市场调查报告书
商品编码
1466754
药用辅料市场:按类型、剂型、功能分类 - 全球预测 2024-2030Pharmaceutical Excipient Market by Type (Inorganic, Organic), Formulation (Oral Formulations, Parenteral Formulations, Topical Formulations), Function - Global Forecast 2024-2030 |
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预计2023年药用辅料市场规模为86.2亿美元,2024年将达到92.2亿美元,预计2030年将达到144.2亿美元,复合年增长率为7.62%。
药用辅料添加到药品的目的有很多种,包括改进製造流程、提高稳定性、确保药物生物利用度以及促进最终产品的给药和剂量。赋形剂本质上惰性成分,整体支持活性成分的配製和递送。药用辅料市场主要受到全球人口成长和慢性病对药品需求增加的推动。配方技术的进步和新辅料的开发也促进了市场的成长。此外,学名药产业的扩张和针对轻微健康问题的自我治疗趋势也为辅料市场带来了强劲动力。然而,严格的监管要求和漫长的核准流程可能会阻碍新辅料的推出,而开发和製造先进辅料的高成本也阻碍了市场成长。向多功能赋形剂和共加工赋形剂的转变、生物基赋形剂开发的持续进步和研究活动为市场参与者提供了提高产品性能和生产效率等好处。
主要市场统计 | |
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基准年[2023] | 86.2亿美元 |
预计年份 [2024] | 92.2亿美元 |
预测年份 [2030] | 144.2亿美元 |
复合年增长率(%) | 7.62% |
各类有机辅料的潜在需求及利用
无机赋形剂是非有机来源的物质,包含在药物製剂中以发挥各种功能。这些赋形剂包括碳酸钙,它广泛用作填充剂和稀释剂以及锭剂中的钙源。碳酸钙因其高纯度、无毒和成本效益而成为优选。使用磷酸钙赋形剂,包括磷酸二氢钙和磷酸三钙,因为它们具有优异的可压缩性和流动性,使其成为压片操作的理想选择。硫酸钙在药品中用作锭剂赋形剂和共加工赋形剂,以提高锭剂的机械强度。岩盐,特别是氯化钠,可产生等渗溶液,并在口服药物中用作稳定剂和调味剂。在药物配方中,金属氧化物(例如氧化镁和氧化锌)可用作 pH 调节剂、着色剂和营养补充。有机赋形剂是指药物配方中所包含的有机(碳基)来源的物质。碳水化合物是口服固体製剂中的填充剂、粘合剂和稳定剂。纤维素衍生物,包括结晶纤维素,广泛应用于赋形剂市场,并因其结合、崩坏和成膜特性而受到重视。淀粉及其衍生物在锭剂中用作崩坏、粘合剂和填充剂,赋予药物形式良好的机械性能。蔗糖等糖常用于糖浆和锭剂中,作为水溶性药物的甜味剂和结晶基质。
脂醇类是非离子界面活性剂,可作为外用製剂的润肤剂,帮助原料药渗透皮肤。甘油在多种药物製剂中用作溶剂、保湿剂和防腐剂,包括口服、局部和肠胃外製剂。矿物硬脂酸盐(例如镁)主要用作锭剂製造中的润滑剂,以确保压锭剂的高效运作。在锭剂配方中,石化产品(例如丙烯酸聚合物,包括聚甲基丙烯酸甲酯)用作薄膜包衣、粘合剂和缓释性基质形成剂。丙二醇等二元醇作为原料药溶剂用途广泛,可用于许多药物製剂,例如注射剂、外用製剂和糖浆。石蜡等矿物碳氢化合物用于胶囊中,并因其润滑特性而用作各种软膏和霜剂的基质。此外,聚维酮也可用作锭剂中的粘合剂、液体製剂中的增溶剂以及口腔应用中的黏剂。明胶和胶原蛋白等蛋白质用于形成药物胶囊和成膜剂。其生物分解性和与人体的相容性使其对于某些製药应用至关重要。
製剂:由于给药方便,口服製剂的需求量大。
