Hydroxychloroquine Market

Market Definition

The market encompasses the production, distribution, and consumption of hydroxychloroquine across the pharmaceutical and healthcare sectors. It includes manufacturers, suppliers, and healthcare providers using the drug for autoimmune diseases such as lupus and rheumatoid arthritis, along with off-label applications.

The report provides insights into major factors of market growth, supported by an in-depth evaluation of industry trends and regulatory frameworks.

Hydroxychloroquine Market Overview

The global hydroxychloroquine market size was valued at USD 900.1 million in 2023 and is projected to grow from USD 1,091.5 million in 2024 to USD 5,055.1 million by 2031, exhibiting a CAGR of 24.48% during the forecast period. This growth is driven by its widespread use in treating autoimmune conditions such as rheumatoid arthritis and lupus erythematosus.

Increased global prevalence of these chronic disorders has increased demand for long-term disease management solutions, positioning hydroxychloroquine as a key therapeutic agent.

This growth is further supported by growing awareness among healthcare professionals and patients about the benefits of early and sustained treatment with disease-modifying antirheumatic drugs.

Major companies operating in the hydroxychloroquine industry are Sanofi, Mylan N.V., Teva Pharmaceuticals USA, Inc., Zydus Group, Dr. Reddy’s Laboratories, Inc., Apotex Inc., HANLIM PHARM.CO.LTD., Cipla, Torrent Pharmaceuticals Ltd., McW Healthcare Pvt. Limited, Fermion Oy, Tamin Pharmaceutical Investment Company, TAGOOR LABORATORIES PVT. LTD., SCI PHARMTECH, INC., and Novalab Healthcare.

Additionally, expanding healthcare infrastructure and improved access to prescription medications in emerging markets are leading to increased consumption. Technological advancements in drug formulation and distribution channels have streamlined access and improved patient compliance.

Moreover, ongoing clinical research into the drug's potential therapeutic applications in other inflammatory and infectious diseases continues to generate interest, fostering market expansion.

Key Highlights

1. The hydroxychloroquine industry size was valued at USD 900.1 million in 2023.
2. The market is projected to grow at a CAGR of 24.48% from 2024 to 2031.
3. North America held a share of 36.12% in 2023, valued at USD 325.1 million.
4. The rheumatoid arthritis segment garnered USD 306.9 million in revenue in 2023.
5. The tablet segment is expected to reach USD 4,071.5 million by 2031.
6. The hospital pharmacies segment is expected to reach USD 1,998.9 million by 2031.
7. Asia Pacific is anticipated to grow at a CAGR of 26.78% over the forecast period.

Market Driver

"Rising Geriatric Population and Expanding Healthcare Access"

The hydroxychloroquine market is witnessing significant growth, mainly fueled by the rising global geriatric population and increased healthcare spending in emerging economies.

As the global population aged 60 and above continues to expand, particularly in developed and middle-income countries, the prevalence of chronic autoimmune conditions like rheumatoid arthritis and lupus erythematosus-primary indications for hydroxychloroquine-will increase.

This trend is expected to drive substantial demand for long-term therapies aimed at managing inflammation and immune response.

• In June 2023, the World Health Organization (WHO) highlighted the global impact of rheumatoid arthritis, affecting approximately 18 million people worldwide. The organization focused on improving access to treatment and rehabilitation services, and assistive products while also promoting strategies to reduce disease progression.

Moreover, emerging economies are witnessing a surge in healthcare investments, supported by economic growth, rapid urbanization, and public health reforms. Countries are prioritizing access to essential medicines by expanding insurance coverage, upgrading hospital infrastructure, and promoting local pharmaceutical manufacturing.

These efforts are reducing the treatment gap for chronic diseases andincreasing access to affordable hydroxychloroquine therapy, thereby improving market outlook.

Market Challenge

"Price Volatility and Competitive Pricing Pressures"

A major challenge hampering the expansion of the hydroxychloroquine market is price volatility due to fluctuating market dynamics and increasing competition from generics. Although hydroxychloroquine is widely available as a generic drug, the price at which it is offered can vary significantly across different regions and suppliers.

This price instability is influenced by factors such as raw material costs, changes in manufacturing expenses, and price negotiations with healthcare providers and insurance companies.

Additionally, the growing presence of generic manufacturers intensifies pricing pressures, further impacting profit margins for existing producers and complicating the pricing strategies of companies operating in the market.

To address this challenge, companies must adopt cost-efficiency strategies in their production processes, such as optimizing supply chain management and reducing manufacturing overheads. Strategic partnerships and long-term contracts with suppliers can help stabilize raw material costs and ensure predictable pricing.

Market Trend

"Increased Clinical Research Initiatives and Adoption of Digital Pharmacy Channels"

The hydroxychloroquine market is evolving, fueled by increased clinical research initiatives and the widespread adoption of digital pharmacy channels. A key trend is the rise in clinical trials exploring its efficacy beyond traditional indications such as rheumatoid arthritis and lupus. Researchers are actively investigating its potential in treating various conditions, including neurodegenerative diseases, cancer, and metabolic disorders.

Furthermore, the proliferation of online and telehealth pharmacy services is significantly enhancing the global distribution network for hydroxychloroquine. The rise in e-prescriptions and virtual consultations has made the medication more accessible, particularly in remote and underserved regions.

This digital shift is enabling faster delivery timelines, reducing dependency on traditional brick-and-mortar pharmacies, and improving patient adherence through automated refill systems and digital monitoring tools. These trends are offering manufacturers and distributors new channels for growth and market penetration.

Hydroxychloroquine Market Report Snapshot

Market Segmentation

• By Disease Indication (Rheumatoid Arthritis, Lupus Erythematosus, Malaria, COVID-19 (residual use), and Others): The rheumatoid arthritis segment earned USD 306.9 million in 2023 due to the rising prevalence of autoimmune disorders and the drug’s established role as a first-line treatment.
• By Formulation Type (Tablet, Injection, and Suspension): The tablet segment held a share of 80.12% in 2023, fueled by its widespread availability, ease of administration, and patient preference for oral dosage forms.
• By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies): The hospital pharmacies segment is projected to reach USD 1,998.9 million by 2031, propelled by increased hospitalization rates, streamlined drug access in clinical settings, and greater reliance on institutional channels for chronic disease treatment.

Hydroxychloroquine Market Regional Analysis

Based on region, the market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

North America hydroxychloroquine market accounted for a substantial share of 36.12% in 2023, valued at USD 325.1 million. This dominance is primarily attributed to the high prevalence of autoimmune diseases such as lupus and rheumatoid arthritis, particularly in the U.S., where hydroxychloroquine remains a key treatment in long-term disease management.

The regional market further benefits from an advanced healthcare infrastructure, high diagnostic rates, and a strong presence of leading pharmaceutical manufacturers engaged in the production and distribution of branded and generic hydroxychloroquine.

Moreover, continuous clinical research activities conducted by U.S.-based institutions and robust insurance coverage have further supported the uptake of the drug across various healthcare settings.

Additionally, the presence of specialized rheumatology centers and integration of hydroxychloroquine into standard treatment protocols have sustained consistent demand, while favorable reimbursement practices have enhanced patient adherence to long-term therapies.

• In February 2025, A UCLA-led study revealed that U.S. outpatient prescriptions for hydroxychloroquine and ivermectin surged 2- to 10-fold from pre-pandemic levels for COVID-19 treatment, despite substantial clinical evidence disproving their efficacy. This trend highlights peristent gaps in aligning prescribing practices with scientific evidence, underscoring the need for improved evidence-based decision-making in healthcare.

Asia Pacific hydroxychloroquine industry is expected to register the fastest CAGR of 26.78% over the forecast period. This surge is fueled by rising awareness of autoimmune disorders, growing healthcare spending, and an expanding middle-class population seeking long-term therapeutic solutions.

Countries such as India and China, with their large patient pools and increasing access to healthcare services, are contributing significantly to regional market expansion. India, in particular, plays a dual role as both a key consumer and a leading global supplier of hydroxychloroquine, with a strong base of cost-effective manufacturing capabilities.

Additionally, rapid urbanization and improving diagnostic practices are contributing to earlier disease detection and higher prescription volumes across the region. The expansion of retail pharmacy networks and e-pharmacy platforms is boosting accessibility to hydroxychloroquine, accelerating regional market penetration.

Regulatory Frameworks

• In the United States, hydroxychloroquine is regulated by the Food and Drug Administration (FDA) as a prescription medication. The FDA also provides guidance on manufacturing and safety through Good Manufacturing Practices (GMP) and labeling requirements.
• In the European Union, hydroxychloroquine is governed by the European Medicines Agency (EMA). It is approved for medical use and regulated under the European Union Medicines Legislation. The Committee for Medicinal Products for Human Use (CHMP) evaluates hydroxychloroquine for its safety, efficacy, and quality.
• In China, hydroxychloroquine is regulated by the National Medical Products Administration (NMPA). The drug is approved for medical use under National Drug Standards (GB/T) and Chinese Pharmacopoeia regulations.
• In Japan, hydroxychloroquine is regulated by the Pharmaceuticals and Medical Devices Agency (PMDA). It is approved for use under the Pharmaceutical Affairs Law and must adhere to Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines, ensuring the safety and efficacy of the drug for its approved indications.
• In India, hydroxychloroquine is regulated by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940. The drug is approved for the treatment of malaria, rheumatoid arthritis, and lupus, and manufacturers must comply with GMP guidelines issued by the Drugs Controller General of India (DCGI).

Competitive Landscape

The hydroxychloroquine industry is characterized by established pharmaceutical manufacturers and emerging generic drug producers. Key market players are primarily focused on expanding their production capacities to meet fluctuating global demand, particularly in regions with high disease prevalence.

There is a strong emphasis on cost-effective manufacturing and supply chain optimization, enabling companies to maintain competitive pricing and ensure uninterrupted product availability.

Market participants are prioritizing vertical integration strategies to control raw material sourcing and streamline formulation processes, reducing dependency on third-party suppliers.

Additionally, partnerships with regional distributors and healthcare providers are being leveraged to strengthen market presence and ensure deeper penetration across emerging economies.

To sustain long-term market position, companies are investing in R&D to improve drug formulation, such as creating modified-release versions or combination therapies, to enhance patient compliance. Furthermore, they are focusing on strategic acquisitions and geographic expansion to capture untapped markets and broaden their global footprint.

List of Key Companies in Hydroxychloroquine Market:

• Sanofi
• Mylan N.V.
• Teva Pharmaceuticals USA, Inc.
• Zydus Group
• Dr. Reddy’s Laboratories, Inc.
• Apotex Inc.
• HANLIM PHARM.CO.LTD.
• Cipla
• Torrent Pharmaceuticals Ltd.
• McW Healthcare Pvt. Limited
• Fermion Oy
• Tamin Pharmaceutical Investment Company
• TAGOOR LABORATORIES PVT. LTD.
• SCI PHARMTECH, INC.
• Novalab Healthcare