So to decide which is the best option in medicine and biopharma between biologics or small molecule drugs, we have to consider many factors. But let´s start from the beginning.
What Is a Small Molecule Drug?
Small molecule drugs are typically derived from natural compounds produced by plants, fungi and bacteria or are designed to imitate them.
These drugs use biochemical processes to prevent or treat diseases. They are highly effective as allosteric modulators and enzyme inhibitors, and are employed to target proteins outside of cells or receptors inside the cytosol, nuclei, and central nervous system.
The small molecule drug discovery market is projected to have a compound annual growth rate (CAGR) of 6.8 percent between 2018 and 2023. This, in conjunction with the profitable market for manufacturing generic drugs, indicates that small molecule drugs will continue to generate substantial revenue in the foreseeable future.
Small Molecule Drug Advantages
- Low molecular weight: this allows for more predictable dosing, making treatment easier for patients.
- Simple chemical structure: this is a key advantage over biologics in terms of their pharmacokinetics (PK) and pharmacodynamics (PD)
- Stable and orally bioavailable, enabling patients to take them anywhere, at any time, without special storage requirements.
- Easier development than biologics: small molecule drugs are chemically synthesized, providing greater predictability in the development process. However, this also makes them easier to replicate, leading to more competition from generic manufacturers.
Now, let’s turn to biologics.
What Is a Biologic?
Biologic drugs are derived from living organisms through various methods, including extraction, semi-synthesis, and recombinant DNA technology, making them more complex than small molecule drugs.
Biologics encompass a range of drug types, including vaccines, antibodies, interleukins, therapeutic proteins, peptides, nucleic-acid-based therapies, blood components, tissue therapies, and cellular therapies. They are most commonly associated with the treatment of cancer and autoimmune diseases, but can also be used to prevent and treat other conditions such as anemia, cystic fibrosis, and diabetes.
Due to their complex nature, biologics present unique challenges in manufacturing, regulation, and quality control. However, they also offer significant therapeutic benefits, including the ability to target specific disease pathways and reduce side effects compared to traditional treatments.
Biologic Drug Advantages
- High potential to treat diseases that were once considered untreatable or difficult to treat. In addition, some researchers believe that bacterial and cancer cells are developing resistance to small molecule drugs, making biologics a more effective treatment option.
- Biologics provide more targeted treatment options compared to small molecule drugs. This is because biologics are designed to bind with high specificity to their targets on intracellular components or cell surfaces.
- Low drug-drug interactions: less likely to interact with other medications a patient may be taking. Therapeutic proteins are metabolized and eliminated in the same way as endogenous molecules. This allows biologics to be used in combination with oral systemic medications with minimal risk of adverse interactions.
Both small molecule drugs and biologics have their own unique advantages and are valuable for treating different diseases and patients. According to a recent study published in Nature Biotechnology , the median total development time for the 275 new drugs approved between 2007 and 2016 was 12 years for both biologics and small molecule drugs.
In other words, there’s no need to let concerns about time or costs hold your company back when it comes to investing in biologics—with a good idea and a skilled development and manufacturing partner (like us), you’ll get the return on investment you expect. At 53Biologics, we work on the cutting edge of pharmaceuticals, including monoclonal antibodies.
Take a closer look at what we do here! You can also contact us today to discuss your biologics formulation and manufacturing needs.