Market Overview
Adrenocorticotropic Hormone Market size was valued at USD 1.0 billion in 2024 and is anticipated to reach USD 1.95 billion by 2032, growing at a CAGR of 3.5% during the forecast period.
| REPORT ATTRIBUTE |
DETAILS |
| Historical Period |
2020-2023 |
| Base Year |
2024 |
| Forecast Period |
2025-2032 |
| Adrenocorticotropic Hormone Market Size 2024 |
USD 1.0 Billion |
| Adrenocorticotropic Hormone Market, CAGR |
3.5% |
| Adrenocorticotropic Hormone Market Size 2032 |
USD 1.95 Billion |
The Adrenocorticotropic Hormone Market is led by major players including Mallinckrodt (US), GlaxoSmithKline plc (UK), Ferring B.V. (Switzerland), Merck & Co., Inc. (US), Hikma Pharmaceuticals PLC (UK), Pfizer Inc. (US), Merck KGaA (Germany), Viatris, Inc. (US), Avantor, Inc. (US), and Novartis AG (Switzerland). Mallinckrodt maintains dominance with its flagship ACTH therapy, Acthar Gel, supported by a strong distribution network and clinical presence. These companies focus on advancing synthetic ACTH formulations and expanding therapeutic applications across neurology and endocrinology. North America leads the global market with a 41% share, driven by advanced healthcare infrastructure, early adoption of peptide-based therapies, and favorable reimbursement policies supporting long-term hormonal treatments.
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Market Insights
- The Adrenocorticotropic Hormone Market was valued at USD 1.10 billion in 2024 and is expected to reach USD 1.95 billion by 2032, growing at a CAGR of 3.5%.
- Rising prevalence of autoimmune and endocrine disorders such as multiple sclerosis and Addison’s disease drives the demand for ACTH-based therapies globally.
- The market trend leans toward synthetic ACTH formulations, holding over 68% share due to their higher purity, consistency, and large-scale manufacturing advantages.
- Competition remains moderate, with key players like Mallinckrodt, GlaxoSmithKline, and Pfizer focusing on clinical trials, biosimilar innovation, and expansion in emerging markets.
- Regionally, North America leads with 41% market share, followed by Europe at 28%, while Asia-Pacific is the fastest-growing region, supported by rising healthcare investments and improved access to advanced hormonal treatments.
Market Segmentation Analysis:
By Source:
The synthetic segment dominates the Adrenocorticotropic Hormone Market with over 68% share in 2024. Its leadership is driven by higher purity, consistent therapeutic performance, and scalable production compared to natural sources. Pharmaceutical manufacturers prefer synthetic ACTH due to lower risk of contamination and improved stability during formulation. Continuous advancements in peptide synthesis technology and regulatory approvals for synthetic corticotropin analogs strengthen this segment’s growth. The natural source segment holds the remaining market share, supported by limited use in specific clinical and research applications.
- For instance, Bachem AG, a leading supplier of synthetic ACTH APIs, has expanded its production capacity to meet rising demand for high-purity synthetic corticotropin, supporting global pharmaceutical manufacturers in developing stable and reliable ACTH-based therapies.
By Indication:
The neurology segment leads the market with around 37% share, fueled by increasing use of ACTH in treating multiple sclerosis exacerbations, infantile spasms, and other neurological disorders. Rising awareness among neurologists about ACTH’s therapeutic benefits and its proven efficacy in corticosteroid-resistant patients drives demand. Rheumatology follows as another key segment, supported by its use in managing systemic lupus erythematosus and rheumatoid arthritis. Growing research into ACTH’s immunomodulatory effects further supports sustained utilization across multiple neurological conditions.
- For instance, a clinical case documented the use of ACTH gel in a patient with severe multiple sclerosis exacerbation, where ACTH treatment stabilized and improved brainstem symptoms after steroids failed, allowing initiation of long-term immune-modulating therapy.
