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市场调查报告书
商品编码
1372020
2030 年临床试验市场预测:按阶段、服务类型、治疗领域、研究设计、申办者、应用和地区进行的全球分析Clinical Trials Market Forecasts to 2030 - Global Analysis By Phase, Service Type, Therapeutic Area, Study Design, Sponsor, Application and By Geography. |
根据 Stratistics MRC 的数据,2023 年全球临床试验市场规模为 536.8 亿美元,预计到 2030 年将达到 908.1 亿美元,预测期内年复合成长率为 7.8%。
临床试验本质上是研究人员对人类进行的研究,目的是发现新的治疗方法,例如新药物、用餐或医疗设备。它也用于确定它对人们是否安全有效。这些临床试验旨在推动医学知识、改善医疗保健,并为医疗专业人员、法规和患者做出明智的资讯提供实证资讯。临床试验可应用于药物开发、疫苗测试、医疗设备评估、行为介入、癌症研究、基因研究等。
世界心臟联合会发布的报告显示,心血管疾病持续影响全球超过5亿人,到2021年将导致2050万人死亡,成为全球头号死因,占总死亡人数的近三分之一。 CVD导致的死亡人数比预计的1.21 亿人增加。
印度、中国、巴西和东欧国家等新兴国家因其庞大且多样化的患者群体、熟练的医疗专业人员以及具有成本效益的试验实践,为临床试验提供了有吸引力的环境。由于快速招募参与者、降低试验成本和缩短试验时间表的潜力,申办者和委外研发机构(CRO) 被这些地区所吸引。此外,全球化将透过更广泛地代表不同种族和人口统计数据以及更好地了解治疗在不同人群中的有效性和安全性来帮助应对全球健康挑战。这促进了医疗保健和医学领域的创新和进步,并有助于建立一个强大而充满活力的临床试验市场。因此,市场成长的需求不断增加。
进行临床试验的高成本是临床试验市场的主要抑制因素。研究和开发成本、受试者招募、试验管理、资料收集和法律规章合规性是主要的财务负担因素。此外,满足不断变化的法规要求的成本进一步增加了财务负担。将新药和治疗方法推向市场的成本不断急剧上升,使得小型组织和学术机构难以资助试验。因此,这抑制了市场需求。
生物技术和製药行业研发 (R&D) 活动的活性化代表了临床试验市场的主要商机。这两个行业都在创新药物、生技药品、医疗设备和治疗方法的发现和开发方面进行了大量投资,以治疗各种疾病和健康状况。对疾病分子基础的了解和先进技术的可用性的进步正在支持研究和开发工作。生物技术专注于利用活的有机体和生物系统来开发产品和技术,并为药物开发开闢了新的途径。同时,製药业正在透过计算模型、高通量筛选和其他先进方法积极研究和创造新化合物以及传统药物。因此,临床试验市场预计将出现利润丰厚的成长。
临床试验专业人才的短缺对临床试验市场构成重大威胁。进行临床试验需要多学科专家团队,包括临床研究人员、临床实验协调员、资料管理员、法规专家和生物统计学家。随着临床试验的增加和复杂性,对这些专业人员的需求正在迅速增加。然而,缺乏训练有素、经验丰富的人员来满足这项需求。这种不足可能会导致临床试验进行延迟、资料品质不佳以及业务成本增加。因此,这是市场拓展的主要障碍。
COVID-19大流行的影响减缓了大流行期间的市场成长。 COVID-19 突然爆发后,由于封锁法规和资源匮乏,许多临床研究被搁置。然而,许多製药和生物技术公司已将重点转向开发针对 SARS-CoV-2 病毒的药物、检测套组和疫苗。这些公司越来越注重与 CRO 服务提供者在研发和临床研究方面的合作和伙伴关係。在临床试验领域,人们对虚拟/分散式试验越来越感兴趣,它们长期以来一直出现在会议议程和报导中。
第三阶段预计将占据最大份额。临床试验市场的第三阶段是药物、治疗和疗法等医疗干预措施开发和评估的关键阶段。 III 期临床试验非常复杂,需要强大的技术和可靠的临床资源来有效地招募患者、快速推出试验地点并经济有效地管理试验。它被视为临床试验。此外,在第三阶段临床试验中,研究人员仔细收集资料以确认和扩展早期阶段。目的是证明具有统计意义的结果,并将介入措施与标准护理、安慰剂或其他相关比较物进行比较。
由于製药和生物技术行业的持续增长,对全面有效的资料管理服务的需求不断增加,预计临床试验资料管理服务行业将在预测期内出现良好的增长。该服务包括临床试验期间产生的资料的系统收集、整合和管理。这些服务确保收集的资料准确、可靠并符合法规要求。临床试验资料管理服务包括资料库设计、资料输入、资料检验、编码、品管和资料库锁定等各种活动。它还有助于识别潜在的安全问题,评估经过测试的干预措施的有效性,并最终影响医学决策。
在估计期间,北美占据了最大的市场占有率。在北美,由于多种因素的影响,市场正在扩大,包括感染疾病和慢性病患病率的上升、对个体化治疗的需求以及蓬勃发展的製药部门的存在。该地区的法规环境也很有利,FDA 在核准和监督临床试验方面发挥关键作用。随着疫苗和治疗研究的不断增加,COVID-19大流行也推动了北美临床试验市场的成长。因此,该地区强大的医疗基础设施、有利的政府政策等预计将推动北美临床试验市场的成长。
由于患者人数的增加和负担得起的治疗,预计亚太地区在预测期内将出现有益的增长。亚太临床试验市场具有良好的市场开拓潜力。这是由于该地区负担得起的临床试验、生产设施的扩张、支持性的政府法规以及製药业务的扩张。较低的成本、更大的治疗人群、保留临床试验参与者以及法规程序的持续改进是该地区临床试验活动增加的主要驱动力。由于这些优势,许多製药、生物製药和医疗设备公司现在将其临床试验业务委託给该领域的 CRO。
According to Stratistics MRC, the Global Clinical Trials Market is accounted for $53.68 billion in 2023 and is expected to reach $90.81 billion by 2030 growing at a CAGR of 7.8% during the forecast period. Clinical trials are basically research studies performed by researchers on people that are aimed at finding out a new treatment, like a new drug, diet, or medical device. It is also used to find out whether it is safe and effective for people. These trials aim to advance medical knowledge, improve healthcare, and provide evidence-based information for informed decision-making by healthcare professionals, regulators, and patients. Clinical trials apply to drug development, vaccine testing, medical device evaluation, behavioural interventions, cancer research, and genetic studies.
