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The Global Addison's disease therapeutics market size is estimated to grow by USD 442 million, at a CAGR of 6.93% between 2022 and 2027. Factors such as the reformulation of drugs, production of special drug designations, and advanced diagnostics procedures are helping patients fight Addison's disease which in turn is driving the market growth. Additionally, diagnostic tests as clinical guidelines are also influencing the market growth. Vendors are also focussing on the production of oral drugs and parenteral drugs to treat the disease. With new innovations, competitors are expected to face high challenges in the market. For instance, Leading vendors such as Pfizer Inc. and Merck and Co. Inc., are expected to face huge competition from the emerging vendor, Diurnal. Diurnal received regulatory approvals for its products Alkindi and Chronocort and has already launched these products in the major market, including the US, Europe, and Japan. Such launches associated with the entry of new players are expected to lead the market toward further fragmentation during the forecast period.
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Patients with rare diseases often face significant challenges due to the lack of healthcare services and specialized treatments. Conditions affecting the adrenal system and other organ systems can lead to severe symptoms such as extreme fatigue, salt craving, abdominal pains, and even life-threatening events like the Addisonian crisis. According to the Eurordis International Survey, chronic disease patients, including those with rare diseases, require tailored hormone replacement therapy and ongoing medical management. Pipeline analysis for new treatments aims to address these unmet needs, offering hope for improved outcomes. Patients may require care in various settings including Ambulatory Surgical Centers and Office Based Clinics, depending on the severity of their condition and the need for acute active infection management or hospitalization. Glucocorticoids are commonly used to manage symptoms and prevent further damage to the adrenal glands. Early diagnosis and access to appropriate treatment are critical for managing symptoms like lightheadedness and severe gastrointestinal problems associated with adrenal insufficiency.
Key Driver
The special drug designation is the key factor driving the global Addison's disease therapeutics market growth. Under the Orphan Drug Act (ODA) of 1983, the drugs indicated for treating rare diseases are referred to as 'orphan drugs.' In the US, a rare disease is defined as a condition that affects less than 200,000 people. Similarly, in the EU, a disease is defined as rare if it affects less than five in 10,000 people.
Moreover, the rare diseases are not as prevalent as mainstream conditions, such as diabetes, asthma, and hypertension. Hence, manufacturers often hesitate to invest large amounts in the research and development (R&D) of drugs for the treatment of rare diseases such as neuroblastoma. Federal regulatory bodies such as the US FDA support manufacturers through public programs, acts, policies, and other incentives to encourage the development of drugs to treat rare diseases. This, in turn, drives market growth.
Key Trend
The expanding research into the development of regenerative therapy will fuel the global Addison's disease therapeutics market growth. The current treatment options involve the life-long use of exogenous corticosteroids. The long-term use of these drugs predisposes the patients to a series of harmful side effects, including muscle weakness, buffalo hump, headache, facial hair growth, puffiness of the face (moon face), glaucoma, hypernatremia, and cataract. To reduce the duration of treatment and overcome these side effects, researchers are focusing on developing regenerative therapies for treating Addison's disease.
Moreover, the adoption of regenerative medicine is expected to increase owing to its minimal side effects and curative nature. Various research institutions, as well as companies, are focusing on investing in the R&D of these medicines for curing rare and orphan diseases, including Addison's disease, along with chronic illnesses such as central nervous system disorders, cardiovascular disorders, and cancers.
Key Challenge
Delayed diagnosis is a major challenge to the global Addison's disease therapeutics market growth. The clinical manifestations and the symptoms of Addison's disease are often subtle and non-specific, because of which the disease often goes underdiagnosed. Some of the common symptoms of Addison's disease include hyperpigmentation, fatigue, anorexia, orthostasis, nausea, muscle and joint pain, and craving for salt. These symptoms progress gradually and are often ignored until stress or illness unmasks the deficiency of cortisol and mineralocorticoids. Since the disease is a rare clinical manifestation, it is often misdiagnosed as another condition, resulting in a life-threatening adrenal crisis.
However, the diagnostic delay can be by the patient or at the primary, or secondary care level, leading to increased chances of morbidity and mortality. The lack of awareness regarding the signs and symptoms of Addison's disease, especially in developing countries, is responsible for the diagnostic delays at the patient level. The failure to diagnose the disease at the early stage results in its progression to the chronic stage, which limits the use of hormonal replacement therapy and increases the mortality associated with the disease.
Key Addison's Disease Therapeutics Market Customer Landscape
Our analysis of the Life Cycle of the market indicates a movement from the innovator’s stage to the laggard’s stage. The report illustrates the lifecycle of the market, focusing on the adoption rates of the major countries including the US, Canada, Germany, the UK, and Japan. Technavio has included key purchase criteria, adoption rates, adoption lifecycles, and drivers of price sensitivity to help companies evaluate and develop growth strategies from 2022 to 2027.
Global Addison's Disease Therapeutics Market 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.
We also have detailed analyses of the market’s competitive landscape and offer information on 15 market companies, including :
Qualitative and quantitative analysis of vendors 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 vendors as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize vendors as dominant, leading, strong, tentative, and weak.
The market share growth by the oral drugs segment will be significant during the forecast period. Oral drugs are the first-line treatment for Addison's disease and are indicated to restore the levels of corticosteroids in patients. As they are administered through the mouth, they have good patient compliance, owing to which the segment dominates the global Addison's disease therapeutics market.
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The oral drugs segment showed a gradual increase in market share with USD 698.77 million in 2018. Although the market remains dominated by generic drugs, the growth of this segment is expected to accelerate due to the availability of reformulated versions of existing corticosteroid preparations. The modified-release dosage forms of oral drugs offer significant pharmacokinetic and pharmacodynamic advantages, leading to more effective treatment, which enhances the patient adherence ratio. Owing to these advantages, the newer versions of oral drugs have gained traction among end-users, which is expected to lead to their increased uptake by patients and, in turn, is expected to propel the growth of the market segment during the forecast period.
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North America is projected to contribute 41% of market growth by 2027. Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period. The presence of favourable reimbursement schemes in the region exerts a positive impact on disease control among patients. Government and private healthcare insurers in the US are striving to improve patient access to medicines by providing full-time coverage for drugs, including corticosteroids. For instance, the Medicare Advantage Prescription Drug and the Medicare Part D programs provide full-time coverage for hydrocortisone preparations (oral and parenteral). The availability of reimbursement policies attracts many patients to take these drugs for disease management, which is expected to drive the growth of the Addison's disease therapeutics market in North America during the forecast period.
The market research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD Billion" for the period 2023 to 2027, as well as historical data from 2017 to 2021 for the following segments.
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The landscape for rare disease patients is complex, influenced by factors such as underdiagnosis, canceled/postponed appointments, and the challenges posed by non-healthcare businesses entering the healthcare sector. There is a growing recognition of the rising incidences of conditions like tuberculosis, including latent tuberculosis infection, which require timely diagnosis and treatment medications to prevent escalation. The healthcare expenditure continues to rise, driven partly by the need for improved infrastructure and resources to manage diseases affecting the adrenal cortex and other organs. Disorders such as adrenal tuberculosis can lead to complications like hypertrophy and granulomas, affecting metabolism, immune function, and blood pressure regulation.
In addition to the response, pharmaceutical companies are developing innovative drugs targeting endocrine disorders and autoimmune conditions that impact the adrenal gland. Medications like prednisone, methylprednisone, and fludrocortisone acetate are critical in managing adrenal insufficiency and preventing adrenal crises. Biotech companies are investing in drug delivery systems and advancing genetic testing to enhance diagnostic accuracy and identify biomarkers for better patient outcomes. Initiatives such as the Fast Track designation for new therapies and platforms like Vai auto-injector by Antares Pharma are facilitating access to treatments like Recorlev and Levoketoconazole from Spruce Biosciences and Tildacerfont, respectively.
Moreover, the pursuit of effective vaccines, alongside medications such as hydroxychloroquine, aims to mitigate infections and manage the surge in drug demand, despite challenges such as high costs and drug misuse. As research progresses into self-reacting autoimmune cells and investment opportunities in vaccine development, the healthcare industry adapts to meet the evolving needs of patients with adrenal and other endocrine disorders.
Addison's Disease Therapeutics Market Scope |
|
Report Coverage |
Details |
Page number |
157 |
Base year |
2022 |
Historical year |
2017-2021 |
Forecast period |
2023-2027 |
Growth momentum & CAGR |
Accelerate at a CAGR of 6.93% |
Market growth 2023-2027 |
USD 442 million |
Market structure |
Fragmented |
YoY growth (%) |
5.85 |
Regional analysis |
North America, Europe, Asia, and the Rest of the World (ROW) |
Performing market contribution |
North America at 41% |
Key consumer countries |
US, Canada, Germany, UK, and Japan |
Competitive landscape |
Leading companies, Competitive Strategies, Consumer engagement scope |
Key companies profiled |
Actiza Pharmaceutical Pvt. Ltd., Akorn Operating Co. LLC, Amneal Pharmaceuticals Inc., Bristol Myers Squibb Co., Neurocrine Biosciences Inc., Hikma Pharmaceuticals Plc, Merck & Co. Inc., Novartis AG, Pfizer Inc., Takeda Pharmaceutical Co. Ltd., GlaxoSmithKline Plc, Abbott Laboratories, Amgen Inc., Eli Lilly and Co., Biogen Inc., Boehringer Ingelheim International GmbH, Bio-Techne Corp., Lupin Ltd., BTL Biotechno Labs Pvt. Ltd., and Bayer AG |
Market dynamics |
Parent market analysis, Market forecasting growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and Market condition analysis for the forecast period. |
Customization purview |
If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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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 Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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