吸入型生物製剤の市場規模、シェア、動向分析レポート：生物製剤別、用途別、剤形別、流通チャネル別、地域別、セグメント予測、2025年～2030年

吸入型生物製剤市場の成長と動向

Grand View Research, Inc.の最新レポートによると、世界の吸入可能生物製剤市場規模は2030年までに100億6,000万米ドルに達すると予測され、2025～2030年にかけて17.6％のCAGRで成長すると予測されています。

成長促進要因としては、呼吸器疾患の有病率の増加、非侵襲的ドラッグデリバリーに対する需要の高まり、生物学的安定性を高める製剤技術の進歩などが挙げられます。同市場は、自己投与に対する患者の嗜好、肺デリバリーによる薬剤発現の迅速化、吸入型モノクローナル抗体、ペプチド、RNAiベースの治療に関する調査から利益を得ています。規制上の支援と技術革新が市場機会をさらに拡大します。

喘息、COPD、嚢胞性線維症などの呼吸器疾患の有病率の高さは、依然として主要な促進要因です。CDCとACAAIによると、喘息は2023年には米国人の7.7％（2,490万人）が罹患し、多額の医療利用とコストにつながっています。吸入型生物製剤は、肺を標的とした迅速な投与が可能で、全身性の副作用を最小限に抑えながら治療効果を高めることができます。Ocugen、Moderna、Pfizer-BioNTech、AstraZenecaなどの企業は、吸入ワクチンや治療を通じてポートフォリオを拡大しています。例えば、Ocugenは2025年1月に吸入COVID-19ワクチンOCU500の第1相検査でFDAの認可を取得し、MannKind Corporationは第3相検査の良好な結果を受けてインドの薬事承認を取得し、Afrezzaの市場拡大を続けています。

市場のパイプラインは依然として活発で、呼吸器疾患、糖尿病、感染症、がんを対象とした吸入型生物製剤があります。注目すべき技術革新としては、双性イオン性ポリマーで機能化した脂質ナノ粒子（LNP）を用いた吸入型mRNA治療があり、2024年11月にJournal of the American Chemical Societyに掲載され、安定したネブライゼーションと効果的な肺送達が実証されました。

2024年12月、MannKind CorporationとCipla Ltd.は、米国とブラジルに続き、インドで成人用Afrezza（インスリンヒト）吸入粉末製剤のCDSCO承認を取得しました。この戦略的イニシアチブの下、MannKindが製品を供給し、Ciplaがマーケティングと流通を管理し、2025年後半までに出荷する予定です。今回の提携は、特に7,400万人以上の成人が糖尿病に罹患しているインドにおいて、Afrezzaの世界的プレゼンスを強化することを目的としています。Afrezzaは、非注射の速効型インスリン製剤で、吸収が早く、2～3時間で効果が現れるため、革新的で患者中心の糖尿病管理ソリューションを求める患者の嗜好に応えることができます。シプラ社の広範な販売網は、インド全土でのアクセスを強化し、患者の転帰を改善するために位置づけられています。安全対策としては、気管支攣縮のリスクがあるため、慢性肺疾患のある患者に対する注意事項が含まれます。

吸入型生物製剤におけるパイプラインの進展の一環として、Ab Initio Pharmaは、2024年12月11日から13日までエディンバラで開催される第35回肺へのドラッグデリバリー（DDL）会議にシルバースポンサーとして参加しました。この参加は、低分子、ペプチド、オリゴヌクレオチド、RNAベースの療法を含むドラッグデリバリーソリューションを強調するための戦略的な取り組みです。会議の主要特徴としては、経鼻mRNAデリバリーに関するプレゼンテーションと吸入オリゴヌクレオチドに関するポスターがあり、非侵襲的治療法における革新性を強調しています。

これらのイニシアチブは、慢性疾患や感染症に焦点を当てた戦略的パートナーシップ、規制当局の承認、パイプラインの革新を通じて、吸入型治療法へのアクセスを拡大し、世界の市場ポジションを強化することに重点が置かれていることを強調するものです。

