Biologics CDMO Market from Mabion Business Perspective
- Biologics CDMO industry is poised for growth. Listen to our most experienced BD decision makers, who will show you the direction of development and which innovative branches are currently trending.
- Collaborations significantly accelerate the time to market for biological drugs. Diversifying the individual stages of the development process and outsourcing them to experts in specific fields improves the quality of the final drug product and enables the highest standards to be maintained, in line with regulatory requirements. Shape the market for biologics together with Mabion!
Get to know our VP of Business Development better and learn about their perspective on the biopharma market. Read about the biopharma market outlook from Marty Henehan and Nigel Stapleton.
Q: Marty, you’ve led market entry strategies and helped build CDMO brands across several continents. What first drew you to this space?
MH: What first drew me to the biologics CDMO space was the unique intersection of science, strategy, and impact. Early in my career, I was fascinated by how biologics were transforming patient care, but I quickly realized that scientific innovation alone wasn’t enough, execution on the manufacturing and commercialization side was equally critical.
The CDMO model intrigued me because it allows you to partner with innovators across the globe, helping them bring complex biologic’s to market efficiently and reliably. That global, collaborative mindset—combined with the constant challenge of adapting to regulatory landscapes and scaling capabilities—has kept me deeply engaged ever since.
Q: How has your technical background influenced your approach to business development in a scientific services environment?
NS: My background is essential to my way of working in many ways.
First, it drives my interest.
Im not selling ballpoint pens or used car, but I work with great scientists on remarkable projects, which have a real life impact.
My scientific background in immunology, working on both increasing basic understanding as well as more applied medical research, provides me with the tools I need to understand how important, how cool, and how clever the current generation of novel investigational medical products are and how fast medical science is advancing.
Having worked for many years in a scientific environment also helps me connect with the wonderful people driving these innovations, understand what makes them tick and share their passion for their work with them.
Finally, my scientific background allows me to understand the services that Mabion offers to its clients in a high level way, helping me to tailor our approach to each clients individual needs. Luckily Mabion has a great team of subject matter experts who can help me dig down into each individual aspect of a project where needed, but having a broad understanding of the science of what we do gives me the ability to tie it all together in a comprehensive way for our clients.
Q: What’s driving demand for biologics CDMO right now?
NS: There are very broadly four dynamics driving demand for outsourced biologics development and manufacturing right now. Ill focus here mainly on the drug substance part, as it does have a different dynamics than the drug product part.
First, the classical need for startup Biotechs to outsource the development and manufacturing of their clinical candidates. They don’t have the infrastructure and often not the in depth knowledge needed to make the steps from pre-clinical to clinical on their own and rely on the knowledge and services of outsource partners to help them with this. In this segment it is highly noticeable that the level of investment has been depressed for several years in both the US and Europe. Although the investment levels are slowly recovering, there is still a noticeable lack of funding, a noticeable risk-averseness amongst VCs, and therefore a fierce competition for available funding, This is causing delays to many clinical trials, and therefore depresses demand for CDMO services in this segment. Interestingly, it also has means that price has started to play a bigger role in the CDMO selection process than before. This is an area where Mabion, being located in Poland, has an edge over its competitors.
Secondly, midsized biotechs with one or more projects in advanced clinical or even commercial stages. Here also the lack of funding is noticeable, although less pronouncedly so than in the first segment. These companies are more stably funded and can weather the storm so to speak. However, we do see an increase in focus on fewer and more advanced projects, at the cost of advancing the early pipeline. Platform approaches are still important, but where before COVID a company might be advancing multiple projects based on a common platform together in order to increase efficiency, my feeling is that there is now a greater focus on advancing and monetizing one or two lead molecules at the time.
Third, the large pharma companies. These are facing a stiff challenge from biosimilar developments, which are eating onto the profits of their blockbuster drugs. This is putting financial strain in their M&A strategy, meaning that the size of deals right now is significantly lower than 5-10 years ago. But paradoxically, the pressure on these companies to onboard successful late stage candidates to replace revenue streams from blockbusters about to go off patent and market shares already lost to biosimilars.
