Opioid use disorder, comprising opioid use, abuse, and/or dependence, is a chronic disease with an estimated prevalent population totaling more than 2.9 million people aged 15 or older in the United States in 2018.1 The transition from opioid use and abuse to opioid dependence (addiction) results from long-lasting, drug-induced changes in the brain. Abused opioids include heroin and prescription narcotic analgesics such as morphine, oxycodone, fentanyl, hydrocodone, and codeine. The most detrimental long-term effect of opioids is the physical dependence; withdrawal symptoms occur if opioid use is reduced abruptly. The number of cases of opioid addiction are rapidly increasing each year, making opioid addiction a serious public health concern.2

Current Treatment Landscape

Our survey of 100 U.S. psychiatrists who regularly treat opioid addiction patients found that most of their patients are addicted to prescription opioid analgesics as compared with illicit opioids, although the specific opioid of abuse for each patient does not generally play a role in treatment decisions.3 The principal goal in the treatment of opioid addiction is abstinence from the use of opioids. Psychiatrists work with patients to decide the preferred course of treatment for that individual; treatment may involve either opioid substitution therapies (e.g., methadone, buprenorphine) or abstinent therapies (e.g., naltrexone). The majority of patients receive opioid substitution treatment, and the success of treatment (e.g., reduced likelihood of relapse) is further enhanced when patients receive psychosocial support in addition to the prescription drug therapy.

A Market Success

Survey data from the same 100 U.S. psychiatrists reveal the most widely prescribed drugs for opioid addiction are buprenorphine sublingual tablet, buprenorphine/naloxone sublingual tablet and the branded Suboxone Film (Indivior).3 Despite being a follow-on product of the generically available sublingual tablet, branded Suboxone Film is the most prescribed drug in the U.S. opioid addiction market, according to DRG research, likely owing to its excellent clinical profile. Suboxone Film’s efficacy in managing addiction with relatively mild adverse effects and low potential for abuse4 has made it a popular agonist in the United States. Another major reason for its success is its favorable formulary coverage, perhaps reflecting physician, patient, and payer familiarity with Suboxone tablets, the precursor to the film formulation, as well as with the marketing company, Indivior, being well-entrenched in the opioid addiction market. DRG’s Fingertip Formulary data found that Suboxone Film has a preferred-brand status (i.e., tier 2) coverage for over two-thirds of commercially insured lives, more than any other branded agent, with surveyed managed care organization (MCO) pharmacy directors/medical directors (PDs/MDs) citing Suboxone Film’s overall cost-effectiveness, supported by good-to-exceptional quality pharmacoeconomic data, as a driving factor for its favorable status.5

Market Challenges

Although additional agents have entered the U.S. opioid addiction market since Suboxone Film became available, uptake of all other later-to-market branded drugs (e.g., Orexo’s Zubsolv and BioDelivery Sciences’ Bunavail) has been minimal, with many confined to nonpreferred status, likely owing to limited differentiation in terms of delivery profile and/or improved patient compliance to other agents on the market. Moreover, DRG survey results indicate market access/reimbursement hurdles to be the major reasons for underperformance of these drugs in opioid addiction market.3 Adverse payer policies of these branded agents, including high copays and prior authorization requirements, are a direct factor in limiting prescribing of these agents by a proportion of surveyed physicians.5 However, it is worth noting that tier placement can change through careful contract negotiations; in the case of Zubsolv, a follow-on buprenorphine/naloxone sublingual tablet, Orexo has managed to gain preferred or exclusive brand status for a number of carriers through negotiations to increase the overall cost-effectiveness compared with branded competitors. Unfortunately for some branded agents, competition for formulary coverage will increase further once generic alternatives of Suboxone Film enter the market.

Recent drug approvals (e.g., Indivior’s Sublocade [buprenorphine depot] and Teva’s Cassipa [buprenorphine/naloxone sublingual film]) or the late-stage drugs in development (e.g., Camurus/Braeburn’s Buvidal [buprenorphine depot]) for the treatment of opioid addiction are reformulations of existing drugs (mostly opioid agonists) targeting better compliance (e.g., depot formulations) and/or low abuse potential. The majority of physicians surveyed by DRG have a favorable view of Sublocade and Buvidal. Solid uptake of these drugs is expected in the next three years with the promise of improved patient compliance and more convenient administration in comparison to Braeburn’s Probuphine, the six-month buprenorphine implant; Probuphine failed to gain much traction on the market because of the difficult process of implanting and removing the device with a daily dose considered too low by many interviewed physicians. Given the number of buprenorphine-containing agents on the market, both branded and generic, developers of recently launched and emerging buprenorphine-containing therapies will, according to surveyed payers, need to demonstrate improved efficacy, particularly in reducing opioid craving and in long-term efficacy compared with standard of care, and/or offer deep discounts to payers in exchange for favorable formulary placement.5 Nevertheless, market opportunity exists for treatment options with a novel mechanism of action that can assist patients to successfully maintain sobriety, prevent craving for opioids, relieve withdrawal symptoms, and thus prevent relapse without the added risk of developing a dependence on the therapy itself. Additionally, a greater need for less restrictive treatment guidelines, more funding for treatments, and more widespread access to the available treatments are needed for enhanced treatment outcomes for patients suffering from opioid addiction and to quell the ongoing opioid addiction epidemic.

For further information, please fill in the form below:


  1. DRG’s Epidemiology, Opioid Addiction, Mature Markets, November 2016.
  2. National Institute on Drug Abuse, Opioid Overdose Crisis, March 2018.
  3. DRG’s Current Treatment: Physician Insights, Opioid Addiction (US), September 2018.
  4. Butler SF, et al. Understanding abuse of buprenorphine/naloxone film vs. tablet products using data from ASI-MV® substance use disorder treatment centers and RADARS® System Poison Centers. Journal of Substance Abuse Treatment. 2018; 84: 42-49.
  5. DRG’s Access & Reimbursement: Opioid Addiction—The Changing U.S. Market Access Landscape of Opioid Addiction Treatment - Impact of New Buprenorphine Depot Therapies and Generic Competition to Suboxone (US), May 2018.

Mainland China’s anticipated biosimilar boom – potential and key drivers of the market

View Now