根据(关键地区、市场参与者、规模和份额)填充成品制造市场 - 到 2030 年的预测

  • Report Code : TIPRE00018228
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 182
Buy Now

【研究报告】填充饰面制造市场规模预计将从2022年的87.0558亿美元增长到2030年的171.6541亿美元;预计 2022 年至 2030 年复合年增长率为 8.9%。
市场洞察和分析师观点:
用于无菌灌装完成的一次性系统 (SUDS) 和一次性系统 (SUS) 可节省时间药品制造商,从而使他们能够简化运营并缩短项目时间表。纳入 SUDS 还可以帮助他们确保法规遵从性,并赋予环境、健康和安全 (EHS) 优势和设施设计优势。此外,SUS 通过简化批次结束分解和净化操作来加速转换灌装操作;净化操作的简化涉及消除耗时的清洁和准备步骤。 SUS 现在用于填充加工操作。批量生物技术业务已成功部署一次性系统用于缓冲液和培养基制备。他们目前正在实施新的一次性技术,例如发酵和色谱系统。最近的技术进步使 SUDS 对于无菌操作越来越有吸引力。例如,一次性生产线非常适合蠕动泵可以传输的批次规模相对较小(50-500L)的注射液产品。因此,无菌灌装制造中一次性系统使用的增加将为灌装制造市场带来未来的增长。
增长动力和挑战:
生物制剂构成了最畅销药物的大部分,它们代表了增长最快的制药行业领域之一。自约 30 年前推出重组蛋白疗法以来,整个生物制剂市场的年增长率超过 12%。此外,目前有超过 5,000 种生物制药候选产品正在开发中。尽管生物制药提供了可观的利润率,但高开发成本和复杂的生产方案是这些药理学干预措施的发起者的主要关注点。因此,一些初创企业和制药巨头已开始将其业务运营的不同流程外包给合同服务提供商。此外,将工作外包给合同制造组织(CMO)和合同开发与制造组织(CDMO)可以减少资本投资的需求,提供更大的生产能力,缩短产品上市时间,并降低与产品相关的风险。产品商业化。
灌装是生产过程的最后一步,也是药品生产中最关键的阶段之一。生物制剂需要特殊的程序和设备来进行灌装操作,以确保产品的完整性和安全性。因此,对生物制品需求的增长导致对灵活的无菌灌装技术的同等需求。制药商与合同服务提供商合作,利用他们在最新灌装技术方面的经验和专业知识。目前约有 180 家公司为各种生物制品提供填充加工制造服务。它们分布在各个地区的 350 多家合同制造公司的灌装工厂中。
此外,许多服务提供商最近收购了其他市场参与者,以增强其服务产品。例如,赛诺菲将其生物制剂的生产外包给勃林格殷格翰。此外,艾伯维 (AbbVie) 的业务已成功开发和交付药品超过 130 年;该公司的全球网络每年灌装超过 1,400 万份小容量注射剂 (SVP),灌装产品销往约 175 个国家/地区。受益于支持生物制剂原料药 (DS) 和药品 (DP) 开发的完全整合的科技团队,艾伯维 (AbbVie) 还拥有良好的审计和监管记录,并在临床和商业方面取得了成功。凭借爱尔兰最先进的无菌生产线,特别是液体和冻干生物瓶,以及艾尔建 SVP 网络的整合,艾伯维进一步将其能力和产能扩大到每年超过 4000 万件。因此,对生物制剂的需求不断增长正在推动市场增长。
制药外包的作用已经从企业的一小部分变成了企业不可或缺的一部分。随着产品管线的扩大、持续的定价压力和新兴市场的出现,制药行业正在转型。随着亚太地区服务提供商数量的不断增加,CMO 市场的竞争也不断升级。美国和欧洲的小型 CMO 正在努力跟上激烈的竞争,最终,大型制药公司或其他 CMOS 正在收购它们。例如,2020 年 2 月,CMO Altasciences 收购了 Alliance Contract Pharma。此次收购为 Altascience 的产品组合增添了小分子合同制造和分析服务。尽管整合不断,CMO 市场仍然分散,只有少数公司实现了全球影响力和规模。
此外,针对抗体药物偶联和高效药物制造等利基领域提供的 CMO 服务需求很高,由于内部拥有这些能力需要大量投资。然而,许多制药公司已开始收购这些设施,以获得相对于竞争对手的竞争优势。这导致这些服务的价格上涨,使外包成为初创企业和小型制药公司的艰难选择。
战略见解
报告细分和范围:
灌装制造市场已细分基于产品、模式和最终用户。根据产品,灌装制造市场分为消耗品和仪器。消耗品部分进一步细分为预充式注射器、玻璃瓶/塑料瓶、药筒等。按形式划分,填充剂制造市场分为重组蛋白、单克隆抗体、疫苗、细胞疗法和生物疗法、基因疗法等。就最终用户而言,填充剂制造市场分为合同制造组织、生物制药公司等。根据地理位置,填充饰面制造市场分为北美(美国、加拿大和墨西哥)、欧洲(英国、德国、法国、意大利、西班牙和欧洲其他地区)、亚太地区(中国、韩国、日本) 、澳大利亚、印度和亚太地区其他地区)、中东和非洲(阿联酋、沙特阿拉伯、南非以及中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷以及中南部和中部其他地区)美国)。
细分市场分析:
根据产品,填充剂制造市场分为消耗品和仪器。消耗品部分进一步分为预充式注射器、玻璃瓶/塑料瓶、药筒等。消耗品部分分为药筒、小瓶、预充式注射器和其他消耗品,例如安瓿、瓶子、袋子和一次性系统。消耗品部门在灌装制造市场中占有重要的市场份额;由于与仪器相比更换率较高,预计在预测期内也将出现类似的增长趋势。此外,消耗品的保质期较短,而且通常需要大量。预充式注射器的日益普及、冻干中小瓶的不同应用以及灌装外包的增加是推动消耗品领域发展的关键因素。
