市場調查報告書
商品編碼
1378981
臨床前 CRO 市場:2023-2028 年全球產業趨勢、佔有率、規模、成長、機會與預測Preclinical CRO Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028 |
2022年,全球臨床前CRO市場規模達到56億美元。展望未來, IMARC Group預計到2028年該市場將達到87億美元,2022-2028年複合年成長率(CAGR)為7.6%。研發(R&D)活動支出不斷增加、監管環境日益複雜、公司對核心能力的日益關注以及專業治療的最新進展是推動市場的一些主要因素。
臨床前合約研究組織(CRO)是指為生物技術、製藥和醫療器材產業提供各種研發(R&D)服務的公司。它提供一系列服務,例如毒理學研究、藥物動力學、製劑開發、監管支持和藥效學研究。臨床前 CRO 在藥物發現、醫療器材測試、生物相容性、疾病建模、安全藥理學和劑型選擇方面有著廣泛的應用。它有助於加快產品開發、增強法規遵循、利用專業知識、最佳化資源管理並提供可擴展的研究解決方案。
公司對核心能力的日益關注正在促進對臨床前 CRO 的需求,以減輕專門的臨床前任務並將更多資源投入其主要領域,例如後期臨床試驗或行銷。此外,由於發展中國家製藥業為應對獨特的醫療保健挑戰而迅速擴張,以及患者人數不斷成長,對臨床前 CRO 的需求不斷成長,這也支撐了市場的成長。此外,個人化醫療、生物製劑和基因療法等專業治療的最新進展需要細緻的臨床前測試,這也是另一個生長誘導因素。除此之外,由於藥物開發的高失敗率,臨床前 CRO 的廣泛採用為公司提供了風險平衡的方法,這也促進了市場的成長。除此之外,在成功的臨床前研究中發揮關鍵作用的尖端技術的引入正在支持市場成長。
研究與開發 (R&D) 活動支出不斷成長
製藥和生物製藥行業的成長和活力與其對研發的承諾密不可分。對新穎療法、更有效的治療方法和突破性醫療解決方案的追求促使公司大力投資研發活動。隨著疾病的變異和新的健康問題的出現,人們永遠需要創新的藥物和醫療設備。這種持續的創新驅動需要廣泛的臨床前研究,這些研究通常外包給 CRO,以利用他們的專業知識和設施。此外,搶先上市的競爭進一步加劇了研發工作。據此,外包臨床前研究使公司能夠快速進入藥物開發的初始階段,從而確保從實驗室到患者的及時有效的路徑。
監管環境日益複雜
全球製藥格局正受到多方面、嚴格的監管框架的審查。這些監管機構制定了嚴格的標準,以確保各種產品的品質、安全性和功效。滿足這些全面的要求需要專業知識、精確性和大量的文檔,這對許多公司來說往往是難以承受的。這就是臨床前 CRO 的專業知識變得無價的地方。這些組織善於理解、駕馭並確保遵守此類複雜的法規。他們專注於臨床前研究,確保他們隨時了解最新的監管變化、採用最佳實踐並維護符合全球標準的最先進的設施。此外,這有助於製藥公司遵守監管要求,並最大限度地減少潛在的挫折,從而節省時間和資源。
藥物開發過程的成本不斷增加
藥物開發是一項資本密集型工作,公司在藥物的生命週期上投入大量資金。包括臨床前研究在內的初始階段尤其重要,因為它們為後續臨床階段奠定了基礎。然而,在這些早期階段建立和維護內部設施、技術和專業知識可能非常昂貴。透過外包給臨床前 CRO,公司可以實現顯著的成本效率。 CRO 提供可擴展的解決方案,讓公司為其所需的特定服務付費。此外,由於其專注的性質,CRO 通常具有規模經濟,將成本效益傳遞給客戶。在財務審慎至關重要的世界中,外包臨床前研究提供了平衡品質研究與經濟考量的途徑。
IMARC Group提供了全球臨床前 CRO 市場報告各細分市場的主要趨勢分析,以及 2023-2028 年全球、區域和國家層面的預測。我們的報告根據服務和最終用途對市場進行了分類。
生物分析和 DMPK 研究
毒理學測試
其他
毒理學測試主導市場
該報告根據服務提供了詳細的市場細分和分析。這包括生物分析和 DMPK 研究、毒理學測試等。根據該報告,毒理學測試代表了最大的市場領域。
由於全球衛生當局製定了嚴格的監管要求,以確保識別對人類健康的潛在不利影響,毒理學測試正在主導市場。此外,隨著藥物變得越來越複雜,了解與生物系統潛在的毒性交互作用變得更加重要。現代藥物,特別是基於新作用機製或生物製劑的藥物,需要徹底的毒理學評估。此外,由於安全問題,許多候選藥物在開發過程中失敗。臨床前階段的毒理學測試有助於及早識別潛在的危險訊號,透過防止不合適候選者的進展,為公司節省大量時間和財務資源。除此之外,體外毒理學、計算建模和高通量篩選等先進技術的出現,增強了毒理學研究的能力並提供更詳細和快速的見解,正在推動市場成長。
