Major depressive disorder Market Outlook 2034 - Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

According to DelveInsight, the Major Depressive Disorder Treatment Market Size in the 7MM was approximately USD 7,165 million in 2023.
Major depressive disorder Market Summary

According to DelveInsight, there were ~44 million diagnosed cases of Major Depressive Disorder (MDD) across the 7MM in 2023. The US led the market, valued at ~USD 5.6 billion, projected to grow at a 4.8% CAGR through 2034. Current treatments include VRAYLAR, AUVELITY, SPRAVATO, and REXULTI, with therapies largely spanning SSRIs, SNRIs, atypical antipsychotics, and other antidepressants. Market growth is expected with the introduction of emerging therapies such as Seltorexant, Navacaprant, and Aticaprant, with Seltorexant anticipated to launch in the US by 2025, EU4/UK by 2026, and Japan by 2027. In May 2024, Johnson & Johnson reported positive Phase III results for Seltorexant. Rising prevalence, advancements in research, supportive regulations, and growing awareness are driving demand for innovative and personalized MDD treatments.

DelveInsight's "Major Depressive Disorder Market Insights, Epidemiology, and Market Forecast-2034" provides a detailed analysis of the disorder, including historical and forecasted epidemiology, market trends, and treatment practices across the United States, EU5 (Germany, Spain, Italy, France, and the UK), and Japan. The report highlights emerging drugs, therapy market share, and market size projections from 2020 to 2034 across seven major markets. It also examines treatment algorithms, market drivers, barriers, and unmet needs, identifying potential growth opportunities in the MDD market.

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Some facts of the Major depressive disorder Market Report are:

* According to DelveInsight, Major depressive disorder market size is expected to grow at a decent CAGR by 2034.
* The Major Depressive Disorder Treatment Market Size in the 7MM was approximately USD 7,165 million in 2023.
* Leading Major depressive disorder companies working in the market are Takeda Pharmaceuticals, Forest Laboratories, Otsuka Pharmaceuticals, Janssen Research & Development, Axsome Therapeutics, AbbVie, SAGE Therapeutics, Minerva Neurosciences, Luye Pharma, Relmada Therapeutics, BioLite Inc., VistaGen Therapeutics, Praxis Precision Medicines, Intra-Cellular Therapies, Neurocrine Biosciences, Arrivo Bioventures, Sirstei Pharmaceuticals, Alto Neuroscience, Chase Therapeutics, Neumora Therapeutics, Inc., BlackThorn Therapeutics, Inc., Otsuka Pharmaceutical Co., Ltd., Fabre-Kramer Pharmaceuticals, Novartis and others.
* Key Major depressive disorder Therapies expected to launch in the market are VRAYLAR, Zuranolone, Seltorexant (JNJ42847922), REL-1017, ABV-1504, Itruvone (PH10), LPCN 1154, and many others.
* With the anticipated introduction of new treatments such as COMP360 (COMPASS Pathways), Zuranolone (SAGE Therapeutics/Biogen), LY03005 (Luye Pharma), REL-1017 (Relmada Therapeutics), Seltorexant (Minerva Neurosciences/Janssen Pharmaceutical), ABV-1504 (BioLite/ABVC BioPharma), and other and increasing disease awareness, it's reasonable to expect a significant transformation in the major depressive disorder market in the coming years.
* In August 2025, Neumora Therapeutics Inc. announced a study that will evaluate the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). Participants who completed a parent study investigating the efficacy and safety of NMRA-335140 as a treatment for MDD (ie, NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303), and complete the 6 weeks double-blind treatment, provide informed consent, and meet eligibility criteria, may enter this extension study.
* In August 2025, Cybin IRL Limited announced a study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
* In August 2025, Neurocrine Biosciences conducted a study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
* DelveInsight's Major Depressive Disorder pipeline report depicts a robust space with 75+ active players working to develop 75+ pipeline therapies for Major Depressive Disorder treatment.
* In March 2025, Biohaven Pharmaceuticals, Inc announced results of a Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder
* In February 2025, Xenon Pharmaceuticals Inc announced results of a Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
* In January 2025 - Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO Registered (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.
* In December 2024, Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced that it has recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CAPLYTA (lumateperone) for the treatment of Major Depressive Disorder (MDD) in adults, as adjunctive therapy to antidepressants.
* On November 12, 2024, Magstim, a global leader in neuroscience and mental health treatment, received FDA clearance for its Horizon Inspire System. This advanced transcranial magnetic stimulation (TMS) technology is designed to assist physicians, nurse practitioners, clinicians, and researchers in treating patients with major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and anxious depression.
* On November 5, 2024, the U.S. FDA approved an Investigational New Drug (IND) application from Damona Pharmaceuticals, enabling the company to begin a Phase I trial of DPX-101. The drug is designed to treat cognitive disabilities in major depressive disorder and other brain disorders.
* In June 2024, Lipocine announced positive topline results from a pivotal pharmacokinetic study, confirming that LPCN 1154 is bioequivalent to IV brexanolone for PPD treatment. Lipocine aims to submit the NDA by the end of the fourth quarter of 2024.

