8 days ago | Pharmaceutical
COVID-19 Impact on ACTH Deficiency in Pharmaceutical Industry
COVID-19 Impact on ACTH Deficiency in Pharmaceutical IndustryOverviewImpact on Pharmaceutical IndustryThe COVID-19 pandemic has posed several kinds of challenges in front of different types of industries which have badly impacted the worldwide economy. The lockdown triggered due to continuous pandemic has led to the disruption of manufacturing and supply activities which has jolted the pharmaceutical sectors among others. Larger players having deeper pockets became able to compensate themselves under such pandemic situations however the smaller companies fall under the stress due to lack of sufficient capital, source of income, and ban on import-export activities among several other factors.Moreover, vigorous research activities conducted by the pharmaceutical players have affected the research and development activities required for boosting up the growth of another pharmaceutical market.COVID-19 Impacts on Adrenal GlandCOVID-19 caused by the SARS-CoV-2 virus has been reported not only to affect the major respiratory parts but also affects the other body organs and hinders the body’s metabolic process which leads to life-threatening diseases.Adrenocorticotropic hormone (ACTH) is produced and secreted by the anterior pituitary gland and is also called serum ACTH, corticotropin among others. ACTH is responsible for maintaining the level of cortisol hormone which is regulated by the adrenal gland. Insufficient ACTH production leads to adrenal malfunctions and pituitary tumors. Decreased production of ACTH has also been reported to cause adrenal insufficiency which results in nausea, anorexia, weight loss among others.The below table demonstrates the amount of different cellular molecules in normal person and person suffering from adrenal insufficiency.Table: 1 Laboratory Findings of Patients with Adrenal Sufficiency Vs. Those with Adrenal InsufficiencyClinical/Laboratory DataOverall TotalAdrenal SufficiencyAdrenal InsufficiencyBaseline Serum Cortisol Levels (mmol/L), MD (IQR)398.0473.0255.0Post-Injection Serum Cortisol Levels (mmol/L), MD (IQR)537.0606.0425.5Δ Serum Cortisol Levels (mmol/L) M±SD147.3 ± 122.7150.2 ± 117.0142.1 ± 142.1Sodium (mmol/L), MD (IQR)135.0135.0137.0Potassium (mmol/L), M± SD3.99 ± 0.776.0 ± 2.95.5 ± 1.8Fasting serum Glucose (mmol/L), MD (IQR)5.1 (4.6, 6.1)5.5 (4.7, 6.4)4.9 (4.4, 5.5)CD4 count MD (IQR)187.0(42.0, 565.0)125.5(29.0, 456.0)197.0(44.0, 713.0)Lipoarabinomannan (LAM), MD (IQR)1.0(1.0, 1.0)1.0(1.0, 1.0)1.0(1.0, 1.0)GeneXpert- Positive Results, n (%)13 (16.7)7 (14.9)6 (21.1)Abbreviation: M: Mean; SD: Standard Deviation; MD: median; IQR: Inter-quartile RangeCOVID-19 has been reported to cause adrenal insufficiency. For instance, as per the publication entitled “Adrenal insufficiency in coronavirus disease 2019: a case report” published in August 2020, this has been suggested that COVID-19 patients develop sepsis and they are likely to develop vasopressor-resistant hypotension that is one of the cause leads to adrenal insufficiency. This has been reported that cancer, hemorrhage, thrombosis, autoimmune issues and infection among other cause leads to sepsis development and enhances the cortisol demand in the body which results to adrenal insufficiency. Moreover the data provided also concluded that excessive production of interleukins and TNF factors influences the hypothalamic-pituitary-adrenal (HPA) axis that in turn leads to decreased production of ACTH and impairment of ACTH function and angiotensin function on adrenal cells. Moreover this has also been reported that that an older member of the Coronaviridae family produces a certain kind of amino acid which mimicks the host ACTH and causes host body to produce antibody against the ACTH peptide that again causes adrenal insufficiency.This, thus suggests that patients infected with COVID-19 are subjected to adrenal insufficiency especially due to development of vasopressor-resistant hypotension.This has been reported that the older people and people having pre-existing medical conditions such as diabetes, asthma among others are more vulnerable to prevailing COVID-19. Moreover, ACTH deficiency has also been reported among individuals of any age but most likely to occur among geriatric population aged between 30 to 50 years. Hence with the rising geriatric population the COVID-19 infection expected to increase and likely to enhance the cases of adrenal insufficiency.Adrenal insufficiency is one of the leading causes of mortality among worldwide population with reported cases of 0.5 per 100 patients per year.Figure: 1 Adrenal Gland Disorders (2002-2017) Among U.S PopulationThe rising patient population suffering from Addison diseases (a complication associated with ACTH deficiency) also enhancing the demand of effective therapy for treatment of ACTH deficiency.As the prevalence of adrenal gland disorder is increasing across several regions worldwide it has become important to provide patients with proper