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Advanced Therapy Medicinal Products Cdmo Market

ID: MRFR/HC/29380-HCR
128 Pages
Rahul Gotadki
October 2025

Advanced Therapy Medicinal Products CDMO Market Research Report By Product Type (Gene Therapy, Cell Therapy, Tissue Engineering), By Indication (Cancer, Immune Disorders, Cardiovascular Diseases, Neurological Disorders), By Scale of Production (Clinical Trial, Commercial Production), By Service Type (Process Development, Manufacturing, Regulatory Support) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

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Advanced Therapy Medicinal Products Cdmo Market 摘要

根据MRFR分析,先进疗法药品CDMO市场规模在2024年估计为299.7亿美元。预计先进疗法药品CDMO行业将从2025年的343.6亿美元增长到2035年的1347.3亿美元,展现出14.64的年复合增长率(CAGR),预测期为2025年至2035年。

主要市场趋势和亮点

先进疗法药品合同开发与生产组织(CDMO)市场正在经历强劲增长,推动因素包括技术进步和对个性化医疗日益增长的需求。

  • 市场正在见证个性化医疗的兴起,反映出向量身定制的治疗方法的转变。
  • 技术整合变得越来越普遍,提升了制造过程和产品质量。
  • 监管演变正在塑造市场格局,促进创新疗法的更快审批和市场准入。
  • 主要驱动因素包括对细胞和基因疗法日益增长的需求以及制造技术的进步,特别是在北美和亚太地区。

市场规模与预测

2024 Market Size 299.7 (美元十亿)
2035 Market Size 134.73(美元十亿)
CAGR (2025 - 2035) 14.64%

主要参与者

隆泽(瑞士)、凯特尔(美国)、三星生物(韩国)、药明康德(中国)、勃林格殷格翰(德国)、富士胶片迪奥生物技术(日本)、艾普塔集团(美国)、诺华(瑞士)、赛默飞世尔科技(美国)

Advanced Therapy Medicinal Products Cdmo Market 趋势

The Advanced Therapy Medicinal Products CDMO Market is currently experiencing a notable evolution, driven by the increasing demand for innovative therapies. This market encompasses a range of products, including gene therapies, cell therapies, and tissue-engineered products, which are gaining traction due to their potential to address previously untreatable conditions. As regulatory frameworks become more accommodating, the landscape for contract development and manufacturing organizations (CDMOs) is expanding, allowing for greater collaboration between developers and manufacturers. The integration of advanced technologies, such as automation and artificial intelligence, is also enhancing operational efficiencies, thereby attracting more stakeholders to this burgeoning sector. Moreover, the focus on personalized medicine is reshaping the Advanced Therapy Medicinal Products CDMO Market. Companies are increasingly seeking CDMO partners that can provide tailored solutions to meet specific therapeutic needs. This trend is likely to foster innovation and expedite the development process, as CDMOs adapt their capabilities to align with the unique requirements of their clients. As the market continues to mature, the emphasis on quality assurance and compliance will remain paramount, ensuring that products meet stringent safety and efficacy standards. Overall, the Advanced Therapy Medicinal Products CDMO Market appears poised for sustained growth, driven by technological advancements and a shift towards more personalized healthcare solutions.

Rise of Personalized Medicine

The Advanced Therapy Medicinal Products CDMO Market is witnessing a shift towards personalized medicine, where therapies are tailored to individual patient needs. This trend is prompting CDMOs to develop specialized capabilities that cater to unique therapeutic requirements, thereby enhancing the overall efficacy of treatments.

Technological Integration

The integration of advanced technologies, such as automation and artificial intelligence, is transforming the operational landscape of the Advanced Therapy Medicinal Products CDMO Market. These innovations are streamlining processes, improving efficiency, and enabling CDMOs to respond more swiftly to market demands.

Regulatory Evolution

As regulatory frameworks evolve, the Advanced Therapy Medicinal Products CDMO Market is experiencing increased collaboration between developers and manufacturers. This evolution is fostering a more conducive environment for innovation, allowing for the rapid development and commercialization of advanced therapies.

