Adrenal Insufficiency Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Primary, Secondary, Tertiary), By Treatment (Glucocorticoid, Corticotropin, Others), By Route of Administration (Oral, Injectables, Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 412.09 Million
CAGR (2026-2031)	9.27%
Fastest Growing Segment	Oral
Largest Market	North America
Market Size (2031)	USD 701.45 Million

Market Overview

The Global Adrenal Insufficiency Market will grow from USD 412.09 Million in 2025 to USD 701.45 Million by 2031 at a 9.27% CAGR. The Global Adrenal Insufficiency Market comprises therapeutic agents and diagnostic tests designed for conditions where the adrenal glands cannot produce adequate steroid hormones. Growth is primarily driven by the rising incidence of secondary adrenal insufficiency linked to long-term glucocorticoid therapy for chronic inflammatory diseases. Additionally, enhanced awareness among clinicians and improved screening protocols are increasing diagnosis rates, thereby expanding the patient population requiring hormone replacement.

However, the market faces significant hurdles regarding the prevention of acute and life-threatening complications. The potential for fatal adrenal crises due to delayed intervention remains a critical barrier to optimal patient care and market confidence. According to the European Society of Endocrinology, in 2025, the incidence of overt adrenal crisis was reported to be 4.4 cases per 100 person-years. This statistic highlights the persistent difficulty in managing the condition effectively and the necessity for improved emergency therapeutic solutions.

Key Market Drivers

The expansion of novel therapeutic product pipelines and R&D is fundamentally reshaping the market by introducing non-glucocorticoid options for conditions like Congenital Adrenal Hyperplasia. Companies are aggressively developing corticotropin-releasing factor type 1 (CRF1) receptor antagonists to mitigate the severe side effects associated with chronic high-dose steroid therapy. This clinical progress is exemplified by Crinetics Pharmaceuticals; according to BioSpace, in January 2026, Phase 2 trial results showed that 88% of patients treated with the company's investigational therapy, atumelnant, achieved physiologic glucocorticoid dose levels. Such advancements signal a robust commercial trajectory for the sector, further underscored by the rapid market uptake of newly approved therapies. For instance, according to BioSpace, in January 2026, Neurocrine Biosciences' newly approved drug Crenessity generated $165.3 million in revenue during the first three quarters of 2025, highlighting the significant demand for effective adrenal insufficiency treatments.

Technological innovations in drug delivery systems are also driving market expansion by addressing the critical need for precise, age-appropriate dosing. The introduction of multiparticulate granules and modified-release capsules has significantly improved treatment adherence, particularly among pediatric patients who historically struggled with fractionated adult tablets. These delivery advancements are translating into strong financial performance for manufacturers focused on niche adrenal insufficiency products. According to Eton Pharmaceuticals, in February 2025, the company reported record quarterly product revenue of $11.6 million for the fourth quarter of 2024, a surge attributed largely to the commercial success of its pediatric-specific hydrocortisone granules. These innovations ensure that the patient population receives consistent hormone replacement, thereby improving disease management and reducing the risk of acute complications.

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Key Market Challenges

The primary challenge hampering the Global Adrenal Insufficiency Market is the persistent difficulty in preventing acute and life-threatening complications, particularly adrenal crises. This safety barrier significantly undermines market confidence, as the inability to guarantee patient stability deters the widespread adoption of standard therapeutic regimens. The complexity of managing hormone dosages to avoid fatal episodes caused by sudden physiological stress creates a high-risk environment that restricts the expansion of the treated patient pool. Clinicians often hesitate to aggressively manage borderline cases due to the severe liability and health implications associated with potential treatment failure, thereby stalling market momentum.

This hurdle is further intensified by the massive scale of the population requiring precise safety monitoring to avoid these complications. The logistical burden of preventing emergencies in such a broad group limits the efficiency of current care delivery models. According to the Endocrine Society, in 2024, at least 1% of the general population was utilizing chronic glucocorticoid therapy, a demographic identified as being at constant risk for adrenal suppression and associated emergencies. This statistic illustrates the magnitude of the challenge; the market struggles to ensure consistent safety across this extensive patient base, directly impeding the scalability of treatment solutions.

Key Market Trends

The development of pre-filled autoinjectors for emergency crisis rescue is significantly altering the safety landscape by addressing the critical need for rapid intervention during adrenal crises. Current emergency protocols often rely on complex vial-and-syringe reconstitution kits, which can be prone to user error and delays during high-stress episodes. The emergence of needle-free or pre-filled auto-injector devices streamlines this process into a single, intuitive action, ensuring immediate hydrocortisone delivery and reducing the risk of fatal outcomes. This innovation represents a substantial commercial segment; according to Crossject, March 2025, in a 'Press Release', the strategic collaboration to commercialize the Zeneo hydrocortisone autoinjector targets a market opportunity estimated to exceed $200 million in the United States alone.

