Opioid Use Disorder Drugs Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drug Type (Agonist Drugs, Antagonist Drugs, Others), By Route of Administration (Oral, Parenteral, Sublingual, Nasal), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region and Competition, 2020-2030F

Market Overview

Global Opioid Use Disorder Drugs Market was valued at USD 3.87 Billion in 2024 and is expected to reach USD 6.59 Billion in the forecast period with a CAGR of 9.26% through 2030. The Global Opioid Use Disorder Drugs Market is a dynamic and critical segment within the broader pharmaceutical industry, dedicated to addressing the escalating crisis of opioid addiction worldwide. With opioid abuse and overdose-related deaths reaching alarming levels, this market plays a pivotal role in providing effective solutions to combat this public health crisis. Opioid Use Disorder (OUD) drugs encompass a range of pharmaceutical interventions designed to treat addiction to opioids, including prescription painkillers and illicit substances like heroin. These medications typically fall into three categories: opioid agonists, partial agonists, and antagonists, each with its unique mechanism of action. Key drugs within this market include methadone, buprenorphine, naltrexone, and naloxone, which are administered in various forms such as oral tablets, sublingual films, or injectables. The market has witnessed significant growth in recent years, driven by multiple factors. The surge in opioid addiction cases, heightened awareness of the opioid epidemic, and increased government initiatives to expand access to treatment have all contributed to market expansion. Additionally, ongoing research and development efforts aim to create safer and more effective drugs to address OUD while minimizing side effects and potential for abuse. Market dynamics are also influenced by evolving regulatory landscapes and changing reimbursement policies. The global OUD drugs market is marked by competition among pharmaceutical companies striving to innovate and capture a share of this rapidly growing sector. Market consolidation, partnerships, and strategic collaborations have become commonplace as industry players seek to bolster their product portfolios and market presence.

Key Market Drivers

Escalating Opioid Epidemic

​The escalating opioid epidemic has significantly influenced the Global Opioid Use Disorder (OUD) Drugs Market, reshaping the pharmaceutical landscape in response to this pressing public health crisis. This crisis, marked by the widespread misuse of prescription opioids and the proliferation of illicit substances like heroin, has led to devastating consequences, including a substantial number of opioid-related deaths. According to provisional data from the Centers for Disease Control and Prevention (CDC), there were an estimated 107,543 drug overdose deaths in the United States during 2023, with approximately 81,083 involving opioids. As communities confront the severe impacts of addiction, the demand for effective treatments has surged, creating opportunities for pharmaceutical companies to develop, market, and distribute a range of OUD drugs.​

The opioid epidemic has unfolded on a global scale, transcending geographical and demographic boundaries. Governments, healthcare organizations, and the public have recognized the urgency of addressing this crisis comprehensively. This collective awareness has spurred significant investments in addiction treatment programs and policies aimed at expanding access to OUD drugs. However, challenges remain. In 2021, an estimated 2.5 million people aged 18 years or older in the U.S. had opioid use disorder, yet only 22% received medications to treat it. Addressing such gaps is crucial for mitigating the epidemic's impact. Furthermore, advancements like extended-release formulations have made treatment more convenient for patients, contributing to improved adherence and outcomes. As healthcare professionals and policymakers continue to grapple with the opioid crisis, the pharmaceutical industry remains pivotal in developing innovative medications to effectively treat OUD.

Advancements in Treatment Options

​Advancements in treatment options have significantly driven the growth of the Global Opioid Use Disorder (OUD) Drugs Market. In response to the escalating opioid epidemic, the pharmaceutical industry has developed innovative and effective solutions to address the complexities of addiction treatment. Notably, the U.S. Food and Drug Administration (FDA) has approved various formulations of buprenorphine, an opioid partial agonist, for OUD treatment. In May 2016, the FDA approved Probuphine, the first buprenorphine implant designed to provide a constant, low-level dose for six months in patients stable on low-to-moderate doses of other buprenorphine forms. Following this, in November 2017, the FDA approved Sublocade, the first once-monthly injectable buprenorphine product for moderate-to-severe OUD in adults. These extended-release formulations offer sustained symptom relief, reducing the need for daily medication administration, thereby improving patient adherence and minimizing the risk of diversion and misuse.​

Further advancements include the FDA's approval in February 2025 of label changes for Sublocade, introducing a rapid initiation protocol and alternative injection sites. Healthcare providers can now initiate treatment with Sublocade after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability. Additionally, Sublocade can be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering increased flexibility in treatment administration. These developments, coupled with ongoing research into higher buprenorphine doses associated with improved retention in treatment, underscore the dynamic evolution of OUD treatment strategies. Such innovations have transformed the OUD treatment landscape, providing diverse and effective options for healthcare professionals and patients alike.

Ongoing Research and Development

​Pharmaceutical companies and academic institutions have significantly invested in research to better understand the neurobiology of addiction and the mechanisms underlying opioid dependence. This deepening understanding has led to the discovery of new drug targets and novel treatment approaches. Researchers are exploring innovative pharmacological agents and therapeutic strategies that aim to not only alleviate withdrawal symptoms and cravings but also address the psychological and behavioral aspects of addiction. One notable area of research has been the development of opioid receptor modulators, which can selectively target specific receptor subtypes, potentially minimizing side effects while optimizing therapeutic benefits. These targeted approaches offer the promise of more personalized treatment regimens, enhancing the overall effectiveness of OUD medications.​

Combination therapies are also gaining traction in research and development. By combining different classes of OUD medications, researchers seek to leverage synergistic effects to improve treatment outcomes. This approach may enhance patient adherence and reduce the risk of relapse, marking a significant advancement in addiction treatment. Moreover, research is focusing on developing non-opioid alternatives for managing pain, as many individuals initially become addicted to opioids through prescription painkillers. The NIH HEAL Initiative, launched in 2018, is accelerating the development and availability of novel treatments for OUD and overdose, including longer-acting formulations of existing OUD drugs like buprenorphine and methadone, as well as immunotherapies such as vaccines designed to block the effects of opioids in the brain. Additionally, research efforts are dedicated to improving drug delivery mechanisms. Scientists are exploring innovative formulations, such as implantable devices and long-acting injectables, to provide sustained symptom relief, minimize diversion, and enhance patient convenience.​

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Key Market Challenges

Regulatory Complexity

One of the primary challenges is the lack of uniformity in regulations across different regions and countries. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and counterparts in other nations, have unique guidelines and requirements for OUD medications. This variation can lead to confusion and increased compliance costs for pharmaceutical companies operating internationally. The opioid epidemic is a rapidly evolving crisis, and regulatory agencies often struggle to keep pace with emerging trends and challenges. This lag in adapting regulations can hinder the timely approval of new medications and treatment modalities, impeding the market's ability to respond effectively to the crisis.

OUD medications, including opioid agonists like methadone and buprenorphine, are subject to strict regulations surrounding their prescription and dispensing. Healthcare providers must undergo specialized training and obtain waivers to prescribe these medications, creating barriers to access. Furthermore, stringent record-keeping requirements and oversight can deter providers from offering these treatments. Some OUD medications are subject to Risk Evaluation and Mitigation Strategies, which impose additional requirements on manufacturers and healthcare providers. While these strategies are intended to enhance the safe use of medications, they can also increase the administrative burden and costs associated with bringing OUD drugs to market.

Cost of Medications

The development of OUD medications requires extensive research, clinical trials, and regulatory approvals, all of which incur substantial costs. Pharmaceutical companies invest heavily in these processes, and these expenses often translate into high drug prices once they reach the market. The OUD Drugs Market often features a limited number of manufacturers producing these specialized medications. The lack of competition allows companies to set higher prices without fear of price undercutting. Consequently, patients and healthcare systems have limited options, and the lack of market competition exacerbates the cost burden. Many OUD medications are protected by patents, granting manufacturers exclusive rights to produce and market these drugs.

While patents are essential for incentivizing research and development, they also allow manufacturers to maintain high prices for an extended period, limiting the availability of more affordable generic versions. Some OUD medications receive orphan drug designation, intended to promote the development of therapies for rare diseases. While this designation offers incentives such as extended exclusivity periods and tax credits, it can lead to substantially higher drug prices, impacting the affordability of these medications for patients.

Key Market Trends

Expansion of Medication-Assisted Treatment (MAT)

One of the most significant trends in the OUD Drugs Market is the increasing adoption of Medication-Assisted Treatment (MAT). MAT combines pharmacotherapy, such as opioid agonists (e.g., methadone and buprenorphine), with counseling and behavioral therapies to address opioid addiction comprehensively. MAT is now widely recognized as the gold standard of care for OUD, and its expansion has significantly boosted the market. Increased Access to Treatment: MAT programs have proliferated, making treatment more accessible to individuals grappling with OUD. The availability of MAT in a variety of healthcare settings, including specialized clinics, primary care offices, and even pharmacies, has broadened the reach of OUD treatment. MAT has demonstrated its effectiveness in reducing opioid misuse, promoting long-term recovery, and preventing opioid overdose deaths. As more individuals have access to MAT, better treatment outcomes become achievable, leading to increased confidence in these therapies.

MAT has played a pivotal role in reducing the stigma associated with OUD treatment. By emphasizing the medical aspect of addiction, MAT has helped change societal attitudes, making it more acceptable for individuals to seek help for their addiction without fear of judgment or discrimination. Governments and healthcare authorities have recognized the value of MAT in addressing the opioid epidemic. They have implemented policies and initiatives aimed at expanding access to MAT, providing financial support, and reducing administrative barriers, which in turn has encouraged market growth. The surge in demand for MAT has sparked innovation in the development of new OUD medications and improved formulations. Researchers are constantly exploring ways to enhance the safety and efficacy of MAT drugs, which stimulates further growth in the OUD Drugs Market.

Telehealth and Digital Solutions

Increased Access to Treatment: Telehealth has expanded the reach of addiction treatment by enabling patients to connect with healthcare professionals from the comfort of their homes. This newfound accessibility is especially vital for individuals residing in rural or underserved areas with limited access to addiction treatment facilities. Telehealth has improved the continuity of care for individuals in OUD treatment programs. Patients can maintain regular contact with healthcare providers, ensuring consistent medication management and support, which is crucial for recovery.Telehealth facilitates remote counseling and support services, which are integral components of addiction treatment. Patients can participate in individual and group therapy sessions virtually, reducing barriers to consistent engagement in counseling.

Telehealth platforms allow healthcare providers to monitor patients' progress, adjust medication regimens, and address any concerns promptly. This remote oversight enhances patient safety and adherence to OUD medications. Telehealth affords individuals seeking OUD treatment a degree of privacy that might not be achievable in traditional in-person settings. This reduction in stigma encourages more individuals to seek help and engage in treatment.Digital solutions, including smartphone apps and web-based platforms, provide additional support for individuals in recovery. These tools can offer medication reminders, coping strategies, and resources to help patients manage their OUD more effectively.

Segmental Insights

Drug Type Insights

Based on the Drug Type, Agonist Drugs emerged as the dominant segment in the Global Opioid Use Disorder Drugs Market in 2024. This is due to their widespread use, proven efficacy, and established role in medication-assisted treatment (MAT) protocols. Agonist drugs such as methadone and buprenorphine work by activating opioid receptors in the brain to reduce withdrawal symptoms and cravings without producing the euphoric effects associated with opioid misuse. These drugs help stabilize patients, prevent relapse, and support long-term recovery. Their effectiveness has been extensively documented in clinical settings, making them the preferred choice among healthcare providers. Government support for agonist-based therapies has further driven their dominance. For instance, countries like the United States, Canada, and several in Europe have expanded access to methadone and buprenorphine programs through outpatient clinics and integrated care models. The World Health Organization (WHO) and the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) also endorse agonist drugs as frontline treatments for OUD.

Route of Administration Insights

Based on the Route of Administration, Oral emerged as the dominant segment in the Global Opioid Use Disorder Drugs Market in 2024. This is due to their ease of use, patient compliance, and wide availability. Oral medications, such as methadone tablets and sublingual buprenorphine formulations, are commonly prescribed in outpatient settings for long-term maintenance therapy. These drugs offer convenience, as they can be self-administered without the need for healthcare professional supervision, making them suitable for large-scale treatment programs and home-based care models. The popularity of oral administration is further supported by established clinical protocols and reimbursement policies in major markets like the United States, Canada, and parts of Europe. Regulatory bodies including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved several oral formulations for OUD treatment, facilitating their widespread adoption. Oral therapies are also associated with reduced stigma compared to injectable treatments, encouraging more individuals to seek help.

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Regional Insights

North America emerged as the dominant region in the Global Opioid Use Disorder Drugs Market in 2024. This is due to the region's high prevalence of opioid misuse and a robust healthcare infrastructure supporting treatment and rehabilitation. The United States, in particular, continues to face a severe opioid crisis, with the Centers for Disease Control and Prevention (CDC) reporting over 80,000 opioid overdose deaths in 2023 alone. This alarming statistic has led to significant federal and state-level investments in opioid addiction treatment programs and expanded access to evidence-based medications such as methadone, buprenorphine, and naltrexone. Government initiatives such as the U.S. Department of Health and Human Services’ (HHS) Overdose Prevention Strategy and increased SAMHSA (Substance Abuse and Mental Health Services Administration) funding have played a critical role in expanding medication-assisted treatment (MAT) access across communities.

Asia-Pacific emerged as the fastest growing region in the Global Opioid Use Disorder Drugs Market during the forecast period. This is due to the rising incidence of opioid misuse and increasing awareness of substance abuse treatment. Countries such as India, China, and Australia are witnessing a growing prevalence of opioid dependence due to factors like the increased availability of prescription painkillers, changing lifestyles, and the illegal trafficking of synthetic opioids such as fentanyl and tramadol. Public health authorities in several Asia-Pacific countries are gradually recognizing the urgent need for opioid addiction treatment programs, resulting in greater investments in public health campaigns and addiction management infrastructure. Moreover, the region has seen a marked increase in funding and support from international organizations, such as the United Nations Office on Drugs and Crime (UNODC), aimed at combating the opioid epidemic through education, harm reduction, and access to evidence-based treatment approaches.

Recent Developments

• In November 2024, Indivior PLC announced positive results from a sub-study (NCT04995029) showing that rapid initiation (RI) with SUBLOCADE (buprenorphine extended-release injection) significantly improves treatment retention in opioid-dependent patients compared to standard initiation (SI). The study suggests that same-day RI could reduce treatment barriers and enhance retention, particularly among fentanyl and injection opioid users, without raising the risk of precipitated withdrawal. The findings were presented at the 2024 Canadian Society of Addiction Medicine (CSAM) conference in Hamilton, Ontario.
• In October 2024, ANANDA Scientific Inc. launched a clinical trial at Yale School of Medicine to evaluate its investigational drug Nantheia ATL5, formulated with CBD and co-administered with THC for treating co-occurring opioid use disorder (OUD) and chronic pain. The trial, led by Dr. Joao P. De Aquino and funded by the National Institute on Drug Abuse (NIDA), utilizes ANANDA’s proprietary delivery technology. (ClinicalTrials.gov ID: NCT06544291)
• In October 2024, Protega Pharmaceuticals Inc. received FDA approval for ROXYBOND (oxycodone HCl) immediate-release 10 mg tablets for severe pain management when alternative treatments are inadequate. ROXYBOND is the first FDA-approved abuse-deterrent IR oxycodone formulation, aimed at reducing misuse via intranasal and intravenous routes. The drug utilizes Protega’s patented SentryBond technology, which resists physical and chemical manipulation while preserving the intended release profile.
• In October 2024, Acadia Healthcare acquired three opioid treatment clinics in South Carolina, formerly Recovery Concepts, Recovery Concepts of the Carolina Upstate, and Clear Skye Treatment Center. These facilities have been rebranded under Acadia’s Comprehensive Treatment Center (CTC) network as Clinton, Easley, and Ridgeland CTCs. This marks Acadia’s entry into South Carolina’s CTC market. The clinics serve all patients, including Medicaid recipients. With this expansion, Acadia’s CTC division now operates 165 centers across 33 states, treating over 72,000 patients daily.
• In March 2024, Gilgamesh Pharmaceuticals secured a USD 14 million multi-year grant from the National Institute on Drug Abuse (NIDA) to advance GM-3009, a novel, cardiac-safe ibogaine analog for treating substance use disorders. The non-dilutive funding will support IND-enabling toxicology studies, GMP manufacturing, and Phase 1/1b clinical trials in healthy volunteers and opioid use disorder (OUD) patients. GM-3009 is designed to retain the therapeutic potential of ibogaine while eliminating its known cardiovascular risks. Upon successful completion of the initial studies, the candidate will be positioned for Phase 2 efficacy trials.

Key Market Players

• Mallinckrodt Pharmaceuticals
• Hikma Pharmaceuticals Inc
• Collegium Pharmaceutical, Inc.
• Braeburn, Inc.
• Purdue Pharma L.P.
• Curia Global Inc.
• EMERGENT
• Bristol-Myers Squibb, S.r.l
• Alkermes, Inc.
• Indivior Inc.

 Report Scope:

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

• Opioid Use Disorder Drugs Market, By Drug Type:

o   Agonist Drugs

o   Antagonist Drugs

o   Others

• Opioid Use Disorder Drugs Market, By Route of Administration:

o   Oral

o   Parenteral

o   Sublingual

o   Nasal

• Opioid Use Disorder Drugs Market, By Distribution Channel:

o   Hospital Pharmacies

o   Retail Pharmacies

o   Online Pharmacies

• Opioid Use Disorder Drugs Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Opioid Use Disorder Drugs Market.

Available Customizations:

Global Opioid Use Disorder Drugs Market   report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).