药物发现和早期开发外包服务的成长机会

併购、合作伙伴关係以及向端到端 CRDMO 模式的转变推动产业扩张

截至 2023 年 4 月，全球药物研发 (R&D) 管道包括超过 21,000 个分子，较 2022 年增长 5.8%，其中有超过 6,100 个分子正在积极开发中。然而，总体而言，製药和生物製药产业的研发活动一直停滞不前。研发支出总额约2,768.1亿美元，2023年至2024年温和成长2.5%。与前一年同期比较成长下降是由于重点从COVID-19治疗转向肿瘤学、神经病学和肺病学等更多疾病的主流治疗，导致整体市场成长率下降正在正常化。此外，研发的平均投资收益(ROI) 下降至 1.2%，每项资产的销售额达到峰值，略高于 3.5 亿美元。

总研发支出中只有 4-5% 用于前 10 名製药公司的研发项目，而前 25 名製药公司的研发支出则不到 10%。另一方面，中小型生物製药公司和新兴生物製药公司（在研产品线有 ​​1-2 个分子的公司）是主要贡献者，占活跃产品线的 16% 以上。因此，全球对外包的需求不断增加，CRO（委外研发机构）和 CDMO（合约药物开发和业务组织）为该行业的强劲成长做出了贡献。

此外，多种新兴生物技术平台（如RNA技术、蛋白质降解[PROTAC]和抗体工程技术）的进步，加上人工智慧（AI）和机器学习等数位健康技术的应用，正在支援前所未有的创新。证实该分子的成功率正在增加。这项活动正在改善全球药物发现和临床前开发行业的合作关係。

总体而言，该领域正在见证专业实验室测试和生物分析 CRO 的兴起。由于药物开发有许多必不可少的技术，例如次世代定序（NGS）和高通量筛检（HTS），因此与CRO和中心实验室的合作正在稳步增加。除此之外，一些专门从事生物资讯学的CRO也出现了，增加了合作的机会。最后，大型CRO建立了独立的实验室测试部门，专注于特定的药物发现和临床前开发测试服务。

展望未来，CRO/CDMO 将专注于透过跨行业和学术合作伙伴关係，并透过对外授权机会确定向製药公司的知识转移，有针对性地扩大临床前测试能力。转向合作伙伴关係，这将支持更大的创新。

目录

策略要务

• 为什么成长如此困难？
• The Strategic Imperative 8（TM）
• 关键策略要务对药物发现和早期开发外包产业的影响
• 成长机会推动Growth Pipeline Engine（TM）

成长机会分析

• 分析范围
• 药物发现/早期开发阶段
• 市场区隔
• 主要竞争对手（按地区）
• 主要竞争对手（以服务类型）
• 药物发现/早期开发服务
• 主要产业趋势分析
• 药物开发价值链的数位化
• 电脑辅助药物发现与临床前研究
• 成长指标
• 生长促进因子
• 成长抑制因素

不断发展的供应商生态系统和新的经营模式

• 药物发现与临床前开发—不断发展的供应商生态系统
• CRDMO - 医药创新的新领先合作伙伴
• 学术界 - 缩小药物创新的研究差距
• 学术研究的演变
• CRO为高效技术转移铺路

投资趋势

• 投资趋势
• 早期CRO/CDMO服务合作-非临床
• 透过产业收购扩大非临床专业知识
• 透过资金筹措和内部投资扩大规模

收益和预测

• 製药公司研发费用
• 药品研发状况
• 按治疗领域和相关人员类型分類的研发规划
• 按治疗领域和相关人员类型分類的开发平臺评估
• 药物发现和临床前开发的细微差别
• 收益预测的假设和技术
• 收益预测
• 按开发阶段分類的收益预测
• 收益预测分析
• 按地区分類的收益预测
• 地区收益占有率
• 按地区分類的收益预测分析
• 竞争环境
• 按服务供应商类型收益占有率
• 收益占有率分析 - CRO
• 收益占有率分析 - CDMO
• 按非临床服务类型分類的竞争格局
• 竞争格局 - CDMO
• 竞争格局 - CRO
• 竞争格局 - CDMO
• 竞争评估

成长机会宇宙

• 成长机会1：次世代定序（NGS）与生物资讯学能力
• 成长机会2：法规咨询与IND申请测试
• 成长机会 3：利用生成人工智慧进行从头药物设计和疾病建模

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