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The addisons disease therapeutics market size is forecast to increase by USD 442.4 million at a CAGR of 6.59% between 2023 and 2028. The market is witnessing significant growth due to several key factors. One such factor is the special drug designations granted by regulatory authorities for the treatment of Addison's disease, providing incentives for pharmaceutical companies to invest in research and development. Another trend influencing the market is the expanding research into the development of regenerative therapies, which hold promise in restoring the function of damaged adrenal glands. However, the delayed diagnosis of Addison's disease remains a significant challenge, leading to a lack of timely treatment and poor patient outcomes. Despite these challenges, the market is expected to grow steadily due to the increasing prevalence of Addison's disease and the development of new and innovative treatment options.
Addison's disease, a chronic condition affecting the adrenal system, impacts the function of various organ systems in chronic disease patients. According to a recent Eurordis international survey, the prevalence of Addison's disease is estimated to be around 1 in 100,000 individuals. The disease is characterized by extreme fatigue, salt craving, abdominal pains, nausea, and various symptoms related to adrenal insufficiency. The therapeutic landscape for Addison's disease primarily consists of hormone replacement therapy using glucocorticoids. In acute active infection or during an Addisonian crisis, hospitalization may be necessary. Hospitals, ambulatory surgical centers, and office-based clinics are common settings for the diagnosis and treatment of Addison's disease.
Furthermore, pipeline analysis reveals several potential therapeutic approaches, including the development of new formulations and delivery systems for hormone replacement therapy. Central sleep apnea and obstructive sleep apnea are common comorbidities in Addison's disease patients, necessitating the involvement of non-healthcare businesses in the development of solutions for these conditions. Symptoms such as hyperpigmentation, lightheadedness, and severe gastrointestinal problems require ongoing management to ensure the quality of life for patients with Addison's disease. The market is expected to grow due to the increasing awareness and diagnosis of the disease, as well as the development of new treatments.
The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million" for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.
The oral drugs segment is estimated to witness significant growth during the forecast period. Addison's disease, an endocrine disorder characterized by damage to the adrenal gland, results in a deficiency of hormones such as aldosterone and cortisol, leading to symptoms like fatigue, weight loss, muscle weakness, and autoimmune disorders. The therapeutic landscape for Addison's disease includes hormone replacement therapy, which involves administering synthetic hormones to replace the deficient ones. Pipeline analysis of Addison's disease therapeutics reveals several innovative drugs under development. For instance, Antares Pharma's Vai auto-injector platform is under Fast Track designation for Recorlev, a dexamethasone subQ injection for the prevention of adrenal insufficiency in adults. Similarly, Spruce Biosciences' Tildacerfont is a selective glucocorticoid receptor antagonist for the prevention of adrenal insufficiency in pediatric patients.
Hospitals, ambulatory surgical centers, and office-based clinics are major settings for the diagnosis and treatment of Addison's disease. The regulatory framework for these therapeutics is stringent due to the critical role of hormonal balance in metabolism, immune function, and blood pressure. Rising healthcare expenditure and the need for patient-centric drug delivery systems, genetic testing, and biomarker identification are driving the market growth. Pharmaceutical companies are focusing on developing patient-compliant drugs to improve patient outcomes.
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The oral drugs segment was valued at USD 728.70 million in 2018 and showed a gradual increase during the forecast period.
North America is estimated to contribute 41% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.
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Addison's disease, an endocrine disorder characterized by adrenal gland damage leading to deficiencies in hormones such as aldosterone and cortisol, affects both males and females. Symptoms include fatigue, weight loss, muscle weakness, autoimmune disorders, and susceptibility to infections, which can culminate in adrenal crises. The therapeutic landscape for Addison's disease includes hormone replacement therapy and innovative drugs under development. Pipeline analysis reveals several promising treatments, including Regulatory framework-approved drugs like Recorlev from Antares Pharma, a hormone replacement therapy delivered via the Vai auto-injector platform. Other notable drugs include Levoketoconazole from Spruce Biosciences and Tildacerfont from Vifor Pharma, all aimed at addressing metabolic and immune function disruptions.
Furthermore, the rising healthcare expenditure and growing awareness of the disease have attracted the attention of pharmaceutical companies, leading to increased investment in research and development. Drug delivery systems, genetic testing, and biomarker identification are crucial areas of focus to improve patient compliance and outcomes. The regulatory framework plays a significant role in ensuring the safety and efficacy of these treatments. In summary, the Addison's disease therapeutics market is witnessing significant growth due to the development of innovative drugs and the increasing focus on patient-centric approaches. Regulatory frameworks, healthcare expenditure, and patient outcomes remain key factors shaping the market's trajectory.
Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
Special drug designations is the key driver of the market. Addison's disease, a rare autoimmune disorder, is characterized by extreme fatigue, salt cravings, abdominal pains, nausea, and various symptoms leading to the Addisonian crisis, including lightheadedness and severe gastrointestinal problems. Patients require medication, including glucocorticoids like methylprednisolone, mineralocorticoids, and androgens, for symptom management.