吸入型生物製剤市場レポートハイライト

• タイプ別では、ペプチドタンパク質セグメントが、幅広い治療用途、安定性の向上、効率的な肺吸収により、2024年に29.85%の最大収益シェアで市場をリードしています。
• RNAiベース薬剤セグメントは、予測期間中に堅調なCAGRで成長すると予測されています。
• 用途別では、糖尿病セグメントが2024年に最大の市場収益シェアを占めました。しかし、呼吸器系疾患は予測期間中に急速なCAGRで成長すると予測されています。
• 剤形別では、ドライ粉末吸入器が2024年に最大の市場収益シェアを占めました。しかし、ネブライザーセグメントは予測期間中最も速いCAGRで確認されると予想されます。
• 流通チャネル別では、病院薬局セグメントが2024年に最大の市場収益シェアを占めました。
• 2024年12月、CiplaはMannKind Corporationが開発したAfrezza（吸入インスリン製剤）をインドで独占的に流通・販売するCDSCOの承認を2024年12月11日に取得しました。Afrezzaは、1型と2型糖尿病用の速効型インスリン製剤で、注射剤に代わる非注射剤であり、迅速な吸収と2～3時間の効果が期待できます。Ciplaは、インド全土で患者の転帰を改善するために販売網を活用し、糖尿病管理へのアクセシビリティの向上を目指しています。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 吸入型生物製剤市場の変数、動向、範囲

• 市場系統の展望
• 市場力学
  • 市場促進要因分析
  • 市場抑制要因分析
• ビジネス環境分析
  • 産業分析-ポーターのファイブフォース分析
  • PESTLE分析
• パイプライン分析
  • 候補薬一覧（第1相から第3相まで）
  • 予測期間中に商品化される可能性のある医薬品
  • フェーズ3医薬品予測
• 使用事例分析

第4章 吸入型生物製剤市場：タイプ別ビジネス分析

• タイプ市場シェア、2024年と2030年
• タイプセグメントダッシュボード
• 市場規模と予測と動向分析、タイプ別、2018～2030年
• ペプチドとタンパク質
• ワクチン
• モノクローナル抗体
• RNAiベース薬剤
• その他

第5章 吸入型生物製剤市場：用途別、ビジネス分析

• 用途市場シェア、2024年と2030年
• 用途セグメントダッシュボード
• 市場規模と予測と動向分析、用途別、2018～2030年
• 呼吸器疾患
• 糖尿病
• がん
• その他

第6章 吸入型生物製剤市場：剤形別、ビジネス分析

• 剤形市場シェア、2024年と2030年
• 剤形セグメントダッシュボード
• 市場規模と予測と動向分析、剤形別、2018～2030年
• ドライ粉末吸入器
• 定量吸入器
• ネブライザー
• その他

第7章 吸入型生物製剤市場：流通チャネル別、ビジネス分析

• 流通チャネル市場シェア、2024年と2030年
• 流通チャネルセグメントダッシュボード
• 市場規模と予測と動向分析、流通チャネル別、2018～2030年
• 病院薬局
• 小売薬局
• オンライン薬局

第8章 吸入型生物製剤市場：地域別、推定・動向分析

• 地域別市場シェア分析、2024年と2030年
• 地域別市場ダッシュボード
• 市場規模と予測動向分析、2018～2030年
• 北米
  • 国別、2018～2030年
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • 英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • デンマーク
  • スウェーデン
  • ノルウェー
• アジア太平洋
  • 日本
  • 中国
  • インド
  • オーストラリア
  • 韓国
  • タイ
• ラテンアメリカ
  • ブラジル
  • アルゼンチン
• 中東・アフリカ
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦
  • クウェート

第9章 競合情勢

• 参加者概要
• 企業の市況分析
• 企業分類
• 戦略マッピング
• 企業プロファイル/上場企業
  • Kamada Pharmaceuticals
  • MannKind Corporation
  • Ab Initio Pharma
  • Ocugen, Inc.
  • CanSino Biologics
  • AstraZeneca

