Risperidone Market – Global Industry Size, Share, Trends, Opportunity, & Forecast, Segmented By Route Of Administration (Injectable, Oral, Parenteral), By Application (Schizophrenia, Bipolar Disorder, Irritability Associated with Autistic Disorder, Others), By End-Users (Hospitals, Homecare, Specialty Clinics, Ambulatory Surgical Centers, Others), By Region, Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 6.36 Billion
CAGR (2026-2031)	5.12%
Fastest Growing Segment	Oral
Largest Market	North America
Market Size (2031)	USD 8.58 Billion

Market Overview

The Global Risperidone Market will grow from USD 6.36 Billion in 2025 to USD 8.58 Billion by 2031 at a 5.12% CAGR. Risperidone is an atypical antipsychotic medication utilized primarily to treat schizophrenia, bipolar disorder, and irritability associated with autism. The market is fundamentally supported by the rising diagnosis of psychiatric conditions and the cost efficiency of generic formulations which ensures accessibility across global healthcare systems. A distinct driver ensuring sustained demand is the established efficacy of the drug in stabilizing acute manic or psychotic episodes in both adult and pediatric patient populations.

Market expansion faces a significant impediment regarding patient compliance due to adverse effects such as weight gain and movement disorders. This safety concern often prompts physicians to prescribe newer generation alternatives with better tolerability profiles. According to the International Federation of Pharmaceutical Manufacturers and Associations, in 2024, mental health conditions affected nearly one billion people worldwide. This vast patient base highlights the critical necessity for accessible treatments like risperidone despite the competitive pressure from novel therapeutic options.

Key Market Drivers

The escalating global prevalence of schizophrenia and bipolar disorder acts as a primary catalyst for the Global Risperidone Market, necessitating consistent pharmacological intervention to manage chronic symptoms. As patient populations expand, healthcare systems are compelled to prioritize accessible antipsychotic treatments to mitigate the societal burden of severe psychiatric conditions. According to the Substance Abuse and Mental Health Services Administration, July 2025, in the '2024 National Survey on Drug Use and Health', approximately 14.6 million adults in the United States were classified as having a serious mental illness in 2024, underscoring the substantial demand for effective therapeutic management. This rising disease burden directly correlates with increased prescription volumes for established antipsychotics like risperidone.

Concurrently, the market is being reshaped by the growing adoption of long-acting injectable formulations designed to enhance patient adherence and reduce relapse rates associated with oral medication irregularity. Pharmaceutical companies are successfully capitalizing on this trend by introducing advanced delivery mechanisms that offer extended release profiles. For instance, according to Teva Pharmaceutical Industries, January 2025, in the 'Fourth Quarter and Full Year 2024 Financial Results', global revenues for its extended-release risperidone injectable, UZEDY, reached $117 million in 2024, surpassing initial projections. This shift towards sophisticated formulations is further evidenced in emerging markets; according to Luye Pharma Group, in 2025, revenue from its central nervous system portfolio, which encompasses the risperidone microsphere Rykindo, increased by 5.4% during the first half of the year.

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Key Market Challenges

The growth of the risperidone market is directly hindered by safety concerns related to adverse effects, specifically weight gain and movement disorders. These physical side effects frequently result in poor patient compliance, creating a substantial barrier to long-term usage. When patients experience significant metabolic changes or involuntary muscle movements, they often discontinue therapy or request changes to their medication regimen. This lack of adherence forces healthcare providers to seek alternative therapeutic options that offer improved tolerability profiles, thereby reducing the reliance on and market share of established treatments like risperidone.

The shift toward newer generation antipsychotics is accelerated by the clinical need for consistent symptom management without debilitating side effects. The magnitude of this challenge is underscored by the high prevalence of conditions requiring continuous care. According to the World Health Organization, in 2024, schizophrenia affected approximately 24 million people globally, representing a vast demographic where treatment continuity is essential yet often interrupted by drug intolerance. Consequently, the availability of safer pharmacological alternatives limits the revenue potential of risperidone as physicians increasingly prioritize patient quality of life and adherence in their prescribing decisions.

Key Market Trends

The Development of Once-Weekly Oral Gastric-Resident Capsules marks a transformative technological advancement designed to bridge the gap between daily oral adherence and the invasiveness of injectable therapies. This trend focuses on a novel dosage form that resides in the stomach and releases the medication consistently over a seven-day period, thereby mitigating the pill burden that frequently compromises treatment outcomes in schizophrenia patients. By maintaining stable plasma levels without the need for needles, this innovation directly addresses compliance challenges while preserving patient autonomy. According to HMP Global Learning Network, June 2025, in the article 'Novel Long-Acting Oral Formulation of Risperidone Shows Promise in Phase 3 Trial', the investigational weekly capsule LYN-005 demonstrated sustained therapeutic concentrations in the STARLYNG-1 study, achieving a geometric mean ratio for minimum concentration of 1.04 at week five compared to daily immediate-release risperidone.

