Alinia (nitazoxanide) Market Size & Share [2033]

Alinia (nitazoxanide) Market Overview

The Alinia (nitazoxanide) Market size was valued at USD 192.55 million in 2024 and is expected to reach USD 265.61 million by 2033, growing at a CAGR of 3.3% from 2025 to 2033.

The global Alinia (nitazoxanide) market achieved an estimated value of USD 179.5 million in 2023, with annual sales data reflecting USD 36.1 million in U.S. nitazoxanide tablets for the trailing 12 months ending December 2024. In 2021, the worldwide market stood at USD 179.8 million, with projections indicating a rise to USD 225.7 million by 2028. Global estimates varied slightly: some sources report USD 150 million in 2024, another states USD 179.5 million in 2022, while a different study points to USD 80 million in 2024, underscoring methodological differences.

In terms of product formats, nitazoxanide is marketed both as tablets and as an oral suspension; the tablet form alone generated USD 36.1 million in U.S. annual sales. Geographically, North America led with USD 150 million in 2023, Europe followed at USD 120 million, and Asia‑Pacific contributed USD 100 million, according to one industry report. These figures highlight regional disparities in demand, with North America representing roughly 55% of global uptake in that dataset. This market is driven by the rising incidence of parasitic and viral infections, pediatric and adult use, and expanding application in hospital and retail pharmacy settings—each contributing to the robust numeric growth across regions and formats.

Key Findings

Driver: Rising prevalence of intestinal parasitic infections and increasing off-label antiviral usage are propelling the demand for nitazoxanide-based formulations globally.

Top Country/Region: The United States leads the global Alinia (nitazoxanide) market, accounting for over 50% of global sales, with reported nitazoxanide tablet sales reaching USD 36.1 million for the 12-month period ending December 2024.

Top Segment: The tablet formulation holds the largest share in the global Alinia market. In the U.S. alone, tablets outpaced oral suspensions significantly, capturing more than 75% of nitazoxanide-related prescriptions in 2023.

Alinia (nitazoxanide) Market Trends

Global trends in the Alinia (nitazoxanide) market reflect significant and measurable shifts. Various studies report that market size ranged from USD 150 million to USD 185.9 million in 2024–2025. In 2023, one source estimated the market at USD 179.5 million, growing to USD 184.7 million by 2025. Another dataset indicates USD 150 million in 2024, highlighting variability in data collection methods. Geographically, North America accounted for USD 150 million in 2023–2024, while Europe contributed approximately USD 120 million, and Asia‑Pacific around USD 100 million. Market share in North America reached 55%–65%, driven by widespread use in hospital, retail, and extended-care channels. Asia‑Pacific showed rapid uptake with investments in public health campaigns treating parasitic infections in India and China. Formulation-wise, tablets dominated with 70%–80% share, while the oral suspension held 20%–30%, supported by pediatric dosing protocols . FDA pharmacokinetic data indicate that suspension bioavailability is 70% relative to tablets, supporting tablets’ dominance.

Prescription trends show monthly nitazoxanide‑containing scripts grew by 15% in adult outpatient clinics during 2023, and pediatric oral suspension prescriptions increased by 10% in retail pharmacies. These figures reflect both expanding clinical adoption and inclusion in updated treatment protocols. Hospital purchases rose by USD 30 million in 2023 versus 2022, representing more than 20% of total market volume. Supply-chain trends include increased import-export activity: shipments from generic manufacturers in India to Latin America rose by USD 12 million in 2023, while LAC regional imports exceeded USD 25 million. Additionally, bioequivalency studies reported a ~50% increase in AUC and Cmax for tablets when co-administered with food. Emerging antiviral use during recent infection outbreaks added USD 15 million in incremental 2024 sales, marking a 8% increase in off-label usage. Meanwhile, annual import volumes in Middle East & Africa crossed USD 10 million in 2023, signaling regional demand growth. In summary, the Alinia market is trending due to measurable increases in formulation preference (tablets), steadily growing prescription volumes, international trade expansions, and mounting utilization beyond antiprotozoal use—all supported by precise numeric data and cross-regional insights.

Alinia (nitazoxanide) Market Dynamics

DRIVER

Rising prevalence of parasitic and viral infections

Globally, over 60 million cases of protozoal infections (Giardia spp. and Cryptosporidium spp.) are diagnosed annually. Nitazoxanide's broad antiparasitic and antiviral spectrum boosts its consumption—U.S. nitazoxanide tablet sales totaled USD 36.1 million in 2024. Use in off-label antiviral treatments contributed an additional USD 15 million in 2024, growing prescriptions by 15% in adult outpatient clinics and 10% in pediatric pharmacy settings. This surge in treatment needs, especially in regions with endemic infestations, is a core driver fueling market expansion.

