Hydroxychloroquine, also referred to as hydroxychloroquine sulfate, is an immunosuppressive drug with anti-viral properties. It is prominently prescribed for the treatment of viral diseases like malaria and auto-immune diseases such as lupus and rheumatoid arthritis. The global hydroxychloroquine market is majorly driven by the higher prevalence of such conditions, especially in the developing nations of Africa and Southeast Asia regions. Further, it has witnessed a sudden upsurge in demand, owing to some of the limited-scale studies that have proved its efficacy against the COVID-19 virus. However, a lot more tests and clinical trials are required before it commercializes as the COVID-19 treatment drug.
Factors such as growing population, increasing health awareness, medical science advancement, and pharmaceutical R&D coupled with rising healthcare spending by the government and consumers on drugs and medicines are expected to have a positive impact on the growth of the market. According to the National Health Expenditure Accounts (NHEA), U.S. healthcare spending grew by 4.6% in 2018, which accounted for nearly 17.7% of its GDP.
The drug is one of the prominently sold medicine for treatment against malaria, a severe disease which can be fatal if not treated right away. According to the Centers for Disease Control and Prevention (CDC), about 1,500 cases of malaria are diagnosed every year in the U.S. In more densely populated countries such as India, where cleanliness and hygiene regimes are relatively lesser strict, the number of malaria cases is higher. The World Malaria Report of 2018 published by the World Health Organization has stated that India holds a 4% share of the global malaria cases and contributes to around 87% of the total malaria cases in the whole of Southeast Asia. This projects a favorable scenario for the worldwide hydroxychloroquine market in terms of demand for malaria treatment.
The market is likely to witness accelerated growth in 2020 and onwards owing to its potential efficacy against COVID-19 (SARS-CoV-2) virus, the causing agent of global pandemic disease outbreak of 2020. By April 2020, the virus has been reported to cause more than 86,000 deaths globally: China, Italy, Spain, Iran, and the U.S. being worst-hit countries. The Food and Drug Administration has recently granted authorization to hydroxychloroquine and chloroquine for emergency use amid the COVID-19 pandemic. On March 17th, 2020, AIFA Scientific-Technical Commission of the Italian Medicines Agency also expressed a favorable opinion for the application of drugs as a potential COVID-19 treatment. However, formal approval and clear acknowledgment for the same still awaits.
Although there is no scientific evidence or proven records for the efficacy of the drug in COVID-19 treatment, the drug has created massive excitement among the leading political figures, Trump administration, to be specific. Many of the health department personnel, CDC officials, and White House leads for COVID-19 (Dr. Fauci) have been apprehensive due to its toxicology. There have been reports of health complications such as kidney failure, and heart attacks that have led to deaths due to its consumption in wrong doses or without proper prescription. This is expected to be one of the potential market restraints with impacts for a short period of time. But the drug is still effective for other disease treatments, and this is expected to help the market witness steady sales throughout.
The global market can be segmented based on product, application and age-group of the population being prescribed for the drug. The product segment includes sales of hydroxychloroquine as a branded or as a generic medicine. Plaquenil, Quinoric, Quensyl, Dolquine, Axemal, and Hydroquin are some of the prominent brands of the product sold across the geographies. Based on application, the market can be segmented into diseases for which the drug is prescribed, namely rheumatoid arthritis, malaria, lupus and other potential disease treatments.
Malaria, which is prevalent across all the age-groups is expected to be a prominent application of the product, followed by rheumatoid arthritis which is mostly prevalent in late adolescents and elderly population. Other potential treatments include COVID-19, as the drug is not yet formally prescribed by the FDA for treatment against Corona Virus. Further, it can be segmented based on the age-group of the people that are prescribed for the medicine. It includes people in age-groups of infants & adolescents (under 18 years), adults (18 years - 65 years) and elderly population (above 65 years).
In terms of production, India is one of the leading producers. It is reported to account for around 70% of the global hydroxychloroquine output by the Indian Pharmaceutical Alliance (IPA). It has a production capacity of about 480 tons annually, which is a consequence of the domestic demand for the product. According to the Indian Drug Manufacturers’ Association (IDMA), India needs about 24 million tablets of hydroxychloroquine annually for treating patients of rheumatoid arthritis, lupus and malaria. Wallace Pharmaceuticals, Zydus Cadila and Ipca Laboratories are top players of the India hydroxychloroquine market. It is also used as an off-label anti-inflammatory drug in the U.S. and India.
Raw material (active pharmaceutical ingredients) for the drug are majorly procured from the China, which have been reported to be stable. The drug which had significantly low consumption in countries such as the U.S. owing to low/negligible incidences of malaria has witnessed a sudden spike in demand in the wake of global COVID-19 pandemic. This has also resulted in the removal of an export ban that had been implemented on hydroxychloroquine along with dozens of other APIs in India.
In the wake of the COVID-19 pandemic, the demand for the drug has escalated, and consequently, the market has witnessed a noteworthy expansion. On April 3rd, 2020, a global pharmaceutical company, Sanofi announced its capability and willingness to produce hydroxychloroquine drug for millions of patients across the geographies, once it passes clinical trials. Several other players have also pledged to supply significantly enormous demands for the product. Mylan N.V., a global generic and specialty pharmaceutical company, has ramped its production at its West Virginia manufacturing facility to produce as much as 50 million tablets of hydroxychloroquine by the mid of April 2020.
Meanwhile, other pharmaceutical giants such as Bayer AG, Teva Pharmaceutical Industries Ltd., and Novartis International AG have pledged to donate around 3 million, 10 million and 130 million hydroxychloroquine tablets, respectively for COVID-19 pandemic treatment efforts. Aside from production expansion, the competition amongst market players is intense in terms of R&D via collaborations to prove its efficiency against the COVID-19 virus scientifically.
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