List of Tables

• Table 1 List of secondary sources
• Table 2 List of abbreviations
• Table 3 Global inhalable biologics market, by region, 2018 - 2030 (USD Million)
• Table 4 Global inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 5 Global inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 6 Global inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 7 Global inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 8 North America inhalable biologics market, by country, 2018 - 2030 (USD Million)
• Table 9 North America inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 10 North America inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 11 North America inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 12 North America inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 13 U.S. inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 14 U.S. Inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 15 U.S. inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 16 U.S. inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 17 Canada inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 18 Canada inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 19 Canada inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 20 Canada inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 21 Mexico inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 22 Mexico inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 23 Mexico inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 24 Mexico inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 25 Europe inhalable biologics market, by country, 2018 - 2030 (USD Million)
• Table 26 Europe inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 27 Europe inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 28 Europe inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 29 Europe inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 30 UK inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 31 UK Inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 32 UK inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 33 UK inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 34 Germany inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 35 Germany inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 36 Germany inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 37 Germany inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 38 France inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 39 France Inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 40 France inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 41 France inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 42 Italy inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 43 Italy inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 44 Italy inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 45 Italy inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 46 Spain inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 47 Spain inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 48 Spain inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 49 Spain inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 50 Norway inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 51 Norway Inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 52 Norway inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 53 Norway inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 54 Denmark inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 55 Denmark inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 56 Denmark inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 57 Denmark inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 58 Sweden inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 59 Sweden inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 60 Sweden inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 61 Sweden inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 62 Asia Pacific inhalable biologics market, by country, 2018 - 2030 (USD Million)
• Table 63 Asia Pacific inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 64 Asia Pacific inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 65 Asia Pacific inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 66 Asia Pacific inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 67 Japan inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 68 Japan inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 69 Japan inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 70 Japan inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 71 China inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 72 China inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 73 China inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 74 China inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 75 India inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 76 India inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 77 India inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 78 India inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 79 Australia inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 80 Australia inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 81 Australia inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 82 Australia inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 83 South Korea inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 84 South Korea inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 85 South Korea inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 86 South Korea inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 87 Thailand inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 88 Thailand inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 89 Thailand inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 90 Thailand inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 91 Latin America inhalable biologics market, by country, 2018 - 2030 (USD Million)
• Table 92 Latin America inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 93 Latin America inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 94 Latin America inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 95 Latin America inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 96 Brazil inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 97 Brazil inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 98 Brazil inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 99 Brazil inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 100 Argentina inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 101 Argentina inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 102 Argentina inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 103 Argentina inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 104 Middle East & Africa Inhalable biologics market, by country, 2018 - 2030 (USD Million)
