预计到 2031 年,制药连续制造市场规模将从 2023 年的 20.8 亿美元增至 46.7 亿美元。预计 2023-2031 年期间,该市场的复合年增长率将达到10.6%。监管机构的支持日益增多、合同和内部制造商越来越多地采用药品制造程序以及连续制造带来的优势可能仍是市场的主要趋势。
制药连续生产市场分析
制药公司不断投资创新制造技术,以获得竞争优势并保持市场领先地位,从而推动连续制造市场的发展。连续制造使制药公司能够更好地控制其生产过程,有助于提高最终产品的质量和一致性,从而减少偏差、浪费、节省返工时间和召回成本。制药连续制造可以提高最终产品的质量,增强过程控制,并允许实时发布测试。欧洲药品管理局 ( EMA ) 和美国食品药品管理局 ( FDA ) 是越来越倾向于在制药行业使用连续制造的监管机构。此外,由于通过自动化、系统控制、数据分析和过程分析技术 (PAT) 手段提供的改进的过程监控、控制和优化,连续制造在制药行业变得更具吸引力和实用性,从而推动了市场的发展。
制药连续生产市场概览
作为减少压力、减少药物开发时间和成本的可行解决方案,连续制造在制药行业中得到了广泛应用,同时还能保持最终产品质量和供应。因此,由于这些优势,连续制造市场正在健康增长。此外,美国食品药品管理局 (FDA) 不断推出推广使用连续制药制造系统的举措,以及连续制造系统相对于批量制造的众多优势,是推动市场增长的一些主要因素。然而,另一方面,制药连续制造系统的高成本实施可能会阻碍市场增长。
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制药连续生产市场驱动因素和机遇
连续制造工艺优势惠及市场
由于对生物制剂和灵活制造替代品的需求不断增长,制药连续制造正受到欢迎并变得越来越重要。正在向连续制造程序过渡的公司正在迅速获得 FDA 的批准。连续制造过程具有许多优势,包括时间效率高、减少能源需求和浪费以及提高生产力。此外,由于制造过程中只涉及很少的人,该过程降低了人为错误的风险。因此,由于连续制造提供的上述优势,市场预计在未来几年将增长。
新兴市场提供高潜力增长机会
亚太地区、中南部等地区正在兴起生物制药行业具有吸引力的外包地点。中国和印度的制造和运营成本较低,这是推动亚太地区市场增长的重要因素。由于两国生物制药行业近期的增长,中国和印度都对市场的未来前景持乐观态度。2020 年 1 月,药 明康德的子公司合全药业有限公司在中国开设了一家新的大型寡核苷酸活性药物成分 (API) 制造工厂。因此,适合生物制药行业的新兴市场很可能成为制药连续制造市场中具有高潜力的增长和收入来源。
制药连续制造市场报告细分分析
有助于得出制药连续制造市场分析的关键部分是产品、应用和最终用户。
- 根据产品,制药连续制造市场分为集成系统、半连续系统和控制系统。集成系统部分在 2023 年占据最大的市场份额,预计在预测期内将实现最高的复合年增长率。
- 根据应用,市场分为最终产品制造和API 制造。最终产品制造部分进一步分为固体剂量制造和液体剂量制造。最终产品制造部分在 2023 年占据了最大的市场份额。然而,API 制造部分预计在 2021-2031 年期间的复合年增长率最高。
- 根据最终用户,制药连续制造市场分为全面制造公司和研发部门。全面制造部门在 2023 年占据最大市场份额,预计在预测期内将实现最高复合年增长率。
医药连续制造市场份额地域分析
制药连续制造市场报告的地理范围主要分为五个区域:北美、亚太、欧洲、中东和非洲、南美和中美。
北美一直主导着制药连续生产市场。导致北美制药连续生产市场增长的因素包括:FDA 越来越多地支持推广连续生产而非批量生产,该地区药品短缺日益严重,以及有制药巨头有能力承担建立连续生产工艺的大量初始投资。几十年来,美国大多数行业都采用了连续生产工艺。美国在北美占据主导地位,原因包括采用连续生产程序的制药公司数量不断增加,生产技术领域的进步,以及这些设备为扩大产量提供的效率。此外,美国 FDA 还采取了各种举措,推动美国制药行业的连续生产。
制药连续制造市场区域洞察
Insight Partners 的分析师已详细解释了预测期内影响制药连续制造市场的区域趋势和因素。本节还讨论了北美、欧洲、亚太地区、中东和非洲以及南美和中美洲的制药连续制造市场细分和地理位置。
- 获取制药连续制造市场的区域特定数据
制药连续制造市场报告范围
报告属性 | 细节 |
---|---|
2023 年的市场规模 | 20.8亿美元 |
2031 年市场规模 | 46.7 亿美元 |
全球复合年增长率(2023 - 2031) | 10.6% |
史料 | 2021-2022 |
预测期 | 2024-2031 |
涵盖的领域 | 按产品
|
覆盖地区和国家 | 北美
|
市场领导者和主要公司简介 |
|
市场参与者密度:了解其对商业动态的影响
制药连续制造市场正在快速增长,这得益于终端用户需求的不断增长,这些需求源于消费者偏好的不断变化、技术进步以及对产品优势的认识不断提高等因素。随着需求的增加,企业正在扩大其产品范围,进行创新以满足消费者的需求,并利用新兴趋势,从而进一步推动市场增长。
