Opioids – Reducing body pain but increasing pain for regulatory authorities
Opioids are drugs primarily prescribed for pain management and treatment of diarrhea and cough. Opioid drugs are of two types namely, agonist and antagonist. Codeine, Fentanyl, Meperidine, Methadone, Morphine, Hydrocodone, Diphenoxylate, Hydromorphone, Methylphenidate, Oxycodone, and Oxymorphone are classified as agonists, while Buprenorphine, Naloxone, Naltrexone, Methylnaltrexone, and Nalbuphine are classified as antagonists. Due to easy availability of opioids, these drugs are rampantly overused globally and the situation is more critical in developed countries, mainly the U.S. This has led to government or regulatory intervention in various countries. Government and regulatory bodies are involved in closely monitoring prescription patterns or in publishing strict prescription guidelines for opioids and in educating the public about its side effects or harmful effects, such as dependence on the drug on regular use. Government bodies have also directed drug-stores such as CVS health to limit opioids delivery and inform the government about the steps they are or planning to undertake to address this crisis.
The prescription of opioids drug has increases rapidly in last two decades across the globe, however, the rate of change is much higher in U.S. These prescriptions are not only for treating chronic pain and other related conditions, but majority of these prescriptions are for patients who are addicted to this drug. According to World Drug Report 2017, 29.5 million people suffered from drug use disorders globally, in 2015. About 70% of this 29.5 million people were on opioids, according to the same report. In U.S. alone, the drug overuse killed 59,000 to 65,000 people in 2016, and about two-thirds were due to opioids overuse only.
The global opioids market was valued at US$ 28,252.3 million in 2016 and is expected to witness a CAGR of 5.3% over the forecast period (2016 - 2024).
Figure 1. Global Opioids Market, by Region, 2016 (US$ Mn)
Increasing incidence of chronic pain is expected to drive the opioids market growth
Incidences of chronic pain is on the rise across the globe, with the rate being much higher in developed economies such as the U.S., UK, Germany, and Canada. According to a study published by BMJ (British Medical Journal), in 2013, around one-third to one-half of the population in UK suffered from some kind of chronic pain. The situation is not quite different in other developed economies such as the U.S. and Japan. According to a study published in NCBI, in 2015, prevalence of chronic pain is estimated to be as high as 20% (one in five) in Japan. The aging population is rapidly increasing in all in developed economies, which is thus expected to further increase incidences of chronic pain, in turn increasing consumption of opioid drugs.
Cannabis as potential alternative for pain relief
Cannabis has recently gained attention from a diverse range of people, including medical professionals, independent health advocacy groups, and government organizations. Cannabis is projected to emerge as a potential alternative therapy to opioids, as it controls nausea associated with intake of opioid drugs, as well as vomiting and dizziness that often accompany severe, prolonged pain. Moreover, risk of addiction associated with cannabis intake is much lower as compared to that of opioids. A poll conducted by the New England Journal of Medicine, in 2013, found that 75% (3 out of 4) clinicians in the U.S. recommended the use of cannabis for hypothetical cancer patients. Currently, medical marijuana is legal in 28 states and the District of Columbia, even though it is illegal under federal law. According to a research published, in 2017, in Annals of Internal Medicine, cannabis, which is also called medical marijuana, is used for pain management for 45-85% cases. However, the same research argues that there is little evidence to show that cannabis helps control chronic pain. Hence, an urgent need is experienced for high-quality clinical trials to test the clinical efficacy of marijuana in pain management. If clinical trials prove marijuana effective beyond a reasonable doubt, it is expected to emerge as a replacement for opioids.
Some of the major players operating in the global opioids market are Purdue Pharma, Titan Pharmaceuticals, Inc., Boehringer Ingelheim GmbH, Janssen Pharmaceuticals, Inc., Sanofi S.A., Sun Pharmaceutical Industries Ltd., Mallinckrodt Pharmaceuticals, Egalet Corporation, Endo Pharmaceuticals Inc., Allergan, Plc, and Pfizer Inc.
Opioid drugs bind to opioid receptors that are present in several areas of the nervous system such as the brain and spinal cord. Medically, they are primarily being used for pain relief. The drug class primarily used in relieving pain includes natural, semi-synthetic, and synthetic opioids. However, its application is not limited to pain relief alone and has been successfully used for treatment of various other medical conditions such as diarrhea and cough. Opioid drugs can be broadly divided into two categories, mild and major opioids, on the basis of its efficacy. Opioids can be administered as oral pills, parenteral, liquids, patches, or lozenges. Overdose and drug abuse is a major concern, with the situation alarming in developed regions. According to World Drug Report 2017, 29.5 million people suffered from drug use disorders in 2015 and staggering 70% of this 29.5 million were attributed to opioids only.
Incidence of chronic pain, which is primarily treated by opioids has witnessed continuous growth over the last decades. According to a report titled Pain in Europe, published in 2006, chronic pain affected around one in five (19%) adults, and prevalence was recorded to be the highest in Norway, Poland, and Italy, where one-fourth of adults were suffering from chronic pain. According to a study titled Prevalence of Chronic Pain in the UK, published in The BMJ (British Medical Journal), in 2013, chronic pain affects between one-third and one-half of the population in the U.K, indicating high prevalence rate. Prevalence rate is similar in other developed countries such as the U.S. Rapidly increasing incidence of chronic pain is thus expected to boost growth of the opioids market over the forecast period.
However, increasing usage of opioids, has led to increase in its overuse or abuse over the recent past. To tackle this situation, CDC published guidelines for prescribing opioids for chronic pain. Similar efforts to curtail opioid overuse are underway in developed economies of Europe. Such intervention by regulatory bodies are expected to obstruct growth of the opioids market.
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