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市場調查報告書
商品編碼
1742161
[月太]藥物複合體的全球市場:藥物銷售額,價格,用量,臨床試驗趨勢(2030年)Global Peptide Drug Conjugate Market, Drug Sales, Price, Dosage & Clinical Trials Insight 2030 |
全球胜肽類藥物偶聯物市場:藥物銷售、價格、劑量、臨床試驗趨勢(2030 年)報告重點
全球胜肽藥物偶聯物市場仍處於起步階段,儘管過去幾年人們對該領域的興趣和投資日益增長,但僅有少數療法獲得批准。目前,僅有兩種胜肽藥物偶聯物獲得藥品監管機構批准。其中第一種是諾華公司的Lutathera,於2017年獲得歐洲藥品管理局批准,用於治療患有胃腸道胰腺神經內分泌腫瘤的成年患者,標誌著一項重大突破。隨後,該藥物於2018年獲得美國FDA批准。值得一提的是,該藥物的適應症在2024年擴展至兒科患者,這是一項罕見舉措,也是兒科癌症領域的重大突破。
Oncopeptides 公司第二個核准的胜肽類藥物偶聯物 Pepaxto 於 2021 年獲得 FDA 核准,用於治療多發性骨髓瘤。然而,其發展之路並非一帆風順。由於安全性和有效性問題,該藥物在獲批當年就退出了美國市場,並於 2024 年正式撤銷。不過,該藥物目前仍在歐洲市場銷售。 Oncopeptides 公司也積極尋求其他監管機會,尤其是在亞洲。例如,該公司將於 2024 年與日本藥品監督管理局 (PMDA) 展開進一步的監管談判,旨在將 Pepaxti 引入日本市場。此舉反映出跨境監管要求日益同步,以及利害關係人對胜肽類藥物偶聯療法日益增長的興趣。
目前,有 30 多種胜肽類藥物偶聯物候選藥物正在積極進行臨床開發,其中大多數處於早期階段。這證實了該領域的新穎性和潛力。肽化學和藥物偶聯方法的穩步創新正在推動這一發展。其中一項關鍵重點是優化用於將胜肽連接到有效載荷的化學連接子。連接子對於在標靶精準釋放活性藥物、提高療效和安全性至關重要。穩定性和選擇性的提高正在推動這些創新,使其能夠更精準地遞送至癌細胞並減少對健康組織的損害。
胜肽-藥物偶聯物開發的日益複雜化促使製藥公司與高度專業化的研發合約公司(例如 BOC Sciences 和 Peptistar)合作。這些聯合開發公司在胜肽合成、有效載荷設計、偶聯策略等方面擁有深厚的專業知識,這對於早期開發至關重要。這種合作模式使公司能夠更快地迭代、降低成本並更有效地將新的候選藥物推向臨床。
從地理上看,美國和中國在強大的投資生態系統和頂級學術機構的支持下,引領研發工作。然而,來自世界各地的眾多公司正在做出重要貢獻。諾華公司和Oncopeptides憑藉已批准的療法和後期臨床資產,依然處於領先地位,而其他創新公司,如Bicycle Therapeutics、PeptiDream和Soricimed Biopharma,則在靶向和有效載荷選擇方面引入了新的概念。正在開發的分子形式的廣度反映了PDC平台的多功能性。
受體特異性標靶治療正蓬勃發展,藥物開發商希望靶向癌症特異性細胞表面受體,以實現更具選擇性的藥物傳遞。這是腫瘤學邁向精準醫療的整個過程的一部分。其目標是降低全身毒性並最大限度地提高腫瘤部位的藥物療效。隨著技術的不斷成熟,它或許能夠治療那些傳統療法難以治療的實體腫瘤。隨著產業發展和技術援助的加強,胜肽藥物偶聯物市場的前景依然光明,儘管前景尚不明朗。
本報告提供全球[月太]藥物複合體市場相關調查,提供市場概要,以及藥物趨勢,臨床試驗趨勢,各地區趨勢,及加入此市場的主要企業競爭情形等資訊。
Global Peptide Drug Conjugate Market, Drug Sales, Price, Dosage & Clinical Trials Insight 2030 Report Highlights:
The global peptide drug conjugate market is still in its nascent stage, with only a few approved therapies despite rising interest and investment over the last few years. Currently, there are only 2 peptide drug conjugates have received approval from drug regulatory agencies. The first of these, Novartis' Lutathera, was a major breakthrough in 2017 when it received approval from the European Medicines Agency for the treatment of adult patients with gastroenteropancreatic neuroendocrine tumors. This was subsequently followed by US FDA approval in 2018. Interestingly, the indication for the drug was also expanded in 2024 to paediatric patients, a rare move and a significant breakthrough in the paediatric oncology sector.
The second peptide drug conjugate that has been approved, Oncopeptides' Pepaxto, was launched for multiple myeloma and was approved by the FDA in 2021, while a year later it got the thumbs up from the EMA. Its journey was not as smooth, though. It was withdrawn from the US market in the year it was approved because of safety and efficacy issues, reaching the point of official withdrawal of its approval in 2024. However, the product remains on the Europe market. Oncopeptides has also been actively pursuing other regulatory opportunities, notably in Asia. For instance, in 2024, it embarked on further regulatory discussions with Japan's PMDA, aiming to bring Pepaxti into that market. This step mirrors increasing synchronization of regulatory requirements across borders and increasing interest among industry stakeholders in peptide drug conjugate therapies.
Today, there are over 30 peptide drug conjugate candidates in active clinical development, with the majority lying in early stages. This underscores the field's novelty and potential. Steady innovation in peptide chemistry and drug conjugation methodologies is driving this development. One key area of focus has been the optimization of the chemical linkers used to attach peptides to their payloads. The linkers are crucial in ensuring that the active drug is released exactly at the target location, thus enhancing efficacy and safety. Improvements in stability and selectivity are powering these innovations, allowing for more targeted delivery to cancer cells and reducing harm to healthy tissue.
The growing sophistication of peptide drug conjugate development has led pharmaceutical firms to collaborate with highly specialized contract research and development firms, such as BOC Sciences and Peptistar. These collaborators bring advanced expertise in peptide synthesis, payload design, and conjugation strategies, among others, making them essential during early-stage development. This model of collaboration is enabling companies to iterate more quickly, lower their costs, and get new candidates into the clinic more effectively.
Geographically, the US & China are leading the research and development effort with strong investment ecosystems and top academic institutions supporting them. However, a large number of companies from all around the globally are making important contributions. Novartis and Oncopeptides remain at the forefront with their approved therapies and late-stage clinical assets, while other innovators like Bicycle Therapeutics, PeptiDream, and Soricimed Biopharma are introducing new concepts in targeting and payload choice. The range of molecular forms under development is a reflection of the versatility of the PDC platform.
There is increasing momentum behind receptor-specific targeting, with drug developers targeting cancer-specific cell surface receptors to provide more selective delivery of drugs. This is part of an oncology-wide movement toward precision medicine. The aim is to decrease systemic toxicity and maximize drug effect at the tumor site. As this technology continues to mature, it has the potential to address difficult solid tumors that have so far been resistant to traditional treatments. With the industry growing and technology aids enhancing, prospects for the peptide drug conjugate market remain brighter although tentatively so.