市场调查报告书
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全球毒理学测试市场预测(-2030):按产品、测试类型、方法、技术、最终用户和地区进行分析Toxicology Testing Market Forecasts to 2030 - Global Analysis By Product, Test Type, Method, Technology, End User and By Geography |
预测期内,全球毒性测试市场规模将以 15.9% 的复合年增长率成长。
毒理学测试涉及评估物质对生物体的影响,以评估对人类健康或环境的潜在危害。确定与化学品、药品、消费品和环境污染物相关的安全性、毒性和风险。其重要性在于透过识别和减轻风险、支持监管合规性以及指南产品开发来保护公众健康。
根据 NCBI 的数据,在发现阶段合成的每 10,000 种化合物中,只有 250 种达到临床前阶段,并且有一种药物最终获得 FDA核准。
增加研发活动
製药、生物技术和化学製造等行业不断寻找新的化合物、配方和产品。毒理学测试在这些领域发挥着至关重要的作用,在这些创新技术引入市场之前对其安全性、有效性和潜在风险进行评估。此外,强大的毒性评估可确保符合监管标准,并有助于减少对人类健康和环境的不利影响。随着消费者需求的变化和技术突破,研发工作不断增加,彻底的毒性测试的需求也在增加,这对于新药、化学品和产品的创造和核准至关重要。这是一个步骤。
资料解释的复杂性
许多实验和最尖端科技产生的复杂多样的资料使得分析具有挑战性,并且难以转化为有用的见解。准确评估这种复杂性需要特定的知识、先进的设备和标准化的框架。解释此类复杂统计资料时的错误和不确定性可能会损害风险评估、监管备案和产品开发中的决策,并可能阻碍市场核准和开发。
对替代测试方法的需求不断增长
试管内测定、类器官、微流体系统和计算模型等先进技术为毒性评估提供了有前途的替代方案,提供更准确、更具成本效益和道德的测试工具。投资研发以检验这些替代品并将其商业化的公司将能够利用这种不断增长的需求。此外,这些替代品的广泛采用将简化测试过程并提供更快的结果,这符合更人性化和可预测的毒性评估的全球趋势。这样,就成为了市场拓展的动力。
监管变化
不断发展和收紧的安全评估法规会影响测试方法、验证要求和产品核可时间表,需要不断调整和遵守。监管标准的突然变化或新指南的引入可能会导致不确定性、成本增加和核准过程的延迟。如果无法快速回应新标准,可能会导致违规处罚、竞争力下降和市场准入减少,从而使毒理学测试市场难以保持效率并应对不断变化的要求,这给企业带来了挑战。
由于业务关闭和研究影响,COVID-19 爆发最初导致资源重新转向与大流行相关的研究。测试和监管流程继续延迟,导致产品核准延迟。然而,这场危机凸显并提高了毒性测试在疫苗开发和药物安全评估中的重要性。业界以远距工作和虚拟考试作为回应,刺激了创新和数数位化。对安全评估意识的提高导致人们重新重视稳健的调查方法,为疫情后的恢復铺路。
遗传毒性测试部分预计将在预测期内成为最大的部分
遗传毒性测试部分估计占最大份额。遗传毒性测试采用评估物质诱导突变、染色体畸变和 DNA 损伤的能力的分析方法,对于识别潜在的致癌物质和有害化合物至关重要。这些试验包括Ames试验、微核试验、彗星试验等体外及体内方法,综合分析遗传毒性。此外,了解基因毒性有助于确定药物、化学物质、农药和消费品的安全性,并为监管评估做出巨大贡献,以确保人类健康和环境免受有害的基因变化的影响。
体内测试领域预计在预测期内复合年增长率最高。
预计体内测试领域在预测期内将出现良好的成长。体内测试是对整个活体(例如植物或动物)进行的实验类型。它有助于确定毒性水平、不良反应和潜在的健康危害,为监管和安全评估提供关键资料。此外,儘管存在伦理方面的考虑,这些测试对于全面了解物质的生物效应并确保保护人类健康和环境免受潜在有害化合物的侵害至关重要。
由于工业化程度不断提高、监管指南更加严格以及环境安全意识不断增强,亚太地区在预测期内占据了最大的市场占有率。技术进步、製药和生物技术领域的扩张以及化妆品和食品行业对毒性评估的需求正在推动市场扩张。此外,中国、印度、日本和韩国等国家正在透过扩大经济和扩大研究倡议做出重要贡献。推动该市场成长的是对产品安全评估的重视以及对可靠毒性测试方法的需求。
由于严格的法律规范、对产品安全的日益关注和技术进步,预计北美在预测期内将实现盈利增长。该地区拥有成熟的製药和生物技术产业,研发活动不断增加,因此市场预计将扩大。此外,对化学品暴露的日益关注以及医疗、化妆品和环境监测等各个领域对有效毒性评估的需求正在推动市场成长。美国和加拿大等主要贡献国家见证了测试方法的不断进步,推动了创新和市场渗透。
According to Stratistics MRC, the Global Toxicology Testing Market is growing at a CAGR of 15.9% during the forecast period. Toxicology testing involves evaluating the effects of substances on living organisms to assess potential hazards to human health and the environment. It determines the safety, toxicity, and risks associated with chemicals, pharmaceuticals, consumer products, and environmental pollutants. Its importance lies in safeguarding public health by identifying and mitigating risks, aiding regulatory compliance, and guiding product development.
According to NCBI, for every 10,000 compounds synthesized in the discovery phase, only 250 reach the preclinical phase, ultimately resulting in one approved drug by the FDA.
