药用辅料市场基于(关键地区、市场参与者、规模和份额)- 到 2031 年的预测

  • Report Code : TIPRE00003534
  • Category : Chemicals and Materials
  • Status : Published
  • No. of Pages : 570
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预计到2028年全球药用辅料市场规模将达到1224504万美元;预计 2022 年至 2028 年复合年增长率为 6.6%。

产品批准和上市数量的增加推动了药用辅料市场的增长。配方科学家已经认识到,单组分赋形剂并不总能提供充分生产某些 API 所需的性能。这些科学家专注于生产具有增强性能的共加工和多功能赋形剂。共加工赋形剂是两种或多种现有赋形剂在亚颗粒水平上的混合物,提供了所掺入的赋形剂的显着优点并最大限度地减少了它们的缺点。这些多用途赋形剂大大减少了片剂中掺入赋形剂的数量。共加工的赋形剂用于改善药物的流动性、崩解性、润滑性和可压缩性。这些赋形剂还简化了配制过程并使其具有成本效益。它们越来越多地用于将复杂且劳动密集型的配方工艺(例如湿法制粒)转换为快速直接压缩工艺,而不会影响最终产品的质量或性能。共加工赋形剂在创建稳定、以结果为导向的药物递送系统方面发挥着至关重要的作用,该系统具有增强的化学、物理和机械性能。

这些公司正致力于开发药物共加工赋形剂配方。例如,2021年7月,DFE Pharma推出了一种共加工赋形剂Pharmacel sMCC 90,即硅化微晶纤维素(MCC)。它已被开发为具有挑战性的口服固体制剂的协同解决方案。共加工赋形剂是药品生产中很有前途的工具。现有的共加工助剂不能满足制备各种新制剂的全部需要。新型共加工辅料的生产也有足够的空间来满足制药行业的需求,预计这将成为预测期内药用辅料市场增长的机会。

战略见解

药用辅料市场由主要竞争者组成,他们采取各种策略,例如产品发布、地域扩张和技术进步。下面列出了市场的一些最新进展:

  • 2022 年 7 月,罗盖特宣布在其 PEARLITOL SD 甘露醇系列中添加一种新等级,用于直接压片 –珍珠醇 150 SD。 PEARLITOL 150 SD 专为对还原糖高度敏感的活性药物成分 (API) 开发,即使在使用具有挑战性的活性成分时,也能提供解锁先进片剂剂型的机会。
  • 2019 年 10 月,亚什兰宣布推出三款新的制药解决方案——Plasdone S630 Ultra、Benecel XR 和 XRF 以及 Viatel 生物可吸收聚合物。亚什兰表示,它正在扩大其产品组合,以满足配方设计师不断增长的需求,并将在即将举行的 AAPS 和 CPhI 贸易展上推出这些产品。
  • 2021 年 1 月,ADM 荣获商业智能集团颁发的 2021 年 BIG 创新奖。 ADM Biopolis 的开创性的益生菌菌株乳双歧杆菌 (BPL1) 入选 2021 年获奖产品。

市场参与者积极参与产品创新和开发,产品获批数量增加,推动了药用辅料市场的增长。此外,凭借先进技术,市场在预测期内将呈指数级增长。

区域概览

由于人们的兴趣不断增加,亚太地区是 2021 年增长最快的药用辅料市场由于制造和劳动力成本较低,发展中国家的主要参与者以及越来越多的全球主要参与者愿意将其辅料制造活动从亚太国家外包。中国和印度等国家人口的增长可能会增加该地区对药用辅料的需求。我国已推出500多种药用辅料。据世界卫生组织(WHO)统计,中国约有400家药用辅料生产商,其中约23%专门生产药用辅料,其余企业则专注于化学和食品加工。目前,美国卡乐康、德国麦格勒、德国德固赛、法国罗盖特等国外药用辅料龙头企业已在中国设立合资公司、独资公司或办事处。卡乐康提供薄膜包衣产品,罗盖特制药提供淀粉,而Meggle主要提供药用乳糖和多元醇。中国药用辅料巨头有三和药用、尔康药业、东宝生物、展望药业、青海明胶、山东聊城阿华药业、曲阜天利等。但市场集中度较低。

尔康药业是中国药用辅料生产企业规模最大、品种最全的企业,拥有药用辅料116种,产能45,000吨(40,823.313公吨)或更多的。公司近两年持续推行外延扩张策略,加强市场布局。同样,尚和药用辅料是国际药用辅料联合会(IPEC)中国成员,主要生产微晶纤维素、羟丙甲纤维素、羟丙基纤维素等18种新型药用辅料,产能达1万吨(9,071.847公吨) .

展望药业供应预糊化淀粉、羟丙甲纤维素、羧甲基淀粉钠、微晶纤维素等28种药用辅料产品,产能超过10,000吨(9,071.847公吨)。公司部分生产基地已获得美国FDA、欧洲COS认证。目前出口已占公司收入的25%。此外,2019年7月,JRS Pharma宣布其许多辅料产品正在国家药品监督管理局(NMPA,前CFDA)注册。 NMPA 是负责起草中国医疗器械和药品法规和法律的中国机构。这些商业数据屏蔽设施 (CDMF) 备案允许世界各地的制药公司利用 JRS Pharma 的辅料在中国生产和销售药品。

全球医药辅料市场的利润丰厚的地区

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应用洞察

根据应用,全球药用辅料市场分为注射剂、口服剂型和注射剂型。片剂、胶囊、液体和预充式注射器、营养保健品和药物中可注射的物理化学赋形剂容器的相互作用非处方药、外用药等。口服制剂& 2021 年,片剂细分市场占据最大市场份额。片剂是使用最广泛的剂型。片剂赋形剂包括稀释剂、粘合剂、润滑剂、助流剂、抗粘剂和超级崩解剂。乳糖、喷雾干燥乳糖、微晶纤维素和山梨糖醇是稀释剂的一些例子。粘合剂的例子包括明胶、葡萄糖、乳糖和纤维素衍生物(甲基纤维素)。润滑剂包括不溶性硬脂酸、硬脂酸镁、硬脂酸钙、滑石粉和石蜡。另一方面,可溶性赋形剂包括十二烷基硫酸钠;苯甲酸钠;以及PEG 400、600和800。此外,片剂中使用的超级崩解剂赋形剂包括交联羧甲基纤维素钠(Ac-di-sol)、交联聚维酮(polyplasdone)以及淀粉钠和乙醇酸淀粉。用于口服制剂的赋形剂包括增量剂或稳定剂、溶解度增强剂和治疗剂。赋形剂还有助于产品的识别,并提高产品在储存期间的整体安全性或功能。

但是,预计预充式注射器领域中物理化学赋形剂与容器相互作用的全球药用赋形剂市场在预测期内增长。根据2022年肠外药物协会(PDA)药物科学与技术杂志发表的一份报告,化学研究表明,肠外制剂赋形剂可能与预充式注射器中的硅油相互作用,从而导致滑动力的变化,影响自动注射器的性能。因此,控制预充式注射器的滑动力以减少剂量不准确至关重要。表面活性剂的化学稳定性分析表明,赋形剂的降解也会影响注射器的功能。已经进行了各种研究来研究不同表面活性剂及其功能对预充式注射器的影响。例如,在不同温度下储存填充有不同表面活性剂溶液的注射器时,注意到注射器滑动力的增加。这些研究结果表明,必须限制预充式注射器中表面活性剂的使用,以避免药用辅料容器相互作用。

全球药用辅料市场,按应用分类 – 2021 年和 2028 年

在药用辅料市场运营的公司采用产品创新战略来满足世界各地不断变化的客户需求,这也使他们能够在市场上保持自己的品牌。

< h3>全球制药辅料市场 –细分

药用辅料市场根据类型、临床适应症、功能、应用、最终用户和地理位置进行细分。根据类型,市场分为生物可吸收聚合物、脂质和脂质体配方;油脂化学品;糖;纤维素;淀粉;石化产品;植物蛋白、多元醇和环糊精;无机化学品;和别的。根据临床适应症,药用辅料市场分为癌症、代谢、传染病、牙科、眼科、基因治疗等。根据功能,市场分为着色剂和着色剂。涂层剂;甜味剂和调味剂;暂停&增稠剂;防腐剂和控释;抗氧化剂和油;片剂填充剂稀释剂;粘合剂、压缩助剂和造粒剂;和别的。按应用,药用辅料市场分为肠胃外制剂、口服制剂和注射剂。片剂、胶囊、液体和注射剂、预充式注射器、营养保健品和药物中的物理化学赋形剂与容器的相互作用非处方药、外用药等。根据最终用户,药用辅料市场分为生物制药行业、制药行业、动物保健等。按地理位置划分,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、日本、印度) 、澳大利亚、韩国和亚太地区其他地区)、中东和美国非洲(阿联酋、沙特阿拉伯、南非以及中东和非洲其他地区)以及南美和非洲中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)。

公司简介

  • JRS PHARMA GmbH & Co KG
  • Roquette Freres SA
  • 巴斯夫股份公司
  • 赢创工业股份公司
  • 阿什兰公司
  • Archer-Daniels -米德兰公司
  • 陶氏化学公司
  • 路博润公司
  • Avantor Inc
  • MEGGLE GmbH &
  • Univar Solutions Inc.
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


What is the regional market scenario of the pharmaceutical excipients market?

Pharmaceutical excipients market is segmented by countries comprising of North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America.

Which type segment held the largest market share in the pharmaceutical excipients market?

The inorganic chemicals segment dominated the pharmaceutical excipients market and accounted for the largest market share in 2021.

Who are the key players in the pharmaceutical excipients market?

JRS Pharma GmbH & Co KG, Roquette Frères SA, BASF SE, Evonik Industries AG, Ashland Inc, Archer-Daniels-Midland Co, The Dow Chemical Co, The Lubrizol Corp, Avantor Inc, MEGGLE GmbH & Co KG, and Univar Solutions Inc among others are among the leading companies operating in the pharmaceutical excipients market.

What is meant by the pharmaceutical excipients market?

Pharmaceutical excipients is also known as cryotherapy which comprises the use of cold materials for pain management in orthopedic conditions, soft tissue injuries, and musculoskeletal disorders. Pharmaceutical excipients reduce the blood flow to the affected area which helps in the reduction of pain, swelling, and inflammation.

What are the driving factors for the pharmaceutical excipients market across the globe?

Growing generics and increasing product launches are the most significant factors responsible for the overall market growth.

Which application segment led the pharmaceutical excipients market?

Based on application, the oral formulations & tablets segment took the forefront leaders in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.

Which end user segment held the largest market share in the pharmaceutical excipients market?

Based on the end user, pharma industries segment took the forefront leaders in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.

The List of Companies - Pharmaceutical Excipients Market

  1. JRS Pharma GmbH & Co KG
  2. Roquette Frères SA
  3. BASF SE
  4. Evonik Industries AG
  5. Ashland Inc
  6. Archer-Daniels-Midland Co
  7. The Dow Chemical Co
  8. The Lubrizol Corp
  9. Avantor Inc
  10. MEGGLE GmbH & Co KG
  11. Univar Solutions Inc

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.

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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:

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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.

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  • 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.

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