Global Active Pharmaceutical Ingredient (API) Market Struggling to Overcome Patent Expiry of Leading Drugs

An active pharmaceutical ingredient(API) is a substance or substance combination in a drug that is biologically active. It is the central ingredient that has a direct effect on the prevention or cure of a disease. While APIs form the active component present in a drug, excipients are the inactive ones.

According to a report by Transparency Market Research, the global market for active pharmaceutical ingredients is anticipated to grow from a value of US$119.7 bn in 2013 to US$185.9 bn in 2020, registering a modest 6.50% CAGR from 2014 to 2020. Even though the overall pharmaceutical industry has been severely hit by the patent expiry of blockbuster drugs over the past few years, the market for active pharmaceutical ingredients is fueled by the need for low-cost substitutes and growing presence of generic medicine manufacturers in emerging economies.

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While the increase in abbreviated new drug applications (ANDA) and in drug master file (DMF) filing from Indian companies has boosted the demand for active pharmaceutical ingredients in the recent past, strict European Union and USFDA regulatory policies have been restraining the growth of the market.

Several API Manufacturers in India under FDA Scanner

Over the past couple of months, a number of Indian active pharmaceutical ingredient manufacturers have come under fire. While some have been issued warning letters by the U.S. Food and Drug Administration (FDA), others have been banned from sending products to the U.S.

This month, leading Indian pharmaceutical company Dr Reddy’s Laboratories received a warning letter from the FDA over quality issues at three of its facilities manufacturing oncology medicines and pharmaceutical raw material. Concerns over inadequate quality control measures were raised regarding two active pharmaceutical ingredient factories, one in Telangana and another in Andhra Pradesh.

Last month, the Nashik, Maharashtra site of Indian API manufacturer Megafine Pharma was banned from sending products to the U.S., citing manipulation of lab tests and unrecorded and unjustified deviations from written lab mechanisms. The site produces 24 active pharmaceutical ingredients for the U.S. market, including drugs for the treatment of depression, Alzheimer’s disease, multiple sclerosis, schizophrenia, and overactive bladders.

Using Marijuana as Active Pharmaceutical Ingredient to Treat Head Injuries

Biopharmaceutical company Kannalife Sciences Inc. based in Huntington, New York made news last year after announcing an R&D plan to study the use of cannabinoid therapeutics to treat chronic traumatic encephalopathy (CTE), a regenerative disease that affects people who have suffered repeated head injuries. The company has been working on a feasibility study for a product that it hopes would treat concussions with the help of marijuana as an active pharmaceutical ingredient.

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It was only recently announced that Bennet Omalu would be joining the scientific advisory board of Kannalife Sciences and will be involved in overlooking the clinical tracking protocols for the study. It was Omalu who conducted the autopsy on a former NFL player, which led to the discovery of CTE.