市場調查報告書
商品編碼
1466754
藥用輔料市場:按類型、劑型、功能分類 - 全球預測 2024-2030Pharmaceutical Excipient Market by Type (Inorganic, Organic), Formulation (Oral Formulations, Parenteral Formulations, Topical Formulations), Function - Global Forecast 2024-2030 |
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預計2023年藥用輔料市場規模為86.2億美元,2024年將達到92.2億美元,預計2030年將達到144.2億美元,複合年成長率為7.62%。
藥用輔料添加到藥品的目的有很多種,包括改進製造流程、提高穩定性、確保藥物生物利用度以及促進最終產品的給藥和劑量。賦形劑本質上惰性成分,整體支持活性成分的配製和遞送。藥用輔料市場主要受到全球人口成長和慢性病對藥品需求增加的推動。配方技術的進步和新輔料的開發也促進了市場的成長。此外,學名藥產業的擴張和針對輕微健康問題的自我治療趨勢也為輔料市場帶來了強勁動力。然而,嚴格的監管要求和漫長的核准流程可能會阻礙新輔料的推出,而開發和製造先進輔料的高成本也阻礙了市場成長。向多功能賦形劑和共加工賦形劑的轉變、生物基賦形劑開發的持續進步和研究活動為市場參與者提供了提高產品性能和生產效率等好處。
主要市場統計 | |
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基準年[2023] | 86.2億美元 |
預計年份 [2024] | 92.2億美元 |
預測年份 [2030] | 144.2億美元 |
複合年成長率(%) | 7.62% |
各類有機輔料的潛在需求及利用
無機賦形劑是非有機來源的物質,包含在藥物製劑中以發揮各種功能。這些賦形劑包括碳酸鈣,它廣泛用作填充劑和稀釋劑以及錠劑中的鈣源。碳酸鈣因其高純度、無毒和成本效益而成為優選。使用磷酸鈣賦形劑,包括磷酸二氫鈣和磷酸三鈣,因為它們具有優異的可壓縮性和流動性,使其成為壓片操作的理想選擇。硫酸鈣在藥品中用作錠劑賦形劑和共加工賦形劑,以提高錠劑的機械強度。岩鹽,特別是氯化鈉,可產生等滲溶液,並在口服藥物中用作穩定劑和調味劑。在藥物配方中,金屬氧化物(例如氧化鎂和氧化鋅)可用作 pH 調節劑、著色劑和營養補充。有機賦形劑是指藥物配方中所包含的有機(碳基)來源的物質。碳水化合物是口服固體製劑中的填充劑、粘合劑和穩定劑。纖維素衍生物,包括結晶纖維素,廣泛應用於賦形劑市場,並因其結合、崩壞和成膜特性而受到重視。澱粉及其衍生物在錠劑中用作崩壞、粘合劑和填充劑,賦予藥物形式良好的機械性能。蔗糖等糖常用於糖漿和錠劑中,作為水溶性藥物的甜味劑和結晶基質。
脂醇類是非離子界面活性劑,可作為外用製劑的潤膚劑,幫助原料藥滲經皮膚。甘油在多種藥物製劑中用作溶劑、保濕劑和防腐劑,包括口服、局部和腸胃外製劑。礦物硬脂酸鹽(例如鎂)主要用作錠劑製造中的潤滑劑,以確保壓錠劑的高效運作。在錠劑配方中,石化產品(例如丙烯酸聚合物,包括聚甲基丙烯酸甲酯)用作薄膜包衣、粘合劑和緩釋性基質形成劑。丙二醇等二元醇作為原料藥溶劑用途廣泛,可用於許多藥物製劑,例如注射劑、外用製劑和糖漿。石蠟等礦物碳氫化合物用於膠囊中,並因其潤滑特性而用作各種軟膏和霜劑的基質。此外,聚維酮也可用作錠劑中的粘合劑、液體製劑中的增溶劑以及口腔應用中的黏劑。明膠和膠原蛋白等蛋白質用於形成藥物膠囊和成膜劑。其生物分解性和與人體的相容性使其對於某些製藥應用至關重要。
製劑:由於給藥方便,口服製劑的需求量大。
