Published Date : 2022-09-29
Published Date : 2022-09-29
Updated On : 2023-07-11
Pages : 150
Thelansis’s “Premenstrual Dysphoric Disorder (PMDD) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Premenstrual Dysphoric Disorder treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Premenstrual Dysphoric Disorder (PMDD) is a depressive disorder categorized as "not otherwise specified" in the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association. It is characterized by mood, appetite, energy, and cognitive changes that manifest during the menstrual cycle's late luteal (premenstrual) phase and subside shortly after the onset of menses. The onset of symptoms is closely linked to the late luteal phase, which coincides with declining levels of estrogen and progesterone. Symptom relief typically occurs during the initial days of the follicular phase when estrogen levels increase due to ovarian follicular growth. The exact cause of PMS/PMDD remains unknown. However, certain risk factors are associated with the development of the condition, some of which have been well-established, while others are still speculative. Proven Risk Factors: 1. Past traumatic events: Traumatic experiences and preexisting anxiety disorders are identified as risk factors for PMDD. 2. Cigarette smoking: A significant link exists between moderate-to-severe forms of PMS and current smoking status, with an elevated risk for former smokers. 3. Obesity: A clear linear relationship exists between baseline Body Mass Index (BMI) and the risk of incident PMS. Each 1 kg/m2 increase in BMI is associated with a significant 3% increase in risk. Speculative Risk Factor: 1. Genetics: Heritable factors play a role in developing PMS/PMDD. The involvement of specific genes, such as the one coding for the serotonergic 5HT1A receptor and allelic variants of the estrogen receptor alpha gene (ESR1), in developing PMS/PMDD. The symptoms of PMDD may overlap with other psychiatric disorders, particularly major depression. Thus, it is crucial to rule out the presence of another existing disorder before confirming the diagnosis of PMS/PMDD. The key factor in diagnosing PMDD is the temporal association of symptoms with the menstrual cycle. Pharmacological approaches to managing PMDD include the use of psychotropic agents and hormonal therapies:
Danazol: This synthetic partial androgen agonist/antagonist and gonadotropin inhibitor has demonstrated efficacy in treating PMDD by inhibiting ovulation. However, it is associated with hirsutism and teratogenicity, making it less preferred as an initial treatment. - Oral contraceptive pills (OCPs): While commonly used in clinical practice. Women on OCPs may experience hormone-related symptoms during hormone-free days, suggesting that OCPs with fewer hormones might benefit more. Drospirenone, a gestagen, has effectively treated PMDD symptoms due to its anti-aldosterone and anti-androgenic effects.
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.
KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs
- Data Inputs with sourcing
- Market Event and Product Event
- Country-specific Forecast Model
- Market uptake and patient share uptake
- Attribute Analysis
- Analog Analysis
- Disease burden and pricing scenario
- Summary and Insights
Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.
The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.
Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.
This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.
S. no | Asset | Company | Stage |
1 | Sepranolone (UC1010) | Asarina Pharma | Phase 2 |
KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.
COUNTRY | No. Of KOLs |
USA | 17 |
GERMANY | 4 |
UK | 4 |
SPAIN | 3 |
FRANCE | 2 |
ITALY | 3 |
JAPAN | 3 |
CHINA | 4 |
Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.
