Gene Therapy:

Market Insight, CDMO Pricing and Competitor Benchmarking

Over 1,000 cumulative hours of qualitative and quantitative data collection and analysis have been utilized to update Nice Insight’s Gene Therapy: Market Insight, CDMO Pricing and Competitor Benchmarking study.

About This Report

• This year we split the 2023 Cell and Gene Therapy report by modality, so that we can dive deeper into the production of viral vectors.

• We have continued our pricing study and updated the 2023 pricing for 2024. We now offer a unique perspective as we can comment on trends as the market has shifted significantly since our first report.

• This is the first time we dove into the FDA’s clinical trial database to analyze the trends in viral vector–based gene therapies. We discuss trends in the trials, along with top sponsors and top indications being studied.

• We provide projections for ongoing growth of viral vector–based gene therapeutics entering the clinic and expecting approval, which will drive the need for manufacturing and analytical services.

• We survey the regulatory, technical, and clinical challenges encountered by innovators and manufacturers in this burgeoning market.

• We obtained input from subject matter experts (SMEs) from contract development and manufacturing service providers and buyers of outsourced services.

• We put the manufacturing market in context of ongoing geopolitical news.

Study Methodology

• For the first edition of Nice Insight’s Gene Therapy: Market Insight, CDMO Pricing and Competitor Benchmarking study we have focused only on the viral vector–based gene therapies from our previous report. We updated all of our trends sections with up-to-date primary, proprietary data and a survey of secondary data from the published literature and industry databases to create a comprehensive outsourced development and manufacturing survey of biologics in mammalian cells. The quantitative research that we performed is supplemented by direct interviews conducted with multiple SMEs with diverse roles in the sector to obtain qualitative perspectives on the dynamics of the space.

• To build a dataset of viral vector–based gene therapy clinical trials, we started with a dataset of every clinical trial published at clinicaltrials.org. We probed the dataset in multiple queries to pull out all clinical trials, including building custom macros to mine the data based on modality and keywords, while categorizing indications. We then carefully curated and cleaned the dataset for use in our analysis.

• The data from 1,197 trials was curated to focus only on the investigation of viral vector–based gene therapies separating them from RNA-based gene therapies and classical vaccine trials based on inactivated viruses. This dataset was used to analyze innovators, funding, modalities, and more.

• The content included here reflects in total over 1,000 hours of dedicated research, interviews, analysis, and composition, both to develop the 2024 pricing study and survey of clinical trials published.

• A team comprising six Ph.D.-level experts collaborated with a group of 25+ existing clients representing CDMOs within the viral vector manufacturing and development sector to probe and better understand benchmarks, current challenges, and the future of the industry.

• Our staff with over 100 years of industry experience worked for over two months to advise on big-picture trends shaping the industry and to unify the data into a holistic view.

• Individual interviews were performed with SMEs representing leadership, manufacturing, innovators, and other operations at small and midsized CDMOs to discuss pricing for contract development and manufacturing services.