What are the emerging opportunities driving growth in biologics CDMOs and AI-enabled clinical trials?
By 2023, biologics made up 44% of the therapeutic pipeline, with antibodies and recombinant proteins leading. However, growth has slowed in these areas, shifting towards heterologous cell treatments, synthetic nucleic acids, and viruses. The future pipeline is leaning towards complex therapies like cell and gene therapy, nucleic acid therapy, antibody-drug conjugate (ADC), and bispecific antibodies. Biopharmaceutical companies are focusing on reducing clinical development times and lowering production costs, with bio-CDMOs forming strategic partnerships to enhance manufacturing and supply chain efficiency.
As clinical pipelines evolve towards complex novel therapies, there is a shift towards using adaptive trial designs with technology-enabled solutions. Artificial intelligence(AI) is increasingly recognized for supporting decentralized trials and patient-centric modalities, streamlining unstructured databases into usable formats. This includes leveraging electronic health records (EHRs) as a rich data source to improve clinical trial design and execution, thereby transforming the global clinical trial landscape.
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Biologics CDMOs
- Customer Value Chain Compression
Diversifying their service offerings to include regulatory affairs, pharmacovigilance, post-approval services, health economic outcomes research, and comprehensive logistical and inventory management to drive strategic growth. - Disruptive Technologies
Embracing green production, achieve operational excellence, and secure external investments for rapid expansion and compliance with environmental regulations.
AI-Enabled Clinical Trials
- Disruptive Technologies
Adopting AI-based platforms with cutting edge solutions like digital twins and external control arms is essential to enhance trial efficiency and outcomes, especially in oncology. - Industry Convergence
Embracing the evolving pharmaceutical landscape by forging new alliances beyond traditional boundaries, integrating technology vendors for accelerated drug development excellence.
Discover the growth opportunities in biologics CDMOs and AI-enabled clinical trials by accessing Frost & Sullivan's latest analysis on these subjects. Download now for comprehensive perspectives!
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