Post-Traumatic Stress Disorder (PTSD): Opportunity Analysis and Forecasts to 2028

Post-traumatic stress disorder (PTSD) is a psychiatric disorder that can occur in people who have experienced or witnessed a traumatic event such as a natural disaster, a serious accident, a terrorist act, war/combat, rape, or other violent personal assault. Symptoms include “re-experiencing” distressing memories, hypervigilance, avoidant behaviors, sweating, tremors, and dissociation. There are numerous PTSD classification systems. In this report, patient populations are divided into subtypes by symptom onset. Symptoms must persist for more than one month to be classified as PTSD. Acute PTSD is defined as symptom onset occurring sooner or equal to three months after the traumatic occurrence. Chronic PTSD is when symptoms occur more than three months but less than six months after the event. Delayed-onset PTSD is defined as when symptoms commence six months or later. The most prevalent form is chronic PTSD and two pipeline products are being specifically developed to treat this form of the disorder.

There are only two approved therapies, SSRIs Zoloft (sertraline hydrochloride) and Paxil (paroxetine hydrochloride), the latter of which has anticholinergic activity and is associated with severe adverse effects. Additionally, these medications have been seen to be inadequate in treating PTSD effectively, and also have black box warnings for increased impulsiveness and suicidal behaviors. The most recent approval, which was for Paxil occurred in 2001. The PTSD marketplace is extremely barren and physicians regularly prescribe off-label therapies with indeterminable safety profiles or efficacy studies. This trial-and-error approach can have consequences such as worsening of symptoms as has been experienced with benzodiazepines, which are still commonly prescribed by psychiatrists worldwide. Treatment regimens need to be tailored to the type of symptoms experienced by patients to boost the likelihood of symptom amelioration.

GlobalData estimates that drug sales for PTSD in 2018 were approximately $211.4M across the seven major markets covered in this report. Over the 10-year forecast period, the market is expected to grow to $1.2B at a CAGR of 18.7%. This growth will be driven by the launch of five late-stage pipeline products. The two highest selling drugs are expected to be Otsuka’s brexpiprazole and MAPS’ midomafetamine, which address the clinical unmet needs in the market.

Key Questions Answered

What were the key PTSD treatments in 2018?

When will the late stage pipeline products launch, and how will it affect drug sales and the overall PTSD market in the 7MM?

Which unmet needs will remain unaddressed in the forecast period and what opportunities remain for pharmaceutical companies?

Scope

Overview of PTSD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

Annualized PTSD therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (acute, chronic and delayed-onset) forecast from 2018 to 2028.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the PTSD therapeutics market

Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for PTSD therapy. The most promising candidates in Phase III development are profiled.

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

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 PTSD therapeutics market.

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

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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

Pfizer

GSK

Tonix Pharmaceuticals

Seelos Therapeutics

Multidisciplinary Association for Psychedelic Studies

Bionomics

Otsuka

NeuroRx

Catalyst Pharmaceuticals

SpringWorks Therapeutics

Pfizer

GSK

Tonix Pharmaceuticals

Seelos Therapeutics

Multidisciplinary Association for Psychedelic Studies

Bionomics

Otsuka

NeuroRx

Catalyst Pharmaceuticals

SpringWorks Therapeutics

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 PTSD: Executive Summary

2.1 Double-Digit Growth Expected in PTSD Market from 2018–2028 ...

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 PTSD: Executive Summary

2.1 Double-Digit Growth Expected in PTSD Market from 2018–2028

2.2 Focus Is on Label Expansion, Comorbidities, and Novel Mechanisms of Action in PTSD Pipeline

2.3 Lack of Efficacious Pharmacotherapeutic Options Is a Major Unmet Need

2.4 Brexpiprazole and Midomafetamine to Be Top-Selling Drugs in 2028

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 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

5.5 Epidemiological Forecast for PTSD (2018–2028)

5.5.1 12-Month Total Prevalent Cases of PTSD

5.5.2 Age-Specific 12-Month Total Prevalent Cases of PTSD

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

5.5.4 12-Month Total Prevalent Cases of PTSD by Onset of Disease

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

6.2 Psychotherapy

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Improved Efficacy of Available Treatments

