市場調查報告書
商品編碼
1466587
臨床前 CRO 市場:按服務、應用和最終用戶分類 - 2024-2030 年全球預測Preclinical CRO Market by Services (Bioanalysis & DMPK Studies, Toxicology Testing), Application (Cardiovascular Disease, Dermatology, Gastrointestinal), End-User - Global Forecast 2024-2030 |
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預計2023年臨床前CRO市場規模為62.5億美元,預計2024年將達68.5億美元,2030年將達到119.5億美元,複合年成長率為9.68%。
臨床前 CRO 是支援中心,提供必要的研發活動 (R&D) 專業知識,透過動物試驗將候選藥物帶入臨床階段。臨床前測試服務包括多項研究,這些研究對於評估藥物在動物模型中的功效和安全性以及提交臨床實驗(IND) 申請非常重要。在臨床前試驗中,CRO受申辦者(例如生物製藥公司)聘請,代表申辦者執行一系列業務,同時承擔各種技術和行政職責。處於臨床前階段的藥物數量迅速增加,以及藥物開發的研發 (R&D) 預算不斷增加,正在推動臨床前 CRO 服務的使用。然而,臨床前CRO服務涉及高成本和耗時的流程,阻礙了市場成長。高通量篩檢和In Silico建模等技術進步預計將實現更有效率、更具成本效益的臨床前研究,為市場成長創造機會。
主要市場統計 | |
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基準年[2023] | 62.5億美元 |
預測年份 [2024] | 68.5億美元 |
預測年份 [2030] | 119.5億美元 |
複合年成長率(%) | 9.68% |
毒理學測試服務的使用率迅速增加,重點關注服務安全和監管合規方面
生物分析和 DMPK 研究對於了解潛在療法的吸收、分佈、代謝和排泄 (ADME) 特性至關重要。該部分提供了有關生物系統中藥物行為的重要資訊,對於確定劑量和評估安全性至關重要。這些研究優先在藥物開發的早期階段進行,此時需要詳細了解藥物的藥物動力學特徵。製藥和生物技術公司通常依賴具有生物分析方法和最尖端科技專業知識的外部 CRO。毒理學測試服務對於評估候選藥物的安全性、確保其進一步開發和人類消費的安全性至關重要。該領域涉及各種測試來評估化合物對生物體的潛在不利影響。這些測試在進行臨床試驗之前非常重要,主要解決藥物必須通過才能獲得核准的監管要求。對於所有需要證明其產品無毒的製藥和生物技術公司來說,這一點至關重要。
最終用戶:生物製藥公司擴大臨床前 CRO 的使用
生物製藥公司是臨床前 CRO 的主要客戶,利用他們的服務來開發和測試生物製藥。這些公司尋求與 CRO 合作,利用他們在藥理學、毒理學和分子生物學方面的專業知識。向生物製藥公司提供的服務通常包括功效和安全性評估、吸收、分佈、代謝和排泄 (ADME) 測試以及監管支持。與臨床前 CRO 合作使生物製藥公司能夠加快藥物開發流程、有效管理成本並有效滿足複雜的監管要求。政府機構和學術機構與臨床前 CRO 合作,進行公共衛生目的的研究和發展。這些合作關係支持新藥發現、疫苗開發和創新治療方法等計劃。臨床前 CRO 為這些機構提供了獲得其內部所沒有的專業資源和專業知識的機會。此外,CRO 還幫助進行高品質、合規的研究,從而實現突破性的醫學進步。政府/學術機構和 CRO 之間的合作對於彌合基礎研究和臨床應用之間的差距至關重要。醫療設備製造商依靠臨床前 CRO 的服務來檢驗其產品的安全性和有效性,然後再進行臨床試驗。這些公司受益於 CRO 的技術和監管專業知識來進行全面的生物醫學測試、動態評估和風險評估。為醫療設備公司量身定做的服務通常包括臨床前研究設計、原型測試以及對遵守國際標準和法規的支援。透過與 CRO 合作,醫療設備公司可以確保其產品符合最高品質和安全標準,確保順利過渡到臨床階段。
區域洞察
人口老化導致的非傳染性疾病以及污染和蟲害等環境條件變化引起的傳染性疾病空前增加,催生了醫療保健領域對有效藥物開發的需求,從而導致對臨床前 CRO 服務的需求日益迫切。 、中東和非洲地區不斷增加。亞太地區政府為促進醫療設備和藥物開發領域的研發 (R&D) 活動而進行的投資預計將為臨床前 CRO 市場的參與者提供成長機會。 2021年8月,澳洲政府投資7,900萬美元用於醫療創新和研究計劃。歐盟新興經濟體建立了政府支持體系,透過優先考慮新技術和藥物開發的研究和創新來支持技術進步。各國政府推出了多項嚴格的法規和標準,以確保開發的藥品和設備安全、可靠和高品質。 2022年1月,決定在歐盟啟動修訂臨床試驗流程的臨床試驗法規(Regulation (EU) No 536/2014)。政府引入了臨床試驗資訊系統(CTIS)來協調監督和評估流程。因此,政府對醫療設備和藥物開發臨床試驗的持續支持預計將推動歐洲、中東和非洲臨床前 CRO 市場的成長。
FPNV定位矩陣
FPNV定位矩陣對於評估臨床前CRO市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對臨床前 CRO 市場供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。這種詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4. 競爭評估和情報:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況和製造能力進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1. 臨床前CRO市場的市場規模與預測是多少?
2.臨床前CRO市場預測期間需要考慮投資的產品、細分市場、應用和領域有哪些?
3. 臨床前CRO市場的技術趨勢和法規結構是什麼?
4.臨床前CRO市場主要廠商的市場佔有率如何?
5. 進入臨床前CRO市場的合適型態和策略手段是什麼?