By Distribution Channel:
Hospital pharmacies hold the largest share at over 54% in 2024, driven by the administration of ACTH injections under medical supervision and the prevalence of inpatient treatments for acute endocrine and neurological disorders. Hospitals remain the primary distribution point due to strict dosage control and immediate availability of emergency care. Retail pharmacies follow with a moderate share, catering to outpatient prescriptions and chronic therapies. Online pharmacies, although smaller, are expanding rapidly with increasing patient preference for digital purchase platforms and home delivery of specialty drugs.
Key Growth Drivers
Rising Prevalence of Autoimmune and Endocrine Disorders
The growing incidence of autoimmune and adrenal disorders such as multiple sclerosis, rheumatoid arthritis, and Addison’s disease drives the Adrenocorticotropic Hormone Market. ACTH therapy is increasingly prescribed to manage inflammation and stimulate cortisol production in patients unresponsive to corticosteroids. Expanding diagnostic awareness and early detection rates further strengthen adoption. Healthcare systems in developed countries continue to support ACTH therapies through favorable reimbursement frameworks and clinical protocols, ensuring steady demand across both hospital and specialty care settings.
- For instance, Acthar Gel’s role in multiple sclerosis relapse management, where clinical studies demonstrate its ability to speed recovery from acute MS relapses.
Advancements in Synthetic ACTH Formulations
Innovation in synthetic ACTH manufacturing enhances therapeutic reliability and reduces variability in dosage response. Pharmaceutical companies are investing in advanced peptide synthesis technologies to achieve greater bioavailability and extended shelf life. These developments improve patient outcomes and allow precise dosing for chronic neurological and rheumatologic conditions. The shift toward synthetic production also minimizes contamination risk, ensuring regulatory compliance and large-scale distribution efficiency. This continuous innovation fosters broader clinical acceptance and long-term market sustainability.
- For instance, CLINUVEL has reached a manufacturing agreement to supply cGMP-grade ACTH, advancing controlled-release formulations that optimize pharmacodynamic profiles for neurological and endocrine conditions.
Growing Research and Clinical Applications
Ongoing clinical research exploring ACTH’s immunomodulatory and anti-inflammatory roles fuels new therapeutic applications. Studies are expanding its use in nephrotic syndrome, ophthalmic inflammation, and pediatric neurology. Pharmaceutical firms and academic centers increasingly collaborate to develop targeted formulations with fewer side effects. These initiatives enhance medical understanding and open avenues for combination therapies. The broadening scope of ACTH in disease management creates lucrative opportunities for manufacturers and strengthens its presence within the global pharmaceutical landscape.
Key Trends & Opportunities
Rising Demand for Personalized Hormonal Therapies
The increasing preference for personalized treatment plans supports the demand for ACTH-based therapies. Physicians are tailoring dosages and formulations based on patient-specific hormonal profiles and comorbidities. This trend enhances treatment efficacy and minimizes side effects, particularly in long-term endocrine and neurological conditions. Pharmaceutical companies are developing flexible ACTH delivery systems and precision dosing methods, aligning with the shift toward individualized medicine. Such patient-centric approaches are expected to redefine therapeutic standards and drive long-term market expansion.
- For instance, Lundbeck is progressing a novel anti-ACTH antibody, Lu AG13909, with orphan drug designation in the US and EU. The ongoing Phase I/II trial for classic CAH patients focuses on safety and efficacy, offering a targeted therapy to manage elevated ACTH through an antibody approach, aiming at individualized disease control.
Expansion in Emerging Healthcare Markets
Developing regions in Asia-Pacific and Latin America are witnessing improved access to advanced endocrine care. Expanding healthcare infrastructure, rising disposable income, and growing awareness of hormonal therapies contribute to market penetration. Governments are investing in diagnostic programs and importing specialized ACTH drugs to enhance disease management capacity. Local partnerships between pharmaceutical companies and hospitals facilitate product availability and training for healthcare professionals. These factors create promising growth opportunities for ACTH suppliers targeting untapped regional markets.
- For instance, Novotech, a specialist clinical research organization in Asia-Pacific, has formed 16 major strategic partnerships with hospitals across India and Thailand to accelerate clinical research and improve access to hormonal therapies.
