Gene Therapy
Market Insight, CDMO Pricing and Competitor Benchmarking
Over 500 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.
Here are some facts about the report:
Research Started:
September 2024
Primary & Secondary Data Collection:
September 2024–October 2024
Collation & Analysis:
September 2024–October 2024
Development & Validation:
October 2024
Report Published:
October 2024
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.
Find Out Insights and Answers to These Questions
Innovators
Who are the major manufacturers in my target region?
Which CDMOs provide full end-to-end services, including development, manufacturing, formulation, and fill/finish?
How much do we need to budget for a typical viral vector manufacturing program?
What have been the pricing trends in recent years?
Which companies are ahead of me in the clinical pipeline?
Which viral vectors are used for different purposes and why?
Which titers can we expect, and therefore at what scale do we prepare RFPs?
Where are talent shortages most impacting CDMOs and what questions should I ask when evaluating a contractor?
What can we expect in the area of viral vectors?
What geopolitical news do I need to pay attention to?
Manufacturers
Who are my CDMO competitors in North America, Europe, and Asia?
What are the projected capacity expansions by my competitors, and where are they expanding?
How are competitors currently pricing their services?
Based on the trends, should I adjust our pricing strategy?
Who are the key innovators in the space, and how many projects are in their portfolios?
Which new vectors does my firm need to consider developing a process for?
What is the scale required for our potential clients?
How are other firms dealing with a shortage of talent and where might we find training programs?
What portion of the market is expected to come from viral vectors?
How might geopolitics affect my firm?
What’s Included in This Report
Five-Year Trends in Pricing
costs for key activities performed by CDMOs in this established industry
62 CDMO Profiles
including CDMOs with viral vector capacity and associated activities
Analysis of Clinical Trial Landscape
to understand the current and future viral vector–based gene therapies and manufacturing requirements
Market Growth Research
including projections for approved and late-stage viral vector products
In-Depth Insight
from manufacturers and innovators on the intellectual property (IP), regulatory, technical, and financial landscape
Market Drivers
behind company expansions, layoffs, onshoring, and offshoring
Study Methodology
For the first edition of Nice Insight’s Gene Therapy: 2024 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.