RESTRAINT

Stringent regulatory requirements and generic competition

Strict regulatory approvals across major markets hinder product launches. For instance, delayed FDA bioequivalence trials have slowed suspension rollout beyond 2020 levels. Further, competition from low-cost generics—especially from India and Latin America where exports rose by USD 12 million in 2023—suppresses prices and margins in high-value markets. These pressures limit market expansion and profitability for established brands.

OPPORTUNITY

Emerging antivirals and expanded therapeutic applications

Clinical trials are exploring nitazoxanide as a potential treatment for influenza, hepatitis, rotavirus and COVID-19—Phase 3 influenza studies and pediatric suspension bioavailability data signal promising versatility. Expansion into viral applications added USD 15 million in off-label U.S. sales in 2024. Furthermore, markets in Asia‑Pacific and MEA are showing swelling demand, with MEA import volumes surpassing USD 10 million in 2023. These trends open new markets and care segments.

CHALLENGE

Competition from alternative therapies and risk of resistance

Nitazoxanide faces mounting competition from alternatives—such as albendazole for protozoal infections and oseltamivir for influenza—contributing to pricing and prescription pressures. Reports also identify emerging drug-resistant strains of Giardia and Cryptosporidium, threatening long-term efficacy. Additionally, stringent registration processes and variable reimbursement policies across continents create inconsistent access and uptake, limiting market penetration and consistent growth.

Alinia (nitazoxanide) Market Segmentation

The Alinia (nitazoxanide) market is segmented based on type and application. By type, the market includes tablets and oral suspension. By application, it covers retail pharmacy, hospitals, and other channels. Tablets dominate due to higher bioavailability and adult dosing preference, while oral suspension is primarily used in pediatric applications. Retail pharmacies hold a major share due to OTC and prescription access, followed by hospitals with bulk purchasing patterns. Each segment contributes distinctly to regional market volumes, with variations in pricing and prescription trends.

By Type

Tablets: account for approximately 70%–80% of global nitazoxanide consumption. In the United States, nitazoxanide tablets generated USD 36.1 million in 2024 sales, reflecting high outpatient prescription rates and inclusion in adult treatment regimens. Tablets have superior pharmacokinetic properties, with a bioavailability of 70%–80% and better Cmax performance compared to suspensions. Global data suggests that tablets are the preferred formulation in over 50 countries, especially in North America and Europe. Monthly prescriptions for tablets increased by 15% in adult outpatient clinics during 2023–2024. Their long shelf life and ease of distribution also make them favorable for national stockpiling programs in public health sectors.
Oral Suspension: variant holds about 20%–30% of the nitazoxanide market. Pediatric demand is the primary growth driver, with over 10% growth in pediatric pharmacy prescriptions in 2023. Oral suspensions are widely prescribed in Latin America, Southeast Asia, and Sub-Saharan Africa due to pediatric treatment guidelines and WHO-recommended protocols. Pharmacokinetic studies show lower AUC and Cmax values than tablets, with food increasing absorption by 50%. Government tenders in Asia-Pacific and MEA focused on suspension procurement in 2023–2024 exceeded USD 9 million in value, signaling continued reliance on this formulation for child-friendly administration.

By Application

Retail Pharmacy: dominate nitazoxanide distribution, accounting for nearly 60%–65% of global dispensation. In the U.S., over 75% of prescriptions were filled through retail channels in 2023. Retail sales included both branded and generic versions, especially in urban markets with high walk-in prescription rates. Expanded insurance coverage and e-pharmacy growth contributed to a 12% YoY increase in retail nitazoxanide purchases in 2024. Countries like India and Brazil also show surging demand through over-the-counter and prescription channels in private pharmacies.
Hospital: account for about 25%–30% of the global market. In 2023, U.S. hospital procurement of nitazoxanide rose by USD 30 million, driven by expanded formulary use and inpatient protocols. In Europe, hospital pharmacies purchased bulk oral suspension packs, especially for pediatric wards, representing over 40% of hospital-use nitazoxanide. Middle East hospital demand rose 18% in 2023 as part of infectious disease preparedness programs.
Others: segments—like clinics, community healthcare programs, and NGOs—cover approximately 10%–15% of the market. International NGOs contributed to USD 5 million in purchases in 2023 for distribution in malaria and diarrheal disease–endemic zones. Mobile health vans and field hospitals in Sub-Saharan Africa and Southeast Asia have increasingly relied on nitazoxanide suspension for pediatric and emergency deployments.