• Table 105 Middle East & Africa inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 106 Middle East & Africa inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 107 Middle East & Africa inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 108 Middle East & Africa inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 109 South Africa inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 110 South Africa inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 111 South Africa inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 112 South Africa inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 113 Saudi Arabia inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 114 Saudi Arabia inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 115 Saudi Arabia inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 116 Saudi Arabia inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 117 UAE inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 118 UAE inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 119 UAE inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 120 UAE inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)
• Table 121 Kuwait inhalable biologics market, by type, 2018 - 2030 (USD Million)
• Table 122 Kuwait inhalable biologics market, by application, 2018 - 2030 (USD Million)
• Table 123 Kuwait inhalable biologics market, by dosage form, 2018 - 2030 (USD Million)
• Table 124 Kuwait inhalable biologics market, by distribution channel, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Inhalable biologics market segmentation
• Fig. 2 Market research process
• Fig. 3 Data triangulation techniques
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Value-chain-based sizing & forecasting
• Fig. 7 Market formulation & validation
• Fig. 8 Market snapshot
• Fig. 9 Therapeutic approach and application outlook (USD Million)
• Fig. 10 Competitive landscape
• Fig. 11 Inhalable biologics market dynamics
• Fig. 12 Inhalable biologics market: Porter's five forces analysis
• Fig. 13 Inhalable biologics market: PESTLE analysis
• Fig. 14 Biologic market, 2018 - 2030 (USD Million)
• Fig. 15 Peptides and Proteins market, 2018 - 2030 (USD Million)
• Fig. 16 Vaccines market, 2018 - 2030 (USD Million)
• Fig. 17 Monoclonal Antibodies market, 2018 - 2030 (USD Million)
• Fig. 18 RNAi-based Therapeutics market, 2018 - 2030 (USD Million)
• Fig. 19 Others market, 2018 - 2030 (USD Million)
• Fig. 20 Applicationmarket, 2018 - 2030 (USD Million)
• Fig. 21 Respiratory diseases market, 2018 - 2030 (USD Million)
• Fig. 22 COPD market, 2018 - 2030 (USD Million)
• Fig. 23 Asthma market, 2018 - 2030 (USD Million)
• Fig. 24 Cystic Forbis market, 2018 - 2030 (USD Million)
• Fig. 25 Covid-19 market, 2018 - 2030 (USD Million)
• Fig. 26 Others market, 2018 - 2030 (USD Million)
• Fig. 27 Diabetes market, 2018 - 2030 (USD Million)
• Fig. 28 Cancer market, 2018 - 2030 (USD Million)
• Fig. 29 Others market, 2018 - 2030 (USD Million)
• Fig. 30 Dosage Form market, 2018 - 2030 (USD Million)
• Fig. 31 Dry Powder Inhalers market, 2018 - 2030 (USD Million)
• Fig. 32 Metered Dose Inhalers market, 2018 - 2030 (USD Million)
• Fig. 33 Nebulizers market, 2018 - 2030 (USD Million)
• Fig. 34 Others market, 2018 - 2030 (USD Million)
• Fig. 35 Distribution Channel market, 2018 - 2030 (USD Million)
• Fig. 36 Hospital Pharmacies market, 2018 - 2030 (USD Million)
• Fig. 37 Retail Pharmacies market, 2018 - 2030 (USD Million)
• Fig. 38 Online Pharmacies market, 2018 - 2030 (USD Million)
• Fig. 39 Inhalable biologics market revenue, by region
• Fig. 40 Regional marketplace: Key takeaways
• Fig. 41 Regional marketplace: Key takeaways
• Fig. 42 North America inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 43 U.S. country dynamics
• Fig. 44 U.S. inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 45 Canada country dynamics
• Fig. 46 Canada inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 47 Mexico country dynamics
• Fig. 48 Mexico inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 49 Europe inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 50 UK country dynamics
• Fig. 51 UK inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 52 Germany country dynamics
• Fig. 53 Germany inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 54 France country dynamics
• Fig. 55 France inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 56 Italy country dynamics
• Fig. 57 Italy inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 58 Spain country dynamics
• Fig. 59 Spain inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 60 Norway country dynamics
• Fig. 61 Norway inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 62 Sweden country dynamics
• Fig. 63 Sweden inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 64 Denmark country dynamics
• Fig. 65 Denmark inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 66 Asia Pacific inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 67 Japan country dynamics
• Fig. 68 Japan inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 69 China country dynamics
• Fig. 70 China inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 71 India country dynamics
• Fig. 72 India inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 73 Australia country dynamics
• Fig. 74 Australia inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 75 South Korea country dynamics
• Fig. 76 South Korea inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 77 Thailand country dynamics
• Fig. 78 Thailand inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 79 Latin America inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 80 Brazil country dynamics
• Fig. 81 Brazil inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 82 Argentina country dynamics
• Fig. 83 Argentina inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 84 MEA inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 85 South Africa country dynamics
• Fig. 86 South Africa inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 87 Saudi Arabia country dynamics
• Fig. 88 Saudi Arabia inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 89 UAE country dynamics
• Fig. 90 UAE inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 91 Kuwait country dynamics
• Fig. 92 Kuwait inhalable biologics market, 2018 - 2030 (USD Million)
• Fig. 93 Company categorization
• Fig. 94 Company market position analysis
• Fig. 95 Strategic framework