Advanced Therapy Medicinal Products Cdmo Market Drivers

制造技术的进步

Technological advancements play a pivotal role in shaping the Advanced Therapy Medicinal Products CDMO Market. Innovations such as automated bioprocessing, continuous manufacturing, and advanced analytics are revolutionizing the production of advanced therapies. These technologies not only improve efficiency but also enhance product quality and consistency. For instance, the implementation of single-use systems has streamlined operations, reducing contamination risks and lowering costs. As a result, CDMOs are better positioned to meet the increasing demands of the market, which is expected to grow significantly, with estimates suggesting a market size of USD 10 billion by 2025. This technological evolution is essential for maintaining competitiveness in a rapidly evolving landscape.

监管支持和框架

The regulatory landscape surrounding the Advanced Therapy Medicinal Products CDMO Market is evolving, with agencies providing clearer guidelines and support for the development and commercialization of advanced therapies. Regulatory bodies are increasingly recognizing the potential of these therapies, leading to expedited approval processes and incentives for manufacturers. This supportive environment encourages investment in research and development, as companies seek to navigate the complexities of regulatory compliance. The establishment of frameworks that facilitate collaboration between CDMOs and regulatory agencies is likely to enhance the overall efficiency of bringing advanced therapies to market. As a result, the industry is poised for growth, with projections indicating a market expansion to USD 15 billion by 2027.

生物制药投资增长

Investment in biopharmaceuticals is a significant driver of the Advanced Therapy Medicinal Products CDMO Market. As pharmaceutical companies increasingly focus on developing biologics and advanced therapies, the demand for specialized manufacturing services is on the rise. Recent reports indicate that biopharmaceutical investments have reached over USD 200 billion, reflecting a robust interest in innovative treatment modalities. This influx of capital is likely to bolster the capabilities of CDMOs, enabling them to expand their service offerings and enhance their technological infrastructure. Consequently, the growth of biopharmaceutical investments is expected to create a favorable environment for CDMOs, facilitating their role in the development and production of advanced therapies.

提高患者意识和接受度

Patient awareness and acceptance of advanced therapies are crucial factors influencing the Advanced Therapy Medicinal Products CDMO Market. As patients become more informed about the benefits of personalized medicine and innovative treatment options, the demand for advanced therapies is likely to increase. Educational initiatives and outreach programs are playing a vital role in enhancing understanding and acceptance among patients and healthcare providers. This growing awareness is expected to drive market growth, as more individuals seek out advanced therapies for conditions that were previously deemed untreatable. The increasing patient advocacy for innovative treatments is likely to create a more favorable landscape for CDMOs, as they align their services with the evolving needs of the healthcare market.

对细胞和基因疗法的需求增加

The Advanced Therapy Medicinal Products CDMO Market is experiencing a notable surge in demand for cell and gene therapies. This trend is largely driven by the growing prevalence of chronic diseases and genetic disorders, which necessitate innovative treatment solutions. According to recent data, the market for cell and gene therapies is projected to reach approximately USD 20 billion by 2026, indicating a compound annual growth rate of around 30%. This increasing demand compels CDMOs to enhance their capabilities in manufacturing and development, thereby fostering a more robust ecosystem for advanced therapies. As a result, companies are investing in state-of-the-art facilities and technologies to meet the stringent requirements of these complex products.

市场细分洞察

By Type: Gene Therapy (Largest) vs. Cell Therapy (Fastest-Growing)

In the Advanced Therapy Medicinal Products CDMO Market, the Type segment is marked by the prominent share of Gene Therapy, which stands out as the largest segment. This sector benefits from high investment levels and extensive R&D initiatives aimed at harnessing the potential of genetic material to treat or prevent diseases. In contrast, Cell Therapy is emerging with a rapid growth trajectory, driven by innovative treatment approaches and escalating demand for personalized medicine.

Gene Therapy (Dominant) vs. Cell Therapy (Emerging)

Gene Therapy, recognized as the dominant player in the market, leverages groundbreaking advancements in genetic modification to target and treat various genetic disorders effectively. Its position is fortified by a steady influx of partnerships and collaborations among biotech firms and research institutions. On the other hand, Cell Therapy is marked as an emerging segment, showcasing significant potential, especially in regenerative medicine and immunotherapy. As it garners increasing attention from stakeholders, this segment is marked by a surge in clinical trials and approvals, demonstrating its transformative capacity in treating chronic conditions and cancers.

