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市场调查报告书
商品编码
1641381
全球医药研发外包市场:特色见解(2024-2029)Global Pharmaceutical R&D Outsourcing Market - Focused Insights 2024-2029 |
全球医药研发外包市场规模预计在2023年至2029年期间以 10.15%的年复合成长率成长。
2024年,勃林格殷格翰收购 Nerio Therapeutics 的临床前资产,扩大其肿瘤学产品组合,以开发癌症的变革性检查点抑制剂,交易价值高达 13亿美元。我们也与 Ochre Bio 合作开发用于肝臟再生和慢性肝病的新药。2024年,AbbVie 宣布达成最终协议,收购致力于治疗中枢神经系统(CNS)疾病的生物技术公司 Aliada。 Aliada 的创新血脑屏障(BBB)穿越技术有可能为中枢神经系统带来突破性的治疗方法。2024年,Merck收购了Modifi Biosciences Inc.,这是一家专门生产基于直接DNA修饰技术的抗癌药物的公司。
由于需求不断增加、技术复杂性不断增加以及对专业知识的需求,细胞和基因治疗行业的外包迅速成长。合约开发和製造组织(CDMO)在帮助小型生物技术公司甚至大型製药公司有效扩大业务规模而无需承担内部运作的高昂成本方面发挥着非常重要的作用。专门设施的建设成本可能高达每平方英尺 2,000 美元,并且需要数年才能完成,因此外包是一种具有成本效益和时间效率的有吸引力的选择。外包热潮的主要驱动力是产业的复杂性以及病毒载体生产和基因编辑等製造过程的高度专业性质。将这些任务外包给 CDMO 可确保遵守严格的监管标准和高品质的结果。例如,Catalent、Lonza 和 Thermo Fisher Scientific 等公司大力投资收购在病毒载体製造方面拥有专业知识的小公司,以扩大其在这个新兴市场的能力。
虚拟和分散临床试验(DCT)利用远距医疗、穿戴式装置和远端监控等技术来改变临床研究,使患者能够在家中或社区环境中参与。这种方法减少了出行并改善了出行管道,并且在新冠肺炎疫情期间获得了发展动力。 DCT 透过克服地理障碍、实现多元化参与和降低成本来改善患者的招募和保留。透过穿戴式装置持续收集资料可增强即时监控,提高准确性和安全性。Pfizer、Novartis等领先公司在 FDA 和 EMA 等监管机构的支持下采用了 DCT。人工智慧、电子同意系统和基于区块链的安全性的进步使 DCT 更具可扩展性和可靠性,ICON Plc 和 Medable 等公司成为拥有全面解决方案的主要参与者。然而,挑战依然存在,包括资料隐私、技术差距和病患数位素养。结合虚拟和传统临床试验元素的混合模型成为可行的解决方案。透过解决这些障碍,DCT 有望促进临床研究的可近性、效率和创新。
本报告研究了全球医药研发外包市场,提供市场概述,以及按发展阶段、产品类型、公司规模、治疗领域和地区划分的趋势,以及参与市场的公司概况。
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