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시장보고서
상품코드
1705112
산후 우울증 시장 : 시장 인사이트, 역학 및 시장 예측(2034년)Postpartum Depression - Market Insights, Epidemiology, and Market Forecast - 2034 |
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산후 우울증 치료 시장 보고서 : 개요
Sage Therapeutics, Marinus Pharmaceuticals, Lipocine, Brii Biosciences 등 다양한 주요 산후 우울증 기업들이 치료 전망을 주도하고 있습니다. 국가별 및 치료법별 산후 우울증 시장 규모에 대한 자세한 내용은 다음과 같습니다.
시판 중인 산후 우울증 치료제
Zuranolone(SAGE-217)은 산후 우울증(PPD)을 대상으로 개발 중인 경구용 신약으로, 1일 1회, 2주간 투여하는 신경활성 스테로이드(NAS) GABAA 수용체 양성 동종 조절제(PAM)로 PPD, 주요우울장애(MDD), 치료 저항성 우울증 등 여러 우울증 장애를 완화하도록 특별히 고안된 약물입니다. SAGE-217은 시냅스 및 시냅스 외 Y-aminobutyric acid (GABAA) 수용체에 대한 선택성과 하루 1정씩 복용하는 SAGE-217은 선택성과 1일 1회 경구 투여에 적합한 약동학적 프로파일에 최적화되어 있습니다.
ZULRESSO는 브렉사놀론(Brexanolone)의 독자적인 정맥주사 제제로, 천연에 존재하는 신경 활성 스테로이드인 알로프레그나놀론과 화학적으로 동일하며, 성인의 PPD 치료에 적응증이 있는 γ-아미노부티르산(GABA) 수용체 양성 알로스테릭 조절제로서 작용합니다. 로 작용합니다. 브렉사놀론은 위험 평가 및 완화 전략(REMS) 프로그램을 통해서만 환자에게 투여할 수 있으며, 반드시 공인된 의료기관에서 투여해야 합니다. 또한, 심각한 부작용의 위험이 있기 때문에 약물 주입 중 환자를 지속적으로 모니터링해야 합니다. 주목할 만한 점은 Zulesso(Brexanolone)가 성인 PPD를 위해 미국 FDA의 승인을 받은 최초의 약물이라는 점입니다.
성인 PPD 치료에서 브렉사놀론의 작용기전은 GABAA 수용체의 양성 동종 조절과 관련이 있습니다. 브렉사놀론은 a1B2Y2 수용체 서브유닛, a4B3δ 수용체 서브유닛, a6B3δ 수용체 서브유닛을 발현하는 포유류 세포에서 재조합 인간 GABAA 수용체로부터 GABA 매개 전류를 향상시켰습니다.
산후 우울증 치료제
Ganaxolone(CCD-1042)은 GABAA 수용체 조절 기전과 풍부한 안전성 데이터베이스를 가지고 있으며, 항경련(항간질), 항불안, 항우울 작용을 나타내는 Marinus Pharmaceuticals가 개발 중인 임상 단계의 선도적 의약품 후보물질입니다. 이 약은 급성기 및 만성기 의료에 종사하는 중증 PPD 성인 및 소아 환자들에게 치료 효과를 극대화하기 위해 3가지 제형(정맥주사, 캡슐, 액상)으로 개발 중입니다. Ganaxolone은 벤조디아제핀 계열 약물과 달리 시냅스 및 시냅스 외 GABAA 수용체에 작용하여 항경련 및 항불안 효과를 나타냅니다. Ganaxolone은 활성형 스테로이드로의 역변환을 방지하는 메틸기를 추가하여 설계되어 Ganaxolone의 만성적 사용 가능성을 열어줍니다. 전임상시험에서 Ganaxolone은 알로프레그나놀론에 필적하는 효능과 효과를 보여주었습니다.
이 약은 임상 2상을 완료했으며, PPD 환자를 대상으로 정맥투여와 경구투여의 제형을 검토했습니다.
