Buprenorphine And Naloxone Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 4.73 Billion |
| Market Size (2029) | USD 5.82 Billion |
| CAGR (2024 - 2029) | 4.23 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Buprenorphine And Naloxone Market Analysis
The Buprenorphine And Naloxone Market size is estimated at USD 4.73 billion in 2024, and is expected to reach USD 5.82 billion by 2029, growing at a CAGR of 4.23% during the forecast period (2024-2029).
The market growth is driven by increasing substance use disorders, the advantages of using buprenorphine and naloxone, and the rising prevalence of acute and chronic pain disorders.
For instance, according to an article published by the StatPearls Journal in April 2023, every year, opioid use disorders affect over 16 million people worldwide and more than 2.1 million people in the United States. Therefore, the global increase in opioid addiction and dependence has created a significant demand for effective treatments.
Buprenorphine and naloxone combination drugs have emerged as popular medications for opioid addiction treatment due to the several advantages associated with using combination drugs. According to a June 2022 article from BioMed Central Ltd, buprenorphine and naloxone are the primary medications for individuals experiencing an opioid overdose. Buprenorphine reduces opioid use and cravings, prevents withdrawal symptoms, and limits the risk of opioid overdose. Naloxone is a life-saving medication that can be administered to reverse an opioid overdose.
Similarly, according to a report published by the DovePress Journal in March 2024, the increasing prevalence of chronic pain and the risks associated with opioid use have highlighted the need for safer alternatives in pain management. Buprenorphine's unique mechanism of action, lower risk of overdose, and clinical efficacy in various formulations have led to its recommendation as a first-line treatment for chronic pain by major US health agencies. These factors have driven greater adoption and demand, thereby propelling the growth of the buprenorphine and naloxone market.
In conclusion, the growing prevalence of substance use disorders and chronic pain, combined with the advantages of buprenorphine and naloxone in providing safer, effective treatment options, has significantly driven the adoption of these combination drugs.
However, stigma and misconceptions regarding the use of suboxone, along with stringent regulatory constraints, are major restraints in the market.
Buprenorphine And Naloxone Market Trends
The Generics Segment is Projected to Show Significant Growth During the Forecast Period
The growth of the generics segment in the buprenorphine and naloxone market is driven by factors such as cost-effectiveness, patent expirations, increasing opioid addiction cases, and the need for affordable treatment options. Generics offer similar efficacy at lower prices, making them more accessible to patients and healthcare systems. Additionally, the expiration of patents on branded medications allows generic manufacturers to enter the market, increasing competition and driving growth in this segment. The rising prevalence of opioid addiction amplifies the demand for cost-effective treatment solutions like generic buprenorphine and naloxone products.
The opioid epidemic has been a significant public health crisis. The increasing misuse and addiction to opioids have resulted in a substantial rise in opioid overdose cases. For instance, according to a report published by the Congressional Budget Office in September 2022, the ongoing opioid crisis in the United States has evolved over two decades. As per the same source, the misuse of opioids can lead to serious side effects, including death. Therefore, to combat the opioid epidemic in several countries, the adoption of buprenorphine and naloxone combination drugs is rising, driving the overall market growth.
Buprenorphine and naloxone combination drugs are widely used as opioid replacement therapy to treat opioid addiction and prevent overdose. For instance, according to an article published by the Journal of Drug and Alcohol Dependence Report in January 2023, buprenorphine is considered to be among the pharmaceutical gold standards for treating opioid use disorder (OUD) or opioid dependence. The source also stated that the Food and Drug Administration (FDA) approved various transmucosal drugs in the United States for the treatment of opioid dependence, which include buprenorphine and naloxone. Thus, the growing usage of buprenorphine and naloxone drugs to treat opioid dependence is also expected to boost segment growth.
Moreover, governments and regulatory bodies have acknowledged the severity of the opioid crisis and have implemented measures to address it. Many jurisdictions have implemented policies to encourage the use of naloxone in opioid overdose situations. For example, some states in the United States have passed laws such as the Comprehensive Addiction and Recovery Act, the 21st Century Cures Act, the Substance Use-disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, allowing pharmacists to dispense naloxone without a prescription. These government initiatives and regulations have facilitated the growth of the opioid overdose indication segment in the buprenorphine and naloxone market.
Hence, due to patent expirations, increasing opioid addiction cases, and the need for affordable treatment options, the generics segment will likely grow significantly during the forecast period.
North America is Expected to Hold a Significant Share in the Market During the Forecast Period
The analysis of the buprenorphine and naloxone market indicates that North America has a significant market share in the global market. This is due to the increasing prevalence of substance use disorders, acute and chronic pain disorders, and the presence of various prominent players in the region.
The growing prevalence of pain associated with operative procedures and other chronic conditions, such as migraine, is expected to boost regional market growth, as it would increase the usage of oral transmucosal buprenorphine and naloxone drugs for effective pain management. For instance, a study published in the Journal of PeriAnesthesia Nursing in June 2023 stated that more than 80% of patients in the United States suffer postoperative pain. Thus, the high prevalence of postoperative pain is expected to boost market growth, as buprenorphine and naloxone are often used to manage postoperative pain.
In addition, the rising prevalence of opioid dependence in the region is creating a demand for buprenorphine and naloxone for the effective treatment of opioid dependence. For instance, according to the data published by the White House in January 2023, there had been an estimated 110,315 fatal drug overdose cases during the 12 months ending March 2022 in the United States, and it included the usage of synthetic and natural opioids. This shows a high burden of opioid dependence, which is expected to increase the regional market growth during the forecast period.