Inhalable Biologics Market Growth & Trends:

The global inhalable biologics market size is anticipated to reach USD 10.06 billion by 2030 and is projected to grow at a CAGR of 17.6% from 2025 to 2030, according to a new report by Grand View Research, Inc. Growth drivers include the increasing prevalence of respiratory diseases, rising demand for non-invasive drug delivery, and advancements in formulation technologies enhancing biologic stability. The market benefits from patient preference for self-administration, faster drug onset through pulmonary delivery, and research on inhalable monoclonal antibodies, peptides, and RNAi-based therapeutics. Regulatory support and technological innovations further expand market opportunities.

The high prevalence of respiratory conditions, including asthma, COPD, and cystic fibrosis, remains a key growth driver. According to the CDC and ACAAI, asthma affected 7.7% of Americans (24.9 million) in 2023, leading to significant healthcare utilization and costs. Inhalable biologics offer targeted lung delivery with rapid onset, enhancing treatment efficacy while minimizing systemic side effects. Companies such as Ocugen, Moderna, Pfizer-BioNTech, and AstraZeneca are expanding their portfolios through inhaled vaccines and therapeutics. For instance, Ocugen received FDA clearance in January 2025 for a Phase 1 trial of OCU500, an inhaled COVID-19 vaccine, while MannKind Corporation continues to expand Afrezza's reach, with Indian regulatory approval following positive Phase 3 trial results.

The market pipeline remains active, with inhalable biologics targeting respiratory diseases, diabetes, infectious diseases, and oncology. A notable innovation includes inhalable mRNA therapeutics using lipid nanoparticles (LNPs) functionalized with zwitterionic polymers, as published in the Journal of the American Chemical Society in November 2024, demonstrating stable nebulization and effective pulmonary delivery.

In December 2024, MannKind Corporation and Cipla Ltd. secured CDSCO approval for Afrezza (insulin human) Inhalation Powder for adults in India, following prior approvals in the U.S. and Brazil. Under this strategic initiative, MannKind will supply the product while Cipla manages marketing and distribution, with shipments expected by late 2025. The move aims to strengthen Afrezza's global presence, particularly in India, where over 74 million adults are affected by diabetes. Afrezza offers a non-injectable, rapid-acting insulin alternative, with quick absorption and a 2-3 hour effect, addressing patient preferences for innovative and patient-centric diabetes management solutions. Cipla's extensive distribution network is positioned to enhance access and improve patient outcomes across India. Safety measures include precautions for patients with chronic lung diseases due to the risk of bronchospasm.

As part of pipeline advancements in inhalable biologics, Ab Initio Pharma participated as a Silver Sponsor at the 35th Drug Delivery to the Lungs (DDL) Conference from December 11-13, 2024, in Edinburgh. This engagement represents a strategic initiative to highlight its drug delivery solutions, including small molecules, peptides, oligonucleotides, and RNA-based therapies. Key conference features include a presentation on intranasal mRNA delivery and a poster on inhaled oligonucleotides, emphasizing innovation in non-invasive treatment modalities.

These initiatives underscore a growing emphasis on expanding access to inhalable therapies and strengthening global market positions through strategic partnerships, regulatory approvals, and pipeline innovations focused on chronic and infectious diseases.

Inhalable Biologics Market Report Highlights:

• Based on type, the peptides and proteins segment led the market with the largest revenue share of 29.85% in 2024, due to their broad therapeutic applications, stability improvements, and efficient pulmonary absorption.
• The RNAi-based therapeutics segment is projected to grow at a robust CAGR over the forecast period.
• Based on applications, the diabetes segment accounted with the largest market revenue share in 2024. However, respiratory diseases are expected to grow at a rapid CAGR over the forecast period.
• Based on dosage form, the dry powder inhalers segment accounted for the largest market revenue share in 2024, aided by approved products in the segment. However, the nebulizers segment is expected to witness at the fastest CAGR over the forecast period.
• Based on the distribution channel, the hospital pharmacies segment accounted for the largest market revenue share in 2024.
• In December 2024, Cipla received CDSCO approval on December 11, 2024, to exclusively distribute and market Afrezza (inhaled insulin) in India, developed by MannKind Corporation. Afrezza is a rapid-acting insulin for type 1 and type 2 diabetes, offering a non-injectable alternative with quick absorption and a 2-3 hour effect. Cipla aims to enhance diabetes management accessibility, leveraging its distribution network to improve patient outcomes across India.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Type
  • 1.2.2. Application
  • 1.2.3. Dosage Form
  • 1.2.4. Distribution Channel
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Inhalable Biologics Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Environment Analysis
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrants
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTLE Analysis
• 3.4. Pipeline Analysis
  • 3.4.1. List of Drug Candidates (Phase 1 to Phase 3)
  • 3.4.2. Potential Drugs to be Commercialized in the Forecast Period
  • 3.4.3. Phase 3 Drug Forecast
• 3.5. Case Study Analysis

