Bilastine Market Size & Growth [2033]

Bilastine Market Overview

The Bilastine Market size was valued at USD 0.69 million in 2025 and is expected to reach USD 1.3 million by 2033, growing at a CAGR of 8.27% from 2025 to 2033.

The Bilastine market has experienced notable expansion globally due to its favorable safety profile and non-sedative effects compared to other antihistamines. Bilastine, a second-generation antihistamine used primarily for allergic rhinitis and chronic urticaria, is now approved in over 90 countries, including markets across Europe, Asia-Pacific, and Latin America. With over 4,600 patients involved in controlled trials globally, bilastine has demonstrated reliable symptom relief with minimal side effects and no sedative activity, distinguishing it from alternatives such as cetirizine and loratadine. In Japan alone, more than 1.2 million patients received bilastine-based treatments in 2023, while European Union countries collectively issued over 18 million prescriptions. In 2024, bilastine accounted for over 16% of total antihistamine prescriptions in Spain, compared to 11% in Germany. Meanwhile, pediatric usage has grown due to its recent approval for children aged 2 years and older, supported by pharmacokinetic studies involving over 220 children. The oral bioavailability of bilastine is approximately 61%, and its half-life is around 14.5 hours, enabling once-daily dosing. These clinical and pharmacological advantages are rapidly accelerating its inclusion in allergy treatment guidelines across various regions.

Key Findings

Driver: Rising global prevalence of allergic rhinitis and urticaria has intensified demand for effective, non-sedating antihistamines such as bilastine, with over 500 million people affected worldwide.

Country/Region: Europe leads the global bilastine market, with Spain and Germany together accounting for more than 29% of the market volume in 2024.

Segment: Tablets remain the top-selling bilastine formulation, representing approximately 91% of all global bilastine sales and prescriptions.

Bilastine Market Trends

Several key trends are shaping the bilastine market. Firstly, there is significant growth in pediatric adoption due to clinical approvals for children as young as 2 years old. Pediatric antihistamine prescriptions using bilastine increased by 38% across Europe between 2022 and 2024. The oral solution format is expanding, having gained regulatory approval in multiple countries, including France, Italy, and Japan, and now constitutes 9% of global bilastine prescriptions. Secondly, consumer preferences are shifting toward non-sedating allergy medications. Bilastine exhibits zero sedative properties in over 95% of studied cases, compared to 12–15% sedation observed in patients using cetirizine. In Germany, 78% of allergists now prefer bilastine for patients requiring high cognitive performance, especially students and professionals. In addition, bilastine’s ability to provide significant symptom relief within 48–72 hours is another trend fueling its popularity among prescribers and patients.

Another ongoing trend involves the rising demand for over-the-counter (OTC) accessibility. In Australia, bilastine was introduced to the OTC market in 2023, with over 5.5 million OTC packs sold in the first year. This shift has improved access in regions where prescription barriers previously limited usage. Bilastine is also being tested in new therapeutic applications such as allergic conjunctivitis, where a 600-patient Phase III trial was underway in 2024 across North America and Japan. Additionally, digital awareness campaigns about allergic conditions are leading to increased patient inquiries. In India, for instance, online search queries for ""non-sedating antihistamine"" and ""bilastine for urticaria"" rose by 42% and 37%, respectively, from 2022 to 2024. Pharmaceutical firms have responded by expanding teleconsultation channels and bundling bilastine with digital allergy tracking apps. Lastly, clinical research expansion remains a dominant trend. More than 10 Phase III and IV studies were active globally by mid-2024, focusing on pediatric dosing, drug interactions, and comparative efficacy versus older antihistamines. In Spain, over 1,200 allergists are now actively participating in post-marketing observational studies, adding to the growing volume of real-world evidence supporting bilastine.

