羊膜の世界市場：洞察、競合情勢、市場予測：2032年

羊膜の市場規模は、2024年には10億9,603万米ドルとなりました。同市場は、2025年から2032年までの予測期間中に7.33%のCAGRで拡大し、2032年には19億2,233万米ドルに達すると予測されています。羊膜製品市場は、複合的な要因によって大きな成長を遂げています。火傷や外傷などの慢性創傷の増加により、効果的な創傷治癒ソリューションに対する需要が高まっています。さらに、ドライアイや角膜炎のような眼科疾患の増加は、眼科医療における羊膜の使用を拡大しています。これらの臨床ニーズは、主要市場参入企業による強固な製品開発イニシアティブと相まって、技術革新と採用を加速させ、羊膜をベースとした治療法の全体的な市場成長を後押ししています。さらに、羊膜の天然の抗炎症・再生特性は、様々な医療用途においてその魅力をさらに高めています。その臨床的利点に関するヘルスケアプロバイダーや患者の意識の高まりも世界の需要を促進しています。これらの動向を総合すると、2025年から2032年までの予測期間において、羊膜市場の世界の拡大に拍車がかかっています。

羊膜市場力学：

世界保健機関（WHO）によると（2023年）、年間約2,000万～5,000万人が非致死的な交通事故に苦しんでいます。交通事故は多くの場合、軟部組織の損傷、火傷、複雑な整形外科的創傷を伴う重傷につながり、効果的な回復には従来の創傷ケア以上のものが必要となります。成長因子、サイトカイン、抗炎症剤、幹細胞を豊富に含む羊膜は、治癒を促進し、炎症を抑え、瘢痕を最小限に抑えるための強力な解決策を提供します。

さらに、国際糖尿病連合が提供したデータ（2024年）によると、2024年には約5億8,900万人の成人が糖尿病を患っています。糖尿病患者は糖尿病性足潰瘍を発症しやすいです。最近の研究では（2023年）、世界中で年間約1,860万人が糖尿病性足潰瘍を発症しています。羊膜は組織の再生を促進し、炎症を抑え、糖尿病性足潰瘍患者の感染や切断のリスクを低下させるため、世界中の羊膜市場全体を押し上げています。

さらに、ドライアイ、角膜炎、緑内障、白内障、角膜潰瘍などの眼科疾患の世界の増加も、羊膜の需要を大きく押し上げています。大学病院機構が提供したデータ（2024年）によると、世界中で約3億人がドライアイを経験しています。50歳以上の女性は推定320万人、50歳以上の男性は168万人がドライアイに罹患しています。ドライアイは、炎症、眼表面の損傷、涙液膜の不安定性を特徴とする慢性疾患で、不快感や視力障害を引き起こします。人工涙液や抗炎症点眼薬などの従来の治療では、一時的な緩和しか得られないことが多いです。羊膜、特に凍結保存または脱水された羊膜は、成長因子、抗炎症性サイトカイン、細胞外マトリックスタンパク質を豊富に含む生物学的に活性な溶液であり、傷ついた眼表面の再生、炎症の軽減、涙液膜の安定性の回復を助けます。これらの膜は、Prokera（R）のような無縫合移植片または自己保持型デバイスとして適用することができ、眼に直接治療効果をもたらします。

DelveInsight Business Research LLP（2024年）が提供したデータによると、2023年、神経栄養性角膜炎（NK）の有病率は主要7ヶ国の中で米国が最も高く、6万6,000件近くを占め、2034年までにさらに増加すると予想されています。NKは、三叉神経の損傷によって引き起こされるまれな変性角膜疾患で、角膜感度の低下、創傷治癒不良、進行性の角膜潰瘍や穿孔を引き起こします。人工涙液や軟膏などの従来の治療法では、角膜上皮の十分な再生が得られないことが多いです。対照的に、成長因子、抗炎症性タンパク質、細胞外マトリックス成分を豊富に含む羊膜は、角膜治癒を促進し、炎症を抑え、瘢痕化を防ぐ再生プラットフォームを提供します。

主要市場参入企業による製品開発活動の活発化が、羊膜市場全体を大きく押し上げています。例えば、Axogen, Inc.は2024年6月、末梢神経治癒のための軟組織バリアとして設計された再吸収性多層羊膜移植片Avive+Soft Tissue Matrix（TM）を発売しました。同製品は、FDAおよび州の規制に従い、361ヒト組織製品として加工・販売されました。

しかし、代替製品との競合や凍結保存の保存期間が限られていることなどが、羊膜市場の成長を制限する主な制約となっています。

羊膜市場のセグメント分析：

羊膜市場のタイプ別セグメントでは、デバイスカテゴリーが2024年に最大の市場シェアを占めると推定されます。脱水羊膜は、保存期間の延長、保管と輸送の容易さ、様々な治療領域での臨床採用の増加により、羊膜市場全体を押し上げる上で重要な役割を果たしています。凍結保存品とは異なり、脱水羊膜は冷蔵や特別な保管を必要としないため、外来診療所、手術センター、特にコールドチェーンのインフラが限られている開発途上地域の遠隔地ヘルスケアでの使用に非常に便利です。

これらの膜は、抗炎症性、抗線維化性、再生促進性など、本来の羊膜組織が持つ本質的な生物学的特性の多くを保持していますが、一部の細胞成分は加工中に損なわれる可能性があります。それにもかかわらず、dHAM製品は糖尿病性足潰瘍、静脈性下腿潰瘍、褥瘡、手術創のような慢性創傷の管理や、角膜欠損や結膜再建のような眼科的応用において、非常に効果的であることが証明されつつあります。

