Blog

By Kris Nelson

The pharmaceutical industry depends on catalysis for both producing most of its products and innovating new ones.  About 90 percent of all chemicals (including active pharmaceutical ingredients or APIs) are derived from catalytic processes, according to a recent article. It reports that the API “market was valued at USD 237.4 billion in 2023 and is expected to increase at a compound annual growth rate (CAGR) of 5.7% from 2024 to 2030.”

The article summarizes the expanding role of pharmaceutical catalysts: “The ability of catalysts to facilitate complex transformations with high selectivity enables the creation of molecular structures that might be challenging or even impossible to access through traditional methods. This expanded chemical space allows researchers to explore new avenues for drug discovery, potentially leading to compounds with improved therapeutic properties, reduced side effects, or novel modes of action. Additionally, the adaptability of catalysis for pharmaceuticals spans its fundamental categories, namely homogeneous and heterogeneous, as well as the following specific types: metal-based catalysis, biocatalysis, organocatalysis, or photocatalysis.”

Homogenous catalysis refers to processes that integrate catalysts into the product because the catalysts operate in the same phase or state as the reagents and products and are usually removed prior to completion. Heterogeneous processes exclude the catalyst in the product, usually as solids, and therefore do not contaminate the product. The spectrum of catalytic categories enables innovation in product development and process optimization. Catalytic tailoring applies to the development and production of intermediary chemicals and key building blocks:  “By efficiently transforming starting materials into more complex intermediates, catalysis contributes to overall process efficiency,” according to the author,  Andrés R. Alcántara.

In sustainable chemistry, catalysis is demonstrating expanded applications and importance. The pharmaceutical industry is integrating green and sustainable practices due to regulatory drivers and concern for environmental impact. Since catalytic processes often increase efficiency of reactions and manufacturing and minimize polluting effects, the industry embraces catalysis to achieve more sustainable practices. In particular, writes the author, “the increasing implementation of flow catalytic procedures is undoubtedly fueling the sustainable production of pharmaceuticals. This efficiency is crucial not only for reducing costs but also for enhancing the overall feasibility of bringing new drugs to market. The pharmaceutical industry’s continuous quest for more economical and sustainable manufacturing processes further underscores the importance of catalysis in this field.”

Recent innovations using oxidative procedures have led to the development of environmentally friendly approaches for the synthesis of APIs and their intermediates using oxidative procedures. According to an article sited, biocatalytic methods are used in many of these approaches, employing mild reaction conditions and reagents; biocatalysed oxidative processes leading to several APIs, islatravir, captopril and modafinil are noted. The article concludes that “catalysis stands as a cornerstone in the synthesis of pharmaceuticals, offering unprecedented benefits in terms of efficiency, selectivity, and sustainability.”

In particular, metal catalysts have the potential to greatly enhance the sustainable practices of pharmaceutical products. They demonstrate shorter and more efficient synthetic routes and more direct access to single stereoisomeric products. Two critical metals, palladium, the metal most widely used in catalysis in both academia and industry, and iridium, have become effective catalytic elements, according to a recent article. “The latter has emerged as a very versatile catalyst for C–H borylation of heteroarenes (starting materials for cross-coupling reactions), and particularly for asymmetric hydrogenation reactions of olefins and ketimines,” states the author. 

Increasingly, the article concludes, “industrial chemists do not only quest for high-yield reactions, but they also have to deal with a number of regulatory issues, such as total impurities in drug substances, crystal form, residual metals, and residual solvents, to mention a few…. In the past two decades, the pharmaceutical industry and the U.S. Food and Drug Administration (FDA) have recognized continuous manufacturing as an economically and environmentally transformative means of drug production.” In the subsequent blog, we will discuss the role of nanofiber materials to significantly reduce the amount of metal catalysts in pharmaceutical manufacturing.