Unlocking Trends in Highly Potent APIs: From Toxicology to Eco-Friendly Manufacturing, Development and More

INTRODUCTION
The process of introducing new pharmaceutical products is evolving. Novel therapies are becoming more complex, global supply chains are increasingly uncertain, competition is intensifying, regulatory scrutiny is more stringent, and timelines are tighter. As a result, pharmaceutical companies must adopt innovative approaches to ensure product safety and quality while maintaining swift market entry. Furthermore, significant trends like the shift towards personalized medicine and the emergence of artificial intelligence are transforming the industry, necessitating greater customization and adaptability for companies to stay competitive.
In the pharmaceutical industry – partly as a response to the issues just mentioned – APIs with strong biological effects are becoming increasingly widespread. High Potency Active Pharmaceutical Ingredients (HPAPIs) are sought after because they provide highly targeted treatments at lower doses, which leads to fewer side effects. They are versatile and are used in drugs for various conditions such as cancer, asthma, diabetes, and autoimmune disorders, etc.
No surprise, the market for highly Active Pharmaceutical Ingredients (APIs) has been growing for a long time. The global HPAPIs market size is estimated being USD 27.19 billion in 2023, and is projected to reach around USD 62.39 billion by 2033 (1).
As the molecular weight and complexity of APIs have increased over time, the importance of biological APIs has also surged significantly. These trends are clearly expected to continue, reflecting ongoing advancements and demands in the pharmaceutical industry.

There are some different classes of highly potent active substances. Without going into details, it is worth to mention the most important groups (the list is not exhaustive).

1. Cytotoxic molecules, oncological APIs (both synthetic and biotechnological)
   Oncology is a major driver for the HPAPI development. The demand for targeted cancer therapies and personalized medicine is increasing. According to the forecast of MarketsandMarkets, the global precision medicine market was estimated to be worth USD 29.1 billion in 2023 and is poised to reach USD 50.2 billion by 2028, in terms of revenue (2).
   This fact is necessitating the development of more potent compounds that can deliver efficacy at lower doses. These compounds exhibit different toxicities, although they are all very potent and thus very toxic.
2. Synthetic, semi-synthetic, natural hormones
   Hormones are chemicals that coordinate different functions in living organisms by carrying chemical messengers. The most well-know group, steroid hormones belong to lipid-derived hormones, further types are the amino-acid derived (e.g. epinephrine, norepinephrine) and the peptide hormones (e.g. oxytocin).
   A few hormone molecules may already be able to transfer a given message, thus not a surprise that a very low dose already has significant biological impact. However the dose that causes adverse effects differ significantly among them (several orders of magnitude).
3. Other synthetic small molecules
   It is an extremely diverse group. The reason why it is mentioned is because although many of the synthetic small molecules are not extremely potent, it can be misleading to think that all of them are harmless (for instance, dronates are very toxic). Actually, hazard is the inherent nature of chemicals.
4. Biological molecules
   It is a large group of potent APIs containing eg. antibodies, immune factors, antibiotics, etc. The common feature of these active substances is that they are all produced by a living organism. We cannot go on without mentioning Antibody Drug Conjugates (ADCs), which are a class of biopharmaceutical drugs designed for targeted therapy for treating cancer.

HUMAN FACTOR
We cannot overestimate the importance of human talent and persistence in problem-solving, as well as in implementation, in general. The expansion of the human factor in the development of high-potency API development hinges on leveraging specialized teams with demonstrated track records in this niche area. These teams continuously undergo regular training to stay abreast of the latest technical and technological trends. Additionally, they meticulously follow regulatory changes to ensure compliance and maintain high standards of safety and efficacy in their development/ production processes.