Lyophilization Services for Biopharmaceuticals Market Report 2023-2028
[研究报告] 生物制药冻干服务市场预计将从 2022 年的 20.5141 亿美元增长到 2028 年的 35.8655 亿美元;预计 2023 年至 2028 年的复合年增长率为 9.9%。
生物制药冻干服务市场的增长 归因于全球对冻干产品的需求不断增长以及合同制造和冻干服务的快速增长。
生物制药冻干服务市场根据服务类型、最终用户和地区进行细分。该报告提供了对该市场的深入分析和见解,重点关注生物制药冻干服务市场趋势、技术进步、市场动态以及主要市场参与者的竞争格局分析等参数。
生物制药市场的冻干服务 - 市场洞察
合同制造和冻干服务的快速增长推动了生物制药冻干服务市场的增长
生物制药市场在全球范围内持续扩张,这将成为制药行业的主要增长动力。随着越来越多的治疗性生物制剂获得批准,生物制药肠外生产最近也得到了扩展。生物技术公司从合同制造组织 (CMO) 外包,以满足其灌装和完成需求并降低微生物污染风险。生物制药公司依赖合同制造组织 (CMO) 提供所需的产能和能力;在某些情况下,CMO 为公司提供了大量的生产。
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生物制药市场的冻干服务:
复合年增长率(2022 - 2028)9.9%- 2022 年市场规模
20.5 亿美元 - 2028 年市场规模
35.9 亿美元
市场动态
- 冻干产品需求不断增长
- 全球合同制造和冻干服务快速增长
- siRNA 和抗体制剂数量的增长
- 推出先进冻干技术
关键人物;主力;重要一员
- ATTWILL 医疗解决方案
- Axcellerate Pharma LLC
- Labyrinth生物制药有限公司
- 伯克希尔无菌制造公司
- PCI 制药服务
- Curia全球公司
- 新兴生物解决方案公司
- Jubilant HollisterStier 有限责任公司
- 生物福星
区域概况
- 北美
- 欧洲
- 亚太
- 南美洲和中美洲
- 中东和非洲
市场细分
- 冻干循环开发
- 临床制造
- 商业制造
- 冷冻干燥分析服务
- 制药及生物技术公司
- 研究机构
- 其他的
- 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。
建立内部冻干能力和运营需要专门的设备和专业知识,这既昂贵又耗时。然而,外包更便宜,而且可以提高制造流程的效率。此外,它还允许生物技术公司将资源重新分配到其他领域。因此,药物开发商和生物制药公司将此类运营外包给 CMO,以节省总体生产和收益成本。几年前,CMO 行业是一个利基服务市场,为生物技术公司提供额外的制造能力或特定服务。现在,许多生物技术公司将各种服务外包,从早期药物开发到商业规模制造。随着生物技术行业从大规模生产转向利基和靶向治疗(个性化医疗),对灵活的运营能力、生产规模和多产品运营的需求正在上升。由于所有这些因素,对 CMO 的倾向正在增长。Jubilant HollisterStier Contract Manufacturing & Services 就是这样一家为冻干操作提供专业设施和专用生产线的 CMO。该 CMO 通过商用无菌注射剂和全套冻干服务提供 I 期无菌灌装/完成服务。为了满足对其服务日益增长的需求,Jubilant 正在安装一台新的 385 平方英尺的冻干机。因此,生物制药 CMO能力和可用性的提高 推动了生物制药市场冻干服务的增长。
生物制药市场的冻干服务 – 按服务类型划分的见解
根据服务类型,全球生物制药冻干服务市场细分为商业制造、冻干周期开发、临床制造和冷冻干燥分析服务。商业制造部分在 2022 年占据最大市场份额。冻干周期开发部分预计在预测期内实现最高复合年增长率。
生物制药市场的冻干服务 – 基于最终用户的见解
根据最终用户,全球生物制药冻干服务市场分为制药和生物技术公司、研究机构和其他。制药和生物技术公司部门在 2022 年占据最大的市场份额。预计研究机构部门在预测期内的复合年增长率最高。
生物制药冻干服务市场中的公司采用并购等无机和有机战略。以下列出了一些近期的关键市场发展:
- 2022 年 11 月,LTI 宣布参与结核病候选疫苗 ID93/GLA-SE 的开发、工艺工程和临床材料制备。该结核病疫苗已成功进入第 2 期临床试验。这项研究是第一份关于成功冻干含有乳剂佐剂的耐热亚单位候选疫苗的报告。
- 2022 年 5 月,Jubilant HollisterStier LLC 与美国陆军承包司令部签订了一项价值 1.496 亿美元的合作协议,并与美国卫生与公众服务部生物医学高级研究与发展局 (BARDA) 代表的化学、生物、放射和核防御联合计划执行办公室 (JPEOCBRND) 进行协调。
- 2021 年 10 月,PCI Pharma Services (PCI) 宣布已签署最终协议,从全球私募股权公司 Permira 手中收购总部位于新罕布什尔州贝德福德的顶级合同开发和制造组织 (CDMO) Lyophilization Services of New England, Inc. (LSNE)。此次收购增加了美国(新罕布什尔州、威斯康星州)和欧洲(西班牙)的五家 FDA 批准的工厂,第六家预计将在未来几个月内获得批准。此外,还有三家工厂正在建设中。这些工厂将加强其全球 30 个站点的网络。
- 2021 年 7 月,Albany Molecular Research, Inc. (AMRI) 宣布将于 2021 年 7 月 12 日起更名为 Curia。新名称强化了公司作为端到端全球 CDMO 的战略定位,将其科学专业知识和从研发 (R&D) 到商业制造的广泛能力应用于使其制药和生物技术客户能够推进改善生活的重要新产品。
生物制药冻干服务市场报告范围
报告属性 | 细节 |
---|---|
2022 年市场规模 | 20.5亿美元 |
2028 年市场规模 | 35.9亿美元 |
全球复合年增长率(2022 - 2028) | 9.9% |
历史数据 | 2020-2021 |
预测期 | 2023-2028 |
涵盖的领域 | 按服务类型
|
覆盖地区和国家 | 北美
|
市场领导者和主要公司简介 |
|
- 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。
公司简介 - 生物制药市场的冻干服务
- ATTWILL 医疗解决方案
- Axcellerate Pharma LLC
- Labyrinth生物制药有限公司
- 伯克希尔无菌制造公司
- PCI 制药服务
- Curia全球公司
