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Companies Aiming for the Billion-Dollar Opioid Addiction Market

- By Alyangka Francheska Manalo

The global opioid market reached $33.924 billion in 2014 and is estimated to have reached $34.89 billion in 2015, data from Persistent Market Research shows. Experts believe the market will reach $42.16 billion by 2021, or a 3.2% compound annual growth rate (CAGR).

The steady rise in the opioid market is being attributed to prescription pain medication and the ease in getting illegal opiate-based drugs. It is estimated at least 9% of the population has misused opioids at one point in their life.


Health care workers are also pointing to increased palliative care facilities, revisions in rules for prescription of opioids and widespread focus of generic manufacturers towards Abuse-Deterrent Formulations (ADF) as catalysts for pushing the opioids market up in North America and Europe. The Asia Pacific market is projected to post the highest CAGR of opioids from 2015 to 2021, followed by North America. The increase in health care expenditure in the Asia Pacific market, coupled with the rising attention toward palliative care, is promoting the growth of opioids in the region.

Rise in opioid prescriptions causing addiction

North America is the largest opioid market. Data from GBI Research shows the U.S. accounts for nearly 70% of the world's opioid market, from $11 billion in 2014 to $17.7 billion by 2021.

The aging population in the U.S., rising cases of obesity, cancer, arthritis, diabetes and growing incidences of chronic pain are leading causes for the surge in the opioid market.

However, the analgesic nature of opioids makes it addictive to its users. An estimated 80% of the world's legal and illegal opioids are sold in the U.S. Researchers at Persistent Market said opioids are the most widely abused class of prescription drugs in the country and predict the unrestrained prescription and development of opioid tolerance toward codeine and morphine will further increase the demand up to 2021.

Deekshita Allavarapu, an analyst at GBI Research, said, "The FDA has raised concerns over the high use, and the potential for misuse, of opioids. This could lead to the enforcement of regulatory checks that affect the opioid treatment market and its potential growth. The result of these possible market restrictions, however, is that opportunities may open up for the development of abuse-deterrent opioids and of products that treat or prevent overdoses."

Pharmaceutical companies respond with more drugs

America's dependence on opioid prescription drugs has reached crisis levels. An estimated 3.5 million Americans, age 12 or older, are believed to be addicted to drugs and alcohol, according to the Substance Abuse and Mental Health Services Administration's (SAMHSA's) National Survey on Drug Use and Health. Interestingly, the pharmaceutical industry's response to this drug addiction crisis is more drugs. The abuse and misuse of opioids has resulted in a $1.4 billion opioid addiction treatment industry in the U.S. as of 2014, according to the Addiction Treatment Advisory Group's (ATAG) report, "The Role of Managed Care Pharmacy in Improving Access to Naloxone." ATAG was established by the Academy of Managed Care Pharmacy (AMCP) in 2015.

This billion-dollar opioid addiction management industry has prompted pharmaceutical companies, including Insys Therapeutics Inc. (INSY), Pfizer Inc. (PFE), Amphastar Pharmaceuticals Inc. (AMPH), Mylan N.V. (MYL), Opiant Technologies Inc. (OPNT), Adapt Pharma Ltd., Kaleo Pharmaceuticals, Alkermes (NASDAQ:ALKS) and newcomer BioCorRx Inc. (BICX), to offer their respective unique approaches to this market.

Anti-opioid addiction stocks

There are three leading opioid addiction treatment drugs currently available on the market. Suboxone, a combination of buprenorphine and naloxone, is being promoted and financed by the U.S. government as a safer alternative to methadone. Naltrexone is a pure opioid antagonist that has proven to be effective in reducing or completely reversing and blocking the effects of intravenously administered opioids. Then there is naloxone, a generic drug approved by the Food and Drug Administration (FDA), which is sold over the counter and without a prescription in some states for the reversal of opioid overdose.

Naltrexone - Alkermes and BioCorRx

Naltrexone is sold in the market under the brand name Vivitrol, which is manufactured by Alkermes. The company is selling Vivitrol at $1,300 per shot and promoting the drug as effective in blocking the effects of opioids. In the first three quarters of 2016, Vivitrol generated $55.8 million in sales for Alkermes. The company is hoping the drug will contribute between $700 million and $800 million in sales by 2018. Oral naltrexone is also available under the name Revia.

BioCorRx has partnered with TheraKine Ltd. in the development of its naltrexone injectable product, BICX101. They also have one or more other naltrexone formularies for use in an implantable form, which lasts several months. BICX101 is currently in preclinical development under BioCorRx Pharmaceuticals, a subsidiary or BioCorRx Inc. Brady Granier, president, CEO and director of BioCorRx, said BICX101 is being developed with the goal of improving patient compliance by reducing dose volume, needle size and many other factors which can make compliance with other products more challenging.

Granier said, "BICX101 is being developed with the goal of changing how addiction treatment will be managed in the future. Much like other chronic diseases, addiction should be managed long term and new products are needed to make that long-term treatment more efficient and accessible. We believe that BICX101 will be a product that can one day be used at home by patients or their caregivers."

Buprenorphine - Reckitt Benckiser

British multinational consumer goods company Reckitt Benckiser Group's (RB) Suboxone is currently dominating the opioid addiction market. Suboxone is intended as a maintenance treatment for opioid addiction. The drug comes in tablet form, however, making it more susceptible to abuse. There are even reports of accidental ingestion by children.

The Substance Abuse and Mental Health Services Administration's (SAMHSA) also expressed concern over buprenorphine since the drug itself is an opioid and can trigger dependency and the same euphoria when taking prescription drugs like acetaminophen/oxycodone (Percocet) or oxycodone (OxyContin).

Adding to the concerns is the case of 20-year-old Miles Malone, who died in 2010 after overdosing on Suboxone.

"I didn't know you could overdose on Suboxone," Shawn Verrill of South Berwick, Maine and a friend of Malone said in an interview at a federal prison in Otisville, New York. "We were just a bunch of friends getting high and hanging out, doing what 20-year-olds do. Then we went to sleep, and Miles never woke up."

Reckitt Benckiser is also at the center of a massive antitrust lawsuit after 35 states and the District of Columbia accused the company of using a series of "deceptive and unconscionable" practices to profit from drug addiction treatment when it spun off Indivior and a third company called MonoSol RX. Reckitt Benckiser is accused of "product hopping" for allegedly making minor tweaks to a product without actual development to apply for a new patent so it could keep its market share on Suboxone.

Naloxone - Adapt Pharma, Opiant Pharmaceuticals, Pfizer, Amphastar Pharmaceuticals, Kaleo

Approved by the FDA in 1971, naloxone is a first responder drug. It is often administered to patients suspected of opioid overdose, but its effect is limited and therefore not intended as a long-term opioid dependency treatment.

Adapt Pharma Ltd. is marketing the NARCAN Nasal Spray formulation. Adapt partnered with Opiant Pharmaceuticals (formerly Lightlake Therapeutics) to develop the NARCAN Nasal Spray using Opiant's intranasal opioid antagonist platform technology through a licensing deal. Two other companies, Hospira (a subsidiary of Pfizer) and Amphastar Pharmaceuticals, are also pioneers in injectable naloxone. The two companies, however, are being blamed for the sudden jump in the price of naloxone. Virginia-based Kaleo is marketing a naloxone auto-injector under the Evzio brand name. Evzio was priced at $690 for two packages in 2014. It is now $4,500, more than a 500% increase in just over two years.

Biotech giant Mylan was granted FDA approval to sell a naloxone injectable in 2014, while struggling company INSYS Therapeutics is hoping to revive its stock price after getting a naloxone candidate assigned as fast track eligible.

Conclusion

Naltrexone is the most promising of the three opioid addiction treatments for two reasons. It is a non-opioid that cannot be abused and it can prevent relapse and overdose.

There is no doubt the opioid addiction treatment market will continue to rise, not only in the U.S. but across the globe as well, due to the rise in opioid prescriptions. Aside from opioid addiction treatment, opioid pain management has also spawned other billion-dollar industries, including overdose and side effects such as constipation. Financial experts believe that if opioid addiction is wiped out, it would also take away billions of dollars of potential income from opioid submarkets - addiction, overdose and side effects.

"I see naltrexone one day becoming the gold standard for long-term addiction treatment," Granier said. "It's not only effective for opioid addiction, but it works very well for alcoholism in terms of craving reduction. You can't say that for the other most commonly used medications administered in medication-assisted treatment of addiction."

Disclosure: I have no positions in any stocks mentioned and no plans to initiate any positions within the next 72 hours. I have no business relationship with any company whose stock is mentioned in this article.

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