세계 의약품 연구개발 아웃소싱 시장 규모는 2023년부터 2029년까지 10.15%의 CAGR로 확대될 것으로 예상됩니다.
2024년, Boehringer Ingelheim은 암에 대한 혁신적인 체크포인트 억제제를 개발하기 위해 Nerio Therapeutics의 전임상 자산을 최대 13억 달러 규모의 거래로 인수하여 암 분야 포트폴리오를 확장합니다. 2024년 AbbVie는 중추신경계(CNS) 질환 치료 전문 바이오기업인 Aliada를 인수하기로 최종 합의했으며, Aliada의 혁신적인 혈액뇌관문(BBB) 통과 기술을 통해 중추신경계(CNS) 질환에 대한 치료제를 개발할 계획입니다. 2024년 머크는 DNA 직접 변형 기술별 암 치료제를 전문으로 하는 Modifi Biosciences Inc.를 인수했습니다.
세포 및 유전자 치료제 산업의 아웃소싱은 수요 증가, 기술의 복잡성, 전문 지식의 필요성 등을 배경으로 급속한 성장을 거듭하고 있습니다. 개발 및 제조 수탁기관(CDMO)은 소규모 생명공학 기업이나 대형 제약사들도 자체적으로 대응하는 데 많은 비용을 들이지 않고도 효율적으로 사업을 확장하는 데 매우 중요한 역할을 하고 있습니다. 전문 시설 건설에 평방피트당 2,000달러의 비용이 소요되고, 완공까지 몇 년이 걸리는 경우도 있기 때문에 아웃소싱은 비용과 시간 모두에서 효율적인 매력적인 선택이 되고 있습니다. 이러한 아웃소싱 붐의 주요 원동력은 산업의 복잡성과 바이러스 벡터 생산 및 유전자 편집과 같은 제조 공정의 고도로 전문화된 특성입니다. 이러한 업무를 CDMO에 맡기면 엄격한 규제 기준을 준수하고 고품질의 결과물을 보장할 수 있습니다. 예를 들어, Catalent, Lonza, Thermo Fisher Scientific과 같은 기업들은 바이러스 벡터 제조 전문성을 갖춘 중소기업을 인수하여 이 신흥 시장에서 역량을 확대하기 위해 많은 투자를 하고 있습니다.
가상 및 분산형 임상시험(DCT)은 원격의료, 웨어러블, 원격 모니터링과 같은 기술을 활용하여 환자가 집이나 지역 환경에서 참여할 수 있도록함으로써 임상 연구에 변화를 가져오고 있습니다. 이러한 접근 방식은 이동을 줄이고 접근성을 향상시키며 COVID-19 팬데믹 상황에서 더욱 탄력을 받고 있습니다. DCT는 지리적 장벽을 극복하고, 다양한 참여를 가능하게 하며, 비용을 절감하여 환자 모집과 유지를 개선합니다. 웨어러블을 통한 지속적인 데이터 수집은 실시간 모니터링을 강화하고 정확성과 안전성을 향상시키며, Pfizer 및 Novartis와 같은 대기업은 FDA 및 EMA와 같은 규제 당국의 지원을 받아 DCT를 채택하고 있습니다. 블록체인 기반 보안의 발전으로 DCT는 더욱 확장 가능하고 신뢰할 수 있게 되었으며, 아이콘(ICON Plc)과 메더블(Medable)과 같은 기업이 종합적인 솔루션으로 선도적인 역할을 하고 있습니다. 그러나 데이터 프라이버시, 기술 격차, 환자의 디지털 리터러시 등의 과제는 여전히 남아있습니다. 가상과 전통적인 임상시험의 요소를 결합한 하이브리드 모델이 실행 가능한 솔루션으로 부상하고 있습니다. 이러한 장벽을 해결함으로써 DCT는 임상 연구의 접근성, 효율성 및 혁신을 촉진할 수 있을 것으로 기대됩니다.
세계의 의약품 R&D 아웃소싱 시장에 대해 조사했으며, 시장 개요와 함께 개발 단계별, 제품 유형별, 기업 규모별, 치료 분야별, 지역별 동향, 시장 진출 기업 프로파일 등의 정보를 전해드립니다.
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