mRNA Vaccines & Therapeutics:
2024 Market Insight, CDMO Pricing and Benchmarking
Over 500 cumulative hours of qualitative and quantitative data collection and analysis have been utilized to craft Nice Insight’s first Messenger RNA (mRNA): Market Insight, CDMO Pricing and Competitor Benchmarking study.
Here are some facts about the 2024 report:
Research Started:
February 2024
Primary & Secondary Data Collection:
February 2023 – March 2024
Collation & Analysis:
March 2024 – May 2024
Development & Validation:
March 2024 – May 2024
Report Published:
May 2024
Revised July 2024
About This Report
The first edition of our mRNA report is the first published study of CDMO Pricing for mRNA production.
This is the first study of the clinical trial landscape for RNA modalities. The clinical trial analysis covers mRNA and synthetic RNA. We breakdown the correlation of RNA modality with their target indications.
We provide projections for ongoing growth of 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.
Find Out Insights and Answers to These Questions
Innovators
Who are the major manufacturers in my target region?
What services are offered by CDMOs for mRNA, and to what extent are CDMOs integrating complementary services?
Which CDMOs provide full end-to-end services, including development, manufacturing, formulation, and LNP encapsulation?
How much do we need to budget for a typical mRNA manufacturing program?
What creative financing strategies can we negotiate for?
What titers can we expect, and therefore what scale do we prepare RFPs?
What are the major drivers of cost in a typical manufacturing program?
What analytical and regulatory challenges do we need to prepare for?
What are the lead times we can expect for our program?
For what therapeutic areas are first-in-class RNA drugs being approved?
Manufacturers
How many new projects are entering the pipeline over the next five years?
Who are the key innovators in the space, and how many projects are in their portfolios?
What is the scale required for our potential clients?
What new modalities should our firm prepare to manufacture?
How are competitors pricing their services?
Who are my CDMO competitors for RNA in North America and Europe?
What are the projected capacity expansions by my competitors, and where are they expanding?
What innovations are increasing throughput in development and manufacturing?
How are analytical technologies evolving, and what has their impact been?
How are LNP technologies evolving, and what can we expect in future projects?
What’s Included in This Report
The First Pricing Study published
costs for key activities performed by CDMOs in this burgeoning industry
68 RNA CDMO Profiles
including mRNA and synthetic RNA CDMOs and capacity expansion announcements
Analysis of Clinical Trial Landscape
to understand the current and future modalities and manufacturing requirements
Market Growth Research
including projections for approved and late-stage mRNA and synthetic RNA therapeutics
In-Depth Insight
from manufacturers and innovators on the IP, regulatory, technical, and financial landscape
Emerging Technology
for manufacturing, purification, and analysis of mRNA
Study Methodology
For the first edition of Nice Insight’s messenger RNA report we have compiled up-to-date primary data, proprietary data, and a survey of secondary data from the published literature and industry databases to create a comprehensive outsourced development and manufacturing of mRNA. The quantitative research that we performed is supplemented by direct interviews conducted with multiple subject matter experts in diverse roles within the sector to obtain qualitative perspectives on the dynamics of the space.
To build a dataset of RNA-based clinical trials, we started with a dataset of every clinical trial published at ClinicalTrials.gov since January 1, 2013. We probed the dataset in three different types of queries to pull out all clinical trials, and built custom macros to mine and curate the data. To our knowledge this is the first such study of the landscape that is published.
The data from over 1,900 trials was curated to focus only on the investigation of RNA therapeutics, and separated them from classical viral vector-based gene therapies and ex vivo gene-modified cell therapies. This dataset was used to analyze innovators, funding, modalities, and more.
The content included here reflects in total over 500 hours of dedicated research, interviews, analysis, and composition, both to develop the first such pricing study and survey of mRNA clinical trials published.
A team comprising six (6) Ph.D.-level experts collaborated with a group of 25+ existing clients representing CDMOs within the mRNA manufacturing and development sector to understand benchmarks, current challenges, and the future of the industry.
We conducted a comprehensive survey of the key players in the sector to develop informative mRNA CDMO profiles for comparison.
Our staff with over 45 years of industry experience worked for over four months to advise on big-picture trends shaping the industry and to unify the data into a holistic view.
We interviewed SMEs representing manufacturing, innovators, and other operations at small and medium-sized CDMOs to discuss pricing for contract development and manufacturing services. We focused on understanding how the manufacturers are addressing the challenges of funding, scale variability, and regulatory uncertainty to serve their clients and what are the drivers of their pricing decisions.