The expansion of pediatric-specific oral liquid formulations is effectively closing the gap in precise dose titration that solid oral dosage forms cannot bridge. While recent granule-based therapies improved adherence, liquid solutions offer superior flexibility, allowing clinicians to infinitely adjust hormone replacement dosages to match a child’s rapid growth velocity and fluctuating body surface area. This shift towards highly titratable liquid options is driving robust financial optimism within the sector. According to Eton Pharmaceuticals, August 2025, in the 'Second Quarter 2025 Financial Results', the company projected an annual revenue run rate of $80 million for the third quarter, a forecast supported by the portfolio addition of Khindivi, the first FDA-approved oral liquid hydrocortisone.

Segmental Insights

The oral segment is identified as the fastest-growing category within the global adrenal insufficiency market, primarily due to the significant advantages regarding patient compliance and ease of administration. This growth is largely driven by the development and approval of modified-release oral glucocorticoids designed to mimic the natural circadian rhythm of cortisol secretion more effectively than traditional therapies. Regulatory endorsements from bodies such as the U.S. Food and Drug Administration for these advanced formulations have further accelerated their adoption. Consequently, the preference for non-invasive, self-administered maintenance treatments continues to fuel the rapid expansion of the oral sector.

Regional Insights

North America maintains a dominant position in the Global Adrenal Insufficiency Market due to established healthcare infrastructure and widespread disease awareness. The region benefits from favorable reimbursement coverage and the presence of major pharmaceutical companies that ensure consistent product availability. Furthermore, the United States Food and Drug Administration supports market stability through structured approval pathways for treatments targeting endocrine disorders. Increased diagnostic rates for conditions like Addison’s disease also contribute to sustained demand. These factors, combined with supportive regulatory environments, cement North America’s status as the leading regional market.

Recent Developments

• In May 2025, Eton Pharmaceuticals received approval from the U.S. Food and Drug Administration for its proprietary hydrocortisone oral solution, marketed as Khindivi, for the treatment of adrenocortical insufficiency in pediatric patients. This product became the first FDA-approved liquid formulation of hydrocortisone designed specifically for children, eliminating the need for compounding or manipulating adult tablets. The company stated that the ready-to-use solution was developed to address dosing challenges and improve administration compliance in young patients. The commercial launch was subsequently executed through a partnership with a specialty pharmacy to ensure broad access for affected pediatric patients in the United States.
• In July 2024, Neurocrine Biosciences announced that the U.S. Food and Drug Administration had accepted two New Drug Applications for crinecerfont to treat children and adults with classic congenital adrenal hyperplasia. The regulatory agency granted Priority Review for the submissions, which covered both capsule and oral solution formulations of the investigational corticotropin-releasing factor type 1 receptor antagonist. If approved, the therapy would represent a novel non-glucocorticoid treatment approach for this rare endocrine disorder. The company highlighted that the filings were supported by robust efficacy and safety data obtained from the global Phase 3 CAHtalyst pediatric and adult clinical studies.
• In June 2024, Crinetics Pharmaceuticals released positive initial findings from its Phase 2 TouCAHn study evaluating atumelnant, an oral ACTH receptor antagonist, for the treatment of congenital adrenal hyperplasia. The data revealed that all participants treated with 80 mg of atumelnant maintained androgen levels below the upper limit of normal throughout the treatment period. Furthermore, the drug demonstrated a substantial reduction in key disease biomarkers, including a greater than 90% decrease in androstenedione and a 97% decrease in 17-hydroxyprogesterone. These results supported the company's plan to advance the therapy into further clinical development stages for patients suffering from adrenal insufficiency conditions.
• In March 2024, Spruce Biosciences announced topline results from the CAHmelia-203 Phase 2b clinical trial evaluating tildacerfont in adults with classic congenital adrenal hyperplasia and severe hyperandrogenemia. The study did not achieve its primary efficacy endpoint, which assessed the dose response for the change in androstenedione levels from baseline to week 12. Consequently, the company decided to terminate the CAHmelia-203 trial and implement cost-saving measures, including a substantial workforce reduction. However, the organization confirmed that the concurrent CAHptain-205 study in pediatric patients showed promising preliminary data, supporting continued dose-ranging research in that specific patient population.

Key Market Players

• Acrotech Biopharma, Inc.
• Bausch Health, Canada Inc
• AdvaCare International Limited
• Weefsel Pharma
• Cipla Inc.
• Pfizer Inc
• Wellona Pharma
• Eugia US LLC
• Sandoz Inc.
• Prevego Healthcare & Research Pvt Ltd

By Type	By Treatment	By Route of Administration	By Distribution Channel	By Region
Primary Secondary Tertiary	Glucocorticoid Corticotropin Others	Oral Injectables Others	Hospital Pharmacies Retail Pharmacies Online Pharmacies	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Adrenal Insufficiency Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Adrenal Insufficiency Market, By Type:

• Primary
• Secondary
• Tertiary

• Adrenal Insufficiency Market, By Treatment:

• Glucocorticoid
• Corticotropin
• Others

• Adrenal Insufficiency Market, By Route of Administration:

• Oral
• Injectables
• Others

• Adrenal Insufficiency Market, By Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

• Adrenal Insufficiency Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE