Global Adrenocortical Hormone API Market - 2024-2031
The global adrenocortical hormones API market reached US$ YY million in 2023 and is expected to reach US$ YY million by 2031, growing at a CAGR of YY% during the forecast period 2024-2031.
The global adrenal cortex produces and releases steroid molecules known as adrenocortical hormones. Corticosteroids and androgens are two types of steroids produced by the adrenal cortex. The pituitary gland produces a hormone called adrenocorticotropic hormone (ACTH). Its primary purpose is to stimulate the generation and release of cortisol from the cortex of the adrenal gland.
It is secreted into the bloodstream in multiple intermittent pulses during the day and distributed throughout the body. Adrenocorticotropic hormone (ACTH) and angiotensin control the secretion of adrenocortical steroids and aldosterone, respectively.
Corticosteroids affect glucose, protein, and lipid metabolism, fluid and electrolyte balance, and the maintenance of normal cardiovascular, immunological, renal, endocrine, neurological, and musculoskeletal systems function. Both corticosteroids and androgens are produced in large quantities in the adrenal cortex. On the other hand, patients with adrenal insufficiency can be recovered to a normal life expectancy with corticosteroid replacement therapy alone.
Market Dynamics: DriversThe Use of Adrenocortical Hormones in Different Treatments
The demand for the adrenocortical hormones API market is driven by multiple factors. Children with intractable seizures who are resistant to standard antiepileptic medicines may benefit from ACTH therapy. However, more research is needed to determine ACTH's long-term efficacy in the treatment of intractable seizures.
Epilepsy and epileptic syndromes are a diverse collection of disorders that affect children under the age of 13 and have a prevalence of 5.3- 8.8 per 1000. All conventional antiepileptic medications are resistant in 20 percent to 25 percent of epileptic individuals. A therapeutic failure of seizure independence in response to two well-tolerated and correctly chosen antiepileptic medications at moderate doses is classified as an intractable seizure.
The intractable seizure was defined as having a high frequency of seizures and a long period of uncontrolled epilepsy. Although corticosteroids and adrenocorticotropic hormone (ACTH) are used to treat various epilepsies and epileptic syndromes, their usefulness in managing refractory seizures other than spasms has only been explored in a few trials. Other epilepsies, such as infantile spasms, can benefit from ACTH therapy. Children with various childhood epilepsy who may not respond to standard seizure medications may benefit from adrenocorticotropic hormone (ACTH) treatment.
ACTH is used to treat infantile spasms Lennox-Gastaut syndrome, Landau-Kleffner syndrome, and sleep-related electrical status epilepticus. After treatment with ACTH, even the most difficult-to-manage epilepsy can notice an improvement in seizure control. The development of the youngster may also improve. It is long-acting when used in gel form (by injection). Therefore it can be administered once or twice a day. Parents are trained on how to administer the injection so that the kid can remain at home during therapy. Injections are typically given once a day for six weeks.
Moreover, key players in the market introducing new APIs for treatment would propel the market growth. For instance, in November 2022, TIEFENBACHER PHARMACEUTICALS launched a generic version of the prostate cancer medicine Abiraterone and the value-added product Abiraterone/Prednisolone.
Restraints
Factors such as the high cost of the development, stringent regulatory requirements, lack of availability of raw materials, competition from generics and biosimilars, and complex biochemical processes involved in the synthesis and manufacture of these APIs, are expected to hamper the market.
Segment AnalysisThe adrenocortical hormones API market is segmented based on type, route of administration, and region.
The glucocorticoids segment accounted for approximately 45.3% of the adrenocortical hormones API market share
The glucocorticoids segment is expected to hold the largest market share over the forecast period. Glucocorticoids are corticosteroid hormones that suppress the immune system and reduce inflammation. Unlike anabolic steroids (used by ""bodybuilders""), Corticosteroids are utilized in inflammatory disorders to reduce inflammation.
They have a quick beginning of action and have a significant impact on many aspects of the immune system as well as the majority of other body systems. Most kinds of vasculitis are treated with corticosteroids, which are frequently combined with other immunosuppressive drugs. Prednisolone is used to treat allergies, blood disorders, skin illnesses, infections, and certain malignancies and to avoid organ rejection following a transplant.
It aids in the reduction of inflammation. It also lowers your immune system's activity, which can help with autoimmune diseases like rheumatoid arthritis, in which the immune system targets its tissues. Prednisolone is only available as a pill and a liquid to consume on prescription. It can also be administered through injection; however, this is normally done in a hospital setting.
For instance, in February 2021, Strides Pharma Science Limited (Strides) saw its stock rise 3% after the US Food and Drug Administration approved Prednisone Tablets USP, 10 mg and 20 mg (USFDA).
Geographical AnalysisNorth America accounted for approximately 41.1% of the adrenocortical hormones API market share
North America region is expected to hold the largest market share over the forecast period. Owing to the increasing pharmaceutical investments and FDA approvals in this region is estimated to dominate the market.
One of Canada's most inventive businesses in the pharmaceutical industry. It comprises companies that develop and manufacture novel medicines, generic pharmaceuticals, and over-the-counter medications.
Isturisa (osilodrostat) oral tablets were approved by the US Food and Drug Administration for adults with Cushing's disease who cannot undergo pituitary gland surgery or have had surgery but still have the disease. Cushing's disease is an uncommon condition in which the adrenal glands produce excessive amounts of cortisol. Isturisa is the first FDA-approved medicine to directly target cortisol overproduction by inhibiting the enzyme 11-beta-hydroxylase and stopping cortisol manufacture.
According to TouchEndocrinology research publication in December 2023, Osilodrostat has recently achieved an emerging role in the medical treatment of CS based on the relevant efficacy and safety data, which demonstrated a rapid control of cortisol secretion in a consistent number of cases, with a sustained improvement in the clinical picture and a good safety profile.
Adrenocortical hormones API market share is being propelled by the increasing need for rising spending on pharmaceuticals and clearances from the FDA, which are all factors fueling this region's expanding industry.
COVID-19 Impact Analysis
The COVID-19 pandemic significantly impacted the adrenocortical hormones API market. To stop its spread, government-imposed lockdown. People are fearful they may experience occupational effects and negative health from the COVID-19 pandemic. Like influenza viruses, SARS-CoV-2 causes viral amino acid expression that resembles molecules of the host's ACTH. Antibodies produced against viruses due to molecular similarity bind to viral amino acids and the host's ACTH. This binding inhibits the host's ACTH's ability to stimulate corticosteroid secretion in response to stress.
The SARS-CoV was discovered in the adrenal glands, indicating that the virus has a direct cytopathic effect. As a result, cortisol dynamics may be altered in SARS and COVID-19 patients. This has partially impacted the adrenocortical hormones API market.
As per NCBI research publication in January 2021, this binding prevents the host's ACTH from stimulating the release of corticosteroids in response to stress. The fact that the SARS-CoV was found in the adrenal glands proves that the virus directly causes cytopathic damage. Cortisol dynamics may be changed in SARS and COVID-19 patients as a result. Aside from that, the companies' business operations have been affected by the outbreak, which affects the overall adrenocortical hormones API industry. This has partially impacted the adrenocortical hormones API industry.
Market SegmentationBy Type
• Glucocorticoid
• Betamethasone
• Hydrocortisone
• Mineralocorticoids
Fludrocortisone
• Others
By Route of Administration
• Injectable Drugs
• Oral Drugs
• For External Use Drugs
• Inhalation Drugs
By Region
• North America
U.S.
Canada
Mexico
• Europe
Germany
U.K.
France
Spain
Italy
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
South Korea
Rest of Asia-Pacific
• Middle East and Africa
Competitive LandscapeThe major global players in the adrenocortical hormones API market include Sanofi, Pfizer CentreOne, GlaxoSmithKline, Symbiotec Pharmalab, Sun Pharmaceutical, Cipla, Hovione, Teva Pharmaceuticals Pvt Ltd, Tianjin Pharmaceutical Group Co. Ltd, Great Pacific Exports among others.
Key Developments On January 11, 2023, AstraZeneca launched the Airsupra (albuterol/budesonide), formerly known as PT027, which has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.
On August 3, 2021, Sanofi entered into a definitive agreement with Translate Bio to acquire all outstanding shares of Translate Bio for $38.00 per share in cash, representing a total equity value of approximately $3.2 billion, as part of its efforts to accelerate the application of messenger RNA (mRNA) to develop therapeutics and vaccines (on a fully diluted basis). The deal was approved by the boards of directors of Sanofi and Translate Bio.
On March 31, 2021, Piramal Pharma Solutions (PPS) expressed its plan to purchase API manufacturer Hemmo Pharmaceuticals for a total of Rs 775 crore. Through this acquisition, PPS expanded its operations to include the development and production of peptide APIs. Hemmo was one of the few companies solely focused on manufacturing synthetic peptide APIs on a global scale.
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• To visualize the adrenocortical hormones API market segmentation based on type, route of administration, and region, as well as understand key commercial assets and players.
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The adrenocortical hormones API market report would provide approximately 54 tables, 46 figures, and 183 Pages.
Target Audience 2024
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies