市場調查報告書
商品編碼
1324205
2030 年藥用輔料市場預測:按產品、功能、給藥途徑、配銷通路、最終用戶和地區進行的全球分析Pharmaceutical Excipients Market Forecasts to 2030 - Global Analysis By Product, Functionality, Route of Administration, Distribution Channel End User and By Geography |
根據 Stratistics MRC 的數據,2023 年全球藥用輔料市場規模為 92 億美元,預計到 2030 年將達到 158 億美元,預測期內年複合成長率為 7.9%。
賦形劑已經以多種方式被描述,包括用作藥物稀釋劑或載體的惰性材料。這種解釋的問題在於,最近已經清楚地表明賦形劑不是惰性的,可以與患者以及配方中的其他成分發生反應,可能導致不愉快和過敏反應。這是事實。這些可能會導致從輕微皮疹到致命反應的任何情況。不同的添加劑,特別是防腐劑和色素,可能存在於同一藥物的多個品牌中。
根據歐洲製藥工業協會聯合會2022年報告,2020年歐洲地區藥品產值為2866.97億歐元,2021年為3000億歐元。
美國國家生物技術資訊中心(NCBI)和美國食品藥物管理局(FDA)決定增加學名藥數量,將學名藥定義為在劑型、安全性、強度、給藥途徑等方面具有不同特徵的藥物、品質和性能。它被定義為與已批准的品牌藥物相似的藥物。使用學名藥所節省的成本並不會因為藥物的專利過期而立即顯現出來。與品牌藥一樣,學名藥也需要學名藥市場的競爭來降低成本。由於印度的人均醫療保健支出最高,這些學名藥將有助於降低成本。近年來,學名藥的使用在全國範圍內急劇擴大。此外,由於學名藥價格低廉,因此被頻繁使用,從而推動了市場成長。
儘管賦形劑在藥品中的使用正在擴大,但該行業仍然難以滿足法規、消費者、藥品製造商和患者設定的高標準。藥效和重要的品質屬性受到輔料製造變化的影響。不同供應商和批次之間賦形劑的差異可能會影響賦形劑與藥物的相互作用,進而影響藥物。大多數藥用輔料的製造是由低成本國家的小公司進行的。由於對積層製造程序和品質的控制水平有限,確保整個供應鏈的工藝透明度比以往任何時候都更加重要。
多用途賦形劑是一種新方法,可解決藥物上市平均需要 10 至 12 年的漫長而用途的過程。多功能添加劑可改善整個製藥過程中的流動性、可壓縮性、生物利用度和粒度分佈。其好處有很多,包括提高生產率、降低成本、加快製造速度、創造新化學品以及配製 ODT。多功能添加劑有助於最佳化研究並協助解決配方開發問題。目前大多數市場參與者都專注於開發現有輔料的新等級,以提高特定用途的性能,例如口腔崩解錠片輔料、控釋製劑、速釋製劑和外用製劑。
各國學名藥的核准流程基本相同,但欠已開發國家略有差異。這是因為生物等效性 (BE) 研究在該地區被豁免。衛生相關人員表示,政府必須確保所有學名藥的品質統一。只有這樣,醫生才能滿意、有信心地開學名藥處方。缺乏圍繞學名藥數量和允許污染物數量的強力的法規標準是醫生對學名藥不信任的一個關鍵要素。此外,由於新型賦形劑和遞送方法的開發,在體內活性的背景下,改進對藥物賦形劑的供應和品質的控制變得更加重要。
COVID-19 大流行對製藥行業產生了重大負面影響。疫情導致的封鎖措施阻止了來自中國和印度等擁有大型工業基地的國家的原料流動。這減緩了藥物研究和製造,對嚴重依賴外包的企業產生了負面影響。整個醫藥生態系統首先被顛覆。為了保證患者用藥後最高水平的安全,法規機構不得不不斷制定新的法律。停工結束後,由於對羥氯喹和瑞德西韋等有效對抗 COVID-19 的藥物需求增加,製藥行業恢復生機。
由於有機化合物無毒並且可以作為口服藥物製劑中的添加劑,因此有機化學品領域預計將出現良好的成長。石化產品、碳水化合物、石化產品、蛋白質和其他有機化學品結構了有機化學品市場的以下五個主要部分:鑑於碳是所有生物的結構要素,有機分子極其重要。有機分子是許多推動地球運動的循環的基本組成部分。以碳循環為例,碳在光合作用和細胞呼吸過程中在植物和動物之間轉移。
預計粘合劑市場在預測期內年複合成長率最高。由於藥品和生物製藥的需求不斷增加以及新產品的推出,預計粘合劑類別在預測期內將出現大幅擴張。隨著時間的推移,製藥行業逐漸認知到粘合劑可以提高活性化合物的性能並提供競爭優勢。此外,隨著藥品產量的增加,對粘合劑的需求預計也會增加,這預計將刺激該領域的擴張。尖端原創產品的推出正在加速該細分市場的成長。
由於製藥行業迅速擴張、功能性輔料需求不斷成長、同一領域存在重要競爭、技術進步等,預計北美將在預測期內佔據最大的市場佔有率,所有這些預計都將佔據最大的市場佔有率。為預測期內最大的市場佔有率,將為整個預測期內的市場成長做出重大貢獻。新的軟膠囊混合物為生產商提供了一種簡單易用的選擇,確保製藥和營養補充食品的快速和可重複的放大。此類新品的推出為市場提供了更多前沿產品,刺激了市場擴張。
預計歐洲在預測期內的年複合成長率最高。這是因為藥品專利即將到期,歐洲多個國家都在關注學名藥行業。因此,德國、英國和法國等歐洲國家預計在預測期內將出現顯著的成長。預計這將增加該地區對藥用輔料的需求。此外,這些國家的學名藥市場預計將受到政府擴大降低市場藥品價格舉措的推動。
According to Stratistics MRC, the Global Pharmaceutical Excipients Market is accounted for $9.2 billion in 2023 and is expected to reach $15.8 billion by 2030 growing at a CAGR of 7.9% during the forecast period. Excipients have been described in a variety of ways, including as inert materials employed as medication diluents and carriers. The issue with this description is that excipients have recently shown themselves to be anything from inert, being capable of reacting not only with other components in the formulation but also with patients, leading to unpleasant and hypersensitive responses. These can cause anything from a little rash to a response that might be fatal. Different excipients, particularly preservatives and colourants, may be present in several brands of the same medication.