medicines and advanced therapies during the prevailing pandemic of COVID-19, this is the reason why pharmaceutical companies and government are taking several steps in order to deal with cumbersome condition.PRICE IMPACTAs no treatment has been discovered yet for coronavirus, the fear of getting infection led the people to remain safe at their home, as a result of which various businesses around the world is suffering a lot involving pharmaceutical companies among others.ACTH deficiency can be treated by administration of hydrocortisone or prednisolone which are corticosteroids. Several market players including Breckenridge Pharmaceutical, Inc., Hikma Pharmaceuticals plc, Pfizer, Inc., Mylan Pharmaceuticals, Inc., and Sandoz, Inc., among others are engaged in the manufacturing of advanced products and therapies so that the suffering patient population can lead a normal and lavish life. As generic hydrocortisone and prednisolone are available in the market, a large patient population relies on those due to their cost-effectiveness.This has been reported that during the pandemic of COVID-19 such drugs have met a price hike. Hydrocortisone and prednisolone have been categorized under Category A by NHS and are currently encountering no governmental controls over the manufacturing and price. Drug category A involves 33 products including hydrocortisone, phenytoin, and nitrofurantoin among others. As per the data provided by NHS these drugs have experienced a price hike during the pandemic due to particular concern in these times when health services are under immense financial pressures to provide funds and financial help for vaccine development to fight against the prevailing COVID-19. During the COVID pandemic, the price of hydrocortisone drugs increased by 671% to 602%.The news published by Xtelligent Healthcare Media, LLC in July 2020 suggested that pharmaceutical companies have raised drug prices during the COVID-19 pandemic with more than 75 percent of drug impacted directly. Corticosteroids are widely used for conducting clinical trials for COVID-19 that led to a shortage of these drugs which led market players to enhance their drug prices. Horizon Pharmaceutical enhanced the price of prednisone by 4.6 percent in 2020 which boosted the drug price to USD 2,762 in February; moreover Par Pharmaceutical enhanced the vasopressin drug price to USD 197 in February.This, thus signifies that due to increased usage of these drugs for clinical trials of COVID-19 led to drug shortage which is responsible for enhanced drug prices.IMPACT ON DEMANDThe coronavirus has affected the various regions of the world and caused widespread closure of companies and local manufacturing plants. This lockdown and isolation has adversely impacted the global economic activity.COVID-19 is expected to be an opportunity for ACTH deficiency market, as the patients having endrocrinological disorders are at an increasing risk of getting COVID-19 infection. Moreover patients grasped with COVID-19 infections are expected to suffer from pituitary gland damage that causes less production or deficiency of ACTH in affected population.THE IMPACT OF COVID-19 INFECTION ON ENDOCRINE AND METABOLIC PROCESSCOVID-19 infection adversely impacts the different endocrine glands/organs. This has been reported that COVID-19 affects the hypothalamic-pituitary dysfunction and causes alterations in antidiuretic hormone metabolism. The adrenal gland is also very much susceptible to COVID infections; moreover, the pituitary gland is also likely to get affected by COVID-19 that leads to abnormal secretion of ACTH.As COVID-19 leads to impairment of pituitary gland function it ultimately leads to disruption of the function of the adrenal gland that is known as adrenal insufficiency. The pituitary gland produces ACTH hormone, a deficiency of which affects the concentration of cortisol produced by the cortex of the adrenal gland. People suffering from adrenal insufficiency are at increased risk of acquiring COVID-19 infections, hence demand effective treatment and therapies amid the pandemic. Moreover, patients are also recommended to rely on hydrocortisone injection prescribed to patients suffering from ACTH deficiency.As COVID-19 infection leads to impairment of pituitary gland function, the affected population usually looks for proper gland functioning. In order to control ACTH deficiency, the patients usually rely on advanced medicines and hormonal therapies.Moreover, corticosteroids have shown a higher potential to reduce the COVID-19 related complications, which is another factor that led to the drug shortage and hence enhanced the overall drug demand.This suggests that the increasing prevalence of COVID-19 enhances the chances of pituitary gland impairment that leads to a lack of ACTH production. ACTH deficiency leads to adrenal insufficiency among other complications. This thus signifies that COVID-19 is accelerating the demand of the ACTH deficiency market.IMPACT ON SUPPLYDue to obstinate COVID-19 lockdown, sanctions have been