![]() |
市场调查报告书
商品编码
1820285
ADME毒理学测试市场规模、份额、趋势及预测(按技术、产品类型、方法、应用和地区),2025-2033年ADME Toxicology Testing Market Size, Share, Trends and Forecast by Technology, Product Type, Method, Application, and Region, 2025-2033 |
2024年,全球ADME毒理学检测市场规模达103亿美元。展望未来, IMARC Group预计到2033年,该市场规模将达到302亿美元,2025-2033年期间的复合年增长率为11.32%。北美在ADME毒理学检测市场占据明显主导地位,市占率达41.5%。该地区凭藉先进的医疗基础设施、高额的研发投入、预测性检测技术的广泛应用以及对药物安全性和有效性标准的监管重视,推动着ADME毒理学检测市场的发展。
减少药物发现后阶段失败的重要性日益凸显,这是ADME毒理学测试市场发展的关键驱动力。製药和生物技术公司日益注重创新现代ADME毒理学方法,这对于早期评估吸收、分布、代谢和排泄特征以及毒性风险至关重要。这一持续的进步正在促进药物开发领域的持续成长。例如,贝克曼库尔特生命科学公司在2024年迈出了革命性的一步,引入了Cydem VT自动克隆筛选系统。该系统能够自动建构细胞株,步骤减少90%,使生物药物发现成为一个完全被动的过程。这种方法最大限度地减少了临床试验期间代价高昂的挫折,增强了药物安全性,并加快了新疗法的上市时间。监管机构对严格的临床前测试标准的需求日益增长,进一步推动了相关方法的采用,使ADME毒理学测试成为现代药物发现和开发流程中的关键组成部分,从而推动了市场的显着增长。
美国凭藉其创新的製药和生物技术领域、重要的药物研发研究以及严格的药品安全监管措施,其ADME毒理学检测市场正呈现快速成长。例如,2024年,Insilico Medicine在2024年AACR年会上展示了五个临床前癌症药物计画。该公司的AI平台开发了小分子抑制剂,包括针对TEAD的ISM6331和FGFR2/FGFR3双重抑制剂ISM8001,后者在临床前模型中显示出80%-120%的肿瘤生长抑制率。 Insilico也建立了合作伙伴关係,包括与Exelixis达成的8,000万美元协议以及与Menarini达成的5亿美元协议,以开发更多癌症治疗方案。此外,高通量筛选和电脑模拟模拟等先进技术的整合,以及学术界和产业界之间日益增长的合作,推动了对精准毒理学检测解决方案的需求,巩固了美国在ADME检测创新领域的领导地位。
慢性病盛行率不断上升
推动ADME毒理学测试行业成长的主要因素之一是全球慢性病的增加。癌症、糖尿病和心血管疾病等严重疾病都需要研发大量新药。世界卫生组织表示,非传染性疾病(NCD)每年导致4,100万人死亡,占全球死亡总数的74%。其中,1,700万人在70岁前死亡,而这些早期死亡人数的86%发生在中低收入国家。 ADME毒性测试是确保相关药物安全性和有效性的最重要方法。在世界各地由某些疾病引起的持续健康问题和状况中,人们迫切需要透过药物测试来减少药物的副作用并保障患者的安全。 ADME毒理学测试提供了关于药物如何在体内吸收、分布、代谢和排泄的关键资讯。这个过程对于开发安全有效的慢性病治疗方法至关重要。因此,对治疗慢性病的新药物解决方案的持续需求推动了市场的成长。
技术进步
技术进步正在迅速扩大ADME毒理学测试市场。与传统的体内方法相比,体外和电脑模拟模拟等现代测试流程正日益被采用,其测试选项的准确性、效率和成本效益都显着提高。例如,2024年,Capstan Therapeutics获得1.75亿美元融资,用于推进其体内细胞治疗平台,该平台旨在重新编程体内细胞,并将其主要候选药物推向临床试验。这种新方法对动物试验的依赖程度较低,符合伦理要求,并且能够更快地获得结果。技术进步也促进了高通量筛选方法的创建,使得同时测试多种药物化合物成为可能,从而大大加快了药物开发进程。此外,计算生物学和生物资讯学的进步正在提高ADME毒理学测试的可预测性,从而提高其可靠性和效率。
提高监理合规性
FDA 和 EMA 等机构对药品审批采取的严格监管措施是 ADME 毒理学测试市场的另一个重要驱动力。这些监管机构要求对新药物进行安全性研究,然后才能批准其用于人体。例如,2024 年 4 月,FDA 批准了 Selarsdi 45 mg/0.5 ml 和 90 mg/ml 注射剂用于皮下给药,以治疗 6 岁及以上患者的中度至重度斑块状干癣和活动性干癣性关节炎。因此,ADME 毒理学测试是一个重要组成部分,因为它提供有关对人体健康潜在毒性作用的必要资讯。在新化合物开发过程中,出现了新的复杂性,人们通常对药物引起的毒性更加熟悉,这带来了更严格的监管要求。
不断扩张的製药业
ADME 市场的一个关键驱动力是製药业研发支出的大幅成长。随着企业将更多资源投入新药开发中,对全面 ADME 毒理学测试的需求也随之增长,以确保这些药物的安全性和有效性。此类测试对于在药物开发早期识别潜在的毒性作用和代谢途径至关重要,从而降低后期失败的风险。全球药品总销售额的成长,加上对创新药物需求的不断增长,进一步推动了研发活动。根据一家领先的製药咨询公司最近的分析,未来五年,全球药品总支出和需求将成长,到 2027 年将达到约 1.9 兆美元。此外,新兴药物化合物日益复杂的复杂性导致人们更加依赖先进的 ADME 毒理学研究来了解这些药物在体内的相互作用。严格的监管标准进一步放大了这种需求,这些标准要求在药品审批前进行全面的毒理学测试,从而推动了该领域的成长。
The global ADME toxicology testing market size reached USD 10.3 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 30.2 Billion by 2033, exhibiting a growth rate CAGR of 11.32% during 2025-2033. North America exhibits a clear dominance in the ADME toxicology testing market with a 41.5% share of the market. This region drives the ADME toxicology testing market through advanced healthcare infrastructure, high R&D investments, widespread adoption of predictive testing technologies, and regulatory emphasis on drug safety and efficacy standards.
The growing importance of reducing post-discovery drug phase failures is a key driver for the ADME toxicology testing market. Pharmaceutical and biotechnology companies are increasingly focused on innovating modern ADME toxicology methods, which are essential for early assessment of absorption, distribution, metabolism, and excretion profiles, as well as toxicity risks. This ongoing advancement is contributing to the continued growth of the drug development sector. For example, in 2024, Beckman Coulter Life Sciences took the revolutionary step of bringing in the Cydem VT Automated Clone Screening System, a process that has the capacity of automatically developing a cell line with 90% fewer steps, thus making biological drug discovery a completely passive process. This approach minimizes costly setbacks during clinical trials, enhances drug safety profiles, and accelerates time-to-market for new therapies. Regulatory authorities' growing demand for stringent preclinical testing standards further bolsters adoption, positioning ADME toxicology testing as a critical component in modern drug discovery and development pipelines, driving significant market growth.
The United States is demonstrating magnifying growth in the ADME toxicology testing market due to its innovative pharmaceutical and biotechnology sectors, significant drug development research, and strict regulatory measures for the safety of drugs. For example, in 2024, Insilico Medicine presented five preclinical cancer drug programs at the 2024 AACR Annual Meeting. The company's AI platform developed small-molecule inhibitors, including ISM6331 targeting TEAD and ISM8001, a dual FGFR2/FGFR3 inhibitor, which showed 80-120% tumor growth inhibition in preclinical models. Insilico also secured partnerships, including an $80M deal with Exelixis and a $500M agreement with Menarini for additional cancer treatments. Additionally, the integration of advanced technologies like high-throughput screening and in silico modeling, alongside growing collaborations between academia and industry, fuels the demand for precise toxicology testing solutions, reinforcing the U.S.'s leadership in ADME testing innovation.