脱水羊膜（dHAM）にはサイトカインや成長因子が豊富に含まれており、炎症を抑え、免疫反応を調節する上で重要な役割を果たしています。これらの特性により、慢性創傷や自己免疫関連疾患の治療に特に有効です。その他の治療上の特典に加えて、dHAMには実用的な利点があります。dHAMは広く入手可能で室温で安定であるため、凍結保存の必要がなく、様々な医療現場で臨床医にとって便利ですぐに使用できる生物学的製剤となります。

さらに、世界の製品開発活動の活発化が、脱水羊膜市場全体をさらに押し上げています。例えば、2023年1月、MiMedx Group, Inc.は、日本におけるEPIFIX脱水ヒト羊膜/絨毛膜移植片の販売について、Gunze Medical Limitedと独占販売契約を締結しました。グンゼの子会社であるGunze Medicalは、創傷・外科用製品の大手販売会社です。

上記のような要因が脱水羊膜の需要増加に拍車をかけており、2025年から2032年までの予測期間中、羊膜市場全体の拡大を後押ししています。

北米は、いくつかの重要な要因によって、2024年には羊膜市場で最大のシェアを占めると予測されています。この市場を牽引するのは、慢性創傷や眼科疾患の有病率の上昇です。さらに、先進的なヘルスケアインフラと、製品開拓活動の増加につながる主要市場参入企業の強力な存在が、羊膜市場全体を押し上げています。

米国国立衛生研究所のデータ（2023年）によると、米国では約160万人が糖尿病性足潰瘍を患っています。糖尿病性足潰瘍は、神経障害、血行不良、免疫機能障害の組み合わせから生じる慢性的で治癒しない創傷であり、感染、入院、切断の高いリスクをもたらします。ヒト胎盤組織由来の羊膜は、DFUのような慢性創傷の治療に非常に効果的な独自の生物学的特性を備えています。羊膜には成長因子、サイトカイン、細胞外マトリックス成分が豊富に含まれており、細胞増殖をサポートし、炎症を調整し、組織再生を促進します。

さらに、DelveInsight Business Research LLPが提供したデータ（2023年）によると、神経栄養角膜症に罹患した男性は約1万3,000人、女性は約1万9,000人でした。神経栄養角膜症は、三叉神経の損傷によって引き起こされる角膜疾患で、角膜の治癒障害につながります。羊膜は神経再生が損なわれた場合の治癒を促進するため、この地域の市場全体を拡大させています。

さらに、同じ情報源によると、2023年には米国で約2,247万5,000件のドライアイ症例が報告されています。羊膜は潤滑を提供し、炎症を抑え、ドライアイ患者の表面回復をサポートし、それによって地域全体の羊膜市場を押し上げます。

米国の市場成長は、主要企業の技術革新によってさらに支えられています。例えば、2023年7月、Celularity Inc.とVersea Health, Inc.は米国における独占的商業化契約を締結し、VerseaはCelularityのBIOVANCE（R）およびBIOVANCE（R）3L Ocular製品を販売しました。これらの単層および3層羊膜移植片は、眼表面疾患の治療や外科的応用をサポートする生物学的膜として使用されました。アセラー製品であるBIOVANCE（R）3L Ocularは、組織保護を提供し、組織平面の境界を維持するのに役立っています。

これらの要因が相まって、2025年から2032年までの予測期間中、北米における羊膜市場の成長を大きく牽引すると期待されています。

羊膜市場の主要参入企業

羊膜市場で事業を展開する主要市場参入企業には、BioTissue, Inc.、Corza Ophthalmology、Integra LifeSciences、Merakris Therapeutics, Inc.、Seed Biotech, Inc.、Atlas Ocular、BioLab Holdings, Inc.、Orthofix Medical Inc、Labtician Ophthalmics Inc.、Smith &Nephew、Organogenesis Inc.、Celularity Inc.、Tides Medical、StimLabs、MIMEDX Group, Inc.、NuVision Biotherapies Ltd.、Next Biosciences、Sanara MedTech Inc.、Axogen Corporation、Dynamic Medical Services DBA Acesso Biologicsなどがあります。

羊膜市場における最近の開発活動：

• 2025年4月、BioTissue Inc.は、ラスベガスで開催される2025年米国泌尿器科学会で、BioTissue Surgical社の極厚凍結保存羊膜Clarix（R）1Kを用いたロボット尿管再建術を評価した新たな調査を発表すると発表しました。17人の患者を対象とした研究では、1年後の追跡調査で88％に症状の改善がみられ、76％にX線写真の改善がみられました。調査チームは、クラリックス（R）1Kは中程度の長さの尿管狭窄に対して、自家移植に代わる安全で効果的な治療法であると結論づけた。
• 2024年11月、先進創傷治療および外科・スポーツ医学市場向け製品ソリューションの開発、製造、商業化に注力する主要再生医療企業であるOrganogenesis Holdings Inc.は、ロードアイランド州スミスフィールドの100 Technology Wayに位置する122,000平方フィートの最新バイオ製造施設の長期リースにより、製造能力を拡大する計画を発表しました。
• 2024年10月、Merakris Therapeuticsは、ラスベガスで開催されたFall Symposium for Advanced Wound Careにおいて、凍結乾燥羊膜絨毛膜移植片であるDermacyte AC Matrixを発表しました。この製品は、複数の膜層と最適化されたバイオプロセスを特徴とし、より優れたタンパク質の保持と、胎盤膜の主要な物理的・生物学的特性を維持しています。
• 2024年6月、BioTissue Inc.は、軽度から中等度のドライアイや眼表面の状態に理想的な、リングレスで無冷蔵のソリューションとして、水和された保存可能な凍結保存羊膜であるCAM360 AGを発売しました。その粘着性により、絆創膏コンタクトレンズの下に固定され、快適性と治療が向上しました。
• 2024年6月、Axogen, Inc.は、末梢神経治癒のための軟組織バリアとして設計された再吸収性多層羊膜移植片Avive+Soft Tissue Matrix（TM）を発売しました。この製品は、FDAおよび州の規制に従い、361ヒト組織製品として加工・流通されました。

