市场调查报告书
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1625205
到 2030 年In Silico临床试验市场预测:按类型、模拟类型、治疗方法、技术、应用、最终用户和地区进行的全球分析In Silico Clinical Trials Market Forecasts to 2030 - Global Analysis By Type, Simulation Type, Therapeutic, Technology, Application, End User and By Geography |
根据 Stratistics MRC 预测,到 2024 年,全球In Silico临床试验市场规模将达到 36 亿美元,预计在预测期内复合年增长率为 8.4%,到 2000 年将达到 58 亿美元。
In Silico临床试验使用电脑模拟和建模来重建人类生物学并预测医疗干预措施的有效性。这些虚拟试验使用大量患者资料、生物模型和计算演算法来模拟药物、治疗方法或设备在现实临床环境中的工作方式。透过取代或减少对传统体内测试的需求,电脑模拟测试提供了一种更快、更具成本效益的方法,可以在临床引入之前评估治疗的安全性和有效性,并提供合乎道德的替代方案。
根据欧洲药品管理局(欧盟)统计,欧盟/欧洲经济区每年批准超过 4,000 项临床试验,其中 60% 由製药公司赞助,40% 由非商业赞助商赞助。印度临床试验註册中心 (CTRI) 的数据显示,2021 年印度核准了100 多项国际临床试验,这是自 2013 年以来的最高数量。
对更安全药物的需求不断增长
市场开发对更安全药物的需求不断增长,这是由于对更高效、更具成本效益和合乎道德的药物开发流程的需求所推动的。In Silico,使用先进的计算模型,透过在实际临床试验之前预测药物疗效、毒性和患者反应,为传统临床试验提供更安全的替代方案。这种方法可以加快药物核准速度,降低风险,最大限度地减少对动物和人体测试的依赖,并满足监管和公共卫生目标。
难以获得高品质资料
市场上高品质资料的有限性阻碍了预测模型的准确性和可靠性。资料不足或偏差可能会为模拟带来缺陷,从而导致对药物疗效、安全性和患者反应的错误预测。这削弱了In Silico临床试验取代传统方法的潜力,减缓了药物开发,增加了风险,并可能导致监管部门核准延迟或不批准新治疗方法。
计算建模和人工智慧的进展
计算建模和人工智慧的发展透过提高药物开发的准确性和效率正在彻底改变市场。人工智慧演算法分析大量资料集来预测药物交互作用、患者反应和潜在副作用。改进的计算模型可以模拟复杂的生物系统并减少对传统临床试验的依赖。这些创新可以实现更快、更准确的药物测试,优化临床结果和安全性,同时降低成本并加快新疗法的上市时间。
监管和道德的不确定性
市场中的监管和道德不确定性对采用提出了重大挑战。药物测试中计算模型的使用缺乏明确的指南可能会延迟核准过程并增加合规风险。此外,有关资料隐私、病患同意和模型透明度的伦理问题可能会阻碍人们对这些技术的信心,减缓进展,并限制其取代传统临床试验方法的潜力。
COVID-19 大流行凸显了对更快、更有效的药物开发方法的需求,并加速了In Silico临床试验的采用。由于传统的临床试验面临中断,计算模型对于快速药物测试和疫苗开发变得至关重要。这次疫情凸显了虚拟模拟在减少临床试验时间、成本和对物理互动的依赖方面的优势,刺激了市场的进一步投资和创新。
预计临床前测试领域在预测期内将是最大的。
预计临床前测试领域将在预测期内占据最大的市场占有率。这些虚拟试验使研究人员能够预测药物功效、安全性和药物动力学,并帮助识别潜在风险、副作用和最佳剂量。透过利用人工智慧、机器学习和其他预测技术,In Silico临床前测试可以减少与传统动物和人体测试相关的成本、时间和伦理问题,加速药物开发并提高成功率。
机器学习领域预计在预测期内复合年增长率最高
预计机器学习领域在预测期内将表现出最高的复合年增长率。这些演算法处理大量资料集来预测患者反应、确定最佳剂量策略并模拟试验结果,从而显着缩短时间。该技术还将增强决策、提高测试准确性并支援个人化医疗。因此,机器学习正成为加速药物开发和推动更有效率、资料主导的临床研究方法的重要工具。
由于计算建模、人工智慧和巨量资料分析的进步,预计北美地区在预测期内将占据最大的市场占有率。这些虚拟模拟透过提高效率、降低成本和最小化风险,正在彻底改变药物开发。监管接受度的提高、个人化医疗需求的增加以及对精准医疗保健的日益关注等关键因素正在促进该地区的市场扩张。
在计算模型进步的推动下,亚太地区预计将在预测期内实现最高成长率。人工智慧 (AI)、机器学习 (ML) 和巨量资料越来越多地融入In Silico临床试验市场。这些技术可以实现更好的预测模型、提高测试准确性并降低开发成本。此外,生物创业公司数量的增加以及政府对医疗保健数位转型的支持也推动了市场成长。
According to Stratistics MRC, the Global In Silico Clinical Trials Market is accounted for $3.6 billion in 2024 and is expected to reach $5.8 billion by 200 growing at a CAGR of 8.4% during the forecast period. In silico clinical trials are the use of computer simulations and modeling to replicate human biology and predict the effects of medical interventions. These virtual trials use vast amounts of patient data, biological models, and computational algorithms to simulate how drugs, therapies, or devices would perform in real-world clinical settings. By replacing or reducing the need for traditional in vivo trials, in silico trials offer a faster, cost-effective, and ethical alternative for evaluating the safety and efficacy of treatments before clinical implementation.
