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市场调查报告书
商品编码
1479062
全球体外毒理学测试市场评估依产品和服务,毒性终点和测试,方法,技术,最终用户,地区,机会,预测 (2017-2031)In-vitro Toxicology Testing Market Assessment, By Product and Services, By Toxicity Endpoint & Test, By Method, By Technology, By End-user, By Region, Opportunities and Forecast, 2017-2031F |
全球体外毒性测试市场规模预计将从 2023 年的 142.2 亿美元增至 2031 年的 307.3 亿美元,2024-2031 年预测期间复合年增长率为 10.11%。近年来市场呈现显着成长,预计未来将维持稳定扩张速度。体外毒性测试允许在实验室等受控环境中测试许多产品,包括各种化学物质、药品和化妆品。开发早期阶段的这一步骤对于瞭解化学生产物质的毒性至关重要,以便它们不会对消费者造成伤害。此测试评估化学物质、药物和化妆品的安全性,无需施用于动物或人类。
由于许多对製药、化学和化妆品行业有直接影响的因素,该市场正在呈现成长。世界各地政府机构不断加强的监管分析和严格的安全评估是这个巨大市场的主要成长动力。这些措施使市场上的行业和企业能够遵守严格的法规并采取措施确保产品安全。此外,高通量、3D 模型和器官晶片模型等技术进步已被证明可以在更短的时间内产生更可靠、更准确的结果。这使市场对其能力充满信心并支持其成长。与行业巨头的策略合作伙伴关係开发各种技术和药品正在推动市场成长。
例如,2023 年 6 月,製药、生物技术和营养保健市场的全球製造合作伙伴 Lonza 宣布决定收购 Synaffix,这是一家专注于将用于开发抗体药物缀合物的临床阶段技术平台商业化的公司。
新药和化学品评估需求不断增加
市场成长是由对新药和化学品安全性评估的需求不断增长所推动的。这些评估是由严格的监管要求所驱动的,这些要求要求进行全面的毒性评估。体外测试经济高效,使您摆脱动物测试等传统方法,并提供更快、更准确的产品洞察。高通量筛选和晶片器官模型等技术的进步使人们不再依赖动物测试等不道德的方法。这些新模型已被证明可以提高检测的预测准确性和有效性。
此外,为了应对因备受瞩目的药物开发停止而引起的日益严重的安全问题,整个药物开发过程中严格的安全性评估变得越来越重要。体外测试具有成本效益和时间效益,可促进更安全、更有效的治疗方法的开发,以应对慢性病的流行和人口老化,从而推动製药和生物技术行业的发展。
2022 年 10 月,Thermo Fisher Scientific Inc.宣布将扩大在肯塔基州的业务,以协助客户提供改变生活的药物。目前的设施包括中心实验室和生物标记服务,为生物製药消费者提供高品质的实验室服务以支援药物开发。这帮助该公司扩大了在世界不同地区的诊断业务,并提高了其全球影响力。
技术进步
许多新开发的技术正在引入该市场,以提高检测的预测准确性和相关性。高通量筛选、3D细胞培养和晶片器官等模型可以实现可靠的毒性评估,并提供不依赖动物实验模型等传统模型的平台。这些先进的模型使我们能够刺激复杂的生理过程和器官间相互作用,同时提供对药物毒性更与人类相关的理解。此外,将人工智慧整合到这些模型中将改善数据解释和分析,帮助识别潜在的毒理学风险。自动化和机器人技术允许同时对大量化合物进行高通量筛选,彻底改变了体外毒性测试程序。
本报告研究和分析了全球体外毒性测试市场,提供市场规模和预测、市场动态以及主要参与者的现状和前景。
Global in-vitro toxicology testing market is projected to witness a CAGR of 10.11% during the forecast period 2024-2031, growing from USD 14.22 billion in 2023 to USD 30.73 billion in 2031. The market has experienced significant growth in recent years and is expected to maintain a strong pace of expansion in the coming years. In-vitro toxicology testing enables testing of various chemicals, drugs, cosmetics and many other products in a controlled environment such as a laboratory. This step in the earlier stages of development is mandatory to know the toxicity of any chemically made substance so that it is not harmful for the consumers. This test evaluates the safety of any chemicals, drugs, or cosmetics without subjecting them to any animals or humans.
