生物製剤向け薬事申請アウトソーシングの世界市場：市場規模・シェア・動向分析 (サービス別、フェーズ別、モダリティ別、サービス別・フェーズ別、モダリティ別・サービス別、地域別、セグメント別、2025年～2030年)

生物製剤向け薬事申請アウトソーシング市場の成長と動向：

Grand View Research, Inc.の最新レポートによると、世界の生物製剤向け薬事申請アウトソーシングの市場規模は2030年までに36億9,000万米ドルに達し、2025年から2030年までのCAGRは9.06%を記録すると予測されています。

バイオ医薬品企業のグローバル化は、市場全体の需要を押し上げる主要な成長要因の1つです。アジア太平洋、ラテンアメリカ、中東・アフリカの新興市場は、製品開発・製造コストが低く、税制優遇があり、熟練労働者が比較的低コストで入手可能で、規制も整備されています。上記の要因により、この地域市場はバイオ医薬品企業にとってアウトソーシングや事業拡大の面で魅力的な見通しとなっており、薬事サービスの需要を刺激しています。さらに、新興国にEMAおよび/またはFDAの認可を受けた施設が存在することで、その国への外国投資が増加し、法定代理人や薬事コンサルティングサービスなどの薬事サービスの需要が高まると予想されます。

新興国で実施される治験の数は大幅に増加しています。これは、米国などの新興経済諸国に比べて比較的低コストで熟練労働力、先端技術、インフラ施設を利用できることに起因しており、これらの地域では治験申請や製品登録などの薬事サービスの需要が刺激されると予想されます。新興国は、全世界の治験申請総件数の30.0%以上を占めており、このシェアは今後数年間で増加し、市場成長に寄与すると予想されます。

いくつかのバイオ医薬品企業は、コアコンピタンスに集中し、非コア機能をアウトソーシングして生産性と業務効率を高めています。このような企業は、国際的な規制への対応といういくつかの課題に直面しており、その対応には時間と手間がかかります。このため、新規分子を実現可能なスケジュールと妥当なコストで市場に投入するための競争が、サービス・プロバイダーに対する需要を押し上げる可能性が高いです。さらに、社内に能力を持たない中小規模のバイオ医薬品企業の多くが薬事業務のアウトソーシングに傾倒しており、これは業界の進展にプラスの影響を与えると推定されます。

バイオシミラー、希少疾病用医薬品、個別化医薬品、適応試験デザインなどの市場の成長は、これらの分野における薬事専門業務の需要を高めると予測されます。複数の企業が新たな分野に進出するにつれて、規制に関する経験を持つ熟練したサービスプロバイダーに対するニーズが高まり、規制を遵守する必要性が生じています。特に新興経済諸国では、政府の支援により希少疾病用医薬品の開発が大幅に増加しています。シムレクト、ベクティビックス、ミルセラ、キネレットなどの生物製剤の特許失効は、バイオシミラーの需要と開発を増加させており、このセグメントにおける薬事サービスの需要に寄与しています。

生物製剤向け薬事申請アウトソーシング市場：分析概要

• 規制文書の執筆・刊行部門が2024年に最大の市場シェアを占めました。このセグメントが高い成長を遂げた背景には、正確で包括的な文書化を必要とする生物製剤の複雑化、徹底的な提出を要求する厳しい国際規制要件、コンプライアンスを確保するための専門知識の必要性などがあります。遺伝子治療やバイオシミラーのような生物製剤の技術革新のペースが速いため、進化する規制に関する最新の知識が必要となり、市場全体の成長が見込まれています。
• 2024年には臨床段階セグメントが最大のシェアを占めています。このセグメント別収益の高い伸びは、過去数年間の治験登録件数の増加に起因しています。
• モノクローナル抗体 (mAb) セグメントは、2024年に最大の収益シェアを占めました。このセグメントの成長は、新規の送達方法や治療標的を含むmAb技術の急速な進歩によるもので、市場全体の成長可能性につながる最新かつ正確な規制戦略が必要とされています。
• アジア太平洋地域の生物製剤向け薬事申請アウトソーシング市場は、2024年に40.94%の最大収益シェアを占め、予測期間中に最も速いCAGRで成長すると予想されます。