Chapter 4. Inhalable Biologics Market: Type Business Analysis

• 4.1. Type Market Share, 2024 & 2030
• 4.2. Type Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Type, 2018 to 2030 (USD Million)
• 4.4. Peptides and Proteins
  • 4.4.1. Peptides and Proteins Market, 2018 - 2030 (USD Million)
• 4.5. Vaccines
  • 4.5.1. Vaccines Market, 2018 - 2030 (USD Million)
• 4.6. Monoclonal Antibodies
  • 4.6.1. Monoclonal Antibodies Market, 2018 - 2030 (USD Million)
• 4.7. RNAi-based Therapeutics
  • 4.7.1. RNAi-based Therapeutics Market, 2018 - 2030 (USD Million)
• 4.8. Others
  • 4.8.1. Other Type Market, 2018 - 2030 (USD Million)

Chapter 5. Inhalable Biologics Market: Application Business Analysis

• 5.1. Application Market Share, 2024 & 2030
• 5.2. Application Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Application, 2018 to 2030 (USD Million)
• 5.4. Respiratory Diseases
  • 5.4.1. Respiratory Diseases Market, 2018 - 2030 (USD Million)
  • 5.4.2. COPD
    • 5.4.2.1. COPD Market, 2018 - 2030 (USD Million)
  • 5.4.3. Asthma
    • 5.4.3.1. Asthma Market, 2018 - 2030 (USD Million)
  • 5.4.4. Cystic Forbis
    • 5.4.4.1. Cystic Forbis Market, 2018 - 2030 (USD Million)
  • 5.4.5. Covid-19
    • 5.4.5.1. Covid-19 Market, 2018 - 2030 (USD Million)
  • 5.4.6. Others
    • 5.4.6.1. Others Market, 2018 - 2030 (USD Million)
• 5.5. Diabetes
  • 5.5.1. Diabetes Market, 2018 - 2030 (USD Million)
• 5.6. Cancer
  • 5.6.1. Cancer Market, 2018 - 2030 (USD Million)
• 5.7. Others
  • 5.7.1. Others Market, 2018 - 2030 (USD Million)

Chapter 6. Inhalable Biologics Market: Dosage Form Business Analysis

• 6.1. Dosage Form Market Share, 2024 & 2030
• 6.2. Dosage Form Segment Dashboard
• 6.3. Market Size & Forecasts and Trend Analysis, by Dosage Form, 2018 to 2030 (USD Million)
• 6.4. Dry Powder Inhalers
  • 6.4.1. Dry Powder Inhalers Market, 2018 - 2030 (USD Million)
• 6.5. Metered Dose Inhalers
  • 6.5.1. Metered Dose Inhalers Market, 2018 - 2030 (USD Million)
• 6.6. Nebulizers
  • 6.6.1. Nebulizers Market, 2018 - 2030 (USD Million)
• 6.7. Others
  • 6.7.1. Others Market, 2018 - 2030 (USD Million)

Chapter 7. Inhalable Biologics Market: Dosage Form Business Analysis

• 7.1. Dosage Form Market Share, 2024 & 2030
• 7.2. Dosage Form Segment Dashboard
• 7.3. Market Size & Forecasts and Trend Analysis, by Dosage Form, 2018 to 2030 (USD Million)
• 7.4. Hospital Pharmacies
  • 7.4.1. Hospital Pharmacies Market, 2018 - 2030 (USD Million)
• 7.5. Retail Pharmacies
  • 7.5.1. Retail Pharmacies Market, 2018 - 2030 (USD Million)
• 7.6. Online Pharmacies
  • 7.6.1. Online Pharmacies Market, 2018 - 2030 (USD Million)