Increasing Prevalence of Chronic Diseases
One of the principal factors driving growth in the ADME toxicology testing sector is the rise of chronic diseases worldwide. Serious ailments such as cancer, diabetes, and cardiovascular diseases need the need for lots of new medicines to be researched and developed. The World Health Organization says noncommunicable diseases (NCDs) cause 41 million deaths each year, making up 74% of all deaths globally. Of these, 17 million people die before age 70, with 86% of these early deaths happening in low- and middle-income countries. ADME toxicity testing stands out as the most important method of ensuring the safety and efficacy of the pharmaceuticals concerned. In the midst of the continued health problems and conditions caused by some diseases all over the world, there is a big need for the reduction of side effects of drugs as well as the safety of patients through drug testing. ADME toxicology testing provides crucial information on how drugs are absorbed, distributed, metabolized, and eliminated by the body. This process is essential for developing safe and effective treatments for chronic conditions. Thus, this continued demand for new pharmaceutical solutions to chronic conditions drives the growth of the market.
Technological Advancements
Technological advancements are rapidly increasing the ADME toxicology testing market. The modern testing processes like in vitro and in silico models over traditional methods of in vivo are increasingly adopted with a lot more accuracy, efficiency, and cost-effectiveness in the testing options. For instance, in 2024, Capstan Therapeutics secured $175 million to advance its in vivo cell therapy platform, which aims to reprogram cells within the body and move its lead candidate into clinical trials. This type of new approach is animal test-dependent to a reduced degree, complies with ethical considerations, and shows quicker results. Technological advances have also facilitated the creation of high-throughput screening methods, where it is possible to test multiple drug compounds at the same time, greatly speeding up the drug development process. In addition, the progress in computational biology and bioinformatics is improving the predictability of ADME toxicology tests, thus increasing their reliability and efficiency.
Increasing Regulatory Compliance
The strict regulatory measures made by authorities like the FDA and EMA for drug approval are another significant driver for the ADME Toxicology Testing market. These regulatory agencies require safety studies of novel drug substances to be conducted before the latter can be approved for human use. For example, in April 2024, the FDA approved Selarsdi 45 mg/0.5 ml and 90 mg/ml injections for subcutaneous administration to treat moderate to severe plaque psoriasis and active psoriatic arthritis in patients aged 6 and older. Thus, ADME toxicology testing is an important component since it provides necessary information on potential toxic effects on human health. In new compound development, new complexity emerges where people, in general, are much more sophisticated in drug-induced toxicities, and this brings stronger regulatory requirements.
Expanding Pharmaceutical Industry
A key driver of the ADME market is the substantial rise in research and development spending within the pharmaceutical industry. As companies allocate more resources to developing novel drugs, the demand for thorough ADME toxicology testing grows, ensuring both the safety and effectiveness of these medications. This testing is critical in identifying potential toxic effects and metabolic pathways early in the drug development process, thereby reducing the risk of late-stage failures. Increasing overall sales of pharmaceuticals across the globe coupled with rising demand for innovative drugs is further augmenting research and development. According to a recent analysis from one of the leading pharma consulting firms, the overall spending and global demand for medicines will rise over the next five years to around USD 1.9 Trillion by 2027. Additionally, the increasing complexity of emerging pharmaceutical compounds has led to a greater dependence on advanced ADME toxicology studies to comprehend how these drugs interact within the body. This demand is further amplified by stringent regulatory standards, which require comprehensive toxicology testing prior to drug approval, fueling growth in this sector.
Cell culture leads the market with around 43.6% of the market share in 2024. This recognition is associated with the ability to mimic the behavior of living organisms, producing accurate and reliable data for drug absorption, distribution, metabolism, and excretion research. The application of sophisticated methods, like 3D cell cultures, and organ-on-a-chip models, has significantly increased the significance of cell culture in preclinical studies. Through the ability to decrease the use of animals, testing and to enhance predictive capability, cell culture remains a leader in the development of drugs.
This leadership of software solutions is to a great extent due to their effectiveness in making data analysis more efficient and decision-making more effective in several different industries. Their usage is the most in the fields of healthcare, finance, and logistics for operations such as predictive modeling, automation, and operational optimization. Advanced software, including AI-driven platforms and cloud-based tools, enables organizations to process large datasets accurately and efficiently. The demand for software solutions is further fueled by the need for scalability, cost reduction, and enhanced productivity across diverse applications.
In-vivo leads the market as methods play a crucial role in making toxicology studies more capable and more accurate by giving more sophisticated methods of data analysis, modeling, and simulation. Through the alignment of software and cloud-based AI tools, reliable results of drug absorption, distribution, metabolism, and excretion are obtained, enabling faster and more cost-effective preclinical evaluations. Their integration reduces the reliance on manual processes and animal testing, streamlining drug development pipelines. The growing emphasis on precision and regulatory compliance further drives their adoption.
Systematic toxicity leads the market with around 53.8% of the market share in 2024. This testing focuses on assessing the adverse effects of drug candidates on various organ systems over time, ensuring comprehensive safety evaluations. It plays a critical role in identifying potential long-term and cumulative toxicities that could compromise drug efficacy or patient health. Regulatory bodies emphasize systematic toxicity studies to meet stringent safety standards. Advances in predictive modeling and integration with in-vivo and in-vitro techniques further enhance its precision, solidifying its market leadership.
In 2024, North America accounted for the largest market share of over 41.5%. This leadership is driven by the region's advanced healthcare infrastructure, significant investment in pharmaceutical and biotechnology research, and a strong focus on regulatory compliance. The widespread adoption of advanced technologies, such as high-throughput screening and in-silico modeling, enhances the precision and efficiency of toxicology testing. Additionally, the growing prevalence of chronic diseases and demand for innovative drug therapies further fuel market growth. North America remains at the forefront of innovations and industry advancements in ADME toxicology testing.
United States ADME Toxicology Testing Market Analysis
The US accounts for 84.8% share of the market in North America. The strong pharmaceutical and biotechnology industries in the US are driving the market for ADME toxicity testing. To guarantee drug safety and efficacy, dependable ADME (Absorption, Distribution, Metabolism, and Excretion) testing is essential due to significant investment in drug development and strict regulatory standards enforced by organizations such as the FDA. More than USD 100 Billion was spent on pharmaceutical R&D in the United States in 2022, which greatly increased the need for sophisticated testing techniques. Although this is a rather expanding market, around less than 30% of the newly discovered drugs successfully transition to Phase III clinical trials after passing through Phase II. Examples of technology revolutions that are saving costs and time in the testing procedures are high-throughput screening, as well as in silico testing. More dependence on artificial intelligence by humans in the ADME investigation satisfies the demand for techniques of non-animal testing in which better predictive toxicology becomes feasible. Another area that the U.S. is experiencing is an upsurge in outsourcing ADME services to dedicated CROs for greater efficiency and reduced cost-effectiveness. The development of chronic diseases and customized therapies also generates a high need for precise toxicological tests. For example, accurate profiles for ADME are a significant requirement for targeted anticancer therapy. Intersectoral agreements of the government with the private sectors and the academia-like NIH's NCATS program-is supporting the market to grow as well. The U.S. industry is likely to lead with a healthy compound annual growth rate (CAGR) propelled by ongoing innovation and regulatory compliance.
Europe ADME Toxicology Testing Market Analysis
Due to strict regulatory frameworks, including the European Medicines Agency's (EMA) recommendations for medication safety assessment, Europe is a major player in the ADME toxicity testing market. Key contributions include nations like Germany, the United Kingdom, and France, which profit from robust pharmaceutical industries and significant R&D expenditures. the pharmaceutical business made a substantial contribution to the EU economy in 2022, contributing Euro 311 Billion (USD 326 Billion). However, according to the most recent data from the European Federation of Pharmaceutical Industries and Associations (EFPIA), Europe's R&D investment growth has averaged 4.4% per year since 2010. The region's focus on minimizing animal testing is consistent with developments in substitute techniques like as computational toxicology and organ-on-a-chip technology. The need for thorough toxicological testing is further fuelled by programs like REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals), particularly for environmental safety. ADME testing is required due to the rising incidence of lifestyle-related diseases such as diabetes and cardiovascular problems, which drive medication development efforts. Furthermore, the necessity for accurate ADME profiling is increased by Europe's emphasis on biologics and personalised treatment. With a growing ecosystem of CROs and government support for innovative research, the market is projected to grow steadily in the coming years.
