市場調查報告書
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1577256
細胞和基因治療CDMO市場至2030年的預測:按治療類型、服務類型、技術、最終用戶和地區的全球分析Cell and Gene Therapy CDMO Market Forecasts to 2030 - Global Analysis By Type of Therapy (Cell Therapy, Gene Therapy and Other Type of Therapies), Service Type, Technology, End User and By Geography |
根據 Stratistics MRC 的資料,2024年全球細胞和基因治療 CDMO 市場規模為 64.8億美元,預計到2030年將達到 311.4億美元,預測期內年複合成長率為 29.9%。
細胞和基因治療 CDMO(合約開發和製造組織)是協助生物製藥公司進行細胞開發、製造和商業化的專業服務供應商。這些組織提供端到端服務,包括製程開發、臨床和商業製造以及監管支援。透過與 CDMO 合作,生物製藥公司可以外包複雜且資源集中的業務,致力於研究、創新和產品發布,同時確保合規性和可擴展的生產。
對細胞和基因治療的需求不斷增加
生技公司致力於創造針對遺傳性疾病、癌症和慢性病的新治療方法,而對細胞和基因療法的需求不斷成長,導致對基因編輯、病毒載體生產、細胞培養等的需求增加。的專業知識。 CDMO 透過提供可擴展的製造、合規性和更快的上市時間來滿足不斷成長的需求,使生物技術公司能夠致力於研究和創新,而無需大量投資基礎設施,加速市場成長。
高成本、製造流程複雜
高成本和複雜的製造流程需要高度專業化的設施和設備,增加了營運成本。此外,還需要嚴格的品管措施和個人化的製造程序,進一步增加了成本。這些因素可能使 CDMO 難以實現規模經濟,限制盈利並阻礙市場成長。因此,與製造細胞和基因療法相關的高成本可能會對新參與企業造成進入壁壘,限制這些治療方法對患者的可用性,並阻礙市場成長。
聯盟和夥伴關係
生物製藥公司、學術機構和 CDMO 之間的合作和夥伴關係共同加速研究、簡化臨床開發和規模化生產。這些合作可以實現更快的創新、成本分攤和風險緩解,特別是在複雜且高成本的細胞和基因療法開發方面。透過利用每個合作夥伴的優勢,此次合作將促進高效的技術轉移、監管支援和市場進入,最終推動 CDMO 市場的成長和成功。
監管和品質問題
細胞和基因療法 CDMO 市場容易受到多種不利影響,包括由於監管和品質缺陷導致的成本增加、聲譽受損、產品開發延遲、市場進入有限以及法律問題。 CDMO 獲得新業務和夥伴關係的能力可能會因違規受到阻礙,導致處罰、召回和暫停營運。此外,品質差會損害 CDMO 的信譽、減少潛在客戶並阻礙市場成長。
COVID-19 的影響
COVID-19 大流行對細胞和基因治療 CDMO 市場產生了重大影響,導致供應鏈、臨床試驗和監管流程中斷。由於進入實驗室的機會有限和勞動力短缺,許多 CDMO 面臨計劃進度的延誤。然而,疫情也加速了對生物製造能力的投資和數位技術的採用,以提高業務效率。對新出現的健康危機進行快速治療反應的需求凸顯了靈活且可擴展的CDMO 服務的重要性。
細胞治療領域預計將成為預測期內最大的市場
透過為癌症、自體免疫疾病、退化性疾病等疾病提供突破性治療,細胞治療領域預計將在預測期內佔據最大的市場佔有率。由於 CAR-T 和幹細胞療法等細胞療法需要高水準的專業知識,因此許多生技公司將其工作委託給 CDMO。對個人化醫療和再生醫學的需求不斷成長,加上擴大臨床使用生產規模的挑戰,導致對 CDMO 的依賴增加。該領域的快速發展和監管部門的核准進一步推動了市場的成長。
病毒載體產業預計在預測期內年複合成長率最高
鑑於其在向目標細胞傳遞治療基因方面的重要作用,預計病毒載體部分在預測期內將在病毒載體市場中表現出最高的年複合成長率。隨著對創新基因療法的需求增加,腺病毒、慢病毒和腺結合病毒等病毒載體已成為有效基因轉殖的重要工具。專門生產病毒載體的CDMO 提供開發、製造、品管和臨床試驗和商業化所需的其他服務。此外,載體設計和生產技術的進步提高功效和安全性,進一步推動需求,並鼓勵生物製藥公司與擁有該領域專業知識的CDMO 合作。
由於生物技術投資增加、醫療基礎設施改善以及對創新治療方法的需求不斷成長,預計亞太地區將在預測期內佔據最大的市場佔有率。中國、日本和印度等國家已成為主要參與者,並受惠於政府推動研發的舉措。該地區多樣化的患者群體為個人化醫療提供了充足的機會,而當地的CDMO 日益擴大其服務國內和國際客戶的能力。與全球製藥公司的合作進一步增強了該地區在細胞和基因治療競爭格局中的競爭力。
在估計和預測期內,由於研發投入較高,預計北美地區的成長率最高。該地區擁有強大的基礎設施、先進的技術以及生物技術公司和學術機構的集中地。此外,FDA 等機構的監管支持加快細胞和基因療法的核准流程。遺傳疾病盛行率的上升進一步刺激了對客製化治療的需求,使北美成為這個快速成長市場的關鍵參與者。
According to Stratistics MRC, the Global Cell and Gene Therapy CDMO Market is accounted for $6.48 billion in 2024 and is expected to reach $31.14 billion by 2030 growing at a CAGR of 29.9% during the forecast period. A cell and gene therapy CDMO (Contract Development and Manufacturing Organization) is a specialized service provider that supports biopharmaceutical companies in the development, manufacturing, and commercialization of cell. These organizations offer end-to-end services, including process development, clinical and commercial manufacturing, and regulatory support. By partnering with CDMOs, biotech firms can outsource complex and resource-intensive tasks, enabling them to focus on research, innovation, and product launch while ensuring regulatory compliance and scalable production.