羊膜市場レポート調査から得られる主な事項

• 現在の羊膜市場規模（2024年）と8年間（2025年～2032年）の市場予測に関する市場規模分析
• 過去3年間に起こった主な製品／技術開発、合併、買収、提携、合弁事業
• 羊膜市場を独占している主要企業
• 羊膜市場の競合他社が利用できる様々な機会
• 2024年に上位を占めるセグメントと2032年におけるこれらのセグメントの業績
• 現在の羊膜市場シナリオにおいて、上位の業績を上げている地域と国
• 今後、羊膜市場の成長機会に企業が集中すべき地域や国

羊膜市場のよくある質問

1.羊膜

• 羊膜は胎盤の最内層で、コラーゲンと成長因子を豊富に含む薄い無血管組織で構成されています。抗炎症作用、抗瘢痕作用、創傷治癒作用があり、特に創傷治療、眼科、再生医療などの医療用途に広く使用されています。

2.羊膜市場

• 羊膜市場は2024年に10億9,603万米ドルと評価され、2025年から2032年までの予測期間中にCAGR 7.33%で成長し、2032年には19億2,233万米ドルに達します。

3.羊膜市場の促進要因

• 羊膜製品市場は、複合的な要因によって大きな成長を遂げています。火傷や外傷のような慢性創傷の症例が増加しており、効果的な創傷治癒ソリューションに対する高い需要が生まれています。さらに、ドライアイや角膜炎のような眼科疾患の増加は、眼科医療における羊膜の使用を拡大しています。このような臨床ニーズは、主要市場参入企業による強固な製品開発イニシアティブと相まって、技術革新と採用を総体的に加速させ、羊膜ベースの治療法の市場全体の成長を後押ししています。さらに、羊膜の天然の抗炎症・再生特性は、様々な医療用途においてその魅力をさらに高めています。その臨床的利点に関するヘルスケアプロバイダーや患者の意識の高まりも世界の需要を促進しています。これらの動向は、2025年から2032年までの予測期間中、羊膜市場の世界の拡大を後押ししています。

4.羊膜市場に参入している主要企業

• 羊膜市場に参入している主な参入企業には、BioTissue, Inc.、Corza Ophthalmology、Integra LifeSciences、Merakris Therapeutics, Inc.、Seed Biotech, Inc.、Atlas Ocular、BioLab Holdings, Inc.、Orthofix Medical Inc、Labtician Ophthalmics Inc.、Smith &Nephew、Organogenesis Inc.、Celularity Inc.、Tides Medical、StimLabs、MIMEDX Group, Inc.、NuVision Biotherapies Ltd.、Next Biosciences、Sanara MedTech Inc.、Axogen Corporation、Dynamic Medical Services DBA Acesso Biologicsなどがあります。

5.羊膜市場で最もシェアが高い地域

• 北米は、いくつかの重要な要因により、2024年には羊膜市場で最大のシェアを占めると予測されています。この市場を牽引するのは、慢性創傷や眼科疾患の有病率の上昇です。さらに、先進的なヘルスケアインフラと、製品開発活動の増加につながる主要市場参入企業の強力なプレゼンスが、羊膜市場全体を押し上げています。

目次

第1章 羊膜市場レポートのイントロダクション

第2章 羊膜市場のエグゼクティブサマリー

第3章 競合情勢

第4章 規制分析

• 米国
• 欧州
• 日本
• 中国

第5章 羊膜市場の主な要因分析

• 羊膜市場促進要因
  • 火傷や外傷などの慢性創傷の増加
  • ドライアイや角膜炎などの眼疾患の増加
  • 主要参入企業による製品開発活動の増加
• 羊膜市場抑制要因と課題
  • 代替製品との競合
  • 冷凍保存された製品の保存期間が限られている
• 羊膜市場の機会
  • 整形外科や脊椎手術などの新しい治療分野への継続的な拡大

第6章 羊膜市場のポーターのファイブフォース分析

第7章 羊膜市場の評価

• タイプ別
  • 乾燥羊膜
  • 凍結保存羊膜
• 用途別
  • 手術創
  • 眼疾患
  • その他
• エンドユーザー別
  • 病院
  • 外来手術センター
• 地域別
  • 北米
  • 欧州
  • アジア太平洋
  • その他の地域

