subcutaneous-high-concentration-biologics
The biotech market faces tough times, with cautious investments and complex new drug types. De-risking the development of advanced biologics, like subcutaneous high concentration formulations, is now vital for success. Discover strategies to navigate these challenging waters.
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The Current Situation
Typical Market Trends
Current Challenges and How Companies Are Solving Them
How Leukocare Can Help with These Challenges
What We Offer Our Customers
Common Questions
De-risking Drug Development: A Smart Move in a Tough Market
Things are a bit complicated for biotech companies, especially smaller and mid-sized ones. Even though the biopharmaceutical market is expected to grow a lot, reaching an estimated $921.5 billion by 2034, getting there is tough. [1] The time after the pandemic brought a more cautious investment mood. Funding rounds are pickier, and investors want more developed clinical projects. [3, 34] This financial strain, plus new drug types being more complex and regulations always changing, means making drug development less risky isn't just a nice-to-have, it's essential.
The Current Situation
The global biopharmaceutical market is growing, driven by the need for advanced biologics and targeted therapies for ongoing and rare illnesses. [1] The cancer treatment area, especially, is a big reason for this growth. The funding situation has changed, though. After a period of high investment, venture capital is harder to come by, forcing many biotech companies to operate with limited money and make it last longer. [3, 34] In fact, a 2023 report noted that almost a third of public biotech companies in the U.S. and Europe had less than a year's worth of cash left. [3, 34] This has led to widespread cost-cutting, including layoffs and focusing only on their main projects. [3, 34]
Meanwhile, the scientific landscape is becoming more complex. New types of treatments, like viral vectors, RNA therapies, and cell and gene therapies, come with unique manufacturing and regulatory hurdles. [6, 7, 24] These advanced therapies often have really complex ways to make them and require specific knowledge that many smaller companies don't have in-house. [7, 8]
Typical Market Trends
Several key trends are shaping the biopharmaceutical market:
Outsourcing is on the rise: To manage costs and get specialized help, more companies are outsourcing various functions, from research and development to manufacturing. [9] The global pharmaceutical outsourcing market is projected to reach $91.4 billion by 2028. [12] This means companies can focus on what they do best while using the experience of contract development and manufacturing organizations (CDMOs). [13, 14]
Strategic partnerships are becoming more common: The way biotech companies and CDMOs work together is changing from just buying services to being real partners. [15, 16] This includes more flexible payment plans and earlier collaboration in the development process. [16]
AI is transforming drug development: Artificial intelligence is being used to speed up drug discovery, make formulation development better, and improve how efficient clinical trials are. [17, 18, 19, 20] AI tools can look at huge amounts of data to predict how drugs and other ingredients will react and forecast stability, cutting down on needing to do a lot of traditional trial-and-error. [17, 18, 20]
Focus on new modalities: There's a growing interest in advanced therapies like cell and gene therapies, as well as new approaches to treating diseases like cancer and autoimmune disorders. [21, 5] But these new methods come with their own challenges, especially when it comes to manufacturing and formulation. [22, 23, 30]
Current Challenges and How Companies Are Solving Them
Biotech companies are running into several problems that can be handled with smart planning and partnerships:
Limited internal resources: Many small and mid-sized biotech companies don't have enough in-house experts, especially in Chemistry, Manufacturing, and Controls (CMC) and drug product development. This problem is often solved by working with specialized CDMOs who can offer the right knowledge and facilities. [8, 9]
Complex manufacturing processes: New drug types often have intricate manufacturing processes that are hard to make bigger. [7] Companies are fixing this by collaborating with CDMOs experienced in these advanced therapies, who can help them create strong and scalable manufacturing methods. [8]
Regulatory hurdles: The rules for new drug types are still changing, which can make things uncertain for developers. [24, 6] Talking early and often with regulatory agencies, and working with partners who know how to handle these new rules, can help lower this risk. [25, 26, 27]
Investor pressure: Since funding is pickier, there's more pressure to show progress and make development projects less risky as early as possible. [27] You can do this by using advanced analytical tools and computer modeling to get data that proves your drug candidate will work.
How Leukocare Can Help with These Challenges
Leukocare can really help biotech companies handle these problems. By focusing on formulation development based on data, we can help make your program less risky right from the start. Our smart formulation platform, along with AI-based stability prediction, lets us create strong formulations ready for the market, even for the trickiest drug types. [17, 18, 20]
If you're working with new drug types like viral vectors or RNA, we have a lot of knowledge in formulation development to tackle the specific stability issues these treatments bring. [23, 30] We can help you create a formulation that keeps your product intact, making sure it works well and is safe.
We also know how important a good CMC plan is for investors. Our organized processes and complete paperwork give you the data-backed proof you need to build confidence and get funding. [31] We act as a smart partner, not just doing the work, but also giving helpful advice and working together to solve problems.
What We Offer Our Customers
When you work with Leukocare, you get:
A quicker way to the clinic and market: Our data-driven method and expertise in formulation development can help you steer clear of expensive delays and having to redo work. [32]
Less risk of failure: By tackling formulation problems early on, we help make your program less risky and boost your chances of success. [28, 33]
A strong CMC package, backed by data: Our complete documentation and data-driven insights give you solid proof to please regulators and investors. [26, 27]
A partner who works with you: We act like an extension of your team, offering helpful support and smart advice throughout the whole development process.
Common Questions
1. What are the biggest challenges for small biotech companies right now?
The toughest problems are getting money in a crowded market, dealing with how complicated new drug types are, and handling not having a lot of people or equipment internally. [3, 34]
2. How can outsourcing help my company?
Outsourcing can give you access to special knowledge and facilities you might not have on your own. [13, 14] It can also help you keep costs down and focus on what your company does best. [9]
3. When should I start thinking about formulation development?
As early as you can! Bringing in formulation development early in the process can help make your program less risky and prevent expensive hold-ups later. [32]
4. What is the role of AI in formulation development?
AI can look at huge amounts of data to guess how a drug will act in different formulations, which helps make its stability and performance better. [17, 18, 20] This can really speed up how you develop formulations and mean you don't need to do as much lab work. [19]
5. How can a good formulation strategy help with fundraising?
A clear formulation strategy, backed by solid data, can show investors that you've got a good plan for making a stable product that's ready for market. [27] This can make them more confident in what you're doing and boost your chances of getting funding.