1. Premenstrual Dysphoric Disorder (PMDD) – Key Findings Summary |
1.1. Clinical findings |
1.1.1. Disease overview |
1.1.2. Therapeutic practices |
1.1.3. Future outlook |
1.2. Commercial findings |
1.2.1. Premenstrual Dysphoric Disorder (PMDD) market scenario 2022 |
1.2.2. Premenstrual Dysphoric Disorder (PMDD) market scenario 2025 |
1.2.3. Premenstrual Dysphoric Disorder (PMDD) market scenario 2032 |
2. Premenstrual Dysphoric Disorder (PMDD) Overview |
2.1. Disease Introduction |
2.2. Pathophysiology |
2.3. Signs and Symptoms |
2.4. Risk Factors |
2.5. Etiology |
2.6. Classification |
2.7. Pathogenesis |
2.8. Diagnosis |
2.9. Complications |
2.10. Treatment Algorithm |
2.10.1. Treatment in US (guidelines) |
2.10.2. Treatment in EU-5 (guidelines) |
2.10.3. Treatment in Japan (guidelines) |
2.10.4. Treatment in China (guidelines) |
2.11. Treatment Goals for Premenstrual Dysphoric Disorder (PMDD) |
2.12. Referral Patterns |
2.12.1. Referral Scenario in US |
2.12.2. Referral Scenario in EU-5 |
2.12.3. Referral Scenario in Japan |
2.12.4. Referral Scenario in China |
2.13. Premenstrual Dysphoric Disorder (PMDD) Prognosis |
2.14. Healthcare burden |
2.14.1. Healthcare burden in US |
2.14.2. Healthcare burden in EU-5 |
2.14.3. Healthcare burden in Japan |
2.14.4. Healthcare burden in China |
2.15. Unmet Needs in Premenstrual Dysphoric Disorder (PMDD) management |
2.16. Market Opportunity for Premenstrual Dysphoric Disorder (PMDD) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Premenstrual Dysphoric Disorder (PMDD) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Premenstrual Dysphoric Disorder (PMDD) Epidemiology in US (2022-2032) |
3.2.1.1. Incidence of Premenstrual Dysphoric Disorder (PMDD) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Premenstrual Dysphoric Disorder (PMDD) Epidemiology in EU-5 (2022-2032) |
3.2.2.1. Incidence of Premenstrual Dysphoric Disorder (PMDD) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Premenstrual Dysphoric Disorder (PMDD) Epidemiology in Japan (2022-2032) |
3.2.3.1. Incidence of Premenstrual Dysphoric Disorder (PMDD) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Premenstrual Dysphoric Disorder (PMDD) Epidemiology in China (2022-2032) |
3.2.4.1. Incidence of Premenstrual Dysphoric Disorder (PMDD) |
3.2.4.2. Diagnosed cases |
3.2.4.3. Treatable Patient Pool |
3.2.4.4. Epidemiology Trends |
3.3. Epidemiology Trends (World-wide) |
4. Market Outlook |
4.1. US Premenstrual Dysphoric Disorder (PMDD) Market Forecast 2022-2032 |
4.1.1. Market Progression (Futuristic) |
4.1.2. Market Trends and Expectations |
4.1.2.1. Worst case scenario |
4.1.2.2. Base Case Scenario |
4.1.2.3. Best Case Scenario |
4.1.3. Drivers and Barriers |
4.2. UK Premenstrual Dysphoric Disorder (PMDD) Market Forecast 2022-2032 |
4.2.1. Market Progression (Futuristic) |
4.2.2. Market Trends and Expectations |
4.2.2.1. Worst case scenario |
4.2.2.2. Base Case Scenario |
4.2.2.3. Best Case Scenario |
4.2.3. Drivers and Barriers |
4.3. France Premenstrual Dysphoric Disorder (PMDD) Market Forecast 2022-2032 |
4.3.1. Market Progression (Futuristic) |
4.3.2. Market Trends and Expectations |
4.3.2.1. Worst case scenario |
4.3.2.2. Base Case Scenario |
4.3.2.3. Best Case Scenario |
4.3.3. Drivers and Barriers |
4.4. Germany Premenstrual Dysphoric Disorder (PMDD) Market Forecast 2022-2032 |
4.4.1. Market Progression (Futuristic) |
4.4.2. Market Trends and Expectations |
4.4.2.1. Worst case scenario |
4.4.2.2. Base Case Scenario |
4.4.2.3. Best Case Scenario |
4.4.3. Drivers and Barriers |
4.5. Italy Premenstrual Dysphoric Disorder (PMDD) Market Forecast 2022-2032 |
4.5.1. Market Progression (Futuristic) |
4.5.2. Market Trends and Expectations |
4.5.2.1. Worst case scenario |
4.5.2.2. Base Case Scenario |
4.5.2.3. Best Case Scenario |
4.5.3. Drivers and Barriers |