By Indication: Cancer (Largest) vs. Immune Disorders (Fastest-Growing)

In the Advanced Therapy Medicinal Products CDMO Market, the indication segment is prominently led by Cancer therapies, which hold the largest market share. This segment's dominance is attributed to the increasing incidence of cancer worldwide and advancements in personalized medicine. Following closely are Immune Disorders, which have gained significant traction due to rising awareness and research in immunotherapies. The market dynamics indicate that while Cancer treatments continue to be the mainstream focus, Immune Disorders are rapidly catching up, driven by innovations in cellular therapies and gene editing technologies.

Indication: Cancer (Dominant) vs. Immune Disorders (Emerging)

Cancer therapies, characterized as the dominant force in the Advanced Therapy Medicinal Products CDMO Market, are supported by extensive research and development investments, along with regulatory support that fosters innovation. This area is witnessing robust growth due to effective treatment options such as CAR T-cell therapies and gene therapies, which offer targeted and personalized approaches. On the other hand, Immune Disorders represent an emerging segment, reflecting a paradigm shift towards immunotherapeutics and biologics. With a growing understanding of the immune system's role in various diseases, this segment is poised for accelerated growth, supported by breakthroughs in understanding autoimmune diseases and the development of cutting-edge therapies.

按生产规模:商业生产(最大)与临床试验(增长最快)

In the Advanced Therapy Medicinal Products Contract Development and Manufacturing Organization (CDMO) market, the distribution of market share between Clinical Trial and Commercial Production segments reveals a significant dominance of Commercial Production. This segment not only holds the largest share of the market, reflecting the established need for production capabilities at scale, but also showcases the ongoing investments made by CDMOs to enhance their manufacturing processes and infrastructure. On the other hand, the Clinical Trial segment, while smaller in terms of market share, represents a rapidly growing area as more innovative therapies enter the trial phase, highlighting the CDMO's adaptive manufacturing landscape. The growth trends within this segment are notably driven by increasing investments in biopharmaceuticals and gene therapies. As the demand for Advanced Therapy Medicinal Products surges, CDMOs are expanding their service offerings to include tailored solutions for clinical trials, which is the current fastest-growing segment. Factors such as regulatory support for cell and gene therapies and partnerships between biotech firms and CDMOs are propelling this growth, as companies look to efficiently bring their products to market. Clinical trials require specialized production capabilities, which are essential for maintaining compliance and achieving successful outcomes, further underscoring the critical role that CDMOs play in the advancement of these therapies.

Production Scale: Commercial Production (Dominant) vs. Clinical Trial (Emerging)

The Commercial Production segment in the Advanced Therapy Medicinal Products CDMO market is characterized by its robust infrastructure and established processes, positioning it as the dominant force in this sector. Companies in this segment are equipped with large-scale manufacturing facilities designed to comply with stringent regulatory standards, enabling them to meet the demands of high-volume production. In contrast, the Clinical Trial segment, while emerging, focuses on the unique challenges of producing therapies for research purposes, where flexibility and innovation are paramount. As clinical studies require smaller batches and rapid turnaround times, CDMOs engaged in this area are increasingly adopting agile manufacturing practices. The collaboration between CDMOs and biotechnology firms in clinical settings is fostering advancements in production technology and enhancing process efficiencies.

按服务类型:制造业(最大)与工艺开发(增长最快)

在先进疗法药品合同开发和制造组织(CDMO)市场中,服务类型细分主要由制造主导,由于其在先进疗法生产中的关键作用,制造占据了最大的市场份额。该细分市场已确立为行业的支柱,提供必要的能力以确保复杂产品的一致性和合规性制造。随后是工艺开发,作为增长最快的细分市场,越来越多的组织认识到优化和改进制造工艺以提高治疗效果和生产效率的重要性。

制造(主导)与工艺开发(新兴)

先进疗法药物合同开发与制造组织(CDMO)市场中的制造领域以其广泛的能力为特征,能够满足多种治疗方式的需求,包括细胞和基因疗法。它作为生物制药公司的关键推动力,确保其产品在遵循监管标准的同时实现大规模生产。相反,工艺开发正在兴起,重点是通过创新技术和方法来增强制造工作流程和优化生产过程。随着公司寻求定制满足特定产品要求的流程,该领域正在迅速发展,旨在缩短上市时间并提高效率。