The in-vitro toxicology testing market is witnessing growth driven by many factors directly affecting the pharmaceutical, chemical and cosmetics industries. Increasing regulatory analysis and stringent safety evaluations imposed by governmental bodies worldwide are the main factors fueling the growth of this huge market. These measures make industries and players in its market comply with strict regulations and enable them to follow a procedure that ensures the safety of the product. Additionally, advancements in technology such as high-throughput and 3D models, organ-on-a-chip models, have proven to offer much more reliable and accurate results in less times. It has given the market confidence to function, hence supporting its growth. Strategic partnerships between industry giants to develop different technologies and drugs is driving the market growth.
For instance, in June 2023, a global manufacturing partner of pharmaceutical, biotech, and nutraceutical markets, Lonza announced its decision to acquire Synaffix which focuses on commercializing its clinical-stage technology platform for developing antibody-drug conjugates.
Rising Demand for Assessment of New Drugs and Chemicals
The growth of in-vitro toxicology testing market is fueled by increasing demand for safety assessments of new drug and chemicals. These assessments are driven by stringent regulatory requirements mandating comprehensive toxicity evaluations. In-vitro testing is cost-effective and efficient and saves us from the old methods such as animal testing and provides us with quick and more accurate insights for our product. Technological advancements like that of high-throughput screening and organ-on-a-chip models have given us the freedom to not rely on unethical methods such as that of animal-testing. These new models have been proven to enhance the predictive accuracy and relevance of assays.
Moreover, rigorous safety assessments have become increasingly important throughout the drug development process following the increased safety concerns for high-profile drug withdrawals. In-vitro testing offers cost and time efficiencies and supports the pharmaceutical and biotechnology industries' robust growth by facilitating the development of safer and more effective therapeutic agents to address the increasing prevalence of chronic diseases and aging populations.
In October 2022, Thermo Fisher Scientific Inc. announced that they will expand operations in Kentucky to help customers by delivering life-changing medicines to patients. The current facility includes central lab and biomarker services, providing biopharma consumers with high-quality lab work to boost drug development. It has helped the company expand its diagnostics business across various regions in the world and helped increase its global presence.
Technological Advancements
Many newly developed technologies have been introduced to this market to enhance the predictive accuracy and relevance of assays. Models such as high-throughput screening, 3D cell culture, and organ-on-a-chip have enabled reliable toxicity assessments giving us the platform to be able to not rely on traditional models like that of animal testing models. These advanced models allow stimulation of complex physiological processes and organ interactions, while providing a more human-relevant understanding of drug toxicity. Additionally, integration of AI with these models improves the data interpretation and analysis which is helpful in identifying any potential toxicological risks. Automation and robotics have revolutionized the procedure of in-vitro toxicology testing by enabling high-throughput screening of a large number of compounds simultaneously.
The adoption of stringent guidelines, standardized protocols, and regulations ensure consistency and reproducibility across assays, strengthening their acceptance by regulatory agencies and pharmaceuticals. It underscores the importance of in-vitro testing in the early stages of drug development and ensures the market of in-vitro toxicology testing is driven by expansion of its applications during pre-clinical trials and drug screening. Thermo Fisher Scientific launched the first of 37 CE-IVD- marked real-time PCR assay kits in April 2023 for infectious diseases. These assays were available in countries recognizing CE marking for use with the CE-IVD marked QS5 Dx, a diagnostic testing platform compliant with the EU's new in-vitro medical devices regulation framework.