生物製藥公司
政府和學術機構
醫療器材公司
生物製藥公司主導市場
該報告根據最終用途提供了詳細的市場細分和分析。這包括生物製藥公司、政府和學術機構以及醫療器材公司。報告稱,生物製藥公司代表了最大的細分市場。
由於生物製劑(包括單株抗體、重組蛋白和基因療法)的不斷發展,生物製藥公司正在主導市場,這些生物製劑需要徹底的臨床前評估,通常需要 CRO 提供的專業知識。此外,生物製藥實體正在大力投資研發,這轉化為大量的臨床前活動,其中許多活動被外包給 CRO 以提高效率和專業知識。除此之外,生物製劑的開發涉及使用活細胞的複雜生產過程。這種複雜性需要專門的臨床前研究,包括對潛在雜質或污染物的評估。此外,生物製藥因其潛在的免疫原性和獨特的作用機製而受到嚴格的監管審查,這往往需要臨床前 CRO 提供詳細和專業的服務。
北美洲
美國
加拿大
亞太
中國
日本
印度
韓國
澳洲
印尼
其他
歐洲
德國
法國
英國
義大利
西班牙
俄羅斯
其他
拉丁美洲
巴西
墨西哥
其他
中東和非洲
北美市場佔據明顯主導地位,佔據最大的臨床前CRO市場佔有率
該報告還對所有主要區域市場進行了全面分析,其中包括北美(美國和加拿大);亞太地區(中國、日本、印度、韓國、澳洲、印尼等);歐洲(德國、法國、英國、義大利、西班牙等);拉丁美洲(巴西、墨西哥等);以及中東和非洲。報告稱,北美是最大的細分市場。
由於許多領先的製藥和生物技術公司的存在,北美在臨床前 CRO 市場佔據主導地位,這與臨床前研究服務需求的增加直接相關。此外,區域公司在研發 (R&D) 投資方面始終處於領先地位。這種對創新的承諾推動了對臨床前研究的巨大需求,從而推動了對專業 CRO 服務的需求。此外,北美領先的大學和研究機構提供最先進的基礎設施並進行尖端研究。這個複雜的生態系統經常與 CRO 合作並補充其服務。除此之外,地方政府對藥品安全提出嚴格的監管要求,也促進了對臨床前合約研究機構滿足嚴格要求並順利通過複雜核准流程的需求。
臨床前 CRO 市場的頂尖公司正在擴大其產品組合,以提供端到端解決方案,涵蓋從早期發現到臨床前開發的所有內容,確保客戶能夠在同一屋簷下獲得全套服務。此外,該公司正在投資體外毒理學、高通量篩選和計算建模等技術,以增強其臨床前研究能力。此外,他們還透過建立新設施、升級現有設施或收購區域參與者來擴大全球業務。除此之外,一些市場參與者正在吸引頂尖人才並專注於持續培訓,以確保他們的團隊隨時了解最新的科學進展和監管變化。此外,他們正在與製藥公司建立長期合作,以簡化藥物開發流程、減少冗餘並促進各方之間更深入的了解。
查爾斯河實驗室公司
科文斯公司(美國實驗室控股公司)
歐陸科技
圖示公司
MD Biosciences Inc.(傳銷醫學實驗室)
醫療空間
精銳國際公司
PPD公司
無錫藥明康德
2021年3月,Charles River Laboratories Inc.收購了Retrogenix,這是一家提供專業生物分析服務的早期CRO。
2020年10月,科文斯公司(美國實驗室控股公司)宣布轉型為去中心化的CRO。
2021 年 2 月,ICON Plc 宣布將收購 PRA Health Sciences,以鞏固自身作為 CRO 的地位。
The global preclinical CRO market size reached US$ 5.6 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 8.7 Billion by 2028, exhibiting a growth rate (CAGR) of 7.6% during 2022-2028. The growing expenditure on research and development (R&D) activities, rising complexity of regulatory environment, increasing focus on core competencies among companies, and recent advancements in specialized treatments are some of the major factors propelling the market.