7.3 Improving Side-Effect Profiles and Patient Compliance

7.4 Increased Access to Treatment for Vulnerable Populations

7.5 Clearer Diagnostic Guidelines

8 R&D Strategies

8.1 Overview

8.1.1 Repurposing Atypical Antipsychotics and Other Marketed Drugs

8.1.2 Drug Candidates with Novel Mechanisms of Action

8.1.3 Targeting Key Comorbidities of PTSD

8.2 Clinical Trials Design

8.2.1 The Preference for Straightforward Treatment Regimens

8.2.2 The Interplay of Psychotherapeutic and Pharmacotherapeutic Strategies

8.2.3 Studying Off-Label Therapeutics to Generate Reliable Clinical Data

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 5EU

10.4.3 Japan

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 Therapy Area Director

11.6.3 Epidemiologist

11.6.4 Reviewers

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.6.6 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: Post-Traumatic Stress Disorder: Key Metrics in the 7MM

Table 2: Overview of PTSD symptoms included in DSM-5

Table 3: Risk Factors and Comorbid ...

Table 1: Post-Traumatic Stress Disorder: Key Metrics in the 7MM

Table 2: Overview of PTSD symptoms included in DSM-5

Table 3: Risk Factors and Comorbid Conditions Associated with PTSD

Table 4: Off-Label Drugs for PTSD in the 7MM

Table 5: Treatment Guidelines for PTSD

Table 6: Approved Treatments for PTSD, 2019

Table 7: Comparison of Therapeutic Classes in Development for PTSD, 2018–2028

Table 8: Innovative Early-Stage Approaches for PTSD, 2019

Table 9: Drugs in Development for PTSD, 2019

Table 10: Clinical Benchmark of Key Pipeline Drugs – PTSD

Table 11: Commercial Benchmark of Key Pipeline Drugs – PTSD

Table 12: Key Events Impacting Global Sales for PTSD, 2018–2028

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

Table 14: Key Historical and Projected Launch Dates for PTSD

Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for PTSD in 2018 and 2028

Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against ...

Figure 1: Global Sales Forecast by Country for PTSD in 2018 and 2028

Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Zoloft

Figure 3: Fight-or-Flight Response Overview and Pathophysiological Aspects of PTSD

Figure 4: 7MM, 12-Month Total Prevalence of PTSD (%), Men and Women, Ages ≥18 Years, 2018

Figure 5: 7MM, Sources Used and Not Used to Forecast the 12-Month Total Prevalent Cases of PTSD

Figure 6: 7MM, Sources Used to Forecast the 12-Month Total Prevalent Cases of PTSD by Onset of Disease

Figure 7: 7MM, 12-Month Total Prevalent Cases of PTSD, Both Sexes, Ages ≥18 Years, 2018

Figure 8: 7MM, Age-Specific 12-Month Total Prevalent Cases of PTSD, Both Sexes, Ages ≥18 Years, 2018

Figure 9: 7MM, Sex-Specific 12-Month Total Prevalent Cases of PTSD, Ages ≥18 Years, 2018

Figure 10: 7MM, 12-Month Total Prevalent Cases of PTSD by Onset of Disease, Both Sexes, Ages ≥18 Years, 2018

Figure 11: Unmet Needs and Opportunities in PTSD

Figure 12: Overview of the Development Pipeline in PTSD

Figure 13: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for PTSD in the 7MM During the Forecast Period

Figure 14: Competitive Assessment of the Marketed and Pipeline PTSD Drugs Benchmarked Against the SOC, Zoloft

Figure 15: Global (7MM) Sales Forecast by Country for PTSD in 2018 and 2028

Figure 16: Global Sales Forecast by Brand for PTSD in 2018 and 2028

Figure 17: Sales Forecast by Brand for PTSD in the US in 2018 and 2028

Figure 18: Sales Forecast by Brand for PTSD in the 5EU Markets in 2018 and 2028

Figure 19: Sales Forecast by Brand for PTSD in Japan in 2018 and 2028

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