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市場調查報告書
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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

出版日期: | 出版商: KuicK Research | 英文 120 Pages | 商品交期: 最快1-2個工作天內

價格

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

  • 全球胜肽類藥物偶聯物市場機會:>14 億美元
  • 全球胜肽類藥物偶聯物市場趨勢:按地區、按適應症
  • 2018-2024 年全球胜肽類藥物偶聯物市場成長:絕對成長率 >300%,複合年增長率 27%
  • 已獲批准肽類藥物偶聯物的數量、劑量、銷售和定價洞察
  • 全球已獲核准胜肽類藥物偶聯物銷售額及地區洞察:2 種已核准藥物
  • 全球胜肽類藥物偶聯物臨床試驗洞察:>30 多種產品
  • 全球胜肽藥物偶聯物臨床試驗洞察:按公司、國家、適應症、階段
  • 胜肽藥物偶聯物專有技術和研究方法:按公司

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。

目錄

第1章 [月太]藥物複合體的簡介

  • 概要
  • 歷史與演進
  • [月太]藥物複合體和抗體藥物複合體

第2章 [月太]藥物複合體- 結構成分和作用機制

  • 零組件
  • 作用機制

第3章 [月太]藥物複合體的研究開發趨勢(各適應症)

  • 癌症
  • 其他

第4章 全球[月太]藥物複合體的調查與市場趨勢(各地區)

  • 美國
  • 中國
  • 日本
  • 歐洲
  • 韓國

第5章 全球[月太]藥物複合體市場展望

  • 目前臨床及市場趨勢
  • 未來市場展望和機會

第6章 [月太]藥物複合體開發獨家技術和方法論

第7章 世界[月太]藥物複合體的臨床實驗平台概要

  • 各企業
  • 各國
  • 各適應症
  • 患者各市場區隔
  • 各相

第8章 世界[月太]藥物複合體臨床試驗的洞察,企業,國家,適應症,各相

  • 調查
  • 前臨床
  • 第一階段
  • 第一/二階段
  • 第二階段
  • 第三階段

第9章 市售[月太]藥物複合體的臨床性洞察

第10章 Lutathera- 臨床及商業性洞察

  • 概要,可得性,專利資訊
  • 與劑量價格分析
  • 銷售額分析

第11章 Pepaxt/Pepaxti- 臨床及商業性洞察

  • 概要,可得性,專利資訊
  • 劑量分析
  • 銷售額分析

第12章 競爭情形

  • Angiochem
  • Avacta
  • Bicycle Therapeutics
  • Cybrexa Therapeutics
  • ITM Solucin
  • Novartis
  • Oncopeptides
  • PepGen Corporation
  • Soricimed Biopharma
  • Theratechnologies

Global Peptide Drug Conjugate Market, Drug Sales, Price, Dosage & Clinical Trials Insight 2030 Report Highlights:

  • Global Peptide Drug Conjugate Market Opportunity: > USD 1400 Million
  • Global Peptide Drug Conjugate Market Trends By Region & Indications
  • Global Peptide Drug Conjugate Market Growth 2018-2024: > 300% Absolute Growth & 27% CAGR Growth
  • Approved Peptide Drug Conjugate Dosage, Sales & Price Insight
  • Approved Peptide Drug Conjugate Sales Global & Regional Insight: 2 Drugs Approved
  • Global Peptide Drug Conjugate Clinical Trials Insight: > 30 Drugs
  • Global Peptide Drug Conjugates Clinical Trials Insight By Company, Country, Indication & Phase
  • Peptide Drug Conjugate Proprietary Technologies & Methodologies Insight By Company

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.

Table of Contents

1. Introduction To Peptide Drug Conjugates

  • 1.1 Overview
  • 1.2 History & Evolution
  • 1.3 Peptide Drug Conjugates v/s Antibody Drug Conjugates

2. Peptide Drug Conjugates - Structural Components & Mechanism of Action

  • 2.1 Components
  • 2.2 Mechanism of Action

3. Peptide Drug Conjugates Research & Development Trends By Indication

  • 3.1 Cancer
  • 3.2 Others

4. Global Peptide Drug Conjugates Research & Market Trends By Region

  • 4.1 US
  • 4.2 China
  • 4.3 Japan
  • 4.4 Europe
  • 4.5 South Korea

5. Global Peptide Drug Conjugates Market Outlook

  • 5.1 Current Clinical & Market Trends
  • 5.2 Future Market Outlook & Opportunities

6. Peptide Drug Conjugate Development Proprietary Technologies & Methodologies

7. Global Peptide Drug Conjugates Clinical Pipeline Overview

  • 7.1 By Company
  • 7.2 By Country
  • 7.3 By Indication
  • 7.4 By Patient Segment
  • 7.5 By Phase

8. Global Peptide Drug Conjugates Clinical Trials Insight By Company, Country, Indication & Phase

  • 8.1 Research
  • 8.2 Preclinical
  • 8.3 Phase-I
  • 8.4 Phase-I/II
  • 8.5 Phase-II
  • 8.6 Phase-III

9. Marketed Peptide Drug Conjugates Clinical Insight

10. Lutathera - Clinical & Commercial Insight

  • 10.1 Overview, Availability & Patent Insight
  • 10.2 Dosage & Price Analysis
  • 10.3 Sales Analysis

11. Pepaxto/Pepaxti - Clinical & Commercial Insight

  • 11.1 Overview, Availability & Patent Insight
  • 11.2 Dosage Analysis
  • 11.3 Sales Analysis

12. Competitive Landscape

  • 12.1 Angiochem
  • 12.2 Avacta
  • 12.3 Bicycle Therapeutics
  • 12.4 Cybrexa Therapeutics
  • 12.5 ITM Solucin
  • 12.6 Novartis
  • 12.7 Oncopeptides
  • 12.8 PepGen Corporation
  • 12.9 Soricimed Biopharma
  • 12.10 Theratechnologies

List of Figures

  • Figure 1-1: Timeline of Key Events in Development of Peptide Drug Conjugates
  • Figure 2-1: Peptide Drug Conjugates - Components
  • Figure 2-2: Peptide Drug Conjugate - Mechanism Of Action
  • Figure 3-1: Approved Peptide Drug Conjugates
  • Figure 3-2: TH1902-CTR-0001 Phase I (NCT04706962) Study - Initiation & Completion Year
  • Figure 3-3: CBX-12-101 Phase I/II (NCT04902872) Study - Initiation & Completion Year
  • Figure 3-4: CBX-12-201 Phase II (NCT06315491) Study - Initiation & Completion Year
  • Figure 3-5: Duravelo-1 Phase I/II (NCT04561362) Study - Initiation & Completion Year
  • Figure 3-6: Duravelo-2 Phase II/III (NCT06225596) Study - Initiation & Completion Year
  • Figure 3-7: Duravelo-3 Phase II (NCT06840483) Study - Initiation & Completion Year
  • Figure 3-8: Duravelo-4 Phase II (NCT06933329) Study - Initiation & Completion Year
  • Figure 3-9: BT5528-100 Phase I/II (NCT04180371) Study - Initiation & Completion Year
  • Figure 3-10: ALS-6000-101 Phase I (NCT04969835) Study - Initiation & Completion Year
  • Figure 5-1: Global - Peptide drug Conjugates Market (US$ Million), 2018-2025
  • Figure 5-2: Global - Peptide drug Conjugates Market (US$ Million), 2025-2030
  • Figure 5-3: Potential Future Directions in Peptide-Drug Conjugate Development
  • Figure 6-1: Alphalex Platform - Cybrexa
  • Figure 6-2: Decoy Platform - Candidate Life Cycle
  • Figure 6-3: Decoy Platform - Modular Peptide Engineering & Conjugation Chemistry
  • Figure 6-4: Decoy Platform - Features
  • Figure 6-5: EDO Platform - Drug Structure
  • Figure 6-6: OncoPDCs - Excellamol
  • Figure 6-7: PDPS Platform - PeptiDream
  • Figure 6-8: Rational Design Based Drug Discovery - Mainline Biosciences
  • Figure 6-9: pre|CISION(R) Platform - Generations & Features
  • Figure 6-10: PIP - Mechanism of Action
  • Figure 6-11: PIP Platform - TwoStep Toolbox
  • Figure 6-12: Peptide - Advantages
  • Figure 6-13: SORT1+ Technology - PDC Structure
  • Figure 6-14: MPD-1 - Mechanism of Action
  • Figure 6-15: Bi-XDC Technology - Coherent Biopharma
  • Figure 6-16: NIPEP-TPP - NIBEC
  • Figure 7-1: Global - Peptide Drug Conjugate Clinical Pipeline by Company (Number of Drugs), 2025 Till 2030
  • Figure 7-2: Global - Peptide Drug Conjugate Clinical Pipeline by Country (Number of Drugs), 2025 Till 2030
  • Figure 7-3: Global - Peptide Drug Conjugate Clinical Pipeline by Indication (Number of Drugs), 2025 Till 2030
  • Figure 7-4: Global - Peptide Drug Conjugate Clinical Pipeline by Patient Segment (Number of Drugs), 2025 Till 2030
  • Figure 7-5: Global - Peptide Drug Conjugate Clinical Pipeline by Phase (Number of Drugs), 2025 Till 2030
  • Figure 10-1: Lutathera - Approval Year by Region
  • Figure 10-2: Lutathera - Patent Filing & Expiration Year
  • Figure 10-3: Global - Lutathera Sales (US$ Million), 2018-2025
  • Figure 10-4: Global - Lutathera Quarterly Sales (US$ Million), 2025
  • Figure 10-5: Regional - Lutathera Sales (US$ Million), Q1'2025
  • Figure 10-6: Regional - Lutathera Sales (US$ Million), Q1'2025
  • Figure 10-7: Global - Lutathera Quarterly Sales (US$ Million), 2024
  • Figure 10-8: US - Lutathera Quarterly Sales (US$ Million), 2024
  • Figure 10-9: US - Lutathera Sales (US$ Million), 2023-2025
  • Figure 10-10: ROW - Lutathera Quarterly Sales (US$ Million), 2024
  • Figure 10-11: ROW - Lutathera Sales (US$ Million), 2023-2025
  • Figure 11-1: Pepaxto/Pepaxti - Approval Year by Region
  • Figure 11-2: Pepaxti - Patent Filing & Expiration Year
  • Figure 11-3: Europe - Pepaxti Sales (US$ Million), 2021-2025

List of Tables

  • Table 1-1: Antibody Drug Conjugates v/s Peptide Drug Conjugates
  • Table 10-1: Lutathera - Recommended Amino Acid Solution Dosing
  • Table 10-2: Lutathera - Recommended Dosage Modifications for Adverse Reactions
  • Table 11-1: Pepaxti - Recommended Dose Reduction for Adverse Reactions
  • Table 11-2: Pepaxti - Recommended Dose Modifications for Adverse Reactions