDA 的批准,重组药物的数量预计将增长。因此,考虑到上述所有因素,预计市场将会增长。
随着主要市场进入者增加对各种研究机构的投资以改进产品,预计未来几年合同研究机构市场将出现强劲增长。合同研究机构大力投资药物发现基础设施的能力以及初创企业、学术机构、製药公司和小型生物技术公司等组织越来越多地将药物发现服务外包给 CRO 是推动全球需求的一个关键因素。美国病毒清除市场的非凡增长。
预计北美将在整个预测期内主导病毒清除市场。重要参与者的存在及其对尖端医疗技术的进步是获得最大份额的主要因素。市场扩张的主要驱动力是重组蛋白和疫苗产量的增加以及保护它们免受病毒和风险影响的需要。此外,人们对使用生物製药的好处的认识不断增强,增加了对病毒清除相关服务的需求。此外,由于美国各地药品资金的增加,市场正在扩大。
由于政府对医学研究的投资增加和医疗保健成本飙升,以及中国、日本和印度等国家细胞培养物污染和 CRO 存在的风险增加,预计亚太地区在预测期内将出现显着增长. 增加。据世界卫生组织统计,超过1500万年龄在35岁至69岁之间的人死于慢性病,其中发达国家和发展中国家均占过早死亡的85%。此外,还有许多临床研究服务,尤其是在中国,预计将刺激未来市场的扩张。
2022 年 9 月,Merck将开设病毒清除 (VC) 实验室,作为其耗资 2,900 万欧元新建的中国生物製品检测中心 1 号楼的一部分。
2022 年 4 月,研究员 (PRO) Abzena 宣布在其位于加利福尼亚州圣地亚哥的生物製剂工艺开发和製造中心附近开设一个生物製剂测试实验室。该设施将为合作伙伴提供基于细胞和 PCR 安全检测、病毒清除研究的机会,以支持 IND、IMPD、BLA 和 MAA 提交。
2022年4月,WuXi Biologics荣获亚太生物工艺卓越奖(ABEA)第二届病毒清除和安全性生物工艺卓越奖。
According to Stratistics MRC, the Global Viral Clearance Market is accounted for $764.64 million in 2023 and is expected to reach $1938.15 million by 2030 growing at a CAGR of 14.21% during the forecast period. The development of recombinant proteins, glycoproteins, tissue- and blood-derived products, medical devices, and monoclonal antibodies all depend on the viral clearance process. Animal or human cells can become infected by viruses, which have the capacity to multiply on their own. Additionally, they have the power to multiply and spread within the host cell of bacteria, causing damage and infection. An important component of the viral clearance method is the evaluation of the capacity to produce a product without risk and guarantee the product's safety for human use. Raw materials, downstream processing, and cell culture processes are all impacted by viral infections. This would contribute to the development of viral safety practices and the implementation of the virus clearance process.
According to BioSpace, in 2018, 386 drugs were registered for clinical development, observing a significant growth from 2008, when the number of drugs was only 178. The increase in the number of drugs in the development process has increased viral clearing services' demand.
Some of the factors propelling the growth of the viral inactivation market include the rising prevalence of chronic viral infections and diseases and the rising demand for effective treatment methods. Additionally, the market is expected to grow as a result of rising investment in the life sciences industry, the introduction of more new drugs, and increased R&D innovation.
The market expansion is being hampered by high development costs for goods and technology. Additionally, the lengthy drug development process and some issues related to virus clearance, such as protein crosslinking, protein denaturation, and protein degradation, are restricting the market's expansion.
The evaluation of viral safety is an important step in ensuring the safety of products. Regulatory agencies place a lot of emphasis on viral safety and demand high-caliber data to support it, particularly for IND and BLA approvals. For effective strategic planning, it is crucial to be knowledgeable about the regulatory requirements, the process, and the key areas of the process. These viral safety regulations during the development of pharmaceutical products have increased the demand for services to conduct studies more successfully.
Virus removal service providers face challenges in attracting and retaining highly skilled professionals as they compete for qualified and experienced scientists with pharmaceutical companies, biotechnology companies, medical device companies, and research and academic institutions. Companies have to offer higher compensation and other incentives to compete, which affects the finances and performance of players, especially smaller analytics test providers. This scarcity of skilled professionals may hinder the adoption of new technologies and processes, limiting the growth of the market in the coming years.
