産後うつ病市場 - 市場の洞察、疫学、市場予測：2034年

主なハイライト

• 主要7ヶ国の産後うつ病治療の市場規模は、2023年に2億6,000万米ドルと推定されました。
• EU4ヶ国と英国の中で、2023年の産後うつ病市場規模が最も大きいのは英国で、2,500万米ドルでした。
• 主要7カ国のうち、2023年に産後うつ病と診断された有病者数は131万人でした。
• EU4ヶ国と英国では、女性の産後うつ病診断有病者数は2023年に46万人でした。
• 産後うつ病（PPD）は、出産する女性に最もよくみられる非精神病性合併症です。産後うつ病は、母親と乳児の正常な結びつきを阻害し、子どもの急性および長期的な発達に悪影響を及ぼす可能性があります。
• 産後うつ病は、少なくとも5つの抑うつ症状が2週間以上存在する場合に診断されます。精神障害の診断と統計マニュアル（DSM-5）では、PPDは周産期発症とともに大うつ病エピソードがある場合に考慮され、別の疾患としては言及されていません。
• 産後うつ病のスクリーニングは、産後2～6ヵ月後に行うことができます。産後うつ病の女性は、躁病の特徴についても評価されるべきです。いくつかのスクリーニングツールが利用可能であり、最も頻繁に使用されるもの1つがエジンバラ産後うつ病尺度（EPDS）です。
• 選択的セロトニン再取り込み阻害薬（SSRI）が伝統的な第一選択です。中等度から重度のうつ病の女性には、抗うつ薬と治療の併用が推奨されます。
• ZURZUVAE（ズラノロン）とZULRESSO（ブレキサノロン）は、産後うつ病（PPD）に対して唯一承認されている薬です。ズレッソは持続点滴静注で投与されるのに対し、ZURZUVAEは50mgを14日間経口投与することが推奨されています。新たなPPD治療薬の開発に取り組んでいる主な産後うつ病企業には、Sage Therapeutics、Marinus Pharmaceuticals、Lipocine、Brii Biosciencesなどがあります。

産後うつ病治療市場レポート：サマリー

• 当レポートは、産後うつ病市場について調査し、疫学セグメントと予測に関する広範な知識を提供しており、診断率、疾患の進行、治療ガイドラインにおける将来の潜在的な成長に関する深い理解を提示します。これらの側面に関する包括的な洞察を提供し、主題の徹底的な評価を可能にします。
• さらに、現在の産後うつ病管理市場の技術や新たな治療法の包括的な説明や、現在の産後うつ病治療市場の展望に影響を与え、全体的な市場シフトをもたらす後期（第III相および第II相）および著名な治療法の詳細なプロファイルが報告書に記載されています。
• また、産後うつ病治療薬市場の包括的な分析を包含し、その市場規模（2020年～2034年）の歴史と予測に関する詳細な検討を提供します。また、治療薬の産後うつ病市場シェア、詳細な前提条件、調査手法の根拠も記載しています。産後うつ病治療薬市場レポートには、主要7ヶ国地域における医薬品アウトリーチも含まれています。
• 当レポートには、主要7ヶ国の産後うつ病治療薬市場を形成し促進するのに役立つ、SWOT分析、様々な病院や著名大学の専門家を含む専門家の洞察/KOLの見解、患者の旅、治療の嗜好など、動向を理解することにより、事業戦略を策定する際に強みとなる定性的洞察が含まれています。

産後うつ病市場の展望

Sage Therapeutics、Marinus Pharmaceuticals、Lipocine、Brii Biosciencesなど、さまざまな主要産後うつ病企業が治療展望をリードしています。国別および治療法別の産後うつ病市場規模の詳細は以下の通りです。

• 主要7ヶ国の産後うつ病治療の市場規模は、2023年には2億6,000万米ドルになると推定されました。
• 主要主要7ヶ国の産後うつ病治療薬市場において、SNRIとSSRIは産後うつ病治療薬市場全体の20％の市場シェアを占め、非定型抗うつ薬と抗精神病薬は2023年に19％の市場シェアを占めました。
• 主要7ヶ国では、ZURZUVAEは2034年までに～6億米ドルの産後うつ病治療薬市場の収益を獲得すると予想されています。
• 主要7市場の中で、米国は産後うつ病治療薬市場全体の中で最も高いシェア（64％）を占めています。
• EU4ヶ国と英国の中で、英国が最も高い産後うつ病治療市場規模を占め、2023年には2,500万米ドルに達します。
• 日本は2023年に2,000万米ドルの産後うつ病市場規模を占め、2034年までに緩やかな増加が見込まれます。