目次

第1章 分析方法・範囲

第2章 エグゼクティブサマリー

第3章 生物製剤向け薬事申請アウトソーシング市場：変動要因・傾向・範囲

• 市場連関の見通し
  • 親市場の見通し
  • 関連/付随市場の見通し
• 市場力学
  • 市場促進要因の分析
  • 市場抑制要因の分析
• 技術進歩
  • 既存・新規技術と推奨ツールの使用
  • 社内ツールと広く利用可能なツールの差別化
  • 主要な技術の柱
  • ビッグデータと分析
  • RTP、テキスト処理、分析
  • 音声およびビデオ分析
  • IoT (モノのインターネット)
  • AIツール
• 価格モデル分析
• 治験件数の分析 (2024年)
  • 治験の総数：地域別 (2024年)
  • 治験の総数：フェーズ別 (2024年)
  • 治験の総数：研究デザイン別 (2024年)
  • 治験の総数：主な治療領域別 (2024年)
• 市場分析ツール
  • ポーターのファイブフォース分析
  • PESTEL分析
  • COVID-19の影響分析

第4章 生物製剤向け薬事申請アウトソーシング市場の推定と動向分析：サービス別

• セグメントダッシュボード
• 世界の生物製剤向け薬事申請アウトソーシング市場：変動分析
• 世界の生物製剤向け薬事申請アウトソーシング市場：市場規模と動向分析、サービス別 (2018～2030年)
  • 規制コンサルティング
  • 法的代理
  • 規制文書の執筆・刊行
  • 製品登録と治験申請
  • 規制当局への提出
  • 規制業務
  • その他のサービス

第5章 生物製剤向け薬事申請アウトソーシング市場の推定と動向分析：フェーズ別

• セグメントダッシュボード
• 世界の生物製剤向け薬事申請アウトソーシング市場：変動分析
• 世界の生物製剤向け薬事申請アウトソーシング市場：市場規模と動向分析、フェーズ別 (2018～2030年)
  • 前臨床
  • 臨床

第6章 生物製剤向け薬事申請アウトソーシング市場の推定と動向分析：モダリティ別

• セグメントダッシュボード
• 世界の生物製剤向け薬事申請アウトソーシング市場：変動分析
• 世界の生物製剤向け薬事申請アウトソーシング市場：市場規模と動向分析、モダリティ別 (2018～2030年)
• モノクローナル抗体 (mAb)
• 組み換えタンパク質
• ワクチン
• 細胞・遺伝子治療
• バイオシミラー
• その他

第7章 生物製剤向け薬事申請アウトソーシング市場の推定と動向分析：フェーズ別・サービス別

• セグメントダッシュボード
• 世界の生物製剤向け薬事申請アウトソーシング市場：変動分析
• 世界の生物製剤向け薬事申請アウトソーシング市場：市場規模と動向分析、フェーズ別・サービス別 (2018～2030年)
  • 前臨床
  • 臨床

第8章 生物製剤向け薬事申請アウトソーシング市場の推定と動向分析：フェーズ別・モダリティ別

• セグメントダッシュボード
• 世界の生物製剤向け薬事申請アウトソーシング市場：変動分析
• 世界の生物製剤向け薬事申請アウトソーシング市場：市場規模と動向分析、モダリティ別・フェーズ別 (2018～2030年)
  • 前臨床
  • 臨床

第9章 生物製剤向け薬事申請アウトソーシング市場の推定と動向分析：サービス別・モダリティ別

• セグメントダッシュボード
• 世界の生物製剤向け薬事申請アウトソーシング市場：変動分析
• 世界の生物製剤向け薬事申請アウトソーシング市場：市場規模と動向分析、サービス別・モダリティ別 (2018～2030年)
  • モノクローナル抗体 (mAb)
  • 組み換えタンパク質
  • ワクチン
  • 細胞・遺伝子治療
  • バイオシミラー
  • その他

第10章 生物製剤向け薬事申請アウトソーシング市場の推定と動向分析：地域別

• 市場ダッシュボード：地域別
• 世界市場のスナップショット：地域別
• 市場規模の予測と動向分析 (2018～2030年)
• 北米
  • 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
  • 中国
  • 日本
  • 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11章 競合情勢

• 市場参入企業の分類
  • 市場リーダー
  • 新興企業
• 競争市場シェア/評価分析 (2024年)
• 企業プロファイル
  • Lonza AG
  • Wuxi Apptec Inc.
  • Thermo Fisher Scientific Inc.
  • Eurofins Scientific SE
  • Freyrsolutions
  • Catalent Inc.
  • Piramal Group
  • AGC Biologics
  • ICON Plc.

