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市場調查報告書
商品編碼
1641381
全球醫藥研發外包市場:特色見解(2024-2029)Global Pharmaceutical R&D Outsourcing Market - Focused Insights 2024-2029 |
全球醫藥研發外包市場規模預計在2023年至2029年期間以 10.15%的年複合成長率成長。
2024年,勃林格殷格翰收購 Nerio Therapeutics 的臨床前資產,擴大其腫瘤學產品組合,以開發癌症的變革性檢查點抑制劑,交易價值高達 13億美元。我們也與 Ochre Bio 合作開發用於肝臟再生和慢性肝病的新藥。2024年,AbbVie 宣布達成最終協議,收購致力於治療中樞神經系統(CNS)疾病的生物技術公司 Aliada。 Aliada 的創新血腦屏障(BBB)穿越技術有可能為中樞神經系統帶來突破性的治療方法。2024年,Merck收購了Modifi Biosciences Inc.,這是一家專門生產基於直接DNA修飾技術的抗癌藥物的公司。
由於需求不斷增加、技術複雜性不斷增加以及對專業知識的需求,細胞和基因治療行業的外包迅速成長。合約開發和製造組織(CDMO)在幫助小型生物技術公司甚至大型製藥公司有效擴大業務規模而無需承擔內部運作的高昂成本方面發揮著非常重要的作用。專門設施的建設成本可能高達每平方英尺 2,000 美元,並且需要數年才能完成,因此外包是一種具有成本效益和時間效率的有吸引力的選擇。外包熱潮的主要驅動力是產業的複雜性以及病毒載體生產和基因編輯等製造過程的高度專業性質。將這些任務外包給 CDMO 可確保遵守嚴格的監管標準和高品質的結果。例如,Catalent、Lonza 和 Thermo Fisher Scientific 等公司大力投資收購在病毒載體製造方面擁有專業知識的小公司,以擴大其在這個新興市場的能力。
虛擬和分散臨床試驗(DCT)利用遠距醫療、穿戴式裝置和遠端監控等技術來改變臨床研究,使患者能夠在家中或社區環境中參與。這種方法減少了出行並改善了出行管道,並且在新冠肺炎疫情期間獲得了發展動力。 DCT 透過克服地理障礙、實現多元化參與和降低成本來改善患者的招募和保留。透過穿戴式裝置持續收集資料可增強即時監控,提高準確性和安全性。Pfizer、Novartis等領先公司在 FDA 和 EMA 等監管機構的支持下採用了 DCT。人工智慧、電子同意系統和基於區塊鏈的安全性的進步使 DCT 更具可擴展性和可靠性,ICON Plc 和 Medable 等公司成為擁有全面解決方案的主要參與者。然而,挑戰依然存在,包括資料隱私、技術差距和病患數位素養。結合虛擬和傳統臨床試驗元素的混合模型成為可行的解決方案。透過解決這些障礙,DCT 有望促進臨床研究的可近性、效率和創新。
本報告研究了全球醫藥研發外包市場,提供市場概述,以及按發展階段、產品類型、公司規模、治療領域和地區劃分的趨勢,以及參與市場的公司概況。
The global pharmaceutical R&D outsourcing market is expected to grow at a CAGR of 10.15% from 2023 to 2029.
RECENT VENDORS ACTIVITIES
KEY TAKEAWAYS
MARKET OPPORTUNITIES & DRIVERS
Outsourcing In The Cell And Gene Therapy Industry Is Booming
Outsourcing in the cell and gene therapy industry is experiencing rapid growth, driven by increasing demand, technological complexities, and the need for specialized expertise. Contract Development and Manufacturing Organizations (CDMOs) play a pivotal role in enabling small biotech firms and even large pharmaceutical companies to scale their operations effectively without incurring the prohibitive costs associated with in-house capabilities. Building specialized facilities can cost up to $2,000 per square foot and take several years to complete, making outsourcing an attractive alternative for both cost and time efficiency. Key drivers of this outsourcing boom include the industry's complexity and the highly specialized nature of manufacturing processes such as viral vector production and gene editing. Outsourcing these operations to CDMOs ensures adherence to stringent regulatory standards and high-quality outcomes. For instance, companies like Catalent, Lonza, and Thermo Fisher Scientific have made significant investments in acquiring smaller firms with expertise in viral vector production, expanding their capabilities in this emerging market.