- 新兴生物解决方案公司
- Jubilant HollisterStier 有限责任公司
- 生物福星
- 冻干技术公司
- SYNERLAB 集团
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
This text is related
to country scope.
Frequently Asked Questions
Based on service type, the global lyophilization services for biopharmaceuticals market is divided into commercial manufacturing, lyophilization cycle development, clinical manufacturing, and freeze-drying analytical services. The commercial manufacturing segment held the largest share of the market in 2022. The lyophilization cycle development segment is expected to grow at the highest CAGR during the forecast period.
Based on end user, the global lyophilization services for biopharmaceuticals market is divided into pharmaceutical and biotechnology companies, research institutes, and others. The pharmaceutical and biotechnology companies segment held the largest share of the market in 2022. The research institutes segment is expected to grow at the highest CAGR during the forecast period.
The growth of market is likely to grow due to factors such as rising demand for lyophilized products and rapid growth in contract manufacturing and lyophilization services across the world are expected to boost the growth of the global lyophilization service for biopharmaceuticals market. However, the market is likely to get impacted by the demerits associated with lyophilization process during the forecast period.
Companies operating in the market are ATTWILL Medical Solutions; Axcellerate Pharma LLC; Labyrinth Biopharma LLC; Berkshire Sterile Manufacturing; PCI Pharma Services; Curia Global Inc; Emergent BioSolutions Inc.; Jubilant HollisterStier LLC; Biofortuna; Lyophilization Technology Inc.; and SYNERLAB GROUP.
Lyophilization is a process of isolating a solid substance from a solution. It is also known as freeze-drying is a process. The process is carried by freezing the solution and evaporating under vacuum. It helps in optimizing lyophilization cycle times and improves stability for critically complexes of injectable during the parenteral product development.
Global lyophilization services for biopharmaceuticals market is segmented by region into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. North America is likely to continue its dominance in the lyophilization services for biopharmaceuticals market during 2023–2028. The US holds the largest share of the market in North America and is expected to continue this trend during the forecast period.
The List of Companies - Lyophilization Services for Biopharmaceuticals Market
- ATTWILL Medical Solutions
- Axcellerate Pharma LLC
- Labyrinth Biopharma LLC
- Berkshire Sterile Manufacturing
- PCI Pharma Services
- Curia Global Inc
- Emergent BioSolutions Inc
- Jubilant HollisterStier LLC
- Biofortuna
- Lyophilization Technology Inc.
- SYNERLAB GROUP
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.