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北美生物製药冻干服务市场预测至 2028 年 - COVID-19 影响和区域分析 - 按服务类型和最终用户North America Lyophilization Services for Biopharmaceuticals Market Forecast to 2028 - COVID-19 Impact and Regional Analysis - by Service Type and End User |
北美生物製药冻干服务市场预计将从2023年的9.7405亿美元成长到2028年的15.8777亿美元。预计2023年至2028年的复合年增长率为10.3%。
对冷冻干燥产品的需求不断增长推动了北美生物製药市场的冷冻干燥服务
冷冻干燥是一种冷冻干燥方法,可去除材料中的水分,以延长其保质期和稳定性。冻干加工的产品在高真空下冷冻,主要用于製药业,製造高品质且价格实惠的产品。许多新的胃肠外产品,包括生物技术衍生产品、体外诊断和抗感染药物,都是以冷冻干燥产品的形式生产的。冷冻干燥过程可生产头孢菌素、半合成青霉素、红霉素盐、氯霉素和强力霉素等抗生素。批处理抗生素製剂时预计生物负荷较低,可透过冷冻干燥来实现。同样,其他一些剂型如甲泼尼龙琥珀酸钠、氢化可的松琥珀酸钠和许多生物技术衍生产品也是冷冻干燥的。
过去几年,美国食品药物管理局 (FDA) 每年批准 10 多种新型生物製剂。根据 FDA 2022 年 2 月公布的资料,生物製剂继续占 FDA 接受的所有药物的 25% 以上。大多数这些产品作为水性配方并不稳定,因此难以长期保存。因此,冷冻干燥是製备干燥生物药物製剂的优选方法,以实现更长且商业上可行的保质期。根据路博润生命科学发布的资料,2019年10月,市场上超过60%的生物製剂生产离不开冻干技术,并且由于生物仿製药和新型生物製剂的不断发展,市场对冻干技术的需求将会增加。当存在稳定性问题同时提供精确的生物製剂剂量(例如,非常小且高度浓缩的剂量)时,该方法被证明是有益的。此外,它也适用于对热、氧和湿度敏感的生物製品。此外,冻干在生物技术行业中已变得重要,因为一些供应商正在向市场推出冻干或预冻干产品。因此,冻干服务的需求快速成长,推动生物製药冻干服务市场的成长。
北美生物製药冻干服务市场概述
北美生物製药市场的冷冻干燥服务进一步细分为美国、加拿大和墨西哥。 2022年,美国在北美生物製药冻干服务市场中占据最大份额。美国市场的成长归因于广泛的研发活动、创新生物製药和医药产品的先进製造等因素。同样,加拿大生物製药行业的显着增长和国际公司投资的增加可能会加速市场的成长。美国、加拿大和墨西哥不断发展的生物製药产业正在为各国创造就业机会。
北美生物製药冻干服务市场收入及 2028 年预测(百万美元)
北美生物製药冻干服务市场细分
北美生物製药市场冻干服务分为服务类型、最终用户和国家。
根据服务类型,北美生物製药市场冻干服务分为冷冻干燥循环开发、临床製造、商业製造和冷冻干燥分析服务。 2023年,商业製造领域在北美生物製药冻干服务市场中占据最大份额。
根据最终用户,北美生物製药市场冻干服务分为製药和生技公司、研究机构等。 2023年,製药和生技公司部门在北美生物製药冻干服务市场中占据最大份额。
根据国家/地区,北美生物製药市场冻干服务分为美国、加拿大和墨西哥。 2023年,美国在北美生物製药冻干服务市场份额中占据主导地位。
ATTWILL 医疗解决方案; Axcellerate Pharma LLC;伯克希尔无菌製造;库里亚全球公司;紧急生物解决方案公司;欣欣向荣的 HollisterStier 有限责任公司;迷宫生物製药有限责任公司;冻干技术有限公司;和 PCI Pharma Services 是北美生物製药市场冻干服务的领先公司。
The North America lyophilization services for biopharmaceuticals market is expected to grow from US$ 974.05 million in 2023 to US$ 1,587.77 million by 2028. It is estimated to register a CAGR of 10.3% from 2023 to 2028.
