市場調查報告書
商品編碼
1403379
臨床前CRO(委外研發機構)市場至2030年的預測:按模型類型、服務、動物模型、最終用戶和地區進行的全球分析Preclinical Contract Research Organization Market Forecasts to 2030 - Global Analysis By Model Type, Service, Animal Model, End User and By Geography |
根據Stratistics MRC預測,2023年全球臨床前CRO(委外研發機構)市場規模達到49.9億美元,預測期內年複合成長率為9.5%,預計到2030年將達到94.2億美元。
臨床前委外研發機構(CRO)是製藥和生物技術行業的專業服務供應商,在實驗藥物和治療方法進入臨床試驗之前對其進行研究和測試。臨床前 CRO 提供廣泛的服務來評估新化合物的安全性、有效性和風險。此外,臨床前 CRO 的知識和資源可以透過提供關鍵資訊和監管支援以及遵守監管和行業規範來幫助最佳化藥物開發。
根據IFPMA2021年報告,國際生物製藥產業的年度研發支出比航太和國防工業高7.3倍,比化學工業高6.5倍,比軟體和電腦服務業高出1.5倍。
全球化進程
CRO 是國際業務,為製藥和生技公司提供多個司法管轄區的廣泛資源、知識和監管管道。透過利用監管優勢、多樣化的患者群體和新興市場,公司可以透過全球化最佳化其藥物開發策略。此外,透過促進合作和創新以及加快新藥的上市時間和效率,可以改善醫療保健成果並改善公眾獲得尖端治療的機會。
高成本
遵守嚴格法規和維持品質標準的需要增加了費用。為了正確地進行臨床前研究,CRO 必須投入大量資金購買最先進的設施、機械和高素質的員工。激烈的競爭對 CRO 來說是常見的,提高了市場競爭的價格和業務開拓。此外,由於這些高昂的成本,小型或新的 CRO 可能很難進入市場,阻礙市場成長。
技術進步
製藥和生物技術公司可以利用先進技術做出更好的藥物開發決策。 CRO 利用這些特定知識來降低開發風險,加快識別有前途的候選藥物,並提高新治療方法的整體品質和安全性。此外,CRO 的專業知識和經驗使他們成為在嚴格的政府監管範圍內推動藥物開發和創新,擴大市場規模的有利盟友。
嚴格的法規環境
在這一領域營運的 CRO 面臨複雜法律規範的挑戰,這可能導致合規成本增加和計劃進度延遲。嚴格的法規環境也會影響製藥和生技公司選擇 CRO 合作夥伴時的決策流程。此外,監管負擔導致核准流程延長和檢查增加,影響 CRO 進行臨床前研究的整體有效性和進度。這種不利的環境抑制了創新,降低了臨床前研究服務的可用性,並抑制了市場擴張。
COVID-19的疫情對臨床前CRO(委外研發機構)市場產生了顯著的負面影響。延遲或取消的臨床前試驗數量減少了對 CRO 服務的需求。疫情造成的財務不確定性減少了研發投資,影響了為外包臨床前測試預留的資金。此外,景氣衰退和疫情造成的不確定性導致一些客戶推遲或取消臨床前研究,影響了CRO收益和成長前景,進一步阻礙了該市場。
預計預測期內毒理學測試領域規模最大
預計毒理學檢測領域將佔據最大佔有率。專門從事毒理學的 CRO 透過徹底評估潛在藥物以滿足嚴格的監管標準,為生物技術和製藥公司提供關鍵服務。這些測試透過評估化學物質如何影響各種生物系統來幫助發現不良反應和給藥。因此,透過最大限度地降低開發風險,加快監管核准和確保藥物安全來保護公共衛生和藥物開發舉措的成功,推動該領域的成長。
患者來源的異質骨移植(PDX)領域預計在預測期內年複合成長率最高
患者來源的異質骨移植(PDX)領域預計在預測期內年複合成長率最高。這是由於 PDX 模型,將患者的腫瘤組織移植到免疫力缺乏小鼠體內,以重建患者的腫瘤環境。如果候選藥物在更臨床相關的環境中進行評估,這些模型更有可能在人體試驗中取得成功。此外,PDX CRO 還提供個體化醫療見解,為特定患者提供治療。由於精準醫療的重要性日益增加,PDX 市場對於進一步開發高效、有針對性的癌症治療非常重要,推動了這一領域的擴張。
由於促進製藥公司和 CRO 之間順利資料交換和協作的整合平台的成長,亞太地區在預測期內獲得了最大的市場佔有率。 Covance Inc.、Medpace Holdings, Inc.、MPI Research 和 Eurofins Scientific 等主要企業為國際合作提供了有吸引力的環境,並為全球製藥和生物技術行業的發展做出了貢獻。此外,政府支持的增加,監管的協調以及高通量篩檢,機器學習和資料處理人工智慧等技術進步推動該地區的擴張。
鑑於北美在藥物開發臨床前階段對支持製藥和生物技術公司的關鍵作用,預計在預測期內年複合成長率最高。美國、加拿大和墨西哥地區的特點是強大的基礎設施、最尖端科技和高技能的勞動力。這些領域包括藥理學、毒理學、生物分析以及對監管核准非常重要的各種其他臨床前研究。此外,該地區的 CRO 受益於有利的法規環境以及與學術機構的合作,促進創新和專業知識,並支持該地區的成長。
According to Stratistics MRC, the Global Preclinical Contract Research Organization (CRO) Market is accounted for $4.99 billion in 2023 and is expected to reach $9.42 billion by 2030 growing at a CAGR of 9.5% during the forecast period. A Preclinical Contract Research Organization (CRO) is a specialized service provider in the pharmaceutical and biotechnology industry that conducts research and testing on experimental drugs and therapies before they enter clinical trials. To evaluate the safety, efficacy, and possible dangers associated with novel compounds, preclinical CROs provide a broad range of services. Furthermore, their knowledge and resources aid pharmaceutical businesses in optimizing drug development by offering vital information and regulatory support and by providing adherence to regulatory and industry norms.
