biopharmaceutical-contract-development
The relationship between biopharmaceutical companies and their contract development partners is evolving. Discover why moving beyond transactional exchanges to strategic collaboration is crucial for navigating complex drug development and accelerating market access.
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Beyond the Order Form: The Shift to True Partnership in Biopharmaceutical Development
Current Situation
Typical Market Trends
Current Challenges and How They Are Solved
How Leukocare Can Support These Challenges
Value Provided to Customers
FAQ
Beyond the Order Form: The Shift to True Partnership in Biopharmaceutical Development
The relationship between biopharmaceutical companies and their contract development partners is changing. What was once a transactional exchange of services is becoming a deeper, more strategic collaboration. For leaders in CMC and Drug Product Development, choosing the right partner is less about finding a vendor and more about identifying a co-pilot who can navigate the scientific and regulatory path to market.
Current Situation
Outsourcing in the biopharmaceutical industry is a core part of how companies operate now, not just a niche strategy. The global biologics CDMO market was valued at around $22 billion in 2024 and is expected to grow significantly, with some projections reaching over $92 billion by 2034.[1, 2, 3] This growth isn't just about cutting costs; it shows a real need for specialized expertise, particularly as drug modalities become more complex.[4, 5, 9, 13] A recent survey showed that nearly 87% of biopharma companies outsource at least some of their activities.[6] From virtual biotechs to large pharmaceutical companies, reliance on external partners for development, formulation, and manufacturing is standard practice.[7, 8]
Typical Market Trends
Here are some key trends in the market right now:
The Rise of Advanced Modalities: Companies are developing more and more complex molecules like viral vectors, cell and gene therapies, and RNA-based treatments.[4, 9, 12] The market for advanced therapy medicinal products (ATMPs) is expanding rapidly, with a projected compound annual growth rate (CAGR) of around 18.9%.[10, 11] These new therapies come with unique formulation and manufacturing challenges that need highly specialized knowledge.[12, 9]
A Move Toward Strategic Partnerships: Companies are moving past just paying for services. Now, they want partners who can offer strategic advice, share risks, and truly act as part of their own team.[13, 5] This is especially true for the more than 5,500 smaller biotech companies that often lack in-house scale-up capabilities and drive over 60% of the industry's growth.[7]
Bringing in Data Science and AI: AI and machine learning are getting more involved in making formulations. These tools can speed things up and make formulations better by predicting things like stability.[14] The market for AI in clinical trial solutions alone is projected to hit $1.73 billion by 2025.[17]
Current Challenges and How They Are Solved
Even with all the opportunities, CMC and Drug Product leaders still face challenges that affect how well a program succeeds.
The Need for Speed vs. The Risk of Missteps: Many companies, especially well-funded virtual biotechs, really want to reach the Biologics License Application (BLA) fast. This puts a lot of pressure on them from their boards and investors, so there's no room for mistakes. Usually, companies thoroughly check out contract development and manufacturing organizations (CDMOs). But this can be slow, and often, what a vendor promises doesn't match their actual strategic smarts.
Limited Bandwidth and Resources: Small and mid-size biotechs often have small teams. Their internal capacity is limited, and they might have had bad experiences with service providers who act more like researchers than partners focused on goals.[8] The tough part is finding a partner who doesn't just do tasks but also thinks ahead, easing your team's workload and helping you build a strong CMC story for investors.
Navigating New and Complex Modalities: Even large pharma companies with experienced teams still aren't sure how to handle new therapies like viral vectors or RNA. Their own processes can be slow, and regular vendors might just offer generic, templated solutions that don't really fix the unique problems of these new products. They need specific expertise and a true partner to help with internal discussions and make development less risky.[18]
The Onboarding Hurdle: If you're a mid-size biotech with existing vendor relationships, adding a new partner can be tough. Your internal purchasing processes are often strict, and people naturally don't want to bring in something new that could cause problems or uncertainty. Usually, companies just stick with partners they know, even if those partners are swamped or don't have the specific expertise for a special project.
How Leukocare Can Support These Challenges
A partner focused on formulation science from the start can handle these challenges differently. At Leukocare, we base our approach on deep scientific understanding combined with a practical, goal-focused mindset.
If you're trying to move fast, we offer a clear, efficient way forward. Our Smart Formulation Platform uses AI to predict stability and is built to speed up development and create the strong, regulatory-friendly data you need for a successful BLA filing. We work like a strategic co-pilot, collaborating with CMC pros as equals.[14]
For smaller teams, we act like an extension of your group, giving you proactive ideas and a clear process. We focus on clear talk and delivering reliable results without all the confusing jargon, making sure your data and documents meet investor and regulatory needs.
When you're dealing with new therapies, we offer specific, targeted help. We bring deep technical knowledge in areas like vectors and ADCs through short workshops and custom materials that help your internal teams get approval and make good decisions. We don't use templates; we use real data to guide how you develop things.
If you're unsure about bringing on a new partner, we offer a low-risk way to start. We often begin with a specific, tough challenge, like lyostability or a new therapy, to show what we can do. Our goal is to support and help your internal drug product teams, not to replace them. We think the results of a small pilot project should speak for themselves before we grow the relationship.
Value Provided to Customers
The real value of a true development partner isn't just about getting a simple result. It's about confidently reaching your big strategic goals.
Data-Driven Decision-Making: We give you reliable, data-driven formulation expertise that makes development less risky for both standard and new therapies. This helps you make smart choices and see a clear way forward.
Accelerated and Secure Development: If you're an early-stage company, our help gives you a faster, more secure way to get to IND/Phase I. For programs further along, we help you get to the BLA faster with a formulation made for regulatory success.
A Seamless and Strategic Partnership: We offer a quiet, easy-to-manage partnership that works as a silent, smooth, and scientifically sound extension of your team. For our CDMO partners, this means we act as their formulation branch, always staying loyal to their client relationship.
Expertise for Complex Challenges: We bring the special expertise needed to solve tough formulation problems, helping your team get past obstacles and keep projects moving.
FAQ
Q: We are a virtual biotech with no in-house lab. How can you support us?
A: We are structured to support fully outsourced models. We act as your strategic formulation team, managing the development process and collaborating with your other external partners. Our process is designed to give you a clear, efficient path to your clinical and regulatory milestones, backed by robust data.
Q: We already have established CDMO partners. Why should we consider working with you?
A: We often work with companies that have existing partners but face specific challenges, such as tight bandwidth, a shift to a new modality, or a particularly difficult formulation problem. We can take on these niche projects to relieve your internal teams and deliver results. Our "pilot first, scale second" approach allows you to test our capabilities on a single complex problem with minimal risk.
Q: How do you handle new and complex modalities like viral vectors or mRNA?
A: We have deep technical expertise in these areas. Our approach is to provide specific insights and data-backed solutions tailored to the unique challenges of your modality. We don't use generic templates. We can provide case studies, tailored support materials, and act as a true sparring partner to help your team navigate internal buy-in and make confident, regulatory-sound decisions.
Q: We are a CDMO that doesn't offer formulation services. How can we partner with you?
A: We partner with CDMOs to provide a neutral, external formulation unit. This allows you to offer a full-service solution to your clients without the investment of building an internal team. We handle the formulation development independently and discreetly, ensuring a smooth project execution while remaining loyal to your client relationship—we do not engage in client poaching.