Abilify (aripiprazole), Zoloft (sertraline hydrochloride), Spravato (esketamine), Prozac (fluoxetine capsules), Celexa (citalopram hydrobromide), Luvox CR (Fluvoxamine Maleate), Paxil CR (paroxetine) 등의 항우울제가 산후 우울증 치료의 주축을 이루고 있습니다. 이들 약물은 주요우울장애(MDD), 강박장애(OCD), 외상 후 스트레스 장애(PTSD), 치료 저항성 우울증(TRD) 등 우울증 관련 질환의 치료제로 승인되었지만 PPD 치료에는 적응증이 없는 약물로 사용되고 있습니다. 의사가 처방하는 약물의 유형은 환자의 증상, 중증도, PPD의 유형에 따라 크게 달라집니다. 항우울제에 대한 주요 우려는 모유 수유로 인한 신생아에 대한 결과의 불확실성과 부작용입니다. 항우울제는 PPD의 영구적인 치료제는 아니지만, 우울증 증상을 관리하고 삶의 질을 회복하는 중요한 수단입니다.
GABAA 수용체 양성 알로스테릭 조절제, Y-아미노부티르산(GABA) 수용체 알로스테릭 조절제 등 새로운 기전을 가진 많은 새로운 분자들이 Sage Therapeutics, Marinus Pharmaceuticals, Lipocine, Brii Biosciences 등의 주요 기업에서 PPD 치료를 위해 개발되고 있습니다.
결론적으로, 현재 산후 우울증 치료제 시장에는 적절한 치료법이 없음에도 불구하고, 새로운 메커니즘을 가진 많은 잠재적 치료법이 시장에 진입하여 산후 우울증의 미충족 수요를 해결하고 산후 우울증 환자의 치료 결과를 크게 개선할 수 있을 것으로 기대됩니다. 따라서, 새로운 치료 옵션의 가용성과 주요 7개국에서 헬스케어 지출이 증가함에 따라 산후 우울증 치료 시장 시나리오는 예측 기간(2024-2034년) 동안 큰 성장을 이룰 것으로 예상됩니다.
산후 우울증(PPD)은 여성의 약 10-15%가 경험하는 출산과 관련된 가장 흔한 비정신병적 합병증으로, 여성과 그 가족에게 영향을 미치는 중요한 공중보건 문제입니다. 산후는 심각한 기분 장애의 발병 위험이 증가하는 시기로 잘 알려져 있습니다. 산후 정서 질환에는 세 가지 일반적인 형태가 있습니다 : 블루스(베이비 블루, 출산 블루), 산후(또는 산후) 우울증, 산후(산후 또는 산후) 정신병, 각각 다른 유병률, 임상 증상 및 관리가 다릅니다. 산후 우울증은 산모, 부부관계, 자녀에게 미치는 영향 때문에 진단, 치료, 예방이 중요한 질환입니다. 치료하지 않은 PPD는 장기적으로 부정적인 영향을 미칠 수 있습니다. 어머니의 경우, 이 에피소드는 만성 재발성 우울증의 전조가 될 수 있습니다. 자녀의 경우, 어머니의 우울증이 지속되면 이후 정서적, 행동적, 인지적, 대인관계 문제를 유발할 수 있습니다.
산욕기와 기분장애의 연관성은 히포크라테스 시대부터 지적되어 왔습니다. 여성은 산후에 심각한 정신질환에 걸릴 위험이 높습니다. 산후 1개월 이내에 정신과 병원에 입원할 가능성이 다른 어떤 시기보다 높다는 연구 결과가 있습니다. 여성 정신과 입원의 최대 12.5%가 산욕기에 발생합니다.
산후 우울증의 선별검사는 강력하게 고려해야 하지만, 보편적인 선별검사 도구를 지지하는 증거는 부족합니다. 알려진 위험 요인을 가진 환자는 산후 우울증을 선별하기 위해 널리 사용되는 10가지 항목의 자가 평가 척도인 EPDS를 통해 선별 검사를 받을 수 있습니다. 산후 우울증 진단은 Edinburgh Postnatal Depression Scale에서 12점 이상인 여성, 중등도에서 중증의 사회적 기능 장애를 유발하는 증상을 경험하는 여성, 자살 충동을 보고하는 여성, 10일 이상 증상을 경험하는 여성에게 강력히 고려해야 합니다.
산후 우울증의 진단에는 환자에게 과거 조증 에피소드에 대해 물어보는 것도 포함되어야 합니다. 조증 또는 경조증의 병력은 양극성 장애의 가능성이 있으며, 특정 약수처리가 필요합니다. 양극성 장애는 또한 산후 기분 에피소드의 위험이 높습니다. 과거 조증 에피소드의 스크리닝을 위해 권장되는 질문은 다음 두 가지입니다.