口服製剂是经由口服途径给药的剂型,是最方便且常用的药物传递方法之一。该细分市场包括各种旨在帮助活性药物成分的稳定性、释放和生物有效性(API) 的赋形剂。硬明胶胶囊是包含一种或多种原料药和赋形剂的固态剂型,封装在小壳中。硬明胶胶囊还具有剂量准确性和出色的稳定性等优点。软明胶胶囊(软胶囊)是类似胶囊的口服剂型,但具有围绕液体填充物的明胶外壳。它是优选的,因为它易于吞嚥并且可以增加难溶性原料药的生物有效性。液体製剂包括口服给药的溶液剂、混悬剂和乳剂。这些製剂中赋形剂的选择对于确保原料药的稳定性、偏好和适当吸收至关重要。锭剂是一种常见的口服剂型,而锭剂赋形剂市场依然强劲。锭剂製造中使用的成分将化合物结合在一起,有助于崩坏并提高稳定性。肠胃外製剂是用来直接施用到身体组织的无菌製剂。局部製剂涂布皮肤或黏膜,将活性成分直接输送到作用部位和全身循环。
作用:被覆剂对药物提供物理和化学保护。
粘合剂是锭剂中使用的黏合材料,可提高锭剂的强度和完整性,使粉末颗粒凝结并保持在一起。被覆剂涂布各种剂型的外表面,以遮罩不良味道,为药物提供物理和化学保护,并控制药物释放。医药产品中添加着色剂以方便产品识别并增强美观。崩坏是重要的赋形剂,可促进锭剂给药后在胃肠道中崩坏,使活性药物成分快速释放和吸收。其功能使锭剂在进入流体环境后能够有效地崩坏成更小的碎片。乳化剂透过降低不混溶液体之间界面的表面张力来帮助乳化的形成和稳定。乳化剂在乳膏剂、软膏剂和混悬剂等製剂中至关重要,可促进药物在系统内的均匀分布。填充剂和稀释剂是惰性添加剂,可增加锭剂和胶囊的体积,使其更易于製造且更易于处理。调味剂和甜味剂可改善口服药物的偏好并遮罩由原料药和其他赋形剂引起的令人不愉快的味道和气味。组合药物中添加润滑剂可防止成分结块并确保锭剂在压缩过程中顺利从模具中排放。防腐剂抑制药品中微生物的生长,延长保存期限,确保使用过程中的安全。悬浮剂和增稠剂可保持液体製剂中不溶性颗粒的均匀分散,并调节液体製剂的流动特性(黏度)。这确保了每次给药的剂量一致,并提高了实践的稳定性。
区域洞察
美洲地区在市场格局中占有重要地位,由于严格的监管环境、先进的医疗保健系统和强大的智慧财产权框架,该地区对辅料的需求量很大。鑑于製药创新的重要前景,该地区各国都大力关注用于药物配方的先进和新颖的辅料。欧洲、中东和非洲地区包括欧洲、中东和非洲,呈现多样化的市场特征。同时,随着对製药基础设施和监管的投资增加,中东和非洲市场正在快速成长。欧盟市场对复杂药物和先进药物输送系统的尖端药用辅料有很高的需求。此外,欧盟对生物製药和生物相似药的投资得到了这些领域对新型辅料不断增长的需求的补充。亚太地区国家是药用辅料产业的主要参与者,由于庞大的患者群、不断增加的医疗支出和政府的支持措施,该行业正在经历显着增长。该地区透过持续研发高性能辅料并减少对进口产品的依赖来专注于技术创新。
FPNV定位矩阵
FPNV定位矩阵对于评估药用辅料市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对药用辅料市场供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,以获得市场竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争评估与资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.药用辅料市场规模及预测如何?
2.药用辅料市场预测期间需要考虑投资的产品、细分市场、应用和领域有哪些?
3.药用辅料市场的技术趋势和法规结构是什么?
4.药用辅料市场主要厂商的市场占有率为何?
5.进入药用辅料市场合适的型态和策略手段是什么?
[194 Pages Report] The Pharmaceutical Excipient Market size was estimated at USD 8.62 billion in 2023 and expected to reach USD 9.22 billion in 2024, at a CAGR 7.62% to reach USD 14.42 billion by 2030.
