藥物發現和早期開發外包服務的成長機會

併購、合作夥伴關係以及向端到端 CRDMO 模式的轉變推動產業擴張

截至 2023 年 4 月，全球藥物研發 (R&D) 管道包括超過 21,000 個分子，較 2022 年成長 5.8%，其中有超過 6,100 個分子正在積極開發中。然而，總體而言，製藥和生物製藥產業的研發活動一直停滯不前。研發支出總額約2,768.1億美元，2023年至2024年溫和成長2.5%。與前一年同期比較成長下降是由於重點從COVID-19治療轉向腫瘤學、神經病學和肺病學等更多疾病的主流治療，導致整體市場成長率下降正在正常化。此外，研發的平均投資收益(ROI) 下降至 1.2%，每項資產的銷售額達到峰值，略高於 3.5 億美元。

總研發支出中只有 4-5% 用於前 10 名製藥公司的研發項目，而前 25 名製藥公司的研發支出則不到 10%。另一方面，中小型生物製藥公司和新興生物製藥公司（在研產品線有 ​​1-2 個分子的公司）是主要貢獻者，佔活躍產品線的 16% 以上。因此，全球對外包的需求不斷增加，CRO（委外研發機構）和 CDMO（合約藥物開發和業務組織）為該行業的強勁成長做出了貢獻。

此外，多種新興生物技術平台（如RNA技術、蛋白質分解[PROTAC]和抗體工程技術）的進步，加上人工智慧（AI）和機器學習等數位健康技術的應用，正在支援前所未有的創新。證實該分子的成功率正在增加。這項活動正在改善全球藥物發現和臨床前開發行業的合作關係。

總體而言，該領域正在見證專業實驗室測試和生物分析 CRO 的興起。由於藥物開發有許多必不可少的技術，例如次世代定序（NGS）和高通量篩檢（HTS），因此與CRO和中心實驗室的合作正在穩步增加。除此之外，一些專門從事生物資訊學的CRO也出現了，增加了合作的機會。最後，大型CRO建立了獨立的實驗室測試部門，專注於特定的藥物發現和臨床前開發測試服務。

展望未來，CRO/CDMO 將專注於透過跨行業和學術合作夥伴關係，並透過對外授權機會確定向製藥公司的知識轉移，有針對性地擴大臨床前測試能力。轉向合作夥伴關係，這將支持更大的創新。

目錄

策略要務

• 為什麼成長如此困難？
• The Strategic Imperative 8（TM）
• 關鍵策略要務對藥物發現和早期開發外包產業的影響
• 成長機會推動Growth Pipeline Engine（TM）

成長機會分析

• 分析範圍
• 藥物發現/早期開發階段
• 市場區隔
• 主要競爭對手（按地區）
• 主要競爭對手（以服務類型）
• 藥物發現/早期開發服務
• 主要產業趨勢分析
• 藥物開發價值鏈的數位化
• 電腦輔助藥物發現與臨床前研究
• 成長指標
• 生長促進因子
• 成長抑制因素

不斷發展的供應商生態系統和新的經營模式

• 藥物發現與臨床前開發—不斷發展的供應商生態系統
• CRDMO - 醫藥創新的新領先合作夥伴
• 學術界 - 縮小藥物創新的研究差距
• 學術研究的演變
• CRO為高效技術轉移鋪路

投資趨勢

• 投資趨勢
• 早期CRO/CDMO服務合作-非臨床
• 透過產業收購擴大非臨床專業知識
• 透過資金籌措和內部投資擴大規模

收益和預測

• 製藥公司研發費用
• 藥品研發狀況
• 按治療領域和相關人員類型分類的研發規劃
• 按治療領域和相關人員類型分類的開發平臺評估
• 藥物發現和臨床前開發的細微差別
• 收益預測的假設和技術
• 收益預測
• 按開發階段分類的收益預測
• 收益預測分析
• 按地區分類的收益預測
• 地區收益佔有率
• 按地區分類的收益預測分析
• 競爭環境
• 按服務供應商類型收益佔有率
• 收益佔有率分析 - CRO
• 收益佔有率分析 - CDMO
• 按非臨床服務類型分類的競爭格局
• 競爭格局 - CDMO
• 競爭格局 - CRO
• 競爭格局 - CDMO
• 競爭評估

成長機會宇宙

• 成長機會1：次世代定序（NGS）與生物資訊學能力
• 成長機會2：法規諮詢與IND申請測試
• 成長機會 3：利用生成人工智慧進行從頭藥物設計和疾病建模

下一步

M&As, Partnerships, and the Shift Toward an End-to-end CRDMO Model will Boost Sector Expansion

The global pharmaceutical research and development (R&D) pipeline accounts for more than 21,000 molecules, as of April 2023, indicating a 5.8% hike over 2022, with more than 6,100 molecules in active development. In general, however, the pharma/biopharma industry has stagnated with respect to R&D activity. Overall R&D expenditure totals about $276.81 billion, with slow 2.5% growth between 2023 to 2024. Decline in the year-on-year growth rate is the result of a shift in focus from COVID-19 therapies to more mainstream therapies across oncology, neurology, respiratory, and many more conditions, which is resulting in overall market normalization with respect to growth rates. Furthermore, the industry witnessed a decline in the average return on investment (ROI) for R&D to as low as 1.2%, and the peak sales per asset valued just above $350 million, indicating a need to build more efficient drug development processes with the implementation of newer technologies.

