Orexo’s key market today is the American market for buprenorphine/naloxone products. Orexo operates in the market through the commercialization of Zubsolv®, which is an effective drug for people suffering form opioid addiction. Dying from an overdose is one of the most common causes of deaths in the US and in 2017 more than 70,200 Americans died of an overdose, mainly caused by opioids.1 The problem is classified as an epidemic. Several important federal initiatives have been taken to increase access to treatment, and this creates scope for continued strong growth.

 1 Center of Disease Control

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

Many impacted, few treated
  • Approximately 100 million suffer from chronic pain
  • Approximately 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
  • Approximately 2 million are diagnosed as opioid addicts1
  • Approximately 0.8 million are treated

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

Substantial market growing strongly
  • The pharmaceutical market for treatment of opioid dependence has a gross worth of approximately USD 2.8 billion 
  • In 2018 the average annual market growth reached 14 percent

Source: IMS Data

Federal changes to improve access to treatment
  • 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. 
  • In 2017 the American president declared the opioid crisis a Public Health Emergency situation, which i general means that state resources should be allocated to avert or avoid public health crises.
  • A federal bill was approved in 2018 which amongst other things expands the waiver eligibility to additional types of medlevel practitioners. 

 

Some of 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 range of dose strengths, offering the potential for finer titration and individualized dosing
  • Most comprehensive clinical 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