Virtual & Decentralized Clinical Trials (DCTs) Gaining Momentum
Virtual and decentralized clinical trials (DCTs) are transforming clinical research by using technologies like telemedicine, wearables, and remote monitoring to enable patient participation from home or local settings. This approach reduces travel, enhances accessibility, and gained momentum during the COVID-19 pandemic. DCTs improve patient recruitment and retention by overcoming geographic barriers, enabling diverse participation, and reducing costs. Continuous data collection via wearables enhances real-time monitoring, improving accuracy and safety. Major companies like Pfizer and Novartis are adopting DCTs, supported by regulatory agencies like the FDA and EMA, which have guided digital tools. Advancements in AI, e-consent systems, and blockchain-based security are making DCTs more scalable and reliable, with companies like ICON Plc and Medable leading in comprehensive solutions. However, challenges such as data privacy, technological disparities, and patient digital literacy remain. Hybrid models that combine virtual and traditional trial elements are emerging as viable solutions. As these barriers are addressed, DCTs are expected to drive accessibility, efficiency, and innovation in clinical research.
Increasing Complexity of Drug Development
The increasing complexity of drug development, particularly with biologics, gene therapies, and personalized medicines, is driving the growth of pharmaceutical R&D outsourcing. These advanced therapies involve intricate processes like protein engineering and complex manufacturing, which require specialized expertise and cutting-edge technologies. Pharmaceutical companies are turning to Contract Research Organizations (CROs) to handle these tasks more efficiently and cost-effectively. Additionally, the demanding regulatory landscape, with agencies like the FDA and EMA imposing stricter requirements, has made outsourcing essential. CROs with regulatory expertise help ensure compliance, mitigate risks, and accelerate drug development timelines. Beyond formulation challenges, patient recruitment for clinical trials has become increasingly difficult, requiring diverse and representative populations. Outsourcing partners are using technology and big data to streamline recruitment, manage trial data efficiently, and ensure smooth trial execution. This combination of technical and regulatory expertise positions CROs as critical partners in navigating the complexities of modern drug development.
INDUSTRY RESTRAINT
Maintaining Quality and Consistency Across Regions
Ensuring quality and consistency in global R&D outsourcing is challenging due to varying regulatory standards across regions, especially in emerging markets. Companies rely on robust quality assurance and communication with authorities like the FDA and EMA while adapting to local regulations. In low-cost regions like Asia or Eastern Europe, strict oversight is crucial to maintaining data integrity and patient safety in multi-continent clinical trials.
SEGMENTATION INSIGHTS
INSIGHTS BY STAGE OF DEVELOPMENT
The global pharmaceutical R&D outsourcing market by stage of development is segmented into clinical and non-clinical. The clinical segment dominates and holds the largest market share. The growth is driven by the unique outsourcing needs of each development phase. Early stages like preclinical and Phase I focus on drug discovery, target validation, and toxicity testing, often handled by CROs and CDMOs to leverage their expertise and cost-efficient infrastructure. Companies like Covance, Charles River, and Syneos Health now offer end-to-end project management and patient recruitment to expedite timelines. Later phases, particularly Phases II and III, require advanced data management, global logistics, and diverse patient recruitment. To address these demands, CROs are adopting digital and decentralized trial models, including virtual trials powered by AI and robotic process automation, which streamline recruitment, enhance patient engagement, and reduce delays, as seen in partnerships like those between AstraZeneca, Bayer, and AI-focused tech companies.
By Stage Of Development
INSIGHTS BY PRODUCT TYPE
The global pharmaceutical R&D outsourcing market by product type is categorized into small molecules and biologics. The biologics segment shows significant growth, with the fastest-growing CAGR of 11.14%. The Biologics complex therapies, derived from living organisms, are a key focus in pharmaceutical R&D. Their development and manufacturing are increasingly outsourced to specialized CDMOs due to the high costs, time intensity, and advanced equipment required, which can be challenging for many biotech firms and pharmaceutical companies to handle internally. Partnering with CDMOs allows these firms to leverage advanced technologies and expertise, significantly reducing production costs and time to market.