Dominance of Cell Culture Technology
In-vitro toxicology testing market is experiencing robust growth due to advancing cell culture technology. The advancements in cell culture technology are driving the in-vitro toxicology testing market with its ability to provide predictive, demonstrative, and reliable results while toxicity screening of a wide range of chemicals, including nanomaterials and airborne materials. The advancements have enabled the expansion of the toxicology testing market as it involves using cells and tissues grown and maintained in controlled environments inside laboratories. Toxic properties of any drug or chemical can be examined easily.
For instance, Xenobiotics can be examined at the basic level of cell without involving the interplay of complex physiological systemic effects. Cellular assays can be easily integrated with technology such as high throughput formats or 3D formats enabling faster screening of large numbers of compounds for potential toxicity. The level of efficiency and accuracy is important on a large scale for pharmaceutical industries, biotechnology companies, or any company developing chemically related substances.
On November 17, 2023, the University of Texas MD Anderson Cancer Centre and Toppan Holdings signed a research collaboration agreement to assess Toppan Holdings' cell culture technology to advance personalized medicine and drug screening initiatives. During the three-year partnership, patient-derived tumor tissue will be used to produce in vitro "cancer patient avatars" utilizing Toppan Holdings' exclusive 3D cell culture technology, Invivoid. The avatars will be given anticancer medications, and the therapeutic usefulness of this technique for determining medication efficacy will be evaluated.
North America Will Dominate In-vitro Toxicology Testing Market Share
North America is anticipated to dominate the global market share over the forecast period in the in-vitro toxicology testing market. Due to the rising burden of chronic diseases and population in North America, healthcare-related engagement is increasing, which encourages more R&D of drugs and vaccines. North America is experiencing a significant increase in different diseases that can be treated or managed with drugs.
For instance, about 2.4 million Canadians have a heart disease according to a report by Canadian Institute for Health Information updated in June 2022. According to a report by Spotlight on Heart failure published in 2022, more than 100,000 Canadians are likely to be diagnosed with heart failure each year. North America, being a hub of healthcare and pharmaceutical companies expedites innovation and product launches which enables growth in research and development activities. Evotec announced in February 2023 about the relocation of its subsidiary, Cyprotex US, LLC, from Watertown to Framingham, U.S. It was done to expand the new facility to enable faster turnaround times.
Future Market Scenario (2024 - 2031F)
Increasing prevalence of various chronic diseases is the biggest reason behind the growth of in-vitro toxicology testing market. For management and treatment of diseases a lot of R&D is required to develop a drug with high clinical efficacy. Rapidly developing healthcare and biotechnological forums present an evergreen opportunity for the global in-vitro toxicology testing market value to grow and multiply manifolds. The scope of the market extends beyond pharmaceutical industry. Scientists, biotechnologists, healthcare professionals, and other healthcare professionals in the industry are dedicated towards introducing advanced technologies and modern diagnostic techniques which will contribute towards market growth.
For instance, Eurofins Scientific in January 2023, expanded its presence in India with the establishment of a new, fully equipped, state-of-the-art laboratory campus in Hyderabad. The lab is aimed at supporting pharma and biotechnology companies in the domain of synthetic organic chemistry, analytical R&D, bioanalytical services, in vivo pharmacology safety toxicology, and formulation R&D.
Key Players Landscape and Outlook
Several companies are expanding their business by planning and adopting new strategies. Companies are forming strategic partnerships to increase their presence in different geographies. Product launches, distribution agreements, mergers and acquisitions, and investments, and partnerships are some of the strategies being followed by leading pharmaceutical and biotechnology companies.
Agilent Technologies (US) acquired e-MSion (US) in March 2023. Through this acquisition, they plan to integrate the e-MSion's ExD cell into portfolio of advanced workflows, instruments, and analytical solutions for biotherapeutic characterization and development.
In August 2023, Evotec announced its partnership with STORM, the world's leading small RNA molecule modifying enzyme drug discovery company. They aimed to present the discovery of STORM's leading clinical candidate, STC-15. STC-15 is a highly selective, orally bioavailable, and RME inhibitor for METTL3, which was developed by both STORM and Evotec.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.