A preclinical contract research organization (CRO) refers to a company that provides various research and development (R&D) services to the biotechnology, pharmaceutical, and medical device industries. It offers a range of services, such as toxicology studies, pharmacokinetics, formulation development, regulatory support, and pharmacodynamics studies. Preclinical CRO finds extensive applications in drug discovery, medical device testing, biocompatibility, disease modeling, safety pharmacology, and dosage form selection. It aids in expediting product development, enhancing regulatory compliance, leveraging specialized expertise, optimizing resource management, and offering scalable research solutions.
The increasing focus on core competencies among companies is facilitating the demand for preclinical CROs to offload specialized preclinical tasks and dedicate more resources to their primary areas, such as late-phase clinical trials or marketing. Additionally, the rising demand for preclinical CRO due to the rapid expansion of the pharmaceutical sector in developing countries to address unique healthcare challenges and the growing patient population is supporting the market growth. Furthermore, the recent advancements in specialized treatments, such as personalized medicine, biologics, and gene therapies, which require nuanced preclinical testing, are acting as another growth-inducing factor. Apart from this, the widespread adoption of preclinical CROs to provide companies with a risk-balanced approach owing to the high failure rate of drug development is contributing to the market growth. Besides this, the introduction of cutting-edge technologies that play a pivotal role in successful preclinical studies is supporting the market growth.
The growing expenditure on research and development (R&D) activities
The growth and vitality of the pharmaceutical and biopharmaceutical sectors are inextricably linked to their commitment to R&D. The quest for novel therapeutics, more efficacious treatments, and groundbreaking medical solutions has propelled companies to invest heavily in R&D activities. As diseases mutate and new health concerns emerge, there's a perpetual need for innovative medications and medical devices. This continuous drive for innovation necessitates extensive preclinical studies, which are generally outsourced to CROs to harness their specialized expertise and facilities. Additionally, the competition to be first-to-market further intensifies R&D endeavours. In line with this, outsourcing preclinical research allows companies to swiftly navigate the initial stages of drug development, thus ensuring a timely and efficient path from the lab to the patient.
The rising complexity of regulatory environment
The global pharmaceutical landscape is under the scrutiny of multifaceted and rigorous regulatory frameworks. These regulatory bodies mandate stringent standards to ensure the quality, safety, and efficacy of various products. Meeting these comprehensive requirements demands expertise, precision, and extensive documentation, often overwhelming for many companies. This is where the specialized knowledge of preclinical CROs becomes invaluable. These organizations are adept at understanding, navigating, and ensuring compliance with such intricate regulations. Their dedicated focus on preclinical research ensures they remain updated with the latest regulatory changes, employ best practices, and maintain state-of-the-art facilities that adhere to global standards. Additionally, this helps pharmaceutical companies adhere to regulatory mandates and also minimizes potential setbacks, saving both time and resources.
The increasing cost of drug development process
Drug development is a capital-intensive endeavor, with companies investing heavily in the lifecycle of a drug. The initial stages, including preclinical studies, are especially critical as they set the foundation for subsequent clinical phases. However, establishing and maintaining in-house facilities, technologies, and expertise for these early stages can be expensive. By outsourcing to preclinical CROs, companies can achieve significant cost efficiencies. CROs offer scalable solutions, allowing companies to pay for the specific services they need. Additionally, CROs often have economies of scale due to their focused nature, passing on the cost benefits to their clients. In a world where financial prudence is paramount, outsourcing preclinical research provides an avenue to balance quality research with economic considerations.
IMARC Group provides an analysis of the key trends in each segment of the global preclinical CRO market report, along with forecasts at the global, regional and country levels from 2023-2028. Our report has categorized the market based on service and end use.
