Loratadine Market

Market Overview

The global loratadine market size was valued at USD 158.2 million in 2023 and is projected to reach  USD 219.4 million by 2032, registering a CAGR of 3.7% during the forecast period (2024-2032). The growing prevalence rate of allergies worldwide, changing lifestyles, and favorable regulatory landscape are significant factors driving the Loratadine market growth.

Loratadine is a common antihistamine medication classified as second-generation or non-sedating antihistamines. It is mainly used to treat allergy-related symptoms, such as allergic rhinitis (hay fever) and chronic idiopathic urticaria. Loratadine works by inhibiting the activity of histamine, a substance produced by the body during allergic responses, which relieves symptoms like sneezing, itching, runny nose, and watery eyes.

The loratadine market is primarily driven by lifestyle changes and an increasing burden of allergies that cause hypersecretion of histamine. The market is rising as allergy rates rise, as do allergy research and development programs. Furthermore, the drug's wide range of applications and the increasing use of loratadine in various allergies are expected to drive market expansion throughout the projection period. Moreover, the market is expected to rise due to the ongoing development of loratadine medications. 

Highlights

• USP Standard Grade holds a significant market share by grade type.
• Tablets dominate the market by dosage form.
• Hospital Pharmacy is the major end-user of the market.

Market Dynamics

Global Loratadine Market Drivers

Rising Prevalence of Allergic Diseases

The rising prevalence of allergic illnesses such as allergic rhinitis, hay fever, and chronic urticaria is a significant driver of the loratadine industry. Urbanization, pollution, changing lifestyles, and exposure to environmental allergens contribute to the global prevalence of allergies. Loratadine is a regularly prescribed drug for controlling allergy symptoms. Therefore, the growing prevalence of allergic disorders fuels the demand for this antihistamine prescription. According to the World Allergy Organization (WAO), allergic illnesses such as allergic rhinitis, asthma, and atopic dermatitis have become a global public health concern, impacting 30-40% of the world's population. The incidence of allergic rhinitis varies by region, with higher rates recorded in cities than in rural areas, with rising trends reported in developed and developing countries.

According to NCHS Data Brief No. 460 for January 2023, seasonal allergies are the most frequent, accounting for 25.7% of all adult allergies. Eczema is the second most prevalent allergy, accounting for 7.3% of adults, followed by food allergies, which account for 6.2% of adults. Women are more likely than men to have been diagnosed with allergies. In addition, According to a 2023 study, the prevalence of physician-diagnosed allergy rhinitis (AR) in the United States has risen over the years, from 8.39% in 2012 to 2015 to 19.87% in 2016–2022. The prevalence of self-reported present AR is 18.12%, with self-reported lifetime AR being 19.93%. Genetic predisposition, early-life exposures, dietary habits, and environmental factors all contribute to the development and progression of allergy illnesses in children, emphasizing the importance of good management and treatment choices like loratadine.

Global Loratadine Market Restraints

Regulatory Challenges

Regulatory difficulties, such as stringent licensing processes and compliance standards, limit the loratadine market. Pharmaceutical businesses must follow regulatory requirements established by health authorities such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to assure loratadine products' safety, efficacy, and quality. Delays in regulatory approvals, changes in regulatory regulations, and compliance concerns can stymie product launches, expansion into new markets, and overall market growth.

Additionally, generic manufacturers often follow the FDA's Abbreviated New Drug Application (ANDA) procedure to obtain clearance for generic loratadine. Generic drug applicants must provide comprehensive data demonstrating that their product is pharmaceutically equivalent (i.e., identical in active ingredients, dosage form, strength, and route of administration) and bioequivalent (i.e., has comparable pharmacokinetic parameters) to the reference listed drug (RLD), which is usually the branded loratadine product. Before permitting commercialization, the FDA evaluates the ANDA filing to confirm that it meets regulatory requirements.

Similarly, generic manufacturers seeking approval for generic loratadine products in the European Union (EU) must adhere to the EMA's centralized, decentralized, or mutual recognition procedures. The generic application contains a thorough dossier containing data on pharmaceutical quality, bioequivalence, and non-clinical and clinical tests demonstrating the generic product's safety and efficacy compared to the reference product. The EMA evaluates applications and issues marketing authorization for generic loratadine products that meet regulatory standards.

Moreover, generic producers confront regulatory compliance issues because of the complexities of the approval process, data requirements, and regulatory scrutiny. The FDA has delayed the final approval of generic medications until all patent or exclusivity issues have been resolved. This includes a 30-month delay for patent litigation. Delays in approval deadlines, requests for additional information or studies, and changes in regulatory rules can all slow down the generic approval process and affect market entrance dates.

Global Loratadine Market Opportunity

Expanding Over the Counter Market

The growing over-the-counter (OTC) market for allergy drugs, including loratadine, represents a profitable potential for producers and merchants. As people seek self-care options to manage mild to moderate allergy symptoms, the availability of over-the-counter loratadine products in pharmacies, retail stores, and online platforms provides convenience, accessibility, and choice. Pharmaceutical businesses may benefit from the trend of self-medication by developing innovative OTC formulations, dosage forms, and packaging alternatives that cater to consumer preferences and improve the overall consumer experience.

According to the 022 OTC Value Study, every dollar spent on OTC drugs saves the US healthcare system USD 7.33, for a total annual savings of USD 167.1 billion. CHPA's new study analyzed survey results from over 5,000 consumers, revealing USD 56.8 billion in savings when consumers rely on less expensive OTC medicines rather than prescription drugs, as well as another USD 110.3 billion in savings when consumers can avoid unnecessary doctor visits for minor ailments by caring for themselves with OTCs.

Moreover, global market trends show a consistent increase in OTC allergy medication sales, including loratadine, in regions such as North America, Europe, Asia-Pacific, and Latin America. Market research estimates predict that the OTC allergy medicine market will continue to rise due to changing customer demographics, urbanization, rising healthcare costs, and expanding retail infrastructure. Pharmaceutical companies are capitalizing on these changes by increasing their OTC product portfolios, investing in marketing campaigns, and developing distribution networks to reach more consumers and increase sales.

Regional Analysis

The global loratadine market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global loratadine market shareholder and is estimated to grow at a CAGR of 3.4% over the forecast period. The high illness burden and the existence of several producers are expected to drive market expansion in this area. The region's increasing prevalence of seasonal and permanent allergies is driving up demand for antihistamine drugs such as loratadine. Increasing population awareness of allergies and customer demand for non-drowsy formulations is expected to boost regional revenue development potential. 

Furthermore, increased government activities to raise allergy awareness are driving market expansion. For example, the World Allergy Organization had World Allergy Week in 2022 from June 5th to 11th. The awareness week highlights the need for increased attention. It provides clinicians and the general public with a webinar, infographic, and other resources to educate and raise awareness about the allergy.

Additionally, according to the Asthma and Allergy Foundation of America's (AAFA) Allergy Capitals Report March 2022, Scranton, Pennsylvania, ranks first in allergy population. According to the same research, more than 50 cities face an average risk of allergy attacks. The same research underlines the need for a public health emergency since communities across the country suffer from the detrimental consequences of climate change on their health in the US. Asthma patients include children, adults, seniors, pregnant women, people of color, low-income people, persons with impairments, and many more. As there is a more significant number of people suffering from allergies and asthma attacks, the market for antihistamines such as loratadine is expanding. 

Asia-Pacific is anticipated to exhibit a CAGR of 3.8% over the forecast period. The Asia Pacific loratadine market is being driven by rapidly expanding awareness of allergic ailments, a growing senior population that is especially susceptible to a variety of allergic problems, and the rising prevalence of lifestyle diseases. An Indian study found that allergic rhinitis was prevalent in 11.3% of children aged 6-7 years and 24.4% of children aged 13-14. The country's vast population, rising disposable incomes, and increased health awareness drive growth in the pharmaceutical sector, particularly for antihistamines like loratadine.

Europe holds a moderate share of the market. The UK's aging population and extended pollen seasons have increased the need for allergy treatment drugs like loratadine. In the UK, self-medication and over-the-counter (OTC) purchases of these medications are increasing, driving market growth. The UK's robust healthcare infrastructure and regulatory frameworks promote safe and effective drug use, contributing to market growth. 

Segmental Analysis

The global loratadine market is segmented based on grade type, dosage form, and end-user.

The market is further segmented by grade type into Medicine Standard Grade, USP Standard Grade, and EP Standard Grade.