上市済み産後うつ病治療薬

• ZURZUVAE（ズラノロン）：Sage Therapeutics/Biogen

ズラノロン（SAGE-217）は、産後うつ病（PPD）を対象に開発中の経口新薬です。1日1回、2週間投与の神経活性ステロイド（NAS）GABAA受容体陽性アロステリックモジュレーター（PAM）で、PPD、大うつ病性障害（MDD）、治療抵抗性うつ病など、いくつかのうつ病性障害を緩和するために特別にデザインされています。GABAシステムは脳の主要な抑制性シグナル伝達経路であり、中枢神経系（CNS）はCNS機能を著しく制御しています。SAGE-217は、シナプスおよびシナプス外Y-アミノ酪酸（GABAA）受容体に対する選択性と、1日1回の経口投与に適した薬物動態プロファイルに最適化されています。

• ZULRESSO：Sage Therapeutics

ZULRESSOはBrexanoloneの独自の静注製剤です。Brexanoloneは、天然に存在する神経活性ステロイドであるアロプレグナノロンと化学的に同一であり、成人のPPD治療に適応のあるγ-アミノ酪酸（GABA）受容体の陽性アロステリックモジュレーターとして作用します。ブレキサノロンは、リスク評価・軽減戦略（REMS）プログラムを通じてのみ患者に投与可能であり、認定を受けたヘルスケア施設で投与されなければなりません。また、重篤な副作用の危険性があるため、薬剤注入中は患者を継続的に監視しなければならないです。注目すべきは、ズレッソ（ブレキサノロン）が成人のPPDに特化して米国FDAに承認された最初の薬剤であることです。

成人のPPD治療におけるブレキサノロンの作用機序は、GABAA受容体の陽性アロステリック調節に関連しています。ブレキサノロンは、a1B2Y2受容体サブユニット、a4B3δ受容体サブユニット、およびa6B3δ受容体サブユニットを発現する哺乳類細胞において、組換えヒトGABAA受容体からのGABA媒介電流を増強しました。

産後うつ病の新興治療薬

• ガナキソロン：Marinus Pharmaceuticals

ガナキソロン（CCD-1042）は、GABAA受容体の調節機構と豊富な安全性データベースを持ち、抗てんかん（抗てんかん作用）、抗不安（抗不安作用）、抗うつ作用を示すMarinus Pharmaceuticalsが開発中の臨床段階のリード医薬品候補です。本薬は、急性期および慢性期医療に従事する重篤なPPDの成人および小児患者への治療効果を最大化するため、3つの異なる剤形（静注、カプセル、液剤）で開発中です。ベンゾジアゼピン系薬剤とは異なり、ガナキソロンはシナプスおよびシナプス外GABAA受容体への作用により抗痙攣・抗不安作用を示します。ガナキソロンは、活性型ステロイドへの逆変換を防ぐメチル基を付加して設計されており、ガナキソロンの慢性使用の可能性を解き放ちます。前臨床試験において、ガナキソロンはアロプレグナノロンに匹敵する効力と有効性を示しました。

本薬は臨床開発の第II相段階を終了しており、PPD患者を対象に静脈内投与と経口投与の製剤が検討されました。

エビリファイ（アリピプラゾール）、ゾロフト（塩酸セルトラリン）、スプラバト（エスケタミン）、プロザック（フルオキセチン・カプセル）、セレクサ（臭化水素酸シタロプラム）、ルボックスCR（マレイン酸フルボキサミン）、パキシルCR（パロキセチン）などの抗うつ薬が、産後うつ病治療の主力を形成しています。これらの薬は、大うつ病性障害（MDD）、強迫性障害（OCD）、心的外傷後ストレス障害（PTSD）、治療抵抗性うつ病（TRD）などのうつ病関連疾患の治療薬として承認されていますが、PPDの治療には適応外薬として使用されています。医師が処方する薬の種類は、患者の症状、重症度、PPDの種類によって大きく異なります。抗うつ薬に関する主な懸念は、母乳育児による新生児への結果の不確実性と副作用です。抗うつ薬は必ずしもPPDの永久的な治療薬ではないが、うつ病の症状を管理し、生活の質を回復させるための重要な手段です。

