Pharmaceutical Excipients Market Size, Share, Analysis 2028
预计到 2028 年全球药用辅料市场规模将达到 122.4504 亿美元;预计 2022 年至 2028 年的复合年增长率为 6.6%。
产品获批和上市数量的不断增加推动了药用辅料市场的增长。配方科学家已经认识到,单一成分辅料并不总是能够提供必要的性能,以充分制造某些 API。这些科学家专注于生产性能增强的共加工和多功能辅料。共加工辅料是两种或多种现有辅料在亚颗粒级的混合物,可充分发挥所掺入辅料的优势,并最大限度地减少其缺点。这些多用途辅料大大减少了药片中掺入辅料的数量。共加工辅料用于改善药物的流动性、崩解性、润滑性和可压缩性。辅料还简化了配方工艺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。共加工辅料在创建具有增强的化学、物理和机械性能的稳定、以结果为导向的药物输送系统中起着至关重要的作用。
这些公司正专注于开发用于药物制剂的共加工辅料。例如,2021 年 7 月,DFE Pharma 推出了一种共加工辅料 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剂型的协同解决方案。共加工辅料是生产药品的有前途的工具。现有的共加工辅料不能满足制备各种新配方的所有需求。还有足够的空间生产新的共加工辅料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。
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药用辅料市场:
复合年增长率(2021 - 2028 年)6.6%- 2021 年市场规模
78.3 亿美元 - 2028 年市场规模
122.5 亿美元
市场动态
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关键人物;主力;重要一员
- JRS 制药有限公司
- 罗盖特兄弟公司
- 巴斯夫
- 赢创工业集团
- 阿什兰公司
- 阿彻丹尼尔斯米德兰公司
- 陶氏化学公司
- 路博润公司
- 先锋公司
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
- 生物可吸收聚合物
- 脂质
- 基于脂质体的配方
- 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
- 其他的
- 癌症
- 新陈代谢
- 传染性疾病
- 牙科
- 眼科
- 基因疗法
- 其他的
- 着色剂及涂层剂
- 甜味剂和调味剂
- 悬浮剂和粘度剂
- 防腐剂和控释剂
- 抗氧化剂和油脂
- 片剂填充剂和稀释剂
- 粘合剂
- 压缩辅助器
- 造粒剂
- 其他的
- 肠外
- 口服制剂和药片
- 胶囊
- 液体和注射剂
- 预充式注射器中的物理化学辅料-容器相互作用
- 保健食品和非处方药
- 主题
- 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。
药用辅料市场由主要竞争者组成,他们采用各种策略,如产品发布、地域扩张和技术进步。以下列出了市场的一些最新发展:
- 2022 年 7 月,罗盖特宣布在其 PEARLITOL SD 甘露醇系列中增加一个用于直接压片的新等级——PEARLITOL 150 SD。PEARLITOL 150 SD 专为对还原糖高度敏感的活性药物成分 (API) 而开发,即使在使用具有挑战性的活性成分时,也能为解锁高级片剂剂型提供机会。
- 2019 年 10 月,Ashland 宣布推出三种新的药物解决方案——Plasdone S630 Ultra、Benecel XR 和 XRF 以及 Viatel 生物可吸收聚合物。Ashland 表示,它正在扩大其产品组合以满足配方师日益增长的需求,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 的突破性益生菌菌株乳双歧杆菌 (BPL1) 被列为 2021 年获奖产品之一。
市场参与者积极参与产品创新和开发,加上产品审批的增加,推动了药用辅料市场的增长。此外,随着技术的进步,预测期内市场将呈指数级增长。
区域概况
2021 年,亚太地区是增长最快的药用辅料市场,这得益于发展中国家主要参与者的兴趣日益浓厚,以及越来越多的全球主要参与者愿意将其辅料制造活动外包给亚太国家,因为这些国家制造成本低廉、劳动力成本低廉。中国和印度等国人口不断增长,可能会增加该地区对药用辅料的需求。中国已推出 500 多种药用辅料。根据世界卫生组织 (WHO) 的数据,中国约有 400 家药用辅料制造商,其中约 23% 专门生产药用辅料,其余则专注于化学和食品加工。目前,卡乐康 (美国)、美格 (德国)、德固赛 (德国)、罗盖特 (法国) 等领先的外国药用辅料公司已在中国设立合资企业、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,而美格主要提供药用乳糖和多元醇。国内药用辅料巨头有尚和药业、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中规模最大、品种最齐全的企业之一,拥有116个药用辅料品种,产能达4.5万吨(40,823.313公吨)以上。近两年公司持续实施外延式扩张战略,不断完善市场布局。而尚和药用辅料是国际药用辅料联合会(IPEC)中国会员,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 28 种药用辅料产品,包括预糊化淀粉、羟丙甲纤维素、羧甲基淀粉钠和微晶纤维素,产能超过 10,000 吨(9,071.847 公吨)。该公司的部分生产基地已获得美国 FDA 和欧洲 COS 认证。出口现已为公司贡献了 25% 的收入。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,前身为 CFDA) 注册。NMPA 是中国负责起草中国医疗器械和药品法规和法律的机构。这些商业数据掩蔽设施 (CDMF) 备案允许全球制药公司利用 JRS Pharma 的辅料在中国生产和销售药品。
应用程序洞察
根据应用,全球药用辅料市场细分为肠外、口服制剂和片剂、胶囊、液体和注射剂、预充式注射器中的物理化学辅料容器相互作用、营养品和非处方药、外用药等。口服制剂和片剂细分市场在 2021 年占据了最大的市场份额。片剂是最广泛使用的剂型。片剂辅料包括稀释剂、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几个例子。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,可溶性辅料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膨胀剂或稳定剂、溶解增强剂和治疗剂。赋形剂还有助于识别产品,同时提高产品在储存期间的整体安全性或功能。
然而,在预测期内,全球药用辅料市场在预充式注射器物理化学辅料-容器相互作用领域预计将增长。根据 2022 年《肠外药物协会 (PDA) 制药科学与技术杂志》上发表的一份报告,化学研究表明,肠外制剂辅料可能会与预充式注射器中的硅油相互作用,从而导致滑动力发生变化并影响自动注射器的性能。因此,控制预充式注射器的滑动力对于减轻剂量不准确至关重要。表面活性剂的化学稳定性分析表明,辅料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,在不同温度下储存装有不同表面活性剂溶液的注射器时,发现注射器滑动力有所增加。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,以避免药物-辅料容器相互作用。
在药用辅料市场运营的公司采用产品创新战略来满足全球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名称。
药用辅料市场报告范围
报告属性 | 细节 |
---|---|
2021 年市场规模 | 78.3亿美元 |
2028 年市场规模 | 122.5亿美元 |
全球复合年增长率(2021 - 2028) | 6.6% |
历史数据 | 2019-2020 |
预测期 | 2022-2028 |
涵盖的领域 | 按类型
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覆盖地区和国家 | 北美
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市场领导者和主要公司简介 |
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- 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。
全球药用辅料市场 – 细分
药用辅料市场根据类型、临床指征、功能、应用、最终用户和地理位置进行细分。根据类型,市场细分为生物可吸收聚合物、脂质和基于脂质体的配方;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;及其他。根据临床指征,药用辅料市场细分为癌症、代谢、传染病、牙科、眼科、基因疗法和其他。根据功能,市场细分为着色剂和涂层剂;甜味剂和调味剂;悬浮剂和粘度剂;防腐剂和控释剂;抗氧化剂和油;片剂填充剂和稀释剂;粘合剂、压缩助剂和造粒剂;及其他。根据应用,药用辅料市场细分为肠外、口服制剂和片剂、胶囊、液体和注射剂、预充式注射器中的物理化学辅料-容器相互作用、保健食品和非处方药、外用药和其他。根据最终用户,药用辅料市场细分为生物制药行业、制药行业、动物保健和其他。根据地域,市场细分为北美(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、韩国和亚太其他地区)、中东和非洲(阿联酋、沙特阿拉伯、南非和中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷和南美洲和中美洲其他地区)。
公司简介
- JRS PHARMA 有限公司
- 罗盖特兄弟公司
- 巴斯夫
- 赢创工业集团
- 阿什兰公司
- 阿彻丹尼尔斯米德兰公司
- 陶氏化学公司
- 路博润公司
- 先锋公司
- MEGGLE GmbH & Co KG.
- Univar Solutions Inc.
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
Growing generics and increasing product launches are the most significant factors responsible for the overall market growth.
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.
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.
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.
Pharmaceutical excipients market is segmented by countries comprising of North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America.
The inorganic chemicals segment dominated the pharmaceutical excipients market and accounted for the largest market share in 2021.
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.
The List of Companies - 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
- 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.
- 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.