4.6. Spain Premenstrual Dysphoric Disorder (PMDD) Market Forecast 2022-2032 |
4.6.1. Market Progression (Futuristic) |
4.6.2. Market Trends and Expectations |
4.6.2.1. Worst case scenario |
4.6.2.2. Base Case Scenario |
4.6.2.3. Best Case Scenario |
4.6.3. Drivers and Barriers |
4.7. Japan Premenstrual Dysphoric Disorder (PMDD) Market Forecast 2022-2032 |
4.7.1. Market Progression (Futuristic) |
4.7.2. Market Trends and Expectations |
4.7.2.1. Worst case scenario |
4.7.2.2. Base Case Scenario |
4.7.2.3. Best Case Scenario |
4.7.3. Drivers and Barriers |
4.8. China Premenstrual Dysphoric Disorder (PMDD) Market Forecast 2022-2032 |
4.8.1. Market Progression (Futuristic) |
4.8.2. Market Trends and Expectations |
4.8.2.1. Worst case scenario |
4.8.2.2. Base Case Scenario |
4.8.2.3. Best Case Scenario |
4.8.3. Drivers and Barriers |
4.9. Key Expected Milestones (world-wide) Impacting the Market |
5. Competitive Landscape |
5.1. Pipeline Therapies Overview |
5.1.1. Phase III Therapies |
5.1.1.1. Current Status |
5.1.1.2. Trial details, results |
5.1.1.3. Approval Timeline |
5.1.1.4. Likelihood of approval |
5.1.1.5. Expected Product Positioning |
5.1.1.2. All other Phase III Therapies ….. |
5.1.1.3. Attribute Analysis of Phase III molecules |
5.1.2. Phase II and Phase I/II Therapies |
5.1.2.1. Current Status |
5.1.2.2. Trial details, results |
5.1.2.3. Approval Timelines |
5.1.3. List of active Pre-clinical Therapies |
5.1.3.1. Status in Premenstrual Dysphoric Disorder (PMDD) |
5.1.3.2. Company positioning |
5.1.3.2. All other pre-clinical therapies |
5.1.4. List of Inactive/discontinued assets |
5.1.4.1. Business impact of discontinuations on current pipeline |
5.1.5. Potential winners from Premenstrual Dysphoric Disorder (PMDD) Pipeline |
5.1.5.1. Potential Blockbusters across the pipeline |
6. Regulatory/Approval Scenario |
6.1. Regulatory/Approval Framework in US |
6.1.1. Policy Framework |
6.1.2. Payer Expectations |
6.2. Regulatory/Approval Framework in UK |
6.2.1. Policy Framework |
6.2.2. Payer Expectations |
6.3. Regulatory/Approval Framework in France |
6.3.1. Policy Framework |
6.3.2. Payer Expectations |
6.4. Regulatory/Approval Framework in Germany |
6.4.1. Policy Framework |
6.4.2. Payer Expectations |
6.5. Regulatory/Approval Framework in Italy |
6.5.1. Policy Framework |
6.5.2. Payer Expectations |
6.6. Regulatory/Approval Framework in Spain |
6.6.1. Policy Framework |
6.6.2. Payer Expectations |
6.7. Regulatory/Approval Framework in Japan |
6.7.1. Policy Framework |
6.7.2. Payer Expectations |
6.8. Regulatory/Approval Framework in China |
6.8.1. Policy Framework |
6.8.2. Payer Expectations |
7. Clinical Trial Assessment – Current and Future Paradigm |
7.1. Distribution of Primary Endpoints across trials |
7.2. Distribution of Secondary Endpoints across trials |
7.3. Evolution and acceptance of surrogate endpoints |
7.4. Key Investigator initiated trials |
7.5. Attrition analysis |
7.5.1. Suspended/Discontinued Assets |
7.5.2. Failed Trials, Reasons and Business Impact |
7.5.3. Terminated Trials, Reasons and Business Impact |
7.5.4. Withdrawn Trials, Reasons and Business Impact |
7.6. Trial enrollment scenario and challenges |
7.7. Clinical Trial Guidance (across geographies) |
8. Thelansis Commentary |
8.1. Key Unmet needs in Premenstrual Dysphoric Disorder (PMDD) |
8.2. Possible Best-case Clinical Trial Strategies |
8.3. Possible Best Case Targeted Product Profile (TPP) |
8.4. Possible Best-case Market positioning strategies |
8.5. Possible Best-case Market Access Strategies |
8.6. Possible Best-case LCM Strategies |
8.7. Overall View on Premenstrual Dysphoric Disorder (PMDD) Market in Dollar Value |
9. Report Methodology |
9.1. Secondary research |
9.2. Primary research |
9.3. Data collation |
9.4. Insight Generation |
10. About Thelansis |
10.1. Our Capabilities |
10.2. Our Services |
10.3. Our Contacts |
10.4. Disclaimer |