第8章 羊膜市場の企業と製品プロファイル

• BioTissue, Inc.
• Corza Ophthalmology
• Integra LifeSciences
• Merakris Therapeutics, Inc.
• Seed Biotech, Inc.
• Atlas Ocular
• BioLab Holdings, Inc.
• Orthofix Medical Inc.
• Labtician Ophthalmics Inc.
• Smith & Nephew
• Organogenesis Inc.
• Celularity Inc.
• Tides Medical
• StimLabs
• MIMEDX Group, Inc.
• NuVision Biotherapies Ltd.
• Next Biosciences
• Sanara MedTech Inc.
• Axogen Corporation
• Dynamic Medical Services DBA Acesso Biologics

第9章 KOLの見解

第10章 プロジェクトアプローチ

第11章 DelveInsightについて

第12章 免責事項とお問い合わせ

List of Tables

• Table 1: Competitive Analysis
• Table 2: Amniotic Membrane Market in Global (2022-2032)
• Table 3: Amniotic Membrane Market in Global by Type (2022-2032)
• Table 4: Amniotic Membrane Market in Global by Application (2022-2032)
• Table 5: Amniotic Membrane Market in Global by End-User (2022-2032)
• Table 6: Amniotic Membrane Market in Global by Geography (2022-2032)
• Table 7: Amniotic Membrane Market in North America (2022-2032)
• Table 8: Amniotic Membrane Market in the United States (2022-2032)
• Table 9: Amniotic Membrane Market in Canada (2022-2032)
• Table 10: Amniotic Membrane Market in Mexico (2022-2032)
• Table 11: Amniotic Membrane Market in Europe (2022-2032)
• Table 12: Amniotic Membrane Market in France (2022-2032)
• Table 13: Amniotic Membrane Market in Germany (2022-2032)
• Table 14: Amniotic Membrane Market in United Kingdom (2022-2032)
• Table 15: Amniotic Membrane Market in Italy (2022-2032)
• Table 16: Amniotic Membrane Market in Spain (2022-2032)
• Table 17: Amniotic Membrane Market in the Rest of Europe (2022-2032)
• Table 18: Amniotic Membrane Market in Asia-Pacific (2022-2032)
• Table 19: Amniotic Membrane Market in China (2022-2032)
• Table 20: Amniotic Membrane Market in Japan (2022-2032)
• Table 21: Amniotic Membrane Market in India (2022-2032)
• Table 22: Amniotic Membrane Market in Australia (2022-2032)
• Table 23: Amniotic Membrane Market in South Korea (2022-2032)
• Table 24: Amniotic Membrane Market in Rest of Asia-Pacific (2022-2032)
• Table 25: Amniotic Membrane Market in the Rest of the World (2022-2032)
• Table 26: Amniotic Membrane Market in the Middle East (2022-2032)
• Table 27: Amniotic Membrane Market in Africa (2022-2032)
• Table 28: Amniotic Membrane Market in South America (2022-2032)

List of Figures

• Figure 1: Competitive Analysis
• Figure 2: Amniotic Membrane Market in Global (2022-2032)
• Figure 3: Amniotic Membrane Market in Global by Type (2022-2032)
• Figure 4: Amniotic Membrane Market in Global by Application (2022-2032)
• Figure 5: Amniotic Membrane Market in Global by End-User (2022-2032)
• Figure 6: Amniotic Membrane Market in Global by Geography (2022-2032)
• Figure 7: Amniotic Membrane Market in North America (2022-2032)
• Figure 8: Amniotic Membrane Market in the United States (2022-2032)
• Figure 9: Amniotic Membrane Market in Canada (2022-2032)
• Figure 10: Amniotic Membrane Market in Mexico (2022-2032)
• Figure 11: Amniotic Membrane Market in Europe (2022-2032)
• Figure 12: Amniotic Membrane Market in France (2022-2032)
• Figure 13: Amniotic Membrane Market in Germany (2022-2032)
• Figure 14: Amniotic Membrane Market in United Kingdom (2022-2032)
• Figure 15: Amniotic Membrane Market in Italy (2022-2032)
• Figure 16: Amniotic Membrane Market in Spain (2022-2032)
• Figure 17: Amniotic Membrane Market in the Rest of Europe (2022-2032)
• Figure 18: Amniotic Membrane Market in Asia-Pacific (2022-2032)
• Figure 19: Amniotic Membrane Market in China (2022-2032)
• Figure 20: Amniotic Membrane Market in Japan (2022-2032)
• Figure 21: Amniotic Membrane Market in India (2022-2032)
• Figure 22: Amniotic Membrane Market in Australia (2022-2032)
• Figure 23: Amniotic Membrane Market in South Korea (2022-2032)
• Figure 24: Amniotic Membrane Market in Rest of Asia-Pacific (2022-2032)
• Figure 25: Amniotic Membrane Market in the Rest of the World (2022-2032)
• Figure 26: Amniotic Membrane Market in the Middle East (2022-2032)
• Figure 27: Amniotic Membrane Market in Africa (2022-2032)
• Figure 28: Amniotic Membrane Market in South America (2022-2032)
• Figure 29: Market Drivers
• Figure 30: Market Barriers
• Figure 31: Marker Opportunities
• Figure 32: PORTER'S Five Force Analysis

Amniotic Membrane Market by Type (Dehydrated Amniotic Membranes and Cryopreserved Amniotic Membranes), Appication (Surgical Wounds, Ophthalmic Disorders, and Others), End-User (Hospitals, Ambulatory Surgical Centres, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the increasing cases of chronic wounds such as burn injuries and trauma cases, increasing cases of ophthalmic disorders such as dry eye, keratitis, among others, and increasing product development activities among the key market players.

The amniotic membrane market was valued at USD 1,096.03 million in 2024, growing at a CAGR of 7.33% during the forecast period from 2025 to 2032 to reach USD 1,922.33 million by 2032. The market for amniotic membrane products is witnessing significant growth, driven by a combination of factors. Increasing cases of chronic wounds, such as burns and trauma, are creating a high demand for effective wound healing solutions. Additionally, the rise in ophthalmic disorders like dry eye and keratitis is expanding the use of amniotic membranes in eye care. These clinical needs, coupled with robust product development initiatives by key market players, are collectively accelerating innovation and adoption, thereby boosting the overall market growth for amniotic membrane-based therapies. Moreover, the membrane's natural anti-inflammatory and regenerative properties further enhance its appeal across a range of medical applications. Growing awareness among healthcare providers and patients about its clinical benefits is also fueling demand globally. Collectively, these trends are fueling the expansion of the amniotic membrane market worldwide during the forecast period from 2025 to 2032.

Amniotic Membrane Market Dynamics:

According to the World Health Organization (2023), approximately 20 to 50 million people suffer from non-fatal road traffic injuries annually. Road accidents often lead to severe injuries involving soft tissue damage, burns, and complex orthopedic wounds, which require more than conventional wound care for effective recovery. Amniotic membrane, rich in growth factors, cytokines, anti-inflammatory agents, and stem cells, offers a powerful solution for promoting accelerated healing, reducing inflammation, and minimizing scarring.

Additionally, according to the data provided by the International Diabetes Federation (2024), in 2024, approximately 589 million adults were living with diabetes. Diabetic patients are more prone to develop diabetic foot ulcers. As per a recent study (2023), approximately 18.6 million individuals worldwide develop diabetic foot ulcers annually. Amniotic membranes promote tissue regeneration, reduce inflammation, and lower the risk of infection and amputation in diabetic foot ulcer patients, thereby boosting the overall market of amniotic membranes across the globe.

Moreover, the increasing global volume of ophthalmic disorders such as dry eyes, keratitis, glaucoma, cataracts, and corneal ulcers are significantly propelling the demand for amniotic membranes. According to the data provided by the University Hospitals Organization (2024), nearly 300 million people worldwide experience dry eye. An estimated 3.2 million women aged 50 and over, and 1.68 million men aged 50 and over were affected by dry eye. Dry eye disease is a chronic condition characterized by inflammation, ocular surface damage, and tear film instability, leading to discomfort and vision disturbances. Traditional treatments like artificial tears and anti-inflammatory drops often provide only temporary relief. Amniotic membranes, especially cryopreserved or dehydrated forms, offer a biologically active solution rich in growth factors, anti-inflammatory cytokines, and extracellular matrix proteins that help regenerate the damaged ocular surface, reduce inflammation, and restore tear film stability. These membranes can be applied as sutureless grafts or self-retaining devices like Prokera(R), delivering therapeutic benefits directly to the eye.

According to the data provided by DelveInsight Business Research LLP (2024), in 2023, the prevalence of Neurotrophic Keratitis (NK) was highest in the US among the 7MM, accounting for nearly 66 thousand cases which was further expected to increase by 2034. NK is a rare, degenerative corneal disease caused by damage to the trigeminal nerve, leading to reduced corneal sensitivity, poor wound healing, and progressive corneal ulceration or perforation. Traditional therapies such as artificial tears and ointments often fail to provide adequate regeneration of the corneal epithelium. In contrast, amniotic membranes, rich in growth factors, anti-inflammatory proteins, and extracellular matrix components, offer a regenerative platform that accelerates corneal healing, reduces inflammation, and prevents scarring.

The increase in product development activities by key market players is significantly boosting the overall market for amniotic membranes. For instance, in June 2024, Axogen, Inc. launched Avive+ Soft Tissue Matrix(TM), a resorbable, multi-layer amniotic membrane allograft designed as a soft tissue barrier for peripheral nerve healing. The product was processed and distributed in compliance with FDA and state regulations as a 361 human tissue product.

However, the competition from alternative products and the limited shelf life of cryopreserved, among others are some of the key constraints that may limit the growth of the amniotic membrane market.

Amniotic Membrane Market Segment Analysis:

Amniotic Membrane Market by Type (Dehydrated Amniotic Membranes and Cryopreserved Amniotic Membranes), Application (Surgical Wounds, Ophthalmic Disorders, and Others), End-User (Hospitals, Ambulatory Surgical Centres, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the type segment of the amniotic membrane market, the devices category is estimated to account for the largest market share in 2024. Dehydrated amniotic membranes, are playing a vital role in boosting the overall amniotic membrane market due to their extended shelf life, ease of storage and transport, and growing clinical adoption across a range of therapeutic areas. Unlike cryopreserved variants, dehydrated amniotic membranes do not require refrigeration or specialized storage, making them highly convenient for use in outpatient clinics, surgical centers, and remote healthcare settings especially in developing regions with limited cold chain infrastructure.

These membranes retain many of the essential biological properties of the native amniotic tissue, including anti-inflammatory, anti-fibrotic, and pro-regenerative characteristics, though some cellular components may be compromised during processing. Nevertheless, dHAM products are proving to be highly effective in managing chronic wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, and surgical wounds, as well as in ophthalmic applications like corneal defects and conjunctival reconstruction.

