市场调查报告书
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1383469
到 2030 年口溶锭市场预测:按产品、药物类别、适应症、配销通路和地区分類的全球分析Orally Disintegrating Tablet Market Forecasts to 2030 - Global Analysis By Product, Drug Class, Indication, Distribution Channel and by Geography |
根据Stratistics MRC的数据,2023年全球口溶锭市场规模为150.7974亿美元,预计到2030年将达到382.6971亿美元,预测期内年复合成长率为14.23%。
口溶锭,也称为口溶片、速溶片或快速崩解锭,是放置在口腔或舌头上时迅速溶解或崩坏的固态剂型。此外,透过使用各种技术配製,已经实现了能够透过口腔黏膜快速吸收药物的快速崩坏和快速溶解片剂。 ODT 的配方需要仔细考虑味道、稳定性和可製造性之间的平衡,以保持活性成分的有效性,同时让患者满意。
根据 FDA (2008) 的规定,使用 USP崩坏试验,口溶锭最好在 30 秒内崩坏[23]。製剂F1和F2显示崩坏时间小于30秒。
ODT 可能会提高某些药物的生物利用度。血液中的高药物浓度是口腔黏膜溶解的结果,它逃避了肝臟首过代谢。此外,ODT 对于生物利用度低的药物或经历广泛肝臟代谢的药物特别有用,因此现在已包含在各种药物组合中。
并非所有药物都可以用于 ODT。有些药物味道不好,在潮湿环境中不稳定,溶解很快,或不具备口服给药技术所需的物理特性。此外,这种限制可能导致难以为特定化合物或治疗层级提供更多 ODT。
ODT在儿童医学领域具有巨大潜力。随着儿童医疗保健需求的增加,儿童友善剂型的市场也增加。 ODT 透过提供美味且易于服用的替代品来解决儿童用药医嘱遵从性的挑战。此外,製药公司可以透过开发各种儿童用药物(例如过敏药物和抗生素)的 ODT 配方来扩展其产品组合。
ODT 配方通常受到专利和智慧财产权的保护,这可能会限制专有技术和掩味策略的取得。特别是对于知名的 ODT 製剂,仿製药製造商可能会在专利到期后进入市场,这可能导致价格下降和竞争加剧。此外,ODT药品生产商的收入也可能受到威胁。
口溶锭(ODT) 市场受到了 COVID-19大流行的各种影响。非接触式自我给药剂型 (ODT) 已被证明是有益的,但供应链中断、临床试验延迟和法规流程阻碍了 ODT 产品的开发和可用性。此外,疫情加速了远端医疗的普及,为 ODT 药物的宅配上门和远距处方打开了大门。挑战包括改变医疗保健优先事项、重新分配应对大流行的资源以及财务影响。这些尤其影响新 ODT 研究和开发的资金和投资。
在口溶锭市场中,市场占有率最高的细分市场是质子帮浦抑制剂。质子帮浦抑制剂 (PPI) 药物常用于治疗胃肠道疾病、消化性溃疡和胃食道逆流症 (GERD)。 PPI 透过减少胃酸分泌来缓解胃酸逆流相关症状的患者。该领域受到关注的部分原因是质子帮浦抑制剂长期用于治疗慢性疾病以及酸相关疾病的广泛流行。此外,质子帮浦抑制剂现在是製药业的重要参与者,有处方药和非处方药 (OTC) 可供选择,且市场不断成长。
呼吸系统疾病领域预计将以最高年复合成长率成长。呼吸系统疾病包括多种疾病,包括多种呼吸道感染疾病、气喘和慢性阻塞性肺病(COPD)。由于吸烟、空气污染和高龄化等因素,世界各地呼吸系统疾病的发生率不断增加,因此需要新的治疗方法。精准医学、生技药品和吸入技术的进步正在彻底改变呼吸系统疾病的治疗。此外,COVID-19大流行提高了人们对呼吸系统健康问题的认识,并促使研发活动活性化。
北美占据口溶锭市场的最大份额。北美强大的医疗保健系统、庞大的医疗预算、广泛的研究和开发以及大量患有各种医疗状况的患者群体被认为是其在该领域占据主导地位的部分原因。凭藉先进的医疗技术、强大的研究机构以及对医疗保健创新的重视,美国是推动进步的主要力量,尤其是在製药领域。此外,北美透过积极应对新的医疗保健挑战,维持了全球製药业领导者的地位。
口溶锭市场正以亚太地区最高的年复合成长率成长。许多因素促成了这种巨大的成长,包括经济发展、医疗保健意识的提高以及获得医疗保健服务的机会的改善。随着医疗保健公司的大量投资,亚太地区已成为药物开发、临床试验和医学研究的重要中心。此外,该地区在生物技术、新药和医疗基础设施方面正在快速进步,成为全球製药业扩张和创新的主要催化剂。
According to Stratistics MRC, the Global Orally Disintegrating Tablet Market is accounted for $15079.74 million in 2023 and is expected to reach $38269.71 million by 2030 growing at a CAGR of 14.23% during the forecast period. Orally disintegrating tablets, sometimes referred to as melt-in-mouth, fast-dissolving, or fast-disintegrating tablets, are solid dosage forms that, when placed in the oral cavity or on the tongue, dissolve or disintegrate quickly. Moreover, the rapid disintegration and dissolution of these tablets, which enable quick drug absorption through the oral mucosa, are ensured by their formulation, which utilizes a variety of technologies. In order to give patients a satisfying experience while preserving the effectiveness of the active pharmaceutical ingredient, the formulation of ODTs requires a careful balancing act between taste, stability, and manufacturability.