按类型划分的灌装制造市场 – 2022 年和 2030 年
根据模式,填充剂制造市场分为重组蛋白、单克隆抗体、疫苗、细胞疗法和生物疗法、基因疗法等。疫苗灌装成品制造是生产过程中的关键阶段。它包括将准备好的疫苗装入小瓶并确保精确的数量。此步骤需要严格的质量控制以保持功效和安全性。填充后,小瓶将进行密封和包装。这一细致的流程在向全球人口提供疫苗、通过满足质量标准和监管要求来保障公众健康方面发挥着关键作用。此外,与疫苗灌装成品制造相关的关键发展不断增加正在推动市场增长。例如,2023 年 5 月,Novocol Pharma(安大略省领先的无菌注射剂合同开发和制造组织 (CDMO))和 Moderna, Inc.(一家率先开发信使 RNA (mRNA) 疗法和疫苗的生物技术公司)宣布了长期合作计划协议对预计在加拿大生产的 mRNA 呼吸道疫苗进行无菌灌装、标签和包装。生产周期的最后阶段称为灌装-完成无菌制造,需要将疫苗药物产品放入小瓶中并准备使用。此外,与 Novocol Pharma 的合作将提高 Moderna 位于拉瓦尔的 mRNA 工厂生产疫苗的灌装能力。根据规划和监管许可,该设施预计将于 2024 年底开业
根据最终用户,填充剂制造市场分为合同制造组织、生物制药公司等。 2022 年,合同制造组织细分市场占据最大市场份额,预计在预测期内复合年增长率最高。合同制造组织 (CMO) 通过最大限度地减少设施投资要求和药物开发成本,从而改善净现金流,从而使制药公司受益。外包是一种更便宜的方法,可以提高制造流程的效率。此外,它还允许制药和生物技术公司将资源重新分配到其他必要的领域。 CMO在过去几年被认为是一个利基行业,为制药公司提供额外的制造能力或特定服务。药品生产失败数量的增加导致 CMO 数量的增加。制药公司传统上拥有专门的生产设施来开发创新药物。然而,为了降低产能过剩的风险,制造外包的需求不断上升。
许多药企开始重新关注研发等核心能力,导致内部制造能力的剥离,导致制造业越来越依赖 CMO。此外,集体管理组织形式的额外产能减轻了供应短缺的风险。他们还为制药公司提供其他站点,以实施多站点供应策略并保持备用能力。例如,2020年,三星生物制品公司与GI Innovation公司签署了免疫化疗合同。根据该协议,三星生物制品公司通过从 f 细胞系开发到 I 期原料药生产的服务促进 GI 创新。
区域分析:
根据地理位置,填充剂制造市场分为北美、欧洲、亚太地区、中东和非洲以及南美洲和中美洲。北美是填充饰面制造市场增长的最重要贡献者。加拿大是生物制药行业发展最快的国家之一。多家国际公司正在投资加拿大生物制药行业。在加拿大,生物制药公司的数量正在显着增加。例如,不列颠哥伦比亚省温哥华市拥有大多数生物制药公司,每年产生 9030 万美元(1.2 亿加元)的收入。全国有约35-40家国内生物制药公司。一些加拿大生物制药公司包括 Inex Pharmaceuticals、Quest Vitamins、StressGen Biotechnologies、Stanley Pharmaceuticals、QLT Phototherapeutics 和 Stemcell Technologies。各种公共和私人研究组织包括分子医学和治疗中心、不列颠哥伦比亚大学生物技术实验室、不列颠哥伦比亚省癌症研究中心、加拿大艾滋病毒试验网络和疫苗评估中心。因此,该国生物制药行业的发展将促进预测期内的市场增长。
亚太地区预计将成为未来几年增长最快的市场。在亚太地区,中国是填充饰面制造的最大市场。市场的增长主要归因于中国填充剂制造工艺的技术进步、市场参与者的不断发展、生物制药行业的扩张以及慢性病患病率的不断上升。中国有超过500家生物制品/生物制药公司。大多数从事研发的机构是由海归或西方/合资公司设立的。尽管估计差异很大,但分析人士认为,中国政府每年通过资助计划在生物技术研发上花费超过 6 亿美元。中国国家和地方政府也投资投资IT企业的准风险投资公司。市场参与者正在通过有机和无机增长战略扩大业务。例如,药明生物在中国无锡开设药品工厂,于 2022 年 6 月将预充式注射器 (PFS) 产能提高至 1700 万支/年。由合同开发制造组织 (CDMO) 药明生物运营的最新 DP 设施被称为 DP5,它拥有先进的隔离器灌装线,可提供可靠、连续的灌装服务。据该公司称,这为 PFS 提供了多种容量输送选项,包括 1.25 mL、3 mL、1 mL 和 1 mL。
竞争格局和主要公司:
IMA Industria Macchine Automatione SpA、Nipro Medical Europe NV、Maquinaria Industrial Dara SL、Groninger and Co GmbH、SGD SA、Optima Packaging Group Gmbh、NNE AS、Stevanato Group SpA、Syntegon Technology GmbH、West Pharmaceutical Services Inc、Gerresheimer AG、Schott AG 和 Becton Dickinson and Co 是在填充饰面制造市场上运营的知名企业很少。这些公司专注于扩大服务范围,以满足全球不断增长的消费者需求。他们的全球业务使他们能够为大量客户提供服务,从而扩大他们的市场份额。
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