Industries such as pharmaceuticals, biotechnology, and chemical manufacturing are continually exploring novel compounds, formulations, and products. Toxicology testing plays a pivotal role in these sectors by evaluating the safety, efficacy, and potential risks of these innovations before market introduction. Moreover, robust toxicological assessments ensure compliance with regulatory standards and help mitigate adverse effects on human health and the environment. The need for thorough toxicological testing is growing as R&D efforts to address changing consumer demands and technological breakthroughs rise, making it an essential step in the creation and approval of novel medications, chemicals, and products.
The complex and varied data produced by many experiments and cutting-edge technologies presents analytical difficulties that make it difficult to analyze and translate into useful insights. Accurate assessment of this complexity necessitates specific knowledge, advanced instruments, and standardized frameworks. Errors or uncertainty when interpreting these complex statistics can impair decision-making in risk assessments, regulatory filings, and product development, thereby impeding market approvals and developments.
Advanced technologies such as in vitro assays, organoids, microfluidics systems, and computational models offer promising alternatives for toxicology assessments, providing more accurate, cost-effective, and ethical testing avenues. Companies investing in research and development to validate and commercialize these alternative methods stand to capitalize on this growing demand. Moreover, the widespread adoption of these alternatives also streamlines testing processes, fosters quicker results, and aligns with the global trend towards more humane and predictive toxicology evaluations. Thus, there is propelling market expansion.
Evolving and stringent regulations governing safety assessments necessitate continuous adaptation and compliance, impacting testing methodologies, validation requirements, and timelines for product approvals. Sudden shifts in regulatory standards or the introduction of new guidelines may lead to uncertainties, increased costs, and delays in the approval process. Failure to promptly align with new standards could result in non-compliance penalties, reduced competitiveness, and impediments to market access, posing challenges for companies in maintaining efficiency and meeting evolving requirements within the toxicology testing market.
The COVID-19 outbreak initially affected operations and research due to lockdowns and redirected resources towards pandemic-related studies. Delays in trials and regulatory processes ensued, slowing down product approvals. However, the crisis highlighted the criticality of toxicology testing in vaccine development and drug safety assessments, elevating its importance. The industry adapted with remote work and virtual trials, fostering innovation and digitalization. Increased awareness of safety evaluations resulted in a renewed emphasis on robust testing methodologies, paving the way for a resilient recovery post-pandemic.
The genetic toxicology testing segment is estimated to hold the largest share. Genetic toxicology testing employs assays to evaluate a substance's ability to induce mutations, chromosomal aberrations, or DNA damage, which is crucial in identifying potential carcinogens or harmful compounds. These tests encompass in vitro and in vivo methods, such as the Ames test, micronucleus assay, and comet assay, to comprehensively analyze genotoxicity. Moreover, understanding genetic toxicity aids in determining the safety of pharmaceuticals, chemicals, pesticides, and consumer products, contributing significantly to regulatory evaluations, and ensuring the protection of human health and the environment from harmful genetic alterations.
The in-vivo testing segment is anticipated to have lucrative growth during the forecast period. In vivo tests refer to a type of experiment that is carried out within a whole, living organism, such as a plant or animal. It helps to determine toxicity levels, adverse reactions, and potential health hazards, providing crucial data for regulatory assessments and safety evaluations. Moreover, these tests, despite ethical considerations, remain essential for comprehensively understanding the biological effects of substances and ensuring the protection of human health and the environment from potentially harmful compounds.
Asia Pacific commanded the largest market share during the extrapolated period owing to increasing industrialization, stringent regulatory guidelines, and rising awareness regarding environmental safety. Advancements in technology and expanding pharmaceutical and biotechnology sectors, coupled with the demand for toxicological evaluations in the cosmetics and food industries, drive market expansion. Moreover, countries like China, India, Japan, and South Korea are pivotal contributors due to their expanding economies and growing research initiatives. This market's growth is fuelled by the emphasis on product safety assessment and the need for reliable toxicology testing methods.
North America is expected to witness profitable growth over the projection period, due to stringent regulatory frameworks, heightened focus on product safety, and technological advancements. The region's well-established pharmaceutical and biotechnology industries, along with increased R&D activities, propel market expansion. Moreover, rising concerns about chemical exposure, coupled with the need for efficient toxicological evaluations in various sectors, including healthcare, cosmetics, and environmental monitoring, are driving market growth. Key contributors like the United States and Canada witness continual advancements in testing methodologies, fostering innovation and market penetration.
Some of the key players in the Toxicology Testing Market include Abbott Laboratories, Eurofins Scientific, Laboratory Corporation Of America Holdings, Thermo Fisher Scientific, Inc., Danaher Corporation, Agilent Technolgies, Inc., Catalent, Inc., Bio-Rad Laboratories, Inc., Bioivt and Gentronix.
In November 2023, Thermo Fisher Scientific & Flagship Pioneering Expand Ongoing Strategic Partnership to Jointly Create New Platform Companies with First-in-Class Enabling Technologies for Life Sciences.
In October 2023, Thermo Fisher Scientific, the world leader in serving science, has introduced the Thermo Scientific™ Meridian™ EX System- an electron-beam-based failure analysis solution designed to enable precise fault localization on advanced semiconductor logic technologies.
In September 2023, Thermo Fisher Scientific and National Minority Quality Forum Collaborate to support biopharmaceutical and biotech customers in meeting regulatory expectations to enroll and retain patients in clinical trials who more fully reflect real-world populations experiencing the disease or health condition being studied, including U.S. Food and Drug Administration requirements around diversity action plans.