Simultaneously, the Market Entry of Generic Extended-Release Injectables is reshaping the competitive landscape by introducing cost-effective alternatives to long-standing branded microsphere formulations. The approval and commercialization of complex generic versions of established long-acting antipsychotics are dismantling the exclusivity previously held by originator products, creating significant price erosion and expanding accessibility for healthcare payers and patients. This shift forces branded manufacturers to pivot towards newer delivery technologies while generics capture volume in the mature injectable segment. According to Lupin Limited, November 2025, in the 'Lupin Launches Generic Risperidone Extended-Release Injectable Suspension' announcement, the company introduced its generic alternative in the United States, targeting a total annual addressable market estimated at approximately $187 million.

Segmental Insights

Recent industry analysis identifies the Oral segment as the fastest-growing category within the Global Risperidone Market. This accelerated expansion is primarily driven by the widespread availability of generic formulations, which provide a cost-effective alternative to injectable therapies, particularly in price-sensitive developing regions. Furthermore, the non-invasive nature of oral tablets and solutions remains the preferred option for many patients and healthcare providers, fostering higher adherence to daily treatment regimens. Continuous approvals of these generic versions by regulatory authorities further broaden market access, ensuring the oral segment sustains its superior growth trajectory.

Regional Insights

North America maintains a dominant position in the global risperidone market, primarily driven by the high prevalence of psychiatric conditions such as schizophrenia and bipolar disorder within the United States and Canada. The region benefits from robust healthcare infrastructure and favorable reimbursement policies that ensure widespread access to essential antipsychotic therapeutics. Additionally, the strategic presence of key pharmaceutical manufacturers combined with rigorous product approvals by the US Food and Drug Administration fosters a stable commercial environment. These factors, alongside increasing initiatives to raise mental health awareness, sustain the region's leadership in the global landscape.

Recent Developments

• In November 2025, Lupin Limited announced the commercial launch of its risperidone extended-release injectable suspension in the United States following its earlier regulatory clearance. This product was introduced for the treatment of schizophrenia and as a maintenance treatment for bipolar I disorder. The launch was significant for the company as it was the first pharmaceutical product to utilize its proprietary PrecisionSphere long-acting injectable technology, developed by its subsidiary. The medication entered the market with 180 days of exclusivity, underscoring the company's strategic focus on delivering complex, differentiated products to the global risperidone market.
• In October 2025, Teva Pharmaceutical Industries Ltd. and its partner Medincell secured an expanded approval from the U.S. Food and Drug Administration for UZEDY, a risperidone extended-release injectable suspension. The new indication authorized the use of the drug as a monotherapy or as an adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. This regulatory decision relied on existing clinical data and modeling methodologies that bridged safety and efficacy findings from prior risperidone formulations. The approval broadened the commercial scope of the product, which had previously been marketed solely for the treatment of schizophrenia.
• In September 2025, Amneal Pharmaceuticals, Inc. received approval from the U.S. Food and Drug Administration for its risperidone extended-release injectable suspension, a generic version of the branded product Risperdal Consta. This approval covered indications for the treatment of schizophrenia and the maintenance treatment of bipolar I disorder. The product was granted 180 days of market exclusivity under the FDA’s Competitive Generic Therapy designation. The company emphasized that the development of this complex long-acting injectable involved sophisticated microsphere formulation and cold-chain manufacturing capabilities, positioning the firm to launch the medication in the United States market in the fourth quarter.
• In March 2024, Laboratorios Farmacéuticos Rovi, S.A. announced that the U.S. Food and Drug Administration had approved Risvan, a once-monthly risperidone extended-release injectable suspension for the treatment of schizophrenia in adults. This regulatory milestone introduced a new therapeutic option in the global risperidone market, distinguished by its ability to provide therapeutic plasma levels from the first injection without the need for a loading dose or oral supplementation. The approval was supported by data from the Phase 3 PRISMA-3 trial, which demonstrated significant efficacy in reducing symptoms in patients with acute exacerbation of schizophrenia compared to placebo.

Key Market Players

• Otsuka Pharmaceutical Co., Ltd
• AbbVie Inc
• Dr. Reddy's Laboratories Ltd
• Pfizer Inc
• Endo International plc
• Teva Pharmaceutical Industries Ltd
• Sun Pharmaceutical Industries Ltd
• Viatris Inc
• Novartis AG
• Lupin Limited

By Route Of Administration	By Application	By End-Users	By Region
Injectable Oral Parenteral	Schizophrenia Bipolar Disorder Irritability Associated with Autistic Disorder Others	Hospitals Homecare Specialty Clinics Ambulatory Surgical Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Risperidone Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Risperidone Market , By Route Of Administration:

• Injectable
• Oral
• Parenteral

• Risperidone Market , By Application:

• Schizophrenia
• Bipolar Disorder
• Irritability Associated with Autistic Disorder
• Others

• Risperidone Market , By End-Users:

• Hospitals
• Homecare
• Specialty Clinics
• Ambulatory Surgical Centers
• Others

• Risperidone Market , By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE