Market Definition

Opioid use disorder (OUD) is a medical condition characterized by the compulsive use of opioids despite harmful consequences, which often involves dependence and withdrawal symptoms. The market refers to the healthcare sector focused on diagnosing, treating, and managing OUD through medications, therapies, and support services.

Opioid Use Disorder Market Overview

The global opioid use disorder market size was valued at USD 5.67 billion in 2024, which is estimated to be valued at USD 6.22 billion in 2025 and reach USD 13.20 billion by 2032, growing at a CAGR of 11.34% from 2025 to 2032.

Growth of the market is driven by the rising prevalence of opioid use disorder (OUD) globally, leading to an increased demand for effective, long-term treatment options and innovative therapies that can address complex patient needs and reduce relapse rates.

Key Highlights:

The opioid use disorder industry size was valued at USD 5.67 billion in 2024.
The market is projected to grow at a CAGR of 11.34% from 2025 to 2032.
North America held a market share of 36.55% in 2024, with a valuation of USD 2.07 billion.
The buprenorphine segment garnered USD 2.57 billion in revenue in 2024.
The parenteral segment is expected to reach USD 5.75 billion by 2032.
The online pharmacies segment is anticipated to witness the fastest CAGR of 13.40% during the forecast period.
Europe is anticipated to grow at a CAGR of 13.43% during the forecast period.

Major companies operating in the opioid use disorder industry are Indivior PLC, Pfizer Inc., Collegium Pharmaceutical, Alkermes, Orexo AB, Acura Pharmaceuticals, Omeros Corporation, Camurus AB, Hikma Pharmaceuticals PLC, Advin Biotech, BioCorRx, Inc., DemeRx, Lisata Therapeutics, Inc., Bicycle Health, Inc., and Ophelia Health, Inc.,.

The market is experiencing steady growth due to rising awareness, increasing diagnosis rates, and urgent need for effective treatment options. Government initiatives, expanded access to medication-assisted therapies, and growing support for integrated behavioral health approaches are key factors driving the market.

Additionally, the rising prevalence of OUD among pregnant individuals has intensified the demand for safe, long-acting treatment solutions. Innovations in drug formulations and supportive healthcare infrastructure are further propelling market expansion, positioning OUD treatment as a critical public health priority

In May 2025, Indivior announced a study showing that SUBLOCADE, a monthly buprenorphine injection, poses no increased pregnancy risks and may be a safe treatment for opioid use disorder during and after pregnancy. It offers promising outcomes for mothers and infants while addressing rising perinatal opioid-related complications in the U.S.

Market Driver

Rising Prevalence of OUD

The global surge in opioid use disorder (OUD) cases has emerged as a key driver for growth in the opioid use disorder market.

According to a U.S. Food & Drug Administration (FDA) report from December 2024, over 6.1 million individuals aged 12 and older are affected by OUD, highlighting the widespread nature of the crisis. As addiction rates rise due to over-prescription, illicit drug use, and synthetic opioids like fentanyl, the need for comprehensive treatment options becomes critical.

Healthcare systems and governments are actively seeking scalable, evidence-based interventions to curb the growing crisis. This has intensified the demand for pharmacological and behavioral therapies that are not only effective but also tailored to individual and genetic needs, supporting the development of personalized and long-acting treatments for sustained recovery.

In February 2025, Adial Pharmaceuticals received a new U.S. patent for its genotype-specific treatment approach for opioid-related disorders. This strengthens Adial’s intellectual property portfolio and supports the development of AD04, a genetically targeted therapy that is designed to treat substance use disorders through precision medicine based on individual genetic profiles.

Market Challenge

Cost and Insurance Coverage Issues

One significant challenge faced by the opioid use disorder market is the high cost of therapy and limited insurance coverage, which restricts access for many patients, especially in low-income or uninsured populations. These financial barriers often prevent consistent treatment and contribute to relapse rates.

Expanding public and private insurance coverage for evidence-based treatments, increasing government funding for addiction care, and promoting value-based reimbursement models that support long-term recovery can be potential solutions. Enhancing affordability is crucial for improving access and ensuring equitable treatment outcomes across diverse patient groups.

Market Trend

Adoption of AI in Drug Discovery

The most prominent trend in the opioid use disorder market is the growing adoption of artificial intelligence (AI) in drug discovery. Companies are increasingly utilizing AI and multiomics platforms to identify new drug candidates, predict therapeutic efficacy, and streamline development processes.

This approach reduces the time and cost traditionally associated with R&D and enhances precision in targeting specific biological pathways. The integration of AI is driving innovation and expanding the pipeline of more effective OUD therapies.

In June 2024, Lisata Therapeutics expanded its partnership with GATC Health to accelerate AI-driven drug discovery and development. The partnership focuses on advancing a novel, non-opioid therapeutic for opioid use disorder (OUD) into human clinical trials by early 2026, using GATC’s Multiomics Advanced Technology to enhance precision, predict outcomes, and improve development efficiency.

Opioid Use Disorder Market Report Snapshot

Segmentation	Details
By Drug Type	Buprenorphine, Methadone, Naltrexone, Others
By Route of Administration	Oral, Parenteral, Others
By Distribution Channel	Hospital Pharmacies, Retail Pharmacies, Online Pharmacies
By Region	North America: U.S., Canada, Mexico
	Europe: France, UK, Spain, Germany, Italy, Russia, Rest of Europe
	Asia-Pacific: China, Japan, India, Australia, ASEAN, South Korea, Rest of Asia-Pacific
	Middle East & Africa: Turkey, U.A.E., Saudi Arabia, South Africa, Rest of Middle East & Africa
	South America: Brazil, Argentina, Rest of South America

Market Segmentation:

By Drug Type (Buprenorphine, Methadone, Naltrexone, and Others): The buprenorphine segment earned USD 2.57 billion in 2024, due to its effectiveness in reducing withdrawal symptoms, widespread use in medication-assisted treatment, and strong clinical acceptance.
By Route of Administration (Oral, Parenteral, and Others): The parenteral segment held 45.34% of the market in 2024, attributed to the rapid onset of action, improved bioavailability, and increased use in emergency OUD management and inpatient settings.
By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies): The hospital pharmacies segment is projected to reach USD 5.11 billion by 2032, owing to growing hospital admissions for OUD, better access to prescription therapies, and institutional treatment protocols.

Opioid Use Disorder Market Regional Analysis

Based on region, the market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

Opioid Use Disorder Market Size & Share, By Region, 2025-2032

The North America opioid use disorder market share stood at 36.55% in 2024, with a valuation of USD 2.07 billion. North America dominates the market due to its high prevalence of opioid addiction, advanced healthcare infrastructure, and the early adoption of innovative therapies. Government-led initiatives, strong reimbursement frameworks, and increased awareness about OUD have significantly boosted treatment uptake.

In February 2025, Holon Health expanded its operations to Virginia to address the state’s opioid crisis by offering evidence-based care. The program combines telehealth, contingency management, behavioral therapy, and recovery support, helps improve treatment adherence, extend sobriety periods, and reduce relapse rates through a personalized and tech-enabled care approach.

Additionally, the presence of major pharmaceutical companies, active research funding, and widespread access to traditional and digital treatment modalities contribute to the region’s leadership. Continued policy support and technological integration further strengthen North America’s position in the global OUD market.

Europe opioid use disorder industry is poised for significant growth at a CAGR of 13.43% over the forecast period. It is emerging as the fastest-growing region in the market, driven by rising awareness, increasing cases of opioid misuse, and expanding access to treatment services. Governments across the region are strengthening public health initiatives, improving reimbursement policies, and supporting harm reduction strategies.

Additionally, the adoption of innovative therapies and growing investments in mental health infrastructure are enhancing treatment accessibility. Collaborations between healthcare providers and research institutions are also accelerating the development and deployment of effective OUD treatment solutions across Europe.

Regulatory Frameworks

In the U.S., the Controlled Substances Act (CSA), enforced by the Drug Enforcement Administration (DEA), classifies drugs into five schedules based on their accepted medical use, abuse potential, and the risk of dependence or safety concerns.
In the EU, the European Medicines Agency (EMA) regulates opioid use disorder therapies by conducting centralized evaluations and authorizations, ensuring consistent safety, efficacy, and quality standards across all member states.
In India, the regulation of opioid-related substances, including opium cultivation and the use of narcotic and psychotropic drugs, is governed by the Narcotic Drugs and Psychotropic Substances (NDPS) Act and its corresponding rules.

Competitive Landscape

Companies operating in the opioid use disorder industry are increasingly investing in advanced research and clinical trials to develop novel and non-addictive therapies. Many companies are using proprietary drug delivery technologies, personalized medicine approaches, and AI-powered platforms to enhance treatment efficacy, safety, and patient adherence.

Partnerships with academic institutions and government bodies are also being pursued to validate innovative therapies. These efforts reflect a strong commitment to expanding effective treatment options and addressing needs in the OUD patient population.

In October 2024, ANANDA Scientific initiated a clinical trial evaluating Nantheia ATL5 for treating co-occurring opioid use disorder and chronic pain. The study, conducted at Yale School of Medicine and funded by NIDA, explores cannabidiol (CBD) co-administered with THC, using ANANDA’s proprietary Liquid Structure technology to improve treatment efficacy and absorption for patients suffering from these debilitating conditions.

Key Companies in Opioid Use Disorder Market:

Indivior PLC
Pfizer Inc.
Collegium Pharmaceutical
Alkermes
Orexo AB
Acura Pharmaceuticals
Omeros Corporation
Camurus AB
Hikma Pharmaceuticals PLC
Advin Biotech
BioCorRx, Inc.
DemeRx
Lisata Therapeutics, Inc.
Bicycle Health, Inc.
Ophelia Health, Inc.

Recent Developments (Clinical Research/ Public-Private Collaboration/ M&A)

In June 2025, Indivior PLC unveiled new findings at the CPDD Annual Scientific Meeting, showing that a higher 300 mg maintenance dose of SUBLOCADE (buprenorphine extended-release) improved treatment outcomes for opioid use disorder (OUD) patients with heavy fentanyl use. The research revealed that significant treatment barriers among American Indian/Alaska Native populations are underscoring the need for culturally responsive care models and improved access to medication for opioid use disorder (MOUD). These insights aim to shape evidence-based strategies to enhance outcomes in underserved and high-risk communities.
In June 2024, Hikma Pharmaceuticals reaffirmed its commitment of expanding access to naloxone by participating in a White House discussion hosted by the ONDCP. The company highlighted efforts including donating over 450,000 naloxone doses, manufacturing various formulations, and collaborating with harm-reduction groups to enhance opioid overdose prevention across the U.S.
In March 2023, Indivior acquired Opiant Pharmaceuticals, strengthening its addiction treatment portfolio. The deal adds OPNT003, a potential new opioid overdose therapy targeting synthetic opioids like fentanyl, enhancing Indivior’s capabilities in addressing the U.S. opioid crisis through science-driven treatment innovations.