Times have never been more competitive for the pharma and biotech industry. According to Informa’s Pharma R&D Annual Review 2022, the industry has reached a record high of 20,000 products under active development.
Naturally, some of these come from global giants such as Pfizer, Roche, Takeda and Novartis, but the vast majority are being developed by much smaller organizations. Our research has found that small to medium-sized biotechs currently comprise as much as 80% of the small molecules pipeline.
But with this comes an array of challenges. These companies have to raise funds through convincing investors that their molecule is better than others in this enormous pipeline, and design trials which can meet regulatory requirements and show safety and efficacy to health authorities. They must manage their costs and ensure they have enough funds for the next clinical milestone, all with a relatively small team.
At the same time, the actual process of developing drugs is becoming even more complex. Approximately 30% of new molecules are classified as highly potent, while 70% have problems with solubility, which means that the molecules are active, but it is difficult to absorb them.
Because the clinical pipeline is shifting increasingly towards rare diseases and oncology, many of the drugs which are being approved by regulators tend to come with fast-track designation. Lonza has found that as many as 65% of new molecules receive accelerated approvals, something which poses an additional challenge for smaller organizations. These companies have to come up with a process which is sustainable, robust and suitable for commercial batches and long-term supply, as well as making everything happen in a shorter timeframe. Somehow they have to address all the existing challenges which companies face during the development of a new molecule, but in a more agile way.
When we speak to our biotech customers, we repeatedly hear that they want shorter lead times from suppliers, more flexibility, as well as an ability to adapt to fit their priorities and pace amidst this shifting landscape for drug development. With fewer internal resources, they need contract development and manufacturing organizations (CDMOs) which can provide access to different technologies and serve as expert consultants to help them overcome problems along the path to commercialization.
As an example, a big CDMO such as Lonza can provide a team of experts to identify the right technology for improving the solubility of small molecule drugs. Potential options could include spray drying, lipid formulation and micronization, but identifying the best solution as soon as possible is vital because if patients are not absorbing the molecule, the clinical trial endpoints will not be met, even if that molecule would otherwise have a very high efficacy.
Because we understand the myriad of challenges faced by biotech companies, we present customers with a fully integrated offer where we help manage all aspects of the drug development process, from drug substance, particle engineering to solving bioavailability challenges, to drug product and regulatory affairs services. Small biotechs often do not have an internal regulatory affairs team, so we can support them through the process of preparing for different regulatory bodies worldwide.
This kind of integrated offering has numerous advantages because with one supplier who is taking care of the entire clinical program, it is easier to move faster through the phases, as you are cutting out the waiting time and logistical hurdles that you might otherwise have with multiple suppliers. Having a single point of contact makes it easier for companies with fewer internal resources to keep track of the whole process, without any breakdowns in communication.
As the world’s clinical pipelines become more and more dependent on the biotech industry, we predict there will be greater reliance on CDMOs who can provide the technological expertise and know-how to guide the development of these products from bench to commercialization.