Increasing demand for cell and gene therapies
The increasing demand for cell and gene therapies in biotech companies focus on creating novel treatments for genetic disorders, cancers, and chronic diseases, they rely on CDMOs for expertise in complex processes like gene editing, viral vector production, and cell culture. CDMOs help meet the rising demand by offering scalable manufacturing, regulatory compliance, and faster time to market, enabling biotech firms to focus on research and innovation without the heavy investment in infrastructure, thereby accelerating the market's growth.
High costs and complex manufacturing processes
High costs and complex manufacturing processes requires highly specialized facilities and equipment, driving up operational costs. Additionally, the need for stringent quality control measures and personalized manufacturing processes further increases expenses. These factors can make it challenging for CDMOs to achieve economies of scale, limiting their profitability and hindering market growth. Consequently, the high costs associated with cell and gene therapy manufacturing can create barriers to entry for new players and limit the availability of these therapies to patients, hampering the market growth.
Collaborations and partnerships
Collaborations and partnerships in Biopharma companies, academic institutions, and CDMOs work together to accelerate research, streamline clinical development, and scale manufacturing. These alliances enable faster innovation, cost-sharing, and risk mitigation, particularly in the complex and high-cost development of cell and gene therapies. By leveraging each partner's strengths, collaborations foster efficient technology transfer, regulatory support, and market entry, ultimately propelling the growth and success of the CDMO market.
Regulatory and quality failures
The Cell and Gene Therapy CDMO Market is susceptible to several negative effects such as increased costs, reputational harm, delayed product development, restricted market access, and legal concerns due to regulatory and quality failures. CDMOs' capacity to draw in new business and partnerships may be hampered by non-compliance, which may result in penalties, recalls, and shutdowns. Moreover, poor quality might undermine CDMOs' credibility and shrink their prospective clientele thereby, hindering the market growth.
