Impact of COVID-19 on the Global Active Pharmaceutical Ingredients (API) in the Pharmaceuticals Industry
WHO (World Health Organization) has characterized novel coronavirus as a global pandemic on March 11, 2020. This present pandemic has led to an intolerable impact on both the health and pharmaceutical structure which has ultimately created an ultimate issue on patients’ health.
APIs are the effective ingredient present in the medicine, and even small amount of active ingredients known to produce effective result. APIs are either used as single dose or as mixed dose combination in order to produce an effective medicine. However, raw materials are confused with the APIs used for making medicine, but the raw materials are the substances which are used for manufacturing of APIs and the chemical compound used for making the raw material is called as an intermediate. Even more than 10 kinds of intermediate chemical compounds are used for manufacturing of a single API. In order to manufacture API, the manufacturer has to first develop the chemical compound at first which is used for further processing of APIs. These API molecules are formed in large sized reactors. After manufacturing, these APIs are checked for purity and their effectiveness as API market is such a huge market and has a great application in the medical field there is a huge demand of close monitoring of manufacturing process. But due to continuous pandemic of COVID-19 and long term shut down has put an adverse effect on overall drug manufacturing companies. The government of several countries has reported that there is huge scarcity of APIs amid the COVID-19 pandemic. The reason behind that is the barrier across the countries border that has an ultimatum effect over the import and export facilities of medicinal product among others.
As the Indian pharmaceutical industry is largely dependent upon the China for procurement of APIs, as China is the first global leader involved in the manufacturing of low cost APIs. This has been reported that approximately 70% of APIs raw materials are imported from China to India. But the continuous pandemic of COVID-19 and barrier across the borders have a massive effect on export of good from one country to another and has led to the scarcity of APIs in India, the U.S. and the U.K. among other countries. As India is the world’s third largest supplier of low-cost and affordable generic drugs to millions of people all over the world and operates about 250 the U.S. FDA, the U.K Medicine and Healthcare product Regulatory Agency approved plants. Hence any impact on Indian APIs pharmaceutical industry led to a negative impact on overall global APIs manufacturing plants.
STRATEGIC DECISIONS FOR MANUFACTURERS
Sudden voluminous demand of APIs in order to fight against the COVID-19 has led the manufacturers to take several strategic initiatives. Large number of population affected with this COVID-19 virus and expanding spread across the world from last few months has enhanced the need of effective treatment options. To deal with the COVID-19 outbreak challenges, many APIs manufacturers are creating new strategies. To meet an actual as well as prompt increase in customer demand or to anticipated prospective increase in customer demand APIs market players are exclusively concentrating on gaining the production capacity. It is predicted that these strategies are anticipated to escalate up the company revenue and its growth in the forecasted period.
· In January 2021, Sanofi had opened a new European company named EUROAPI which is engaged in the manufacturing and commercialization of APIs. The company established considered as one of the largest APIs manufacturing company in Europe. Through this initiative company has expanded its APIs business worldwide.
· In December 2020, DSM achieved ANVISA certification for its Colombia manufacturing plant. The certification achieved by the company allowed it to expand its commercialization of pharmaceutical premix products into other countries including Brazil among others. This certification boosted the company’s manufacturing activities.
· In October 2020, Recipharm AB signed an agreement with BIAL for boosting up the supply capabilities of APIs.
· In September 2020, Recipharm AB announced for the expansion of API facility in terms of capacity and financials in Israel. The company has invested USD 2.5 million in the clinical GMP API facility, in order to fulfill the increasing unmet demand of consumers in the API market.
· In September 2020, Jubilant Pharmova Limited signed an agreement with Saptagir Laboratories for the manufacturing of Remdesivir indicated for the treatment of COVID-19. The agreement signed helped the company to boost up the existing product portfolio and to earn a lucrative growth in the market amid COVID-19 pandemic.
· In May 2020, Sun Pharmaceutical Industries Ltd. initiated the product trial for the anti-coagulants and anti-inflammatory drugs. The clinical trial included the nafamostat and the other drug is plant based dengue drug. This initiative adopted by the company helped it to expand its business even during the COVID-19 pandemic.
· In May 2020, HIKAL ltd. has developed Favipiravir API and its intermediates. The product developed has been proved effective against the influenza viruses and is under various clinical trials for treatment of COVID-19. This initiative demonstrated the company’s strength for providing high quality medicines for its customer globally.
This signifies that various strategic initiatives adopted by the companies allow them to attain a lucrative growth even during the COVID-19 pandemic.
IMPACT ON DEMAND
Coronavirus disease (COVID-19) is one of the infectious diseases caused by a SARS-CoV-2 virus and has affected and still affecting a large pool of the population worldwide. Coronavirus disease (COVID-19) causes acute respiratory illness ranges from mild to severe pneumonia along with respiratory failure. As there is no specific and approved treatment to treat the coronavirus disease (COVID-19), the need of effective treatment is at high demand. Due to these all affirmative factors there is direct requirement of APIs for drugs manufacturing, which is indicating the future huge demand of API.
