市场调查报告书
商品编码
1494860
到 2030 年合约药物开发和受託製造厂商的市场预测:按服务类型、分子类型、剂型、应用、最终用户和区域进行全球分析Pharmaceutical Contract Development & Manufacturing Organization Market Forecasts to 2030 - Global Analysis By Service Type, Molecule Type, Dosage Form, Application, End User and By Geography |
根据Stratistics MRC预测,2024年全球合约药物开发和受託製造厂商市场规模将达2,432.9亿美元,预计2030年将达到3,546.8亿美元,复合年增长率为8.4%。
合约药物开发和受託製造厂商(CDMO)是为製药和生物技术公司提供综合服务的专业公司。这些服务涵盖整个药物开发和製造过程,从最初的产品概念到商业生产。 CDMO 列出了配方开发、分析测试、製程优化、法规遵循等方面的专业知识。 CDMO 外包药物开发和製造的各个方面,使客户能够专注于其核心能力,同时受益于 CDMO 的专业能力和基础设施。
根据美国国家卫健委统计,我国有超过1.8亿老年人患有慢性病,其中75%患有多种慢性病。
不断成长的生物製药市场
生物製药市场的扩张刺激了对专业知识和基础设施的需求,推动了 PCDMO 的扩张。这些组织为药物开发、製造和测试提供客製化解决方案,满足生物製药的独特要求。 CDMO 简化製药公司的流程、降低成本和风险,促进创新并加快新治疗方法的上市时间。随着生物製药继续主导市场开拓,CDMO 在支持开发和商业化方面发挥着至关重要的作用,推动了该领域的成长轨迹。
严格的监管要求和合规标准
CDMO 严格的监管要求和合规标准对于确保产品品质、安全性和有效性至关重要。这些标准可能会增加营运成本、延长开拓时间并为中小型企业设置进入壁垒,从而阻碍市场成长。合规工作通常需要大量资源,并导致服务和产品价格上涨。此外,严格的法规可能会抑制创新并限制适应市场需求的灵活性,从而抑制整体市场扩张和竞争。
对专业知识的需求不断增长
随着製药公司寻求在利用外部专业知识的同时专注于核心能力,CDMO 在提供配方开发、製造和包装等专业服务方面发挥关键作用。这一趋势是由现代药物开发的复杂性、严格的监管要求以及对具有成本效益的策略的需求所推动的。 CDMO 提供广泛的服务,包括配方开发、分析测试、製造和包装,使製药公司能够加速产品平臺,有效地将创新疗法推向市场,并推动市场扩张。
价格压力
CDMO 面临的价格压力来自竞争加剧、监管变化以及原材料和人事费用上升。这些压力往往导致价格下降,压缩利润率并阻碍创新和业务扩张的投资。因此,CDMO 可能难以维持盈利,且无法投资于先进技术和基础设施升级。这种投资限制循环可能会阻碍新药的开发,并限制该行业应对不断变化的医疗需求的能力。
COVID-19 的影响
COVID-19 大流行对药物开发和受託製造厂商市场产生了多种影响。疫情扰乱了供应链,减缓了临床试验和监管流程,同时对疫苗和治疗等某些药物的需求激增,为支持生产而向 CDMO 外包的情况也有所增加。总体而言,这场流行病凸显了敏捷和弹性製造能力的重要性,并刺激了对技术和基础设施的投资,以减轻未来的干扰。
预计开发服务部门将在预测期内成为最大的部门
开发服务业务预计将出现良好成长。为药物开发和受託製造厂商提供的开发服务包括从药物发现到临床试验的全面支持。这些服务包括配方开发、分析方法开发、稳定性测试和监管提交。 CDMO 使製药公司能够缩短开发时间、降低成本并利用专业知识,确保候选药物从概念到临床评估的高效、合规进展。
生技公司领域预计在预测期内复合年增长率最高。
生技公司领域预计在预测期内复合年增长率最高。 CDMO 列出了为生物技术公司进行药物开发和製造的专业服务。 CDMO 列出了配方、临床试验支援和大规模生产等领域的专业知识。透过外包这些业务,生物技术公司可以专注于创新并加快新治疗方法的上市时间,同时受益于 CDMO 的先进技术和监管合规专业知识。
预计亚太地区在预测期内将占据最大的市场占有率。主要驱动因素包括製药和生物技术行业的快速扩张、西方公司寻求具有成本效益的解决方案日益增长的外包趋势以及低成本技术纯熟劳工的可用性。此外,有利的法规环境和政府促进生命科学领域的措施正在进一步推动市场成长。随着对学名药和生技药品的需求迅速增长,亚太地区正在成为提供广泛开发和製造服务的 CDMO 的战略地点。
预计北美在预测期内的复合年增长率最高。北美 CDMO 专注于创新、品质和效率,提供涵盖药物开发、製造、包装和供应链管理的端到端解决方案。该地区受益于强有力的法律规范、熟练的劳动力和先进的基础设施,吸引了国内外客户。主要企业不断投资于研发和技术进步,以满足不断变化的行业需求,确保市场的竞争力和永续性。
According to Stratistics MRC, the Global Pharmaceutical Contract Development & Manufacturing Organization (CDMO) Market is accounted for $243.29 billion in 2024 and is expected to reach $354.68 billion by 2030 growing at a CAGR of 8.4% during the forecast period. A Pharmaceutical Contract Development & Manufacturing Organization (CDMO) is a specialized corporation that provides comprehensive services to pharmaceutical and biotechnology companies. These services encompass the entire drug development and manufacturing process, from initial product concept to commercial production. CDMOs offer expertise in formulation development, analytical testing, process optimization, and regulatory compliance. They enable clients to outsource various aspects of drug development and production, allowing them to focus on core competencies while benefiting from the CDMO's specialized capabilities and infrastructure.