Furthermore, biotech companies are exploring vaccine development as a potential solution, with several vaccine candidates under investigation. The demand for these medications has risen due to the high costs and limited treatment options. Reimbursement policies and drug misuse pose challenges while self-reacting autoimmune cells complicate treatment. Hydroxychloroquine and other immunosuppressive drugs are sometimes used off-label to manage symptoms. Despite these challenges, investment pockets exist for companies committed to developing effective treatments for Addison's disease.
The expanding research into the development of regenerative therapy is the upcoming trend in the market. Addison's Disease, a chronic and rare endocrine disorder, is characterized by extreme fatigue, salt cravings, abdominal pains, nausea, and various other symptoms such as lightheadedness and severe gastrointestinal problems during an Addisonian crisis. Long-term treatment involves the administration of glucocorticoids, mineralocorticoids, and androgens as medication. However, the prolonged use of these drugs can lead to harmful side effects, including muscle weakness, moon face, headache, facial hair growth, and glaucoma. To mitigate these side effects and potentially cure Addison's Disease, researchers are exploring regenerative therapies.
Furthermore, these treatments, which have minimal side effects and a curative nature, are gaining popularity. Various research institutions and biotech companies are investing in the development of regenerative medicines for treating not only rare diseases like Addison's but also chronic illnesses such as central nervous system disorders, cardiovascular disorders, and cancers. Hydroxychloroquine and methylprednisolone are among the current medication options. However, the high costs and reimbursement policies pose challenges to the demand rise for these drugs. Moreover, the risk of drug misuse due to their potent nature is a concern. The focus on vaccine development and vaccine candidates is another area of investment in the Addison's Disease therapeutics market.
The delayed diagnosis is a key challenge affecting the market growth. Addison's disease, a rare autoimmune disorder, results in the deficiency of cortisol and mineralocorticoids, leading to a range of symptoms. These symptoms, including extreme fatigue, salt cravings, abdominal pains, nausea, and lightheadedness, can be subtle and nonspecific, often leading to misdiagnosis. Severe gastrointestinal problems and joint and muscle pain may also occur. In some cases, an Addisonian crisis, a life-threatening adrenal insufficiency episode, can occur due to diagnostic delays. Hyperpigmentation is a common symptom, but it may not always be present. The disease is caused by self-reacting autoimmune cells that attack the adrenal glands, leading to a deficiency in glucocorticoids, mineralocorticoids, and androgens.
Moreover, current treatment involves the use of medication, including glucocorticoids like methylprednisolone and mineralocorticoids. Biotech companies are exploring vaccine development as a potential solution, with several vaccine candidates in the pipeline. However, high costs and reimbursement policies pose challenges to drug demand. The misuse of medication and the potential for addiction to glucocorticoids are also concerns. Hydroxychloroquine is sometimes used off-label to manage symptoms.
The market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.
Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
Actizapharma- The company offers Addison's disease therapeutics such as AXSYM Cortisol. Also, the company is involved in manufacturing, exporting, and distributing generic, branded, and other allied pharmaceutical products.
The market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
Addison's disease, a chronic condition affecting the adrenal system, impairs the function of the organ systems responsible for producing cortisol and aldosterone. The Eurordis international survey reported that chronic disease patients with Addison's disease face numerous challenges, including acute active infections leading to hospitalization and canceled/postponed appointments. The rising incidences of Addison's disease and growing awareness of adrenal insufficiency have led to increased healthcare expenditure.
Furthermore, non-healthcare businesses and the lack of awareness among healthcare providers contribute to the underdiagnosis of this rare disease. Effective treatment involves the use of treatment medications such as hydrocortisone, prednisone, methylprednisone, fludrocortisone acetate, cortisol, and aldosterone. Adrenal tuberculosis, a significant cause of Addison's disease, can lead to adrenal cortex hypertrophy, granulomas, and adrenal crisis. Central sleep apnea is also an indication of Addison's disease. The oral segment holds a significant market share in the therapeutics market for Addison's disease. The onset of Addison's disease can be acute or chronic, and tuberculosis cases and latent tuberculosis infection can trigger the disease.
Market Scope |
|
Report Coverage |
Details |
Page number |
166 |
Base year |
2023 |
Historic period |
2018-2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 6.59% |
Market Growth 2024-2028 |
USD 442.4 million |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
6.07 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 41% |
Key countries |
US, Germany, UK, Japan, and Canada |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
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. |
Market dynamics |
Parent market analysis, market growth inducers and obstacles, market forecast, fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, market condition analysis for the forecast period |
Customization purview |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Therapy
7 Market Segmentation by End-user
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Opportunity/Restraints
11 Competitive Landscape
12 Competitive Analysis
13 Appendix
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