According to the FDA (2008), orodispersible tablets should disintegrate within 30 s using the USP disintegration test [23]. Formulations F1 and F2 showed a disintegration time of less than 30 s.
The bioavailability of some medications may be improved by ODTs. Higher drug concentrations in the bloodstream are the consequence of their dissolution in the oral mucosa, which evades the liver's first-pass metabolism. Additionally, ODTs are now included in a variety of pharmaceutical portfolios because of their particular value for medications with low bioavailability and those that undergo extensive hepatic metabolism.
Every medication cannot be formulated for ODT. Certain medications may not taste well, may not stabilize well in damp environments or dissolve quickly, or may not have the physical qualities needed to be used as oral drug delivery technologies. Furthermore, this restriction might make it more difficult to offer more ODT for particular drug compounds and therapeutic classes.
In pediatric medicine, ODTs offer a great deal of potential. The market for kid-friendly dosage forms has expanded in tandem with the growth in the need for pediatric healthcare. ODTs address the difficulties related to pediatric medication adherence by providing a tasty and simple-to-administer alternative. Moreover, pharmaceutical companies can broaden their product offerings by creating ODT formulations for a variety of pediatric drugs, such as allergy treatments and antibiotics.
Patents and intellectual property rights frequently shield ODT formulations, which can restrict access to exclusive technology and taste-masking strategies. Especially for well-known ODT products, generic manufacturers may enter the market as patents expire, which could lead to price erosion and increased competition. Additionally, the income of ODT drug manufacturers may be threatened by this.
The Orally Disintegrating Tablet (ODT) market has been impacted by the COVID-19 pandemic in a number of ways. Although contactless, self-administered dosage forms (ODTs) have been shown to be beneficial, the development and accessibility of ODT products have been hampered by supply chain disruptions, delays in clinical trials, and regulatory processes. Additionally, the pandemic hastened the adoption of telemedicine, opening doors for home delivery of ODT medications and remote prescribing. Challenges have included shifting healthcare priorities, reallocating resources toward pandemic response efforts, and facing financial ramifications. These have especially affected funding and investment for new ODT research and development.
In the Orally Disintegrating Tablet Market, the segment with the largest market share is proton pump inhibitors. Medications known as proton pump inhibitors (PPIs) are frequently prescribed to treat gastrointestinal disorders, peptic ulcers, and gastroesophageal reflux disease (GERD). They relieve patients experiencing symptoms related to acid reflux by decreasing the production of stomach acid. The prominence of this segment is partly due to the long-term use of PPIs for chronic conditions and the widespread prevalence of disorders related to acidity. Moreover, PPIs are now a significant player in the pharmaceutical industry due to their expanded market reach and availability in both prescription and over-the-counter (OTC) versions.
The respiratory disorders segment is expected to grow at the highest CAGR. A broad spectrum of illnesses is categorized as respiratory disorders, such as multiple respiratory infections, asthma, and chronic obstructive pulmonary disease (COPD). The need for novel treatments is fueled by the rising incidence of respiratory illnesses worldwide, which is a result of factors like smoking, air pollution, and aging populations. Improvements in precision medicine, biologics, and inhalation technologies are revolutionizing the treatment of respiratory illnesses. Furthermore, the COVID-19 pandemic has raised awareness of respiratory health issues and prompted more research and development activities.
In the oral disintegrating tablet market, North America has the largest share. Its strong healthcare system, large healthcare budget, extensive R&D, and sizable patient base with a variety of medical conditions are all considered contributing factors to its dominance in the field. Due to its sophisticated medical technology, strong research institutions, and emphasis on healthcare innovation, the United States in particular is a major force behind pharmaceutical advancements. Moreover, by leading the world's pharmaceutical industry, North America maintains its position thanks to its proactive response to new healthcare challenges.
The oral disintegrating tablet market is growing at the highest CAGR in the Asia-Pacific region. A number of factors, including growing economic development, increased healthcare awareness, and increased access to healthcare services, are responsible for this amazing growth. With major investments from healthcare companies, Asia-Pacific has emerged as a key hub for pharmaceutical development, clinical trials, and medical research. Furthermore, the region is experiencing swift progress in biotechnology, novel pharmaceuticals, and healthcare infrastructure, establishing it as a primary catalyst for expansion and novelty in the worldwide pharmaceutical industry.
Some of the key players in Orally Disintegrating Tablet market include: Takeda Pharmaceutical Company Limited, AstraZeneca, Mylan N.V, Otsuka Pharmaceutical Co., Ltd., Merck & Co., Inc., Pfizer Inc, Johnson & Johnson Services, Inc., Novartis AG, Sun Pharmaceutical Industries Ltd., F. Hoffmann-La Roche Ltd., Eli Lily and Company, GlaxoSmithKline plc., Teva Pharmaceutical Industries Ltd. and Dr. Reddy's Laboratories Ltd., Bausch Health and Bayer AG.
In November 2023, AstraZeneca announced a collaboration and investment agreement with Cellectis to accelerate the development of next-generation therapeutics in areas of high unmet need, including oncology, immunology and rare diseases. Under the terms of the collaboration agreement, AstraZeneca will leverage the Cellectis proprietary gene editing technologies and manufacturing capabilities, to design novel cell and gene therapy products, strengthening AstraZeneca's growing offering in this space.
In May 2023, Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that it has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies.
In January 2023, Takeda announced that it has entered into an exclusive licensing agreement with HUTCHMED (China) Limited and its subsidiary HUTCHMED Limited, for the further development and commercialization of fruquintinib outside of mainland China, Hong Kong and Macau.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.