获取关于Advanced Therapy Medicinal Products Cdmo Market的更多详细见解

区域洞察

先进疗法药品CDMO市场分为北美、欧洲、亚太地区、南美和中东及非洲。北美在2023年占据了最大的市场份额,并预计将在整个预测期内继续主导市场。

北美市场的增长归因于慢性疾病的日益普遍、个性化医疗需求的上升,以及该地区大量制药和生物技术公司的存在。预计欧洲将在2023年成为第二大先进疗法药品CDMO市场,并预计在预测期内以稳定的速度增长。

欧洲市场的增长归因于医疗支出的增加、对创新疗法需求的上升,以及该地区多家领先制药和生物技术公司的存在。

亚太市场预计将在预测期内成为增长最快的先进疗法药品CDMO区域市场。亚太市场的增长归因于慢性疾病的日益普遍、个性化医疗需求的上升,以及该地区多家新兴制药和生物技术公司的存在。

南美和中东及非洲预计将成为相对较小的先进疗法药品CDMO市场,但预计在预测期内将以稳定的速度增长。

这些市场的增长归因于医疗支出的增加、对创新疗法需求的上升,以及该地区多家新兴制药和生物技术公司的存在。

先进疗法药品CDMO市场区域洞察图

来源:初步研究、二次研究、MRFR数据库和分析师评审

Advanced Therapy Medicinal Products Cdmo Market Regional Image

主要参与者和竞争洞察

先进疗法药品CDMO市场的主要参与者正专注于开发创新技术,并通过战略合作和收购扩大其全球影响力。

领先的先进疗法药品CDMO市场参与者正在大力投资于研发,以增强其产品组合并获得竞争优势。先进疗法药品CDMO市场的发展受到个性化医疗需求上升和政府对再生疗法支持增加的推动。

竞争格局预计将保持分散,几家主要参与者将占据显著的市场份额。

Lonza是先进疗法药品CDMO市场的领先服务提供商,提供全面的细胞和基因疗法解决方案,包括细胞培养基、生物工艺开发和制造。

该公司在欧洲、北美和亚洲拥有强大的全球影响力。Lonza对创新和客户服务的承诺使其赢得了生物技术和制药公司的信任,成为值得信赖的合作伙伴。

Samsung Biologics是先进疗法药品CDMO市场的另一主要参与者。该公司提供全面的细胞和基因疗法开发和制造服务,包括细胞株开发、工艺优化和GMP制造。

Samsung Biologics在韩国拥有一座先进的制造设施,并通过与领先生物技术公司的合作伙伴关系扩大其全球影响力。

Advanced Therapy Medicinal Products Cdmo Market市场的主要公司包括

行业发展

  • 2024年第二季度:Catalent在比利时开设新的细胞治疗生产设施 Catalent宣布在比利时戈塞利斯开设一座新的商业规模细胞治疗生产设施,扩展其在欧洲的先进疗法药品(ATMP)合同开发和生产组织(CDMO)能力。
  • 2024年第二季度:Charles River Laboratories与Cellarity宣布战略合作以推进细胞治疗生产 Charles River Laboratories与Cellarity达成战略合作,以加速细胞治疗的开发和生产,利用Charles River在先进疗法药品方面的CDMO专业知识。
  • 2024年第二季度:WuXi Advanced Therapies扩展费城设施以提升细胞和基因治疗生产能力 WuXi Advanced Therapies完成了其费城设施的重大扩展,增加了作为先进疗法药品CDMO的细胞和基因治疗生产服务的能力。
  • 2024年第二季度:Minaris Regenerative Medicine与Autolus Therapeutics签署新的商业生产协议 Minaris Regenerative Medicine与Autolus Therapeutics签署了一项商业生产协议,为Autolus的先进细胞治疗产品提供CDMO服务。
  • 2024年第一季度:Lonza在休斯顿扩展细胞和基因治疗生产能力,开设新生产套件 Lonza宣布在其休斯顿设施开设一套新的生产套件,增强其为先进疗法药品提供CDMO服务的能力。
  • 2024年第一季度:Samsung Biologics收购基因治疗CDMO Senda Biosciences的股份 Samsung Biologics同意收购Senda Biosciences的少数股份,该公司专注于基因治疗的CDMO,以扩展其先进疗法药品服务组合。
  • 2024年第二季度:Thermo Fisher Scientific在加利福尼亚州推出新的质粒DNA生产设施 Thermo Fisher Scientific在加利福尼亚州卡尔斯巴德开设了一座新的质粒DNA生产设施,以支持对先进疗法药品领域CDMO服务日益增长的需求。
  • 2024年第二季度:AGC Biologics与Adaptimmune达成细胞治疗生产合作 AGC Biologics与Adaptimmune达成合作,为Adaptimmune的细胞治疗管线提供合同生产服务,扩展AGC的先进疗法药品CDMO产品。
  • 2024年第一季度:CellPoint与Lonza达成制造合作,开发即时CAR-T疗法 CellPoint与Lonza宣布合作开发和制造即时CAR-T细胞疗法,利用Lonza在先进疗法药品方面的CDMO专业知识。
  • 2024年第二季度:VIVEbiotech在西班牙扩展慢病毒载体生产设施 VIVEbiotech完成了其在西班牙圣塞巴斯蒂安的慢病毒载体生产设施的扩展,以满足对先进疗法药品市场CDMO服务日益增长的需求。
  • 2024年第一季度:Cellares筹集2.55亿美元C轮融资以扩大自动化细胞治疗生产 Cellares获得2.55亿美元的C轮融资,以加速其自动化细胞治疗生产平台的开发和部署,服务于先进疗法药品CDMO客户。
  • 2024年第二季度:Resilience与Takeda签署多年制造协议以生产细胞治疗产品 Resilience与Takeda签署了一项多年协议,生产细胞治疗产品,Resilience为Takeda的先进疗法药品管线提供CDMO服务。

