Naltrexone and Buprenorphine Market Set to Double by 2032 Amid Rising Opioid Use Disorders and Medication-Assisted Therapy Adoption

Global Naltrexone and Buprenorphine Market Overview

The naltrexone and buprenorphine market size was valued at USD 4.20 billion in 2024 and is expected to reach USD 8.54 billion by 2032, growing at a CAGR of 9.30% over 2025-2032. The market expansion is primarily fueled by the rising prevalence of opioid use disorders (OUD) worldwide and the growing acceptance of medication-assisted treatment (MAT) programs. Increasing awareness among healthcare professionals and patients regarding opioid dependence is also contributing to the broader adoption of naltrexone and buprenorphine therapies.

In April 2024, Indivior introduced a digital support program linked to buprenorphine therapy, incorporating AI-based adherence tracking. This initiative highlights the integration of digital health solutions with MAT, further driving patient engagement and compliance. According to UNODC data, around 296 million people globally used drugs in 2021, underlining the urgent need for effective treatments for opioid dependence.

Government initiatives such as expanded Medicaid coverage in the U.S. and other insurance schemes globally are facilitating access to MAT, while pharmaceutical companies continue to invest in research and development to launch long-acting injectables and combination products that enhance treatment efficacy and adherence. FDA approvals for extended-release buprenorphine (Sublocade) and injectable naltrexone (Vivitrol) have also strengthened market presence and patient adherence, contributing to increased naltrexone and buprenorphine market share.

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Market Dynamics

Drivers: Expanding Access and Technological Advancements

Global adoption of naltrexone and buprenorphine is being propelled by increased access to MAT, government support, and innovations in drug delivery devices. The number of individuals with OUD, exceeding 60 million worldwide, is a key factor driving demand for medication-assisted therapies.

Government commitments, particularly in the U.S., are significant. In 2023, Congress allocated USD 4.8 billion to support opioid treatment programs and improve MAT access through SAMHSA. Additionally, advancements in long-acting depot injections and subdermal implants have improved patient compliance and reduced relapse risk, thereby stimulating market growth. Braeburn Pharmaceuticals and other companies are developing long-acting buprenorphine formulations, such as Brixadi, approved for weekly and monthly dosing by the FDA in 2023. The removal of the X-waiver requirement in the U.S. has expanded the pool of licensed prescribers, while telehealth adoption post-COVID-19 has improved MAT access in rural and underserved regions, enhancing overall market potential.

Restraints: Stigma, Regulatory Barriers, and Limited Access

Despite rising demand, the market faces challenges. Stigma surrounding MAT restricts treatment reach, with only 11% of individuals needing MAT receiving it in 2022, according to NSDUH. Limited provider infrastructure and shortages of MAT-trained physicians, especially in low- and middle-income countries, hamper market expansion.

Strict regulatory requirements, high manufacturing costs for depot or implantable formulations, and legal scrutiny of pharmaceutical companies also act as barriers. Indivior, for instance, settled for over USD 600 million in 2020 over marketing practices, raising concerns with regulators. Additionally, perceptions of MAT as substituting one drug for another, side effects, and withdrawal considerations continue to hinder adoption in certain populations, limiting potential market growth.

Segmentation Analysis

By Product

Buprenorphine accounted for 73.53% of global revenue in 2024, attributed to its high efficacy in treating OUD, lower abuse potential, and multiple formulations suitable for clinical and outpatient use. Naltrexone is expected to witness the fastest growth, driven by increasing adoption for alcohol use disorder treatment and demand for long-acting injectable formats that improve patient adherence.

By Route of Administration

Injectable buprenorphine dominated the market in 2024 with a 68.14% share due to the growing preference for depot injections, which reduce dosage frequency and enhance compliance. Oral naltrexone is projected to register the highest CAGR, capturing 55.14% of the naltrexone segment, given its convenience and affordability compared to implantable options.

By Application

OUD remains the primary application, contributing 69.52% revenue in the naltrexone segment in 2024. Alcohol use disorder treatment with naltrexone is expected to grow rapidly, fueled by improved diagnosis rates and updated treatment guidelines recognizing naltrexone’s effectiveness in reducing relapse.

By Distribution Channel

Hospital pharmacies accounted for the largest market share of 47.93% in 2024 due to controlled treatment protocols and monitored care. Retail pharmacies are anticipated to experience the fastest growth as regulatory changes expand outpatient MAT access and prescribing of oral agents for relapse prevention increases.

Regional Analysis

North America led the naltrexone and buprenorphine market in 2024, driven by high OUD prevalence, government initiatives, and easy MAT access. The U.S. market was valued at USD 1.30 billion in 2024, projected to reach USD 2.48 billion by 2032, supported by reimbursement frameworks, treatment protocols, and regulatory changes such as the removal of the X-waiver for buprenorphine prescribing.

Europe is the second-largest market, with the U.K. leading due to advanced drug policies, free NHS treatment availability, and widespread buprenorphine adoption. Germany shows the fastest growth due to eased MAT access and increasing opioid dependence. France and Spain are expanding government-supported addiction centers, while ongoing R&D into extended-release naltrexone fuels regional growth.

The Asia Pacific market is set for the fastest expansion, driven by rising opioid abuse, government awareness programs, and investments in mental health infrastructure. India’s population of over 2 million opioid-dependent individuals, along with initiatives like Nasha Mukt Bharat Abhiyaan, boosts market demand. China, Japan, and Australia also contribute through OAT programs, clinical research, and telemedicine-based addiction care, improving treatment accessibility and adoption.

Recent Developments

In February 2025, FDA approved updated labeling for SUBLOCADE, including rapid initiation protocols and authorization for additional injection sites, enhancing flexibility and adherence. In January 2025, Delpor Inc. advanced Phase 3 development of a titanium-based naltrexone implant capable of delivering treatment for up to one year, backed by NIH HEAL funding, supporting both opioid and alcohol use disorder management.

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Key Players

Indivior PLC, Collegium Pharmaceutical (BioDelivery Sciences International, Inc.), Alkermes, Inc., Orexo US, Inc., Titan Pharmaceuticals, Omeros Corporation, Camurus, Sun Pharmaceutical Industries Ltd., Teva Pharmaceuticals, Dr. Reddy’s Laboratories

Future Outlook

The naltrexone and buprenorphine market is poised for robust growth, driven by rising OUD prevalence, expanding MAT access, technological innovations, and regulatory support. Integration of digital health and telemedicine is expected to enhance patient adherence, particularly in underserved regions. Long-acting injectable and implantable formulations will continue to capture market share, alongside expanding public health initiatives and government-backed treatment programs globally. Despite challenges such as stigma, regulatory barriers, and limited infrastructure in certain regions, the market is likely to witness sustained expansion through 2032.

Conclusion

The global naltrexone and buprenorphine market is on a trajectory of substantial growth, fueled by the increasing prevalence of opioid use disorders and supportive government policies. Technological advancements, improved drug delivery systems, and digital integration are enhancing patient adherence, while expanding access through hospital and retail channels is broadening market reach. With strategic investments and regulatory facilitation, the market is projected to reach USD 8.54 billion by 2032, reflecting the growing role of medication-assisted therapy in managing opioid and alcohol dependence worldwide.

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