How CDMOs Can Use Data Analytics as a New Source of Revenue
The global biologics market is one of the fastest growing segments of the pharmaceutical industry. Annual revenues are expected to exceed $300 billion in the next 2-3 years.¹ But development and production can’t keep pace with discovery. That’s one reason outsourcing to contract development and manufacturing organizations (CDMOs) continues to increase. CDMOs, which currently represent 20% of the industry’s manufacturing capacity, are expected to grow to 30% of global manufacturing volume by 2025. ¹
The CDMOs that will succeed in this scenario are those which do the best job of proving they are trustworthy long-term partners and provide transparency in their processes. That means adopting next-generation methods of quality management and easing partners’ concerns about loss of control and process visibility. Incorporating advanced data analytics tools can reduce these concerns and help CDMOs create processes that are more transparent, controlled and cost-effective.
This article is posted on our Science Snippets Blog.
Employing data analytics tools can help you mitigate risks and better manage manufacturing to avoid common cause of batch failure.
CDMOs Fill Niche Markets
Advances in the biotechnology industry have led to the emergence of a number of niche biotherapeutic classes, which present significant opportunities for contract service providers. Over 800 biospecific antibodies and antibody drug candidates are currently in the discovery and preclinical stages of development.² Plus, more than 1000 gene therapy and cell therapy drug candidates are also in R&D and preclinical development. All of these new segments are growing at over 20 percent annually.²
Demand for new niche biologic modalities requires rapid capacity expansion and new expertise from contract manufacturers.
In addition, newer and more potent protein biologics will require the use of less drug per year. As a result, more than 70 percent of therapeutics in the next five years² could be commercially manufactured, with some of these technologies allowing smaller CDMOs to compete for a larger market share and for larger ones to rapidly expand their capacity and increase flexibility.
Antibody-based therapeutics make up roughly 60 percent of the total biologics market. Small innovative biotech companies hold roughly 70 percent of that pipeline, but lack the facilities and the infrastructure to manufacture, so the obvious path forward is to outsource.
All of these factors are contributing to a growing movement to outsource operations related to biopharma product development and manufacturing to CDMOs.
What Your Partners Want
Pharmaceutical and biopharma companies are driven by the need to get their products manufactured at the right time with the highest quality and for the lowest cost possible.
Speed and timing are critical to achieving drug development milestones. Speed to IND (investigational new drug) is the first step in speed to market. This can be especially critical for startups looking for funding – after all, the company with the first-to-market drug candidate will certainly be valued higher than others in a competitive market.
Other top considerations include:
- Molecule expertise. The suitability of a CDMO partner is also dependent on their expertise with a particular molecule type. This can be especially important when outsourcing takes place earlier in the drug lifecycle.
- Broader relationship. More and more, companies are looking for CDMOs that act as a “one-stop shop” and can integrate themselves along the entire value chain from cell-line development to analytics development to manufacturing. Smaller CDMOs can counter by being more rapidly available, delivering superior agility and speed, and providing the necessary customer focused interaction.
- Cost effectiveness. Although every company needs to have strategies for meeting cost control requirements, it is especially vital for small companies simply because of the constraints of their financial resources. A good cost-control and process control strategy will increase the chance of success.
- Quality management. Effective process control and quality management is essential for regulatory compliance as well as product quality and efficacy.
- Process transparency. Enabling process transparency and providing proof of meeting performance metrics is critical for CDMOs. In fact, these were found to be among the most important factors in selecting a CDMO in a recent survey.³
The survey conducted by Biopharma Associates³ identified key issues biopharma companies consider when outsourcing to a CDMO:
- establishing a reliable relationship with the CDMO
- complying with quality standards
- demonstrating cost effectiveness
- meeting standard performance metrics
- providing superior tech transfer services
(Source: 17th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associations, Inc., April 2020)
The same survey identified top new development areas needed by customers. These all reflect areas that can be supported using advanced data analytics tools: real-time testing, continuous bioprocessing, bioprocess control and monitoring, design of experiments (DOE) and process analytical technologies (PAT).
(Source: 17th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associations, Inc., April 2020)
Gain an Advantage with Data Analytics
Clients often stand to lose a significant amount of control and visibility over their process when they hand it over to an external partner, either for development or for manufacturing operations. Being able to supply partners with real-time access to view their processes and up-to-date data that supports quality control, will give your company a competitive advantage.
When it comes to quality management, delivering a system that uses data-driven solutions to ensure process traceability and product quality can make a big difference for CDMOs. Being able to tap into the real value of data and use it as a strategic differentiator will not only help to secure long-term partnerships, but also help your company gain recognition as innovators and market leaders.
Give Your Clients Real-Time Access
With a data analytics solution such as SIMCA®-online, you have a way to give your partners a real-time window into their process as it happens. Using this tool, you can stream your processes live so partners can see which batches are complete, which are clearly active, know when alarms occurred and what corrections were made, and keep track of batch production timelines. You can, of course, fine tune this to your customer’s needs and adjust visibility where it makes sense.
Here we have an example of what that might look like for your clients.
In the chart below, we can see how a process compares to the “golden batch scenario,” in which the ideal process is the green line. The data points (dots) are presented in real-time, and whenever your process deviates, or goes outside the control limits (indicated by the red line), your partner would be able to see in real time how you responded to it and what corrections were taken.
Your partners have visibility into real-time process monitoring and can view the data points you want them to see.
Real-time monitoring allows for real-time risk mitigation. This kind of technology can represent a change in culture at CDMOs – so where decisions in the past may have been made from limited or independent data, now you gain a data analytics culture in which decisions are made based historical or mechanistic data, or some combination of both.
Reduce Common Batch Failures
Data analytics can also help you eliminate some of the primary causes of batch failure: equipment failure, operator error, material failure, contamination, and failure to meet specs.
(Source: 17th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associations, Inc., April 2020)
Employing data analytics tools can help you mitigate risks and better manage manufacturing to avoid batch common failures. This means increasing process monitoring and PAT, and improving failure analysis, or root cause analysis. Data analytics can support a better system of inspection of equipment as well as raw materials, and also provide tools for improved operator training and transfer of expertise.
Deliver Quality Assurance with Data Analytics
Being able to put all your data from various processes to use, whether it's an upstream process, some sort of filtration or purification process, raw material parameters or analytical measurements like spectroscopy or PAT, means you can go beyond remote monitoring and fault detection to process forecasting and predictive modeling. Data analytics gives you tools to take quality control to the next level.
ROI Calculator for Advanced Service Offerings
Sartorius Data Analytics has developed an ROI calculator that helps you consider more advanced service models and calculate your ROI for offering data analytics solutions to your partners.
In pricing services, most CDMOs generally price the production of large molecule API on a per-batch basis. However, with the changing market dynamics, more biopharma companies are seeking out strategic partnership models.
Some examples of these types of strategic partnership models include:
- Reserved capacity – Contractual guarantee of access to specific capacity for an agreed-upon time
- Joint venture – Co-investments with CDMO partner to expand an existing facility, payment varying from upfront costs or fixed annual suite fee
- Global enterprise agreements – Co-investment in new assets with a CMO partner to gain access to its global network
Wondering how to calculate your ROI from using one of these models?
Webinars for CDMOs
Watch a webinar to learn more about various service models and ways to achieve ROI.
How Data Analytics Can Boost the Bottom Line at a CDMO
How CDMOs Can Leverage Their Most Important Asset: Data
Register to Watch Webinar
References
1. Biopharmaceutical Contract Manufacturing Market (3rd edition) 2019-2030, Roots Analysis
2. GlobalData pipeline information, April 2020
3. 17th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associations, Inc., April 2020
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