List of Tables

• Table. 1 List of Secondary Sources
• Table. 2 List of Abbreviations
• Table. 3 Global Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 4 Global Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 5 Global Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 6 Global Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 7 Global Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 8 Global Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 9 Global Biologics Regulatory Affairs Outsourcing, by Region, 2018 - 2030 (USD Million)
• Table. 10 North America Biologics Regulatory Affairs Outsourcing, by Country, 2018 - 2030 (USD Million)
• Table. 11 North America Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 12 North America Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 13 North America Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 14 North America Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 15 North America Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 16 North America Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 17 U.S. Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 18 U.S. Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 19 U.S. Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 20 U.S. Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 21 U.S. Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 22 U.S. Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 23 Canada Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 24 Canada Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 25 Canada Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 26 Canada Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 27 Canada Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 28 Canada Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 29 Mexico Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 30 Mexico Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 31 Mexico Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 32 Mexico Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 33 Mexico Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 34 Mexico Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 35 Europe Biologics Regulatory Affairs Outsourcing, by Country, 2018 - 2030 (USD Million)
• Table. 36 Europe Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 37 Europe Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 38 Europe Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 39 Europe Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 40 Europe Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 41 Europe Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 42 Germany Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 43 Germany Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 44 Germany Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 45 Germany Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 46 Germany Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 47 Germany Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 48 UK Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 49 UK Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 50 UK Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 51 UK Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 52 UK Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 53 UK Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 54 France Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 55 France Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 56 France Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 57 France Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 58 France Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 59 France Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 60 Italy Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 61 Italy Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 62 Italy Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 63 Italy Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 64 Italy Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 65 Italy Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 66 Spain Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 67 Spain Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 68 Spain Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 69 Spain Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 70 Spain Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 71 Spain Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 72 Denmark Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 73 Denmark Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 74 Denmark Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 75 Denmark Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 76 Denmark Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 77 Denmark Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 78 Sweden Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 79 Sweden Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 80 Sweden Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 81 Sweden Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 82 Sweden Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 83 Sweden Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 84 Norway Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 85 Norway Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 86 Norway Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 87 Norway Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 88 Norway Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 89 Norway Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 90 Asia Pacific Biologics Regulatory Affairs Outsourcing, by Country, 2018 - 2030 (USD Million)
• Table. 91 Asia Pacific Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 92 Asia Pacific Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 93 Asia Pacific Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 94 Asia Pacific Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 95 Asia Pacific Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 96 Asia Pacific Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 97 China Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 98 China Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 99 China Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 100 China Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 101 China Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 102 China Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 103 Japan Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 104 Japan Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 105 Japan Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 106 Japan Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 107 Japan Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 108 Japan Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 109 India Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 110 India Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 111 India Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 112 India Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 113 India Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 114 India Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 115 South Korea Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 116 South Korea Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 117 South Korea Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 118 South Korea Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 119 South Korea Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 120 South Korea Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 121 Australia Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 122 Australia Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 123 Australia Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 124 Australia Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 125 Australia Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 126 Australia Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 127 Thailand Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 128 Thailand Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 129 Thailand Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 130 Thailand Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 131 Thailand Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 132 Thailand Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 133 Latin America Biologics Regulatory Affairs Outsourcing, by Country, 2018 - 2030 (USD Million)
• Table. 134 Latin America Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 135 Latin America Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 136 Latin America Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 137 Latin America Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 138 Latin America Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 139 Latin America Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 140 Brazil Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 141 Brazil Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 142 Brazil Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 143 Brazil Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 144 Brazil Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 145 Brazil Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 146 Argentina Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 147 Argentina Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 148 Argentina Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 149 Argentina Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 150 Argentina Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 151 Argentina Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 152 Middle East & Africa Biologics Regulatory Affairs Outsourcing, by Country, 2018 - 2030 (USD Million)
• Table. 153 Middle East & Africa Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 154 Middle East & Africa Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 155 Middle East & Africa Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 156 Middle East & Africa Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 157 Middle East & Africa Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 158 Middle East & Africa Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 159 South Africa Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 160 South Africa Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 161 South Africa Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 162 South Africa Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 163 South Africa Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 164 South Africa Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 165 Saudi Arabia Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 166 Saudi Arabia Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 167 Saudi Arabia Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 168 Saudi Arabia Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 169 Saudi Arabia Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 170 Saudi Arabia Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 171 UAE Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 172 UAE Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 173 UAE Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 174 UAE Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 175 UAE Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 176 UAE Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)
• Table. 177 Kuwait Biologics Regulatory Affairs Outsourcing, by Service, 2018 - 2030 (USD Million)
• Table. 178 Kuwait Biologics Regulatory Affairs Outsourcing, by Phase, 2018 - 2030 (USD Million)
• Table. 179 Kuwait Biologics Regulatory Affairs Outsourcing, by Modality, 2018 - 2030 (USD Million)
• Table. 180 Kuwait Biologics Regulatory Affairs Outsourcing, Phase by Service, 2018 - 2030 (USD Million)
• Table. 181 Kuwait Biologics Regulatory Affairs Outsourcing, Phase by Modality, 2018 - 2030 (USD Million)
• Table. 182 Kuwait Biologics Regulatory Affairs Outsourcing, Modality by Service, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Information Procurement
• Fig. 2 Primary Research Pattern
• Fig. 3 Market Research Approaches
• Fig. 4 Value Chain-Based Sizing & Forecasting
• Fig. 5 Market Formulation & Validation
• Fig. 6 Biologics Regulatory Affairs Outsourcing, Market Segmentation
• Fig. 7 Market Driver Relevance Analysis (Current & Future Impact)
• Fig. 8 Market Restraint Relevance Analysis (Current & Future Impact)
• Fig. 9 SWOT Analysis, By Factor (Political & Legal, Economic and Technological)
• Fig. 10 Porter's Five Forces Analysis
• Fig. 11 Regional Marketplace: Key Takeaways
