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市場調查報告書
商品編碼
1372020
2030 年臨床試驗市場預測:按階段、服務類型、治療領域、研究設計、申辦者、應用和地區進行的全球分析Clinical Trials Market Forecasts to 2030 - Global Analysis By Phase, Service Type, Therapeutic Area, Study Design, Sponsor, Application and By Geography. |
根據 Stratistics MRC 的數據,2023 年全球臨床試驗市場規模為 536.8 億美元,預計到 2030 年將達到 908.1 億美元,預測期內年複合成長率為 7.8%。
臨床試驗本質上是研究人員對人類進行的研究,目的是發現新的治療方法,例如新藥物、用餐或醫療設備。它也用於確定它對人們是否安全有效。這些臨床試驗旨在推動醫學知識、改善醫療保健,並為醫療專業人員、法規和患者做出明智的資訊提供實證資訊。臨床試驗可應用於藥物開發、疫苗測試、醫療設備評估、行為介入、癌症研究、基因研究等。
世界心臟聯合會發布的報告顯示,心血管疾病持續影響全球超過5億人,到2021年將導致2050萬人死亡,成為全球頭號死因,佔總死亡人數的近三分之一。 CVD導致的死亡人數比預計的1.21 億人增加。
印度、中國、巴西和東歐國家等新興國家因其龐大且多樣化的患者群體、熟練的醫療專業人員以及具有成本效益的試驗實踐,為臨床試驗提供了有吸引力的環境。由於快速招募參與者、降低試驗成本和縮短試驗時間表的潛力,申辦者和委外研發機構(CRO) 被這些地區所吸引。此外,全球化將透過更廣泛地代表不同種族和人口統計數據以及更好地了解治療在不同人群中的有效性和安全性來幫助應對全球健康挑戰。這促進了醫療保健和醫學領域的創新和進步,並有助於建立一個強大而充滿活力的臨床試驗市場。因此,市場成長的需求不斷增加。
進行臨床試驗的高成本是臨床試驗市場的主要抑制因素。研究和開發成本、受試者招募、試驗管理、資料收集和法律規章合規性是主要的財務負擔因素。此外,滿足不斷變化的法規要求的成本進一步增加了財務負擔。將新藥和治療方法推向市場的成本不斷急劇上升,使得小型組織和學術機構難以資助試驗。因此,這抑制了市場需求。
生物技術和製藥行業研發 (R&D) 活動的活性化代表了臨床試驗市場的主要商機。這兩個行業都在創新藥物、生技藥品、醫療設備和治療方法的發現和開發方面進行了大量投資,以治療各種疾病和健康狀況。對疾病分子基礎的了解和先進技術的可用性的進步正在支持研究和開發工作。生物技術專注於利用活的有機體和生物系統來開發產品和技術,並為藥物開發開闢了新的途徑。同時,製藥業正在透過計算模型、高通量篩選和其他先進方法積極研究和創造新化合物以及傳統藥物。因此,臨床試驗市場預計將出現利潤豐厚的成長。
臨床試驗專業人才的短缺對臨床試驗市場構成重大威脅。進行臨床試驗需要多學科專家團隊,包括臨床研究人員、臨床實驗協調員、資料管理員、法規專家和生物統計學家。隨著臨床試驗的增加和複雜性,對這些專業人員的需求正在迅速增加。然而,缺乏訓練有素、經驗豐富的人員來滿足這項需求。這種不足可能會導致臨床試驗進行延遲、資料品質不佳以及業務成本增加。因此,這是市場拓展的主要障礙。
COVID-19大流行的影響減緩了大流行期間的市場成長。 COVID-19 突然爆發後,由於封鎖法規和資源匱乏,許多臨床研究被擱置。然而,許多製藥和生物技術公司已將重點轉向開發針對 SARS-CoV-2 病毒的藥物、檢測套組和疫苗。這些公司越來越注重與 CRO 服務提供者在研發和臨床研究方面的合作和夥伴關係。在臨床試驗領域,人們對虛擬/分散式試驗越來越感興趣,它們長期以來一直出現在會議議程和報導中。
第三階段預計將佔據最大佔有率。臨床試驗市場的第三階段是藥物、治療和療法等醫療干涉措施開發和評估的關鍵階段。 III 期臨床試驗非常複雜,需要強大的技術和可靠的臨床資源來有效地招募患者、快速推出試驗地點並經濟有效地管理試驗。它被視為臨床試驗。此外,在第三階段臨床試驗中,研究人員仔細收集資料以確認和擴展早期階段。目的是證明具有統計意義的結果,並將介入措施與標準護理、安慰劑或其他相關比較物進行比較。
由於製藥和生物技術行業的持續成長,對全面有效的資料管理服務的需求不斷增加,預計臨床試驗資料管理服務行業將在預測期內出現良好的成長。該服務包括臨床試驗期間產生的資料的系統收集、整合和管理。這些服務確保收集的資料準確、可靠並符合法規要求。臨床試驗資料管理服務包括資料庫設計、資料輸入、資料檢驗、編碼、品管和資料庫鎖定等各種活動。它還有助於識別潛在的安全問題,評估經過測試的干涉措施的有效性,並最終影響醫學決策。
在估計期間,北美佔據了最大的市場佔有率。在北美,由於多種因素的影響,市場正在擴大,包括感染疾病和慢性病患病率的上升、對個體化治療的需求以及蓬勃發展的製藥部門的存在。該地區的法規環境也很有利,FDA 在核准和監督臨床試驗方面發揮關鍵作用。隨著疫苗和治療研究的不斷增加,COVID-19大流行也推動了北美臨床試驗市場的成長。因此,該地區強大的醫療基礎設施、有利的政府政策等預計將推動北美臨床試驗市場的成長。
由於患者人數的增加和負擔得起的治療,預計亞太地區在預測期內將出現有益的成長。亞太臨床試驗市場具有良好的市場開拓潛力。這是由於該地區負擔得起的臨床試驗、生產設施的擴張、支持性的政府法規以及製藥業務的擴張。較低的成本、更大的治療人群、保留臨床試驗參與者以及法規程序的持續改進是該地區臨床試驗活動增加的主要驅動力。由於這些優勢,許多製藥、生物製藥和醫療設備公司現在將其臨床試驗業務委託給該領域的 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.