Bioanalysis and DMPK Studies
Toxicology Testing
Others
Toxicology testing dominates the market
The report has provided a detailed breakup and analysis of the market based on the service. This includes bioanalysis and DMPK studies, toxicology testing, and others. According to the report, toxicology testing represented the largest market segment.
Toxicology testing is dominating the market due to the stringent regulatory requirements set by health authorities across the globe to ensure that potential adverse effects on human health are identified. Furthermore, as pharmaceuticals become more complex, understanding potential toxic interactions with biological systems becomes even more critical. Modern drugs, especially those based on novel mechanisms of action or biologics, require thorough toxicological evaluations. Additionally, many drug candidates fail during the development process due to safety concerns. Toxicology testing in the preclinical stage helps identify potential red flags early on, saving companies significant time and financial resources by preventing the progression of unsuitable candidates. Besides this, the advent of advanced technologies, such as in vitro toxicology, computational modeling, and high-throughput screening, which are enhancing the capabilities of toxicological studies and providing more detailed and rapid insights, is boosting the market growth.
Biopharmaceutical Companies
Government and Academic Institutes
Medical Device Companies
Biopharmaceutical companies dominate the market
The report has provided a detailed breakup and analysis of the market based on the end use. This includes biopharmaceutical companies, government and academic institutes, and medical device companies. According to the report, biopharmaceutical companies represented the largest market segment.
Biopharmaceutical companies are dominating the market due to the increasing development of biologics, including monoclonal antibodies, recombinant proteins, and gene therapies, which require thorough preclinical evaluation, often necessitating specialized expertise that CROs provide. Furthermore, biopharmaceutical entities are investing heavily in R&D, which translates to a multitude of preclinical activities, many of which are outsourced to CROs for efficiency and expertise. Apart from this, the development of biologics involves intricate production processes using living cells. The complexity warrants specialized preclinical studies, including assessments of potential impurities or contaminants. Moreover, biopharmaceutical drugs are under intense regulatory scrutiny due to their potential immunogenicity and unique mechanisms of action, which often demand the detailed and specialized services of preclinical CROs.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America exhibits a clear dominance in the market, accounting for the largest preclinical CRO market share
The report has also provided a comprehensive analysis of all the major regional markets, which includes North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represented the largest market segment.
North America is dominating the preclinical CRO market owing to the presence of many leading pharmaceutical and biotech companies, which directly correlates with heightened demand for preclinical research services. Additionally, the regional firms consistently lead in terms of research and development (R&D) investments. This commitment to innovation drives a considerable need for preclinical studies, pushing the demand for specialized CRO services. Furthermore, leading universities and research institutions in North America provide state-of-the-art infrastructure and generate cutting-edge research. This sophisticated ecosystem often collaborates with and complements the services of CROs. Apart from this, the imposition of stringent regulatory requirements by regional governments regarding drug safety is facilitating the demand for preclinical CROs to meet rigorous requirements and navigate the intricate approval process.
The top companies in the preclinical CRO market are broadening their portfolio to provide end-to-end solutions, encompassing everything from early-stage discovery to preclinical development, which ensures clients can access a full suite of services under one roof. Additionally, companies are investing in technologies, such as in vitro toxicology, high-throughput screening, and computational modeling, to enhance their preclinical study capabilities. Furthermore, they are expanding their operations globally by setting up new facilities, upgrading existing ones, or acquiring regional players. Apart from this, several market players are attracting top talent and focusing on ongoing training to ensure their teams stay updated on the latest scientific advances and regulatory changes. Moreover, they are entering into long-term collaborations with pharmaceutical companies to streamline the drug development process, reduce redundancies, and foster deeper understanding between parties.
Charles River Laboratories Inc.
Covance Inc. (Laboratory Corporation of America Holdings)
Eurofins Scientific
ICON Plc
MD Biosciences Inc. (MLM Medical Labs)
Medpace
Parexel International Corporation
PPD Inc.
Wuxi AppTec
In March 2021, Charles River Laboratories Inc. acquired Retrogenix, an early-stage CRO providing specialized bioanalytical services.
In October 2020, Covance Inc. (Laboratory Corporation of America Holdings) announced it is transforming into a decentralized CRO.
In February 2021, ICON Plc announced that it is acquiring PRA Health Sciences to consolidate itself as a CRO.