• Fig. 12 Global Biologics Regulatory Affairs Outsourcing, for Regulatory Consulting, 2018 - 2030 (USD Million)
• Fig. 13 Global Biologics Regulatory Affairs Outsourcing, for Strategy & Development Planning, 2018 - 2030 (USD Million)
• Fig. 14 Global Biologics Regulatory Affairs Outsourcing, for QA Consulting, 2018 - 2030 (USD Million)
• Fig. 15 Global Biologics Regulatory Affairs Outsourcing, for Agent Services, 2018 - 2030 (USD Million)
• Fig. 16 Global Biologics Regulatory Affairs Outsourcing, for Others, 2018 - 2030 (USD Million)
• Fig. 17 Global Biologics Regulatory Affairs Outsourcing, for Legal Representation, 2018 - 2030 (USD Million)
• Fig. 18 Global Biologics Regulatory Affairs Outsourcing, for Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
• Fig. 19 Global Biologics Regulatory Affairs Outsourcing, for Product Registration & Clinical Trial Applications, 2018 - 2030 (USD Million)
• Fig. 20 Global Biologics Regulatory Affairs Outsourcing, for Regulatory Submissions, 2018 - 2030 (USD Million)
• Fig. 21 Global Biologics Regulatory Affairs Outsourcing, for Regulatory Operations, 2018 - 2030 (USD Million)
• Fig. 22 Global Biologics Regulatory Affairs Outsourcing, for Preclinical, 2018 - 2030 (USD Million)
• Fig. 23 Global Biologics Regulatory Affairs Outsourcing, for Clinical, 2018 - 2030 (USD Million)
• Fig. 24 Global Biologics Regulatory Affairs Outsourcing, for Phase I, 2018 - 2030 (USD Million)
• Fig. 25 Global Biologics Regulatory Affairs Outsourcing, for Phase II, 2018 - 2030 (USD Million)
• Fig. 26 Global Biologics Regulatory Affairs Outsourcing, for Phase III, 2018 - 2030 (USD Million)
• Fig. 27 Global Biologics Regulatory Affairs Outsourcing, for Phase IV, 2018 - 2030 (USD Million)
• Fig. 28 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Regulatory Consulting, 2018 - 2030 (USD Million)
• Fig. 29 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Legal Representation, 2018 - 2030 (USD Million)
• Fig. 30 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
• Fig. 31 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Product Registration & Clinical Trial Applications, 2018 - 2030 (USD Million)
• Fig. 32 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Regulatory Submissions, 2018 - 2030 (USD Million)
• Fig. 33 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Regulatory Operations, 2018 - 2030 (USD Million)
• Fig. 34 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Other Services, 2018 - 2030 (USD Million)
• Fig. 35 Global Biologics Regulatory Affairs Outsourcing, for Clinical Regulatory Consulting, 2018 - 2030 (USD Million)
• Fig. 36 Global Biologics Regulatory Affairs Outsourcing, for Clinical Legal Representation, 2018 - 2030 (USD Million)
• Fig. 37 Global Biologics Regulatory Affairs Outsourcing, for Clinical Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
• Fig. 38 Global Biologics Regulatory Affairs Outsourcing, for Clinical Product Registration & Clinical Trial Applications, 2018 - 2030 (USD Million)
• Fig. 39 Global Biologics Regulatory Affairs Outsourcing, for Clinical Regulatory Submissions, 2018 - 2030 (USD Million)
• Fig. 40 Global Biologics Regulatory Affairs Outsourcing, for Clinical Regulatory Operations, 2018 - 2030 (USD Million)
• Fig. 41 Global Biologics Regulatory Affairs Outsourcing, for Clinical Other Services, 2018 - 2030 (USD Million)
• Fig. 42 Global Biologics Regulatory Affairs Outsourcing, for Monoclonal Antibodies (mAbs), 2018 - 2030 (USD Million)
• Fig. 43 Global Biologics Regulatory Affairs Outsourcing, for Recombinant Proteins, 2018 - 2030 (USD Million)
• Fig. 44 Global Biologics Regulatory Affairs Outsourcing, for Vaccines, 2018 - 2030 (USD Million)
• Fig. 45 Global Biologics Regulatory Affairs Outsourcing, for Cell & Gene Therapies, 2018 - 2030 (USD Million)
• Fig. 46 Global Biologics Regulatory Affairs Outsourcing, for Biosimilars, 2018 - 2030 (USD Million)
• Fig. 47 Global Biologics Regulatory Affairs Outsourcing, for Others, 2018 - 2030 (USD Million)
• Fig. 48 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Monoclonal Antibodies (mAbs), 2018 - 2030 (USD Million)
• Fig. 49 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Recombinant Proteins, 2018 - 2030 (USD Million)
• Fig. 50 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Vaccines, 2018 - 2030 (USD Million)
• Fig. 51 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Cell & Gene Therapies, 2018 - 2030 (USD Million)
• Fig. 52 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Biosimilars, 2018 - 2030 (USD Million)
• Fig. 53 Global Biologics Regulatory Affairs Outsourcing, for Preclinical Others, 2018 - 2030 (USD Million)
• Fig. 54 Global Biologics Regulatory Affairs Outsourcing, for Clinical Monoclonal Antibodies (mAbs), 2018 - 2030 (USD Million)
• Fig. 55 Global Biologics Regulatory Affairs Outsourcing, for Clinical Recombinant Proteins, 2018 - 2030 (USD Million)
• Fig. 56 Global Biologics Regulatory Affairs Outsourcing, for Clinical Vaccines, 2018 - 2030 (USD Million)
• Fig. 57 Global Biologics Regulatory Affairs Outsourcing, for Clinical Cell & Gene Therapies, 2018 - 2030 (USD Million)
• Fig. 58 Global Biologics Regulatory Affairs Outsourcing, for Clinical Biosimilars, 2018 - 2030 (USD Million)
• Fig. 59 Global Biologics Regulatory Affairs Outsourcing, for Clinical Others, 2018 - 2030 (USD Million)
• Fig. 60 Global Biologics Regulatory Affairs Outsourcing, for Monoclonal Antibodies (mAbs) Regulatory Consulting, 2018 - 2030 (USD Million)
• Fig. 61 Global Biologics Regulatory Affairs Outsourcing, for Monoclonal Antibodies (mAbs) Legal Representation, 2018 - 2030 (USD Million)
• Fig. 62 Global Biologics Regulatory Affairs Outsourcing, for Monoclonal Antibodies (mAbs) Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
• Fig. 63 Global Biologics Regulatory Affairs Outsourcing, for Monoclonal Antibodies (mAbs) Product Registration & Clinical Trial Applications, 2018 - 2030 (USD Million)
• Fig. 64 Global Biologics Regulatory Affairs Outsourcing, for Monoclonal Antibodies (mAbs) Regulatory Submissions, 2018 - 2030 (USD Million)
• Fig. 65 Global Biologics Regulatory Affairs Outsourcing, for Monoclonal Antibodies (mAbs) Regulatory Operations, 2018 - 2030 (USD Million)
• Fig. 66 Global Biologics Regulatory Affairs Outsourcing, for Monoclonal Antibodies (mAbs) Other Services, 2018 - 2030 (USD Million)
• Fig. 67 Global Biologics Regulatory Affairs Outsourcing, for Recombinant Proteins Regulatory Consulting, 2018 - 2030 (USD Million)
