市场调查报告书
商品编码
1533039
北美填充饰面製造市场预测至 2030 年 - 区域分析 - 按产品、方式和最终用户North America Fill Finish Manufacturing Market Forecast to 2030 - Regional Analysis - by Product, Modality, and End User |
2022年北美填充饰面製造市值为34.3958亿美元,预计2030年将达到65.0556亿美元;预计2022年至2030年复合年增长率为8.3%。
越来越多地采用预充式註射,推动了北美填充剂製造市场的发展
肠胃外给药是刺激即时免疫反应并确保药品完全生物利用度的最重要途径之一。肠外药物的开发和市场供应的稳定成长推动了对先进、经济高效且易于给药的药物输送设备的需求。与传统输送系统相比,预充式註射器的优点包括易于管理、提高安全性、准确剂量和降低污染风险。在药物传输装置中,预充式註射器是成长最快的初级包装形式之一,其设计用于剂量管理。在过去的十年中,肠外药物的开发显着增加(特别是随着几类生物製剂的引入),这导致预充式註射器的消耗量增加了约三倍。人们对预充式註射器的持续偏好归因于这些产品的安全性和易用性。最近的变异体设计有减少剂量错误、闭塞风险、液体渗漏(即外渗)和静脉发炎(静脉炎)的规定。由于上述优点,几种注射药物(Humira、Enbrel、Avastin、PREVNAR 13、ALPROLIX 和 Benefix 等)稀释剂和其他需要肠胃外给药的产品被包装在预充式註射器中。
在过去的七年里,约 90 种药物以预充式註射器包装形式在不同地区获得批准,包括北美、欧洲和亚太地区。几种处于药物开发临床阶段的药物正在与预充式註射器结合进行评估。
将无菌药物装入预充式註射器被认为是药品生产过程中最关键的步骤之一。适当的填充-完成操作必须在无菌条件下进行,以保持药理学功效和品质并确保最终用户的安全。预充式註射器填充是一项复杂的操作,因为它需要极其密切地监控注射器填充体积以及注射器中填充的液体与柱塞底部之间的顶部空间。此外,小分子原料药复杂性的增加和生物药物多样性的增加增加了对先进无菌填充操作的需求。
公司,包括小型企业和大型企业,将各自的填充加工业务外包给合约服务提供者。根据第十次生物製药产能和生产年度报告和调查,生物製药製造商将超过 30% 的填充作业外包。随着预充式註射器需求的增加以及填充完成製程的日益复杂,未来这些业务的外包可能会增加。全球有 100 多家公司正在为预灌封注射器製造商提供填充服务。为了满足不断增长的药品需求,服务提供者正在积极投资扩大其现有的基础设施和能力;过去几年,他们也透过服务协议扩大了客户群。由于注射剂占全球研发管线中候选药物的约55%,预充式註射器製造商和相关服务提供者的业务也在成长。由于COVID-19危机的出现,全球范围内的疫苗开发措施有所增加,这大大增加了对预充式註射器的需求。因此,越来越多地采用预充式註射器进行肠外给药,推动了填充剂製造市场的发展。
北美填充饰面製造市场概览
美国的填充饰面製造市场预计将成为世界上最大且成长最快的市场。广泛的研发活动以及创新生物製药和医药产品的先进製造等多种因素导致了市场的成长。市场成长的另一个主导因素是全球生物製药和医药产品的持续多样性和大规模供应。
生物製药业是该国最大的创收行业之一。 2023年,它为美国创造了超过130万个就业机会。因此,生物製药产业的成长极大地有助于维持该国的总体经济平衡。它每年产生约 5.5 亿美元的收入。因此,预计研究和产品开发的增加将增加美国对冷冻干燥服务的需求。
北美填充饰面製造市场收入及 2030 年预测(百万美元)
北美填充饰面製造市场细分
北美填充表面製造市场根据产品、模式、最终用户和国家进行细分。根据产品,北美灌装製造市场分为消耗品和仪器。到2022年,消耗品细分市场将占据更大的市场份额。
就形式而言,北美填充剂製造市场分为重组蛋白、单株抗体、疫苗、细胞疗法和生物疗法、基因疗法等。 2022 年,疫苗领域占据最大的市场。
依最终用户划分,北美填充剂製造市场分为合约製造组织、生物製药公司等。 2022 年,合约製造组织细分市场占据最大的市场份额。
根据国家/地区,北美填充饰面製造市场分为美国、加拿大和墨西哥。 2022 年,美国将主导北美填充饰面製造市场。
Becton Dickinson and Co、Gerresheimer AG、Groninger and Co GmbH、IMA Industria Macchine Automatiche SpA、Maquinaria Industrial Dara SL、Nipro Medical Europe NV、NNE AS、Optima Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SG , 和West Pharmaceutical Services Inc 是北美填充剂製造市场的一些领先参与者。
The North America fill finish manufacturing market was valued at US$ 3,439.58 million in 2022 and is expected to reach US$ 6,505.56 million by 2030; it is estimated to grow at a CAGR of 8.3% from 2022 to 2030 .
Growing Adoption of Prefilled Syringes for Parenteral Administration Fuels North America Fill Finish Manufacturing Market
Parenteral administration is one of the most prominent routes chosen to stimulate immediate immune response and ensure the complete bioavailability of pharmaceutical products. A steady rise in the development and market availability of parenteral drugs has propelled the demand for advanced, cost-effective drug delivery devices that promise ease of administration. The benefits of prefilled syringes over traditional delivery systems include easy administration, improved safety, accurate dosing, and reduced contamination risks. Among drug delivery devices, prefilled syringes represent one of the fastest-growing primary packaging formats, which are designed for dose administration. In the past ten years, there has been an evident increase in the development of parenteral drugs (especially with the introduction of several classes of biologics), which has resulted in approximately three-fold increase in the consumption of prefilled syringes. The sustained preference for the prefilled syringes is attributed to the safety and ease of use of these products. Recent variants are designed with provisions to reduce errors in dosing, risk of occlusions, leakage of fluids (i.e., extravasation), and inflammation of veins (phlebitis). Owing to the benefits mentioned above, several injectable drugs-Humira, Enbrel, Avastin, PREVNAR 13, ALPROLIX, and Benefix, among others-diluents and other products requiring parenteral administration are packaged in prefilled syringes.
Over the past seven years, ~90 drugs have been approved in the prefilled syringe packaging form across different geographies, including North America, Europe, and Asia Pacific. Several drugs in the clinical stages of drug development are being evaluated in combination with prefilled syringes.
The loading of sterile drugs into prefilled syringes is considered one of the most crucial steps in the pharmaceutical production process. Proper fill-finish operations are necessarily carried out under aseptic conditions to maintain pharmacological efficacy and quality and to ensure the safety of end users. The prefilled syringe filling is a complex operation as it requires extremely close monitoring of both the syringe fill volume and the headspace between the liquid filled in the syringe and the bottom of the plunger. In addition, the rise in complexity of small molecule APIs and the increasing diversity of biological drugs contribute to the demand for advanced aseptic fill finish operations.
Companies, including small enterprises and large businesses, outsource their respective fill finish operations to contract service providers. Per the 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, manufacturers of biological have been observed to outsource more than 30% of their fill finish operations. With the rise in the demand for prefilled syringes and the growing complexity of fill finish processes, outsourcing these operations is likely to increase in the future. Over 100 companies across the globe are providing fill finish services for prefilled syringe manufacturers. To cater to the growing demand of pharmaceutical products, service providers are actively investing in expanding their existing infrastructure and capabilities; they have also expanded their clientele through service agreements over the past few years. As injectables account for ~55% of drug candidates in the global R&D pipeline, the businesses of prefilled syringe manufacturers and associated service providers are also growing. Due to the emergence of the COVID-19 crisis, vaccine development initiatives have increased across the globe, which significantly boosted the demand for prefilled syringes. Thus, the rising adoption of prefilled syringes for parenteral administration drives the fill finish manufacturing market.
North America Fill Finish Manufacturing Market Overview
The fill finish manufacturing market in the US is anticipated to be the largest and fastest-growing market in the world. Several factors such as extensive research and development activities and advanced manufacturing of innovative biopharmaceutical and pharmaceutical products lead to the growth of the market. The other leading factor for market growth is sustained diversity and large-scale supply of biopharmaceutical and pharmaceutical products across the globe.
The biopharmaceutical industry is among the largest revenue-generating sector in the country. In 2023, it generated more than 1.3 million jobs in the US. Thus, the growth in the biopharmaceutical industry has assisted in maintaining the total economic balance in the country substantially. It generates ~US$ 550 million in revenue annually. Therefore, it is expected that the rise in research and product development will increase the demand for lyophilization services in the US.
North America Fill Finish Manufacturing Market Revenue and Forecast to 2030 (US$ Million)
North America Fill Finish Manufacturing Market Segmentation
The North America fill finish manufacturing market is segmented based on product, modality, end user, and country. Based on product, the North America fill finish manufacturing market is bifurcated into consumables and instruments. The consumables segment held a larger market share in 2022. Furthermore, the consumables is sub segmented into prefilled syringes, glass vial/plastic vials, cartridges, and others.
In terms of modality, the North America fill finish manufacturing market is segmented into recombinant proteins, monoclonal antibodies, vaccines, cell therapies and biological therapies, gene therapies, and others. The vaccines segment held the largest market share in 2022.
By end user, the North America fill finish manufacturing market is segmented into contract manufacturing organizations, biopharmaceutical companies, and others. The contract manufacturing organizations segment held the largest market share in 2022.
Based on country, the North America fill finish manufacturing market is segmented into the US, Canada, and Mexico. The US dominated the North America fill finish manufacturing market share in 2022.
Becton Dickinson and Co, Gerresheimer AG, Groninger and Co GmbH, IMA Industria Macchine Automatiche SpA, Maquinaria Industrial Dara SL, Nipro Medical Europe NV, NNE AS, Optima Packaging Group Gmbh, Schott AG, SGD SA, Stevanato Group SpA, Syntegon Technology GmbH, and West Pharmaceutical Services Inc are some of the leading players operating in the North America fill finish manufacturing market.