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市場調查報告書
商品編碼
1624982
全球藥用輔料市場規模(依產品、劑型、功能、地區、範圍和預測)Global Pharmaceutical Excipients Market Size By Product (Organic Chemicals, Inorganic Chemicals), By Formulation (Oral Formulations, Parenteral Formulations), By Functionality (Fillers And Diluents, Binders), By Geographic Scope And Forecast |
2023 年藥用輔料市場規模價值 88.219 億美元,預計到 2031 年將達到 131.3986 億美元,2024 年至 2031 年的複合年增長率為 6.87%。藥用輔料是與藥物製劑中的活性藥物成分 (API) 一起使用的惰性物質,用於增強藥物穩定性、溶解度、控制釋放和促進藥物傳遞。這些包括黏合劑、填充劑、崩解劑、潤滑劑、防腐劑、色素和香料。應用包括片劑、膠囊、液體、外用藥、週邊製劑、控釋製劑、粉末和塗層。
片劑配方使用黏合劑形成片劑,並使用崩解劑釋放藥物。膠囊製劑填充並密封入膠囊,以方便口服。液體製劑使用溶劑和懸浮劑。局部配方可維持產品的穩定性和一致性。腸外給藥確保藥物的溶解度及其與身體組織的相容性。
控釋製劑控制藥物釋放的速率,而粉末製劑使用賦形劑進行重建、分散和穩定。在塗層應用中,賦形劑用於保護、掩蓋味道和改善釋放特性。整體而言,藥用輔料對藥品的安全性、有效性和品質有重大貢獻。
主要市場驅動因子
不斷擴張的製藥業
隨著製藥業的不斷發展,人們對治療多種疾病和病症的藥物的需求也隨之增加,這推動了對輔料的需求。隨著製藥公司推出創新配方,對合適輔料的需求持續成長。
對仿製藥的需求不斷增加
隨著許多原廠藥專利到期,仿製藥市場正在迅速擴張。輔料的需求是由仿製藥製造商推動的,他們經常尋找價格合理的輔料來用於配製他們的產品。
藥物傳遞技術的發展
需要特定的賦形劑來開發新的藥物傳遞技術,如脂質體、膠束和奈米顆粒,以提高藥物的穩定性、溶解度和生物利用度。這正在刺激輔料開發的創新。
更重視病患的便利性與依從性
因此,透皮貼片、咀嚼錠和口腔崩解錠等患者友善的劑型越來越受到青睞。這些劑型是使用賦形劑配製的。
嚴格的監理要求
監管機構對藥品的品質、安全性和有效性制定了嚴格的標準。要求輔料遵守的法規產生了對符合這些要求的輔料的需求。
主要問題
監理合規
藥用輔料必須遵守世界各地眾多衛生當局製定的嚴格指導方針。對於輔料製造商來說,遵守這些經常更新和修訂的法規可能是一個課題。
品質管制
確保輔料的品質、純度和一致性對於維持藥品的功效和安全性至關重要。由於原材料和生產條件的波動,在整個製造過程中很難保持嚴格的品質控制。
全球供應鏈的問題
藥用輔料市場依賴這個複雜的網絡,包括原料和最終產品。供應鏈中斷,例如原材料短缺或物流困難,可能會影響輔料的供應和成本。
相容性與穩定性
在產品的整個保質期內,輔料必須保持穩定並與活性藥物成分 (API) 相容。確保穩定性和相容性可能具有課題性,尤其是對於複雜劑型或創新配方而言。
保護智慧財產權
開發新的賦形劑和賦形劑配方通常需要大量的研究和開發成本。在競爭激烈的市場中,保護智慧財產權可能很困難,因為專有輔料可能會被模仿或盜用。
主要趨勢
增加藥品銷售
JAMA Network 的一份新報告發現,世界各地的公立醫院對藥品的需求比 COVID-19 之前更多。研究發現,阿奇黴素、羥氯奎、皮質類固醇和肝素的使用量分別增加了11.45%、6.14%、24.68%和49.05%。製藥業的成長和藥品製造的增加推動了醫藥市場的成長。例如,根據 2022 年的報告,歐洲地區的醫藥產值在 2020 年為 2,866.97 億歐元,在 2021 年為 3 億歐元。
對人類衍生產品的需求:
醫療保健產業越來越青睞生物製藥。主要原因是它們與人體中自然存在的生物分子非常相似,因此具有更優異的療效和更少的副作用。生物製藥預計將成為製藥業中成長最快的領域之一。
對生物製藥的需求不斷增加:
生物製藥對以前被認為無法治癒的疾病具有有效治療作用,並且由於其高效性和極佳的安全性,在許多國家越來越受歡迎。例如,生物相似藥開發的最新趨勢表明,中國和印度等國家正在開發新的生物製藥候選藥物。據調查,光在中國就有大約150家生物製藥生產工廠。
專注於方便的口服藥物:
開發患者易於服用的藥物(如可咀嚼或口服溶解的片劑)變得越來越重要。對特定賦形劑的需求是這種發展的驅動力。
生物製劑的趨勢:
生物製劑是一種源自生物體的藥物,用於治療多種疾病。通常需要專門的賦形劑來滿足生物製劑獨特的穩定性和分佈需求。
Pharmaceutical Excipients Market size was valued at USD 8821.9 Million in 2023 and is projected to reach USD 13139.86 Million by 2031, growing at a CAGR of 6.87% from 2024 to 2031. Pharmaceutical excipients are inert substances used alongside active pharmaceutical ingredients (APIs) in drug formulations to enhance drug stability, solubility, control release, and facilitate drug delivery. They include binders, fillers, disintegrants, lubricants, preservatives, colorants, and flavorings. Their applications include tablet formulations, capsule formulations, liquid formulations, topical formulations, peripheral formulations, controlled release formulations, powder formulations, and coating applications.
Tablet formulations use binders for tablet formation and disintegrants for drug release. Capsule formulations fill and seal capsules for convenient oral dosage. Liquid formulations use solvents and suspending agents. Topical formulations maintain product stability and consistency. Parenteral formulations ensure drug solubility and compatibility with body tissues.