Covid-19 Impact
The COVID-19 pandemic has significantly impacted the Cell and Gene Therapy CDMO market by causing disruptions in supply chains, clinical trials, and regulatory processes. Many CDMOs faced delays in project timelines due to restrictions on laboratory access and workforce shortages. However, the pandemic also accelerated investments in bio manufacturing capabilities and the adoption of digital technologies, enhancing operational efficiency. The demand for rapid therapeutic responses to emerging health crises highlighted the importance of flexible and scalable CDMO services.
The cell therapy segment is expected to be the largest during the forecast period
The cell therapy segment is projected to account for the largest market share during the projection period, by offering groundbreaking treatments for conditions like cancer, autoimmune disorders, and degenerative diseases. Cell therapies, such as CAR-T and stem cell treatments, require highly specialized which many biotech companies outsource to CDMOs. The growing demand for personalized and regenerative medicine, coupled with the challenges of scaling production for clinical use, has led to increased reliance on CDMOs. This segment's rapid advancements and regulatory approvals further boost market growth.
The viral vectors segment is expected to have the highest CAGR during the forecast period
The viral vectors segment is projected to have the highest CAGR in the viral vectors market during the extrapolated period, due to their essential role in delivering therapeutic genes into target cells. As the demand for innovative gene therapies grows, viral vectors, such as adenoviruses, lentiviruses, and adeno-associated viruses, have become vital tools for effective gene transfer. CDMOs specializing in viral vector production provide essential services, including development, manufacturing, and quality control, which are crucial for clinical trials and commercialization. Additionally, advancements in vector design and production techniques enhance efficacy and safety, further driving demand and encouraging biopharmaceutical companies to collaborate with CDMOs for their expertise in this area.
The Asia Pacific region is projected to account for the largest market share during the forecast period due to increased investments in biotechnology, improving healthcare infrastructure, and rising demand for innovative therapies. Countries like China, Japan, and India are emerging as key players, benefiting from government initiatives promoting research and development. The region's diverse patient population offers ample opportunities for personalized medicine, while local CDMOs are expanding their capabilities to cater to both domestic and international clients. Collaborations with global pharmaceutical companies further enhance the region's competitiveness in the cell and gene therapy landscape.
During the estimation period, the North America region is forecasted to record the highest growth rate, owing to significant investments in research and development. The region boasts a robust infrastructure, advanced technologies, and a high concentration of biotechnology companies and academic institutions. Additionally, regulatory support from agencies like the FDA has accelerated the approval process for cell and gene therapies. The rising prevalence of genetic disorders further fuels demand for tailored therapies, positioning North America as a key player in this rapidly growing market.
Key players in the market
Some of the key players profiled in the Cell and Gene Therapy CDMO Market include Aldevron, Atara Biotherapeutics, Inc., Bluebird Bio, Inc., Bristol-Myers Squibb (Celgene), Catalent, Inc., Cytiva (part of GE Healthcare), Fujifilm Diosynth Biotechnologies, Kite Pharma (a Gilead Company), Lonza Group AG, NantKwest, Inc., Novartis AG, Paragon Bioservices, Inc., Pioneer BioTech, Precision BioSciences, Inc., Regenative Labs, Roche, Sangamo Therapeutics, Inc., Thermo Fisher Scientific Inc., VivaCell Biotechnology and WuXi AppTec.
In October 2024, Lonza completed acquisition of large-scale Biologics site in Vacaville, one of the largest biologics manufacturing facilities in the world. Acquisition extends Lonza's US Biologics footprint with a significant presence on the West Coast, complementing its existing global manufacturing network.
In September 2024, Lonza and Vertex signed a long-term commercial supply agreement for CASGEVY(R). By this Vertex will leverage Lonza's scientific, regulatory and manufacturing expertise, global manufacturing network, and Lonza will manufacture CASGEVY(R) at the state-of-the-art cGMP cell therapy manufacturing facilities, with plans to expand to its Portsmouth (US) facility.
In May 2024, Catalent and Siren Biotechnology entered into partnership a strategic partnership to support the development and manufacturing of Siren Biotechnology's AAV immuno-gene therapies. This partnership demonstrates Catalent commitment to a robust manufacturing process that will move therapeutic programs into the clinic as quickly as possible.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.