According to the European Medicines Agency - European Union, in the EU / EEA, more than 4,000 clinical trials are authorised each year, of which 60% of clinical trials are sponsored by the pharma industry and 40% by non-commercial sponsors. As per the Clinical Trials Registry India (CTRI), India approved over 100 global clinical trials in 2021, the highest since 2013.
Growing demand for safer drugs
The growing demand for safer drugs in the market is driven by the need for more efficient, cost-effective, and ethical drug development processes. In silico trials, using advanced computational models, offer a safer alternative to traditional clinical trials by predicting drug efficacy, toxicity, and patient responses before real-world testing. This approach accelerates drug approval, reduces risks, and minimizes the reliance on animal and human testing, aligning with regulatory and public health goals.
Limited availability of high-quality data
The limited availability of high-quality data in the market hampers the accuracy and reliability of predictive models. Inadequate or biased data can lead to flawed simulations, resulting in incorrect predictions about drug efficacy, safety, or patient responses. This undermines the potential of in silico trials to replace traditional methods, slowing down drug development, increasing risks, and potentially leading to delayed or failed regulatory approvals for new treatments.
Advances in computational modeling and AI
Advances in computational modeling and AI are revolutionizing market by enhancing the accuracy and efficiency of drug development. AI algorithms analyze vast datasets to predict drug interactions, patient responses, and potential side effects. Improved computational models simulate complex biological systems, reducing reliance on traditional trials. These innovations enable faster, more precise drug testing, optimizing clinical outcomes and safety while lowering costs and accelerating time-to-market for new treatments.
Regulatory and ethical uncertainty
Regulatory and ethical uncertainty in the market poses a significant challenge to widespread adoption. The lack of clear guidelines on the use of computational models in drug testing can delay approval processes and increase compliance risks. Additionally, ethical concerns about data privacy, patient consent, and model transparency may hinder trust in these technologies, slowing progress and limiting their potential to replace traditional clinical trial methods effectively.
The COVID-19 pandemic accelerated the adoption of In Silico Clinical Trials by highlighting the need for faster, more efficient drug development methods. With traditional trials facing disruptions, computational models became crucial for rapid drug testing and vaccine development. The pandemic emphasized the benefits of virtual simulations in reducing trial timelines, costs, and reliance on physical interactions, driving further investment and innovation in the market.
The preclinical trials segment is expected to be the largest during the forecast period
The preclinical trials segment is expected to account for the largest market share during the projection period. These virtual trials enable researchers to predict drug efficacy, safety, and pharmacokinetics, helping to identify potential risks, side effects, and optimal dosages. By utilizing AI, machine learning, and other predictive technologies, in silico preclinical trials reduce the cost, time, and ethical concerns associated with traditional animal and human studies, accelerating drug development and improving success rates.
The machine learning segment is expected to have the highest CAGR during the forecast period
The machine learning segment is expected to have the highest CAGR during the extrapolated period. These algorithms process vast datasets to predict patient responses, identify optimal dosing strategies, and simulate trial outcomes, significantly reducing the time. This technology also enhances decision-making, improves trial accuracy, and supports personalized medicine. As a result, ML is becoming a crucial tool in accelerating drug development and advancing more efficient, data-driven clinical research methodologies.
North America region is projected to account for the largest market share during the forecast period driven by advancements in computational modeling, artificial intelligence, and big data analytics. These virtual simulations are revolutionizing drug development by enhancing efficiency, reducing costs, and minimizing risks. Key factors such as increasing regulatory acceptance, a rising demand for personalized medicine, and a growing focus on precision healthcare contribute to the market's expansion in the region.
Asia Pacific is expected to register the highest growth rate over the forecast period driven by advancements in computational models. Artificial Intelligence (AI), Machine Learning (ML), and Big Data are being increasingly integrated into the in silico clinical trials market. These technologies enable better prediction models, improve trial accuracy, and reduce development costs. Additionally, the rise in biotech startups, along with government support for digital transformation in healthcare, is helping the market grow.
Key players in the market
Some of the key players in In Silico Clinical Trials market include Novadiscovery, Dassault Systemes, GNS Healthcare, Clarivate, Evotec, Abzena Ltd., PerkinElmer Inc., Schrodinger, Inc., Selvita, Tracxn Technologies, WuXi AppTec, Hoffmann- La Roche, Mars, PYC Therapeutics and Immatics.
In October 2024, Dassault Systemes announced the availability of the world's first guide for the medical device industry that outlines how to use virtual twins to accelerate clinical trials. The in silico clinical trial "ENRICHMENT Playbook" marks a significant advancement in the integration of virtual twins into the regulatory process in response to needs for improved patient safety, regulatory compliance, and pace of innovation.
In July 2024, Clarivate Plc announced the launch of its new OFF-X platform. It delivers critical drug and target safety information to proactively identify risks. Integrated with Cortellis Drug Discovery Intelligence(TM), OFF-X(TM) provides a comprehensive, one-stop resource for drug safety information, streamlining processes, increasing efficiencies and delivering a competitive advantage.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.