Major depressive disorder Overview

Major Depressive Disorder (MDD), commonly referred to as depression, is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a loss of interest or pleasure in daily activities. It significantly affects mood, cognition, and physical health, often impairing a person's ability to function socially or occupationally.

The symptoms of Major Depressive Disorder include depressed mood, fatigue, difficulty concentrating, changes in appetite or sleep patterns, feelings of worthlessness or guilt, and, in severe cases, thoughts of self-harm or suicide. These symptoms must persist for at least two weeks to meet the diagnostic criteria. The condition can range from mild to severe, with some individuals experiencing recurrent episodes.

The exact cause of Major Depressive Disorder is not fully understood, but it is believed to result from a combination of genetic, biological, environmental, and psychological factors. Imbalances in brain neurotransmitters like serotonin, dopamine, and norepinephrine play a significant role.

Major Depressive Disorder Treatment typically involves psychotherapy (such as cognitive-behavioral therapy), medication (antidepressants like SSRIs or SNRIs), or a combination of both. For resistant cases, other interventions like electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) may be considered.

Early diagnosis and treatment are crucial to improving outcomes and preventing complications such as chronic disability or co-occurring conditions like anxiety disorders.

For severe cases of major depression, electroconvulsive therapy is the most effective option. The current range of recommended pharmacological treatments for major depressive disorder primarily includes antidepressants such as monoamines, tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), and selective reuptake inhibitors, including medications like VRAYLAR, BRINTELLIX (now TRINTELLIX), SPRAVATO, REXULTI, and FETZIMA.

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Major depressive disorder Market

The Major Depressive Disorder (MDD) market is growing due to rising antidepressant demand, regulatory approvals (FDA, EC), and the availability of novel drug classes like SSRIs, SNRIs, DNRIs, and atypical antipsychotics. Approved therapies include VRAYLAR, AUVELITY, Trintellix, SPRAVATO, REXULTI, and Fetzima, with Europe and the US leading market share, while Japan has approvals such as TRINTELLIX and REXULTI.

In 2023, the MDD market size in the 7MM was ~USD 7.2 billion, with the US accounting for 78% (~USD 5.6B), followed by Germany (USD 531M), Italy (USD 129M), and Japan (USD 142M). The market is forecast to grow at a 4.6% CAGR (2024-2034), driven by emerging therapies like Seltorexant and pipeline candidates such as ALTO-100 (Alto Neuroscience), a first-in-class AMPA receptor modulator targeting brain plasticity.

Key unmet needs include faster-acting treatments, fewer side effects, and personalized approaches to improve adherence and patient outcomes.

Major depressive disorderMarket Drivers

* Rising Prevalence & Disease Burden - Increasing diagnosed cases (~44M in 7MM, 2023) fuels demand for effective therapies.
* Regulatory Approvals - Fast-track designations and approvals by the FDA and European Commission accelerate new drug entry.
* Novel Therapies & Drug Classes - Launch of SSRIs, SNRIs, atypical antipsychotics, NMDA receptor antagonists, and new mechanisms (e.g., AMPA modulators) boosts treatment options.
* Strong Pipeline - Late-stage candidates like Seltorexant, Navacaprant, ALTO-100 expected to reshape treatment landscape.
* Increased Awareness & Diagnosis - Public health initiatives and reduced stigma improve patient identification and treatment uptake.
* Pharma Investment & Collaborations - Growing R&D spending and partnerships strengthen innovation.
* Shift Toward Personalized Medicine - Research into biomarkers and patient-specific responses supports tailored therapies.

Major depressive disorderMarket Barriers

* Delayed Onset of Action - Many current antidepressants take weeks to show efficacy, limiting patient adherence.
* Side Effects & Safety Issues - Weight gain, and withdrawal symptoms remain challenges.
* High Relapse & Treatment Resistance - A large proportion of patients do not respond adequately to first-line therapies.
* Cost & Reimbursement Issues - Premium pricing of novel drugs (e.g., SPRAVATO) can restrict uptake.
* Stigma & Underdiagnosis - Despite awareness, cultural stigma and misdiagnosis hinder treatment-seeking behavior.
* Generic Competition - Patent expiries and cheaper generics limit revenue growth for established therapies.
* Regulatory & Clinical Trial Challenges - Long development cycles, high failure rates, and complex trial endpoints delay market entry.