산후 우울증의 치료에는 항우울제, 인지행동치료(CBT), 대인관계치료가 효과적입니다. 기타 산후 우울증 치료에는 정신역동요법, 광선요법, 운동요법, 요가 등이 있으나, 이러한 치료법의 효과에 대한 현재 연구 증거는 예비적인 수준에 머물러 있습니다.
본 보고서는 주요 7개국의 산후 우울증 시장에 대해 조사했으며, 시장 개요, 역학, 환자 동향, 새로운 치료법, 2034년까지 시장 규모 예측, 미충족 의료 수요 등을 정리하여 전해드립니다.
Postpartum Depression Treatment Market Report: Summary
Various key Postpartum Depression companies are leading the treatment landscape, such as Sage Therapeutics, Marinus Pharmaceuticals, Lipocine, Brii Biosciences, and others. The details of the country-wise and therapy-wise Postpartum Depression market size have been provided below.
Postpartum Depression Pipeline Drugs Market Chapters
The section dedicated to drugs in the Postpartum Depression pipeine drugs market report provides an in-depth evaluation of late-stage Postpartum Depression pipeline drugs (Phase III and Phase II) related to Postpartum Depression. The drug chapters section provides valuable information on various aspects related to Postpartum Depression clinical trials, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent Postpartum Depression news updates and press releases on drugs targeting Postpartum Depression.
Postpartum Depression Marketed Therapies
Zuranolone (SAGE-217) is an investigational, oral, novel medicine in development for postpartum depression (PPD). It is given once daily, a 2-week therapy neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM) specifically designed to relieve several depression disorders, including PPD, major depressive disorder (MDD), and treatment-resistant depression. The GABA system is the major inhibitory signaling pathway of the brain, and the central nervous system (CNS) significantly regulates CNS function. SAGE-217 has been optimized for selectivity to synaptic and extrasynaptic type a Y-aminobutyric acid (GABAA) receptors and a pharmacokinetic profile for daily oral dosing.
ZULRESSO is a proprietary IV formulation of brexanolone. Brexanolone is chemically identical to allopregnanolone, a naturally occurring neuroactive steroid that acts as a positive allosteric modulator of gamma-aminobutyric acid (GABA) receptors indicated for treating PPD in adults. Brexanolone is available to patients only through a Risk Evaluation and Mitigation Strategy (REMS) program and must be administered at a certified healthcare facility. In addition, patients must be monitored continuously during the drug infusion due to the risk of serious side effects. Notably, ZULRESSO (brexanolone) is the first drug approved by the US FDA specifically for PPD in adults.
The mechanism of action of brexanolone in treating PPD in adults is related to its positive allosteric modulation of GABAA receptors. Brexanolone potentiated GABA-mediated currents from recombinant human GABAA receptors in mammalian cells expressing a1B2Y2 receptor subunits, a4B3δ receptor subunits, and a6B3δ receptor subunits.
Postpartum Depression Emerging Therapies
Ganaxolone (CCD-1042) is a lead clinical-stage drug candidate that brings a GABAA receptor modulating mechanism and an extensive safety database with exhibited anti-epileptic (antiseizure), anxiolytic (anti-anxiety) and anti-depressive activity in development by Marinus Pharmaceuticals. It is being developed in three different dosage forms (IV, capsule, and liquid) to maximize therapeutic reach to adult and pediatric patients in acute and chronic care settings with severe PPD. Unlike benzodiazepines, ganaxolone exhibits antiseizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors. Ganaxolone has been designed with an added methyl group that prevents back conversion to an active steroid, which unlocks ganaxolone's potential for chronic use. In preclinical studies, ganaxolone exhibited potency and efficacy comparable to allopregnanolone.
The drug has completed the Phase II stage of clinical development, which was investigated in IV and oral formulations for patients with PPD.
Antidepressants, such as Abilify (aripiprazole), Zoloft (sertraline hydrochloride), Spravato (esketamine), Prozac (fluoxetine capsules), Celexa (citalopram hydrobromide), Luvox CR (Fluvoxamine Maleate), and Paxil CR (paroxetine) form the mainstay in the Postpartum Depression treatment. Although these drugs are approved for treating depression-related disorders such as major depressive disorder (MDD), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), treatment-resistant depression (TRD), etc., they are being used as off-label drugs for the treatment of PPD. The type of medication prescribed by the doctors largely depends on the set of symptoms, severity and the specific type of PPD the patient is suffering from. The primary concern about antidepressants is the uncertainty in the outcomes and their side effects on new born due to breastfeeding. Though antidepressants are not necessarily a permanent cure for PPD, they are an important aspect of managing depression symptoms and restoring quality of life.