Pharmaceutical excipients are added to pharmaceutical products for various purposes, including improving the manufacturing process, enhancing stability, ensuring the bioavailability of the drug, and facilitating the administration and dosing of the final product. Excipients are essentially inactive components that support the overall formulation and delivery of the active ingredient. The market for pharmaceutical excipients is primarily driven by the increasing demand for pharmaceutical products due to the rising global population and chronic diseases. Technological advancements in drug formulation and developing novel excipients also contribute to market growth. Furthermore, the expansion of the generic pharmaceuticals sector and the trend toward self-medication for minor health issues provide a strong impetus for the excipient market. However, stringent regulatory requirements leading to lengthy approval processes can impede the introduction of new excipients, and the high cost associated with developing and producing advanced excipients hamper its market growth. The shift toward multifunctional and co-processed excipients and ongoing advancements and research activities for developing biobased excipients opens significant opportunities for market players, offering benefits such as improved product performance and production efficiency.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 8.62 billion |
Estimated Year [2024] | USD 9.22 billion |
Forecast Year [2030] | USD 14.42 billion |
CAGR (%) | 7.62% |
Type: Potential demand and utilization of organic excipients
Inorganic excipients are substances not of organic origin and are included in pharmaceutical formulations to serve various functions. These excipients include calcium carbonate, widely used as a filler or diluent, and a source of calcium in pharmaceutical tablets. It is favored for its high purity, non-toxic nature, and cost-effectiveness. Calcium phosphate excipients, including dicalcium phosphate and tricalcium phosphate, are utilized for their excellent compressibility and flow properties, making them ideal for tableting operations. Calcium sulfate is used in pharmaceuticals as a tablet excipient and a co-processed excipient to improve the mechanical strength of tablets. Halites, especially sodium chloride, create isotonic solutions and are used as stabilizers and taste-masking agents in oral medications. In pharmaceutical formulations, metal oxides such as magnesium and zinc oxide function as pH adjusters, colorants, and nutrient supplements. Organic excipients refer to substances of organic (carbon-based) origin that are included in pharmaceutical formulations. Carbohydrates are fillers, binders, and stabilizers in oral solid dose formulations. Cellulose derivatives, including microcrystalline cellulose, are prolific in the excipient market, valued for their binding, disintegrating, and film-forming properties. Starch and its derivatives are used as disintegrants, binders, and fillers in tablets, providing good mechanical properties to pharmaceutical forms. Sugars such as sucrose are often used in syrups and lozenges as sweeteners and crystalline bases for water-soluble drugs.
Fatty alcohols are non-ionic surfactants and emollients in topical formulations, aiding in skin penetration of APIs. Glycerin is used as a solvent, humectant, and preservative in various pharmaceutical preparations, including oral, topical, and parenteral formulations. Mineral stearates such as magnesium are predominantly used as lubricants in tablet manufacture, ensuring the efficient running of tablet presses. In tablet formulations, petrochemicals such as acrylic polymers, including polymethyl methacrylate, serve as film coatings, binders, and sustained-release matrix formers. Glycols such as propylene glycol are versatile solvents for APIs and are used in many pharmaceutical preparations, including injectables, topical formulations, and syrups. Mineral hydrocarbons such as paraffin are used for their lubricating properties in capsules and as bases in various ointments and creams. Furthermore, povidones are used as binders in tablet formulations, as solubilizers in liquids, and as bioadhesives for buccal applications. Proteins such as gelatin and collagen are used to form drug capsules and as film-forming agents. Their biodegradability and compatibility with the human body make them vital for specific pharmaceutical applications.
Formulation: Significant demand for oral formulations owing to its convenient drug delivery
Oral formulations are dosage forms administered through the oral route, one of the most convenient and commonly used drug delivery methods. This segment includes a variety of excipients designed to aid the active pharmaceutical ingredient's stability, release, and bioavailability (API). Hard gelatin capsules are solid dosage forms in which one or more drug substances and excipients are enclosed within a small shell. They also offer advantages such as dose precision and good stability. Soft gelatin capsules (soft gels) are an oral dosage form for medicine similar to capsules; however, they consist of a gelatin-based shell surrounding a liquid fill. They are favored for their ease of swallowing and ability to enhance the bioavailability of poorly soluble APIs. Liquid formulations include solutions, suspensions, and emulsions that are taken orally. The choice of excipients in these formulations is critical to ensure stability, palatability, and proper absorption of the API. Tablets are a popular oral dosage form, and the excipient market for tablets remains robust. The ingredients used in tablet manufacturing bind the compound, aid in disintegration, and enhance stability. Parenteral formulations are sterile preparations intended to be administered directly into the body tissues. Topical formulations are applied to the skin or mucous membranes to deliver active ingredients directly to the site of action or systemic circulation.