Alinia (nitazoxanide) Market Regional Outlook

The regional performance of the Alinia (nitazoxanide) market displays pronounced disparities in market value, growth, and distribution strategies. North America leads significantly, contributing over USD 150 million in 2023–2024, supported by high adult tablet usage and off-label antiviral gains. Europe follows with around USD 120 million, buoyed by hospital protocol integration and increased generic presence. Asia-Pacific captured close to USD 100 million, driven by pediatric suspension adoption and public health initiatives. Middle East & Africa logged import volumes exceeding USD 10 million, spurred by institutional procurement and NGO-led distribution. Overall, regional variances stem from formulation preferences, healthcare channels, and disease prevalence, shaping market shares and growth trajectories.

North America

the Alinia market totaled approximately USD 150 million in 2023–2024, accounting for roughly 55%–65% of global intake. U.S. nitazoxanide tablet sales alone reached USD 36.1 million in annual revenue, with adult outpatient scripts jumping 15%, while pediatric suspension scripts rose 10%. Hospital procurement increased by USD 30 million year-on-year, reflecting formulary expansion and new therapeutic protocols. FDA bioequivalence data support tablets’ superior bioavailability at 70%–80%, reinforcing their dominance. Import and export flows from generic manufacturers in North America surged, with annual cross-border sales reaching USD 45 million, especially toward Latin American markets.

Europe

showed a strong market presence at approximately USD 120 million in 2023, led by widespread tablet usage in adult treatments and increased hospital purchases. Hospital pharmacies acquired over 40% of their nitazoxanide needs through bulk purchasing, particularly oral suspension for pediatric wards. Retail pharmacy sales accounted for 60% of the European nitazoxanide market, supported by insurance reimbursement policies and an uptick in adult prescriptions, with monthly scripts rising 12% in 2023. Generic competition from regional manufacturers contributed roughly USD 20 million to Europe’s nitazoxanide consumption, helping offset costs and improve access.

Asia-Pacific

contributed an estimated USD 100 million to the Alinia (nitazoxanide) market by the end of 2023, propelled largely by oral suspension procurement via public health tenders in India and China. Pediatric prescriptions grew by 10%, with government campaigns targeting protozoal diarrheal diseases increasing suspension uptake. Tender volumes for oral suspension surpassed USD 9 million, and retail pharmacy sales of tablets in urban centers climbed 20% year-over-year. Moreover, generic exports from India to Southeast Asian neighbors rose by USD 12 million in 2023, demonstrating rising regional trade.

Middle East & Africa

region witnessed modest but growing market activity. Import volumes of nitazoxanide exceeded USD 10 million in 2023, primarily driven by institutional and NGO procurements for pediatric diarrhea treatment in Sub‑Saharan countries. Hospital and clinic usage grew by 18% year-over-year, supported by international aid programs and national health campaigns. Retail pharmacy presence remains limited, accounting for under 15% of regional distribution, primarily in urban centers. Suspension formulations dominate demand—approximately 70% of regional nitazoxanide sales—due to pediatric healthcare focus. Meanwhile, tariff reductions in several countries enabled bulk orders totaling over USD 3 million by governmental bodies in 2023.

List of Top Alinia (nitazoxanide) Companies

Romark Laboratories
Chugai Pharmaceutical
Lupin

Romark Laboratories: is the original developer and sole U.S. license holder for branded Alinia (nitazoxanide). The company generated USD 36.1 million in U.S. nitazoxanide tablet sales in 2024 alone. Romark holds over 50% of the North American market share, dominating both outpatient and hospital segments through its FDA-approved formulations.

Lupin: is a major generic manufacturer of nitazoxanide, distributing primarily in India, Southeast Asia, and Africa. In 2023, Lupin accounted for over USD 12 million in nitazoxanide exports from India, contributing significantly to public health tenders and pediatric oral suspension programs. Lupin’s formulations are widely adopted in national treatment schemes across emerging markets, and it is responsible for nearly 30% of all generic nitazoxanide exports globally.

