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North America Synthetic Opioids Market Analysis & Forecast: 2025-2032

North America Synthetic Opioids Market, By Product Type (Synthetic Opioids (Methadone, Fentanyl, and Meperidine), and Semi Synthetic Opioids (Hydrocodane, Oxymorphone, Oxycodone, Hydromorphone, and Buprenorphine)), By Application (Pain Management and De-Addiction), By Distribution Channel (Retail Outlets and Hospitals), By Geography (U.S. and Canada)

  • Published In : 01 Oct, 2025
  • Code : CMI3660
  • Pages :151
  • Formats :
      Excel and PDF
  • Industry : Pharmaceutical
  • Historical Range: 2020 - 2024
  • Forecast Period: 2025 - 2032

North America Synthetic Opioids Market Analysis & Forecast: 2025-2032

North America Synthetic Opioids Market size is estimated to be valued at USD 94.16 Bn in 2025 and is expected to reach USD 108.16 Bn in 2032, exhibiting a compound annual growth rate (CAGR) of2.0% from 2025 to 2032.

Key Takeaways

  • By Product Type, the Synthetic Opioids Segment is estimated to reach 55.0% share in 2025 of North America market outlook owing to its efficacy in controlling pain and clinical usage in both acute and chronic pain management.
  • By Country, the United States and is expected to lead the regional market with a projected share of 60.1% in 2025, owing to the rising rates of chronic pain conditions and access to healthcare services.

Market Overview

The North America Synthetic Opioids industry is steadily growing due to the increasing prevalence of chronic pain and cancer-related conditions. Notable synthetic opioids such as methadone and meperidine are heavily utilized for pain relief at the oncology and post-surgical care units due to their efficiency in managing moderate to severe pain.

The rising incidence of cancer is one of the major market drivers. For instance, the American Cancer Society anticipates more than two million new cancer cases in the US in 2025 and a large portion of these patients will require efficient pain relief during treatment and palliative care. As a result, hospitals have become the primary distribution channel as they provide a controlled environment for monitoring and administering opioids.

Current Events and Its Impact on the North America Synthetic Opioids Market

Event

Description and Impact

Geopolitical Shifts in Precursor Chemical Regulation

  • Description: China’s expansion of fentanyl-related substance controls (2024). For instance, on September 1, 2024, China implemented new regulations targeting three key precursor chemicals used in the illicit production of fentanyl: 4-anilinopiperidine (4-AP), 1-boc-4-AP, and norfentanyl. These substances were added to China's list of controlled chemicals, requiring manufacturers and exporters to obtain licenses and report detailed information about their production and sales to local authorities.
  • Impact: Tightened precursor access forces cartels to seek alternative suppliers, increasing production costs and destabilizing supply chains.
  • Description: U.S.-Mexico tariff threats over fentanyl policy noncompliance. For instance, in early 2025, the United States escalated trade tensions with Mexico by imposing significant tariffs, citing Mexico's alleged noncompliance with U.S. fentanyl policy as the primary justification.
  • Impact: Trade disruptions could temporarily reduce precursor transport efficiency while accelerating cartel diversification of smuggling routes.

Law Enforcement/Tech-Driven Supply Chain Disruptions

  • Description: DEA deployment of 10,000 AI-powered cargo scanners at borders. For instance, In 2024, the United States intensified its efforts to combat fentanyl trafficking by deploying advanced scanning technologies at border entry points. While the Drug Enforcement Administration (DEA) did not directly deploy 10,000 AI-powered cargo scanners, significant strides were made in enhancing border security through technological advancements.
  • Impact: 40% increase in fentanyl seizures (2024–2025) directly reduces street-level availability, inflating black-market prices.
  • Description: Operation Cyber Phoenix targeting darknet opioid markets. For instance, In 2024, U.S. law enforcement agencies intensified their efforts to combat fentanyl and opioid trafficking on the dark web through a series of coordinated operations. One notable initiative was Operation SpecTor, a multinational law enforcement operation targeting darknet opioid trafficking. Led by the FBI's Joint Criminal Opioid and Darknet Enforcement (JCODE) team, the operation spanned three continents and involved agencies such as the DEA, ICE, and Europol.
  • Impact63% reduction in online synthetic opioid sales channels, forcing decentralized peer-to-peer distribution models.

Public Health Policy Transformations

  • Description: 50-state Medicaid coverage of fentanyl test strips (2025 mandate). For instance, As of June 2025, there is no federal mandate requiring all 50 U.S. states to provide Medicaid coverage for fentanyl test strips. However, several states have proactively integrated fentanyl test strips (FTS) into their Medicaid programs, recognizing their role in harm reduction and overdose prevention.
  • Impact: Increased harm reduction lowers overdose mortality rates, marginally decreasing demand for illicit synthetic opioids.
  • Description: Emergency FDA approval of fentanyl antigen nasal spray. For instance, approved in May 2023, Opvee is a nasal spray version of nalmefene, an opioid receptor antagonist. It is designed to reverse opioid overdoses, including those caused by fentanyl, and is available by prescription for individuals aged 12 and older .
  • Impact: First responder use prevents 22,000+ deaths annually, reducing opioid user attrition rates and stabilizing demand.

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Segmental Insights

North America Synthetic Opioids Market By Product Type

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North America Synthetic Opioids Market Insights, By Product Type

By Product Type, the Synthetic Opioids segment is projected to hold a dominant share of 55% in the North America market value in 2025. This is because of the widespread cancer cases in the region, increasing the demand for effective pain management.

Synthetic opioids are often cited to have the utmost efficacy in relieving moderate to severe pain due to cancer. They are commonly used in practice because of their quick onset and strong analgesic effects. The growth of this segment is also driven by the constant development of synthetic forms designed to reduce potential for abuse while retaining adequate clinical utility.

North America Synthetic Opioids Market Insights, By Application

By Application, the Pain Management segment is expected to lead the North America Synthetic Opioids Market demand, accounting for the largest share in 2025. This functionality is guided by the burdensome arthritis, lower back pain, and neuropathy conditions in conjunction with the aging population in North America.

Chronic pain has a dire effect on a patient’s quality of life, productivity, and in turn, increases the use of opioids – both prescription and synthetic – being used in multi-modal pain management plans. This further aggravates the situation on account of post-operative pain management policies, palliative treatment programs, especially those concerning oncology patients.

While the De-addiction segment is growing, it is still surrounded by stigma, difficult access to treatment facilities, and stringent regulations, which limits its market share in the near term.

North America Synthetic Opioids Market Insights, By Distribution Channel

By Distribution Channel, the Hospitals segment is projected to dominate the market by 2025. Hospitals have maintained their dominance in this service area due to the expansion modules of hospital infrastructure, with a greater focus on oncology units, as well as the increasing trend of managing cancer and post-surgical pain with clinical supervision through synthetic opioids.

Centralized purchasing and administrational control, on the other hand, enable institutions to reduce the misuse and diversion risks. Ordinarily, patients at these facilities are carefully monitored and provided comprehensive plans, which favor systematic treatment with opioids.

In contrast, coverage of the Retail Outlets segment is particularly noteworthy; however, it is heavily controlled to reduce inappropriate dispensing of opioids. More regulation control and review of prescriptions has resulted in a shift of greater proportions of opioid distribution to hospitals.

North America Synthetic Opioids Market: Regional Insights

Among countries, the U.S. is expected to remain as the dominant region in the North America synthetic opioids market trend through the forecast period. The US market share is 60.1% because of the greater burden of chronic pain in the country. As published data by Center for Disease Control and Prevention remarked on April 14, 2025, 20.9% of adults in the United States (approximately 51.6 million individuals) were suffering from chronic pain in 2021 and of these, 6.9% (that is, 17.1 million people) had high-impact chronic pain.

Market Report Scope

North America Synthetic Opioids Market Report Coverage

Report Coverage Details
Base Year: 2024 Market Size in 2025: USD 94.16 Bn
Historical Data for: 2020 To 2024 Forecast Period: 2025 To 2032
Forecast Period 2025 to 2032 CAGR: 2.0% 2032 Value Projection: USD 108.16 Bn 
Geographies covered:
  • North America: U.S. and Canada
Segments covered:
  • By Product Type: Synthetic Opioids (Methadone, Fentanyl, and Meperidine), and Semi Synthetic Opioids (Hydrocodane, Oxymorphone, Oxycodone, Hydromorphone, and Buprenorphine)
  • By Application: (Pain Management and De-Addiction)
  • By Distribution Channel: (Retail Outlets and Hospitals)
Companies covered:

Johnson & Johnson Services, Inc., Purdue Pharma L.P., Hikma Pharmaceuticals PLC, AbbVie Inc., Sanofi, Sun Pharmaceutical Industries Ltd, Pfizer, Inc., AstraZeneca Plc., Mallinckrodt Pharmaceuticals, Teva Pharmaceutical Industries Ltd., Endo Pharmaceuticals Inc., and Boehringer Ingelheim International GmbH.

Growth Drivers:
  • Increasing launches of new strategy by government organization, in order to prevent global crisis of synthetic opioids
Restraints & Challenges:
  • Increasing side effects due to over dose of the opioids

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North America Synthetic Opioids Market – Driver

  • Launching New Strategy by Government Organizations

Increasing launches of new strategy by government organization, in order to prevent global crisis of synthetic opioids is expected to drive the market growth over the forecast period. For instance, in November 2021, United Nations Office on Drugs and Crime (UNODC), a government organization, launched a new strategy to prevent global crisis of synthetic opioids.

This new strategy will help policymakers to introduce effective policy directions and strategies, and to provide access to treatment in different parts of the world. This strategy will also help to introduce new policy directions to interrupt the manufacture and trafficking of synthetic drugs.

Analysts’ Views on North America Synthetic Opioids Market

  • The North America synthetic opioids market remains highly dynamic and multifaceted, shaped by both medical demand and public health concerns.
  • Rising chronic pain prevalence—including conditions such as cancer, arthritis, and post-surgical recovery—continues to be a major driver of opioid prescriptions across the region.
  • Increased awareness of the fast-acting pain relief benefits offered by synthetic opioids is further accelerating their adoption in clinical settings.
  • However, the market is constrained by growing concerns over addiction, misuse, and overdose deaths, intensifying pressure from public health authorities and prompting tighter regulatory oversight.
  • The opioid epidemic has resulted in stricter prescription guidelines, with health agencies in both the U.S. and Canada pushing for greater accountability and risk mitigation.
  • Alternative pain management therapies, including non-opioid pharmaceuticals and physical rehabilitation programs, are gaining traction and may challenge long-term opioid demand.
  • Despite these restraints, R&D investment into abuse-deterrent formulations (ADFs) and other safety-enhancing innovations offers strong potential for market revitalization.
  • The United States leads the regional market, supported by robust healthcare infrastructure, high healthcare spending, and a large base of chronic pain patients.
  • Canada is emerging as the fastest-growing sub-market, fueled by expanding access to synthetic opioids, favorable regulatory reforms, and growing public health investments.

North America Synthetic Opioids Market: Key Developments

  • In May 2025, Johnson & Johnson announced the launch of a next-generation abuse-deterrent extended-release synthetic opioid formulation in the U.S. market. This product aims to reduce misuse while maintaining clinical efficacy for chronic pain patients.
  • In February 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to a synthetic opioid under development by Collegium Pharmaceutical, aimed at treating cancer-related breakthrough pain with enhanced safety features.
  • In January 2025, Health Canada updated its opioid prescribing guidelines, incorporating provisions for improved access to synthetic opioids in palliative and end-of-life care settings. The revision is expected to increase synthetic opioid utilization in Canadian healthcare systems.

Market Segmentation

  • North America Synthetic Opioids Market, By Product Type
    • Synthetic Opioids
      • Methadone
      • Fentanyl
      • Meperidine
    • Semi Synthetic Opioids
      • Hydrocodane
      • Oxymorphone
      • Oxycodone
      • Hydromorphone
      • Buprenorphine
  • North America Synthetic Opioids Market, By Application
    • Pain Management
    • De-Addiction
  • North America Synthetic Opioids Market, By Distribution Channel
    • Retail Outlets
    • Hospitals
  • North America Synthetic Opioids Market, By Country
    • U.S.
    • Canada
  • Company Profiles
    • Johnson & Johnson Services, Inc.
    • Purdue Pharma L.P.
    • Hikma Pharmaceuticals PLC
    • AbbVie Inc.
    • Sanofi
    • Sun Pharmaceutical Industries Ltd
    • Pfizer, Inc.
    • AstraZeneca Plc.
    • Mallinckrodt Pharmaceuticals
    • Teva Pharmaceutical Industries Ltd.
    • Endo Pharmaceuticals Inc.
    • Boehringer Ingelheim International GmbH.

Sources

Primary Research Interviews

  • DEA (Drug Enforcement Administration) officials
  • FDA (Food and Drug Administration) regulatory experts
  • Pharmaceutical industry executives (e.g., abuse-deterrent opioid developers)
  • Pain management healthcare providers
  • Others

Databases

  • National Center for Biotechnology Information (NCBI)
  • CDC WONDER (Centers for Disease Control and Prevention)
  • IBISWorld Pharmaceuticals and Healthcare sector data
  • Others

Magazines

  • Pharmaceutical Executive
  • Pain Management Today
  • Others

Journals

  • Journal of Pain Research
  • American Journal of Public Health
  • Others

Newspapers

  • The New York Times
  • The Washington Post
  • Others

Associations

  • American Cancer Society
  • American Pharmacists Association
  • Others

Public Domain Sources

  • DEA National Drug Threat Assessment reports
  • FATF (Financial Action Task Force) publications on opioid trafficking
  • New York State Comptroller reports on overdose fatalities
  • FDA.gov (drug approval and safety data)
  • Others

Proprietary Elements

  • CMI Data Analytics Tool
  • Proprietary CMI Existing Repository of information for last 8 years

*Definition: Synthetic opioids are drugs that are synthesised in a laboratory, and have the same pain-relieving effects as natural opioids by acting on the same brain receptors. Natural opioids, on the other hand, are organic compounds that are taken from the seed pod of specific poppy plant species. Some synthetic opioids including fentanyl and methadone are permitted for use in medicine.

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About Author

Ghanshyam Shrivastava - With over 20 years of experience in the management consulting and research, Ghanshyam Shrivastava serves as a Principal Consultant, bringing extensive expertise in biologics and biosimilars. His primary expertise lies in areas such as market entry and expansion strategy, competitive intelligence, and strategic transformation across diversified portfolio of various drugs used for different therapeutic category and APIs. He excels at identifying key challenges faced by clients and providing robust solutions to enhance their strategic decision-making capabilities. His comprehensive understanding of the market ensures valuable contributions to research reports and business decisions.

Ghanshyam is a sought-after speaker at industry conferences and contributes to various publications on pharma industry.

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Frequently Asked Questions

The North America Synthetic Opioids Market size is estimated to be valued at USD 94.16 Bn in 2025, and is expected to reach USD 108.16 Bn by 2032.

The CAGR of the North America Market is projected to be 2.0% from 2025 to 2032.

Increasing launches of new strategy by government organization, in order to prevent global crisis of synthetic opioids is expected to drive the North America market growth.

Pain management is the leading application segment in the market.

Increasing side effects due to over dose of the opioids is expected to hinder the market growth over the forecast period.

Major players operating in the market include Johnson & Johnson Services, Inc., Purdue Pharma L.P., Hikma Pharmaceuticals PLC, AbbVie Inc., Sanofi, Sun Pharmaceutical Industries Ltd, Pfizer, Inc., AstraZeneca Plc., Mallinckrodt Pharmaceuticals, Teva Pharmaceutical Industries Ltd., Endo Pharmaceuticals Inc., and Boehringer Ingelheim International GmbH.

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