From its beginnings, the pharmaceutical sector has come a long way. The industry that we know today is considered to have roots that lie back with the apothecaries and pharmacies that offered traditional medicinal remedies. The industry keeps evolving and is not just limited to traditional forms of drugs or medicines. A study indicates that the global pharmaceuticals market is expected to grow from $1228.45 billion in 2020 to $1250.24 billion in 2021 at a compound annual growth rate (CAGR) of 1.8%.
The modern Pharmaceutical industry consists of organizations that develop and manufactures generic drug products, over-the-counter drug product as well as innovative medicines required for specific medical requirements. These medicines contain various combinations of ingredients to make them effective for curing diseases. The most important ingredient of all is an Active Pharmaceutical Ingredients (API).
What are pharmaceutical APIs?
Any drug has two components that include API and excipient. The term API refers to a biologically active component used in drugs. While excipient is the inactive substance that acts as a carrier of the API. Predominantly, pharma APIs are responsible for inducing the desired effect. A drug may contain multiple active ingredients to treat various symptoms.
How APIs are manufactured?
As APIs are the most important elements that a drug contains, they remain in demand and thus have a multi-billion dollar market globally. These are chemical compounds that often pass through several processes to become active API. The process starts at the laboratories where these compounds are manufactured in high quantities. Later they are purified to achieve desired quality.
Traditionally, many drug companies used to manufacture APIs by themselves. However, today many outsourcing pharma companies accept APIs from overseas organizations. China has been at the forefront and had several working pharmaceutical APIs export companies in the country.
The steps in the API manufacturing process are:
- Chemical synthesis
- Fermentation processes
- Recombinant DNA
- Isolation and recovery from natural sources
- A combination of these processes
Furthermore, the manufacturers are required to maintain the desired level of quality for APIs by Food and Drugs Administration (FDA). Then they are given permission to be released in the market for commercial use by drug companies.
Quality of API
Medicines not only cure your mild illness but also save individuals from potentially life-threatening situations. As medicines are to be consumed by patients they must meet the safety standards. As APIs are crucial components, they should be safe to use. Thus regardless of the type of manufacturing process, quality laboratory conditions, and several quality checks, APIs are required to comply with quality criteria. Only then do they receive approval from the FDA for further use.
Strength of pharmaceutical APIs
The industry does follow certain standards to determine the strength of APIs for each drug or medicine manufactured. However, the types of standardizing the strong points of APIs within medication often differ from one product or another. Also, the standards differ between different manufacturers. Nevertheless, drug manufacturers need to gain approval from the FDA for all their products.
API market segmentation
API market is segmented into some broad categories such as
Based on the type of synthesis the market is segmented into
- Synthetic chemical API
- Biological API
Based on drug type market is segmented as to whether API is used for innovative drugs or not
- Generic API
- Innovative API
Market segmentation according to the end product
- Therapeutic Enzymes
- Monoclonal Antibodies
- Fusion Proteins
- Blood Factors
- Vaccines
- Cytokines
Market segmentation based on Therapeutic application
- Neurological
- Central Nervous System
- Cardiovascular and Respiratory
- Oncology
- Diabetes
- Others
What is the difference between raw material and API?
People often confuse raw materials with APIs or use these terms interchangeably. However, APIs are manufactured from raw materials which are used as base elements. Moreover, raw materials are chemical compounds that are specially procured to manufacture required APIs. The end product i.e., API is then supplied to pharmaceutical organizations which use them in drug manufacturing.
Meanwhile, the raw material has to go through many different stages/processes to reach the final stage of API. Later APIs go through a purification process to reach the ultimate quality standard.
Rules and regulations
APIs significantly affect medicine’s effects. Nevertheless, they can cause ill effects or potentially life-threatening consequences when manufacturers use poor-quality APIs. Because of the dire ill effects, APIs have to go through a number of tests and scrutiny. API manufacturers have to comply with rules and regulations related to manufacturing quality, laboratory conditions, etc.
Additionally, pharmaceutical API exporters from India and other countries are subject to strict regulations and must receive approval from the FDA to export APIs overseas.
Conclusion
Due to stringent rules and regulations, one must consider a few factors before choosing an API product. These factors include quality, Guarantee about products, detailed information about API supplier and their clients, as well as supply procedure.
