The Promise & Pressures of Biologics

Biologics have delivered much promise in treating cancer and rare diseases and they continue to gain ground in other wide-ranging areas, from neurological and metabolic disorders to respiratory and cardiovascular diseases. But along with the incredible potential biologics offer, there is also incredible pressure to deliver novel treatments both quickly and cost-effectively.

Growing Momentum of Biologics Research and Development

Biologics represent a rising share of FDA drug approvals, and their market size is projected to reach over $700 billion by 2030. According to The Antibody Society, over 150 therapeutic monoclonal antibodies have been approved for use in the US and Europe since first appearing more than two decades ago. And while it was RNA therapies that came crashing into the mainstream with 2020’s mRNA-based COVID-19 vaccines, all areas of gene and cell therapy have been gaining momentum. The American Society of Gene and Cell Therapy (ASGCT) reports that, as of Q2 2022, 19 gene therapies, 18 RNA therapies, and 59 cell therapies have been approved for clinical use globally and many promising candidates are in trials.

Investment in biologics is strong, with ASGCT reporting that start-ups working in gene, cell, and RNA therapies raised nearly $800 million in Q2 of 2022 alone. Interestingly, a trend toward financing and alliances has emerged, letting investors and pharmaceutical companies support innovators without the full commitment of an acquisition.

Conflicting Financial Reality

Even as financing flows, innovators face a conflicting reality. On one side, there is incredible potential. Biologics offers several upsides, such as favorable safety, longer patents, and relatively low generic competition compared to small molecule drugs. There is also rising demand for novel treatments for prevalent chronic diseases, and biologics are poised to deliver thanks to incredible research advances; recent examples include work researchers are doing to:

• prevent the premature termination of protein expression caused by atypical stop codons that resulted from genetic mutation

• inhibit or alter protein expression by modifying RNA, such as with enzymes or small molecule drugs

• uncover potential RNA target and drug candidates with the aid of artificial intelligence and machine learning

• develop exosome delivery systems for gene therapy and RNA drugs

• apply protein degraders to conditions outside oncology

• perform gene editing with technology such as CRISPR

Unfortunately, the flipside to incredible potential is incredible pressure. Development costs for biologics are notoriously high. Patent cliffs are on the horizon. Federal policies have made biosimilar competition more viable. And the call to lower drug prices and improve patient accessibility to novel biologic treatments is louder than ever. Innovators are left with no choice but to work smarter and faster, even from the earliest days of discovery. This is where Dotmatics can help.

Dotmatics Biologics Discovery Solutions

Dotmatics Biologics Discovery capabilities and expertise empower researchers to make the most of their data and accelerate programs across multiple modalities, including CAR-T, RNA, and antibody therapeutics.

The Dotmatics ecosystem includes trusted bioinformatics and molecular biology applications, including Geneious, SnapGene, Prism, and Protein Metrics, and provides an organized and harmonized structure needed to:

• Maximize efficiency and productivity

• Enable flexibility and easy access to shared data

• Accelerate discovery based on the quickly changing needs of the life science industry

To learn more and about how Dotmatics can help address your team's specific challenges and make your data flow, talk to one of our experts today.