口服製劑是經由口服途徑給藥的劑型,是最方便且常用的藥物傳遞方法之一。該細分市場包括各種旨在幫助活性藥物成分的穩定性、釋放和生物有效性(API) 的賦形劑。硬明膠膠囊是包含一種或多種原料藥和賦形劑的固態劑型,封裝在小殼中。硬明膠膠囊還具有劑量準確性和出色的穩定性等優點。軟明膠膠囊(軟膠囊)是類似膠囊的口服劑型,但具有圍繞液體填充物的明膠外殼。它是優選的,因為它易於吞嚥並且可以增加難溶性原料藥的生物有效性。液體製劑包括口服給藥的溶液劑、混懸劑和乳劑。這些製劑中賦形劑的選擇對於確保原料藥的穩定性、偏好和適當吸收至關重要。錠劑是一種常見的口服劑型,而錠劑賦形劑市場依然強勁。錠劑製造中使用的成分將化合物結合在一起,有助於崩壞並提高穩定性。腸胃外製劑是用來直接施用到身體組織的無菌製劑。局部製劑塗布皮膚或黏膜,將活性成分直接輸送到作用部位和全身循環。
作用:被覆劑對藥物提供物理和化學保護。
粘合劑是錠劑中使用的黏合材料,可提高錠劑的強度和完整性,使粉末顆粒凝結並保持在一起。被覆劑塗布各種劑型的外表面,以遮罩不良味道,為藥物提供物理和化學保護,並控制藥物釋放。醫藥產品中添加著色劑以方便產品識別並增強美觀。崩壞是重要的賦形劑,可促進錠劑給藥後在胃腸道中崩壞,使活性藥物成分快速釋放和吸收。其功能使錠劑在進入流體環境後能夠有效地崩壞成更小的碎片。乳化劑透過降低不混溶液體之間界面的表面張力來幫助乳化的形成和穩定。乳化劑在乳膏劑、軟膏劑和混懸劑等製劑中至關重要,可促進藥物在系統內的均勻分佈。填充劑和稀釋劑是惰性添加劑,可增加錠劑和膠囊的體積,使其更易於製造且更易於處理。調味劑和甜味劑可改善口服藥物的偏好並遮罩由原料藥和其他賦形劑引起的令人不愉快的味道和氣味。組合藥物中添加潤滑劑可防止成分結塊並確保錠劑在壓縮過程中順利從模具中排放。防腐劑抑制藥品中微生物的生長,延長保存期限,確保使用過程中的安全。懸浮劑和增稠劑可保持液體製劑中不溶性顆粒的均勻分散,並調節液體製劑的流動特性(黏度)。這確保了每次給藥的劑量一致,並提高了實踐的穩定性。
區域洞察
美洲地區在市場格局中佔有重要地位,由於嚴格的監管環境、先進的醫療保健系統和強大的智慧財產權框架,該地區對輔料的需求量很大。鑑於製藥創新的重要前景,該地區各國都大力關注用於藥物配方的先進和新穎的輔料。歐洲、中東和非洲地區包括歐洲、中東和非洲,呈現多樣化的市場特徵。同時,隨著對製藥基礎設施和監管的投資增加,中東和非洲市場正在快速成長。歐盟市場對複雜藥物和先進藥物輸送系統的尖端藥用輔料有很高的需求。此外,歐盟對生物製藥和生物相似藥的投資得到了這些領域對新型輔料不斷成長的需求的補充。亞太地區國家是藥用輔料產業的主要參與者,由於龐大的患者群、不斷增加的醫療支出和政府的支持措施,該行業正在經歷顯著成長。該地區透過持續研發高性能輔料並減少對進口產品的依賴來專注於技術創新。
FPNV定位矩陣
FPNV定位矩陣對於評估藥用輔料市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對藥用輔料市場供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,以獲得市場競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭評估與資訊:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況、製造能力等進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1.藥用輔料市場規模及預測如何?
2.藥用輔料市場預測期間需要考慮投資的產品、細分市場、應用和領域有哪些?
3.藥用輔料市場的技術趨勢和法規結構是什麼?
4.藥用輔料市場主要廠商的市場佔有率為何?
5.進入藥用輔料市場合適的型態和策略手段是什麼?
[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?