The market was negatively impacted by the COVID-19 pandemic. The market was challenged by a lack of workers and staff, a risk of infection spread, and a slowdown in manufacturing in the biopharmaceutical and biotech sectors. However, the market witnessed a sharp acceleration in growth in 2021. This growth was attributed to an increase in clinical trials. To develop vaccines and medications against the SARS-CoV-2 virus, many pharmaceutical and biopharmaceutical companies increased their R&D and manufacturing processes. Additionally, following the COVID-19 outbreak, there have been numerous new global partnerships and collaborations with pharmaceutical companies and academic institutions for the development of COVID-19 vaccines.
During the forecast period, the recombinant proteins segment is anticipated to hold the largest market share. One of the main factors influencing the segment's growth is the rising demand for biopharmaceuticals for managing inflammatory diseases like psoriasis, multiple sclerosis, rheumatic diseases, and inflammatory bowel diseases. The production and development of biotherapeutics have been completely transformed by the introduction of recombinant proteins. As numerous biologics and vaccines made of recombinant proteins are currently in the pipeline and are anticipated to receive FDA approval, it is anticipated that the number of recombinant drugs will increase. The market is therefore anticipated to grow in light of all the aforementioned factors.
Due to growing investments by major market players in various research organizations to improve their products, the contract research organizations segment is anticipated to experience strong market growth in the upcoming years. The ability of contract research organizations to make significant investments in drug discovery infrastructure and an increase in the outsourcing of drug discovery services to CROs by organizations like start-ups, academic institutions, pharmaceutical companies, and small biotechnology companies are the main factors behind their extraordinary growth in the global viral clearance market.
Throughout the forecast period, North America is anticipated to dominate the viral clearance market. The presence of important players and their use of cutting-edge medical technologies to advance are primarily responsible for the largest share. The primary driver of market expansion is the rise in the production of recombinant proteins and vaccines, as well as the requirement to keep them virus- and risk-free. Additionally, the population is becoming more aware of the benefits of using biopharmaceuticals, which is driving up demand for services related to viral clearance. Furthermore, the market is expanding as a result of increased funding for pharmaceuticals across the United States.
Due to rising government investments in medical research and rising healthcare costs, Asia Pacific is expected to grow significantly during the forecast period, which will increase the risk of cell culture contamination and the presence of CROs in nations like China, Japan, and India. According to statistics from the WHO, more than 15 million people between the ages of 35 and 69 die from chronic diseases, and both developed and developing nations account for 85% of premature deaths. Additionally, a large number of clinical research services, particularly in China, are anticipated to fuel market expansion in the upcoming years.
Some of the key players profiled in the Viral Clearance Market include Avance Biosciences Inc., BioReliance Corporation, Bioscience Laboratories, BSL Bioservice Scientific Laboratories GmbH, Charles River Laboratories, Inc., Clean Cells Inc., Cytovance Biologics Inc., Eurofins Scientific, F. Hoffmann-La Roche Ltd., GE Healthcare Life Sciences, Kedrion Biopharma Inc., Labor Dr. Merk & Kollegen GmbH, Lonza Group AG, Merck KGaA, Nelson Laboratories LLC, Novartis AG, Sartorius AG, Sigma-Aldrich Corporation, Syngene International Limited, Texcell, Inc., Vironova AB, ViruSure GmbH and WuXi AppTec.
In September 2022, Merck opened a viral clearance (VC) laboratory as part of the first building phase of its new EUR 29 million China Biologics Testing Center.
In April 2022, Abzena, a partner research organization (PRO), announced the opening of a biologics testing laboratory situated near the company's biologics process development and manufacturing hub in San Diego, California. The facility will give partners access to cell-based and PCR safety assays; and viral clearance studies to support their IND, IMPD, BLA, and MAA applications.
In April 2022, WuXi Biologics awarded the bioprocessing excellence in viral clearance and safety accolade for the second time at the Asia Pacific Bioprocessing Excellence Awards (ABEA) event.