Orexo’s principal market today is the American market for treatment of opioid dependence using buprenorphine/naloxone. Orexo operates in the market through the commercialization of Zubsolv®, which is an effective drug for people with an opioid addiction. Dying from an overdose is one of the most common causes of death in the US and in 2016 more than 60,000 americans died of an overdose, mainly caused by opioids.1 The problem is classified as an epedemic. Several important federal initiatives have been taken to increase access to treatment, and this creates scope for continued strong growth.

 1 https://www.cdc.gov/nchs/products/databriefs/db294.htm

The buprenorphine/naloxone market in the US can be summarized as follows:

Many impacted, few treated
  • 100 million suffer from chronic pain
  • 50 million use opioids for pain relief
  • More than 10 million Americans use opioids for non-medicinal purposes1
  • A quarter of those receiving chronic opioid treatment in primary care have dependency problems and over 5 million are dependent on opioids1
  • 2 million are diagnosed as opioid addicts1
  • Approximately 0.8 million treated

1 https://www.surgeongeneral.gov/priorities/opioids

Substantial market growing strongly
  • Pharmaceutical market for treatment of opioid dependence has gross worth of approximately USD 2.6 billion
  • In 2017 the average annual market growth reached 11 percent
One player dominant

The market is dominated by one player who had a monopoly on buprenorphine-based treatment over a long period of time and has thus been involved since the start of this market. This leading player still has a strong position in the market. Besides Orexo there is also a smaller company in the market, selling under its own brand, and there are approximately five generic company players.

Legal changes expected to increase growth in the short term
  • In 2016 the US Department of Health and Human Services (HHS) announced that doctors’ ceiling for treatment with buprenorphine/naloxone is to be raised from 100 to 275 patients per year
  • Also in 2016 the American Congress signed The Comprehensive Addiction and Recovery Act, CARA, which amongst other things means that nurses and doctors’ assistants may write prescriptions. This will be implemented in 2017 and 2018.

    In addition to more people receiving care, the market has been given a chance to normalize. The decisions increase financial incentives for doctors to start clinics and begin to treat patients to a greater extent.

 

Zubsolv’s competitive advantages

 

  • Historically Zubsolv has had stronger growth among new patients, with a market share of more than 10 percent for completely new patients 
  • Broadest offering of dosage strengths and only company in the market offering a unique low dosage for winding down treatment 
  • Most comprehensive data in the market
  • 70 percent of patients prefer Zubsolv compared to the market-leading drug in the USA and 79 percent compared to the leading and only drug containing buprenorphine/naloxone in Europe1

1 Results from ISTART STUDY in the US- largest trial (N=758); EU bio-equivalence study with data on file at Orexo