Chapter 8. Inhalable Biologics Market: Regional Estimates & Trend Analysis

• 8.1. Regional Market Share Analysis, 2024 & 2030
• 8.2. Regional Market Dashboard
• 8.3. Market Size & Forecasts Trend Analysis, 2018 to 2030:
• 8.4. North America
  • 8.4.1. North America Inhalable Biologics Market Estimates And Forecasts, By Country, 2018 - 2030 (USD Million)
  • 8.4.2. U.S.
    • 8.4.2.1. Key Country Dynamics
    • 8.4.2.2. Target Disease Prevalence
    • 8.4.2.3. Regulatory Framework
    • 8.4.2.4. Reimbursement Framework
    • 8.4.2.5. U.S. Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.3. Canada
    • 8.4.3.1. Key Country Dynamics
    • 8.4.3.2. Target Disease Prevalence
    • 8.4.3.3. Regulatory Framework
    • 8.4.3.4. Reimbursement Framework
    • 8.4.3.5. U.S. Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.4. Mexico
    • 8.4.4.1. Key Country Dynamics
    • 8.4.4.2. Target Disease Prevalence
    • 8.4.4.3. Regulatory Framework
    • 8.4.4.4. Reimbursement Framework
    • 8.4.4.5. Mexico Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.5. Europe
  • 8.5.1. Europe Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.2. UK
    • 8.5.2.1. Key Country Dynamics
    • 8.5.2.2. Target Disease Prevalence
    • 8.5.2.3. Regulatory Framework
    • 8.5.2.4. Reimbursement Framework
    • 8.5.2.5. UK Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.3. Germany
    • 8.5.3.1. Key Country Dynamics
    • 8.5.3.2. Target Disease Prevalence
    • 8.5.3.3. Regulatory Framework
    • 8.5.3.4. Reimbursement Framework
    • 8.5.3.5. Germany Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.4. France
    • 8.5.4.1. Key Country Dynamics
    • 8.5.4.2. Target Disease Prevalence
    • 8.5.4.3. Regulatory Framework
    • 8.5.4.4. Reimbursement Framework
    • 8.5.4.5. France Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.5. Italy
    • 8.5.5.1. Key Country Dynamics
    • 8.5.5.2. Target Disease Prevalence
    • 8.5.5.3. Regulatory Framework
    • 8.5.5.4. Reimbursement Framework
    • 8.5.5.5. Italy Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.6. Spain
    • 8.5.6.1. Key Country Dynamics
    • 8.5.6.2. Target Disease Prevalence
    • 8.5.6.3. Regulatory Framework
    • 8.5.6.4. Reimbursement Framework
    • 8.5.6.5. Spain Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.7. Denmark
    • 8.5.7.1. Key Country Dynamics
    • 8.5.7.2. Target Disease Prevalence
    • 8.5.7.3. Regulatory Framework
    • 8.5.7.4. Reimbursement Framework
    • 8.5.7.5. Denmark Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.8. Sweden
    • 8.5.8.1. Key Country Dynamics
    • 8.5.8.2. Target Disease Prevalence
    • 8.5.8.3. Regulatory Framework
    • 8.5.8.4. Reimbursement Framework
    • 8.5.8.5. Sweden Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.9. Norway
    • 8.5.9.1. Key Country Dynamics
    • 8.5.9.2. Target Disease Prevalence
    • 8.5.9.3. Regulatory Framework
    • 8.5.9.4. Reimbursement Framework
    • 8.5.9.5. Norway Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.6. Asia Pacific
  • 8.6.1. Asia Pacific Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.2. Japan
    • 8.6.2.1. Key Country Dynamics
    • 8.6.2.2. Target Disease Prevalence
    • 8.6.2.3. Regulatory Framework
    • 8.6.2.4. Reimbursement Framework
    • 8.6.2.5. Japan Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.3. China
    • 8.6.3.1. Key Country Dynamics
    • 8.6.3.2. Target Disease Prevalence
    • 8.6.3.3. Regulatory Framework
    • 8.6.3.4. Reimbursement Framework
    • 8.6.3.5. China Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.4. India
    • 8.6.4.1. Key Country Dynamics
    • 8.6.4.2. Target Disease Prevalence