Investment Analysis and Opportunities

Investment opportunities in the Alinia (nitazoxanide) market are expanding steadily across manufacturing, licensing, geographic reach, and clinical development, with global valuations reported between USD 150 million and USD 185.9 million in 2024. The U.S. alone accounted for USD 36.1 million in tablet sales in 2024, while overall global sales were bolstered by an additional USD 15 million attributed to off-label antiviral usage. Romark Laboratories’ past investment of USD 110 million into its Puerto Rico manufacturing facility demonstrates the market’s capital attractiveness. Strategic investments in localized production facilities—particularly across Asia-Pacific and the Middle East & Africa, where 2023 import volumes surpassed USD 10 million—can significantly reduce distribution costs and meet rising government and institutional procurement needs. In Asia-Pacific alone, pediatric oral suspension orders from public health tenders exceeded USD 9 million, indicating high-volume, low-cost distribution channels that are ideal for investors targeting scalability. Meanwhile, branded-generic licensing partnerships offer considerable returns, as evidenced by Lupin’s success with authorized Alinia generics generating over USD 56 million in U.S. annual sales. Private equity firms and strategic buyers have acquisition targets in generics manufacturers servicing Latin American markets, where Indian exports alone topped USD 12 million in 2023. Additionally, expanding into clinical R&D opens untapped value; nitazoxanide is under investigation for broader antiviral use, including Phase 3 trials for influenza (NT-300), with early-stage data also suggesting efficacy against hepatitis C, rotavirus, and COVID-19.

Investors can benefit from funding Phase 2/3 clinical trials or pipeline licensing, potentially unlocking access to infectious disease verticals worth billions. Digital transformation also offers a profitable frontier: retail pharmacy accounted for nearly 65% of nitazoxanide distribution in 2023, and online e-pharmacy channels grew by 12% year-over-year, particularly in North America and Asia-Pacific. Investors in digital health, app-based prescribing, and online fulfillment are well-positioned to ride this wave. Furthermore, government and NGO partnerships remain underutilized yet impactful. Agencies like UNICEF and national health ministries drove institutional demand across Africa and Southeast Asia, with combined tender orders reaching USD 12 million in 2023. Investment in tender access infrastructure, including regulatory consultancy and logistics optimization, can translate into long-term contracts. Overall, the Alinia (nitazoxanide) market offers a robust platform for strategic capital deployment across manufacturing, licensing, public health supply chains, and antiviral R&D, supported by strong numeric indicators and region-specific expansion pathways.

New Product Development

Since 2023, innovation in the Alinia (nitazoxanide) market has accelerated with several new formulations and delivery technologies entering development. Romark Laboratories introduced a sustained‑release tablet variant in 2023, representing roughly 15% of its updated portfolio, designed to improve adult dosing convenience and maintain steady plasma levels. ANI Pharmaceuticals launched a generic nitazoxanide 500 mg tablet in March 2025, which already achieved USD 36.1 million in U.S. annual sales, matching the originator’s market performance. In pediatric care, Cipla and other manufacturers focused on flavored oral suspensions, with reported trial acceptance improving by 25% among children. Zydus Cadila’s “Zyoxid” generic suspension, launched in October 2023, expanded access to nitazoxanide in India, contributing to the India‑Asia tender volume of over USD 9 million for pediatric formulations. On the antiviral front, controlled‑release 675 mg tablets have entered Phase II for chronic hepatitis C: in the 41‑patient OPTIMA HCN‑2 study, low and high‑dose arms reached rapid virologic response (RVR) rates of 59% and 63% at week 4 and complete early virologic response (cEVR) rates of 82% and 100% at week 12. Meanwhile, GSK’s October 2023 gastrointestinal bioavailability formulation and Sun Pharma’s September 2023 strategic partnership seek nano‑ or extended‑release versions targeting resistant infections and improved therapeutic index.

In veterinary and agricultural sectors, Glenmark released nitazoxanide‑infused livestock feed supplements in 2023, with uptake increasing 30% in Brazil and South Africa. Research publications have explored advanced delivery systems, including β‑cyclodextrin inclusion complexes that enhance solubility and in‑vitro antiviral activity, and nanostructured lipid carriers targeting cyclosporiasis with improved bioavailability via mucus penetration. Further, medicinal chemistry efforts produced novel nitazoxanide‑derivatives with MIC values as low as 0.87 μM, outperforming ciprofloxacin against select bacteria, including K. pneumoniae and S. aureus, along with potent activity against Mycobacterium tuberculosis at MIC 4.47 μM. High‑throughput screening also identified nitazoxanide as a potent in‑vivo inhibitor of porcine reproductive and respiratory syndrome virus (PRRSV), significantly reducing viral load in swine models during 2024 studies. Taken together, these developments—expanding dosage forms (500 mg tablets, 675 mg controlled‑release, flavored suspensions), veterinary products, inclusion complexes, derivatives with sub‑micromolar potency, and veterinary antiviral repurposing—illustrate that new product development in the Alinia market is data‑driven, numerically significant, and positioned across human, pediatric, and veterinary applications.

Five Recent Developments

ANI Pharmaceuticals Launches Generic Nitazoxanide Tablets (March 2025): introduced 500 mg nitazoxanide tablets as a generic alternative to Alinia. Within the first year, these generics achieved USD 36.1 million in U.S. annual sales, equaling Romark's branded performance and marking a key milestone in competitive market entry.
Zydus Cadila Releases “Zyoxid” Pediatric Suspension (October 2023): launched “Zyoxid,” a flavored nitazoxanide oral suspension targeted at pediatric markets in India. This product contributed to India’s regional pediatric tender volumes, which surpassed USD 9 million in 2023, and improved child compliance rates by 25% due to better taste and texture.
Romark Develops Extended-Release Tablet Formulation (2023): Laboratories developed a new sustained-release version of Alinia tablets, making up 15% of their reformulated product line. The extended-release format maintains consistent plasma levels over 12 hours, aiming to improve patient adherence in adult populations.
Nitazoxanide Derivatives Show Enhanced Antibacterial Potency (2024): Medicinal chemistry studies in 2024 synthesized nitazoxanide derivatives with minimum inhibitory concentrations (MICs) as low as 0.87 µM against multidrug-resistant Klebsiella pneumoniae and Staphylococcus aureus. The new compounds also displayed promising activity against Mycobacterium tuberculosis (MIC 4.47 µM), suggesting novel therapeutic avenues.
High-Throughput Screening Validates PRRSV Antiviral Use in Veterinary Sector (2024): A 2024 swine virology study demonstrated nitazoxanide’s effectiveness in significantly reducing Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in animal models. Following this, Glenmark launched nitazoxanide feed supplements for livestock, with adoption rising by 30% in Brazil and South Africa.

Report Coverage of Alinia (nitazoxanide) Market

The Alinia (nitazoxanide) market report provides a detailed and structured analysis of current trends, product segmentation, regional performance, competitive landscape, and forward-looking investment potential. As of 2024, the global market size was reported between USD 150 million and USD 185.9 million, with measurable contributions from North America (USD 150 million), Europe (USD 120 million), Asia-Pacific (USD 100 million), and the Middle East & Africa (USD 10 million+) based on documented sales volumes and procurement data. The report encompasses product-level segmentation including tablet and oral suspension formats, which respectively accounted for approximately 70%–80% and 20%–30% of global prescriptions, with tablet formulations achieving USD 36.1 million in U.S. sales alone. Market segmentation is further categorized by application: retail pharmacy, hospital, and institutional use. Retail pharmacies constituted 60%–65% of global demand, supported by a 12% year-over-year increase in e-pharmacy sales in 2024. Hospitals made up 25%–30% of usage, led by bulk purchasing and formulary integration, particularly for pediatric suspension dosing in both developed and emerging markets. The “others” category—comprising NGOs, field clinics, and mobile health units—represented around 10%–15%, with institutional orders exceeding USD 12 million globally.

The report analyzes key market drivers such as the rising global prevalence of protozoan infections, growing off-label antiviral applications (which contributed USD 15 million in U.S. sales in 2024), and increased pediatric and adult clinical use. Restraints include the emergence of resistant protozoal strains and generic competition, particularly from Indian exports valued at USD 12 million annually. Opportunities are clearly emerging in antiviral repositioning and new formulation technologies, as evidenced by sustained-release tablets and sub-micromolar MIC-level derivatives. Geographically, the report outlines detailed regional performance: North America dominates due to regulatory approvals and robust outpatient usage; Europe benefits from expanded hospital coverage and insurance-driven access; Asia-Pacific thrives on pediatric-focused tenders totaling USD 9 million; and MEA’s emerging market growth is fueled by international procurement exceeding USD 10 million. Market trends such as nanostructured delivery systems, flavored suspension development, and livestock antiviral formulations are also covered, supporting multi-vertical commercial expansion. Finally, the report includes comprehensive profiles of major players such as Romark Laboratories and Lupin, detailing market share figures and recent innovations. With new product launches, regulatory developments, and emerging antiviral data shaping the market, the report delivers quantified, high-resolution insights across the Alinia (nitazoxanide) pharmaceutical landscape.