Asia Pacific ADME Toxicology Testing Market Analysis
The market for ADME toxicity testing is growing quickly in Asia-Pacific due to the expansion of pharmaceutical manufacturing in nations like China and India. Global pharmaceutical companies are drawn to the region's affordable drug development capabilities, which increases demand for ADME testing services. As Asia accounts for a growing share of their global revenues and, more significantly, most of their growth, many multinational pharmaceutical firms are witnessing this personally. As per several industrial reports, about 20% to 30% of their 2021 sales came from Asia, with China accounting for about half of that total. More than 220 novel treatments have been approved since China joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the period between China's approval and the first approval has been reduced. Government programs like China's emphasis on developing breakthrough medicines and India's "Pharma Vision 2020" also help the market grow. Adoption of ADME testing is fuelled by the incidence of chronic diseases and rising healthcare costs, which increase the demand for safer medications. To satisfy the region's expanding needs, technological innovations including automated testing and high-throughput are being adopted. Asia-Pacific is expected to grow at a faster rate than the rest of the world, making it a major hub for ADME toxicity testing services.
Latin America ADME Toxicology Testing Market Analysis
The market for ADME toxicity testing is expanding in Latin America owing to increased pharmaceutical research and development as well as growing healthcare consciousness. Due in large part to expanding domestic drug production and government funding for research projects, Brazil, Mexico, and Argentina are major producers. Due to the region's emphasis on generic and biosimilar medications, significant ADME testing is required for regulatory clearance. Testing skills are further improved by collaborations between domestic and international pharmaceutical businesses. The need for safe and efficient drugs is also fuelled by the increase in chronic illnesses and easier access to healthcare systems. With its growing pharmaceutical infrastructure and affordable services, Latin America offers a profitable market. Moreover, in Latin America and the Caribbean, chronic conditions like heart disease, cancer, and diabetes are leading contributors to death and disability worldwide. Diabetes affects one in ten adults, while nearly 80% of fatalities are linked to these long-term illnesses, as per an industrial report.
Middle East and Africa ADME Toxicology Testing Market Analysis
The MENA region is experiencing a troubling increase in chronic conditions. Heart disease, diabetes, cancer, and respiratory disorders represent a substantial share of the region's overall health challenges. According to the World Health Organization (WHO), NCDs account for approximately 70% of deaths in the region. Urbanization, sedentary lifestyles, unhealthy diets, tobacco use, and obesity contribute to the high prevalence of these diseases. The increased pharmaceutical investments in nations like South Africa and the United Arab Emirates are driving growth in the Middle East and Africa (MEA) ADME toxicity testing market. The need for ADME services is increased by growing healthcare infrastructure and government funding for research and development. The necessity for accurate toxicological testing is fuelled by the region's rising clinical trials and high prevalence of infectious diseases. Partnerships with international pharmaceutical companies also improve local testing capacities. The MEA market is anticipated to increase steadily as knowledge of cutting-edge ADME technology rises, albeit more slowly than in other areas.
Market leaders are pursuing strategic actions to strengthen their market position. These efforts involve mergers and acquisitions to broaden their range of services, partnerships with pharmaceutical firms for early-stage toxicity evaluations, and the creation of advanced technologies for ADME testing. Additionally, market leaders are focusing on geographic expansion, especially in high-growth regions like Asia-Pacific and Latin America, to tap into emerging markets. For instance, in 2024, BioIVT showcased its new Ki67 tissue staining service for ADC development at Biomarkers U.S. 2024 and SITC 2024, emphasizing its commitment to advancing drug and diagnostic research.