Multi-Sponsor Study: Biosimilars
Manufacture of Biosimilar Drugs for the U.S. Market: Defining the Market Opportunity for Life Science Suppliers
✭ The Deadline to Order is March 22, 2013 ✭
Report Scope & Objectives
As scientific and analytical instrument manufactures seek to define new markets to offset decreases in funding and saturation in current markets, attention turns to the potential for revenues generated by the pending authorization for pharmaceutical companies to move forward with the development and commercialization of biosimilar drugs in the U.S.
In this unique report, BioInformatics LLC will explore how pharmaceutical companies are gearing up for this new market opportunity, what types of new instrumentation (or features) will be required to test similarity, how biosimilar drug demand will impact production capacity and which molecules will be targeted early on.
To provide insights to life science suppliers who stand to benefit from the introduction of biosimilars development in the U.S. market, in this study we will explore the following objectives:
- Describe the scale of the opportunity presented by biosimilars for analytical instrumentation manufacturers.
- Identify best practices at European pharmaceutical companies to demonstrate comparable physicochemical characteristics, molecular characteristics, purity, biological activity and stability.
- Understand how US pharmaceutical companies are planning to demonstrate biosimilarity and what affect these strategies will have on their choice of analytical instruments and consumables.
- Explore how different classes of biosimilars (monoclonal antibodies vs. other protein therapeutics) will influence the selection of tools necessary for establishing biosimilarity.
- Determine whether existing analytical instrumentation is sufficient for the needs of biosimilar manufacturers and what improvements to sensitivity, specificity, precision and accuracy may be required.
- Highlight what pharmaceutical customers expect from their analytical instrumentation vendors in terms of partnerships, services and support.
Contents, pricing and deadline
Comprised of 25 interviews from U.S. pharmaceutical/CRO companies and 25 interviews with EU pharmaceutical/CRO companies—to include both R&D and regulatory personnel—this report will be an in-depth exploration of what the decision-makers are saying about what’s on the near horizon for biosimilar drug development.
Due to the high level of interest in this topic expressed by multiple life science suppliers and to defray the costs inherent in such a complex study, we are offering this report as a multi-sponsor opportunity.
The fee for this study is $15,000 for each sponsor, but the report you will receive would be a $50,000-$60,000 investment for a single company to commission it individually.
Click here (PDF) for more information on the scope of the report and for details on becoming a sponsor.
Please note that the deadline for inclusion in the May 2013 study is Friday, March 22, 2013.*
For more information on this report, contact:
703.778.3080 ext. 13
*We will require a minimum of 6 sponsors to move forward with this study, so if you could indicate your intention to participate as soon as you've made a decision, that will be helpful to us for planning purposes.