    • 8.6.4.3. Regulatory Framework
    • 8.6.4.4. Reimbursement Framework
    • 8.6.4.5. India Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.5. Australia
    • 8.6.5.1. Key Country Dynamics
    • 8.6.5.2. Target Disease Prevalence
    • 8.6.5.3. Regulatory Framework
    • 8.6.5.4. Reimbursement Framework
    • 8.6.5.5. Australia Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.6. South Korea
    • 8.6.6.1. Key Country Dynamics
    • 8.6.6.2. Target Disease Prevalence
    • 8.6.6.3. Regulatory Framework
    • 8.6.6.4. Reimbursement Framework
    • 8.6.6.5. South Korea Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.7. Thailand
    • 8.6.7.1. Key Country Dynamics
    • 8.6.7.2. Target Disease Prevalence
    • 8.6.7.3. Regulatory Framework
    • 8.6.7.4. Reimbursement Framework
    • 8.6.7.5. Thailand Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.7. Latin America
  • 8.7.1. Latin America Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.2. Brazil
    • 8.7.2.1. Key Country Dynamics
    • 8.7.2.2. Target Disease Prevalence
    • 8.7.2.3. Regulatory Framework
    • 8.7.2.4. Reimbursement Framework
    • 8.7.2.5. Brazil Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.3. Argentina
    • 8.7.3.1. Key Country Dynamics
    • 8.7.3.2. Target Disease Prevalence
    • 8.7.3.3. Regulatory Framework
    • 8.7.3.4. Reimbursement Framework
    • 8.7.3.5. Argentina Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.8. Middle East and Africa
  • 8.8.1. Middle East and Africa Inhalable Biologics Market Estimates and Forecasts, 2017 - 2030 (USD Million)
  • 8.8.2. South Africa
    • 8.8.2.1. Key Country Dynamics
    • 8.8.2.2. Target Disease Prevalence
    • 8.8.2.3. Regulatory Framework
    • 8.8.2.4. Reimbursement Framework
    • 8.8.2.5. South Africa Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.8.3. Saudi Arabia
    • 8.8.3.1. Key Country Dynamics
    • 8.8.3.2. Target Disease Prevalence
    • 8.8.3.3. Regulatory Framework
    • 8.8.3.4. Reimbursement Framework
    • 8.8.3.5. Saudi Arabia Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.8.4. UAE
    • 8.8.4.1. Key Country Dynamics
    • 8.8.4.2. Target Disease Prevalence
    • 8.8.4.3. Regulatory Framework
    • 8.8.4.4. Reimbursement Framework
    • 8.8.4.5. UAE Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.8.5. Kuwait
    • 8.8.5.1. Key Country Dynamics
    • 8.8.5.2. Target Disease Prevalence
    • 8.8.5.3. Regulatory Framework
    • 8.8.5.4. Reimbursement Framework
    • 8.8.5.5. Kuwait Inhalable Biologics Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Participant Overview
• 9.2. Company Market Position Analysis
• 9.3. Company Categorization
• 9.4. Strategy Mapping
• 9.5. Company Profiles/Listing
  • 9.5.1. Kamada Pharmaceuticals
    • 9.5.1.1. Overview
    • 9.5.1.2. Financial Performance
    • 9.5.1.3. Product Benchmarking
    • 9.5.1.4. Strategic Initiatives
  • 9.5.2. MannKind Corporation
    • 9.5.2.1. Overview
    • 9.5.2.2. Financial Performance
    • 9.5.2.3. Product Benchmarking
    • 9.5.2.4. Strategic Initiatives
  • 9.5.3. Ab Initio Pharma
    • 9.5.3.1. Overview
    • 9.5.3.2. Financial Performance
    • 9.5.3.3. Product Benchmarking
    • 9.5.3.4. Strategic Initiatives
  • 9.5.4. Ocugen, Inc.
    • 9.5.4.1. Overview
    • 9.5.4.2. Financial Performance
    • 9.5.4.3. Product Benchmarking
    • 9.5.4.4. Strategic Initiatives
  • 9.5.5. CanSino Biologics
    • 9.5.5.1. Overview
    • 9.5.5.2. Financial Performance
    • 9.5.5.3. Product Benchmarking
    • 9.5.5.4. Strategic Initiatives
  • 9.5.6. AstraZeneca
    • 9.5.6.1. Overview
    • 9.5.6.2. Financial Performance
    • 9.5.6.3. Product Benchmarking
    • 9.5.6.4. Strategic Initiatives