According to the European Federation of Pharmaceutical Industries and Associations, 2022 report, the production of pharmaceuticals in the European region was valued at EUR 286,697 million in 2020 and EUR 300,000 million in 2021.
The National Centre for Biotechnology Information (NCBI) and the U.S. Food and Drug Administration (FDA) have decided to increase the generic medication and they define a generic drug as a medication that has been produced to resemble an authorised brand-name medication in terms of dosage form, safety, and strength, route of administration, quality, and performance. The cost reductions linked to using common drugs are not immediately evident when the drug's patent expires. Generic pharmaceuticals, like brand-name drugs, need competition in the generic drug market before costs may be reduced. These generic medicines would save money because India has the greatest per-capita spending. The usage of generic medications has dramatically expanded nationwide in recent years. Additionally, because generic medications are less expensive, they are used more frequently thus propelling the growth of the market.
Despite the expanding usage of excipients in medicines, the industry still has a difficult time living up to the high standards set by regulators, consumers, medication manufacturers, and patients. The efficacy and vital quality characteristics of the medicine are impacted by variations in excipient manufacture. Excipient variability from supplier to supplier or batch to batch influences the excipient-drug interaction, which in turn affects the drug. Smaller businesses in low-cost nations handle a significant portion of the manufacturing of pharmaceutical excipients. Due to the limited level of control over the excipient manufacturing process and quality, process transparency throughout the whole supply chain is now more important than ever.
Excipients with numerous uses have been developed as a fresh approach to the lengthy and expensive process of bringing a medicine to market, which can take, on average, 10 to 12 years. Multifunctional excipients increase flowability, compressibility, bioavailability, and particle size distribution throughout the medication production process. They have a number of benefits, including increased productivity, lower costs, faster manufacturing, the creation of novel chemical entities, and the formulation of ODT. Multifunctional excipients will make optimisation studies easier and aid with formulation development problems. To enhance their performance for certain applications, such as excipients for orally disintegrating tablets, controlled-release formulations, immediate-release applications, and topical formulations, the majority of market companies are currently concentrating on developing new grades of existing excipients.
