市場調查報告書
商品編碼
1383469
到 2030 年口溶錠市場預測:按產品、藥物類別、適應症、配銷通路和地區分類的全球分析Orally Disintegrating Tablet Market Forecasts to 2030 - Global Analysis By Product, Drug Class, Indication, Distribution Channel and by Geography |
根據Stratistics MRC的數據,2023年全球口溶錠市場規模為150.7974億美元,預計到2030年將達到382.6971億美元,預測期內年複合成長率為14.23%。
口溶錠,也稱為口溶片、速溶片或快速崩解錠,是放置在口腔或舌頭上時迅速溶解或崩壞的固態劑型。此外,透過使用各種技術配製,已經實現了能夠透過口腔黏膜快速吸收藥物的快速崩壞和快速溶解片劑。 ODT 的配方需要仔細考慮味道、穩定性和可製造性之間的平衡,以保持活性成分的有效性,同時讓患者滿意。
根據 FDA (2008) 的規定,使用 USP崩壞試驗,口溶錠最好在 30 秒內崩壞[23]。製劑F1和F2顯示崩壞時間小於30秒。
ODT 可能會提高某些藥物的生物利用度。血液中的高藥物濃度是口腔黏膜溶解的結果,它逃避了肝臟首過代謝。此外,ODT 對於生物利用度低的藥物或經歷廣泛肝臟代謝的藥物特別有用,因此現在已包含在各種藥物組合中。
並非所有藥物都可以用於 ODT。有些藥物味道不好,在潮濕環境中不穩定,溶解很快,或不具備口服給藥技術所需的物理特性。此外,這種限制可能導致難以為特定化合物或治療層級提供更多 ODT。
ODT在兒童醫學領域具有巨大潛力。隨著兒童醫療保健需求的增加,兒童友善劑型的市場也增加。 ODT 透過提供美味且易於服用的替代品來解決兒童用藥醫囑遵從性的挑戰。此外,製藥公司可以透過開發各種兒童用藥物(例如過敏藥物和抗生素)的 ODT 配方來擴展其產品組合。
ODT 配方通常受到專利和智慧財產權的保護,這可能會限制專有技術和掩味策略的取得。特別是對於知名的 ODT 製劑,學名藥製造商可能會在專利到期後進入市場,這可能導致價格下降和競爭加劇。此外,ODT藥品生產商的收入也可能受到威脅。
口溶錠(ODT) 市場受到了 COVID-19大流行的各種影響。非接觸式自我給藥劑型 (ODT) 已被證明是有益的,但供應鏈中斷、臨床試驗延遲和法規流程阻礙了 ODT 產品的開發和可用性。此外,疫情加速了遠端醫療的普及,為 ODT 藥物的宅配上門和遠距處方打開了大門。挑戰包括改變醫療保健優先事項、重新分配應對大流行的資源以及財務影響。這些尤其影響新 ODT 研究和開發的資金和投資。
在口溶錠市場中,市場佔有率最高的細分市場是質子幫浦抑制劑。質子幫浦抑制劑 (PPI) 藥物常用於治療胃腸道疾病、消化性潰瘍和胃食道逆流症 (GERD)。 PPI 透過減少胃酸分泌來緩解胃酸逆流相關症狀的患者。該領域受到關注的部分原因是質子幫浦抑制劑長期用於治療慢性疾病以及酸相關疾病的廣泛流行。此外,質子幫浦抑制劑現在是製藥業的重要參與者,有處方藥和非處方藥 (OTC) 可供選擇,且市場不斷成長。
呼吸系統疾病領域預計將以最高年複合成長率成長。呼吸系統疾病包括多種疾病,包括多種呼吸道感染疾病、氣喘和慢性阻塞性肺病(COPD)。由於吸菸、空氣污染和高齡化等因素,世界各地呼吸系統疾病的發生率不斷增加,因此需要新的治療方法。精準醫學、生技藥品和吸入技術的進步正在徹底改變呼吸系統疾病的治療。此外,COVID-19大流行提高了人們對呼吸系統健康問題的認知,並促使研發活動活性化。
北美佔據口溶錠市場的最大佔有率。北美強大的醫療保健系統、龐大的醫療預算、廣泛的研究和開發以及大量患有各種醫療狀況的患者群體被認為是其在該領域佔據主導地位的部分原因。憑藉先進的醫療技術、強大的研究機構以及對醫療保健創新的重視,美國是推動進步的主要力量,尤其是在製藥領域。此外,北美透過積極應對新的醫療保健挑戰,維持了全球製藥業領導者的地位。
口溶錠市場正以亞太地區最高的年複合成長率成長。許多因素促成了這種巨大的成長,包括經濟發展、醫療保健意識的提高以及獲得醫療保健服務的機會的改善。隨著醫療保健公司的大量投資,亞太地區已成為藥物開發、臨床試驗和醫學研究的重要中心。此外,該地區在生物技術、新藥和醫療基礎設施方面正在快速進步,成為全球製藥業擴張和創新的主要催化劑。
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.