Dehydrated amniotic membranes (dHAMs) are rich in cytokines and growth factors that play a crucial role in reducing inflammation and modulating the immune response. These properties make them particularly effective in the treatment of chronic wounds and autoimmune-related conditions. In addition to their therapeutic benefits, dHAMs offer practical advantages: their widespread availability and room-temperature stability eliminate the need for frozen storage, making them a convenient, ready-to-use biologic solution for clinicians across various care settings.

Additionally, the increase in product development activities across the globe is further boosting the overall market of dehydrated amniotic membranes. For instance, in January 2023, MiMedx Group, Inc. entered into an exclusive distribution agreement with Gunze Medical Limited for the sales of EPIFIX dehydrated human amnion/chorion membrane allografts in Japan. Gunze Medical, a subsidiary of Gunze Limited, is a leading distributor of wound and surgical products.

Together, these above mentioned factors are fueling the increasing demand for dehydrated amniotic membranes, thereby propelling the growth of the overall expansion of the amniotic membrane market during the forecast period from 2025 to 2032.

North America is expected to dominate the overall amniotic membrane market:

North America is projected to hold the largest share of the amniotic membrane market in 2024, driven by several key factors. The market is driven by the rising prevalence of chronic wounds and ophthalmic disorders. Additionally, advanced healthcare infrastructure and the strong presence of key market players leading to increased product development activities are boosting the overall market of amniotic membranes.

As per the data from the National Institute of Health (2023), approximately 1.6 million people were living with diabetic foot ulcers in the United States. DFUs are chronic, non-healing wounds that result from a combination of neuropathy, poor circulation, and immune dysfunction, and they pose a high risk of infection, hospitalization, and amputation. Amniotic membranes, derived from human placental tissue, offer unique biological properties that make them highly effective in treating chronic wounds like DFUs. They are rich in growth factors, cytokines, and extracellular matrix components that support cell proliferation, modulate inflammation, and promote tissue regeneration thereby boosting the overall market across the region.

Additionally, according to the data provided by DelveInsight Business Research LLP (2023), approximately, ~13 thousand males and ~19 thousand females were affected with neurotrophic keratopathy. It is a corneal condition caused by trigeminal nerve damage leading to impaired corneal healing. The amniotic membrane promotes healing in cases where nerve regeneration is compromised thus escalating the overall market across the region.

Additionally, as per the same source, in 2023, about 22,475 thousand cases of dry eye diseases were reported in the United States. The amniotic membrane provides lubrication, reduces inflammation, and supports surface restoration for dry eye patients thereby boosting the overall market of amniotic membrane across the region.

Market growth in the U.S. is further supported by innovation from key players. For example, in July 2023, Celularity Inc. and Versea Health, Inc. entered into an exclusive U.S. commercialization agreement under which Versea distributed Celularity's BIOVANCE(R) and BIOVANCE(R) 3L Ocular products. These single-layer and three-layer amniotic membrane allografts were used as biological membranes to support ocular surface disease treatment and surgical applications. BIOVANCE(R) 3L Ocular, an acellular product, provided tissue protection and helped preserve tissue plane boundaries.

Together, these factors are expected to significantly drive the growth of the amniotic membrane market in North America during the forecast period from 2025 to 2032.

Amniotic Membrane Market Key Players:

Some of the key market players operating in the amniotic membrane market include BioTissue, Inc., Corza Ophthalmology, Integra LifeSciences, Merakris Therapeutics, Inc., Seed Biotech, Inc., Atlas Ocular, BioLab Holdings, Inc., Orthofix Medical Inc., Labtician Ophthalmics Inc., Smith & Nephew, Organogenesis Inc., Celularity Inc., Tides Medical, StimLabs, MIMEDX Group, Inc., NuVision Biotherapies Ltd., Next Biosciences, Sanara MedTech Inc., Axogen Corporation, Dynamic Medical Services DBA Acesso Biologics, and others.

Recent Developmental Activities in the Amniotic Membrane Market:

• In April 2025, BioTissue Inc. announced that the new research will be presented at the 2025 American Urological Association Conference in Las Vegas which evaluated robotic ureteral reconstruction using Clarix(R) 1K, an ultra-thick cryopreserved amniotic membrane by BioTissue Surgical. In a study of 17 patients, 88% showed symptomatic improvement and 76% had radiographic improvement at one-year follow-up. Researchers concluded that Clarix(R) 1K was a safe and effective alternative to autologous grafts for medium-length ureteral strictures.
• In November 2024, Organogenesis Holdings Inc., a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, announced plans to expand manufacturing capacity with a long-term lease for a 122,000-square foot state-of-the-art biomanufacturing facility located at 100 Technology Way in Smithfield, Rhode Island.
• In October 2024, Merakris Therapeutics launched Dermacyte AC Matrix, a lyophilized amnion-chorion membrane allograft, at the Fall Symposium for Advanced Wound Care in Las Vegas. The product featured multiple membrane layers and an optimized bioprocess, offering better protein retention and maintaining key physical and biological properties of placental membranes.
• In June 2024, BioTissue Inc., launched CAM360 AG, a hydrated, shelf-stable cryopreserved amniotic membrane, as a ringless, no-refrigeration solution ideal for mild to moderate dry eye and ocular surface conditions. Its adhesive properties helped it stay in place under a bandage contact lens, enhancing comfort and treatment.
• In June 2024, Axogen, Inc. launched Avive+ Soft Tissue Matrix(TM), a resorbable, multi-layer amniotic membrane allograft designed as a soft tissue barrier for peripheral nerve healing. The product was processed and distributed in compliance with FDA and state regulations as a 361 human tissue product.

