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製薬・バイオテクノロジー業界における臨床段階の提携条件および契約 (2020~2025年)

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2020-2025


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英文 1500+ Pages
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即日から翌営業日
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製薬・バイオテクノロジー業界における臨床段階の提携条件および契約 (2020~2025年)
出版日: 2025年03月01日
発行: Current Partnering
ページ情報: 英文 1500+ Pages
納期: 即日から翌営業日
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概要

当レポートでは、製薬・バイオテクノロジー業界における臨床段階の提携条件および契約について調査し、企業が臨床段階の提携契約を締結する方法と理由、およびこれらの契約を支える財務的・戦略的条件について、データに基づいて包括的に分析しています。また、本レポートは、製薬・バイオテクノロジー業界における臨床段階の医薬品開発提携における契約構造、交渉力学、財務上の考慮事項に関する比類のない洞察を提供します。

臨床段階では、ライセンシング契約は通常、ライセンシーにライセンサーの製品または技術を開発する独占的な権利またはオプションを付与するものであり、多くの場合、第I相、第II相、第III相試験を対象とします。このような契約は、共同研究開発、共同開発、商業化戦略など、複数の要素を含むことが多くあります。

本レポートは、ヘルスケア分野における最新の臨床段階契約に関する詳細な情報を提供し、企業が市場動向を評価し、交渉戦略を最適化し、契約構造をベンチマークするのに役立ちます。

本レポートは以下の内容を提供します:

  • 2020年以降のバイオ医薬品業界における臨床段階の取引動向の分析
  • 契約一時金、マイルストーン、ロイヤルティなどの詳細な契約形態
  • 実際の臨床段階の契約に関するケーススタディ
  • 1,670件以上の臨床段階案件へのアクセス (入手可能な場合は契約記録付き)
  • 2020年以降のもっとも活発な臨床段階のディールメーカーの提携プロファイル
  • 最高額の臨床段階案件の詳細分析

目次

エグゼクティブサマリー

第1章 イントロダクション

第2章 企業が臨床段階の化合物で提携を行うのはなぜか?

  • 臨床段階の提携の役割
    • 臨床段階でのライセンス導入
    • 臨床段階でのライセンス供与
  • フェーズI、II、III段階の取引の違い
  • 臨床段階の提携契約を締結する理由
    • ライセンサーが臨床段階の取引に参入する理由
    • ライセンシーが臨床段階の取引に参入する理由
  • 臨床段階の提携契約の将来

第3章 臨床段階の取引戦略と構造

  • 企業はどの段階で提携するか?
    • 製薬/バイオテクノロジー分野での早期提携
    • 製薬/バイオテクノロジー分野での提携
  • 初期段階と後期段階の提携:リスクとコストの比較
  • 企業は臨床段階の提携にいくら費やしているか?
  • 純粋な提携契約と複数コンポーネント提携契約
  • 純粋なライセンシング契約の構造
    • 純粋なライセンシング契約の例
    • ケーススタディ
  • 複数コンポーネントの臨床段階提携契約
    • 複数コンポーネントの臨床段階条項の例
    • ケーススタディ

第4章 臨床段階の提携支払い戦略

  • 臨床段階の支払い戦略
  • 支払いオプション
    • ヘッドライン
    • アップフロント
    • ローン
    • 転換ローン
    • 公平性
    • 研究開発資金
    • ライセンシング料
    • マイルストーン
    • ロイヤリティ
    • クイッズ
    • オプション

第5章 臨床段階の取引の動向

  • 長期臨床段階の提携
    • 2020年以降のフェーズI取引の動向
    • 2020年以降のフェーズII取引の動向
    • 2020年以降のフェーズIII取引の動向
  • 臨床段階の提携:取引タイプ別
  • 臨床段階の提携:疾患タイプ別
  • 臨床段階の提携:技術タイプ別
  • 2020年以降最もっとも活発な企業による臨床段階の提携

第6章 臨床段階の提携における支払い条件

  • 臨床段階の支払い条件に関するガイドライン
    • アップフロント
    • マイルストーン
    • ロイヤリティ
  • 臨床段階の支払い条件:取引データ分析
    • 公開データ
    • 調査データ
  • 支払条件分析
    • 臨床段階提携のヘッドライン支払い
    • 臨床段階取引のアップフロント支払い
    • 臨床段階取引のマイルストーン支払い
    • 臨床段階のロイヤリティ率
  • 臨床段階の財務の中央値
    • 臨床段階のヘッドライン額
    • 臨床段階のアップフロント額
    • 臨床段階のマイルストーン額
    • 臨床段階のロイヤリティ額

