Hydroxyzine Market

Market Overview

The global hydroxyzine market size was valued at USD 200 million in 2023 and is projected to reach USD 315 million by 2032, registering a CAGR of 5.2% during the forecast period (2024-2032). The significant increase in the prevalence of anxiety disorders among the older population primarily drives the global market's growth. 

Hydroxyzine molecule is frequently employed as an intermediary substance in the production of antihistamine medications like cetirizine and hydroxyzine, which acts as a CNS depressant to alleviate anxiety and enhance serotonin levels in the brain.

The increasing frequency of anxiety disorders and atopic contact dermatitis has generated significant prospects for major market participants. Furthermore, the market growth is propelled by several other reasons, including the increasing elderly population, heightened patient consciousness regarding antihistamine medications, technological breakthroughs, and augmented investments in research and development.

Highlights

• Tablets generate the highest revenue share based on the dosage form.
• Atopic contact dermatoses account for the largest market share by indication type.

Market Dynamics

Global Hydroxyzine Market Drivers

Prevalence of Allergies or Related Diseases

The global prevalence of allergies or related disorders has steadily increased over the past few decades. Multiple factors contribute to the increase in instances of allergy diseases. Allergic illnesses have become increasingly common throughout the years, affecting over 10-30% of the global population. Allergic illnesses are the most economically burdensome among all skin diseases, with an estimated yearly cost of around USD 5.297 billion in the USA. According to the latest Allergy Facts and Figures from April 2022, over 50 million individuals in the United States suffer from different types of allergies annually. Allergies rank as the sixth leading cause of chronic diseases in the country. Consequently, the nation has a substantial prevalence of allergies, necessitating improved treatment alternatives.

In November 2021, an article published in IJERPH stated that the causes of allergies remain unclear. Still, both hereditary and environmental variables are essential contributors to the global prevalence of allergic illnesses. Moreover, multiple investigations indicate that hydroxyzine imine can remedy pruritus induced by allergens. This medication is an antihistamine that inhibits specific endogenous molecules, known as histamine, produced by the human body in response to an allergic reaction. Therefore, there is a growing need for hydroxyzine imine to manage the condition's prevalence. Consequently, the prevalence of allergies in the specific population and the advantages of hydroxyzine imine for treating allergies are anticipated to drive the expansion of the market.

Thus, the market under investigation will experience substantial growth throughout the study period due to the variables described above. 

Global Hydroxyzine Market Restraints

Side Effects of Hydroxyzine

Although hydroxyzine has demonstrated efficacy in the management of anxiety and its related diseases, its side effects pose substantial obstacles that could hinder its global commercial expansion. Typical adverse reactions consist of drowsiness, vertigo, impaired visual acuity, xerostomia, and constipation. The potential side effects of this medicine, specifically sleepiness and dizziness, are a cause for concern regarding its usage, particularly in vulnerable groups like older people. These symptoms can increase the likelihood of falls and associated injuries. 

In addition, hydroxyzine possesses anticholinergic qualities that, although helpful in alleviating anxiety symptoms, can result in unwanted anticholinergic side effects, including urine retention, disorientation, and worsening of glaucoma. These symptoms are especially troublesome in older individuals due to the widespread use of many medications and the possibility of drug combinations that worsen adverse effects. The cognitive impacts, such as perplexity and sporadic memory deterioration, are particularly problematic in this population, which is already vulnerable to cognitive decline.

Additionally, the regulatory environment plays a key role. As healthcare regulators and organizations intensify their examination of medicine safety, the reported side effects of hydroxyzine could result in more stringent restrictions and recommendations, potentially restricting its usage. Given the current worldwide market's status on safety and effectiveness, the adverse effects of hydroxyzine are of considerable importance. Hydroxyzine uptake may be limited, especially in markets with strict regulatory standards and a strong emphasis on medication safety. As a result, these concerns could hinder the expansion of the market as healthcare professionals and patients look for alternative treatments with more desirable side effect profiles.