未来展望

Advanced Therapy Medicinal Products Cdmo Market 未来展望

The Advanced Therapy Medicinal Products CDMO Market is projected to grow at a 14.64% CAGR from 2024 to 2035, driven by technological advancements, regulatory support, and increasing demand for personalized medicine.

新机遇在于:

  • Expansion of automated manufacturing processes for efficiency gains.
  • Development of strategic partnerships with biotech firms for innovative therapies.
  • Investment in advanced analytics for predictive quality control in production.

到2035年,市场预计将巩固其在生物制药制造领域的领导地位。

报告范围

MARKET SIZE 202429.97(USD Billion)
MARKET SIZE 202534.36(USD Billion)
MARKET SIZE 2035134.73(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR)14.64% (2024 - 2035)
REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR2024
Market Forecast Period2025 - 2035
Historical Data2019 - 2024
Market Forecast UnitsUSD Billion
Key Companies ProfiledMarket analysis in progress
Segments CoveredMarket segmentation analysis in progress
Key Market OpportunitiesGrowing demand for personalized medicine drives innovation in Advanced Therapy Medicinal Products CDMO Market.
Key Market DynamicsRising demand for personalized medicine drives competition among Advanced Therapy Medicinal Products Contract Development and Manufacturing Organizations.
Countries CoveredNorth America, Europe, APAC, South America, MEA

发表评论

FAQs

先进疗法药品CDMO市场的当前估值是多少?

2024年市场估值为299.7亿美元。

到2035年,先进疗法药品CDMO市场的预计市场规模是多少?

预计到2035年,市场将达到1347.3亿美元。

在2025年至2035年的预测期内,先进疗法药品CDMO市场的预期CAGR是多少?

预计在预测期内,CAGR为14.64%。

在先进疗法药品CDMO市场中,哪些公司被视为关键参与者?

主要参与者包括Lonza、Catalent、Samsung Biologics、WuXi AppTec和Boehringer Ingelheim。

先进疗法药品CDMO市场的主要细分领域是什么?

主要细分包括基因治疗、细胞治疗和组织工程。

市场在指示细分领域的表现如何?

市场在癌症、免疫疾病、心血管疾病和神经系统疾病方面表现显著。

先进疗法药品CDMO市场的生产规模是多少?

生产规模包括临床试验和商业生产,后者在2024年的估值为199.7亿美元。

在先进疗法药物产品CDMO市场中提供哪些类型的服务?

服务包括流程开发、制造和监管支持。

2024年细胞治疗部门的估值是多少?

细胞治疗部门在2024年的估值为100亿美元。

到2035年,基因治疗领域的预计增长是多少?

基因治疗领域预计到2035年将增长至400亿美元。

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