Opioid Use Disorder – Opportunity Analysis and Forecasts to 2028

 

Opioids are synthetic or natural agents that stimulate opioid receptors in the brain and nervous system. Opioids are often used to treat patients suffering from pain. When taken in the prescribed quantities, opioids do not generally lead to addiction. Opioid use disorder (OUD) is a chronic neurological disorder that is described as the consequences associated with repeated, compulsive use of opioid drugs, and prolonged self-administration of opioid drugs. As the brain adapts to a prolonged opioid use, the patient’s tolerance increases, so a higher dose of opioid is needed to stimulate the mesolimbic system in the same way as the original dose, leading patients to use continued higher doses of the drug. There are two subsets of patients who suffer from OUD: patients who become addicted to medical opioids, which are used to treat chronic pain conditions, and patients who become addicted to non-medical opioids, such as heroin and fentanyl. There is no single cause of OUD, but rather a combination of genetic and environmental factors that influence the patient.

Currently, several drugs have been approved for the treatment of OUD, which can be split into two classes: synthetic opioid receptor agonists (buprenorphine, methadone, morphine, and medical-grade heroin) and opioid antagonists (naltrexone). Many of these drugs have been widely available for decades and are genericized across the markets covered in this report. Some reformulations that have been released more recently, and some are expected to launch during the forecast period, making them a market driver toward the end of the forecast period.

Key Questions Answered

How will the OUD market landscape in the 8MM (US, Canada, Germany, Austria, Belgium, Denmark, Switzerland, and Australia) change from 2018–2028?

What are the most promising late-stage pipeline drugs for OUD?

How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options?

What are the remaining unmet needs in OUD treatment management?

What drivers and barriers will affect OUD therapeutics sales in the 8MM over the forecast period?

Scope

Overview of OUD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

Topline OUD market revenue from 2018–2028. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.

Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting OUD therapeutics sales in the 8MM.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.

Analysis of the current and future market competition in the global OUD therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

During the 10-year forecast period, the OUD market is expected to grow from $1.6B in 2018 to $3.7B in 2028 in the 8MM, which represents a CAGR of 8.8%. The US is expected to maintain its position as the market leader in 2028, with sales contributing 87.7% to the global market.

The main driver of growth over the forecast period will be the launch of new formulations of buprenorphine, particularly Indivior’s Sublocade, which is already launched in the US, Canada, and Australia, as well as Camurus’ Buvidal, which is already launched in Europe and Australia. Both are subcutaneous monthly forms of buprenorphine.

There are several drugs that will see their patents expire throughout the forecast period, the most high-profile being Indivior’s Suboxone, which is a key barrier of growth in this market. Suboxone, the sublingual buprenorphine + naloxone combination, was the highest-selling drug with sales of $859M in 2018. However, its sales are expected to fall throughout the forecast period at a negative CAGR of 16.9%, due to generic erosion.

Reasons to buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the Global OUD market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the OUD therapeutics market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Companies mentioned

Alkermes

Azanta

BioDelivery Sciences International

Braeburn

Bristol-Myers Squibb

Camarus

Chiesi Pharmaceuticals

DiaMo Narcotics

Hikma Pharmaceuticals

Indivior

Knight Therapeutics

MaynePharma Group

MediciNova

Molteni Farmaceutici

Mundipharma

Omeros Corp

Orexo

Reckitt Benckiser Group

Sandoz

Swissmedic

Teva Pharmaceuticals

Titan Pharmaceuticals

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Opioid Use Disorder: Executive Summary

2.1 Reformulations of Buprenorphine Will Drive Growth in the OUD Market

2.2 Experienced and New Players Go Head-to-Head with Buprenorphine Reformulations

2.3 Environmental Unmet Needs of Greater Importance than Clinical Needs

2.4 Late-Stage Pipeline Remains Focused on Reformulations, While Early Stage Pipeline Looks to Novel MOAs

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification or Staging Systems

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources Used

5.4.2 Forecast Assumptions and Methods

5.4.3 Forecast Assumptions and Methods: 12-Month Total Prevalent Cases of OUD

5.4.4 Forecast Assumptions and Methods: 12-Month Diagnosed Prevalent Cases of OUD

5.4.5 Forecast Assumptions and Methods: 12-Month Total and Diagnosed Prevalent Cases of OUD by Severity

5.4.6 Sources Not Used

5.5 Epidemiological Forecast for OUD (2018–2028)

5.5.1 12-Month Total Prevalent Cases of OUD

5.5.2 Age-Specific 12-month Total Prevalent Cases of OUD

5.5.3 Sex-Specific 12-Month Total Prevalent Cases of OUD

5.5.4 12-Month Total Prevalent Cases of OUD by Severity

5.5.5 12-Month Diagnosed Prevalent Cases of OUD

5.5.6 Age-Specific 12-Month Diagnosed Prevalent Cases of OUD

5.5.7 Sex-Specific 12-Month Diagnosed Prevalent Cases of OUD

5.5.8 12-month Diagnosed Prevalent Cases of OUD by Severity

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Removal of Access Barriers

7.3 Novel Mechanisms of Action

7.4 Improved Treatment Guidelines

8 R&D Strategies

8.1 Overview

8.1.1 Drug Formulations That Have Less Potential for Abuse

8.1.2 Novel Mechanisms of Action

8.1.3 Extended-Release Formulations That Improve Compliance

8.2 Clinical Trials Design

8.2.1 Endpoints

8.2.2 Trial Duration

8.2.3 Comparator Arms

8.2.4 Patient Population

9 Pipeline Assessment

9.1 Overview

9.2 Innovative Early Stage Approaches

9.3 Other Drugs in Development

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.2 Commercial Benchmark of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 Canada

10.4.3 Europe

10.4.4 Australia

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic Erosion

11.3.9 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.4.1 KOLs

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Managing Analyst

11.6.3 Therapy Area Director

11.6.4 Epidemiologist

11.6.5 Managing Epidemiologists

11.6.6 Global Director of Therapy Analysis and Epidemiology

11.6.7 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

List of Tables

Table 1: Opioid Use Disorder: Key Metrics in the 8MM

Table 2: Symptoms of Opioid Use Disorder

Table 3: Long Term Psychological Impacts of Opioid Use Disorder

Table 4: DSM-5 Diagnostic Criteria for Opioid Use Disorder

Table 5: Risk Factors and Comorbidities for OUD

Table 6: Treatment Guidelines for Opioid Use Disorder

Table 7: Leading Treatments for Opioid Use Disorder, 2020

Table 8: Vaccines in Development for OUD, 2020

Table 9: Drugs in Development for Opioid Use Disorder, 2020

Table 10: Clinical Benchmark of Key Pipeline Drugs – OUD

Table 11: Commercial Benchmark of Key Pipeline Drugs – OUD

Table 12: Key Events Impacting OUD Sales, 2018–2028

Table 13: OUD Market – Global Drivers and Barriers, 2018–2028

Table 14: Key Historical and Projected Launch Dates for OUD

Table 15: Key Historical and Projected Patent Expiry Dates for OUD

Table 16: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for Opioid Use Disorder, 2018 and 2028

Figure 2: Competitive Assessment of the Pipeline Drugs Benchmarked Against the SOC, Suboxone

Figure 3: The Impact of Opioid Use Disorder on Brain Function

Figure 4: 8MM, 12-Month Total Prevalence of OUD, Men and Women, %, Ages ≥18 Years, 2018

Figure 5: 8MM, 12-Month Diagnosed Prevalence of OUD, Men and Women, %, Ages ≥18 Years, 2018

Figure 6: 8MM, Sources Used and Not Used to Forecast the 12-Month Total and 12-Month Diagnosed Prevalent Cases of OUD

Figure 7: 8MM, Sources Used to Forecast the Severity of 12-Month Total Prevalent Cases of OUD

Figure 8: 8MM, Sources Used to Forecast the Severity of 12-Month Diagnosed Prevalent Cases of OUD

Figure 9: 8MM, 12-Month Total Prevalent Cases of OUD, Both Sexes, Ages ≥18 Years, N, 2018

Figure 10: 8MM, 12-Month Total Prevalent Cases of OUD by Age, N, Both Sexes, 2018

Figure 11: 8MM, 12-Month Total Prevalent Cases of OUD by Sex, N, Ages ≥18 Years, 2018

Figure 12: 8MM 12-Month Total Prevalent Cases of OUD by Severity, N, Ages ≥18 Years, 2018

Figure 13: 8MM, 12-Month Diagnosed Prevalent Cases of OUD, N, Both Sexes, Ages ≥18 Years, 2018

Figure 14: 8MM, 12-Month Diagnosed Prevalent Cases of OUD by Age, N, Both Sexes, 2018

Figure 15: 8MM, 12-Month Diagnosed Prevalent Cases of OUD by Sex, N, Ages ≥18 Years, 2018

Figure 16: 8MM, 12-Month Diagnosed Prevalent Cases of OUD by Severity, N, Ages ≥18 Years, 2018

Figure 17: Unmet Needs and Opportunities in Opioid Use Disorder

Figure 18: Overview of the Development Pipeline in Opioid Use Disorder

Figure 19: Key Trials for the Promising Pipeline Agents Profiled by GlobalData in the Associated Excel File

Figure 20: Competitive Assessment of Pipeline Drugs Benchmarked Against the SOC, Suboxone

Figure 21: 8MM, OUD Sales Forecast by Country, 2018 and 2028

Figure 22: 8MM, OUD Sales Forecast by Class, 2018 and 2028

Figure 23: US OUD Sales Forecast by Class, 2018 and 2028

Figure 24: Canada OUD Sales Forecast by Class, 2018 and 2028

Figure 25: Europe OUD Sales Forecast by Country, 2018 and 2028

Figure 26: Europe OUD Sales Forecast by Class, 2018 and 2028

Figure 27: Australia OUD Sales Forecast by Class, 2018 and 2028

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