According to the IFPMA's 2021 report, the annual R&D spending by the international biopharmaceutical industry is 7.3 times higher than that of the aerospace and defense industries, 6.5 times more than the chemicals industry, and 1.5 times more than the software and computer services industry.
CROs are international businesses that provide pharmaceutical and biotech firms with access to a wide range of resources, knowledge, and regulatory routes in several jurisdictions. By taking advantage of regulatory benefits, diversified patient populations, and developing markets, corporations can optimize their drug development strategy through globalization. Additionally, it improves healthcare outcomes and public access to cutting-edge therapeutics by encouraging cooperation and innovation and accelerating the time and efficiency of bringing new drugs to market.
The need to adhere to stringent regulatory regulations and uphold quality standards increases expenditures. To properly undertake preclinical research, CROs must invest a significant amount of money in cutting-edge facilities, machinery, and highly qualified staff. Intense competition is a common occurrence for CROs, which raises the price of marketing and business development initiatives. In addition, smaller or newly established CROs may find it difficult to enter the market due to these exorbitant costs, which thereby hinder market growth.
Pharmaceutical and biotech businesses may make well-informed judgments on drug development with the help of their advanced technologies, which enables them to provide reliable and efficient preclinical testing and data analysis. CROs use this specific knowledge to lower development risks, speed up the identification of promising drug candidates, and improve the general quality and safety of novel treatments. Furthermore, because of their specialization and experience, CROs are advantageous collaborators for promoting drug development and innovation in a tough, government-regulated setting thereby driving this market size.
CROs operating in this space encounter challenges in navigating the intricate regulatory frameworks, leading to increased compliance costs and potential delays in project timelines. The stringent regulatory environment also influences the decision-making process of pharmaceutical and biotechnology companies when selecting CRO partners. Furthermore, the regulatory load results in longer approval processes and more inspection, affects the general effectiveness and pace of preclinical research carried out by CROs. This unfavourable environment inhibits innovation, lowers the availability of preclinical research services, and thereby impedes this market expansion.
The COVID-19 pandemic has had a notable negative impact on the preclinical contract research organization (CRO) market. The number of preclinical studies that were postponed or cancelled resulted in a decline in the need for CRO services. The pandemic's financial insecurity has resulted in decreased investment in research and development, which has an effect on the money set aside for preclinical study outsourcing. Furthermore, the pandemic-induced economic downturn and uncertainty prompted some clients to postpone or cancel preclinical projects, impacting the revenue and growth prospects of CRO and further impeding this market.
The toxicology testing segment is estimated to hold the largest share. Toxicology-focused CROs offer vital services to biotech and pharmaceutical firms by thoroughly assessing potential drugs in order to satisfy strict regulatory standards. These tests help discover harmful reactions and dosage levels by assessing how chemicals affect different biological systems. Therefore, it protects public health and the success of drug development initiatives by minimizing development risks, expediting regulatory approvals, and guaranteeing the safety of pharmaceutical goods, which thereby boosts this segment's growth.
The patient derived xenograft (PDX) segment is anticipated to have highest CAGR during the forecast period due to the tumor tissues from patients being transplanted into immunodeficient mice in PDX models to replicate the tumor environment of the patient. These models show a greater chance of success in human trials when drug candidates are evaluated in a more clinically appropriate setting. Furthermore, customized medicine insights are provided by PDX CROs, enabling treatmentsfor specific patients. The PDX market is essential for further developing efficient and targeted cancer treatments because of the growing significance of precision medicine, thereby driving this segment's expansion.
Asia Pacific commanded the largest market share during the extrapolated period due to the growth of integrated platforms that facilitate smooth data exchange and cooperation between pharmaceutical corporations and CROs. Key players such as Covance Inc., Medpace Holdings, Inc., MPI Research, and Eurofins Scientific offer a compelling environment for international collaborations and are establishing themselves in advancing the global pharmaceutical and biotechnology industries. Additionally, growing government support, regulatory harmonization, and technological advancements such as high-throughput screening, machine learning, and artificial intelligence for data processing drive this region's expansion.
North America is expected to witness highest CAGR over the projection period, owing to its pivotal role in supporting pharmaceutical and biotechnology companies in the preclinical phase of drug development. The United States, Canada, and Mexico regions are characterized by a robust infrastructure, cutting-edge technology, and a highly skilled workforce. They include pharmacology, toxicology, bioanalysis, and various other preclinical studies essential for regulatory approval. Furthermore, the region's CROs benefit from a favorable regulatory environment and collaboration with academic institutions, fostering innovation and expertise that are propelling this region's growth.
Some of the key players in the Preclinical Contract Research Organization (CRO) Market include Crown Bioscience, Eurofins Scientific, Laboratory Corporation of America, Inc., PRA Health Sciences, Inc., Intertek Group Plc (IGP), Wuxi AppTec, SGS SA (SGS), Medpace, Inc., Pharmaceutical Product Development (PPD), LLC, Charles River Laboratories International, Inc., PPD (Thermo Fisher Scientific, Inc.) and WuXi AppTec, Inc. (WAI).
In November 2023, Intertek, announced the launch of iCare in Turkiye, one of its most successful markets. iCare is an innovative one-stop digital portal providing textile manufacturers with a pioneering solution that enables seamless management and monitoring of their testing processes from start to finish.
In October 2023, SGS is signed an agreement to divest its US powertrain testing operations as part of its strategic portfolio evolution to Columbia River Partners, a private equity firm focused on the industrials, business services and IT services sectors, headquartered in California.
In September 2023, Intertek, proudly announced the integration of advanced PhotonAssay technology into its Minerals laboratory facility in Tarkwa, Ghana. With a legacy of excellence and a commitment to innovation, Intertek Minerals aims to revolutionise gold industry support in West Africa through the implementation of this groundbreaking technology.