GABAA受容体陽性アロステリックモジュレーター、Y-アミノ酪酸（GABA）受容体アロステリックモジュレーターなど、新規メカニズムを持つ多くの新規分子が、Sage Therapeutics、Marinus Pharmaceuticals、Lipocine、Brii Biosciencesなどの主要企業によって、PPD治療のために開発されています。

結論として、現在の産後うつ病治療市場には適切な治療法がないにもかかわらず、新規メカニズムを持つ多くの潜在的な治療法が市場に参入し、産後うつ病の切実なアンメットニーズを解決し、産後うつ病患者の治療成績の大幅な改善につながると期待されています。したがって、新たな治療オプションの利用が可能になりつつあり、主要7ヶ国全体でヘルスケア支出が増加していることから、産後うつ病治療市場のシナリオは予測期間（2024年～2034年）に大きな成長を遂げると予想されます。

産後うつ病（PPD）は、女性の約10～15％が罹患する、出産に伴う最も一般的な非精神病性合併症であり、女性とその家族に影響を及ぼす公衆衛生上の大きな問題です。産後は重篤な気分障害の開発リスクが高まる時期であることはよく知られています。産後の感情疾患には3つの一般的な形態がある：ブルース（ベビーブルー、マタニティブルー）、産後（または産後）うつ病、産褥（産後または産後）精神病であり、それぞれ有病率、臨床症状、管理が異なります。産後うつ病の母親、夫婦関係、子どもへの影響から、診断、治療、予防が重要な疾患です。未治療のPPDは長期的に悪影響を及ぼす可能性があります。母親にとって、このエピソードは慢性再発性うつ病の前兆となりうる。子供にとっては、母親のうつ病が続くことで、その後の人生で感情的、行動的、認知的、対人的な問題を引き起こす可能性があります。

産褥期と気分障害との関連は、ヒポクラテスの時代から指摘されています。女性は産褥期に重篤な精神疾患を発症するリスクが高いです。産後1ヵ月以内に精神科病院に入院する可能性が、他のどの時期よりも高いことが研究で示されています。女性の精神科入院の最大12.5％が産褥期に起こっています。

産後うつ病のスクリーニングは強く考慮されるべきですが、普遍的なスクリーニングツールを支持する証拠は不足しています。既知の危険因子を有する患者は、EPDSによるスクリーニングの対象として選択されます。EPDSは、産後うつ病のスクリーニングに広く用いられている10項目の自己評価尺度です。産後うつ病の診断は、Edinburgh Postnatal Depression Scaleで12点以上である女性、中等度から重度の社会的機能障害を引き起こす症状を経験する女性、自殺念慮を報告する女性、10日以上症状を経験する女性に強く考慮されるべきです。

産後大うつ病の診断には、過去の躁病エピソードについて患者に尋ねることも含まれるべきです。躁病または軽躁病の病歴は双極性障害の可能性があり、特異的な薬物治療を必要とします。双極性障害は産後の気分エピソードのリスクも高いです。過去の躁病エピソードのスクリーニングに推奨される質問は以下の2つです。

• 「気分がとても良かったり、ハイになったり、興奮したり、ハイパーになったりして、他の人からいつもの自分ではないと思われたり、トラブルに巻き込まれたりした日が4日間続いたことがありますか？」
• 「人に怒鳴ったり、喧嘩や口論を始めたりするほどイライラした日が4日続いたことがありますか？」肯定的な回答には精神科医への紹介が必要です。

産後うつの治療には、抗うつ薬、認知行動療法（CBT）、対人関係療法が効果的です。その他の産後うつ病治療には、精神力動療法、光療法、運動療法、ヨガなどがあるが、これらの治療法の有効性に関する現在の研究証拠は予備的なものです。

• 抗うつ薬別薬物療法-産後うつ病は、治療と抗うつ薬を組み合わせて治療することができます。妊娠中または授乳中に抗うつ薬を使用することには一定のリスクがあります。そのため、治療中に薬を使用するかどうかを決める前に、利益とリスクを十分に比較・分析します。
• 心理学的および心理社会的治療-既存の研究は、心理学的治療（特に対人関係療法、認知行動療法、精神力動的心理療法）および非指示的カウンセリングなどの心理社会的介入の使用を支持しています。
• 非薬理学的治療-非薬理学的治療には、電気けいれん療法、明光療法、オメガ3脂肪酸、鍼治療、マッサージなどがあります。

