Addison's Disease - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Adrenal insufficiency is a hormonal disorder in which the adrenal glands fail to produce adequate levels of steroid hormones, particularly cortisol and, in some cases, aldosterone. It is classified as primary, secondary, or tertiary adrenal insufficiency, with Addison's disease referring specifically to primary adrenal insufficiency.
• Addison's disease is a rare autoimmune condition in which the immune system attacks the adrenal cortex, impairing the production of cortisol and aldosterone.
• According to findings, the total number of people affected by this condition at a given time ranges from 4 to 11 per 100,000 of the population. In adults, the typical age of Addison's disease presentation is 30 to 50 years, and it is more frequently seen in women.
• Management of Addison's disease requires lifelong hormone replacement therapy, with hydrocortisone used to replace cortisol and fludrocortisone for aldosterone. Doses must be adjusted during periods of physical stress to avoid adrenal crisis, which can be life-threatening if not managed promptly.
• Available therapies focus solely on hormone replacement, and patients must adhere strictly to dosing regimens to maintain hormonal balance.
• Although there has been progress in adrenal insufficiency management, such as oral hydrocortisone solutions (KHINDIVI) and emergency-use autoinjectors, the pipeline remains inactive for therapies specifically targeting Addison's disease as a distinct entity.
• This highlights a significant unmet need for therapies that go beyond symptomatic hormone replacement and target underlying disease mechanisms, adrenal regeneration, or more physiological cortisol delivery.

DelveInsight's "Addison's Disease - Market Insights, Epidemiology and Market Forecast - 2034" report delivers an in-depth understanding of Addison's disease, historical and forecasted epidemiology as well as the Addison's disease market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Addison's disease market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Addison's disease market size from 2020 to 2034. The report also covers current Addison's disease treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Addison's Disease Understanding and Treatment Algorithm

Addison's Disease Overview, Country-Specific Treatment Guidelines, and Diagnosis

Addison's disease, also known as autoimmune adrenalitis, is an acquired primary adrenal insufficiency. Primary adrenal insufficiency is termed Addison's disease when an autoimmune process causes the condition and is a rare but potentially life-threatening emergency condition. Addison's disease results from the destruction of the bilateral adrenal cortex, leading to decreased adrenocortical hormones, including cortisol, aldosterone, and androgens. Addison disease's insidious course of action usually presents with glucocorticoid deficiency followed by mineralocorticoid deficiency.

To confirm the diagnosis of Addison disease, measurements of ACTH, cortisol, plasma renin, and aldosterone are required. These laboratory studies are measured by concentrations in blood samples and are time-sensitive as they fluctuate according to the circadian rhythm.

The Addison's Disease report provides an overview of Addison's disease pathophysiology, diagnostic approaches, and a detailed treatment algorithm, along with a real-world scenario of a patient's journey beginning from the first symptom, the time taken for diagnosis, to the entire treatment process.

Addison's Disease Treatment

Management of Addison's disease involves both acute and long-term hormone replacement therapy. In an adrenal crisis, a life-threatening emergency, immediate treatment should not be delayed for confirmatory testing. Blood should be drawn for ACTH and cortisol levels, but hydrocortisone must be administered immediately. The standard adult regimen includes a 100 mg IV bolus of hydrocortisone, followed by 50-100 mg IV every 6 hours. In children, a 50 mg/m2 IV bolus is given, followed by maintenance dosing. Hydrocortisone provides both glucocorticoid and mineralocorticoid effects, eliminating the need for fludrocortisone during the acute phase. Intravenous saline and dextrose are administered to correct hypovolemia and hypoglycemia. Dexamethasone may be used if cortisol assays are needed, as it does not interfere with test results. Once stabilized, lifelong maintenance therapy includes oral hydrocortisone or prednisone and fludrocortisone to maintain fluid and electrolyte balance.

Addison's Disease Epidemiology

The Addison's disease epidemiology chapter in the report provides historical as well as forecasted data in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2025 to 2034. The Addison's disease epidemiology is segmented with detailed insights into Total Prevalent cases of Addison's Disease, Total Diagnosed Prevalent cases of Addison's Disease, Gender-specific Prevalent cases of Addison's Disease, Age-specific Prevalent cases of Addison's Disease, and Treated Cases of Addison's Disease.

• As per the findings, the total number of people affected by this condition at a given time ranges from 4 to 11 per 100,000 of the population.
• Addison's disease can potentially affect individuals of any age, but usually occurs in individuals between 30-50 years of age.
• About 9,000 people in the UK have Addison's disease, with over 300 new cases diagnosed each year.

Addison's disease Drug Chapters

The drug chapter segment of the Addison's disease report encloses a detailed analysis of Addison's disease marketed drugs.

Marketed Drugs

PLENADREN: Takeda

PLENADREN is a medicine used to treat adrenal insufficiency in adults. Adrenal insufficiency (including primary insufficiency or Addison's disease. The active substance in PLENADREN, hydrocortisone, is the pharmaceutical form of cortisol, the main steroid hormone secreted by the adrenal gland. Hydrocortisone replaces the natural cortisol that is missing in patients with adrenal insufficiency. The European Commission granted a marketing authorisation valid throughout the European Union for PLENADREN in November 2011.

Addison's Disease Market Outlook

The current Addison's disease market is anchored in lifelong corticosteroid replacement therapy, primarily using hydrocortisone to substitute for cortisol, and fludrocortisone for aldosterone in cases requiring mineralocorticoid support. While hydrocortisone remains the mainstay, alternatives like prednisolone and dexamethasone are used less frequently due to their limited mineralocorticoid activity. Despite advancements in adrenal insufficiency therapies-such as oral solutions and autoinjectors-there remains a lack of pipeline assets specifically targeting Addison's disease as a distinct entity. This underscores a continued unmet need for precision therapies that address the unique physiological and clinical demands of primary adrenal insufficiency.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as Nationwide Children's Hospital, Columbus, OH, the United States, University Hospitals Dorset NHS Foundation Trust, North Shore University Health System, Evanston, Illinois, etc., were contacted. Their opinion helps understand and validate current and emerging treatment patterns of Addison's disease. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement of rare disease therapies can be limited due to a lack of supporting policies and funding, challenges of high prices, a lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers' concerns about budget impact. The high cost of rare disease drugs usually has a limited effect on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of Addison's disease, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression, along with country-specific treatment guidelines.
• Additionally, an all-inclusive account of current therapies.
• A detailed review of the Addison's disease market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Addison's disease market.

Addison's disease Report Insights

• Patient Population
• Therapeutic Approaches
• Addison's disease Market Size and Trends
• Existing and future Market Opportunity

Addison's disease Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• Addison's disease Epidemiology Segmentation
• Inclusion of country-specific treatment guidelines
• KOL's feedback on approved and emerging therapies
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Addison's disease Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

• What is the growth rate of the 7MM Addison's disease treatment market?
• What was the Addison's disease total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current options for the treatment of Addison's disease?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Addison's disease Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.