2026年欧洲生命科学产业十大成长机会

Top 10 Growth Opportunities in the European Life Sciences Industry, 2026

出版日期: 2025年12月16日 | 出版商:

Frost & Sullivan | 英文 16 Pages | 商品交期: 最快1-2个工作天内

价格

简介目录

到2026年，变革性政策将透过人工智慧驱动的创新、数位化临床规模化和生物製造韧性来推动生命科学领域的成长。

欧洲生命科学领域将在2026年迎来关键转捩点。一系列重大的监管和政策改革将共同重塑製药、诊断、生命科学IT、生物技术和生物经济的格局。这些框架将为整个价值链开闢清晰的成长路径：临床试验法规（CTR）和欧洲健康数据空间（EHDS）将透过统一的程序和可互通的患者数据加速罕见疾病和跨国临床试验；人工智慧法案（AI法案）和生物技术法案（Biotech法案）将为人工智慧驱动的药物发现、多组体学分析和数位化品质系统提供可预测的环境；体外诊断医疗设备法规（IVDR）将推动对伴随诊断和生物标记主导的精准医疗的需求；而卫生技术评估（HTA）法规将透过简化证据要件和统一欧洲各国的报销预期来支持下一代技术的发展。在製造业方面，欧盟生物经济策略将促进永续生物製造和合成生物学的规模化发展，而《基本药物法》（CMA）将为活性药物原料药（API）、抗菌药物和生物类似药的近岸生产创造机会，以加强供应链的韧性。

欧洲掌握这些机会的能力受到许多因素的製约，包括註册体系分散、生物标誌物基础设施不统一、生物製造领域存在诸多壁垒（需要大量资本投资）、中小企业面临合规压力以及对海外原料药供应的依赖。要将监管势头转化为竞争优势，需要有针对性地投资于数位化临床基础设施、统一的营运框架以及公私合营，以消除碎片化并加速规模化发展。弥合这些结构性差距将使欧洲能够充分实现2026年法规结构所规定的成长目标，同时促进技术自主、以患者为中心的创新以及在生物製造领域保持领先地位。

策略要务
十大成长机会
成长机会1：基于人工智慧的新型药物设计与合成
成长机会2：多体学资料整合在精准医疗的应用
成长机会3：下一代生物製剂
成长机会 4：生物相似药生产的策略性近岸外包伙伴关係
成长机会五：生命科学与消费者健康领域的融合
增长机会 6：罕见疾病临床试验
成长机会7：永续与环境友善生物製造
成长机会 8：人工智慧驱动的体外诊断医疗设备法规 (IVDR) 和品质系统合规性
成长机会 9：伴随诊断协作开发生态系统
成长机会10：加强抗菌药物抗药性与原料药生产

十大成长机会

基于人工智慧的新型药物设计与合成
用于精准医疗的多组体学资料整合
下一代生物製剂
生物相似药生产的策略性近岸外包伙伴关係
生命科学与消费者健康的融合
罕见疾病临床试验
永续和环境友善生物製造
人工智慧驱动的体外诊断医疗设备法规 (IVDR) 合规性和品质体系
伴随诊断协作开发生态系统
抗菌素抗药性和原料药生产弹性

简介目录

Product Code: KC43-52

Transformational Policies Will Unlock Life Sciences Growth in 2026 Through AI-Enabled Innovation, Digital-Clinical Scale-Up, and Biomanufacturing Resilience

Europe's life sciences sector is approaching a defining inflection point in 2026, as major regulatory and policy reforms converge to reshape pharma, diagnostics, life sciences IT, biotechnology, and the bioeconomy. Together, these frameworks open clear growth pathways across the value chain: the Clinical Trials Regulation (CTR) and European Health Data Space (EHDS) accelerate rare disease and multi-country clinical trials through harmonized procedures and interoperable patient data; the Artificial Intelligence Act (AI Act) and Biotechnology Act (Biotech Act) provide a predictable environment for AI-enabled drug discovery, multi-omics analytics, and digital quality systems; the In Vitro Diagnostic Regulation (IVDR) fuels demand for companion diagnostics and biomarker-driven precision medicine; and the Health Technology Assessment (HTA) regulation supports next-generation modalities by streamlining evidence requirements and aligning reimbursement expectations across European countries. At the manufacturing end, the EU Bioeconomy Strategy drives sustainable biomanufacturing and synthetic-biology scale-up, while the Critical Medicines Act (CMA) unlocks opportunities for nearshore active pharmaceutical ingredient (API), antimicrobial, and biosimilar production to strengthen supply chain resilience.

Europe's ability to capture these opportunities is constrained by fragmented registries, uneven biomarker infrastructure, high-capital expenditure biomanufacturing barriers, small- and medium-sized enterprise (SME) compliance pressures, and dependency on offshore API supply. Converting regulatory momentum into competitive advantage will require targeted investment in digital-clinical infrastructure, harmonized operational frameworks, and public-private partnerships that reduce fragmentation and accelerate scale-up. By closing these structural gaps, Europe can fully realize the growth unlocked by its 2026 regulatory architecture while advancing technological sovereignty, patient-centric innovation, and resilient biomanufacturing leadership.

Top Growth Opportunities for 2026

Strategic Imperatives
Top 10 Growth Opportunities
Growth Opportunity 1: AI-driven De Novo Drug Design and Synthesis
Growth Opportunity 2: Multi-omics Data Integration for Precision Medicine.
Growth Opportunity 3: Next-generation Biologic Modalities
Growth Opportunity 4: Strategic Nearshoring Partnerships for Biosimilar Manufacturing
Growth Opportunity 5: Life Sciences Consumer Wellness Convergence
Growth Opportunity 6: Clinical Trials for Rare Diseases
Growth Opportunity 7: Sustainable and Green Biomantufacturing
Growth Opportunity 8: AI-driven IVDR Compliance and Quality Systems
Growth Opportunity 9: Companion Diagnostic Co-development Ecosystems
Growth Opportunity 10: Resilient Antimicrobial and API Manufacturing