当レポートでは、主要7ヶ国における産後うつ病市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2034年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 重要な洞察

第2章 報告書のイントロダクション

第3章 産後うつ病市場概要

• 市場シェア（％）2020年の産後うつ病（PPD）の治療法別分布
• 市場シェア（％）2034年の産後うつ病（PPD）の治療法別分布

第4章 産後うつ病のエグゼクティブサマリー

第5章 主要な出来事

第6章 疾患の背景と概要

• イントロダクション
• 臨床症状
• リスク要因
• 病因
• 診断とスクリーニング

第7章 治療と管理

• 抗うつ薬
• 心理的および心理社会的治療
• 非薬物療法
• ホルモン療法
• 治療アルゴリズム
• ユニケアによる治療ガイドライン
• 英国国立医療技術評価機構（NICE）による治療ガイドライン

第8章 調査手法

第9章 疫学と患者人口

• 主な調査結果
• 仮定と根拠
• 主要7ヶ国における産後うつ病の診断を受けた有病者総数
• 米国の疫学シナリオ
• EU4ヶ国と英国における疫学シナリオ
• 日本における疫学シナリオ

第10章 患者動向

第11章 市販されている治療法

• キークロス
• ズルレッソ：Sage Therapeutics

第12章 新たな治療法

• キークロス
• SAGE-217/BIIB-125：Sage Therapeutics/Biogen
• ガナキソロン：Marinus Pharmaceuticals
• LPCN 1154：Lipocine
• BRII-296：Brii Biosciences Limited

第13章 産後うつ病（PPD）：主要7ヶ国市場分析

• 主な調査結果
• 市場見通し
• 主要な市場予測の前提条件
• 主要7ヶ国における産後うつ病（PPD）の総市場規模
• 主要7ヶ国における産後うつ病（PPD）の市場規模（治療法別）
• 米国の市場規模
• EU4ヶ国と英国の市場規模
• 日本の市場規模

第14章 KOLの見解

第15章 SWOT分析

第16章 アンメットニーズ

第17章 市場アクセスと償還

• 米国
• EU4ヶ国と英国
• 日本

第18章 付録

第19章 DelveInsightのサービス内容

第20章 免責事項

第21章 DelveInsightについて

List of Tables

• Table 1: Summary of Postpartum Depression (PPD), Market, and Epidemiology (2020-2034)
• Table 2: Key Events
• Table 3: Key Recommendations for Practice
• Table 4: Depression in DSM Evolution
• Table 5: Depression in DSM
• Table 6: DSM-V Diagnostic Criteria for Major Depressive Episode
• Table 7: Commercially Available Antidepressants to Use During Pregnancy or Breastfeeding
• Table 8: Total Diagnosed Prevalent Population of Maternal Postpartum Depression in the 7MM, in Thousand (2020-2034)
• Table 9: Total Diagnosed Prevalent Population of Maternal Postpartum Depression in the United States, in Thousand (2020-2034)
• Table 10: Total Diagnosed Prevalent Population of Maternal Postpartum Depression in EU4 and the UK, in Thousand (2020-2034)
• Table 11: Total Diagnosed Prevalent Population of Maternal Postpartum Depression in Japan, in Thousand (2020-2034))
• Table 12: Comparison of Marketed Drugs
• Table 13: Patents for ZULRESSO
• Table 14: ZULRESSO, Clinical Trial Description, 2024
• Table 15: Comparison of Emerging Drugs Under Development
• Table 16: Zuranolone, Clinical Trial Description, 2024
• Table 17: SKYLARK Study Summary Results
• Table 18: Ganaxalone; Clinical Trial Description, 2024
• Table 19: Key Market Forecast Assumptions for Zuranolone
• Table 20: Total Market Size of Postpartum Depression (PPD) in the 7MM, in USD million (2020-2034)
• Table 21: Market Size of Postpartum Depression (PPD) by Therapies in the 7MM, in USD million (2020-2034)
• Table 22: Total Market Size of Postpartum Depression (PPD) in the United States, in USD million (2020-2034)
• Table 23: Market Size of Postpartum Depression (PPD) by Therapies in the United States, in USD million (2020-2034)
• Table 24: Total Market Size of Postpartum Depression (PPD) in EU4 and the UK, in USD million (2020-2034)
• Table 25: Market Size of Postpartum Depression (PPD) by Therapies in EU4 and the UK, in USD million (2020-2034)
• Table 26: Total Market Size of Postpartum Depression (PPD) in Japan, in USD million (2020-2034)
• Table 27: Market Size of Postpartum Depression (PPD) by Therapies in Japan, in USD million (2020-2034)