According to a report published by the World Heart Federation, Cardiovascular illnesses continue to impact more than half a billion people worldwide and were responsible for 20.5 million deaths in 2021, or close to a third of all deaths worldwide, and a rise from the anticipated 121 million CVD fatalities.
Emerging economies, such as India, China, Brazil, and Eastern European nations, provide attractive environments for clinical trials due to their large and varied patient populations, skilled medical professionals, and cost-effective trial conduct. Sponsors and contract research organisations (CROs) are drawn to these regions because of the potential for quicker participant recruitment, reduced trial costs, and accelerated trial timelines. Additionally, globalisation helps address global health challenges by ensuring a broader representation of ethnicities and demographics, leading to a better understanding of treatment efficacy and safety across diverse populations. This will contribute to a robust and dynamic clinical trials market, fostering innovation and advancements in healthcare and pharmaceuticals. Therefore, there is an increasing demand for market growth.
The high costs associated with conducting clinical trials present a significant restraint in the clinical trials market. Research and development expenses, participant recruitment, trial management, data collection, and regulatory compliance contribute to the substantial financial burden. Additionally, the expense of addressing evolving regulatory requirements further amplifies the financial strain. The cost of bringing a new drug or treatment to market is consistently escalating, making it challenging for smaller organisations and academic institutions to fund trials. Thus, this factor is hampering market demand.
The rise in research and development (R&D) activities within the biotechnology and pharmaceutical industries represents a significant opportunity in the clinical trials market. Both sectors are investing extensively in the discovery and development of innovative drugs, biologics, medical devices, and therapies to address a wide array of diseases and health conditions. The advancement in understanding the molecular basis of diseases, coupled with the availability of sophisticated technologies, has propelled R&D efforts. Biotechnology, with its focus on utilising living organisms and biological systems to develop products and technologies, has opened new avenues for drug development. The pharmaceutical industry, on the other hand, is actively researching and creating traditional drugs as well as novel compounds through computational modelling, high-throughput screening, and other advanced methodologies. Thus, there is a lucrative growth for clinical trials market.
The shortage of skilled professionals in clinical trials poses a significant threat to the clinical trials market. Conducting trials requires a multidisciplinary team of experts, including clinical researchers, trial coordinators, data managers, regulatory specialists, and biostatisticians. The demand for these professionals is rapidly increasing due to the growing number and complexity of clinical trials. However, there is a shortage of adequately trained and experienced personnel to meet this demand. This scarcity can lead to delays in trial execution, compromised data quality, and increased operational costs. Therefore, it is a significant barrier to market expansion.
The impact of COVID-19 pandemic resulted in the slow growth of the market during the pandemic. Many clinical studies were put on hold after the sudden outbreak of COVID-19 due to lockdown restrictions and the low presence of resources. However, many pharmaceutical and biotechnological companies increased their focus on the development of drugs, test kits, and vaccines against the SARS-CoV-2 virus. These companies increased their focus on collaboration and partnership with CRO service providers for R&D and clinical studies. There has been an increased interest in virtual/decentralized trials in the clinical trial space, and those have been featured on conference agendas and in articles for a long time.
The Phase 3 segment is estimated to hold the largest share. The Phase 3 segment of the clinical trials market represents a crucial stage in the development and evaluation of medical interventions, such as drugs, treatments, or therapies. Phase III clinical trials are considered complex clinical trials that require both robust technologies and reliable clinical resources to recruit patients efficiently, initiate sites quickly, and provide cost-effective study management. Furthermore, during Phase 3 trials, researchers carefully gather data to confirm and extend the findings from earlier phases. They aim to demonstrate statistically significant results and compare the intervention against standard treatments, placebos, or other relevant comparators.
The Clinical Trial Data Management Services segment is anticipated to have lucrative growth during the forecast period, owing to the increase in demand for comprehensive and effective data management services as the pharmaceutical and biotechnology sectors continue to grow. It involves the systematic collection, integration, and management of data generated during clinical trials. These services ensure that the data collected is accurate, reliable, and in compliance with regulatory requirements. Clinical Trial Data Management Services encompass a range of activities, including database design, data entry, data validation, coding, quality control, and database lock. Also, it helps in identifying potential safety concerns, evaluating the efficacy of the tested interventions, and ultimately influencing medical decision-making.
North America commanded the largest market share during the extrapolated period. The market is expanding in North America due to a number of factors, including the rising incidence of infectious and chronic diseases, the demand for personalised treatment, and the existence of a thriving pharmaceutical sector. The regulatory climate in the area is also supportive, with the FDA playing a key role in the approval and supervision of clinical trials. With an increase in vaccine and therapy studies, the COVID-19 pandemic has also fuelled growth in the North American clinical trials market. As a result, the region's robust healthcare infrastructure, favourable government policies, and other factors are projected to fuel the growth of the North American clinical trials market.
Asia-Pacific region is expected to witness profitable growth over the projection period, due to the growing patient base and affordable treatments. The clinical trials market has excellent development potential in Asia and the Pacific. This can be attributed to the region's affordable clinical trials, expanding manufacturing facilities, enacting supportive government regulations, and expanding pharmaceutical business. Cost savings, a large treatment population, participant retention in clinical trials, and ongoing regulatory procedural improvements are mostly responsible for the rise of clinical trial activities in the area. Most pharmaceutical, biopharmaceutical, and medical device companies now outsource their clinical trial work to CROs in this sector due to these advantages.
Some of the key players in the Clinical Trials Market include: Parexel, IQVIA, Pharmaceutical Product Development, LLC, Wuxi AppTec Inc, Charles River Laboratory ICON Plc, Syneos Health, SGS SA, Chiltern International Ltd, Novo Nordisk A/S, Clinipace, Pfizer, Omnicare, Laboratory Corporation of America Holdings, Medpace Holdings, Inc. and Lilly.
In March 2023, Syneos Health entered into a multiyear agreement with Microsoft to create a platform that uses machine learning to elevate biopharma companies' commercial performance and speed up clinical trial analysis, planning, and operation.
In March 2023, LEO Pharma and ICON plc announced a strategic partnership that will enable LEO Pharma to scale clinical trial execution in a patient-centric and cost-effective way. The partnership would also support LEO Pharma's overall ambition of building one of the most effective and efficient clinical portfolio execution organizations in the industry.
In February 2023, Syneos Health partnered with Haystack Health, a Roivant Health portfolio company engaged in developing advanced artificial intelligence (AI) and natural language processing (NLP) solutions to improve the identification and enrollment of patients for clinical trials.
In February 2023, Parexel launched a new expert series, New Medicines, Novel Insights. The series features fresh insights from the company's global, cross-functional experts analyzing drug development trends and offering evidence-based guidance to the biopharmaceutical industry.
In January 2023, Rznomics announced a partnership with Charles River Laboratories International, Inc., a viral vector contract development and manufacturing organization (CDMO). Rznomics would leverage Charles River's viral vector CDMO experience to initiate clinical development of its RNA-based anticancer gene therapy in liver cancer patients.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.