Rising Demand for Lyophilized Products Fuel North America Lyophilization Services for Biopharmaceuticals Market
Lyophilization is a freeze-drying method that removes water from the material to extend its shelf life and stability. The products processed under lyophilization are frozen under high vacuum and are majorly used in pharmaceutical industries to manufacture high-quality and affordable products. Many new parenteral products, including biotechnology-derived products, in-vitro diagnostics, and anti-infectives, are manufactured as lyophilized products. The lyophilization process makes antibiotics such as cephalosporins, semi-synthetic penicillin, erythromycin salts, chloramphenicol, and doxycycline. Low bioburden is expected when batching antibiotics formulations, which can be attained using lyophilization. Similarly, a few other dosage forms such as methylprednisolone sodium succinate, hydrocortisone sodium succinate, and many biotechnology-derived products are lyophilized.
Over 10 novel biologics have been approved annually by the US Food and Drug Administration (FDA) in the last few years. According to the data published by FDA in February 2022, biologics continue to account for slightly more than 25% of all drugs accepted by the FDA. Most of these products are not stable as aqueous formulations, making it challenging to preserve them for longer durations. Thus, lyophilization is preferred for making dry biopharmaceutical formulations to achieve longer and commercially viable shelf lives. According to the data published by Lubrizol Life Science, in October 2019, over 60% of biologics production in the market would not be possible without lyophilization, and market demand for lyophilization technology will increase due to the growing biosimilars and novel biologics development. The method proves beneficial when there is a stability issue while providing exact biologics dosage (for instance, very small and highly concentrated doses). Furthermore, it is suitable for biologics sensitive to heat, oxygen, and humidity. Further, lyophilization has become important in the biotech industry, as several suppliers are introducing lyo-ready or pre-lyophilized products to the marketplace. As a result, the demand for lyophilization services is growing rapidly, driving the growth of the lyophilization services for biopharmaceuticals market.
North America Lyophilization Services for Biopharmaceuticals Market Overview
The lyophilization services for biopharmaceuticals market in North America is further segmented into the US, Canada, and Mexico. The US held the largest share of the North America lyophilization services for biopharmaceuticals market in 2022. The market growth in the US is attributed to factors such as extensive research and development activities, advanced manufacturing of innovative biopharmaceutical and pharmaceutical products. Likewise, the significant growth of the biopharmaceutical industry in Canada and increasing investment by international companies are likely to accelerate the market growth at a faster pace. The growing biopharmaceutical industry in the US, Canada, and Mexico is generating job opportunities across the countries.
North America Lyophilization Services for Biopharmaceuticals Market Revenue and Forecast to 2028 (US$ Million)
North America Lyophilization Services for Biopharmaceuticals Market Segmentation
The North America lyophilization services for biopharmaceuticals market is segmented into service type, end user, and country.
Based on service type, the North America lyophilization services for biopharmaceuticals market is segmented into lyophilization cycle development, clinical manufacturing, commercial manufacturing, and freeze drying analytical services. The commercial manufacturing segment held the largest share of the North America lyophilization services for biopharmaceuticals market in 2023.
Based on end user, the North America lyophilization services for biopharmaceuticals market is segmented into pharmaceutical & biotechnology companies, research institutes, and others. The pharmaceutical & biotechnology companies segment held the largest share of the North America lyophilization services for biopharmaceuticals market in 2023.
Based on country, the North America lyophilization services for biopharmaceuticals market is segmented into the US, Canada, and Mexico. The US dominated the share of the North America lyophilization services for biopharmaceuticals market in 2023.
ATTWILL Medical Solutions; Axcellerate Pharma LLC; Berkshire Sterile Manufacturing; Curia Global Inc; Emergent BioSolutions Inc; Jubilant HollisterStier LLC.; Labyrinth BioPharma LLC; Lyophilization Technology, Inc.; and PCI Pharma Services are the leading companies operating in the North America lyophilization services for biopharmaceuticals market.