第7章 主な臨床段階の取引

  • 上位の臨床段階の取引:金額別

第8章 臨床段階のディールメーカー上位25社

  • もっとも活発な臨床段階のディールメーカー上位25社

第9章 臨床段階の提携契約ディレクトリ

  • 2020年以降の臨床段階の取引契約

第10章 臨床段階の取引:開発段階別

  • 臨床段階別の取引
  • フェーズI
  • フェーズII
  • フェーズIII
  • 申請段階

付録

Wildwood Venturesについて

目次
Product Code: CP2058

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech (2020-2025)

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2020-2025 report provides a comprehensive, data-driven analysis of how and why companies engage in clinical-stage partnering agreements, as well as the financial and strategic terms shaping these collaborations. This essential industry resource delivers unparalleled insights into deal structures, negotiation dynamics, and financial considerations for clinical-stage drug development partnerships.

At the clinical stage, licensing agreements typically grant the licensee exclusive rights or options to develop a licensor's product or technology, often covering Phase I, Phase II, and Phase III trials. These agreements are frequently multi-component, involving collaborative R&D, co-development, and commercialization strategies.

This report provides detailed intelligence on the latest clinical-stage agreements in the healthcare sector, helping companies evaluate market trends, optimize negotiation strategies, and benchmark deal structures.

A Must-Have Resource for Biotech and Pharma Dealmakers

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech (2020-2025) report is an indispensable resource for business development, legal, and financial professionals involved in biopharma dealmaking.

With comprehensive insights, a vast deal database, and direct access to contract documents, this report serves as the ultimate tool for:

  • Benchmarking deal structures and financial terms
  • Optimizing negotiation strategies
  • Assessing potential partners' flexibility
  • Identifying trends in clinical-stage partnerships
  • Why This Report is Essential for Dealmakers
  • Understanding the flexibility and negotiation strategies of potential partners is critical when structuring clinical-stage partnerships. While headline financial terms (e.g., upfront payments, milestones, royalties) provide a broad overview, contract documents reveal the actual triggers and conditions for these payments-details often missing from press releases and traditional deal databases.
  • This report provides a comprehensive listing of over 1,670 clinical-stage deals announced since 2020, including financial terms where available. Additionally, it features direct links to online deal records, along with publicly available contract documents submitted to the SEC.
  • By analyzing these agreements, companies can gain critical insights to refine deal strategies, assess partner flexibility, and structure competitive agreements.
  • Comprehensive Analysis of Clinical-Stage Partnering Trends

The first chapters of this report offer a detailed orientation to clinical-stage deal-making, including:

Chapter 1 - Introduction to the report

Chapter 2 - Why companies engage in clinical-stage partnerships

Chapter 3 - Strategic approaches and deal structures, with case studies

Chapter 4 - Payment strategies, including upfronts, milestones, and royalties

Chapter 5 - Analysis of clinical-stage deal activity (2020-2025), categorized by year, stage of development, therapeutic area, technology type, and key dealmakers

Chapter 6 - In-depth financial analysis of headline values, upfront payments, milestone triggers, and royalty rates for Phase I, Phase II, and Phase III deals

Chapter 7 - A review of the leading clinical-stage deals by headline value

Chapter 8 - Profiles of the top 25 most active clinical-stage dealmakers

Chapter 9 - A database of clinical-stage partnering agreements, including contract documents where available

Chapter 10 - A comprehensive directory of all clinical-stage deals announced since 2020, categorized by Phase I, Phase II, and Phase III

  • Key Benefits of the Report

This must-have industry resource provides exclusive insights to help companies assess, structure, and negotiate their own clinical-stage partnerships. Key benefits include:

  • Unparalleled Market Insights - Gain a deep understanding of clinical-stage deal trends shaping the pharma and biotech industry since 2020.
  • Exclusive Financial Data Access - Unlock headline values, upfront payments, milestone structures, and royalty terms, giving you a competitive edge in deal negotiations.
  • Comprehensive Deal Database - Access a curated repository of over 1,670 clinical-stage agreements, including contract documents where available, for unmatched transparency and benchmarking.
  • Deep-Dive into Industry Leaders - Analyze actual clinical-stage deals entered into by the top 25 global pharma and biotech companies, alongside emerging biopharma players.
  • Proven Case Studies & Structural Analysis - Examine real-world deal structures and case studies to refine your own partnering and negotiation strategies.
  • High-Value Deal Identification - Pinpoint the most lucrative clinical-stage deals signed since 2020, gaining insight into premium industry transactions.
  • Profile the Most Active Dealmakers - Identify the key players driving clinical-stage collaborations, ensuring you target the right partners.
  • Strategic Deal Mapping - Navigate a full A-Z listing of clinical-stage agreements, categorized by company, development phase, deal type, therapeutic area, and technology focus.
  • Negotiate with Confidence - Understand the key terms and conditions top-tier companies have agreed to in previous deals, helping you structure optimal agreements.
  • Robust Due Diligence Support - Conduct data-backed assessments to determine the viability and competitiveness of your proposed deal terms with potential partners.
  • Report Scope

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech (2020-2025) report provides:

  • Trends in clinical-stage dealmaking in the biopharma industry since 2020
  • Detailed deal structures, including upfront, milestone, and royalty terms
  • Case studies of real-life clinical-stage agreements
  • Access to over 1,670 clinical-stage deals, with contract records where available
  • Partnering profiles of the most active clinical-stage dealmakers since 2020
  • Analysis of the highest-value clinical-stage deals

Each deal record is indexed by:

  • Company (A-Z)
  • Headline Value
  • Stage of Development at Signing (Phase I, Phase II, Phase III)
  • Deal Type
  • Specific Therapy Focus
  • Critical Questions Answered

By analyzing actual contract agreements, this report provides definitive answers to critical questions such as:

  • What specific rights are granted in each agreement?
  • What exclusivity terms apply?
  • How is the deal structured financially? (Upfronts, milestones, royalties)
  • Who controls development, manufacturing, and commercialization?
  • How are intellectual property rights handled?
  • What are the termination conditions for the agreement?
  • What dispute resolution mechanisms are in place?
  • How are confidentiality and publication rights managed?
  • Gain the competitive edge-explore the report today.

Table of Contents

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Why do companies partner clinical stage compounds?

  • 2.1. Introduction
  • 2.2. The role of clinical stage partnering
    • 2.2.1. In-licensing at clinical stage
    • 2.2.2. Out-licensing at clinical stage
  • 2.3. Difference between phase I, II and III stage deals
  • 2.4. Reasons for entering into clinical stage partnering deals
    • 2.4.1. Licensors reasons for entering clinical stage deals
    • 2.4.2. Licensees reasons for entering clinical stage deals
  • 2.5. The future of clinical stage partnering deals

Chapter 3 - Clinical stage deal strategies and structure

  • 3.1. Introduction
  • 3.2. At what stage do companies partner?
    • 3.2.1. Partnering early in pharmaceutical/biotech
    • 3.2.1.1. Discovery and preclinical stage partnering case studies
    • 3.2.1.1.a. Case study 1
    • 3.2.1.1.b. Case study 2
    • 3.2.1.1.c. Case study 3
    • 3.2.1.1.d. Case study 4
    • 3.2.2. Partnering later in pharmaceutical/biotech
    • 3.2.2.1. Clinical stage partnering case studies
    • 3.2.2.1.a. Case study 5
    • 3.2.2.1.b. Case study 6
    • 3.2.2.1.c. Case study 7
    • 3.2.2.1.d. Case study 8
  • 3.3. Early and later stage partnering - a risk/cost comparison
  • 3.4. What do companies spend on clinical stage partnering?
  • 3.5. Pure versus multi-component partnering deals
  • 3.6. Pure licensing agreement structure
    • 3.6.1. Example pure licensing agreements
    • 3.6.1.a. Case study 9
    • 3.6.1.b. Case study 10
  • 3.7. Multicomponent clinical stage partnering agreements
    • 3.7.1. Example multicomponent clinical stage clauses
    • 3.7.1.a. Case study 11

Chapter 4 - Clinical stage partnering payment strategies

  • 4.1. Introduction
  • 4.2. Clinical stage payment strategies
  • 4.3. Payment options
    • 4.3.1. Headline values
    • 4.3.2. Upfront payments
    • 4.3.2.1. Conditionality of upfront payments
    • 4.3.3. Loans
    • 4.3.4. Convertible loans
    • 4.3.5. Equity
    • 4.3.6. R&D funding
    • 4.3.7. Licensing fees
    • 4.3.8. Milestone payments
    • 4.3.9. Royalty payments
    • 4.3.9.1. Issues affecting royalty rates
    • 4.3.9.2. Royalties on combination products
    • 4.3.9.2.a. Case study 12
    • 4.3.9.3. Guaranteed minimum/maximum annual payments
    • 4.3.9.4. Royalty stacking
    • 4.3.9.5. Royalties and supply/purchase contracts
    • 4.3.10. Quids
    • 4.3.11. Option payments

Chapter 5 - Trends in clinical stage deal making

  • 5.1. Introduction
  • 5.2. Clinical stage partnering over the years
    • 5.2.1. Trends in phase I deals since 2020
    • 5.2.1.1. Attributes of phase I deals
    • 5.2.2. Trends in phase II deals since 2020
    • 5.2.2.2. Attributes of phase II deals
    • 5.2.3. Trends in phase III deals since 2020
    • 5.2.3.1. Attributes of phase III deals
  • 5.3. Clinical stage partnering by deal type
  • 5.4. Clinical stage partnering by disease type
  • 5.5. Partnering by clinical stage technology type
  • 5.6. Clinical stage partnering by most active company since 2020

Chapter 6 - Payment terms for clinical stage partnering

  • 6.1. Introduction
  • 6.2. Guidelines for clinical stage payment terms
    • 6.2.1. Upfront payments
    • 6.2.2. Milestone payments
    • 6.2.3. Royalty payments
  • 6.3. Clinical stage payment terms - deal data analysis
    • 6.3.1. Public data
    • 6.3.2. Survey data
  • 6.4. Payment terms analysis
    • 6.4.1. Clinical stage partnering headline values
    • 6.4.2. Clinical stage deal upfront payments
    • 6.4.3. Clinical stage deal milestone payments
    • 6.4.4. Clinical stage royalty rates
  • 6.5 Clinical stage median financials
    • 6.5.1. Clinical stage headline value
    • 6.5.2. Clinical stage upfront value
    • 6.5.3. Clinical stage milestone value
    • 6.5.4. Clinical stage royalty value

Chapter 7 - Leading clinical stage deals

  • 7.1. Introduction
  • 7.2. Top clinical stage deals by value

Chapter 8 - Top 25 most active clinical stage dealmakers

  • 8.1. Introduction
  • 8.2. Top 25 most active clinical stage dealmakers

Chapter 9 - Clinical stage partnering contracts directory

  • 9.1. Introduction
  • 9.2. Clinical stage deals with contracts since 2020

Chapter 10 - Clinical stage deal making by development stage

  • 10.1. Introduction
  • 10.2. Deals by clinical stage
  • Phase I
  • Phase II
  • Phase III
  • Regulatory

Appendices

  • Appendix 1 - Clinical stage dealmaking by companies A-Z
  • Appendix 2 - Clinical stage dealmaking by industry sector
  • Appendix 3 - Clinical stage dealmaking by stage of development
  • Appendix 4 - Clinical stage dealmaking by therapy area
  • Appendix 5 - Clinical stage dealmaking by technology type

About Wildwood Ventures

  • Current Partnering
  • Current Agreements
  • Recent report titles from Current Partnering

Table of figures

  • Figure 1: Definition of clinical phases in dealmaking
  • Figure 2: Components of the pure licensing deal structure
  • Figure 3: Payment options for clinical stage partnering deals
  • Figure 4: Issues affecting royalty rates
  • Figure 5: Clinical stage partnering by deal type since 2020
  • Figure 6: Clinical stage partnering by disease type since 2020
  • Figure 7: Clinical stage partnering by technology type since 2020
  • Figure 8: Top 25 most active clinical stage dealmakers, 2020 - 2025
  • Figure 9: Review of upfront payments for clinical stage deals
  • Figure 10: Review of milestone payments for clinical stage deals
  • Figure 11: Review of royalty payments for clinical stage deals
  • Figure 12: Clinical stage deals with a headline value
  • Figure 13: Clinical stage deals with an upfront value
  • Figure 14: Clinical stage deals with a milestone value
  • Figure 15: Clinical stage deals with a royalty rate value
  • Figure 16: Top clinical stage deals by value since 2020
  • Figure 17: Most active clinical stage dealmakers 2020 - 2025