By Product Type
INSIGHTS BY COMPANY SIZE
Based on the company size, the small & mid-sized companies segment accounted for the largest share of the global pharmaceutical R&D outsourcing market. Small and mid-sized companies are becoming key players in the pharmaceutical R&D outsourcing market. Faced with rising costs and the complexity of drug development, they increasingly rely on CROs for preclinical research, clinical trials, and regulatory support. This approach allows them to stay competitive and bring innovative therapies to market without the need for extensive in-house resources. The demand for CRO services is particularly strong in Europe and Asia-Pacific, where these companies benefit from partnerships to navigate regulatory challenges and reduce operational costs. Europe, with its skilled workforce and cost-effective trials, has emerged as a major hub for outsourced R&D.
By Company Size
INSIGHTS BY THERAPY AREA
Based on the therapy area, the oncology segment holds the largest market share of over 30%. The oncology segment leads pharmaceutical R&D outsourcing, driven by the growing demand for innovative cancer treatments and efficient clinical trials. Accounting for about 70% of the global R&D pipeline, oncology sees significant competition and investment in early-stage research, particularly in personalized and cell-based therapies. Emerging biotech firms in North America and Europe are increasingly outsourcing preclinical and clinical trial services to CROs like IQVIA and PPD to reduce costs and speed up timelines. These CROs support complex oncology studies through platform and decentralized trials, improving patient recruitment and data management. The global demand for oncology outsourcing continues to grow, fueled by the rise in difficult-to-treat cancers and the expansion of specialized facilities, particularly in North America, Europe, and Asia-Pacific. North America remains the largest market due to its CRO concentration, while Asia-Pacific offers cost-effective clinical trials, especially for biologics and cell therapies, with firms like Novartis and Pfizer outsourcing extensively in the region.
By Therapy Area
GEOGRAPHICAL ANALYSIS
APAC shows prominent growth, with the fastest-growing CAGR of 11.91% in the global pharmaceutical R&D outsourcing market. The Asia-Pacific (APAC) region is growing rapidly, driven by cost efficiency, specialized expertise, and supportive government policies. Countries like China, India, and South Korea offer lower labor costs and advanced infrastructure, making them hubs for outsourced manufacturing and clinical trials. APAC is now the fastest-growing region in this market, fueled by the rising demand for biologics such as monoclonal antibodies and cell therapies, which require specialized capabilities. As R&D costs rise and patent expirations create pressure, many pharmaceutical companies are partnering with regional CROs to manage preclinical development and clinical trials more cost-effectively. Additionally, APAC is emerging as a key player in-process R&D, particularly in biologics and DMPK, where CROs provide deep expertise and scalable solutions.
By Geography
COMPETITIVE LANDSCAPE
The global pharmaceutical R&D outsourcing market report consists of exclusive data on 44 vendors. Major players like Boehringer Ingelheim, Charles River Laboratories, ICON, IQVIA, Fortrea, Lonza, Medpace, Parexel International Corp, Samsung Biologics, Syneos Health, Thermo Fisher Scientific, and WuXi AppTec dominate the market. These companies offer end-to-end solutions, from drug discovery to clinical trials, providing efficiency and expertise that appeal to large pharmaceutical firms. As R&D grows more complex, outsourcing is shifting toward specialized services like gene and cell therapy research, biologics, and personalized medicine, driving significant investment and innovation. With stricter regulations in markets like the EU and China, companies are increasingly partnering with CROs that excel at navigating the evolving global regulatory landscape.
Key Vendors
Other Prominent Vendors
KEY QUESTIONS ANSWERED:
CHAPTER - 1: Pharmaceutical R&D Outsourcing Market Overview
CHAPTER - 2: Pharmaceutical R&D Outsourcing Market
CHAPTER - 3: Pharmaceutical R&D Outsourcing Market Prospects & Opportunities
CHAPTER - 4: Pharmaceutical R&D Outsourcing Market Segmentation Data
CHAPTER - 5: Key Regions Overview
CHAPTER - 6: Pharmaceutical R&D Outsourcing Market Industry Overview
CHAPTER - 7: Appendix