Many new molecules with novel mechanisms, like GABAA receptor positive allosteric modulator, allosteric modulator of Y-aminobutyric acid ("GABA") receptor among others, are being developed for the treatment PPD by key players like Sage Therapeutics, Marinus Pharmaceuticals, Lipocine, Brii Biosciences among others.
In conclusion, despite the lack of appropriate treatment in the current Postpartum Depression treatment market landscape, many potential therapies with novel mechanisms are expected to enter the market, resolving a dire Postpartum Depression unmet need and leading to significant improvement in the treatment outcome of Postpartum Depression patients. Hence, with the upcoming availability of new treatment options and increasing healthcare spending across the 7MM, the Postpartum Depression treatment market scenario is expected to experience significant growth during the forecast period (2024-2034).
Postpartum Depression Treatment Market: Overview
Postpartum depression (PPD) is the most common non-psychotic complication of childbearing affecting approximately 10-15% of women and, as such, represents a considerable public health problem affecting women and their families. The postnatal period is well established as an increased time of risk for the development of serious mood disorders. There are three common forms of postpartum affective illness: the blues (baby blues, maternity blues), postpartum (or postnatal) depression, and puerperal (postpartum or postnatal) psychosis, each of which differs in its prevalence, clinical presentation, and management. The effects of postnatal depression on the mother, her marital relationship, and her children make it an important condition to diagnose, treat, and prevent. Untreated PPD can have adverse long-term effects. For the mother, the episode can be the precursor of chronic recurrent depression. For her children, a mother's ongoing depression can contribute to emotional, behavioral, cognitive, and interpersonal problems in later life.
The association between the postpartum period and mood disturbances has been noted since the time of Hippocrates. Women are at increased risk of developing severe psychiatric illness during the puerperium. Studies have shown that a woman is more likely to be admitted to a psychiatric hospital within the first month postpartum than at any other time. Up to 12.5% of all psychiatric hospital admissions of women occur during the postpartum period.
Postpartum Depression Diagnosis
Screening for postpartum depression should be considered strongly, although evidence supporting universal screening tools is lacking. Patients with known risk factors may be selected for screening with the EPDS. The EPDS is a 10-item self-rated instrument used widely to screen for postpartum depression. The Postpartum Depression diagnosis should be strongly considered in women who score above 12 on the Edinburgh Postnatal Depression Scale, experience symptoms that cause moderate to severe social dysfunction, report any suicidal ideation, or experience symptoms for more than 10 days.
Diagnosing postpartum major depression should also include asking patients about past manic episodes. A history of mania or hypomania may indicate bipolar disorder, requiring specific pharmacologic treatment. Bipolar disorder is also associated with a higher risk of mood episodes postpartum. Two questions that are recommended for screening for past manic episodes are
Postpartum Depression Treatment
Antidepressant medications, cognitive-behavioral therapy (CBT), and interpersonal therapy are effective in treating Postpartum Depression. Other Postpartum Depression treatments which may be useful include psychodynamic therapy, light therapy, exercise, and yoga, but the current research evidence about the efficacy of such treatment regimens is more preliminary.
The Postpartum Depression epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Population of Maternal Postpartum Depression in the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
KOL Views
To stay abreast of the latest trends in the Postpartum Depression treatment market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research. We have reached out to industry experts to gather insights on various aspects of Postpartum Depression, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility.
The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan. Our team of analysts at Delveinsight connected with more than 15 KOLs across the 7MM. We contacted institutions such as the University of Nevada, University of Pittsburgh Medical Center, UConn Health Center, Strasbourg University, and Feinstein Institutes for Medical Research etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Postpartum Depression management market outlook, which will assist our clients in analyzing the overall epidemiology and market scenario.
Some opinion of experts from various regions has been provided below:
Postpartum Depression Management Market: Qualitative Analysis
We perform Qualitative and Postpartum Depression Pipeline Drugs Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in trials for Postpartum Depression, important primary endpoints are overall survival rate, event-free survival, progression free survival, etc. Based on these parameters, the overall efficacy is evaluated.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, a final weightage score is decided, based on which the emerging therapies are ranked.
Postpartum Depression Therapeutics Market Access and Reimbursement
Because newly Postpartum Depression authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.
The Postpartum Depression management market outlook report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.