Controlled release formulations control drug release rates, while powder formulations use excipients for reconstitution, dispersion, and stability. Coating applications use excipients for protection, taste masking, and modified release characteristics. Overall, pharmaceutical excipients significantly contribute to the safety, efficacy, and quality of pharmaceutical products.
The key market dynamics that are shaping the Pharmaceutical Excipients Market include:
Key Market Drivers:
Expanding Pharmaceutical Sector
: The need for excipients is fueled by the growing pharmaceutical sector, which is being driven by the need for medications to treat a wide range of illnesses and conditions. Appropriate excipients are becoming more and more necessary as pharmaceutical companies innovate and release novel formulations.
Growing Need for Generic Drugs
: As many branded medications' patents expire, the market for generic medications is growing quickly. Excipient demand is driven by generic medication makers, who frequently look for excipients that are affordable to use in the formulation of their products.
Developments in Medication Delivery Technologies
: To improve medication stability, solubility, and bioavailability, certain excipients are needed for the creation of novel drug delivery technologies such liposomes, micelles, and nanoparticles. This stimulates excipient development innovation.
Growing Emphasis on Patient Convenience and Compliance
. As a result, patient-friendly dose forms-like transdermal patches, chewable tablets, and oral disintegrating tablets-are becoming more and more well-liked. These dosage forms are formulated with the use of excipients.
Strict Regulatory Requirements
: When it comes to the quality, safety, and effectiveness of pharmaceutical products, regulatory authorities set stringent standards. Regulations requiring excipients to adhere to them create a demand for excipients that satisfy these requirements.
Key Challenges:
Regulatory Compliance
: Strict guidelines established by numerous global health authorities must be followed by pharmaceutical excipients. Complying with these rules, which are subject to frequent updates and amendments, might provide difficulties for manufacturers of excipients.
Quality Control
: To preserve the effectiveness and security of pharmaceutical goods, it is essential to guarantee the quality, purity, and consistency of excipients. It might be difficult to maintain strict quality control throughout the manufacturing process because of things like fluctuating raw material and production circumstances.
Problems with the Global Supply Chain
: The market for pharmaceutical excipients depends on this intricate network for both raw materials and finished goods. Supply chain disruptions like raw material shortages or logistical difficulties might affect excipient availability and cost.