imposed by governments of several countries across the world. These restrictions and barriers across countries borders adversely impacted the import and export activities that have led to a decrease in supply of APIs needed for drug manufacturing.China is considered to be the manufacturing hub of most of the APIs demanded by India among other countries. India and the U.S heavily dependent on China for APIs needed for manufacturing of drugs and therapies.The U.S largely depends on China and India for 80% of its pharmaceutical APIs supplies. U.S imports approximately 91% of hydrocortisone from China, which is indicated for treatment of ACTH deficiency.Moreover market players are also experiencing supply chain disruptions amid COVID-19 pandemic.For instance,As per the news published on February 2020, this has been reported that Mylan NV is experiencing drug shortage due to continuous spread of COVID-19 infections and lowered the company shares by 3.6%. Moreover the company is also facing logistical issues which are disrupting the drug supplies to destination. Along with this Pfizer is also facing adverse impact on its manufacturing and supply chain capabilities due to prevailing pandemic situations.However several authorities are adopting initiatives in order to overcome such challenges. FDA warned that drugs shortage can occur due to problems associated with product manufacturing delays and discontinuation. This is why FDA is continuously monitoring the drug supply chain so as to provide patients with effective drugs and therapies even during the COVID-19 pandemic.This thus signifies that due to continuous lockdown and several restrictions by government authorities the companies and patients are facing disruption of supply chain for raw materials. However close monitoring of supply chain allowing them to combat such disruptions.STRATEGIC DECISIONS of MANUFACTURERSCollaboration, agreements, strategic initiatives by market players such as Horizon Therapeutics plc, Pfizer Inc., and Mylan NV among others in the ACTH deficiency market will help them to expand their product portfolio and to provide with appropriate solutions to physicians and patients. This in turn will lead to increasing product sales and hence will put a positive impact on overall company’s revenue.ACTH deficiency treatment drug manufacturers are taking so many strategic decisions in order to cope up with the current scenario of COVID-19. The companies engaged in manufacturing of hydrocortisone, prednisone among others are collaborating, opting acquisition among others so as to accelerate the development of medicines and devices.Companies have already taken several kinds of strategic initiatives in order to cope up with the corona virus situation. For instance,In February 2021, Horizon Therapeutics plc signed an agreement for acquisition of Viela Bio, Inc., a company focused on manufacturing of advanced and novel therapies to fight against the prevailing diseases. This acquisition allowed the company to strengthen its existing product portfolio and to accelerate the research and development activities. Moreover this initiative allowed the company to overcome the uncertainty arose due to COVID-19 impact.In January 2021, Hikma Pharmaceuticals PLC signed an acquisition agreement with GlaxosmithKline plc. As per the agreement the company is expected to acquire GlaxosmithKline plc assets of Egypt and Tunisia. This initiative paved the way for the company to boost up its product manufacturing and commercialization capabilities.In January 2020, Breckenridge Pharmaceutical, Inc. became the subsidiary of Towa Pharmaceutical Co., Ltd., a company highly focused on research and development, production and commercialization of generic drugs in Japan. This initiative strengthened the company research and development activities and helped it to attain a lucrative growth during the COVID-19 pandemic by working with a giant pharmaceutical company.With the increasing demand and increasing sales of hydrocortisone, prednisone among other steroids, are fueling the growth of ACTH deficiency market.Thus, companies operating in the ACTH deficiency market are adopting several strategies, including collaboration, agreements, market expansion to enhance their business. These strategic decisions by the companies are expected to provide significant opportunities for the market players operating in the ACTH deficiency market.CONCLUSIONAs the pandemic of COVID-19 has resulted in several restrictions throughout the borders but still, manufacturers of ACTH deficiency treatment medicines can manage their stocks. Various manufacturers have allowed their manufacturers to work remotely for the manufacturing of hydrocortisone, prednisone among other medicines at various manufacturing facilities across safe regions of the world helping them to maintain a continuous supply chain. Moreover, by raising the price of hydrocortisone and prednisone the companies are gaining extra profit which is helping them to combat the negative effect on overall revenue.