Active Pharmaceutical Ingredient (API) is any substance or combination of substances used in a finished
pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the
diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting
or modifying physiological functions in human beings.
All the drugs are made up of two central components. One is API and the second is the pharmaceutical excipient. The
quality of an API plays a very important role in drugs, while the excipient is the substance inside the drugs that
helps the medicine to reach the body system and is chemically inactive.
API is so important that it is necessary to know its market situation and its types.
The APIs Market
Upsurge in occurrences of chronic ailments like CVDs, arthritis, and diabetes, along with growing prevalence of
infectious diseases such influenza, hepatitis, and especially coronavirus are bolstering the demand for drugs and
medications globally. In addition, booming geriatric population who have a higher susceptibility to such health
conditions is adding considerable traction to global API market growth. According to the data of China Chamber of
Commerce for Import & Export of Medicines & Health Products, in 2019, the global API market size reached USD
167.9 billion, and it will reach USD 306.1 billion by 2027.
Fig. 1 2010-2019 Global API market size
2019 Global API market share is showed in figure 2. In the 2019 global API market, North America accounted for 40%.
North America and Asia Pacific are projected to dominate the global market, owing an increase in the demand for
efficient and effective management of APIs manufacturing, high health care IT budgets, and high adoption of
accelerated regulatory review of innovative medicines.
Fig. 2 2019 Global API market share
Types of APIs
API may exist in the form of liquids, powders, crystals that obtained by chemical synthesis, biotechnology, or plant
extraction.
Synthetic chemical API
Around 66.0% of the APIs currently available in the market constitute synthetic chemical APIs, popularly
known as small molecules. Currently, over 3,000 small molecule drugs are available in the market, which
provides significant business opportunities for synthetic API production.
Figure 3 shows a typical example of the technological processes involved in one synthesis step [1].
Fig. 3 Main process flows in API synthesis
Synthetic chemical API can be further divided into inorganic synthetic drugs and organic synthetic drugs.
Example of inorganic synthetic API: Hydrotalcite can be used in the treatment of bile vomiting.
Example of organic synthetic API: tamoxifen citrate, edaravone, epalrestat, etc., are mainly composed of basic
organic chemical raw materials prepared by a series of chemical reactions.
Biotechnology API
Biopharmaceutical technology includes traditional fermentation engineering and a new generation of
pharmaceutical technology represented by gene recombination and monoclonal technology.
Traditional fermentation API Fermentation is the basis to produce a wide range of APIs, especially antibiotic APIs, such as
penicillin, cephalosporin and so on. Penicillin is a typical fermentation API and figure 4 shows the schematic diagram of the fermentation
process for penicillin production [2].
Fig. 4 Schematic diagram of the fermentation process for penicillin production
Modern biotech API Two breakthroughs of the late 1970s became the basis of the modern biotech industry: the interspecies
transplantation of genetic material, and the fusion of tumor cells and certain leukocytes. Modern
pharmaceutical biotechnology encompasses gene cloning and recombinant DNA technology. Modern biotech API
is driving API market by an increase in their application, technological advancements and advantages of
biologics. Biologics produced from living organisms or contain components of living organisms. Biologics
include recombinant proteins, tissues, genes, allergens, cells, blood components, blood, and vaccines.
Advantages of biologics are high effectiveness when compared to small molecule drugs, highly specific
against the target, fewer side effects and low toxicity.
Natural API
Natural APIs offer the following advantages: i) they are natural products, ii) non-narcotic, iii) having no
side-effects, or less side effects, iv) easily available at affordable prices, v) provide opportunity to
genetically engineer them for better use. And the demand for Natural APIs is increasing in both developing
and developed countries
Various strategies for the discovery of drugs from natural resources can be seen in Figure 5.
Fig. 5 Various strategies for the discovery of drugs from natural resources
As for now, Alfa Chemistry offers a variety of synthetic chemical APIs which can be used in the pharmaceutical
preparation. In addition, we offer pre-formulation drug discovery, formulation and process development, custom
synthesis, and scale up services. Please feel free to contact us.
References
The modularisation of chemical API synthesis. Manufacturing CHEMIST, January 15, 2019.
Eduardo Benedicto Lopez-Montero. Use of Multivariate Statistical Methods for Control of Chemical Batch
Processes. The University of Manchester, 2016.