[195 Pages Report] The Preclinical CRO Market size was estimated at USD 6.25 billion in 2023 and expected to reach USD 6.85 billion in 2024, at a CAGR 9.68% to reach USD 11.95 billion by 2030.
A preclinical CRO is a support center providing expertise in research and development activities (R&D) essential for navigating a drug candidate through animal testing and forwarding it into the clinical phase. Preclinical research services encompass several studies critical to assessing drug efficacy & safety in animal models and complete Investigational New Drug (IND) filing studies. In a preclinical trial, CROs are hired by sponsors such as biopharma companies to perform a set of tasks, taking various technical and administrative responsibilities on the sponsor's behalf. A surge in the number of drugs in the preclinical phase and an increased research & development (R&D) budget for drug development are driving the usage of preclinical CRO services. The high cost and time-consuming process of preclinical CROS services hamper the market growth. Advances in technology, which include high-throughput screening and in silico modeling, enable more efficient and cost-effective preclinical research and are expected to create opportunities for market growth.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 6.25 billion |
Estimated Year [2024] | USD 6.85 billion |
Forecast Year [2030] | USD 11.95 billion |
CAGR (%) | 9.68% |
Services: Burgeoning usage of Toxicology testing services focusing on the safety and regulatory compliance aspects
Bioanalysis and DMPK studies are crucial for understanding potential therapeutic agents' absorption, distribution, metabolism, and excretion (ADME) properties. This segment provides vital information on the drug's behavior in a biological system, which is paramount for dosage determination and safety assessment. These studies are preferred in the early stages of drug development when detailed insight into the drug's pharmacokinetic profile is required. Pharmaceutical companies and biotechnology firms often rely on external CROs with specialized expertise in bioanalytical methodologies and state-of-the-art technologies. Toxicology testing services are vital for evaluating the safety profile of drug candidates, ensuring they are safe for further development and human consumption. This segment encompasses a range of studies to assess the potential adverse effects of compounds on living organisms. These tests are critical before advancing to clinical trials, catering mainly to regulatory requirements that drugs must pass for approval. They are indispensable for all pharmaceutical and biotechnological companies needing to demonstrate the non-toxic nature of their products.
