市場調查報告書
商品編碼
1494860
到 2030 年合約藥物開發和受託製造廠商的市場預測:按服務類型、分子類型、劑型、應用、最終用戶和區域進行全球分析Pharmaceutical Contract Development & Manufacturing Organization Market Forecasts to 2030 - Global Analysis By Service Type, Molecule Type, Dosage Form, Application, End User and By Geography |
根據Stratistics MRC預測,2024年全球合約藥物開發和受託製造廠商市場規模將達2,432.9億美元,預計2030年將達到3,546.8億美元,複合年成長率為8.4%。
合約藥物開發和受託製造廠商(CDMO)是為製藥和生物技術公司提供綜合服務的專業公司。這些服務涵蓋整個藥物開發和製造過程,從最初的產品概念到商業生產。 CDMO 列出了配方開發、分析測試、製程最佳化、法規遵循等方面的專業知識。 CDMO 外包藥物開發和製造的各個方面,使客戶能夠專注於其核心能力,同時受益於 CDMO 的專業能力和基礎設施。
根據美國國家衛健委統計,我國有超過1.8億老年人患有慢性病,其中75%患有多種慢性病。
不斷成長的生物製藥市場
生物製藥市場的擴張刺激了對專業知識和基礎設施的需求,推動了 PCDMO 的擴張。這些組織為藥物開發、製造和測試提供客製化解決方案,滿足生物製藥的獨特要求。 CDMO 簡化製藥公司的流程、降低成本和風險,促進創新並加快新治療方法的上市時間。隨著生物製藥繼續主導市場開拓,CDMO 在支持開發和商業化方面發揮著至關重要的作用,推動了該領域的成長軌跡。
嚴格的監管要求和合規標準
CDMO 嚴格的監管要求和合規標準對於確保產品品質、安全性和有效性至關重要。這些標準可能會增加營運成本、延長開拓時間並為中小型企業設置進入壁壘,從而阻礙市場成長。合規工作通常需要大量資源,並導致服務和產品價格上漲。此外,嚴格的法規可能會抑制創新並限制適應市場需求的靈活性,從而抑制整體市場擴張和競爭。
對專業知識的需求不斷成長
隨著製藥公司尋求在利用外部專業知識的同時專注於核心能力,CDMO 在提供配方開發、製造和包裝等專業服務方面發揮關鍵作用。這一趨勢是由現代藥物開發的複雜性、嚴格的監管要求以及對具有成本效益的策略的需求所推動的。 CDMO 提供廣泛的服務,包括配方開發、分析測試、製造和包裝,使製藥公司能夠加速產品平臺,有效地將創新療法推向市場,並推動市場擴張。
價格壓力
CDMO 面臨的價格壓力來自競爭加劇、監管變化以及原料和人事費用上升。這些壓力往往導致價格下降,壓縮利潤率並阻礙創新和業務擴張的投資。因此,CDMO 可能難以維持盈利,且無法投資於先進技術和基礎設施升級。這種投資限制循環可能會阻礙新藥的開發,並限制該行業應對不斷變化的醫療需求的能力。
COVID-19 的影響
COVID-19 大流行對藥物開發和受託製造廠商市場產生了多種影響。疫情擾亂了供應鏈,減緩了臨床試驗和監管流程,同時對疫苗和治療等某些藥物的需求激增,為支持生產而向 CDMO 外包的情況也有所增加。總體而言,這場流行病凸顯了敏捷和彈性製造能力的重要性,並刺激了對技術和基礎設施的投資,以減輕未來的干擾。
預計開發服務部門將在預測期內成為最大的部門
開發服務業務預計將出現良好成長。為藥物開發和受託製造廠商提供的開發服務包括從藥物發現到臨床試驗的全面支持。這些服務包括配方開發、分析方法開發、穩定性測試和監管提交。 CDMO 使製藥公司能夠縮短開發時間、降低成本並利用專業知識,確保候選藥物從概念到臨床評估的高效、合規進展。
生技公司領域預計在預測期內複合年成長率最高。
生技公司領域預計在預測期內複合年成長率最高。 CDMO 列出了為生物技術公司進行藥物開發和製造的專業服務。 CDMO 列出了配方、臨床試驗支援和大規模生產等領域的專業知識。透過外包這些業務,生物技術公司可以專注於創新並加快新治療方法的上市時間,同時受益於 CDMO 的先進技術和監管合規專業知識。
預計亞太地區在預測期內將佔據最大的市場佔有率。主要促進因素包括製藥和生物技術行業的快速擴張、西方公司尋求具有成本效益的解決方案日益成長的外包趨勢以及低成本技術純熟勞工的可用性。此外,有利的法規環境和政府促進生命科學領域的措施正在進一步推動市場成長。隨著對學名藥和生技藥品的需求迅速成長,亞太地區正在成為提供廣泛開發和製造服務的 CDMO 的戰略地點。
預計北美在預測期內的複合年成長率最高。北美 CDMO 專注於創新、品質和效率,提供涵蓋藥物開發、製造、包裝和供應鏈管理的端到端解決方案。該地區受益於強力的法律規範、熟練的勞動力和先進的基礎設施,吸引了國內外客戶。主要企業不斷投資於研發和技術進步,以滿足不斷變化的行業需求,確保市場的競爭力和永續性。
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.