Key Challenges
High Treatment Costs and Limited Accessibility
The high cost of ACTH formulations remains a significant barrier to widespread adoption, especially in developing nations. Complex manufacturing processes and stringent regulatory requirements increase production expenses. Many healthcare systems lack adequate reimbursement coverage, limiting access for low-income patients. Hospitals often restrict ACTH use to severe or refractory cases due to budget constraints. Addressing these cost-related challenges through pricing reforms and generic alternatives is crucial for expanding patient reach and ensuring equitable therapeutic access.
Adverse Effects and Availability of Alternative Therapies
ACTH treatments may cause side effects such as hypertension, edema, and metabolic disturbances, deterring long-term use. The availability of corticosteroid-based drugs with lower cost and faster onset also poses competition. Physicians often prefer alternative anti-inflammatory therapies with fewer complications for mild to moderate cases. Regulatory authorities continue to scrutinize safety profiles, delaying product approvals. To maintain competitiveness, manufacturers must invest in safer formulations and post-marketing surveillance to ensure continued physician confidence and therapeutic reliability.
Regional Analysis
North America
North America dominates the Adrenocorticotropic Hormone Market with 41% share in 2024, driven by advanced healthcare infrastructure and high diagnosis rates for endocrine and autoimmune disorders. The U.S. leads regional demand due to the strong presence of pharmaceutical companies, favorable reimbursement systems, and extensive clinical use of synthetic ACTH formulations. Rising cases of multiple sclerosis and infantile spasms further stimulate adoption. Continuous R&D investments and regulatory support from the FDA for novel peptide therapies enhance product availability, maintaining North America’s leadership in the global ACTH market throughout the forecast period.
Europe
Europe holds 28% share of the global Adrenocorticotropic Hormone Market, supported by strong adoption across rheumatology and neurology applications. The UK, Germany, and France represent major contributors owing to robust healthcare policies and increasing preference for non-steroidal hormonal therapies. The region benefits from the presence of established players like GlaxoSmithKline and Novartis focusing on synthetic ACTH production. Growing geriatric populations and higher prevalence of chronic inflammatory diseases further fuel market expansion. Continued clinical trials and favorable reimbursement frameworks sustain steady growth across Western and Central European markets.
Asia-Pacific
Asia-Pacific accounts for 21% share of the Adrenocorticotropic Hormone Market, emerging as the fastest-growing region due to improving access to endocrine and neurological care. China, Japan, and India lead regional demand with rising healthcare expenditure and expanding patient awareness. Government support for rare disease treatment and clinical trial participation enhances availability of ACTH therapies. Increasing investments from global pharmaceutical companies in regional partnerships strengthen distribution networks. The growing burden of autoimmune disorders and enhanced hospital infrastructure position Asia-Pacific as a high-potential growth hub in the global market.
Latin America
Latin America represents 6% share of the Adrenocorticotropic Hormone Market, driven by expanding healthcare access and rising awareness of hormonal replacement therapies. Brazil and Mexico lead the regional landscape due to growing investments in hospital infrastructure and specialty drug imports. The market experiences moderate growth supported by improving insurance coverage and targeted physician training. However, limited local manufacturing capacity and cost-sensitive healthcare systems restrict broader penetration. Strategic collaborations between multinational and regional pharmaceutical firms are expected to improve ACTH drug availability and treatment outcomes in the coming years.
Middle East & Africa
The Middle East & Africa region holds 4% share of the Adrenocorticotropic Hormone Market, characterized by gradual adoption across specialized hospitals and tertiary care centers. Gulf nations such as Saudi Arabia and the UAE drive regional demand due to rising healthcare modernization and increased focus on endocrine disorder management. Access to ACTH therapies is improving through government-funded healthcare programs and import-driven supply chains. Africa remains in the early stage of adoption due to limited infrastructure and affordability challenges, though expanding clinical awareness promises steady market development ahead.