Moreover, regional government initiatives to manage opioid dependence are expected to boost market growth. For instance, in December 2022, the Substance Abuse and Mental Health Services Administration (SAMHSA) proposed to expand access to treatment for opioid use disorder (OUD) in the United States, as there was a high burden of opioid dependence in the country. The proposed rule change would lead to the use of telehealth in initiating buprenorphine at opioid treatment programs (OTPs). Thus, such government initiatives are expected to increase the usage of combinational such as buprenorphine and naloxone to treat opioid dependence.
Therefore, the increasing prevalence of pain disorders and opioid dependence, coupled with supportive government initiatives, is expected to drive substantial growth in the North American buprenorphine and naloxone market.
Buprenorphine And Naloxone Industry Overview
The buprenorphine and naloxone market is moderately consolidated due to the presence of a limited number of companies that manufacture and distribute buprenorphine and naloxone drugs. The competitive landscape includes an analysis of several international and local companies that hold market shares and are well known, including Indivior PLC, Viatris Inc. (Mylan Inc.), Sandoz AG, Hikma Pharmaceuticals PLC, and Dr. Reddy's Laboratories Ltd.
Buprenorphine And Naloxone Market Leaders
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Indivior PLC
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Viatris Inc. (Mylan Inc.)
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Sandoz AG
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Dr. Reddy's Laboratories Ltd.
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Hikma Pharmaceuticals PLC
*Disclaimer: Major Players sorted in no particular order
Buprenorphine And Naloxone Market News
- May 2024: Purdue Pharma L.P. partnered with MMCAP Infuse to supply buprenorphine and naloxone tablets CIII (generic Suboxone) at a reduced cost to correctional facilities. This initiative aims to provide medication for opioid use disorder (MOUD) to incarcerated individuals struggling with opioid addiction.
- December 2023: Indivior PLC entered a settlement agreement with Actavis Laboratories UT Inc., a Teva Pharmaceuticals subsidiary, to resolve patent disputes over Actavis’s abbreviated new drug application (ANDA) for a generic buprenorphine and naloxone sublingual film.
Buprenorphine And Naloxone Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Substance Use Disorders
4.2.2 Various Advantages Associated with the Use of Suboxone
4.3 Market Restraints
4.3.1 Stigma and Misconceptions Regarding the Use of Suboxone
4.3.2 Stringent Regulatory Constraints
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value-USD)
5.1 By Type
5.1.1 Branded
5.1.2 Generics
5.2 By Formulation
5.2.1 Sublingual Tablets
5.2.2 Sublingual Films
5.3 By Distribution Channel
5.3.1 Hospital Pharmacies
5.3.2 Retail Pharmacies
5.3.3 Online Pharmacies
5.4 Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Indivior PLC
6.1.2 Viatris Inc. (Mylan Inc.)
6.1.3 Sandoz AG
6.1.4 Alvogen Inc.
6.1.5 Dr. Reddy's Laboratories Ltd
6.1.6 Hikma Pharmaceuticals PLC
6.1.7 Teva Pharmaceutical Industries Ltd
6.1.8 Amneal Pharmaceuticals LLC
6.1.9 Mallinckrodt Pharmaceuticals
6.1.10 Lannett Company Inc.
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Buprenorphine And Naloxone Industry Segmentation
As per the scope of the report, buprenorphine and naloxone are a fixed-dose combination that is used for the treatment of opioid addiction and pain management. The drug is mainly given through the sublingual route through tablets and films. The buprenorphine and naloxone market is segmented by type, formulation, distribution channel, and geography. The type segment is divided into branded and generics. The formulation segment is bifurcated into sublingual tablets and sublingual films. The distribution channel is segmented into hospital pharmacies, retail pharmacies, and other distribution channels. By geography, the market is divided into North America, Europe, Asia-Pacific, Middle East and Africa, and South America. The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the market size and forecasts in value (in USD) for the above segments.
| By Type | |
| Branded | |
| Generics |
| By Formulation | |
| Sublingual Tablets | |
| Sublingual Films |
| By Distribution Channel | |
| Hospital Pharmacies | |
| Retail Pharmacies | |
| Online Pharmacies |
| Geography | ||||||||
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Buprenorphine And Naloxone Market Research Faqs
How big is the Buprenorphine And Naloxone Market?
The Buprenorphine And Naloxone Market size is expected to reach USD 4.73 billion in 2024 and grow at a CAGR of 4.23% to reach USD 5.82 billion by 2029.
What is the current Buprenorphine And Naloxone Market size?
In 2024, the Buprenorphine And Naloxone Market size is expected to reach USD 4.73 billion.
Who are the key players in Buprenorphine And Naloxone Market?
Indivior PLC, Viatris Inc. (Mylan Inc.), Sandoz AG, Dr. Reddy's Laboratories Ltd. and Hikma Pharmaceuticals PLC are the major companies operating in the Buprenorphine And Naloxone Market.
Which is the fastest growing region in Buprenorphine And Naloxone Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Buprenorphine And Naloxone Market?
In 2024, the North America accounts for the largest market share in Buprenorphine And Naloxone Market.
What years does this Buprenorphine And Naloxone Market cover, and what was the market size in 2023?
In 2023, the Buprenorphine And Naloxone Market size was estimated at USD 4.53 billion. The report covers the Buprenorphine And Naloxone Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Buprenorphine And Naloxone Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Buprenorphine And Naloxone Industry Report
Statistics for the 2024 Buprenorphine And Naloxone market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Buprenorphine And Naloxone analysis includes a market forecast outlook for 2024 to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