Which modality segment dominates the fill finish manufacturing market?

The modality segment dominated the global fill finish manufacturing market and accounted for the most significant revenue in 2022.

Which product segment dominates the fill finish manufacturing market?

Based on products, the consumables segment took the forefront lead in the global market by accounting for the largest share in 2022 and is expected to continue to do so till the forecast period.

What was the estimated fill finish manufacturing market size in 2022?

The fill finish manufacturing market was valued at US$ 8,705.58 million in 2022.

What are the growth estimates for the fill finish manufacturing market till 2030?

The fill finish manufacturing market is expected to be valued at US$ 17,165.41 million in 2030.

Who are the major players in the fill finish manufacturing market?

The fill finish manufacturing market has major market players, including IMA Industria Macchine Automatiche SpA, Nipro Medical Europe NV, Maquinaria Industrial Dara SL, Groninger and Co GmbH, SGD SA, Optima Packaging Group Gmbh, NNE AS, Stevanato Group SpA, Syntegon Technology GmbH, West Pharmaceutical Services Inc, Gerresheimer AG, Schott AG, and Becton Dickinson and Co.

What is fill finish manufacturing?

The term "fill/finish" describes the final steps of the manufacturing process, which are filling and finishing. Filling in the pharmaceutical industry means putting medication into a container and closing it, whereas finishing refers to the sterilization and standardization of medical supplies and containers. This is a crucial stage in the production of pharmaceuticals. Inadequate fill/finishing can lead to medication batches being ruined or rendered unfit for ingestion in other ways.

The List of Companies - Fill Finish Manufacturing Market

  1. IMA Industria Macchine Automatiche SpA
  2. Nipro Medical Europe NV
  3. Maquinaria Industrial Dara SL
  4. Groninger and Co GmbH
  5. SGD SA
  6. Optima Packaging Group Gmbh
  7. NNE AS
  8. Stevanato Group SpA
  9. Syntegon Technology GmbH
  10. West Pharmaceutical Services Inc
  11. Gerresheimer AG
  12. Schott AG
  13. Becton Dickinson and Co

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. 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.

  1. 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:

Research Methodology

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.

  1. 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.

  1. 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.

Your data will never be shared with third parties, however, we may send you information from time to time about our products that may be of interest to you. By submitting your details, you agree to be contacted by us. You may contact us at any time to opt-out.

Related Reports