Global Hydroxyzine Market Opportunity

Increase in the Prevalence of Anxiety Disorders among the Older Population 

The increasing occurrence of anxiety disorders among the older population globally is expected to have a substantial impact on the hydroxyzine industry. Approximately 14% of those who are 60 years old and above experience a mental condition (2). As per the Global Health Estimates (GHE) 2022, these conditions contribute to 10.6% of the overall disability (measured in disability-adjusted life years, DALYs) in the older adult population. Depression and anxiety are the prevailing mental health disorders in older adults. The Global Health Estimates (GHE) for 2022 indicate that approximately 27.2% of suicide-related deaths occur in individuals aged 60 years or older on a global scale.

Hydroxyzine, an antihistamine that also has anxiety-reducing effects, is commonly used to treat anxiety in different populations. It is beneficial for older people who have complicated medical conditions that make it unsuitable to use other common anxiety medications like benzodiazepines. Recent epidemiological studies have shown a significant rise in anxiety disorders among older adults, which is due to various factors, including longer life expectancy, increased consciousness about mental health issues, and the psychological pressures that come with aging, such as chronic illness, loss of independence, and grief. The high occurrence of anxiety disorders in this particular group is problematic due to the substantial negative impact they have on health, such as an elevated likelihood of developing cardiovascular disease, cognitive decline, and a worse quality of life.

Moreover, Hydroxyzine is a promising therapeutic alternative because of its effectiveness and safe characteristics. Hydroxyzine, unlike benzodiazepines, does not pose the same risk of dependency or adverse severe effects like cognitive impairment and falls, which are especially dangerous for older individuals. Moreover, the calming properties of hydroxyzine are typically advantageous in treating the sleep disruptions commonly associated with anxiety in elderly individuals. The increasing prevalence of anxiety disorders among the senior population is expected to boost the market for hydroxyzine, considering its numerous benefits. 

Regional Analysis

The global hydroxyzine market analysis is conducted across 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 hydroxyzine market shareholder and is estimated to grow at a CAGR of 5.1% over the forecast period.  The growth of the market in the region is being driven by factors such as patient awareness of treatments, the quality of healthcare infrastructure, the early adoption of new medications, and the increasing business partnerships between pharmaceutical companies and contract research organizations in emerging markets.

Furthermore, the primary driver behind the market is the increasing prevalence of atopic dermatitis in the region, particularly in the United States. According to the latest data from the NEA in 2022, over 16.5 million adults in the United States, which is equivalent to 7.3% of the population, have atopic dermatitis that started when they were older than two years old. Out of these, almost 40% had moderate to severe disease symptoms. Consequently, the prevalence of the condition elevates the likelihood of developing contact dermatitis, a significant healthcare issue. Hydroxyzine imine is increasingly being sought after for the treatment of these disorders, which is anticipated to drive market expansion further. 

Europe is anticipated to exhibit a CAGR of 5.5% over the forecast period. Hydroxyzine, an antihistamine usually prescribed for anxiety, stress, allergies, and nausea, is influenced by many market dynamics in Europe that impact its demand and distribution. The increasing frequency of anxiety disorders throughout Europe is a significant factor driving the need for hydroxyzine. According to WHO, anxiety disorders are prevalent mental health conditions in Europe, impacting a substantial proportion of the population at various stages of their lives. The high occurrence of this condition indicates a consistent need for successful pharmacological therapies. Hydroxyzine is particularly important because of its effectiveness and soothing qualities.

Additionally, the rise in allergic responses and ailments, which may be associated with shifting environmental circumstances and heightened pollution levels, also contributes to the demand for antihistamines such as hydroxyzine. The increasing prominence of allergies has led to a growing demand for dependable and secure treatments that effectively alleviate symptoms like itching, rashes, and hives. Consequently, this has contributed to the expansion of the hydroxyzine market. Additionally, the market position of hydroxyzine is strengthened by regulatory support and recommendations from medical organizations for its use in controlling symptoms of anxiety and allergies. The European Medicines Agency (EMA) and National Health Services issue guidelines that endorse hydroxyzine's use, strengthening its legitimacy and recommended usage among healthcare providers.

Moreover, the widespread availability of hydroxyzine in its generic form has rendered it a financially advantageous alternative when compared to more recent antihistamines and anti-anxiety drugs, which frequently carry a higher price tag. The affordability of this product increases its accessibility and uptake, especially in cost-conscious European countries. Collectively, these variables contribute to a conducive climate for hydroxyzine's sustained utilization and market expansion throughout European nations.