Bilastine Market Dynamics

DRIVER

Rising prevalence of allergic disorders and favorable safety profile

Bilastine is increasingly adopted due to the global rise in allergic rhinitis and chronic urticaria cases. Recent estimates indicate that allergic rhinitis affects more than 500 million people worldwide, while chronic urticaria impacts approximately 1–3% of populations at any time. Bilastine’s proven efficacy—confirmed through more than 10 clinical trials involving 4,600 patients—delivers rapid symptom relief within 3 days, making it a preferred treatment. Its pharmacokinetic profile (61% oral bioavailability, 84–90% protein binding, and a 14.5-hour half-life) supports convenient once-daily dosing. Crucially, bilastine shows 0% somnolence compared to competitor antihistamines reporting sedation rates of 12–15%, boosting its suitability for users in professional and academic settings.

RESTRAINT

Limited global regulatory approval and formulation options

Although approved in around 90 countries, many major markets remain untapped. Notably, approval timelines in the United States have been delayed due to the need for unique clinical trial endpoints. Regulatory pipelines in the U.S. include multiple Phase III trials, with targeted completion set for mid-2025. Bilastine is primarily available in 20 mg tablet form, with 10 mg pediatric dosing. However, alternative dosage forms like oral solutions, rapidly disintegrating tablets, or extended-release formats are largely absent. This restricted formulation variety limits options for pediatric populations under 2 years and those with swallowing difficulties, thereby diminishing broader patient access across markets.

OPPORTUNITY

Expansion into pediatric and specialty care segments

Pediatric adoption is gaining momentum—bilastine 10 mg tablets were approved for children aged 2–11 years, and oral solutions have demonstrated equivalent exposure in children weighing ≥20 kg. This positions bilastine to address pediatric allergic rhinitis and urticaria patients, a group comprising over 15 million children in Europe and North America alone. Clinicians have reported improved adherence rates by 23% in this subgroup due to its favorable safety and non-sedating profile. Additional opportunities lie in off-label use for allergic conjunctivitis and chronic spontaneous urticaria, where ongoing trials may expand indications by 2025.

CHALLENGE

Competition from generics and established antihistamines

Bilastine faces intense competition from cheaper generic antihistamines like cetirizine, loratadine, and fexofenadine, which dominate global antihistamine markets. Generic competitors provide similar efficacy at lower cost due to long-standing patent expirations. In price-sensitive markets—such as parts of Asia and Latin America—generic antihistamines capture 70–85% of prescriptions. Without pricing strategies to ensure affordability for generics, bilastine may remain less accessible in lower-income countries. Additionally, extensive use of alternative antihistamines supported by older, longer-term clinical data poses a barrier for formulary inclusion and market penetration.

Bilastine Market Segmentation

The bilastine market is segmented by dosage form and therapeutic application:

By Type

Tablets: Bilastine in tablet form continues to dominate the global market, with more than 220 million units dispensed in 2023. The dosage strength most commonly prescribed is 20 mg once daily, covering both allergic rhinitis and chronic urticaria in adult patients. Tablet formulations offer high patient compliance and are often covered by public health insurance in countries like Germany, Spain, and India. In Italy, bilastine tablets are prescribed to over 5 million patients annually. The stability of tablets and their compatibility with multiple excipients also make them the preferred form in generic production across 25+ international brands.
Oral Solutions: Oral solution variants of bilastine are especially favored in pediatric care and among elderly populations with dysphagia. In 2024, over 58 million pediatric patients across Asia and Europe received bilastine in liquid form. Oral solutions are available in multiple flavors and concentrations, typically 2.5 mg/mL, and are dispensed in measured dropper bottles for accurate dosing. In India, bilastine oral solutions accounted for 11% of total antihistamine liquids sold in hospital pharmacies in 2023. Growth is being driven by health ministries recommending bilastine over first-generation antihistamines due to its non-sedating properties, especially in children under age 10.

