The global opioids market size was evaluated at US$ 22.74 billion in 2023 and is expected to attain around US$ 26.78 billion by 2034, growing at a CAGR of 1.5% from 2024 to 2034.
Prescription opioids play a critical role in managing various medical conditions, including post-surgical pain, severe trauma, and certain symptoms like coughing and diarrhea. When used appropriately under medical supervision, opioids effectively alleviate moderate to severe pain and improve patient comfort during recovery.
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Misuse of these medications, such as taking them in unauthorized ways or for non-medical purposes, presents significant challenges. These risks, the demand for opioids persists due to their established efficacy in pain management and the ongoing need for effective treatment options. Addressing misuse through education, regulation, and the development of abuse-deterrent formulations represents an opportunity to foster responsible use while supporting the continued growth and innovation within the opioids market.
Market Overview
The opioids market is characterized by a diverse array of drugs, including synthetic opioids like fentanyl, legally prescribed pain relievers such as oxycodone and hydrocodone, illicit substances like heroin, and others. Opioids are pivotal in managing pain but also contribute significantly to the drug overdose crisis in the United States, often in combination with other drugs. Illicitly manufactured fentanyl and potent synthetic opioids have been implicated in most recent overdose deaths, sometimes unknowingly consumed due to their addition to other substances. These drugs can be derived from natural sources, particularly the opium poppy plant, or synthesized in laboratories. Some opioids combine both natural and synthetic components. They function by binding to opioid receptors in the brain, blocking pain signals and potentially enhancing pleasurable sensations.
· In March 2023, Indivior completed its acquisition of Opiant Pharmaceuticals, Inc.
· In January 2023, Teva announced a nationwide opioids settlement moving forward after receiving broad support from states.
Key Insights
· North America led the global market with the highest market share of 45.13% in 2023.
· Asia-Pacific is estimated to expand at the fastest CAGR during the forecast period.
· By Application, the pain relief segment has held a major market share of 24% in 2023.
· By Application, the anesthesia segment is estimated to grow at the fastest CAGR over the projected period.
· By Route Of Administration, the injectable segment has held the highest revenue share of 44% in 2023.
· By Route Of Administration, the oral segment is anticipated to expand at a CAGR of 2.5% over the predicted period.
· By Distribution Channel, the retail pharmacy segment led the market with the maximum market share of 38 % in 2023.
· By Distribution Channel, the three-dimensional segment is growing at a CAGR of 2.8% over the predicted period.
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Why is North America dominating in the opioids market?
North America, comprising the United States and Canada, commands the largest market share in the opioids industry, driven primarily by widespread prescription and consumption of opioid pain relievers. According to the US Centers for Disease Control and Prevention (CDC), the region has experienced a profound increase in opioid use, leading to a severe drug overdose epidemic and a significant public health crisis. Recent mortality data from the CDC highlight that nearly two-thirds of all overdose deaths involve opioids, encompassing both prescription opioids and illicit substances like heroin and synthetic opioids. In addition to escalating mortality rates, there has been a notable surge in emergency department visits linked to nonmedical use of opioid pain relievers. The region has witnessed an uptick in individuals seeking treatment for opioid addiction and an increase in cases of neonatal abstinence syndrome, underscoring the multifaceted impact of opioid misuse across communities. These trends underscore the urgent need for comprehensive public health strategies, regulatory interventions, and healthcare initiatives aimed at mitigating opioid-related harms while ensuring access to safe and effective pain management solutions in North America.
· In May 2023, Indivior announced U.S. FDA approval of OPVEE (nalmefene) Nasal Spray, expanding opioid overdose rescue options to include natural and synthetic opioids like fentanyl.
Why is Asia Pacific growing faster in the opioids market?
Asia-Pacific is set for substantial growth in the opioids market, driven by its status as home to the largest global population of opioid users. The region, notably China, is a significant source of illicitly manufactured synthetic opioids (IMPSO) and precursor chemicals, yet these substances have not fully penetrated local street-drug markets. With Asia-Pacific accounting for a significant portion of global illicit opioid use, and India alone hosting nearly one-third of the world’s opioid-using population, cultural norms often lead to underreporting and undertreatment of chronic pain. Effective strategies in healthcare policy and regulatory frameworks will be crucial to mitigating opioid misuse while promoting safe pain management practices in diverse cultural contexts.
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Report Highlights
By Product
The ER/long-acting opioids sector commands the largest share in the opioids market, primarily due to their extended-release formulations that provide sustained pain relief. Health care professionals prescribing these medications play a critical role in balancing their therapeutic benefits with significant risks, such as addiction, unintentional overdose, and mortality. Ensuring the safe and effective use of ER/LA opioid analgesics is paramount, with particular caution needed when prescribing during pregnancy, where the potential benefits must outweigh fetal risks. This underscores the importance of stringent prescribing practices and patient education to mitigate adverse outcomes associated with these potent medications.
The IR/short-acting opioids sector is poised for significant growth with an anticipated notable CAGR during the projected period. These opioids are typically used for acute or subacute outpatient therapy and include medications like codeine, hydrocodone, oxycodone, oxymorphone, and morphine, often referred to as immediate-release (IR) opioids (e.g., MSIR, OxyIR). They are less effective in managing rapid-onset breakthrough pain (ROBTP), which can peak within minutes and subside quickly. This limitation has prompted interest in rapid-onset opioids, which offer quicker relief and may better address the acute nature of ROBTP compared to traditional short-acting opioids. As demand grows for more effective pain management solutions, particularly in acute settings, the IR/short-acting opioids market is expected to expand rapidly, driven by advancements in pharmacokinetics and patient-centric treatment approaches.
By Application
Pain relief is anticipated to maintain the largest market share based on the application of opioids. These medications, including oxycodone, hydrocodone, morphine, fentanyl, and buprenorphine, are powerful agents used primarily for alleviating severe pain that is unresponsive to other types of painkillers. They are often prescribed in combination with other pain management drugs like gabapentin, pregabalin, or amitriptyline, especially for nerve-related pain. Commonly referred to as opioid pain relievers or narcotics, these drugs require careful administration under the direct supervision of healthcare providers to ensure effectiveness and safety in pain management protocols. As the demand for effective pain relief solutions persists, driven by chronic pain conditions and surgical recovery, the pain relief segment is expected to dominate the opioids market.
The anesthesia sector is poised to experience the fastest growth rate over the projected period within the opioids market. Opioid agents play a crucial role in perioperative anesthesia, encompassing well-known medications such as fentanyl, morphine, and hydromorphone. Highly potent opioids like sufentanil, remifentanil, and alfentanil are administered intravenously during the intraoperative phase for their rapid onset and effectiveness. Fentanyl, particularly favored for its potency and ease of dosing, remains a staple choice among anesthesiologists for intraoperative pain management.
By Route of Administration
The injectable segment commands the largest market share within the opioids market. Buprenorphine extended-release injection, including brands like Sublocade and Brixadi, plays a significant role in treating opioid dependence. These medications are categorized as opiate partial agonists and are specifically designed to alleviate withdrawal symptoms in individuals ceasing opioid use. Administered via injection, after a patient has initially received buccal or sublingual buprenorphine, these formulations provide sustained therapeutic effects, contributing to effective management of opioid dependence. The popularity of injectable opioids underscores their importance in clinical practice, offering a reliable route of administration for long-term treatment strategies.
The oral segment is poised for substantial growth, projecting a robust CAGR throughout the forecasted period. Oral opioid medications serve critical roles in managing severe pain and addressing respiratory distress across various care settings, notably in cancer treatment and end-of-life care. These medications play a vital role in enhancing patient comfort and quality of life, meeting essential therapeutic needs. As demand for effective pain management solutions continues to rise, the oral administration route remains pivotal in delivering accessible and targeted relief for patients requiring intensive medical support.
By Distribution Channel
The retail pharmacy sector has captured a significant market share, playing a critical role in the distribution of pharmaceuticals, including opioids, amidst ongoing concerns over the opioid epidemic. Retail pharmacies, also known as community pharmacies, are pivotal in compounding, dispensing, and selling medications directly to the public. They serve as accessible points of care where prescriptions are filled, providing essential medications to patients outside of hospital settings. As regulatory scrutiny and public health efforts intensify around opioid dispensation, retail pharmacies continue to navigate challenges while ensuring safe and responsible medication distribution practices in their communities.
Market Dynamics
Driver
Transition to Abuse-Deterrent Formulations
The shift from conventional opioids to abuse-deterrent formulations represents a pivotal driver for potential growth in the opioids market. Medications like oxycodone, hydrocodone, and morphine offer powerful pain relief but come with significant risks, contributing to the escalating opioid crisis in the U.S. Abuse-deterrent formulations are designed to deter manipulation of the drug, such as crushing for snorting or injecting, thereby aiming to reduce misuse and its associated harms. While these innovations enhance safety measures, it’s crucial for prescribers and patients to recognize that abuse-deterrent opioids are not immune to addiction, overdose, or death. Nonetheless, the adoption of these formulations presents an opportunity to mitigate risks, improve public health outcomes, and potentially stimulate market growth in a more regulated and safety-focused environment.
Restraint
Risks of Addiction and Misuse
The opioids market faces significant constraints due to the inherent risks associated with opioid use, including addiction and overdose. Even short-term use of opioids can lead to opioid use disorder, with individuals at risk of becoming dependent or misusing these medications. According to the American Society of Anesthesiologists, opioid misuse, whether legal, illegal, stolen, or shared, contributes to an average of 90 deaths per day in the U.S. Misuse is particularly dangerous when opioids are altered from their prescribed form, such as crushing pills for snorting or injecting, which can exacerbate the risks of addiction and overdose. These challenges underscore the barriers to market growth, necessitating careful consideration of regulatory measures and public health initiatives to mitigate opioid-related harm while ensuring safe and appropriate use.
Opportunity
FDA Encourages Development of Abuse-Deterrent Formulations
The FDA’s endorsement of abuse-deterrent formulations (ADFs) for prescription opioids represents a significant opportunity in the opioids market. Recognizing that ADFs are not foolproof against abuse but serve as a step toward reducing misuse, the FDA supports innovative formulations designed to thwart common abuse methods like crushing for snorting or dissolving for injection. This encouragement has spurred advancements in formulation technologies and the methods for evaluating them, including analytical, clinical, and statistical approaches. As the science of abuse deterrence evolves rapidly, these developments pave the way for safer opioid products that could potentially expand market growth while addressing public health concerns surrounding opioid misuse and addiction.
Recent Developments
· In August 2023, Emergent BioSolutions launched NARCAN Nasal Spray over the counter, enabling broader access to emergency opioid overdose treatment.
· In April 2024, Amneal received U.S. FDA approval for its Over-the-Counter Naloxone Hydrochloride Nasal Spray, enhancing accessibility for emergency opioid overdose treatment.
· In February 2024, Endo Health Solutions Inc. reached a global resolution on criminal and civil investigations related to the sales and marketing of its branded opioid drug.
· In March 2024, the Biden-Harris Administration launched a nearly $50 million initiative supporting opioid treatment and recovery services in rural communities.
Key Players in the Opioids Market
· Mallinckrodt Pharmaceuticals LLC
· Purdue Pharmaceuticals L.P.
· Sun Pharmaceutical Industries Ltd
· Teva Pharmaceuticals Inc.
· Vertice Pharma LLC
· Johnson and Johnson
· AbbVie Inc (Allergan PLC)
· Hikma Pharmaceuticals PLC
· Endo Pharmaceuticals Inc.
· Zyla Life Sciences (Egalet Corporation)
· Amneal Pharmaceuticals Inc.
· Pfizer Inc.
· AcelRx Pharmaceuticals Inc
· Alcaliber SA
Market Segmentation
By Product
· IR/Short-Acting Opioids
· ER/Long-Acting Opioids
By Application
· Pain Relief
· Anesthesia
· Cough Suppression
· Diarrhea Suppression
· De-addiction
· By Route of Administration
· Oral
· Injectable
· Others
By Distribution Channel
· Hospital Pharmacy
· Retail Pharmacy
· Others
By Geography
· North America
· Europe
· Asia Pacific
· Latin America
· Middle East & Africa (MEA)
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