Market Segmentations:
By Source
By Indication
- Rheumatology
- Neurology
- Nephrotic Syndrome
- Ophthalmology
- Others
By Distribution Channel
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
By Region
- North America
- Europe
- Germany
- France
- U.K.
- Italy
- Spain
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- South Korea
- South-east Asia
- Rest of Asia Pacific
- Latin America
- Brazil
- Argentina
- Rest of Latin America
- Middle East & Africa
- GCC Countries
- South Africa
- Rest of the Middle East and Africa
Competitive Landscape
The competitive landscape of the Adrenocorticotropic Hormone Market features major players including Mallinckrodt (US), GlaxoSmithKline plc (UK), Ferring B.V. (Switzerland), Merck & Co., Inc. (US), Hikma Pharmaceuticals PLC (UK), Pfizer Inc. (US), Merck KGaA (Germany), Viatris, Inc. (US), Avantor, Inc. (US), and Novartis AG (Switzerland). These companies compete through advanced peptide synthesis technologies, clinical research programs, and strategic distribution networks. Mallinckrodt continues to lead with its branded ACTH therapy, Acthar Gel, supported by strong hospital and specialty clinic presence. Other key players focus on developing biosimilar and synthetic variants with improved stability and cost efficiency. Collaborations with research institutions and healthcare providers enhance therapeutic reach across neurology and endocrinology segments. Expansion into emerging markets, combined with digital supply chains and regulatory approvals, reinforces their market position. Increasing emphasis on product innovation, competitive pricing, and patient-centric formulations continues to define competition in the global ACTH landscape.
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Key Player Analysis
- Mallinckrodt (US)
- GlaxoSmithKline plc (UK)
- Ferring B.V. (Switzerland)
- Merck & Co., Inc. (US)
- Hikma Pharmaceuticals PLC (UK)
- Pfizer Inc. (US)
- Merck KGaA (Germany)
- Viatris, Inc. (US)
- Avantor, Inc. (US)
- Novartis AG (Switzerland)
Recent Developments
- In August 2025, Crinetics Pharmaceuticals, Inc. received Orphan Drug Designation from the U.S. FDA for its investigational oral ACTH receptor antagonist, Atumelnant, aimed at treating classic congenital adrenal hyperplasia (CAH), strengthening its position in the hormonal therapeutics segment.
- In August 2024, Mallinckrodt plc introduced its Acthar Gel (repository corticotropin injection) in a single-dose pre-filled SelfJect™ injector in the U.S., enhancing convenience and safety for patients requiring ACTH therapy.
- In August 2024, Mallinckrodt plc made its widely used ACTH therapy Acthar Gel available in a single-dose pre-filled SelfJect™ injector, improving patient self-administration for multiple chronic and acute conditions.
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Report Coverage
The research report offers an in-depth analysis based on Source, Indication, Distribution Channel and Region. It details leading market players, providing an overview of their business, product offerings, investments, revenue streams, and key applications. Additionally, the report includes insights into the competitive environment, SWOT analysis, current market trends, as well as the primary drivers and constraints. Furthermore, it discusses various factors that have driven market expansion in recent years. The report also explores market dynamics, regulatory scenarios, and technological advancements that are shaping the industry. It assesses the impact of external factors and global economic changes on market growth. Lastly, it provides strategic recommendations for new entrants and established companies to navigate the complexities of the market.
Future Outlook
- The market will experience steady growth driven by rising endocrine and autoimmune disease prevalence.
- Synthetic ACTH formulations will gain stronger adoption due to enhanced purity and stability.
- Expanding research on immunomodulatory applications will widen therapeutic use cases.
- Neurology and nephrology indications will continue to generate consistent clinical demand.
- North America will maintain dominance, while Asia-Pacific will record the fastest growth rate.
- Digital and online pharmacy distribution channels will expand treatment accessibility.
- Increasing collaborations between pharmaceutical companies and research institutes will foster innovation.
- Regulatory support for rare disease therapies will strengthen market penetration.
- Growing awareness of hormonal imbalance treatments will drive higher diagnosis rates.
- Cost optimization and improved patient affordability will remain central to long-term market expansion.