Of total R&D expenditure, the top 10 pharma companies accounted for just 4% to 5% of the pipeline, while the top 25 contributed to less than 10%. In contrast, small-to-mid segment and emerging biopharma players (companies with 1 or 2 molecules in the pipeline) are the major contributors, accounting for more than 16% of the active pipeline. As a result, the demand for outsourcing activities is on the rise globally, with contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) contributing to the strong industry growth.

Moreover, advancements in multiple emerging biotechnology platforms (e.g., RNA technology, protein degradation [PROTAC], and antibody engineering technologies) coupled with the application of digital health technologies in the form of artificial intelligence (AI) and machine learning are supporting unprecedented innovation, ascertaining increased success of a molecule. This activity is improving the partnership landscape across the global drug discovery and preclinical development industry.

Overall, the sector is witnessing an emergence of specialized lab testing and bioanalytical CROs. With techniques such as next-generation sequencing (NGS), high throughput screening (HTS), and many more crucial to drug development, a steady rise in CRO and central lab partnerships is underway. To add to this, several specialized bioinformatics CROs are emerging and creating greater partnership opportunities. Last, the larger CROs have developed separate lab testing divisions that allow them to focus on specific drug discovery and preclinical development testing services.

Moving forward, CROs/CDMOs will likely focus on targeted scale up of preclinical capabilities through cross-industry partnerships and academic partnerships, ascertaining knowledge transfer to pharma companies through out-licensing opportunities, thereby supporting greater innovation while transitioning from a vendor-ship to partnership model.

Table of Contents

Strategic Imperatives

• Why is it Increasingly Difficult to Grow?
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on the Drug Discovery and Early Development Outsourcing Industry
• Growth Opportunities Fuel the Growth Pipeline Engine™

Growth Opportunity Analysis

• Scope of Analysis
• Phases of Drug Discovery and Early Development
• Market Segmentation
• Key Competitors by Region
• Key Competitors by Type of Service
• Drug Discovery and Early Development Services
• Key Industry Trend Analysis
• Digitization of the Drug Development Value Chain
• Computer-aided Drug Discovery and Preclinical Research
• Growth Metrics
• Growth Drivers
• Growth Restraints

Evolving Vendor Ecosystem and Emerging Business Models

• Drug Discovery and Preclinical Development-Evolving Vendor Ecosystem
• CRDMOs-The New Go-to Partners for Pharma Innovation
• Academia-Bridging the Research Gap in Pharma Innovation
• Evolution of Academic Research
• CROs Paving Way for Efficient Technology Transfer

Investment Trends

• Investment Trends
• Early-stage CRO/CDMO Service Collaboration-Nonclinical
• Expanding Non-clinical Expertise through Industry Acquisitions
• Scale Up through Funding and In-house Investments

Revenue Forecast

• Pharma R&D Expenditure
• Pharmaceutical R&D Landscape
• R&D Mapping by Therapy Area and Stakeholder Type
• R&D Pipeline Assessment by Therapy Area and Stakeholder Type
• Nuances of Drug Discovery and Preclinical Development
• Revenue Forecast Assumptions and Methodology
• Revenue Forecast
• Revenue Forecast by Phase of Development
• Revenue Forecast Analysis
• Revenue Forecast by Region
• Percent Revenue Share by Region
• Revenue Forecast Analysis by Region
• Competitive Environment
• Revenue Share by Type of Service Vendor
• Revenue Share Analysis-CRO
• Revenue Share Analysis-CDMO
• Competitor Landscape by Type of Non-clinical Service
• Competitor Landscape-CRDMOs
• Competitor Landscape-CROs
• Competitor Landscape-CDMOs
• Competitor Assessment

Growth Opportunity Universe

• Growth Opportunity 1: Next Generation Sequencing (NGS) and Bioinformatics Capabilities
• Growth Opportunity 2: Regulatory Consulting and IND-enabling Studies
• Growth Opportunity 3: De Novo Drug Design and Disease Modeling with Generative AI

Next Steps

• Your Next Steps
• Why Frost, Why Now?
• List of Exhibits
• Legal Disclaimer