The Asia-Pacific is the fastest-growing region. The increasing incidence of anxiety disorders and persistent hives (urticaria) in nations such as China, India, and Japan is driving the need for effective antihistamine treatments. Hydroxyzine is a notable choice among these treatments. Furthermore, the rising consciousness and rates of diagnosis of mental health issues and allergy illnesses are factors that lead to the expansion in the utilization of this medicine.

Similarly, healthcare infrastructure advancements throughout the region enhance the accessibility of drugs and the entire pharmaceutical market, including the hydroxyzine segment. The market is further propelled by government efforts to improve healthcare accessibility and affordability in these regions. Countries such as India, recognized as the “pharmacy" of the world,” have" a significant impact on the hydroxyzine industry by producing and distributing cost-effective generic pharmaceuticals worldwide. Combining these variables guarantees a consistent and ongoing need for hydroxyzine throughout Asia-Pacific. 

Segmental Analysis

The global hydroxyzine market is segmented based on dosage form and indication type. 

Based on dosage form, the hydroxyzine market is segmented into Tablets, Capsules, Injections, and Syrup. 

The tablet segment dominated in 2023. Hydroxyzine pills are antihistamine medications that are quickly taken up by the gastrointestinal tract, and their therapeutic effects are observed within 15 to 30 minutes after being taken orally. These are specifically formulated to regulate anxiety and tension resulting from nervous and emotional problems. It aids in promoting sleep before a surgical procedure. Moreover, the increasing use of tablet formulations for managing anxiety and alleviating symptoms of allergies, along with a rise in the prevalence of nerve disorders, is fueling the expansion of this category.

The injections segment is the fastest growing. The expansion of this segment is primarily propelled by its chemotherapeutic efficacy in treating neuroses and emotional problems resulting from stress, worry, apprehension, or disorientation.

Based on indication type, the market is segmented into Urticaria, Histamine-Mediated Pruritus, and Atopic Contact Dermatitis. 

The atopic contact dermatitis segment dominated in 2023. The increasing occurrence of atopic dermatitis and the need for hydroxyzine dosage forms have expanded market revenue. According to the International Eczema Council in 2022, atopic dermatitis has a significant prevalence, impacting approximately 10% of adults and 20% of children. Furthermore, the illness burden is ranked 15th worldwide regarding nonfatal conditions and holds the top position for skin conditions evaluated in disability-adjusted life years.

Histamine-mediated pruritus is the itchy sensation caused by the release of histamine from mast cells and basophils in the skin. This disease frequently arises due to allergenic stimuli or immunological reactions in which histamine binds to particular receptors (H1 receptors) situated on nerve endings. Activation of these receptors results in heightened sensory nerve activity, resulting in the perception of itchiness. Chronic disorders like urticaria, which refers to hives, are prime illustrations of pruritus caused by histamine. Treatment usually entails the administration of antihistamines that inhibit the H1 receptors, therefore relieving itching by obstructing the action of histamine.

Recent Developments

• December 2023– Sunovion Pharmaceuticals Inc. (Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) reported that the initial patient has been randomly assigned in a Phase 2/3 clinical trial to assess the effectiveness of ulotaront, a drug that activates the trace amine-associated receptor 1 (TAAR1) and also acts as a 5-HT1A agonist, in treating generalized anxiety disorder (GAD). Ulotaront is currently undergoing late-stage clinical trials to evaluate its effectiveness in treating schizophrenia in addition to its existing use for generalized anxiety disorder (GAD).
• March 2024– Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (Cboe Canada MMED), a clinical-stage biopharmaceutical company focused on developing innovative treatments for brain health disorders, received breakthrough designation from the FDA for its MM120 (lysergide d-tartrate) program. This designation is specifically for the treatment of generalized anxiety disorder (GAD). The Company has also reported that its Phase 2b research of MM120 in GAD has achieved its primary and secondary endpoint. The 12-week topline data has shown a solid and lasting effect of the treatment, clinically and statistically, up until Week 12.