Key takeaways from the amniotic membrane market report study

• Market size analysis for current amniotic membrane market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the amniotic membrane market.
• Various opportunities available for the other competitors in the amniotic membrane market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current amniotic membrane market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for amniotic membrane market growth in the coming future?

Target audience who can benefit from this amniotic membrane market report study

• Amniotic membrane product providers
• Research organizations and consulting companies
• Amniotic membrane-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in amniotic membrane
• Various end-users who want to know more about the amniotic membrane market and the latest technological developments in the amniotic membrane market.

Frequently Asked Questions for the Amniotic Membrane Market:

1. What are amniotic membrane?

• The amniotic membrane is the innermost layer of the placenta, composed of a thin, avascular tissue rich in collagen and growth factors. It is widely used in medical applications for its anti-inflammatory, anti-scarring, and wound-healing properties, particularly in wound care, ophthalmology, and regenerative medicine.

2. What is the market for amniotic membrane?

• The amniotic membrane market was valued at USD 1,096.03 million in 2024, growing at a CAGR of 7.33% during the forecast period from 2025 to 2032 to reach USD 1,922.33 million by 2032.

3. What are the drivers for the amniotic membrane market?

• The market for amniotic membrane products is witnessing significant growth, driven by a combination of factors. Increasing cases of chronic wounds, such as burns and trauma, are creating a high demand for effective wound healing solutions. Additionally, the rise in ophthalmic disorders like dry eye and keratitis is expanding the use of amniotic membranes in eye care. These clinical needs, coupled with robust product development initiatives by key market players, are collectively accelerating innovation and adoption, thereby boosting the overall market growth for amniotic membrane-based therapies. Moreover, the membrane's natural anti-inflammatory and regenerative properties further enhance its appeal across a range of medical applications. Growing awareness among healthcare providers and patients about its clinical benefits is also fueling demand globally. Collectively, these trends are fueling the expansion of the amniotic membrane market worldwide during the forecast period from 2025 to 2032.

4. Who are the key players operating in the amniotic membrane market?

• Some of the key market players operating in the amniotic membrane market include BioTissue, Inc., Corza Ophthalmology, Integra LifeSciences, Merakris Therapeutics, Inc., Seed Biotech, Inc., Atlas Ocular, BioLab Holdings, Inc., Orthofix Medical Inc., Labtician Ophthalmics Inc., Smith & Nephew, Organogenesis Inc., Celularity Inc., Tides Medical, StimLabs, MIMEDX Group, Inc., NuVision Biotherapies Ltd., Next Biosciences, Sanara MedTech Inc., Axogen Corporation, Dynamic Medical Services DBA Acesso Biologics, and others.

5. Which region has the highest share in the amniotic membrane market?

• North America is projected to hold the largest share of the amniotic membrane market in 2024, driven by several key factors. The market is driven by the rising prevalence of chronic wounds and ophthalmic disorders. Additionally, advanced healthcare infrastructure and the strong presence of key market players leading to increased product development activities are boosting the overall market of amniotic membranes.

Table of Contents

1. Amniotic Membrane Market Report Introduction

• 1.1. Scope of the Study
• 1.2. Market Segmentation
• 1.3. Market Assumption

2. Amniotic Membrane Market Executive Summary

• 2.1. Market at Glance

3. Competitive Landscape

4. Regulatory Analysis

• 4.1. The United States
• 4.2. Europe
• 4.3. Japan
• 4.4. China

5. Amniotic Membrane Market Key Factors Analysis

• 5.1. Amniotic Membrane Market Drivers
  • 5.1.1. Increasing cases of chronic wounds such as burn injuries and trauma cases
  • 5.1.2. Increasing cases of ophthalmic disorders such as dry eye, and keratitis, among others
  • 5.1.3. Increasing product development activities among the key players
• 5.2. Amniotic Membrane Market Restraints and Challenges
  • 5.2.1. Competition from alternative products
  • 5.2.2. Limited shelf life of cryopreserved products
• 5.3. Amniotic Membrane Market Opportunity
  • 5.3.1. Ongoing expansion into new therapeutic areas such as orthopedic and spinal surgeries

6. Amniotic Membrane Market Porter's Five Forces Analysis

• 6.1. Bargaining Power of Suppliers
• 6.2. Bargaining Power of Consumers
• 6.3. Threat of New Entrants
• 6.4. Threat of Substitutes
• 6.5. Competitive Rivalry

7. Amniotic Membrane Market Assessment

• 7.1. By Type
  • 7.1.1. Dehydrated Amniotic Membranes
  • 7.1.2. Cryopreserved Amniotic Membranes
• 7.2. By Application
  • 7.2.1. Surgical Wounds
  • 7.2.2. Ophthalmic Disorders
  • 7.2.3. Others
• 7.3. By End-User
  • 7.3.1. Hospitals
  • 7.3.2. Ambulatory Surgical Centres
  • 7.3.3. Others
• 7.4. By Geography
  • 7.4.1. North America
    • 7.4.1.1. United States Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.1.2. Canada Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.1.3. Mexico Amniotic Membrane Market Size in USD million (2022-2032)
  • 7.4.2. Europe
    • 7.4.2.1. France Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.2.2. Germany Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.2.3. United Kingdom Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.2.4. Italy Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.2.5. Spain Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.2.6. Rest of Europe Amniotic Membrane Market Size in USD million (2022-2032)
  • 7.4.3. Asia-Pacific
    • 7.4.3.1. China Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.3.2. Japan Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.3.3. India Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.3.4. Australia Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.3.5. South Korea Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.3.6. Rest of Asia-Pacific Amniotic Membrane Market Size in USD million (2022-2032)
  • 7.4.4. Rest of the World (RoW)
    • 7.4.4.1. Middle East Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.4.2. Africa Amniotic Membrane Market Size in USD million (2022-2032)
    • 7.4.4.3. South America Amniotic Membrane Market Size In USD Million (2022-2032)