List of Figures

• Figure 1: Pathogenesis of PPD
• Figure 2: Pharmacological Treatment of PPD
• Figure 3: Total Diagnosed Prevalent Population of Maternal Postpartum Depression in the 7MM (2020-2034)
• Figure 4: Total Diagnosed Prevalent Population of Maternal Postpartum Depression in the United States (2020-2034)
• Figure 5: Total Diagnosed Prevalent Population of Maternal Postpartum Depression in EU4 and the UK (2020-2034)
• Figure 6: Total Diagnosed Prevalent Population of Maternal Postpartum Depression in Japan (2020-2034)
• Figure 7: Total Market Size of Postpartum Depression (PPD) in the 7MM (2020-2034)
• Figure 8: Market Size of Postpartum Depression (PPD) by Therapies in the 7MM, in USD million (2020-2034)
• Figure 9: Total Market Size of Postpartum Depression (PPD) in the United States, in USD million (2020-2034)
• Figure 10: Market Size of Postpartum Depression (PPD) by Therapies in the United States, in USD million (2020-2034)
• Figure 11: Total Market Size of Postpartum Depression (PPD) in EU4 and the UK, in USD million (2020-2034)
• Figure 12: Market Size of Postpartum Depression (PPD) by Therapies in EU4 and the UK, in USD million (2020-2034)
• Figure 13: Total Market Size of Postpartum Depression (PPD) in Japan, in USD million (2020-2034)
• Figure 14: Market Size of Postpartum Depression (PPD) by Therapies in Japan, in USD million (2020-2034)
• Figure 15: Unmet Needs
• Figure 16: Health Technology Assessment
• Figure 17: Reimbursement Process in Germany
• Figure 18: Reimbursement Process in France
• Figure 19: Reimbursement Process in Italy
• Figure 20: Reimbursement Process in Spain
• Figure 21: Reimbursement Process in the United Kingdom
• Figure 22: Reimbursement Process in Japan

Key Highlights:

• The Postpartum Depression Treatment Market Size in the 7MM was estimated to be USD 260 million in 2023.
• Among EU4 and the UK, the UK accounted for the highest Postpartum Depression Market Size of ~USD 25 Million in 2023.
• Among the seven major countries, the Postpartum Depression diagnosed prevalent cases were ~1,310,000, in 2023.
• In EU4 and the UK, the total Postpartum Depression diagnosed prevalent cases in Females were ~4,60,000 in 2023.
• Postpartum Depression (PPD) is the most common non-psychotic complication of childbearing women. It can interfere with normal maternal-infant bonding and adversely affect acute and long-term child development.
• Postpartum Depression is diagnosed when at least five depressive symptoms are present for at least 2 weeks. In the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), PPD is considered when a patient has a major depressive episode along with the peripartum onset, and it is not mentioned as a separate disease.
• Screening for Postpartum Depression can be done 2-6 months after childbirth. Women with Postpartum Depression should also be assessed for manic features. Several screening tools are available, and one of the most frequently used is the Edinburgh Postnatal Depression Scale (EPDS).
• Selective serotonin reuptake inhibitors (SSRIs) are the traditional first choice. Antidepressant medication in combination with therapy is recommended for women with moderate-to-severe depression.
• ZURZUVAE (zuranolone) and ZULRESSO (brexanolone) are the sole approved medications for postpartum depression (PPD). Zulresso is administered as a continuous intravenous (IV) infusion while the recommended dosage for ZURZUVAE is 50 mg orally for 14 days. Key Postpartum Depression Companies in developing emerging PPD therapies include Sage Therapeutics, Marinus Pharmaceuticals, Lipocine, and Brii Biosciences.

Postpartum Depression Treatment Market Report: Summary

• The Postpartum Depression drugs market report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current Postpartum Depression management market techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current Postpartum Depression treatment market landscape and result in an overall market shift has been provided in the report.
• The Postpartum Depression drugs market report also encompasses a comprehensive analysis of the Postpartum Depression therapeutics market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the Postpartum Depression market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The Postpartum Depression therapeutics market report also includes drug outreach coverage in the 7MM region.
• The Postpartum Depression drugs market report includes qualitative insights that provide an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM Postpartum Depression drugs market.

