市場調查報告書
商品編碼
1625205
到 2030 年In Silico臨床試驗市場預測:按類型、模擬類型、治療方法、技術、應用、最終用戶和地區進行的全球分析In Silico Clinical Trials Market Forecasts to 2030 - Global Analysis By Type, Simulation Type, Therapeutic, Technology, Application, End User and By Geography |
根據 Stratistics MRC 預測,到 2024 年,全球In Silico臨床試驗市場規模將達到 36 億美元,預計在預測期內複合年成長率為 8.4%,到 2000 年將達到 58 億美元。
In Silico臨床試驗使用電腦模擬和建模來重建人類生物學並預測醫療干預措施的有效性。這些虛擬試驗使用大量患者資料、生物模型和計算演算法來模擬藥物、治療方法或設備在現實臨床環境中的工作方式。透過取代或減少對傳統體內測試的需求,電腦模擬測試提供了一種更快、更具成本效益的方法,可以在臨床引入之前評估治療的安全性和有效性,並提供合乎道德的替代方案。
根據歐洲藥品管理局(歐盟)統計,歐盟/歐洲經濟區每年批准超過 4,000 項臨床試驗,其中 60% 由製藥公司贊助,40% 由非商業贊助商贊助。印度臨床試驗註冊中心 (CTRI) 的數據顯示,2021 年印度核准了100 多項國際臨床試驗,這是自 2013 年以來的最高數量。
對更安全藥物的需求不斷成長
市場開發對更安全藥物的需求不斷成長,這是由於對更高效、更具成本效益和合乎道德的藥物開發流程的需求所推動的。In Silico,使用先進的計算模型,透過在實際臨床試驗之前預測藥物療效、毒性和患者反應,為傳統臨床試驗提供更安全的替代方案。這種方法可以加快藥物核准速度,降低風險,最大限度地減少對動物和人體測試的依賴,並滿足監管和公共衛生目標。
難以獲得高品質資料
市場上高品質資料的有限性阻礙了預測模型的準確性和可靠性。資料不足或偏差可能會為模擬帶來缺陷,從而導致對藥物療效、安全性和患者反應的錯誤預測。這削弱了In Silico臨床試驗取代傳統方法的潛力,減緩了藥物開發,增加了風險,並可能導致監管部門核准延遲或不批准新治療方法。
計算建模和人工智慧的進展
計算建模和人工智慧的發展透過提高藥物開發的準確性和效率正在徹底改變市場。人工智慧演算法分析大量資料集來預測藥物交互作用、患者反應和潛在副作用。改進的計算模型可以模擬複雜的生物系統並減少對傳統臨床試驗的依賴。這些創新可以實現更快、更準確的藥物測試,最佳化臨床結果和安全性,同時降低成本並加快新療法的上市時間。
監管和道德的不確定性
市場中的監管和道德不確定性對採用提出了重大挑戰。藥物測試中計算模型的使用缺乏明確的指南可能會延遲核准過程並增加合規風險。此外,有關資料隱私、病患同意和模型透明度的倫理問題可能會阻礙人們對這些技術的信心,減緩進展,並限制其取代傳統臨床試驗方法的潛力。
COVID-19 大流行凸顯了對更快、更有效的藥物開發方法的需求,並加速了In Silico臨床試驗的採用。由於傳統的臨床試驗面臨中斷,計算模型對於快速藥物測試和疫苗開發變得至關重要。這次疫情凸顯了虛擬模擬在減少臨床試驗時間、成本和對物理互動的依賴方面的優勢,刺激了市場的進一步投資和創新。
預計臨床前測試領域在預測期內將是最大的。
預計臨床前測試領域將在預測期內佔據最大的市場佔有率。這些虛擬試驗使研究人員能夠預測藥物功效、安全性和藥物動力學,並幫助識別潛在風險、副作用和最佳劑量。透過利用人工智慧、機器學習和其他預測技術,In Silico臨床前測試可以減少與傳統動物和人體測試相關的成本、時間和倫理問題,加速藥物開發並提高成功率。
機器學習領域預計在預測期內複合年成長率最高
預計機器學習領域在預測期內將表現出最高的複合年成長率。這些演算法處理大量資料集來預測患者反應、確定最佳劑量策略並模擬試驗結果,從而顯著縮短時間。該技術還將增強決策、提高測試準確性並支援個人化醫療。因此,機器學習正成為加速藥物開發和推動更有效率、資料主導的臨床研究方法的重要工具。
由於計算建模、人工智慧和巨量資料分析的進步,預計北美地區在預測期內將佔據最大的市場佔有率。這些虛擬模擬透過提高效率、降低成本和最小化風險,正在徹底改變藥物開發。監管接受度的提高、個人化醫療需求的增加以及對精準醫療保健的日益關注等關鍵因素正在促進該地區的市場擴張。
在計算模型進步的推動下,亞太地區預計將在預測期內實現最高成長率。人工智慧 (AI)、機器學習 (ML) 和巨量資料擴大融入In Silico臨床試驗市場。這些技術可以實現更好的預測模型、提高測試準確性並降低開發成本。此外,生物創業公司數量的增加以及政府對醫療保健數位轉型的支持也推動了市場成長。
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.