2026年歐洲生命科學產業十大成長機會

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個工作天內

價格

簡介目錄

到2026年，變革性政策將透過人工智慧驅動的創新、數位化臨床規模化和生物製造韌性來推動生命科學領域的成長。

歐洲生命科學領域將在2026年迎來關鍵轉捩點。一系列重大的監管和政策改革將共同重塑製藥、診斷、生命科學IT、生物技術和生物經濟的格局。這些框架將為整個價值鏈開闢清晰的成長路徑：臨床試驗法規（CTR）和歐洲健康數據空間（EHDS）將透過統一的程序和可互通的患者數據加速罕見疾病和跨國臨床試驗；人工智慧法案（AI法案）和生物技術法案（Biotech法案）將為人工智慧驅動的藥物發現、多組體學分析和數位化品質系統提供可預測的環境；體外診斷醫療設備法規（IVDR）將推動對伴隨診斷和生物標記主導的精準醫療的需求；而衛生技術評估（HTA）法規將透過簡化證據要件和統一歐洲各國的報銷預期來支持下一代技術的發展。在製造業方面，歐盟生物經濟策略將促進永續生物製造和合成生物學的規模化發展，而《基本藥物法》（CMA）將為活性藥物原料藥（API）、抗菌藥物和生物類似藥的近岸生產創造機會，以加強供應鏈的韌性。

歐洲掌握這些機會的能力受到許多因素的阻礙，包括註冊體系分散、生物標記基礎設施不統一、生物製造領域存在諸多壁壘（需要大量資本投資）、中小企業面臨合規壓力以及對海外原料藥供應的依賴。要將監管勢頭轉化為競爭優勢，需要有針對性地投資於數位化臨床基礎設施、統一的營運框架以及公私合營，以消除碎片化並加速規模化發展。彌合這些結構性差距將使歐洲能夠充分實現2026年法規結構所規定的成長目標，同時促進技術自主、以患者為中心的創新以及在生物製造領域保持領先地位。

策略要務
十大成長機會
成長機會1：基於人工智慧的新型藥物設計與合成
成長機會2：多體學資料整合在精準醫療的應用
成長機會3：下一代生物製劑
成長機會 4：生物相似藥生產的策略性近岸外包夥伴關係
成長機會五：生命科學與消費者健康領域的融合
成長機會 6：罕見疾病臨床試驗
成長機會7：永續與環境友善生物製造
成長機會 8：人工智慧驅動的體外診斷醫療設備法規 (IVDR) 和品質系統合規性
成長機會 9：伴隨診斷協作開發生態系統
成長機會10：加強抗菌藥物抗藥性與原料藥生產

十大成長機會

基於人工智慧的新型藥物設計與合成
用於精準醫療的多組體學資料整合
下一代生物製劑
生物相似藥生產的策略性近岸外包夥伴關係
生命科學與消費者健康的融合
罕見疾病臨床試驗
永續和環境友善生物製造
人工智慧驅動的體外診斷醫療設備法規 (IVDR) 合規性和品質體系
伴隨診斷協作開發生態系統
抗菌素抗藥性和原料藥生產彈性

簡介目錄

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