Postpartum Depression Market Outlook

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.

• The Postpartum Depression Treatment Market Size in the 7MM was estimated to be USD 260 Million in 2023.
• In the seven major Postpartum Depression Therapeutics Market, SNRI's and SSRI's constituted 20% market share of the overall Postpartum Depression Drugs Market, while Atypical antidepressants and Antipsychotics held 19% market share, in 2023.
• In the 7MM, ZURZUVAE is expected to garner Postpartum Depression Therapeutics market revenue of ~USD 600 million by 2034.
• Among the seven major market, the United States held the highest Postpartum Depression Drugs Market Share (64%) of the overall Postpartum Depression market.
• Among EU4 and the UK, the UK accounted for the highest Postpartum Depression Treatment Market Size was ~USD 25 million in 2023
• Japan accounted for a Postpartum Depression Market Size of ~USD 20 million in 2023, which is expected to increase at a moderate rate by 2034.

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

• ZURZUVAE (zuranolone) : Sage Therapeutics/Biogen

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: Sage Therapeutics

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: Marinus Pharmaceuticals

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.

Postpartum Depression Market Outlook

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

• "Have you ever had four continuous days when you were feeling so good, high, excited, or hyper that other people thought you were not your normal self, or you got into trouble?" and
• "Have you experienced four continuous days when you were so irritable that you found yourself shouting at people or starting fights or arguments?" Positive responses require referral to a psychiatrist.

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.

• Antidepressant Medication- Postpartum Depression can be treated using a combination of therapy and antidepressant medications. There are certain risks of using antidepressants during pregnancy or breastfeeding. Therefore, the benefits and risks are weighed and analyzed adequately before deciding whether or not to use medications during treatment.
• Psychological and Psychosocial Treatments- Existing research supports the use of psychological treatments (specifically interpersonal therapy, cognitive-behavioral therapy, and psychodynamic psychotherapy) and psychosocial interventions, such as non-directive counseling.
• Non-pharmacologic Treatments- Non-pharmacologic Treatments includes Electroconvulsive therapy, Bright light therapy, Omega-3 fatty acids, Acupuncture and massage.

Postpartum Depression Epidemiology

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.

• Among the seven major countries, the total Postpartum Depression diagnosed prevalence cases were ~1,310,000, in 2023.
• In EU4 and the UK, the total Postpartum Depression diagnosed prevalence cases were ~4,60,000 in 2023.
• In the seven major market, the United States accounted for the highest number of Postpartum Depression diagnosed cases (~720,000), followed by the UK, in 2023.
• In Japan, the total Postpartum Depression diagnosed prevalent cases were ~126,000 in 2023.

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.

Postpartum Depression Treatment Market Report Insights

• Patient-based Postpartum Depression Market Forecasting
• Therapeutic Approaches in the Postpartum Depression Management Market
• Postpartum Depression Market Size
• Postpartum Depression Market Trends
• Postpartum Depression Market Outlook
• Existing Postpartum Depression Pipeline Drugs Market Opportunity

Postpartum Depression Treatment Market Report Key Strengths

• 11 Years- Postpartum Depression Market Forecast
• The 7MM Coverage
• Postpartum Depression Epidemiology Segmentation
• Key Cross Competition in the Postpartum Depression Management Market

Postpartum Depression Treatment Market Report Assessment

• Current Postpartum Depression Treatment Market Practices
• Reimbursements
• Postpartum Depression Market Outlook Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Postpartum Depression Unmet needs)

Key Questions:

• Would there be any changes observed in the current Postpartum Depression treatment market approach?
• Will there be any improvements in Postpartum Depression management market recommendations?
• Would research and development advances pave the way for future tests and Postpartum Depression therapies?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the Postpartum Depression treatment landscape?
• What kind of uptake will the new therapies witness in coming years in Postpartum Depression patients?

