市場調查報告書
商品編碼
1541621
2024-2032 年按服務(生物分析和 DMPK 研究、毒理學測試等)、最終用途(生物製藥公司、政府和學術機構、醫療器材公司)和地區分類的臨床前 CRO 市場報告Preclinical CRO Market Report by Service (Bioanalysis and DMPK Studies, Toxicology Testing, and Others), End Use (Biopharmaceutical Companies, Government and Academic Institutes, Medical Device Companies), and Region 2024-2032 |
2023年,全球臨床前CROIMARC Group規模達到60億美元。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。
主要市場促進因素:對個人化藥物的日益關注是積極影響市場成長的關鍵因素之一。臨床前 CRO 市場的一些關鍵最新發展包括技術進步,例如電腦模擬的高通量篩選和先進的成像技術。
主要市場趨勢:生物技術、製藥和醫療器材產業的發展以及監管支援正在推動臨床前 CRO 市場的成長。此外,臨床試驗數量的不斷增加增加了對具有全球影響力和應對國際監管環境專業知識的 CRO 的需求。這一趨勢進一步推動了對臨床前CRO服務的需求。
地理趨勢:根據臨床前CRO市場前景,北美正在佔據整個市場的主導佔有率。這可以歸因於領先的製藥和生物技術公司的存在。此外,研發投資和臨床前研究顯著增加,這進一步成為該地區的另一個成長誘導因素。
競爭格局:全球臨床前 CRO 市場的一些領導參與者包括 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. 和Wuxi AppTec 等。
挑戰與機會:根據臨床前CRO市場概況,不斷提高的監管合規性、激烈的競爭和成本壓力是市場面臨的一些主要挑戰。然而,臨床前測試技術的不斷進步為 CRO 提供新的機會來增強其服務產品和提高效率。
不斷增加的研發活動
製藥和生物技術行業不斷升級的研發活動正在推動臨床前 CRO 市場佔有率的成長。此外,藥物開發過程變得越來越複雜,因此需要進行廣泛的臨床前測試以確保新藥的安全性和有效性。根據美國食品藥物管理局(FDA)的規定,研究人員必須使用醫療產品開發法規中定義的良好實驗室規範(GLP)進行臨床前研究。此外,對於製藥公司來說,將臨床前研發活動外包給 CRO 比內部進行這些研究更具成本效益。 CRO 通常擁有專業知識、基礎設施和資源,可以簡化藥物開發流程並降低成本。例如,2024 年 1 月,國家轉化科學促進中心與其他 NIH 機構和中心合作開發了臨床前研究工具箱。這些資源包括檢測指導手冊、化合物管理、NCATS 藥物集合、PubChem、探針、表現型藥物發現資源和 BioPlanet。
複雜的監管環境
製藥和生物技術行業複雜的監管環境是增加臨床前 CRO 市場佔有率的重要因素。美國食品藥物管理局 (FDA) 和歐洲藥品管理局 (EMA) 等監管機構要求進行廣泛的臨床前測試,以證明新藥的安全性和有效性。此外,例如,國家轉化科學促進中心與學術界、工業界和患者倡導團體合作,使超過 45 種新藥進入臨床試驗。據他們介紹,一種新藥從實驗室到藥櫃的旅程可能需要長達 15 年的時間。這導致對臨床前 CRO 服務的需求增加,以確保符合監管要求。此外,臨床試驗的全球化使得製藥公司必須應對多個國家複雜的監管環境。具有國際監管要求專業知識的臨床前 CRO 可以幫助公司應對這些挑戰。例如,根據美國疾病管制與預防中心的說法,疫苗的開發需要10到15年的實驗室研究,研究人員需要向FDA提交研究性新藥申請,其中包括有關疫苗的所有資訊。 FDA 的生物製品評估和研究中心負責監管美國疫苗的使用。
藥物開發成本增加
藥物開發成本的不斷上升正在提振臨床前 CRO 市場的收入。藥物開發是一個複雜而漫長的過程,需要大量的研究和測試。這種複雜性可能會導致進行臨床前研究的成本更高。此外,為了證明新藥的安全性和有效性,歐洲藥品管理局(EMA)和美國食品藥物管理局(FDA)等組織要求進行全面的臨床前測試。滿足這些監管要求的成本可能很高。藥物開發本質上是有風險的,儘管投入了大量資金,許多藥物仍未能進入市場。根據美國生物化學與分子生物學學會會員雜誌報道,開發一種成功的藥物需要10到15年的時間。研究人員發現,40% 到 50% 的藥物無法對人類產生預期的影響。大約10%到15%是由於藥物動力學特性不足所造成的。同時,約30%歸因於無法控制的高毒性或不良反應。臨床前 CRO 市場公司可以透過提供臨床前研究專業知識來幫助減輕這些風險,從而幫助他們就考慮哪些藥物做出明智的決定。
IMARC Group提供了全球臨床前 CRO 市場報告各細分市場主要趨勢的分析,以及 2024 年至 2032 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。
根據臨床前 CRO 市場的最新發展,毒理學測試的成長是由全球醫療機構制定的嚴格監管要求所推動的,以確定對人類健康的潛在不利影響。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。臨床前階段的毒理學測試可以防止不合適候選者的發展,從而幫助公司節省大量時間和財務資源。例如,美國食品藥物管理局表示,篩選新分子的藥理活性和潛在毒性至關重要。
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。
根據臨床前CRO市場統計數據,由於生物製劑(包括單株抗體、重組蛋白和基因療法)的持續發展,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臨床前活動,其中許多活動外包給 CRO 以提高效率和專業知識。
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,這與該地區臨床前研究服務需求的增加直接相關。此外,北美公司在研發活動方面的投資始終處於領先地位。此外,這種對創新的承諾推動了對臨床前研究和專業 CRO 服務的巨大需求。這反過來又對區域市場產生正面影響。例如,2022 年 2 月,歐洲生命科學公司 InSilicoTrials 和專門從事臨床前研究服務的加拿大 CRO IonsGatePreclinical Services Inc. (IonsGate) 合作,利用模擬等尖端技術。除此之外,北美政府機構關於藥物安全的監管要求的實施正在不斷增加對臨床前 CRO 的需求,以滿足要求並應對複雜的核准流程。此外,LabCorp 和 Charles River Laboratories 等專門從事早期藥物發現的成熟 CRO 的廣泛存在預計將在預測期內促進北美市場的成長。
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,這確保客戶可以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
(請注意,這只是關鍵參與者的部分列表,報告中提供了完整列表。)
2024 年 4 月:創新和綜合實驗室服務領域的領導企業 Labcorp 擴大了其精準腫瘤學產品組合,以改善全球患者護理和癌症研究。 Labcorp 正在投資科學、診斷和實驗室創新,以支持其製藥、生物技術和臨床研究,從而帶來尖端療法。
2024 年 3 月:全方位服務的合約研究組織 Veeda Clinical Research Limited 收購了專門從事腫瘤學臨床試驗的歐洲 CRO Heads。
2024 年 1 月:國家轉化科學促進中心與其他 NIH 機構和中心合作開發了臨床前研究工具箱。這些資源包括檢測指導手冊、化合物管理、NCATS 藥物集合、PubChem、探針、表現型藥物發現資源和 BioPlanet。
The global preclinical CRO market size reached US$ 6.0 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 11.0 Billion by 2032, exhibiting a growth rate (CAGR) of 6.8% during 2024-2032. The growing expenditure on research and development (R&D) activities, the rising complexity of the regulatory environment, the increasing focus on core competencies among companies, and recent advancements in specialized treatments are some of the major factors propelling the market.
Major Market Drivers: The rising focus on personalized medicines is one of the key factors positively influencing the market growth. Some of the key preclinical CRO market recent developments include technological advancements, such as high-throughput screening in silico modeling and advanced imaging techniques.
Key Market Trends: The development in biotechnology, pharmaceutical, and medical device industries, along with regulatory support, are bolstering the preclinical CRO market growth. Moreover, the rising number of clinical trials has increased the need for CROs with a global presence and expertise in navigating international regulatory environments. This trend is further propelling the demand for preclinical CRO services.
Geographical Trends: According to the preclinical CRO market outlook, North America is acquiring a dominant share of the overall market. This can be attributed to the presence of leading pharmaceutical and biotech companies. Moreover, there has been a significant increase in R&D investments and preclinical studies, which is further acting as another growth-inducing factor across the region.
Competitive Landscape: Some of the leading players in the global preclinical CRO market include 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., and Wuxi AppTec, among many others.
Challenges and Opportunities: According to the preclinical CRO market overview, rising regulatory compliance, surging competition, and cost pressures are some of the major challenges that the market is facing. However, continuous advances in preclinical testing technology are opening new opportunities for CROs to enhance their service offerings and improve efficiency.
Rising Research and Development Activities
The escalating R&D activities in the pharmaceutical and biotechnology industries are driving the preclinical CRO market share. Additionally, the drug development process is becoming more complex, thereby requiring extensive preclinical testing to ensure the safety and efficacy of new drugs. According to the U.S. Food and Drug Administration (FDA), researchers are required to use Good Laboratory Practice (GLP) defined in regulations of medical product development for preclinical studies. Moreover, outsourcing preclinical R&D activities to CROs can be more cost-effective for pharmaceutical companies than conducting these studies in-house. CROs often have specialized expertise, infrastructures, and resources that can streamline the drug development process and reduce costs. For instance, in January 2024, the National Center of Advancing Translational Sciences developed a preclinical research toolbox in collaboration with other NIH institutes and centers. The resources include the Assay Guidance Manual, Compound Management, NCATS Pharmaceutical Collection, PubChem, Probes, Phenotypic Drug Discovery Resource, and BioPlanet.
Complex Regulatory Environment
The complex regulatory environment in the pharmaceutical and biotechnology industries is a significant factor adding to the preclinical CRO market share. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require extensive preclinical testing to demonstrate the safety and efficacy of new drugs. Moreover, for instance, the National Center for Advancing Translational Sciences partnered with academia, industry, and patient advocacy groups to enable more than 45 novel drugs to move into clinical trials. According to them, a new drug's journey from the lab to the medicine cabinet can take up to 15 years. This has led to an increased demand for preclinical CRO services to ensure compliance with regulatory requirements. Moreover, the globalization of clinical trials has made it necessary for pharmaceutical companies to navigate complex regulatory environments in multiple countries. Preclinical CROs with expertise in international regulatory requirements can help companies navigate these challenges. For instance, according to the Centers for Disease Control and Prevention, the development of a vaccine takes 10 to 15 years of laboratory research, and researchers need to submit an investigational new drug application to the FDA, which includes all the information about the vaccine. The FDA's Center for Biologics Evaluation and Research regulates the usage of vaccines in the United States.
Increasing Cost of Drug Development
The escalating cost of drug development is bolstering the preclinical CRO market revenue. Drug development is a complex and lengthy process that requires extensive research and testing. This complexity can lead to higher costs associated with conducting preclinical studies. Furthermore, to prove the safety and effectiveness of new medications, organizations like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) demand comprehensive preclinical testing. Meeting these regulatory requirements can be costly. Drug development is inherently risky, with many drugs failing to reach the market despite significant investments. According to Member Magazine of the American Society for Biochemistry and Molecular Biology, it takes 10 to 15 years to develop one successful drug. Researchers discovered that the drug's inability to have the desired impact in humans was between 40% and 50% of failures. About 10% to 15% were caused by inadequate pharmacokinetic properties. At the same time, around 30% were attributed to uncontrollably high toxicity or adverse effects. Preclinical CRO market companies can help to mitigate these risks by providing expertise in preclinical research, thereby aiding them in making informed decisions about which drugs to consider.
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 2024-2032. Our report has categorized the market based on the 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.
According to the preclinical CRO market recent developments, the growth of toxicology testing is driven by stringent regulatory requirements set by healthcare authorities worldwide to identify the potential adverse effects on human health. Moreover, as pharmaceuticals become more complex, understanding potential toxic interactions with biological systems becomes even more critical. Toxicology testing in the preclinical stage helps in saving companies significant time and financial resources by preventing the progression of unsuitable candidates. For instance, the U.S. Food and Drug Administration states that it is crucial to screen new molecules for pharmacological activity and toxicity potential.
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.
According to the preclinical CRO market statistics, 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 preclinical activities, many of which are outsourced to CROs for efficiency and expertise.
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 across the region. Additionally, firms in North America consistently lead in investments in terms of R&D activities. Moreover, this commitment to innovation drives a considerable need for preclinical studies and specialized CRO services. This, in turn, is positively influencing the regional market. For instance, in February 2022, the European life sciences company InSilicoTrials and the Canadian CRO IonsGatePreclinical Services Inc. (IonsGate), which specialize in preclinical research services, collaborated to take advantage of cutting-edge technologies like simulation. Besides this, the implementation of regulatory requirements by government bodies in North America regarding drug safety is escalating the demand for preclinical CROs to meet requirements and navigate the intricate approval process. Furthermore, the wide presence of established CROs specializing in early drug discovery, such as LabCorp and Charles River Laboratories, is expected to augment the market growth in North America over the forecasted period.
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
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
April 2024: Labcorp, a leading player in innovative and comprehensive laboratory services, expanded its precision oncology portfolio to improve patient care and cancer research globally. Labcorp is investing in scientific, diagnostic, and laboratory innovations to support its pharmaceutical, biotechnology, and clinical research to bring cutting-edge therapies.
March 2024: Veeda Clinical Research Limited, a full-service contract research organization acquired Heads, a European CRO that specializes in clinical trials in oncology.
January 2024: The National Center of Advancing Translational Sciences developed a preclinical research toolbox in collaboration with other NIH institutes and centers. The resources include the Assay Guidance Manual, Compound Management, NCATS Pharmaceutical Collection, PubChem, Probes, Phenotypic Drug Discovery Resource, and BioPlanet.