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.
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.
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 .
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 .
- 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.
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.
- 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.