Compatibility and Stability
: Throughout the course of the product's shelf life, excipients must be stable and compatible with active pharmaceutical ingredients (APIs). It might be difficult to ensure stability and compatibility, especially for complex dosage forms or innovative drug formulations.
Protection of Intellectual Property
: Creating new excipients or excipient formulations frequently necessitates a large expenditure in research and development. In a market that is competitive and may see imitation or unauthorized use of proprietary excipients, protecting intellectual property rights can be difficult.
Key Trends:
Increase in Sales of Medication:
A new report released by JAMA Network indicates that public hospitals worldwide are now requiring more medications than they did prior to COVID-19. The research states that there has been an increase in the use of azithromycin, hydroxychloroquine, corticosteroids, and heparin of 11.45%, 6.14%, 24.68%, and 49.05%, respectively. The growing pharmaceutical industry and increased pharmaceutical manufacturing are driving the growth of the pharmaceutical market. For example, the 2022 report states that the pharmaceutical output in the European region was valued at EUR 286,697 million in 2020 and EUR 300 million in 2021.
Demand for Human Sourced Products:
The healthcare industry is become increasingly fond of biopharmaceuticals. This is mostly because of their remarkable similarity to biological molecules that are naturally present in the human body and offer outstanding efficiency with little side effects. They are thought to have one of the fastest growth rates among the pharmaceutical industry's segments.
Growing Demand for Biopharmaceutical Medicines:
The ability of biopharmaceutical medicines to treat illnesses that were previously thought to be incurable, together with their high efficacy and superior safety, has greatly aided in the spread of these medications throughout numerous nations. For example, a recent study on Biosimilar Development found that new candidates for biopharmaceuticals are developing in countries like China and India. It asserts that China alone is home to around 150 biomanufacturing facilities.
Focus on Convenient Oral Medications:
Creating drugs that are simpler for patients to take like chewable or orally dissolving tablets is becoming more and more important. The need for specific excipients that can help these formulations is being driven by this development.
Inlcination towards Biologics:
A class of medications derived from living things; biologics are being used to treat a wide range of illnesses. Specialized excipients that can satisfy the specific stability and distribution needs of biologics are frequently needed.
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Here is a more detailed regional analysis of the Pharmaceutical Excipients Market:
Europe
Europe holds the largest market share in Pharmaceutical Excipients Market.
The fact that Europe is home to several large pharmaceutical businesses with large production capacities is a significant contributing element. In the course of manufacturing drugs, these behemoths inherently use a large number of excipients.
Both the development of high-quality generic medications and biosimilars drugs that are comparable to name-brand biologics are priorities in Europe. Novel excipients that work well in these drugs are in high demand as a result of this focus.
North America
The area is home to several large pharmaceutical companies that have strong, well-established operations. This translates into a strong need for excipients, which are necessary components used in the production of pharmaceuticals.
Chronic conditions like diabetes and heart disease are very common in North America. This increases the requirement for excipients by requiring a steady supply of medications.
The area is a center for pharmaceutical research and development. Novel excipients are frequently needed to support this continuous innovation, which keeps the market vibrant and promotes expansion.
The Global Pharmaceutical Excipients Market is Segmented on the basis of Product, Formulation, Functionality, And Geography.
Based on Product, the market is segmented into Organic Chemicals, Inorganic Chemicals, and Others. Organic Chemicals accounts for the largest market share over the coming years. The organic segment is expected to lead the market owing to the rise in the use of organic chemicals in various formulations in the pharmaceutical industry.
Based on Formulation, the market is segmented into Oral Formulations, Parenteral Formulations, Topical Formulations, and Other Formulations. The oral formulations is projected to hold the biggest market share. Oral drug administration helps the producer with packaging and shipping while keeping the pharmaceuticals' chemical and physical stability.
Based on Functionality, the market is segmented into Fillers and Diluents, Binders, Suspending and Viscosity Agents, Flavoring Agents and Sweeteners, and Other Functionality. In 2019, Fillers and Diluents held the biggest market share. Oral drug administration helps the producer with packaging and shipping while keeping the pharmaceuticals' chemical and physical stability.
Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.