This combination is creating a dynamics where CDMOs are required to offer high levels of flexibility, and in some cases even share in the risks of their clients in order to win business.
Finally, the biosimilars themselves. In this part there is huge opportunity and huge competition. The risk/benefit profile, especially when plotted against the timeline of development, is fundamentally different than in originators. No biosimilar candidate has ever failed a phase 3 study, meaning that is can be seen as a safer investment than an originator who’s scientific prowess and safety profile still needs to be proven. But on the other side, plenty have hit the market only to find that they were too late and that their competitors have already secured such significant market shares that the earning potential for these newly released biosims is not enough to justify their commercial launch. So in the biosimilar arena, timelines and therefore outsourcing risk profiles are essential to success. This presents CDMOs with a unique set of challenges. Available capacity in the short term to meet the rapid biosimilar dynamics is a key deciding factors, as well as the CDMOs reputation in the market. After all, a delay in development due to an unforeseen scientific challenge or a failed batch can mean the difference between entering the market as first and securing a significant market share, or being too late.
Q: How do you differentiate a CDMO in a market crowded with players offering similar services – especially when you’re not the biggest one?
MH: In a crowded CDMO market, differentiation isn’t about being the biggest—it’s about being flexible to meet the sponsor’s needs, developing trust and being responsive. Clients today are looking for true partners, not just service providers. That means being transparent, flexible, and deeply collaborative throughout the lifecycle of their program.
We focus on combining high scientific and regulatory standards with operational agility—offering clients speed without compromising quality. Geographic location, cost-effectiveness, and available capacity matter too, but ultimately, it’s the consistency of execution and the depth of relationship that set a CDMO apart. When clients feel that you’re as invested in their success as they are, that’s the real differentiator.
Q: What is biopharma asking for today that they weren’t five years ago? How should CDMOs adapt?
MH: Five years ago, the focus was largely on capacity and cost. Today, biopharma is asking for strategic partnership. They want CDMOs that can provide integrated services across the development and manufacturing lifecycle, but also help them navigate regulatory complexity, accelerate timelines, and de-risk supply chains.
There’s a growing expectation for scientific collaboration, not just technical execution. To adapt, CDMOs need to invest in end-to-end capabilities, digitalization, and quality systems that meet evolving global standards. Just as importantly, they need to build teams that can engage early, co-create solutions, and move with the urgency of their clients’ pipelines.
Q: How do you tailor your commercial messaging for customers versus large pharma when introducing a lesser-known biologics CDMO brand?
MH: Tailoring the message starts with understanding what each segment values. Emerging biotech’s are often looking for flexibility, speed, and hands-on scientific support. They want a partner who can scale with them and guide them through development hurdles. So, the messaging focuses on agility, technical depth, and personalized service. With large pharma, the conversation shifts to risk mitigation, compliance track record, and operational robustness. They want to know we can deliver at scale, integrate seamlessly with their systems, and meet global regulatory expectations. In both cases, it’s about building confidence—but the proof points and language must align with what matters most to each audience.
Q: Looking ahead, what role do you see mid-sized CDMOs like Mabion playing in the future of biologics manufacturing?
NS: Although the biologics CDMO market for DS is highly consolidated, with a few large players owning most of the market, this is view does not take into account the variety of modalities and the full clinical development path.
Small CDMOs often have more precarious funding basis and limited capabilities, meaning that these might struggle to survive, unless they find a very defined niche within which they can build their reputations.
Midsized CDMOs however are financially more stable, have at least as much specialized technological expertise and experience in their primary areas of business as their larger counterparts, and yet are far more client focused, agile and flexible due to their smaller size. These midsized CDMOs can therefore meet the demands as set out in the previous paragraphs easier than their larger counterparts. In addition, biologics CDMO located outside of the traditional, high cost biopharmaceutical hotspots like the DACH area and the US, offer greater value for money, making it easier to meet current funding constraints without compromising on quality or reliability.
Prepared by:
Marty Henehan
VP of Business Development – Head of North America
Nigel Stapleton
VP of Business Development – Head of Europe