市场调查报告书
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1324205
2030 年药用辅料市场预测:按产品、功能、给药途径、分销渠道、最终用户和地区进行的全球分析Pharmaceutical Excipients Market Forecasts to 2030 - Global Analysis By Product, Functionality, Route of Administration, Distribution Channel End User and By Geography |
根据 Stratistics MRC 的数据,2023 年全球药用辅料市场规模为 92 亿美元,预计到 2030 年将达到 158 亿美元,预测期内年复合成长率为 7.9%。
赋形剂已经以多种方式被描述,包括用作药物稀释剂或载体的惰性材料。这种解释的问题在于,最近已经清楚地表明赋形剂不是惰性的,可以与患者以及配方中的其他成分发生反应,可能导致不愉快和过敏反应。这是事实。这些可能会导致从轻微皮疹到致命反应的任何情况。不同的添加剂,特别是防腐剂和色素,可能存在于同一药物的多个品牌中。
根据欧洲製药工业协会联合会2022年报告,2020年欧洲地区药品产值为2866.97亿欧元,2021年为3000亿欧元。
美国国家生物技术资讯中心(NCBI)和美国食品药物管理局(FDA)决定增加仿製药数量,将仿製药定义为在剂型、安全性、强度、给药途径等方面具有不同特征的药物、质量和性能。它被定义为与已批准的品牌药物相似的药物。使用仿製药所节省的成本并不会因为药物的专利过期而立即显现出来。与品牌药一样,仿製药也需要仿製药市场的竞争来降低成本。由于印度的人均医疗保健支出最高,这些仿製药将有助于降低成本。近年来,仿製药的使用在全国范围内急剧扩大。此外,由于仿製药价格低廉,因此被频繁使用,从而推动了市场增长。
儘管赋形剂在药品中的使用正在扩大,但该行业仍然难以满足法规、消费者、药品製造商和患者设定的高标准。药效和重要的质量属性受到辅料製造变化的影响。不同供应商和批次之间赋形剂的差异可能会影响赋形剂与药物的相互作用,进而影响药物。大多数药用辅料的製造是由低成本国家的小公司进行的。由于对增材製造工艺和质量的控制水平有限,确保整个供应链的工艺透明度比以往任何时候都更加重要。
多用途赋形剂是一种新方法,可解决药物上市平均需要 10 至 12 年的漫长而用途的过程。多功能添加剂可改善整个製药过程中的流动性、可压缩性、生物利用度和粒度分布。其好处有很多,包括提高生产率、降低成本、加快製造速度、创造新化学品以及配製 ODT。多功能添加剂有助于最佳化研究并协助解决配方开发问题。目前大多数市场参与者都专注于开发现有辅料的新等级,以提高特定用途的性能,例如口腔崩解锭片辅料、控释製剂、速释製剂和外用製剂。
各国仿製药的审批流程基本相同,但欠发达国家略有差异。这是因为生物等效性 (BE) 研究在该地区被豁免。卫生相关人员表示,政府必须确保所有仿製药的质量统一。只有这样,医生才能满意、有信心地开仿製药处方。缺乏围绕仿製药数量和允许污染物数量的强有力的法规标准是医生对仿製药不信任的一个关键要素。此外,由于新型赋形剂和递送方法的开发,在体内活性的背景下,改进对药物赋形剂的供应和质量的控制变得更加重要。
COVID-19 大流行对製药行业产生了重大负面影响。疫情导致的封锁措施阻止了来自中国和印度等拥有大型工业基地的国家的原材料流动。这减缓了药物研究和製造,对严重依赖外包的企业产生了负面影响。整个医药生态系统首先被颠覆。为了保证患者用药后最高水平的安全,法规机构不得不不断制定新的法律。停工结束后,由于对羟氯喹和瑞德西韦等有效对抗 COVID-19 的药物需求增加,製药行业恢復生机。
由于有机化合物无毒并且可以作为口服药物製剂中的添加剂,因此有机化学品领域预计将出现良好的增长。石化产品、碳水化合物、石化产品、蛋白质和其他有机化学品结构了有机化学品市场的以下五个主要部分:鑑于碳是所有生物的结构要素,有机分子极其重要。有机分子是许多推动地球运动的循环的基本组成部分。以碳循环为例,碳在光合作用和细胞呼吸过程中在植物和动物之间转移。
预计粘合剂市场在预测期内年复合成长率最高。由于药品和生物製药的需求不断增加以及新产品的推出,预计粘合剂类别在预测期内将出现大幅扩张。随着时间的推移,製药行业逐渐认识到粘合剂可以提高活性化合物的性能并提供竞争优势。此外,随着药品产量的增加,对粘合剂的需求预计也会增加,这预计将刺激该领域的扩张。尖端原创产品的推出正在加速该细分市场的增长。
由于製药行业迅速扩张、功能性辅料需求不断增长、同一领域存在重要竞争、技术进步等,预计北美将在预测期内占据最大的市场份额,所有这些预计都将占据最大的市场份额。为预测期内最大的市场份额,将为整个预测期内的市场增长做出重大贡献。新的软胶囊混合物为生产商提供了一种简单易用的选择,确保製药和营养补充食品的快速和可重复的放大。此类新品的推出为市场提供了更多前沿产品,刺激了市场扩张。
预计欧洲在预测期内的年复合成长率最高。这是因为药品专利即将到期,欧洲多个国家都在关注仿製药行业。因此,德国、英国和法国等欧洲国家预计在预测期内将出现显着的增长。预计这将增加该地区对药用辅料的需求。此外,这些国家的仿製药市场预计将受到政府扩大降低市场药品价格倡议的推动。
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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