According to the National Health Commission (NHC), China has over 180 million elderly citizens suffering from chronic diseases, of which 75% have more than one.
Rising biopharmaceuticals market
The rising biopharmaceuticals market fuels demand for specialized expertise and infrastructure, driving the expansion of PCDMOs. These organizations offer tailored solutions for drug development, manufacturing, and testing, catering to the unique requirements of biopharmaceuticals. CDMOs streamline processes, reduce costs, and mitigate risks for pharmaceutical companies, fostering innovation and accelerating time-to-market for new therapies. As biopharmaceuticals continue to dominate the market, CDMOs play a pivotal role in supporting their development and commercialization efforts, fueling the growth trajectory of the sector.
Stringent regulatory requirements & compliance standards
Stringent regulatory requirements and compliance standards in CDMOs are essential to ensure product quality, safety, and efficacy. These standards can hamper market growth by increasing operational costs, lengthening development timelines, and creating barriers to entry for smaller companies. Compliance efforts often require substantial resources, leading to higher prices for services and products. Additionally, stringent regulations may deter innovation and limit flexibility in adapting to market demands, thus impeding overall market expansion and competitiveness.
Growing demand for specialized expertise
As pharmaceutical companies seek to focus on core competencies while leveraging external expertise, CDMOs play a crucial role in providing specialized services such as formulation development, manufacturing, and packaging. This trend is fuelled by the complexities of modern drug development, stringent regulatory requirements, and the need for cost-effective strategies. CDMOs provide a range of services including formulation development, analytical testing, manufacturing, and packaging, allowing pharmaceutical companies to accelerate their product pipelines and bring innovative treatments to market efficiently, thereby propelling market expansion.
Pricing pressures
Pricing pressures in CDMOs arise due to increased competition, regulatory changes, and rising costs of raw materials and labor. These pressures often lead to downward pricing trends, squeezing profit margins and hindering investment in innovation and expansion. Consequently, CDMOs may struggle to maintain profitability and may be unable to invest in advanced technologies or infrastructure upgrades. This cycle of constrained investment can impede the development of new drugs and limit the industry's ability to meet evolving healthcare needs.
Covid-19 Impact
The covid-19 pandemic has had mixed impacts on the pharmaceutical contract development & manufacturing organization (CDMO) market. While the demand for certain pharmaceutical products, such as vaccines and treatments, surged, leading to increased outsourcing to CDMOs for manufacturing support, the pandemic also disrupted supply chains and delayed clinical trials and regulatory processes. Overall, the pandemic emphasized the importance of agile and resilient manufacturing capabilities, driving investment in technology and infrastructure to mitigate future disruptions.
The development services segment is expected to be the largest during the forecast period
The development services segment is estimated to have a lucrative growth. A pharmaceutical contract development & manufacturing organization in development services provides comprehensive support from drug discovery to clinical trials. These services include formulation development, analytical method development, stability studies, and regulatory submissions. CDMOs enable pharmaceutical companies to accelerate development timelines, reduce costs, and access specialized expertise, ensuring efficient and compliant progression of drug candidates from concept to clinical evaluation.
The biotechnology companies segment is expected to have the highest CAGR during the forecast period
The biotechnology companies segment is anticipated to witness the highest CAGR growth during the forecast period. CDMOs provide biotechnology companies with specialized services for drug development and production. They offer expertise in areas like formulation, clinical trial support, and large-scale manufacturing. By outsourcing these tasks, biotech firms can focus on innovation and reduce time-to-market for new therapies, benefiting from CDMOs' advanced technologies and regulatory compliance expertise.
Asia Pacific is projected to hold the largest market share during the forecast period. Rapidly expanding pharmaceutical and biotechnology industries, increasing outsourcing trends from Western companies seeking cost-effective solutions, and the availability of skilled labor at lower costs are key drivers. Additionally, favourable regulatory environments and government initiatives to promote the life sciences sector further boost market growth. With a burgeoning demand for generic drugs and biologics, the Asia Pacific region is becoming a strategic hub for CDMOs offering a wide range of development and manufacturing services.
North America is projected to have the highest CAGR over the forecast period. With a focus on innovation, quality, and efficiency, North American CDMOs offer end-to-end solutions spanning drug development, manufacturing, packaging, and supply chain management. The region benefits from a strong regulatory framework, skilled workforce, and advanced infrastructure, attracting both domestic and international clients. Key players constantly invest in R&D and technological advancements to meet evolving industry demands, ensuring competitiveness and sustainability in the market.
Key players in the market
Some of the key players profiled in the Pharmaceutical Contract Development & Manufacturing Organization (CDMO) Market include Lonza Group, Catalent Inc., WuXi AppTec, Samsung Biologics, Boehringer Ingelheim BioXcellence, Parexel International, Thermo Fisher Scientific, Siegfried Holding AG, Fujifilm Diosynth Biotechnologies, Recipharm AB, Albany Molecular Research Inc. (AMRI), Piramal Pharma Solutions, Charles River Laboratories, Ajinomoto Bio-Pharma Services, Alcami Corporation, Cambrex Corporation, Hovione, Fareva, Sartorius Stedim BioOutsource, Micron Technologies.
In June 2023, FUJIFILM Corporation launched a commercial office in Tokyo to provide enhanced sales support and customer service for Contract Development and Manufacturing services for Biologics and Advanced Therapies to Asia-based pharmaceutical and biotechnology companies.
In April 2023, Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, has an agreement with ABL Bio, a pioneering Korean biologics company with a focus on bispecific antibodies for immuno-oncology and neurodegenerative diseases. The collaboration agreement between Lonza and ABL Bio supports the development and manufacturing of ABL Bio's new bispecific antibody product.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.