Addison's Disease Therapeutics Market to Grow by USD 442.4 Million (2024-2028) as Special Drug Designations Drive Growth, with AI Redefining the Market Landscape - Technavio

NEW YORK, Sept. 23, 2024 /PRNewswire/ -- Report with market evolution powered by AI - The global addisons disease therapeutics market size is estimated to grow by USD 442.4 million from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of almost 6.59%  during the forecast period. Special drug designations is driving market growth, with a trend towards expanding research into development of regenerative therapy  However, delayed diagnosis  poses a challenge - Key market players include Abbott Laboratories, Actiza Pharmaceutical Pvt. Ltd., Akorn Operating Co LLC, Amgen Inc., Amneal Pharmaceuticals Inc., Bayer AG, Bio Techne Corp., Biogen Inc., Boehringer Ingelheim International GmbH, Bristol Myers Squibb Co., BTL Biotechno Labs Pvt. Ltd., Eli Lilly and Co., GlaxoSmithKline Plc, Hikma Pharmaceuticals Plc, Lupin Ltd., Merck and Co. Inc., Neurocrine Biosciences Inc., Novartis AG, Pfizer Inc., and Takeda Pharmaceutical Co. Ltd..

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Market Driver

Addison's Disease is a rare endocrine disorder characterized by the destruction of the adrenal glands, leading to a deficiency of cortisol and aldosterone. Current treatment options involve the long-term use of exogenous corticosteroids, which come with harmful side effects such as muscle weakness, facial hair growth, headache, and glaucoma. To mitigate these side effects, researchers are exploring regenerative therapies, specifically stem cell therapy. Stem cells, due to their tissue regenerative properties, hold promise for regenerating destroyed adrenal tissues. Rodent studies suggest the presence of adrenocortical progenitor or stem cells in the adrenal cortex, which can be stimulated by adrenocorticotropic hormone (ACTH). Allogeneic stem cell transplantation is a promising approach for Addison's Disease, potentially eliminating the need for corticosteroids. Pre-clinical studies are underway using embryonic, bone marrow-derived, and mesenchymal stem cells from adipose tissue and umbilical cord. The market for these therapies is expected to grow significantly once approved, as they offer a definitive treatment solution. 

The Addison's Disease therapeutics market is experiencing significant growth due to the rising incidences of this chronic disease among patients with adrenal system disorders. According to the Eurordis International Survey, rare disease patients often face challenges such as canceled or postponed appointments and underdiagnosis. This can lead to acute active infections and hospitalization. Adrenal insufficiency, a key symptom of Addison's Disease, can result from various causes including tuberculosis and latent tuberculosis infection. Effective treatment involves hormone replacement therapy with medications like hydrocortisone, prednisone, methylprednisone, fludrocortisone acetate, cortisol, and aldosterone. Non-healthcare businesses and individuals need to be aware of the signs and symptoms to prevent adrenal crisis. The oral segment dominates the market with corticosteroids being the primary treatment. Key indications include Central Sleep Apnea and Obstructive Sleep Apnea. Hospitals, Ambulatory Surgical Centers, and Office Based Clinics are major end-users. The healthcare infrastructure must be strengthened to address the hypertrophy of the adrenal cortex, granulomas, and adrenal crisis. Diurnal, a leading company, offers innovative solutions for hormone replacement therapy. The growing awareness of adrenal tuberculosis and adrenal cortex diseases will further boost market growth. 

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 Market Challenges

• Addison's disease is a rare endocrine disorder characterized by the deficiency of cortisol and mineralocorticoids, leading to various subtle and nonspecific symptoms. These symptoms include hyperpigmentation, fatigue, anorexia, orthostatic intolerance, nausea, muscle and joint pain, and salt craving. The lack of awareness about these symptoms, particularly in developing countries, can result in diagnostic delays at the patient level. At the primary and secondary care levels, Addison's disease is often misdiagnosed due to symptoms similar to conditions such as chronic fatigue syndrome, depression, hypothyroidism, fibromyalgia, and chronic dyspepsia. This misdiagnosis can lead to the progression of the disease to chronic stages, limiting the effectiveness of hormonal replacement therapy and increasing mortality. The global market for Addison's disease therapeutics may be hampered due to these diagnostic delays and the associated morbidity and mortality.
• Addison's Disease, a hormonal disorder affecting the adrenal gland, presents significant challenges for the therapeutics market. Causes include infections and damage to the adrenal gland, leading to adrenal crises and symptoms such as extreme fatigue, salt cravings, abdominal pains, nausea, and hyperpigmentation. Biotech companies like Antares Pharma, Spruce Biosciences, and Recorlev are developing new treatments, including the Fast Track designation for Recorlev and the Vai auto-injector platform. However, patient compliance, outcomes, and high costs remain concerns. Genetic testing and biomarker identification are crucial for early diagnosis and personalized treatment. Drug delivery systems, such as hydroxychloroquine, are being explored for vaccine development. Reimbursement policies and drug misuse also impact market demand. Self-reacting autoimmune cells pose additional challenges. Investment pockets lie in innovative drug delivery systems, biomarker identification, and vaccine candidates.

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This addisons disease therapeutics market report extensively covers market segmentation by  

1. Therapy 
• 1.1 Oral drugs
• 1.2 Parenteral drugs
2. End-user 
• 2.1 Hospitals and clinics
• 2.2 Diagnostic laboratories
3. Geography 
• 3.1 North America
• 3.2 Europe
• 3.3 Asia
• 3.4 Rest of World (ROW)

1.1 Oral drugs-  Addison's disease is a rare endocrine disorder characterized by the underproduction of certain hormones by the adrenal glands. The therapeutic market for Addison's disease focuses on providing effective treatments to manage symptoms and maintain the health of patients. Key treatments include hydrocortisone replacement therapy, fludrocortisone, and mineralocorticoids. Pharmaceutical companies are developing new formulations and delivery methods to improve patient outcomes and quality of life. The market is expected to grow due to increasing awareness and diagnosis rates, as well as the aging population.

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Research Analysis

Addison's disease, a chronic condition affecting the adrenal system, impacts various organ systems and results in extreme fatigue, salt cravings, abdominal pains, nausea, and other symptoms. Acute active infections or stressors can lead to Addisonian crisis, requiring hospitalization. The therapeutic market for Addison's disease includes various settings such as Hospitals, Ambulatory Surgical Centers, and Office Based Clinics. Central Sleep and Obstructive Sleep Apnea are common comorbidities. The pipeline analysis focuses on hormone replacement therapy with glucocorticoids being the primary treatment. Other symptoms like hyperpigmentation, lightheadedness, and severe gastrointestinal problems are also managed through symptomatic care. Non-healthcare businesses are exploring opportunities in this market by providing supportive devices and nutritional supplements.

Market Research Overview

Addison's disease, also known as primary adrenal insufficiency, is a chronic condition affecting the adrenal system, which regulates various organ functions including metabolism, immune function, and blood pressure. This rare disease primarily affects chronic disease patients, with rising incidences due to growing awareness and underdiagnosis. Adrenal insufficiency results from damage to the adrenal gland, often caused by tuberculosis or autoimmune disorders. Acute active infections, hospitalization, and canceled/postponed appointments can worsen the condition, leading to adrenal crises. Effective treatment includes hormone replacement therapy with corticosteroids such as hydrocortisone, prednisone, methylprednisone, and fludrocortisone acetate, which replace the deficient cortisol and aldosterone. The oral segment holds a significant market share, with key medications including corticosteroids and hormonal therapies. The pipeline analysis for Addison's disease includes innovative drugs like Recorlev, Levoketoconazole, and Tildacerfont, which are under development. The regulatory framework and rising healthcare expenditure are driving the growth of the Addison's disease therapeutics market. Non-healthcare businesses and patients are also contributing to the market through the development of drug delivery systems, genetic testing, and biomarker identification to improve patient compliance and outcomes. The market is expected to grow due to the increasing number of cases, particularly in males and females, and the need for effective treatment options. Adrenal tuberculosis, adrenal cortex hypertrophy, granulomas, and adrenal crisis are some of the indications for Addison's disease treatment. The disease can also manifest as Central Sleep Apnea or Obstructive Sleep Apnea, requiring treatment in Hospitals, Ambulatory Surgical Centers, and Office Based Clinics. The market is expected to witness significant growth due to the increasing awareness and the development of new treatments and drug delivery systems.

1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation

• Therapy
• Oral Drugs
• Parenteral Drugs
• End-user
• Hospitals And Clinics
• Diagnostic Laboratories
• Geography
• North America
• Europe
• Asia
• Rest Of World (ROW)

7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Trends
10 Company Landscape
11 Company Analysis
12 Appendix

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SOURCE Technavio