Function: Coating agents provide physical and chemical protection for the drug
Binders are adhesive materials used in tablet formulations to agglomerate and hold the powder particles together, enhancing the strength and integrity of the tablet. Coating agents are applied to the exterior of various dosage forms to mask unpleasant tastes, provide physical and chemical protection for the drug, and control the release of the drug substance. Colorants are added to pharmaceuticals to facilitate product identification and enhance aesthetic appeal. Disintegrants are critical excipients that promote the breakup of a tablet in the digestive tract after administration, permitting the rapid release and absorption of the active pharmaceutical ingredient. Their functionality ensures the tablet disintegrates efficiently into smaller fragments when it enters a fluid environment. Emulsifying agents assist in the formation and stabilization of emulsions by reducing surface tension at the interface between the immiscible liquids. They are crucial for formulations such as creams, ointments, and suspension-based systems and facilitate the homogeneous distribution of the drug substance within the system. Fillers and diluents are inert additives that increase a tablet or capsule's bulk volume, making it practical to produce and easy to handle. Flavoring agents and sweeteners improve the palatability of oral medications, masking any unpleasant flavors and odors from the active drug or other excipients. Lubricants are added to formulation blends to prevent ingredients from clumping and to ensure a smooth ejection of the tablet from the die during compression. Preservatives contain the growth of microbes in pharmaceutical products, extending their shelf life and ensuring safety during use. Suspending and viscosity agents help maintain a uniformly dispersed state of insoluble particles in a liquid dosage form and can modulate liquid preparations' flow properties (viscosity). This ensures a uniform dose of medication with each administration and improves the stability of the practice.
Regional Insights
The Americas region has a significant landscape in the pharmaceutical excipient market as countries exhibit a high demand for excipients, directed by stringent regulatory environments, advanced healthcare systems, and strong intellectual property frameworks. Having a significant landscape in pharmaceutical innovation, the countries in the region strongly focus on advanced and novel excipients for drug formulations. The EMEA region, which encompasses Europe, the Middle East, and Africa, shows diverse market characteristics. The stringent regulatory environment in the European Union drives the demand for compliant and high-quality excipients, whereas markets in the Middle East and Africa are burgeoning, with increasing investment in pharmaceutical manufacturing infrastructure and regulation. The EU market demonstrates a high need for cutting-edge pharmaceutical excipients that cater to complex drugs and sophisticated drug delivery systems. Moreover, the EU's investment in biopharmaceuticals and biosimilars is complemented by the growing demand for novel excipients in these areas. Countries in the Asia-Pacific region are key players in the pharmaceutical excipient sector experiencing substantial growth due to a large patient pool, increasing healthcare expenditures, and supportive government initiatives. The region focuses on innovating high-functional excipients with ongoing research and development, reducing its historical reliance on imports.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Pharmaceutical Excipient Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Pharmaceutical Excipient Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Pharmaceutical Excipient Market, highlighting leading vendors and their innovative profiles. These include ABITEC Corporation, Aceto Corp., Archer Daniels Midland Company, ARMOR PROTEINES S.A.S., Asahi Kasei Corporation, Ashland Inc., BASF SE, BIOGRUND GmbH, Chemische Fabrik Budenheim KG, Clariant AG, Colorcon Inc., Corel Pharma Chem Private Limited, Croda International Plc, Darling Ingredients, Inc., DFE Pharma GmbH & Co KG, DuPont de Nemours, Inc., Evonik Industries AG, Fuji Chemical Industries Co., Ltd., GATTEFOSSE SAS, Innophos Holdings, Inc., International Flavors & Fragrances Inc., JRS PHARMA GmbH + Co. KG, Kerry Group P.L.C., Lipoid GmbH, Lubrizol Corporation, L'AIR LIQUIDE S.A., Mallinckrodt plc, MEGGLE GmbH & Co. KG, Merck KGaA, Nagase & Co., Ltd., Nipon Soda Co., Ltd., NOF Corporation, Omya International AG, Peter Greven GmbH & Co. KG, R.T. Vanderbilt Holding Company, Inc., Resonac Holdings Corporation, Roquette Freres S.A., Shin-Etsu Chemical Co., Ltd., Solvay S.A., SPI Pharma, Inc., and Thermo Fisher Scientific Inc..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Pharmaceutical Excipient Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Pharmaceutical Excipient Market?
3. What are the technology trends and regulatory frameworks in the Pharmaceutical Excipient Market?
4. What is the market share of the leading vendors in the Pharmaceutical Excipient Market?
5. Which modes and strategic moves are suitable for entering the Pharmaceutical Excipient Market?