8. Amniotic Membrane Market Company and Product Profiles

• 8.1. BioTissue, Inc.
  • 8.1.1. Company Overview
  • 8.1.2. Company Snapshot
  • 8.1.3. Financial Overview
  • 8.1.4. Product Listing
  • 8.1.5. Entropy
• 8.2. Corza Ophthalmology
  • 8.2.1. Company Overview
  • 8.2.2. Company Snapshot
  • 8.2.3. Financial Overview
  • 8.2.4. Product Listing
  • 8.2.5. Entropy
• 8.3. Integra LifeSciences
  • 8.3.1. Company Overview
  • 8.3.2. Company Snapshot
  • 8.3.3. Financial Overview
  • 8.3.4. Product Listing
  • 8.3.5. Entropy
• 8.4. Merakris Therapeutics, Inc.
  • 8.4.1. Company Overview
  • 8.4.2. Company Snapshot
  • 8.4.3. Financial Overview
  • 8.4.4. Product Listing
  • 8.4.5. Entropy
• 8.5. Seed Biotech, Inc.
  • 8.5.1. Company Overview
  • 8.5.2. Company Snapshot
  • 8.5.3. Financial Overview
  • 8.5.4. Product Listing
  • 8.5.5. Entropy
• 8.6. Atlas Ocular
  • 8.6.1. Company Overview
  • 8.6.2. Company Snapshot
  • 8.6.3. Financial Overview
  • 8.6.4. Product Listing
  • 8.6.5. Entropy
• 8.7. BioLab Holdings, Inc.
  • 8.7.1. Company Overview
  • 8.7.2. Company Snapshot
  • 8.7.3. Financial Overview
  • 8.7.4. Product Listing
  • 8.7.5. Entropy
• 8.8. Orthofix Medical Inc.
  • 8.8.1. Company Overview
  • 8.8.2. Company Snapshot
  • 8.8.3. Financial Overview
  • 8.8.4. Product Listing
  • 8.8.5. Entropy
• 8.9. Labtician Ophthalmics Inc.
  • 8.9.1. Company Overview
  • 8.9.2. Company Snapshot
  • 8.9.3. Financial Overview
  • 8.9.4. Product Listing
  • 8.9.5. Entropy
• 8.10. Smith & Nephew
  • 8.10.1. Company Overview
  • 8.10.2. Company Snapshot
  • 8.10.3. Financial Overview
  • 8.10.4. Product Listing
  • 8.10.5. Entropy
• 8.11. Organogenesis Inc.
  • 8.11.1. Company Overview
  • 8.11.2. Company Snapshot
  • 8.11.3. Financial Overview
  • 8.11.4. Product Listing
  • 8.11.5. Entropy
• 8.12. Celularity Inc.
  • 8.12.1. Company Overview
  • 8.12.2. Company Snapshot
  • 8.12.3. Financial Overview
  • 8.12.4. Product Listing
  • 8.12.5. Entropy
• 8.13. Tides Medical
  • 8.13.1. Company Overview
  • 8.13.2. Company Snapshot
  • 8.13.3. Financial Overview
  • 8.13.4. Product Listing
  • 8.13.5. Entropy
• 8.14. StimLabs
  • 8.14.1. Company Overview
  • 8.14.2. Company Snapshot
  • 8.14.3. Financial Overview
  • 8.14.4. Product Listing
  • 8.14.5. Entropy
• 8.15. MIMEDX Group, Inc.
  • 8.15.1. Company Overview
  • 8.15.2. Company Snapshot
  • 8.15.3. Financial Overview
  • 8.15.4. Product Listing
  • 8.15.5. Entropy
• 8.16. NuVision Biotherapies Ltd.
  • 8.16.1. Company Overview
  • 8.16.2. Company Snapshot
  • 8.16.3. Financial Overview
  • 8.16.4. Product Listing
  • 8.16.5. Entropy
• 8.17. Next Biosciences
  • 8.17.1. Company Overview
  • 8.17.2. Company Snapshot
  • 8.17.3. Financial Overview
  • 8.17.4. Product Listing
  • 8.17.5. Entropy
• 8.18. Sanara MedTech Inc.
  • 8.18.1. Company Overview
  • 8.18.2. Company Snapshot
  • 8.18.3. Financial Overview
  • 8.18.4. Product Listing
  • 8.18.5. Entropy
• 8.19. Axogen Corporation
  • 8.19.1. Company Overview
  • 8.19.2. Company Snapshot
  • 8.19.3. Financial Overview
  • 8.19.4. Product Listing
  • 8.19.5. Entropy
• 8.20. Dynamic Medical Services DBA Acesso Biologics
  • 8.20.1. Company Overview
  • 8.20.2. Company Snapshot
  • 8.20.3. Financial Overview
  • 8.20.4. Product Listing
  • 8.20.5. Entropy

9. KOL Views

10. Project Approach

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