The procedures for approving generic drugs are essentially the same everywhere, with very minor variations in underdeveloped nations. This is due to the fact that he is exempt from the bioequivalence (BE) research requirement in this region of the world. Medical professionals assert that governments must guarantee the uniform quality of all generic medications. Only then can physicians be content and confident in writing generic medicine prescriptions. The lack of strong regulatory criteria surrounding the number of generic pharmaceuticals and the number of allowable contaminants has been a key factor in physician's lack of faith in generic medications. Furthermore, improved management of the supply and quality of pharmaceutical excipients has become more crucial in the context of in vivo activity as a result of the development of novel excipients and delivery methods.
The COVID-19 pandemic has had a significant negative impact on the pharmaceutical sector. Lockdowns implemented as a result of the outbreak have stopped the flow of raw materials from countries with large industrial bases, such China and India. This adversely affected businesses that significantly depended on outsourcing by slowing down the research and manufacture of pharmaceuticals. The whole pharmaceutical ecosystem was first upended. In order to assure the highest level of patient safety following drug use, regulatory bodies had to continually craft new legislation. After the shutdowns were over, the pharmaceutical sector took up, thanks in large part to the increased demand for medications like hydroxyl chloroquine and Remdesivir that were effective against COVID-19.
The organic chemicals segment is estimated to have a lucrative growth, due to the fact that organic compounds are non-toxic and work well as excipients in oral medication formulations. Oil chemicals, carbohydrates, petrochemicals, proteins, and other organic chemicals make up the next five key divisions of the market for organic chemicals. Given that carbon is a component of all living things, organic molecules are crucial. They are the fundamental parts of a lot of the earth-moving cycles. Take the carbon cycle as an illustration, which involves the transfer of carbon between plants and animals during photosynthesis and cellular respiration.
The binders segment is anticipated to witness the highest CAGR growth during the forecast period, due to the rising demand for pharmaceutical and biopharmaceutical medications as well as the introduction of new products, the binders category is anticipated to have considerable expansion throughout the projected period. Over time, the pharmaceutical industry has come to understand that binders may help active medicinal compounds perform better and provide them a competitive edge. Additionally, the need for binders is anticipated to rise along with the increase in pharmaceutical output, which is anticipated to fuel the segment's expansion. The introduction of cutting-edge and creative items is accelerating the market segment's growth.
North America is projected to hold the largest market share during the forecast period owing to the rapidly expanding pharmaceutical sector, rising demand for functional excipients, the existence of significant competitors in the area, and technological improvements will all significantly contribute to the market's growth throughout the forecast period. The new soft gel mix offers producers a simple, handy option that guarantees quick, repeatable scale-up for both pharmaceutical and nutraceuticals applications. Such new launches provide more cutting-edge items to the market, which stimulates market expansion.
Europe is projected to have the highest CAGR over the forecast period, owing to the imminent expiration of the drug patents, several European nations are concentrating on the generics industry. As a result, considerable growth rates in European nations like Germany, the United Kingdom, France, and others are predicted to occur throughout the projection period. This is projected to increase demand for pharmaceutical excipients in the area. Additionally, it is projected that the market for generic medications in these nations would be driven by the expanding government initiatives for lowering the prices of the drugs on the market.
Some of the key players profiled in the Pharmaceutical Excipients Market include: Evonik Industries AG, KerryBASF SE, Innophos, Archer Daniels Midland Company, Air Liquide group, Associated British Foods PLC, Croda International PLC, Roquette Freres, The Lubrizol Corporation, DuPont, Ashland, International Flavors & Fragrances, Inc., FMC Corporation, The Dow Chemicals Company, Akzo Nobel NV, Crode International PLC and Ferro Corporation
In June 2023, Evonik company, launches the wound dressing epicite® balance onto the German market. Available from June 2023, the dressing is particularly suited and optimized for the treatment of chronic wounds with low to medium exudation.
In May 2019, Ashland launched the Aquaflow NMS 460E rheology modifier, a nonionic synthetic associative thickener.
In May 2019, Colorcon launched STARTAB, a new starch tableting excipient designed specifically for the direct compression process.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.
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