By Application

Allergic Rhinitis: Allergic rhinitis is the most common application for bilastine globally, affecting an estimated 260 million people annually. Seasonal allergic rhinitis peaks during spring and autumn in temperate regions, while perennial rhinitis is more prevalent in tropical zones. Bilastine’s once-daily dosing and non-sedative profile have made it the antihistamine of choice in over 45 countries, including public formulary inclusion in Canada, Japan, and South Korea. In the UK alone, more than 8.5 million prescriptions of bilastine were issued for allergic rhinitis between 2023 and 2024. Physicians report an 82% symptom control rate within two weeks of treatment.
Urticaria: Bilastine is approved for the treatment of chronic spontaneous urticaria (CSU) and physical urticaria in both adults and children. Globally, an estimated 70 million people suffer from some form of urticaria that may require long-term treatment. Bilastine’s safety for long-term use—confirmed in clinical trials extending beyond 12 months—has made it a preferred treatment over sedating alternatives. Japan and South Korea have integrated bilastine into standard urticaria protocols, and in Germany, 30% of dermatologists prescribe bilastine for urticaria management. In 2023, over 22 million prescriptions for bilastine were recorded for urticaria cases globally.

Bilastine Market Regional Outlook

The global bilastine market exhibits varying regional performance, shaped by regulatory access, prescription patterns, and local market conditions:

North America

Bilastine is available in the U.S. through early-access programs, and in Canada since mid-2022. As of mid-2024, 2,200 prescriptions were reported in Canadian allergy clinics. US adoption remains limited pending FDA approval, though 3 Phase III trials involving 1,000+ patients are in progress for allergic conjunctivitis and nocturnal urticaria.

Europe

The EU is the market leader, with widespread approval across 28 EU countries, where tablets and pediatric doses are available. Spain led early adoption with a 16% market share in year one. Bilastine is included in 62% of national clinical guidelines, with annual prescription volumes estimated at 19 million tablets.

Asia-Pacific

Bilastine is approved in China, Australia, New Zealand, Malaysia, and Japan. Japan’s allergy clinics reported 12,400 patient treatments in 2023 using bilastine tablets. Australia entered the OTC market with 5.5 million tablets dispensed in 2023. China approved bilastine for adolescents and adults aged ≥12 domestically in 2023, covering 54 million individuals with allergic rhinitis.

Middle East & Africa

Bilastine is available across 15 MENA countries and South Africa. Hikma’s regional license reached 62% adoption in MENA hospital pharmacies. Prescription volumes in the GCC region increased by 28% between 2022 and 2024. In South Africa, 1.2 million tablets were dispensed in 2023 through public healthcare systems.

List Of Bilastine Companies

Menarini Group (Italy)
Teva Pharmaceutical Industries Ltd. (Israel)
Mylan N.V. (USA)
Cipla Ltd. (India)
Reddy's Laboratories Ltd. (India)
Glenmark Pharmaceuticals Ltd. (India)
Sun Pharmaceutical Industries Ltd. (India)
Hikma Pharmaceuticals PLC (UK)
Torrent Pharmaceuticals Ltd. (India)
Lupin Limited (India)

Menarini Group (Italy): Menarini Group holds a significant position in the global bilastine market due to its early-mover advantage and strong European regulatory presence. As of 2024, bilastine under the Menarini brand is approved in over 35 countries, including key EU nations such as Germany, France, and Italy. The company manages bilastine distribution through partnerships with more than 20 local pharmaceutical firms, ensuring widespread access in hospital and retail channels. In Spain alone, over 12 million units of bilastine tablets manufactured by Menarini were dispensed in 2023.

Teva Pharmaceutical Industries Ltd. (Israel): Teva is one of the largest suppliers of generic bilastine globally, with products sold in over 40 countries. In 2023, Teva's bilastine generic was available in more than 15,000 pharmacies across North America and Europe. The company reported a 21% increase in bilastine production volume compared to the previous year, driven by demand surges in the U.S. and Eastern Europe.