By recognizing the actual as well as prompt increase in customer demand or to anticipated prospective increase in customer demand, healthcare organization as well as government bodies’ calls on industry to increase manufacturing of APIs.
Moreover, several initiatives are taken by the government in order to meet the demand of drug manufacturing.
· The department of pharmaceuticals (DoP, India) has announced for the proposal for the creation of new drug manufacturing facility with the investment of USD 397.13million in order to allow companies to set up the new manufacturing facilities for APIs
TABLE 1. WORLD –WIDE IMPACT OF COVID-19 ON THE PHARMACEUTICAL SECTOR
The increasing prescriptions for several kinds of illness including respiratory illness, mental illness among others has led to scarcity of drugs and API molecules used for drug manufacturing. Disproportionately high COVID-19 patient volumes putting strain on scarce drugs. Henceforth, it is estimated that global API market anticipated to boom up in the forecasted period.
IMPACT ON SUPPLY CHAIN
The COVID-19 pandemic has affected many organizations’ business environment; supply availability of various drugs has been hampered due to a large number of issues, including import and export restrictions across the countries, and continuous lockdowns that have forced suppliers to (temporarily) shut down the manufacturing facilities and supply capabilities. China occupies a predominant position in the global APIs market. China has secured a considerable market share of APIs market at global level and it exports about 17.87% of vitamin APIs among others to other countries.
Moreover, this has been reported that European pharmaceutical companies also rely on India for manufacturing of their products and India is largely dependent on China for 70% of APIs.
Since 1990, the U.S. is heavily relied on India and China for manufacturing of pharmaceutical products among others because China provides cheaper ingredients and those are not subjected to that much high regulatory rules and laws.
Moreover this has been projected out that UNICEF procures most of the pharmaceutical products from China and India and few of them from Europe as well. For Vitamin, a capsule containing Retinol UNICEF and CIK depend on same supplier and also procures from Canada.
Moreover, as the market players are totally aware of the loss that they may likely to suffer due to disruption of supply chain, they are continuously monitoring their product supplies and manufacturing capabilities in order to prevent the loss to their overall business.
· Teva Pharmaceutical Industries Ltd., manufacturer of Accutane (Isotretinoin capsules) has announced that the company is enacting all appropriate measures in order to ensure the safe supply of their medicines and APIs.
This signifies that COVID-19 is disrupting the supply chain of APIs, it is also restricting the procurement procedure of APIs from different sources among other factors but several initiatives are taken by the manufacturers and government organizations is creating a hope for the improvement of supply chain of APIs.
The Coronavirus disease (COVID-19) pandemic has enormous impact on global pharmaceutical market involving APIs among others. The demand for APIs is on surge across the globe because of increasing prevalence of coronavirus disease (COVID-19) all over the world and demand of effective treatment options.
The COVID-19 pandemic has resulted in an immense increase in cost of drugs due to rising demand of drugs for treatment of several kinds of disease including HIV, cancer, epilepsy, malaria among others.
· As per the data provided by the Pharmaceutical Export Promotion Council (PHARMEXCIL), the cost of Penicillin APIs has raised to USD 8.69 per unit in October 2020 from the USD 6.16 per unit in January 2020.
· Moreover the data procured by the APIs manufacturer suggested that there is an increase in about 13 to 18 percent of APIs prices for antibiotic involving Amikacin, Doxycycline, Azithromycin, Dexamethasone Sodium and Ornidazole among others as India imports most of them from China.
· Montelukast sodium (an anti-asthmatic drug) costs USD 705.93 to USD 787.38 per Kg in October 2020 as compared to USD 447.99 to USD 515.87 per Kg before few months.
· The prices of vitamins and penicillin have also attained a lucrative growth due to sudden rise in their prices by 40 to 50 percent as that of the original existing prices.
· India’s drug pricing regulator has also allowed pharmaceutical companies to enhance the prices of essential drugs by 50 percent including Heparin (an anticoagulant) which is in high demand to increasing risk of COVID-19 infection to patients suffering from heart attacks, strokes and lung or pulmonary embolism.
· As per the publication of April 2020, the cost of azithromycin, paracetamol, anti-inflammatory drug nimesulide APIs enhanced up to 60 to 190% during the pandemic of COVID-19. This price hike was due to shut down of China’s APIs production units. The increasing demand of several kinds of drug during COVID-19 pandemic has enhanced the demand of APIs that in turn led to APIs shortage. These shortages have an ultimatum effect on existing APIs prices.
This signifies that price of APIs hiked due to continuous coronavirus outbreak.
It is predicted that the COVID-19 pandemic outbreak has significant impact on the growth of global APIs market due to huge elevation in the demand of APIs. Moreover, many government and healthcare organization (United Nations Children's Fund (UNICEF), partners and World Health Organization are exclusively focusing on the supply of APIs and its manufacturing due to priorities and essential requirement in this crucial period. Moreover, several clinical trials also expected to provide market with a lucrative growth.