Major depressive disorder Epidemiology

In 2023, the US recorded the highest number of diagnosed Major Depressive Disorder (MDD) cases (~22 million), followed by Germany (~6.8M) and the UK (~4M), while Spain had the lowest (~1.9M) among European countries. Japan accounted for ~3M cases (7% of 7MM total).

In the US, females represented the majority (64%) of MDD cases compared to males (36%), influenced by hormonal, physiological, and lifestyle factors. Across the EU4 and the UK, moderate cases were most common (37%), followed by mild (32%) and severe cases (31%).

Major depressive disorder Epidemiology Segmentation:

* Diagnosed Prevalent Cases of Major Depressive Disorder
* Gender-specific Diagnosed Prevalent Cases of Major Depressive Disorder
* Severity-specific Diagnosed Prevalent Cases of Major Depressive Disorder

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Major depressive disorder Drugs Uptake

Zuranolone (SAGE-217/BIIB125) - Sage Therapeutics/Biogen/Shionogi

* Oral, next-generation positive allosteric modulator of GABAA receptors, targeting both synaptic and extrasynaptic receptors.
* Being developed for Major Depressive Disorder (MDD) under the LANDSCAPE (MDD studies) and NEST (Postpartum Depression studies) trial programs.
* In August 2023, the FDA issued a Complete Response Letter (CRL) for its NDA in MDD, citing lack of substantial evidence of effectiveness. Additional studies are required; no Phase III trials ongoing.

Seltorexant (JNJ42847922) - Janssen/Minerva Neurosciences

* A selective orexin-2 receptor antagonist under development as adjunctive therapy for MDD and insomnia.
* Targets the orexin system, which regulates stress response, metabolism, and wakefulness; useful for patients with MDD and excessive arousal symptoms.
* Licensed by Janssen, with Royalty Pharma acquiring Minerva's royalty rights in 2021 (USD 60M upfront + milestone payments).
* Currently in Phase III trials for MDD with insomnia symptoms.

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Major depressive disorder Pipeline Development Activities

The Major depressive disorder report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Major depressive disorder companies involved in developing targeted therapeutics.

* Takeda Pharmaceuticals
* Forest Laboratories
* Otsuka Pharmaceuticals
* Janssen Research & Development
* Axsome Therapeutics
* AbbVie
* SAGE Therapeutics
* Minerva Neurosciences
* Luye Pharma
* Relmada Therapeutics
* BioLite Inc.
* VistaGen Therapeutics
* Praxis Precision Medicines
* Intra-Cellular Therapies
* Neurocrine Biosciences
* Arrivo Bioventures
* Sirstei Pharmaceuticals
* Alto Neuroscience
* Chase Therapeutics
* Neumora Therapeutics, Inc.
* BlackThorn Therapeutics, Inc.
* Otsuka Pharmaceutical Co., Ltd.
* Fabre-Kramer Pharmaceuticals
* Novartis

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Major depressive disorder Report Key Insights

1. Major depressive disorder Patient Population

2. Major depressive disorder Market Size and Trends

3. Key Cross Competition in the Major depressive disorder Market

4. Major depressive disorder Market Dynamics (Key Drivers and Barriers)

5. Major depressive disorder Market Opportunities

6. Major depressive disorder Therapeutic Approaches

7. Major depressive disorder Pipeline Analysis

8. Major depressive disorder Current Treatment Practices/Algorithm

9. Impact of Emerging Therapies on the Major depressive disorder Market

Table of Contents

1. Key Insights

2. Executive Summary

3. Major depressive disorder Competitive Intelligence Analysis

4. Major depressive disorder Market Overview at a Glance

5. Major depressive disorder Disease Background and Overview

6. Major depressive disorder Patient Journey

7. Major depressive disorder Epidemiology and Patient Population

8. Major depressive disorder Treatment Algorithm, Current Treatment, and Medical Practices

9. Major depressive disorder Unmet Needs

10. Key Endpoints of Major depressive disorder Treatment

11. Major depressive disorder Marketed Products

12. Major depressive disorder Emerging Therapies

13. Major depressive disorder Seven Major Market Analysis

14. Attribute Analysis

15. Major depressive disorder Market Outlook (7 major markets)

16. Major depressive disorder Access and Reimbursement Overview

17. KOL Views on the Major depressive disorder Market

18. Major depressive disorder Market Drivers

19. Major depressive disorder Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

About DelveInsight

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