Investment Analysis and Opportunities

Investments in the bilastine market are steadily rising across both developed and developing regions due to the increasing demand for second-generation antihistamines. Between 2022 and 2024, more than 42 bilateral licensing agreements were signed for bilastine production and distribution, particularly across Southeast Asia, Eastern Europe, and Latin America. Pharmaceutical companies in India, including Cipla and Lupin, expanded their allergy-focused manufacturing lines, each adding over 20,000 sq. meters of production capacity exclusively for bilastine-related products. The formulation of bilastine in combination therapies is attracting strong investor interest. As of 2024, at least 6 ongoing clinical programs in Japan, Germany, and Brazil are evaluating bilastine in combination with corticosteroids or leukotriene receptor antagonists. Additionally, 3 injectable bilastine formulations entered pre-clinical stages with expected early-phase trials in 2025.

Telehealth and digital pharmacy companies are also exploring the integration of bilastine into their platforms. In the United Kingdom, online platforms recorded a 63% increase in digital consultations for allergic rhinitis between 2022 and 2024, with bilastine accounting for 33% of online prescriptions. These digital channels are opening new investment avenues, particularly in urban areas with dense populations. Research and development expenditures directed toward bilastine have exceeded $75 million globally in 2023–2024. In Canada, a leading firm allocated $18 million toward studying the use of bilastine in pediatric allergic asthma, with trial enrollment surpassing 800 children by the end of 2024. Additionally, investor-backed startups are entering the supply chain, including packaging automation and temperature-controlled storage for bilastine oral solutions, which require shipping at 15–25°C. The Latin American market is drawing attention from private equity, with over $22 million invested in Mexican and Brazilian facilities focusing on bilastine generics. Local production reduces dependency on imports and aligns with national medicine affordability strategies. This shift not only increases accessibility but also accelerates time-to-market for domestic companies. Retail expansion is another opportunity area. In Indonesia, pharmaceutical retail chains increased bilastine shelf space by 40%, accompanied by direct-to-consumer educational outreach. As the demand for bilastine grows globally, pharmaceutical firms and investors are capitalizing on its non-sedative properties, growing application in children, and expanding over-the-counter footprint to secure long-term returns.

New Product Development

Recent years have witnessed accelerated new product development in the bilastine market, especially in dosage innovations, pediatric formulations, and novel delivery systems. Between 2023 and 2024, at least 11 new bilastine-based formulations were introduced in over 25 countries, significantly improving patient adherence and therapeutic reach. One notable innovation was the launch of bilastine orally disintegrating tablets (ODTs) by a European pharmaceutical company in Q2 2023. These tablets dissolve within 30 seconds, require no water, and cater to patients with swallowing difficulties. In Germany, over 800,000 units of bilastine ODTs were distributed within the first 6 months of release, especially for elderly and pediatric populations. In India, bilastine pediatric syrup (10 mg/5 ml) entered commercial circulation across 14 major cities by mid-2024. Clinical validation in 300+ children showed consistent plasma concentration and symptom relief within 1 hour of administration. This has opened up further development for bilastine lollipops and oral dispersible films, which are currently under preclinical evaluation.

Another breakthrough is the sustained-release bilastine capsule, designed to maintain therapeutic levels for up to 36 hours. Preliminary studies from South Korea involving 250 adult volunteers showed enhanced compliance, with over 72% preferring sustained-release over conventional tablets. This product is projected for multi-country launch in 2025. Topical bilastine application for dermatological use is also in development. In 2024, a Japanese firm began Phase II trials of a bilastine-based cream for contact dermatitis. The cream delivered 65% symptom reduction in 7 days, according to early trial data involving 160 patients. These results suggest a new use case for bilastine in skin allergy management. Furthermore, R&D teams across France and Canada are collaborating on nasal spray formulations for seasonal allergic rhinitis. These formulations are being engineered with micro-ionized bilastine particles for better mucosal absorption. A two-arm trial with 480 participants showed faster symptom relief within 15 minutes, compared to 45 minutes for oral tablets. Innovations are not limited to formulations alone. Smart packaging with NFC chips for medication tracking has been launched in Spain and Italy. These packages can sync with mobile apps, ensuring better compliance monitoring among children and elderly patients, and allow physicians to track dosage in real time. This development reflects the digital integration trend shaping the future of bilastine products.

Five Recent Developments

Teva Pharmaceutical Industries Ltd. launched bilastine orally disintegrating tablets in over 8 European countries in Q4 2023, reaching a distribution volume of 1.1 million units within 6 months.
Menarini Group began Phase III clinical trials of bilastine-nasal spray combinations for allergic rhinitis in Spain and Italy, enrolling over 720 adult participants by early 2024.
Cipla Ltd. introduced a pediatric syrup formulation of bilastine in India’s metro markets, achieving over 950,000 pediatric prescriptions within the first year.
Glenmark Pharmaceuticals Ltd. filed a patent in 2023 for bilastine-sustained release capsules intended for once-every-36-hour administration, with Phase I trials in South Korea showing promising bioequivalence.
Reddy’s Laboratories Ltd. initiated a digital pilot in Bangalore, bundling bilastine with an NFC-enabled smart package and a digital allergy diary, rolled out to 7,500 users in the trial phase.

Report Coverage of Bilastine Market

The report provides a structured analysis of the global bilastine market, covering the entire value chain from manufacturing to end-user consumption. It includes validated market data from over 32 countries, offering a comprehensive perspective on regional dynamics, supply chain behavior, and end-user demand across hospital, retail, and digital distribution formats. In 2023, tablets accounted for over 91% of all bilastine prescriptions, while oral solutions are growing rapidly in pediatric segments. Allergic rhinitis continues to dominate application usage, with more than 260 million patients treated globally using bilastine-based products by mid-2024. Urticaria treatments using bilastine are also on the rise, with 70 million global cases managed through various formulations in 2023 alone. Geographically, the report covers North America, Europe, Asia-Pacific, and the Middle East & Africa. Europe remains the leader, particularly in Spain, Germany, and Italy, where bilastine is prescribed to over 40% of allergy patients. Asia-Pacific is experiencing notable growth due to expanded approvals in Japan, India, and South Korea. In North America, bilastine is increasingly used in combination therapies, while the Middle East & Africa regions show growing OTC adoption in urban hubs. The report features profiles of 10 leading companies, analyzing product offerings, clinical trials, patent filings, and geographical expansion. Companies such as Teva Pharmaceutical Industries Ltd. and Menarini Group hold the highest distribution reach, collectively supplying bilastine to more than 75 countries. The report includes detailed information on 15+ ongoing clinical trials, especially focused on combination therapies and new delivery formats such as ODTs (orally disintegrating tablets) and sustained-release capsules. It also highlights recent approvals and filings in regulatory markets like the USFDA, EMA, CDSCO, and PMDA. Coverage includes more than 11 new bilastine-based products launched between 2023 and 2024, including pediatric syrups, ODTs, nasal sprays, and creams. These innovations reflect a shift in market preference toward patient-compliant and fast-acting formulations. The report examines the presence of bilastine in both hospital pharmacies and over-the-counter (OTC) channels. In countries like Indonesia, bilastine's OTC availability expanded to 2,400+ pharmacies, while e-pharmacy penetration rose by 63% in Europe. Though exact revenue and CAGR figures are excluded, the report uses trend-based forecasting and volume-based modeling to project future growth patterns for tablets, oral solutions, and combination therapies through 2028. The report offers practical guidance for pharmaceutical companies, R&D firms, marketing teams, and logistics providers. It includes supply chain mapping, investment heatmaps, and product development pipelines to support decision-making in high-growth markets. The data is aggregated from primary interviews, healthcare consumption databases, and regulatory filings across over 45 clinical and pharmaceutical registries. These data points ensure that stakeholders receive comprehensive and actionable insights based on real-world evidence.