The USP standard grade segment had the most significant market share in 2023. USP standard grade loratadine is loratadine that meets the quality requirements defined by the United States Pharmacopeia (USP). This nonprofit organization establishes quality standards for pharmaceuticals, dietary supplements, and other healthcare items in the United States. USP standard grade loratadine is tested and certified to ensure it meets USP monograph requirements for identification, purity, strength, and performance. USP standard grade loratadine is widely recognized for adhering to quality and safety requirements, assuring healthcare professionals, regulatory authorities, and consumers of the product's quality and consistency.USP standard grade emphasizes regulatory conformity with established quality and safety norms, accelerating customer preference and adoption.

EP standard grade loratadine is loratadine that meets the quality requirements set by the European Pharmacopoeia (EP), a reliable reference work for the quality regulation of medicines and healthcare products in Europe. EP standard-grade loratadine meets the requirements described in EP monographs, which specify the identification, purity, and quality of pharmaceutical compounds and dosage forms. EP standard grade loratadine is tested and analyzed to assure compliance with EP standards, ensuring its acceptability in pharmaceutical formulations and medicinal products sold in European nations. Compliance with EP standards ensures that loratadine is high quality, effective, and safe for patients in the European Union and other territories that accept EP standards.

Based on dosage form, the market is fragmented into Syrup, Tablets, and Capsules.

Tablets led the market in 2023 because of patient convenience, ease of administration, widespread availability, dependability, and a longer shelf life. Tablets are one of the most used loratadine dosage forms, and they have various advantages, including ease of administration, precise dose, and stability. Loratadine pills come in a variety of dosages and forms, including conventional, orally disintegrating, and chewable tablets. Conventional loratadine tablets are eaten whole with water, providing patients with a convenient and cost-effective solution.

Additionally, orally disintegrating pills dissolve quickly in the mouth without water, making it convenient for patients who have difficulty swallowing or are on the go. Chewable tablets are an option for individuals who prefer chewable dosage forms or have problems eating solid tablets. The strong presence of multiple industry competitors who manufacture loratadine tablets in various strengths to serve a vast demographic base will drive segment expansion throughout the projected period.

Loratadine syrup formulations provide a liquid dosage form, making it easier for patients who struggle to swallow pills or capsules, such as children and the elderly. Syrups are typically sweetened to promote palatability, making them appropriate for youngsters resistant to treatment. Furthermore, syrup formulations allow for more flexible dosage because they may be readily measured with a dosing cup or syringe. This dose type is suitable for those who want a quick onset of action or have specific taste preferences. Loratadine syrup formulations are commonly used to treat allergic rhinitis and chronic urticaria.

The market can be further bifurcated by end-users into Online, Hospital, and Retail Pharmacies.

Hospital pharmacies are essential in delivering loratadine throughout healthcare institutions such as hospitals, clinics, and outpatient facilities. These pharmacies dispense loratadine and other drugs given by healthcare practitioners to hospitalized patients. Hospital pharmacies ensure the availability, storage, and safe dispensing of loratadine medicines while following stringent quality control and regulatory guidelines. Loratadine may be prescribed to hospitalized patients to treat allergic disorders such as allergic rhinitis and urticaria.

The online pharmacy segment is predicted to develop at the quickest CAGR throughout the forecast period. Online pharmacies are a fast-expanding market in distributing loratadine and other prescription items. These digital platforms allow users to purchase pharmaceuticals from the comfort of their own homes and provide access to a diverse choice of healthcare products, including prescription and over-the-counter medications.

Furthermore, online pharmacies often provide competitive pricing, home delivery choices, and convenient payment ways, making them increasingly popular among people looking for convenience and discretion when ordering loratadine. The adoption of online platforms has increased due to the widespread availability and accessibility of varied product offerings, low pricing, and offers that drive segmented demand. Furthermore, combining online pharmacy platforms and telemedicine will likely create substantial growth prospects for the market.

Recent Developments

• February 2024- Danaher announced a collaboration with Cincinnati Children's Hospital Medical Center to improve patient safety in early drug development.
• February 2024- The Japanese Ministry of Health, Labor, and Welfare (MHLW) approved Dupixent® (sarilumab) for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 and up who are not effectively controlled with current therapy. Japan is the first country to approve Dupixent for CSU, highlighting its value as a unique therapy option for this condition in patients with unmet needs.
• January 2024- Dupixent® is FDA-authorized as the first and only medication indicated for children aged one year and older with eosinophilic esophagitis (EoE).