Emerging biopharma trends to watch for in 2022

New Delhi: Besides the Asia Pacific region being an increasingly critical location for clinical trials, 2021 has been a significant year for the emerging biotech and emerging biopharma industry with COVID-19 being a catalyst for growth and diversification.

IQVIA Biotech suggests a few key trends that emerging biotech and emerging biopharma companies should look out for in 2022:

1. Increasing focus on rare diseases and oncology Two therapeutic areas with large unmet needs which will continue to gain more attention are oncology and rare diseases, with companies creating accelerated and creative pathways in the research and development space. However, both areas come with their own complexities – oncology trials require as much flexibility as possible, and rare disease trials need to navigate the nuances of small, hard-to-find patient populations.

2. Partnerships with academia for asset selection and early clinical development An encouraging development is the increasing number of academic and industry sponsored partnerships for asset selection and early clinical development, especially in the field of cell and gene therapy (CAGT). With emerging biopharma taking the lead in developing advanced therapies, this augurs well for more collaborative partnerships and innovative multi-stakeholder models of engagement in the future.

3. Machine learning to identify potential drug candidates We will see an escalation in advanced predictive analytics such as artificial intelligence and machine learning (AI/ML) that will drive better clinical research and real-world evidence outcomes. An exciting development is the ability of AI to better identify high potential drug candidates. This will allow companies to focus their R&D investments better and make more informed decisions.

4. Emergence of molecule to market An increasing number of emerging biopharma companies are shifting to a fully integrated biotech model, which means they are thinking beyond R&D, and shifting focus on commercializing their assets. These biotechs are hence incorporating data generation and access considerations in parallel to clinical development. However, given limited expertise in commercialization, they are reaching out to commercialization services providers (like IQVIA) to help them navigate the complex regulatory and market access landscape in the region.

5. Advancement of tech-enabled clinical trials COVID-19 has been a key driver for Decentralized Clinical Trials (DCTs) and tech-enabled solutions such as remote monitoring, remote Source Data Verification (SDV) and connected devices to increasingly becoming the norm in clinical trial development. Sponsors now have the insights from these experiences to build them into future protocols to create efficiencies and be able focus on fewer onsite visits during the registration trials to reduce patient burden and improve retention.

6. Insourcing of technologies A small number of biotech companies build their own clinical operation and data management teams and insource resources through an FSP model. A key factor to enable the operations is to have a well-orchestrated clinical technology ecosystem that can be easily configured according to the sponsors’ processes. Sponsors are turning to SaaS-based clinical technology providers who can provide best-in-class products across the clinical development lifecycle – study planning, site engagement, remote patient services, and remote study monitoring. The data generated by these highly interoperable solutions are consistent, better managed and clean, which helps sponsors derive insights to fuel their future study designs and improve their clinical operational efficiencies.

In May 2021, IQVIA announced the Japan and Asia Pacific (JAPAC) expansion of IQVIA Biotech, a tailored approach to delivering integrated clinical and commercial solutions for biotech and emerging biopharma companies.