封面
市场调查报告书
商品编码
1742161

[月太]药物复合体的全球市场:药物销售额,价格,用量,临床试验趋势(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个工作天内

价格

全球胜肽类药物偶联物市场:药物销售、价格、剂量、临床试验趋势(2030 年)报告重点

  • 全球胜肽类药物偶联物市场机会:>14 亿美元
  • 全球胜肽类药物偶联物市场趋势:按地区、按适应症
  • 2018-2024 年全球胜肽类药物偶联物市场成长:绝对成长率 >300%,复合年增长率 27%
  • 已获批准肽类药物偶联物的数量、剂量、销售和定价洞察
  • 全球已获核准胜肽类药物偶联物销售额及地区洞察:2 种已核准药物
  • 全球胜肽类药物偶联物临床试验洞察:>30 多种产品
  • 全球胜肽药物偶联物临床试验洞察:按公司、国家、适应症、阶段
  • 胜肽药物偶联物专有技术和研究方法:按公司

全球胜肽药物偶联物市场仍处于起步阶段,儘管过去几年人们对该领域的兴趣和投资日益增长,但仅有少数疗法获得批准。目前,仅有两种胜肽药物偶联物获得药品监管机构批准。其中第一种是诺华公司的Lutathera,于2017年获得欧洲药品管理局批准,用于治疗患有胃肠道胰腺神经内分泌肿瘤的成年患者,标誌着一项重大突破。随后,该药物于2018年获得美国FDA批准。值得一提的是,该药物的适应症在2024年扩展至儿科患者,这是一项罕见举措,也是儿科癌症领域的重大突破。

Oncopeptides 公司第二个核准的胜肽类药物偶联物 Pepaxto 于 2021 年获得 FDA 核准,用于治疗多发性骨髓瘤。然而,其发展之路并非一帆风顺。由于安全性和有效性问题,该药物在获批当年就退出了美国市场,并于 2024 年正式撤销。不过,该药物目前仍在欧洲市场销售。 Oncopeptides 公司也积极寻求其他监管机会,尤其是在亚洲。例如,该公司将于 2024 年与日本药品监督管理局 (PMDA) 展开进一步的监管谈判,旨在将 Pepaxti 引入日本市场。此举反映出跨境监管要求日益同步,以及利害关係人对胜肽类药物偶联疗法日益增长的兴趣。

目前,有 30 多种胜肽类药物偶联物候选药物正在积极进行临床开发,其中大多数处于早期阶段。这证实了该领域的新颖性和潜力。肽化学和药物偶联方法的稳步创新正在推动这一发展。其中一项关键重点是优化用于将胜肽连接到有效载荷的化学连接子。连接子对于在标靶精准释放活性药物、提高疗效和安全性至关重要。稳定性和选择性的提高正在推动这些创新,使其能够更精准地递送至癌细胞并减少对健康组织的损害。

胜肽-药物偶联物开发的日益复杂化促使製药公司与高度专业化的研发合约公司(例如 BOC Sciences 和 Peptistar)合作。这些联合开发公司在胜肽合成、有效载荷设计、偶联策略等方面拥有深厚的专业知识,这对于早期开发至关重要。这种合作模式使公司能够更快地迭代、降低成本并更有效地将新的候选药物推向临床。

从地理上看,美国和中国在强大的投资生态系统和顶级学术机构的支持下,引领研发工作。然而,来自世界各地的众多公司正在做出重要贡献。诺华公司和Oncopeptides凭藉已批准的疗法和后期临床资产,依然处于领先地位,而其他创新公司,如Bicycle Therapeutics、PeptiDream和Soricimed Biopharma,则在靶向和有效载荷选择方面引入了新的概念。正在开发的分子形式的广度反映了PDC平台的多功能性。

受体特异性标靶治疗正蓬勃发展,药物开发商希望靶向癌症特异性细胞表面受体,以实现更具选择性的药物传递。这是肿瘤学迈向精准医疗的整个过程的一部分。其目标是降低全身毒性并最大限度地提高肿瘤部位的药物疗效。随着技术的不断成熟,它或许能够治疗那些传统疗法难以治疗的实体肿瘤。随着产业发展和技术援助的加强,胜肽药物偶联物市场的前景依然光明,儘管前景尚不明朗。

本报告提供全球[月太]药物复合体市场相关调查,提供市场概要,以及药物趋势,临床试验趋势,各地区趋势,及加入此市场的主要企业竞争情形等资讯。

目录

第1章 [月太]药物复合体的简介

  • 概要
  • 历史与演进
  • [月太]药物复合体和抗体药物复合体

第2章 [月太]药物复合体- 结构成分和作用机制

  • 零组件
  • 作用机制

第3章 [月太]药物复合体的研究开发趋势(各适应症)

  • 癌症
  • 其他

第4章 全球[月太]药物复合体的调查与市场趋势(各地区)

  • 美国
  • 中国
  • 日本
  • 欧洲
  • 韩国

第5章 全球[月太]药物复合体市场展望

  • 目前临床及市场趋势
  • 未来市场展望和机会

第6章 [月太]药物复合体开发独家技术和方法论

第7章 世界[月太]药物复合体的临床实验平台概要

  • 各企业
  • 各国
  • 各适应症
  • 患者各市场区隔
  • 各相

第8章 世界[月太]药物复合体临床试验的洞察,企业,国家,适应症,各相

  • 调查
  • 前临床
  • 第一阶段
  • 第一/二阶段
  • 第二阶段
  • 第三阶段

第9章 市售[月太]药物复合体的临床性洞察

第10章 Lutathera- 临床及商业性洞察

  • 概要,可得性,专利资讯
  • 与剂量价格分析
  • 销售额分析

第11章 Pepaxt/Pepaxti- 临床及商业性洞察

  • 概要,可得性,专利资讯
  • 剂量分析
  • 销售额分析

第12章 竞争情形

  • 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