生物製藥的未來，2040年

人工智慧（AI）的應用將為生物製藥價值鏈帶來變革性成長。

生物製藥產業在過去幾十年中不斷發展演變。本研究分析了2040年將影響生物製藥產業未來發展的十大趨勢。

生物製藥的未來將由人工智慧和機器學習（尤其是生成式人工智慧）的創新，以及轉化醫學和合成生物學的進步所驅動。未來生物製劑的臨床開發將專注於個人化醫療，並在藥物開發過程中更多地採用分散式臨床試驗。在生物製劑生產方面，藥物遞送技術的新方法和進步將徹底改變藥物的給藥方式。這將改善藥物傳遞的治療效果，最終帶來更好的治療結果。

隨著企業推行綠色環保措施和永續原料採購以減少對環境的影響，製造業和供應鏈的永續性變得越來越重要。

在商業方面，數位療法和無人機配送等新興技術將發揮日益重要的作用。就不斷擴張的生物製藥市場而言，新興市場，尤其是中國，預計將在未來幾年內成為生物製藥研發和商業化的關鍵區域，其重要性日益凸顯。生物製藥監管環境將持續發展以適應科學進步，美國FDA和EMA等監管機構將加強與生物製藥公司的合作，以確保患者能夠及時獲得挽救生命的治療。未來幾年，主要市場中基於價值的生物製劑償付體系將更加突出。

大型科技公司正透過人工智慧驅動的蛋白質預測、分子篩檢和標靶辨識平台，徹底革新藥物發現領域。雲端原生模擬和新興的量子運算縮短臨床前開發週期，而研發即服務（R&DaaS）模式則使生物製藥公司無需大量內部投資即可使用這些工具。

目錄

調查範圍

• 分析範圍

策略要務

• 為什麼成長變得越來越困難
• The Strategic Imperative 8
• 三大策略要務對生物製藥產業的影響

成長機會分析

• 成長促進因素
• 成長抑制因素
• 趨勢1：人工智慧主導地位
• 人工智慧對生物製藥產業的影響：2040年時間表
• 趨勢2：精準醫療
• 藥物基因體學和治療診斷學：2040年發展時間表
• 趨勢3：產品系列策略的轉變
• 從投資組合管理到產品引擎
• 趨勢4：新模式的整合
• 排名前20名的生物製藥研發管線公司：將重點轉向生物製劑和新興療法
• 從模態融合到整合產品引擎
• 趨勢5：智慧工廠投資
• 製造業轉型：2040年時間表
• 趨勢6：不斷變化的監管
• 監理發展：2040年時間表
• 趨勢7：供應鏈轉型
• 供應鏈轉型：2040年時間表
• 趨勢8：新興市場
• 新興市場的角色：2040年時間表
• 趨勢9：資料與數位轉型
• 資料策略與數位化：2040年時間表
• 趨勢10：大型科技公司成為生物製藥領域的合作協調者
• 大型科技顛覆：2040年前的時間表

成長機會領域

• 成長機會 1：抗體藥物偶聯物和放射性配體供應生態系統
• 成長機會 2：微批量個人化治療基礎設施
• 成長機會 3：基於人工智慧的臨床開發平台
• 成長機會 4：基於 ESG 的差異化製造和綠色生物製程

下一步

• 成長機會帶來的益處和影響
• 下一步
• 免責聲明

Adoption of Artificial Intelligence Is Driving Transformational Growth Across the Biopharma Value Chain

The biopharma industry has been evolving over the past few decades. This study analyses the top ten trends that will impact the future of the biopharma industry through 2040.

The future of biopharma will be driven by innovation in AI and ML, particularly generative AI, and by advancements in translational medicine and synthetic biology. Future clinical development of biologics will focus on personalized medicine and will leverage more decentralized clinical trials in the drug development process. In biologics manufacturing, novel approaches and advancements in drug delivery will transform how medications are administered. This will improve therapeutic outcomes in drug delivery and transform the way medications are administered, thereby improving therapeutic outcomes.

Sustainability in manufacturing and supply chain will become more important as companies increasingly focus on reducing their environmental footprint by adopting green practices and sustainably sourcing raw materials.

On the commercial side, new age technologies (such as digital therapeutics and drone delivery) will play an increasingly greater role. In terms of biopharma market expansion, emerging markets will gain importance - especially China, which will become an important region for biopharma R&D to commercialization in the coming years. The biopharma regulatory landscape will continue to evolve to keep pace with scientific advancements, while agencies such as the US FDA and EMA will collaborate more with biopharmaceutical companies to ensure patients have timely access to life-saving therapies. Value-based reimbursement will gain greater prominence in the coming years for biologics in major markets.

Big tech will revolutionize drug discovery through AI-driven platforms for protein prediction, molecular screening, and target identification. Cloud-native simulations and emerging quantum computing will accelerate preclinical timelines, while R&D-as-a-service models will give biopharma access to these tools without heavy in-house investment.

Table of Contents

Research Scope

• Scope of Analysis

Strategic Imperatives

• Why Is It Increasingly Difficult to Grow?
• The Strategic Imperative 8
• The Impact of the Top 3 Strategic Imperatives on the Biopharma Industry

Growth Opportunity Analysis

• Growth Drivers
• Growth Restraints
• Trend 1: The AI Advantage
• AI Impact on Biopharma: Timeline to 2040
• Trend 2: Precision Medicine
• Pharmacogenomics and Theranostics: Timeline to 2040
• Trend 3: Shifts in Product Portfolio Strategy
• Portfolio Management to Product Engine
• Trend 4: Convergence of Novel Modalities
• Top 20 Biopharma Pipeline Gravity Shifting Towards Biologics and Emerging Modalities
• Converging Modalities to Integrated Product Engines
• Trend 5: Smart Factory Investments
• Manufacturing Transformation: Timeline to 2040
• Trend 6: Regulatory Evolution
• Regulatory Developments: Timeline to 2040
• Trend 7: Supply Chain Transformation
• Supply Chain Transformation: Timeline to 2040
• Trend 8: Emerging Markets
• Emerging Markets Role: Timeline to 2040
• Trend 9: Data and Digital Transformation
• Data Strategy and Digitalization: Timeline to 2040
• Trend 10: Big Tech is Becoming a Co-Orchestrator in Biopharma
• Big Tech Disruption: Timeline to 2040

Growth Opportunity Universe

• Growth Opportunity 1: ADC & Radioligand Supply Ecosystems
• Growth Opportunity 2: Micro-Batch Personalized Therapy Infrastructure
• Growth Opportunity 3: AI-Augmented Clinical Development Platforms
• Growth Opportunity 4: ESG-Differentiated Manufacturing & Green Bioprocessing

Next Steps

• Benefits and Impacts of Growth Opportunities
• Next Steps
• Legal Disclaimer

Author: Anantharaman Viswanathan