市场参与者密度是指在特定市场或行业内运营的企业或公司的分布情况。它表明相对于给定市场空间的规模或总市场价值,有多少竞争对手(市场参与者)存在于该市场空间中。
在制药连续生产市场运营的主要公司有:
- GEA 集团
- 科倍隆有限公司
- 格律克股份公司
- 格拉特有限公司
- 细川密克光集团
- 芒森机械有限公司
免责声明:上面列出的公司没有按照任何特定顺序排列。
- 获取制药连续制造市场顶级关键参与者概览
制药连续生产市场新闻和最新发展
通过收集主要和次要研究后的定性和定量数据来评估制药连续制造市场,其中包括重要的公司出版物、协会数据和数据库。以下列出了制药连续制造市场的一些发展情况:
- 韩国合同开发和制造组织 (CDMO) SK Bioscience 已开始扩建位于韩国庆尚北道安东的 L House 疫苗制造工厂,扩建面积约为 4,200 平方米,该工厂将作为肺炎球菌结合疫苗候选药物 GBP410 的生产基地,该疫苗由 SK Bioscience 和赛诺菲共同开发,两家公司共同投资扩建。 (SK Bioscience,新闻稿,2024 年 3 月)
- 美国基本药物公益公司 Phlow Corp. 宣布与弗吉尼亚联邦大学 (VCU) 全民药物研究所和 AMPAC Fine Chemicals 建立战略联盟,为小分子药物产品提供合同连续制造研发 (R&D) 服务。除了强大且不断增长的内部能力外,Phlow 成熟、创新且经验丰富的战略合作伙伴网络还将利用最先进的技术和独特的行业见解,为各个开发阶段的小分子活性药物成分 (API) 和注册起始物料 (RSM) 提供高质量的美国先进制造解决方案。(Phlow Corp.,新闻,2022 年 3 月)
制药连续制造市场报告范围和交付成果
“制药连续生产市场规模和预测(2021-2031)”报告对以下领域进行了详细的市场分析:
- 范围内涵盖的所有主要细分市场的全球、区域和国家层面的制药连续制造市场规模和预测
- 制药连续制造市场趋势以及市场动态,如驱动因素、限制因素和关键机遇
- 详细的 PEST 和 SWOT 分析
- 制药连续制造市场分析涵盖主要市场趋势、全球和区域框架、主要参与者、法规和最新市场发展
- 行业格局和竞争分析,涵盖市场集中度、热图分析、知名参与者以及制药连续制造市场的最新发展
- 详细的公司简介
- Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
- PEST and SWOT Analysis
- Market Size Value / Volume - Global, Regional, Country
- Industry and Competitive Landscape
- Excel Dataset
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
The North America region dominated the pharmaceutical continuous manufacturing market in 2023.
Increasing shortage of medicines, and advantages offered by continuous manufacturing process are the driving factors impacting the pharmaceutical continuous manufacturing market.
Growing support from regulatory bodies, rising adoption by contract and in-house manufacturers for drug manufacturing procedures, and advantages associated with continuous manufacturing are likely to act as future trends for the pharmaceutical continuous manufacturing market.
GEA Group and Thermo Fisher Scientific Inc. are the leading players operating in the pharmaceutical continuous manufacturing market.
US$ 4.67 billion would be the estimated value of the pharmaceutical continuous manufacturing market by 2031.
10.6% is the CAGR of the pharmaceutical continuous manufacturing market.
Trends and growth analysis reports related to Life Sciences : READ MORE..
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.