Table of Contents

1. Key Insights

2. Report Introduction

3. Postpartum Depression Market Overview at a Glance

• 3.1 Market Share (%) Distribution of Postpartum Depression (PPD) by therapies in 2020
• 3.2 Market Share (%) Distribution of Postpartum Depression (PPD) by therapies in 2034

4 Executive Summary of Postpartum Depression

5 Key events

6 Disease Background and Overview

• 6.1 Introduction
• 6.2 Clinical Presentation
• 6.3 Risk Factors
• 6.4 Pathogenesis
• 6.5 Diagnosis and Screening
  • 6.5.1 Diagnostic Criteria

7 Treatment and Management

• 7.1 Antidepressant Medication
• 7.2 Psychological and Psychosocial Treatments
• 7.3 Non-pharmacologic Treatments
• 7.4 Hormone Therapy
• 7.5 Treatment Algorithm
• 7.6 Treatment Guidelines by Unicare
• 7.7 Treatment Guidelines by the National Institute for Health and Care Excellence (NICE)

8 Methodology

9 Epidemiology and Patient Population

• 9.1 Key Findings
• 9.2 Assumptions and Rationale
• 9.3 Total Diagnosed Prevalent Population of Postpartum Depression in the 7MM
• 9.4 Epidemiology Scenario in the United States
  • 9.4.1 Total Diagnosed Prevalent Population of Maternal Postpartum Depression in the United States
• 9.5 Epidemiology Scenario in EU4 and the UK
  • 9.5.1 Total Diagnosed Prevalent Population of Maternal Postpartum Depression in EU4 and the UK
• 9.6 Epidemiology Scenario in Japan
  • 9.6.1 Total Diagnosed Prevalent Population of Maternal Postpartum Depression in Japan

10 Patient Journey

11 Marketed Therapies

• 11.1 Key Cross
• 11.2 ZULRESSO: Sage Therapeutics
  • 11.2.1 Product Description
  • 11.2.2 Regulatory Milestones
  • 11.2.3 Other Developmental Activities
  • 11.2.4 Clinical Developmental Activities
  • 11.2.5 Safety and Efficacy

12 Emerging Therapies

• 12.1 Key Cross
• 12.2 SAGE-217/BIIB-125: Sage Therapeutics/Biogen
  • 12.2.1 Product Description
  • 12.2.2 Other Developmental Activities
  • 12.2.3 Clinical Development
  • 12.2.4 Safety and efficacy
• 12.3 Ganaxolone: Marinus Pharmaceuticals
  • 12.3.1 Product Description
  • 12.3.2 Other Developmental Activity
  • 12.3.3 Clinical Development
  • 12.3.4 Safety and efficacy
• 12.4 LPCN 1154: Lipocine
  • 12.4.1 Product Description
  • 12.4.2 Other Developmental Activity
• 12.5 BRII-296: Brii Biosciences Limited
  • 12.5.1 Product Description
  • 12.5.2 Clinical Development
  • 12.5.3 Safety and efficacy

13 Postpartum Depression (PPD): Seven Major Market Analysis

• 13.1 Key Findings
• 13.2 Market Outlook
• 13.3 Key Market Forecast Assumptions
• 13.4 Total Market Size of Postpartum Depression (PPD) in the 7MM
• 13.5 Market Size of Postpartum Depression (PPD) by Therapies in the 7MM
• 13.6 The United States Market Size
  • 13.6.1 Total Market Size of Postpartum Depression (PPD) in the United States
  • 13.6.2 Market Size of Postpartum Depression (PPD) by Therapies in the United States
• 13.7 EU4 and the UK Market Size
  • 13.7.1 Total Market Size of Postpartum Depression (PPD) in EU4 and the UK
  • 13.7.2 Market Size of Postpartum Depression (PPD) by Therapies in EU4 and the UK
• 13.8 Japan Market Size
  • 13.8.1 Total Market Size of Postpartum Depression (PPD) in Japan
  • 13.8.2 Market Size of Postpartum Depression (PPD) by Therapies in Japan

14 KOL Views

15 SWOT Analysis

16 Unmet Needs

17 Market Access and Reimbursement

• 17.1 The United States
  • 17.1.1 Centre for Medicare and Medicaid Services (CMS)
• 17.2 The EU4 and the UK
  • 17.2.1 Germany
  • 17.2.2 France
  • 17.2.3 Italy
  • 17.2.4 Spain
  • 17.2.5 The United Kingdom
• 17.3 Japan
  • 17.3.1 MHLW

18 Appendix

• 18.1 Bibliography
• 18.2 Report Methodology

19 DelveInsight Capabilities

20 Disclaimer

21 About DelveInsight