製薬・バイオテクノロジーにおける臨床段階の提携条件と契約（2020年～2025年）

当レポートでは、製薬・バイオテクノロジー業界について調査分析し、企業が臨床段階の提携契約を締結する方法と理由、これらの提携を形成する主な財務的・戦略的条件に関する、包括的なデータ主導の分析を提供しています。

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を提携する理由

• イントロダクション
• 臨床段階のパートナーシップの役割
  • 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段階の契約の違い
• 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契約に参入する理由
  • ライセンシーが臨床段階の契約に参入する理由
• 臨床段階の提携契約の将来

第3章 臨床段階の契約戦略と構造

• イントロダクション
• 企業はどの段階で提携するか
  • 製薬/バイオテクノロジーにおける早期の提携
  • 製薬/バイオテクノロジーにおける晩期の提携
• 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/多成分の提携契約
• 純粋ライセンシング契約の構造
  • 純粋ライセンシング契約の例
  • a. ケーススタディ9
  • b. ケーススタディ10
• 多成分臨床段階提携契約
  • 多成分臨床段階条項の例
  • a. ケーススタディ11

第4章 臨床段階の提携の決済戦略

• イントロダクション
• 臨床段階の決済戦略
• 決済方法
  • ヘッドライン金額
  • 前払い
  • 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
  • マイルストーン払い
  • ロイヤルティ払い
  • クイッズ
  • オプション決済

第5章 臨床段階の契約の動向

• イントロダクション
• 長年にわたる臨床段階のパートナーシップ
  • フェーズI契約の動向（～2020年）
  • フェーズII契約の動向（～2020年）
  • フェーズIII契約の動向（～2020年）
• 臨床段階の提携：契約タイプ別
• 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
• もっとも活発な企業による臨床段階の提携（2020年～）

第6章 臨床段階の提携における決済条件

• イントロダクション
• 臨床段階の決済条件に関するガイドライン
  • 前払い
  • マイルストーン払い
  • ロイヤルティ払い
• 臨床段階の決済条件 - 契約データの分析
  • 公開データ
  • 調査データ
• 決済条件分析
  • 臨床段階の提携のヘッドライン金額
  • 臨床段階の契約の前払い
  • 臨床段階の契約のマイルストーン払い
  • 臨床段階のロイヤルティ率
• 臨床段階の財務中央値
  • 臨床段階のヘッドライン金額
  • 臨床段階の前払い金額
  • 臨床段階のマイルストーン金額
  • 臨床段階のロイヤリティ金額

第7章 主な臨床段階の契約

• イントロダクション
• 臨床段階の上位契約（金額）

第8章 もっとも活発な前臨床段階の契約企業上位25社

• イントロダクション
• もっとも活発な前臨床段階の契約企業上位25社

第9章 臨床段階の提携契約ディレクトリ

• イントロダクション
• 前臨床段階の契約（2020年～）

第10章 臨床段階の契約：開発段階別

• イントロダクション
• 契約：臨床段階別
• フェーズI
• フェーズII
• フェーズIII
• 規制

付録

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 1,775 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 1,775 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 1,775 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