오피오이드 사용 장애 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the opioid use disorder market size is expected to increase from USD 4.30 billion in 2025 to USD 4.78 billion in 2026 and reach USD 8.04 billion by 2031, growing at a CAGR of 10.97% over 2026-2031.

This report is Segmented by Drug Class (Buprenorphine, Methadone, Naltrexone), Route of Administration (Oral, Injectable), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Opioid Use Disorder Market Trends and Insights

Rising Opioid Dependence and Untreated Treatment Gap

In 2024, the U.S. recorded over 80,000 overdose deaths. Data from early 2026 indicated that, despite a recent decline in total fatalities, the burden of synthetic opioids remained significantly elevated compared to pre-fentanyl levels. A key demand driver in the opioid use disorder market is the low treatment rate, overshadowing mere prevalence figures. SAMHSA's 2024 estimates revealed that only 25% of individuals with substance use disorders received treatment, highlighting a substantial and persistent care gap. The 2026 National Drug Control Strategy emphasized early recognition and treatment access, advocating for broader prescribing opportunities across all approved medication classes. In India, government data indicated that 2.06% of the population faces opioid consumption issues, spotlighting a vast, untreated patient demographic in a pivotal growth region for the opioid use disorder market. The treated population lags significantly behind clinical needs, with market expansion driven more by improved access than by incidence growth.

Telemedicine Expansion for Buprenorphine Prescribing

In December 2025, the DEA and HHS extended COVID-19 telemedicine flexibilities, allowing audio-video and audio-only prescriptions of Schedule III-V opioid use disorder medications through December 31, 2026. This move prevented stricter in-person visit mandates for remote treatment patients, safeguarding a significant portion of the prescribing base. Additionally, a rule effective February 18, 2025, permitted practitioners to prescribe a 6-month supply of buprenorphine post an audio-only telehealth session, contingent on meeting PDMP verification standards. A February 2025 study revealed an 82.6% retention rate for patients using home-delivery pharmacy partners over three months, compared to 58.9% for pharmacy pickups. Policy flexibility for telemedicine prescribing continues to support the opioid use disorder market, though state laws and DEA compliance shape its scalability.

Methadone Access Limited to Certified Opioid Treatment Programs

Under the Controlled Substances Act, methadone is restricted to federally certified opioid treatment programs, creating a significant barrier to growth in the opioid use disorder market. In 2025, ASAM reported that 80% of U.S. counties lacked an opioid treatment program, with half of these counties being rural, highlighting geographic disparities in access. A 2025 study found that states with stricter OTP regulations had lower methadone maintenance treatment rates per ZIP code, even after accounting for demographic differences. Additional challenges, such as state certificate-of-need laws, zoning regulations, and counseling frequency requirements, increase the cost of establishing or expanding treatment sites, limiting competition and slowing new channel development. Reform proposals, including state-led methadone policy changes and community pharmacy dispensing models, remain under discussion, but the lack of federal support suggests these restrictions will persist during much of the forecast period.

Other drivers and restraints analyzed in the detailed report include:

1. Long-Acting Injectable Adoption Improves Adherence and Reduces Diversion Risk
2. Fentanyl-Driven Demand for Higher-Retention Formulations
3. Stigma, Prior Authorization, and Reimbursement Gaps

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

In 2025, Buprenorphine captured 59.58% of the opioid use disorder market share, driven by its partial-agonist profile, superior safety compared to methadone, and availability in various forms such as sublingual and buccal films, tablets, and injectables. Non-OTP prescribers, including primary care and telehealth providers, further boosted its adoption under federal telemedicine regulations. Methadone remained the second-largest drug class, playing a critical role in high-dependency and polysubstance cases, though its reach was limited by OTP access barriers.

Naltrexone is projected to grow at a CAGR of 11.45% through 2031, supported by its opioid-free antagonist mechanism, which appeals to settings and patients favoring full receptor blockade over agonist therapy. Alkermes reported VIVITROL net sales of nearly USD 468 million in FY 2025, with 2026 guidance of USD 460-480 million, indicating sustained demand at premium pricing. The September 2025 authorized generic agreement between Alkermes and Amneal Pharmaceuticals, covering up to 15% of 2024 VIVITROL unit sales, reflects evolving pricing dynamics. Naltrexone's non-scheduled status under the Controlled Substances Act enhances accessibility for community pharmacies and correctional health systems, reducing compliance burdens compared to buprenorphine.

Complete Report Scope:

• By Drug Class
  • Buprenorphine
  • Methadone
  • Naltrexone
• By Route Of Administration
  • Oral
  • Injectable
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

In 2025, North America held 39.25% of the opioid use disorder market share, making it the largest region by value and treatment volume. This dominance stems from a high disease burden, a mature opioid treatment program infrastructure, and significant public-payer involvement in treatment financing. While Canada is advancing injectable treatments in urban centers, Mexico faces limited opportunities due to inadequate OTP infrastructure and low addiction-care spending. Medicaid expansion states in the U.S. saw only a 17% decline in buprenorphine prescriptions during restrictive policy periods, compared to a 47.6% decline in non-expansion states, highlighting the impact of payer structures on demand resilience.

Europe remained the second-largest region in the opioid use disorder market, with Germany and France leading as key national contributors. Their buprenorphine and methadone treatment systems address most opioid agonist therapy needs, providing a strong treatment base. The European Drug Report 2025 indicated that 35% of opioid agonist therapy clients in Europe use buprenorphine, while methadone accounts for 55%, with buprenorphine being the primary option in nine member states.

Asia-Pacific is projected to grow at the fastest CAGR of 11.20% through 2031, making it a key expansion region for the opioid use disorder market. India's 2.06% opioid problem prevalence highlights a large untreated population, even as formal treatment systems are still scaling. China is progressing with early-stage public investments and pilot programs. Mature treatment settings in Australia, South Korea, and Japan, along with Buvidal's traction in Australia, demonstrate the potential for long-acting injectable models to gain market share outside North America. South America, the Middle East, and Africa remain smaller markets, with Brazil and GCC countries offering near-term opportunities, while fragmented regulations and criminalization policies in parts of Southeast Asia limit demand and increase entry costs for global suppliers.

1. Alkermes plc
2. Amneal Pharmaceuticals
3. BioDelivery Sciences International, Inc.
4. Braeburn Inc.
5. Camurus AB
6. Collegium Pharmaceutical, Inc.
7. Dr. Reddy's Laboratories
8. Emergent Bio Solutions
9. Hikma Pharmaceuticals
10. Indivior
11. Johnson & Johnson
12. Mallinckrodt plc
13. Omeros Corporation
14. Orexo
15. Pfizer
16. Sanofi
17. Sun Pharmaceuticals Industries
18. Teva Pharmaceutical Industries
19. Titan Pharmaceuticals, Inc.
20. Viatris

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Opioid Dependence and Untreated Treatment Gap
  • 4.2.2 Telemedicine Expansion for Buprenorphine Access
  • 4.2.3 Long-Acting Injectable Adoption Improves Adherence
  • 4.2.4 Policy Flexibility for Opioid Treatment Programs
  • 4.2.5 Fentanyl-Driven Demand for Higher-Retention MOUD
  • 4.2.6 Expanded Payer Coverage for Chronic Addiction Care
• 4.3 Market Restraints
  • 4.3.1 Methadone Access Limited to Certified Opioid Treatment Programs
  • 4.3.2 Stigma, Prior Authorization, and Reimbursement Friction
  • 4.3.3 Diversion Concerns and Controlled-Substance Monitoring Burden
  • 4.3.4 Adverse Effects and Induction Complexity for Some Therapies
• 4.4 Value Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat Of New Entrants
  • 4.7.2 Bargaining Power Of Suppliers
  • 4.7.3 Bargaining Power Of Buyers
  • 4.7.4 Threat Of Substitutes
  • 4.7.5 Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Drug Class
  • 5.1.1 Buprenorphine
  • 5.1.2 Methadone
  • 5.1.3 Naltrexone
• 5.2 By Route Of Administration
  • 5.2.1 Oral
  • 5.2.2 Injectable
• 5.3 By Distribution Channel
  • 5.3.1 Hospital Pharmacies
  • 5.3.2 Retail Pharmacies
  • 5.3.3 Online Pharmacies
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 India
    • 5.4.3.3 Japan
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Alkermes plc
  • 6.3.2 Amneal Pharmaceuticals, Inc.
  • 6.3.3 BioDelivery Sciences International, Inc.
  • 6.3.4 Braeburn Inc.
  • 6.3.5 Camurus AB
  • 6.3.6 Collegium Pharmaceutical, Inc.
  • 6.3.7 Dr. Reddy's Laboratories Limited
  • 6.3.8 Emergent BioSolutions Inc.
  • 6.3.9 Hikma Pharmaceuticals PLC
  • 6.3.10 Indivior PLC
  • 6.3.11 Johnson and Johnson
  • 6.3.12 Mallinckrodt plc
  • 6.3.13 Omeros Corporation
  • 6.3.14 Orexo AB
  • 6.3.15 Pfizer Inc.
  • 6.3.16 Sanofi
  • 6.3.17 Sun Pharmaceutical Industries Limited
  • 6.3.18 Teva Pharmaceutical Industries Ltd.
  • 6.3.19 Titan Pharmaceuticals, Inc.
  • 6.3.20 Viatris Inc.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment