Covid-19 fuels the need for Orexo’s treatments on the US market

In the wake of Covid-19, societal lockdowns and social distancing have exacerbated the opioid crisis in the US. In 2021 a record-high number of Americans died of an overdose and treatment needs have never been greater. Orexo is established in the US since 2013, with an own sales force and on a daily basis sales representatives visits physicians, medical clinics and minor hospitals treating patients suffering from opioid dependence.

Significant need for treatment options

The use of drugs is growing globally. Approximately 300 million people are using drugs.1 Opioids continue to cause the most harm and are the reason for the majority of drug-related deaths.2 The problem with opioid misuse is by far the greatest in the US where about a fifth of those dependent on opioids live.3 A sharp increase in prescription for opioid painkillers during two decades is the primary reason that today there are an estimated 10 million people abusing opioids in the US.4 Approximately 4 million are considered to be in need of treatment. 5 Of these, approximately 1.5 million receive so-called Medication Assisted Treatment, MAT,6 where the most common form of treatment is buprenorphine/naloxone.

Fentanyl is prevalent and causing the surge in fatal overdoses

The Covid-19 pandemic, with society lockdowns and social distancing, have fuelled the opioid crisis in the US. According to latest available annual data the number of fatal overdoses surpassed 100,000,7 and overdose is today one of the most common cause of death for people under 50 years. 76 percent of the fatal overdoses were related to the misuse of opioids, foremost synthetic opioids, such as fentanyl.8 Fentanyl supply is accelerating in the US due to a significant increase of illegal manufacturing in Mexico.

Large economic burden on the US society

From an economic point of view the misuse of opioids is a considerable problem. In addition to loss of life and lower quality of life, large costs are associated with lower productivity, increased healthcare and correctional treatment costs. The opioid epidemic cost the US society a tremendous amount. Additionally the costs continue to rise which can be explained by the growing death toll in recent years and as it includes a broader societal cost of premature death.

The buprenorphine/naloxone market in the US

The market for treatment of opioid dependence using buprenorphine/naloxone grew 8 percent in 2021. A slowdown from the record-high 15 percent in 2020. A progress explained by high comparison numbers in 2020 as an effect of Covid-19, but is also attributable to a combination of patients to a greater extent were not seeking care during continued lockdown and that physicians were more reluctant to grow patient load. The growth predominantly took place in the largest payer segment, the Public segment, where care is financed by the public sector payers, such as Managed Medicaid, FFS Medicaid and Medicare Part D. Care financed by private insurance companies, often signed by employers, comprised by the Commercial payer segment, showed a lower growth pace compared to the Public segment. Generics part of the market continue to be dominant which mainly refers to the public financed care which is characterized by high price sensitivity.9

1 World Drug Report
2 World Health Organization
3 World Drug Report
4 Substance Abuse and Mental Health Services Administration
5 Clarion Healthcare
6 Substance Abuse and Mental Health Services Administration
7 Center of Disease Control, predicted numbers as of June 2021
8 Center of Disease Control, predicted numbers as of June 2021
9 Generics of Suboxone® Film and tablets and also of Subutex® tablets

Digital therapeutics - a market in its infancy 

In an effort to broaden the business, Orexo has started to work with evidence-based digital therapies. The trigger was the development of MODIA™, which addresses a large unmet need for psychosocial counselling in the medical treatment of opioid dependent patients. The market for digital therapeutics is in its infancy and during 2021 several important steps were taken to facilitate reimbursement of these new and pioneering treatment tools.

Viable reimbursement routes will drive short-term growth

Digital health means digitization of services to prevent and manage clinical disorders and diseases more effectively. Supported by digital technology, patients’ results can be improved and health care costs greatly reduced. The sector has grown significantly in recent years, and Covid-19 has further accelerated these developments. Digital therapeutics are a part of Digital health and the market for the treatment
of mental illness and substance use disorders with these new innovative solutions is in an early phase.

With increased product knowledge and awareness, along with viable reimbursement routes, the market is predicted to show strong growth. In 2021 several important milestones were reached which will, as of the beginning of 2023 facilitate insurance companies and healthcare programs, such as Medicaid and Medicare, to reimburse digital therapies within the mental illness space. The global market for digital therapeutics, which includes all therapeutic areas, is expected to show an average annual growth of 30 percent and amount to USD 13 billion in 2026.1

Underlying drivers to fuel future long-term growth

A. Aging population and sky-rocketing costs are forcing the healthcare providers to rethink how to deliver healthcare
to increase efficiency and value.

B. Patients want to be seen as consumers and requires holistic and customized treatments with access 24/7.

C. Covid-19 has further pushed forward the ongoing tech revolution and the use of telemedicine is pervasive.

D. Providers will be rewarded based on the ability to add patient value. Analyzing RWE data pave the way for efficient allocation of resources.

1 https://www.marketsandmarkets.com/Market-Reports/digital-therapeutics-market-51646724.html

Global forces increasing abuse of opioids and other drugs

The great increase in prescription painkiller drugs in the past decade has led to more and more Americans abusing opioids. This development is also the result of strong underlying global forces that go beyond tablet abuse and which have led to an explosion in the number of opioids and other drugs available and their abuse.

Social exclusion and mental illness

Developed countries often have a larger percentage of drug consumption. Individuals with a higher socioeconomic status tend to introduce but also facilitate the establishment of illegal drug use.1 However, it is usually socially and economically vulnerable people in these societies that develop an addiction or suffer from physical or mental impairment in connection with their abuse. People living on the fringe of society whose lives are characterized by long-term unemployment, social exclusion and shattered dreams are not seldom a hotbed for extensive drug dependence.

Migration

Flows of refugees can have an impact on the use of drugs. People fleeing from war and conflicts often live under difficult circumstances and often lack a social safety net. Studies demonstrate that people suffering from post traumatic stress and depressions run a greater risk of being introduced to drugs. Being a refugee also means increased exposure to new drugs.2

Trafficking

Drug trafficking

With the spread of globalization, trade barriers have been removed, thus promoting world trade. At the same time, the ability of illegal drug cartels to reach out to more markets has been facilitated, which has led to drug trafficking growing. Increased efficiency of distribution channels and increased competition have also generally led to the lowering of drug prices among users.

Human trafficking

After drugs and weapons, human trafficking is the third largest and most profitable organized crime in the world. In 2012 the International Labour Organization (ILO) estimated that 21 million people were the victims of trafficking.3 This type of crime is one of the most profitable, is growing the fastest and is strongly linked to drug abuse.4

Illegal drug industry

To reduce the risk of unlawful distribution and abuse, the market for drugs classified as narcotics is stringently regulated. At the same time it is estimated that more than 5.5 billion people each year have very little or no access to drugs classified as narcotics for the treatment of moderate or severe pain.5 This development is one of several reasons for the great gains made by the illegal drug industry, which further increases the risk of abuse.

1 World Drug Report 2016
World Drug Report 2016
3 International Labour Organization http://www.ilo.org/global/topics/ forced-labour/lang--en/index.htm
4 U-fold, Uppsala Universitet
5 World Drug Report 2016