End-User: Evolving usage of preclinical CRO by biopharmaceutical companies
Biopharmaceutical companies are primary clients of preclinical CROs, leveraging their services for the development and testing of biologic drugs. These companies seek CRO partnerships to access specialized expertise in pharmacology, toxicology, and molecular biology. Services offered to biopharmaceutical companies often include drug efficacy and safety assessments, absorption, distribution, metabolism, excretion (ADME) studies, and regulatory support. Collaborating with preclinical CROs enables biopharmaceutical companies to accelerate their drug development process, manage costs effectively, and navigate complex regulatory requirements efficiently. Government and academic institutes often engage with preclinical CROs for research and development initiatives fundamental to public health objectives. These partnerships support projects, including new drug discoveries, vaccine development, and innovative medical treatments. Preclinical CROs provide these institutions with access to specialized resources and expertise that may not be available in-house. Additionally, CROs assist in conducting high-quality, regulatory-compliant research studies that can lead to groundbreaking medical advancements. Collaborations between government / academic institutes and CROs are pivotal in bridging the gap between basic research and clinical application. Medical device companies utilize preclinical CRO services to validate the security and efficacy of their products before proceeding to clinical trials. These companies benefit from CROs' technical and regulatory expertise to conduct comprehensive biomedical testing, biomechanical evaluation, and risk assessment. Services tailored to medical device companies often encompass preclinical study design, prototype testing, and support in complying with international standards and regulations. By partnering with CROs, medical device companies can assure their products meet the highest quality and safety standards, facilitating smoother transitions into clinical phases.
Regional Insights
The unprecedented rise in non-communicable diseases among the geriatric population and communicable diseases caused by changing environmental conditions, such as pollution, and insect infestation, create a demand for effective drug development in the healthcare sector, subsequently increasing the need for preclinical CRO services across the Americas, Asia-Pacific, and EMEA. The investments made by the governments of Asia-Pacific to push research and development (R&D) activities of medical devices and drug development are estimated to provide growth opportunities for the preclinical CRO market players. In August 2021, the Australian government invested USD 79 million in medical innovation and research projects. The developed economies in the European Union have established a supportive government framework to boost technological advancements by prioritizing research and innovation of new technologies and drug development. The government introduces several stringent regulations and standards to ensure that the medicines and devices developed are safe, reliable, and of high quality. In January 2022, the Clinical Trials Regulation (Regulation (EU) No 536/2014) was set to launch in the EU to modify the clinical trial processes. The government introduced a Clinical Trials Information System (CTIS) to harmonize the supervision and assessment processes. Thus, the ongoing government support for clinical trials for medical devices and drug development is expected to fuel the growth of the preclinical CRO market in EMEA.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Preclinical CRO Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Preclinical CRO Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Preclinical CRO Market, highlighting leading vendors and their innovative profiles. These include 10x Genomics, Inc., AmplifyBio, Atuka Inc., BenchSci, Bioserve Biotechnologies (India) PVT Ltd. by REPROCELL Inc., Biotrofix, Inc., Celerion, Charles River Laboratories International, Inc., Crown Bioscience, Inc., CTI Clinical Trial and Consulting, Inc., Diag2Tec SAS, Eurofins Scientific SE, F. Hoffmann-La Roche Ltd., Gubra, Hera Biolabs, ICON PLC, Immusmol SAS, ImQuest BioSciences, Inotiv, Inc., Intertek Group PLC, Invivotek by Genesis Biotechnology Group, LLC, IQVIA Inc., Jubilant Biosys Ltd. byJubilant Pharmova Limited Company, Laboratory Corporation of America Holding, MCI Group Holding SA, MD Biosciences, Medpace Holdings, Inc., Novartis AG, Parexel International Corporation., PharmaCircle LLC, Phenos GmbH, PPD by Thermo Fisher Scientific Inc., PsychoGenics Inc., QPS Holdings, LLC, Sanofi S.A., SCiAN Services Inc., SGS SA, Shanghai Medicilon Inc., Syneos Health, Inc., Transpharmation, Veristat, LLC, Vimta Labs Limited, and WuXi AppTec Co., Ltd..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Preclinical CRO Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Preclinical CRO Market?
3. What are the technology trends and regulatory frameworks in the Preclinical CRO Market?
4. What is the market share of the leading vendors in the Preclinical CRO Market?
5. Which modes and strategic moves are suitable for entering the Preclinical CRO Market?