• Fig. 68 Global Biologics Regulatory Affairs Outsourcing, for Recombinant Proteins Legal Representation, 2018 - 2030 (USD Million)
• Fig. 69 Global Biologics Regulatory Affairs Outsourcing, for Recombinant Proteins Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
• Fig. 70 Global Biologics Regulatory Affairs Outsourcing, for Recombinant Proteins Product Registration & Clinical Trial Applications, 2018 - 2030 (USD Million)
• Fig. 71 Global Biologics Regulatory Affairs Outsourcing, for Recombinant Proteins Regulatory Submissions, 2018 - 2030 (USD Million)
• Fig. 72 Global Biologics Regulatory Affairs Outsourcing, for Recombinant Proteins Regulatory Operations, 2018 - 2030 (USD Million)
• Fig. 73 Global Biologics Regulatory Affairs Outsourcing, for Recombinant Proteins Other Services, 2018 - 2030 (USD Million)
• Fig. 74 Global Biologics Regulatory Affairs Outsourcing, for Vaccines Regulatory Consulting, 2018 - 2030 (USD Million)
• Fig. 75 Global Biologics Regulatory Affairs Outsourcing, for Vaccines Legal Representation, 2018 - 2030 (USD Million)
• Fig. 76 Global Biologics Regulatory Affairs Outsourcing, for Vaccines Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
• Fig. 77 Global Biologics Regulatory Affairs Outsourcing, for Vaccines Product Registration & Clinical Trial Applications, 2018 - 2030 (USD Million)
• Fig. 78 Global Biologics Regulatory Affairs Outsourcing, for Vaccines Regulatory Submissions, 2018 - 2030 (USD Million)
• Fig. 79 Global Biologics Regulatory Affairs Outsourcing, for Vaccines Regulatory Operations, 2018 - 2030 (USD Million)
• Fig. 80 Global Biologics Regulatory Affairs Outsourcing, for Vaccines Other Services, 2018 - 2030 (USD Million)
• Fig. 81 Global Biologics Regulatory Affairs Outsourcing, for Cell & Gene Therapies Regulatory Consulting, 2018 - 2030 (USD Million)
• Fig. 82 Global Biologics Regulatory Affairs Outsourcing, for Cell & Gene Therapies Legal Representation, 2018 - 2030 (USD Million)
• Fig. 83 Global Biologics Regulatory Affairs Outsourcing, for Cell & Gene Therapies Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
• Fig. 84 Global Biologics Regulatory Affairs Outsourcing, for Cell & Gene Therapies Product Registration & Clinical Trial Applications, 2018 - 2030 (USD Million)
• Fig. 85 Global Biologics Regulatory Affairs Outsourcing, for Cell & Gene Therapies Regulatory Submissions, 2018 - 2030 (USD Million)
• Fig. 86 Global Biologics Regulatory Affairs Outsourcing, for Cell & Gene Therapies Regulatory Operations, 2018 - 2030 (USD Million)
• Fig. 87 Global Biologics Regulatory Affairs Outsourcing, for Cell & Gene Therapies Other Services, 2018 - 2030 (USD Million)
• Fig. 88 Global Biologics Regulatory Affairs Outsourcing, for Biosimilars Regulatory Consulting, 2018 - 2030 (USD Million)
• Fig. 89 Global Biologics Regulatory Affairs Outsourcing, for Biosimilars Legal Representation, 2018 - 2030 (USD Million)
• Fig. 90 Global Biologics Regulatory Affairs Outsourcing, for Biosimilars Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
• Fig. 91 Global Biologics Regulatory Affairs Outsourcing, for Biosimilars Product Registration & Clinical Trial Applications, 2018 - 2030 (USD Million)
• Fig. 92 Global Biologics Regulatory Affairs Outsourcing, for Biosimilars Regulatory Submissions, 2018 - 2030 (USD Million)
• Fig. 93 Global Biologics Regulatory Affairs Outsourcing, for Biosimilars Regulatory Operations, 2018 - 2030 (USD Million)
• Fig. 94 Global Biologics Regulatory Affairs Outsourcing, for Biosimilars Other Services, 2018 - 2030 (USD Million)
• Fig. 95 Global Biologics Regulatory Affairs Outsourcing, for Others Regulatory Consulting, 2018 - 2030 (USD Million)
• Fig. 96 Global Biologics Regulatory Affairs Outsourcing, for Others Legal Representation, 2018 - 2030 (USD Million)
• Fig. 97 Global Biologics Regulatory Affairs Outsourcing, for Others Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
• Fig. 98 Global Biologics Regulatory Affairs Outsourcing, for Others Product Registration & Clinical Trial Applications, 2018 - 2030 (USD Million)
• Fig. 99 Global Biologics Regulatory Affairs Outsourcing, for Others Regulatory Submissions, 2018 - 2030 (USD Million)
• Fig. 100 Global Biologics Regulatory Affairs Outsourcing, for Others Regulatory Operations, 2018 - 2030 (USD Million)
• Fig. 101 Global Biologics Regulatory Affairs Outsourcing, for Others Other Services, 2018 - 2030 (USD Million)
• Fig. 102 Regional Outlook, 2023 & 2030
• Fig. 103 North America Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 104 US Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 105 Canada Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 106 Mexico Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 107 Europe Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 108 Germany Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 109 UK Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 110 France Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 111 Italy Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 112 Spain Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 113 Denmark Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 114 Sweden Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 115 Norway Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 116 Asia Pacific Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 117 Japan Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 118 China Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 119 India Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 120 Australia Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 121 South Korea Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 122 Thailand Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 123 Latin America Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 124 Brazil Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 125 Argentina Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 126 Middle East and Africa Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 127 South Africa Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 128 Saudi Arabia Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 129 UAE Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 130 Kuwait Biologics Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Biologics Regulatory Affairs Outsourcing Market Growth & Trends:

The global biologics regulatory affairs outsourcing market size is expected to reach USD 3.69 billion by 2030, registering a CAGR of 9.06% from 2025 to 2030, according to a new report by Grand View Research, Inc. Globalization of biopharmaceutical companies is one of the major growth drivers boosting overall market demand. Emerging markets of Asia Pacific, Latin America, and MEA regions offer low product development & manufacturing costs, tax benefits, and availability of skilled labor at relatively low costs with supportive regulations. The abovementioned factors have made the regional markets attractive prospects in terms of outsourcing and expansion for biopharmaceutical companies, thereby stimulating the demand for regulatory services. Furthermore, the presence of EMA- and/or FDA-approved facilities in emerging economies is anticipated to increase foreign investments in the country and the demand for regulatory services, such as legal representation and regulatory consulting services.

A significant increase has been witnessed in the number of clinical trials conducted in emerging economies. This can be attributed to the availability of skilled labor, advanced technologies, and infrastructure facilities at relatively lower costs than developed economies such as the U.S., which is expected to stimulate the demand for regulatory services such as clinical trial applications & product registrations in these regions. Emerging economies contribute to more than 30.0% of total clinical trial applications submitted across the globe, and the share is expected to increase over the coming years, contributing to market growth.

Several biopharmaceutical companies are focusing on their core competencies and outsourcing noncore functions to increase their productivity & operational efficiency. These companies face several challenges with regard to complying with global regulations, which can be a lengthy and tedious process. Thus, the race to launch a novel molecule in the market in a feasible timeline and at a reasonable cost will likely propel the demand for service providers. Furthermore, many small- and medium-scale biopharma companies lacking in-house capabilities are inclined towards outsourcing regulatory affairs, which is estimated to positively influence the industry's progression.

Growth in markets for biosimilars, orphan drugs, personalized medicines, adaptive trial designs, and others is projected to boost the demand for regulatory specialization in these areas. As several companies expand into new avenues, the increasing need for skilled service providers with experience in regulations leads to the necessity to comply with regulations. Government support, especially in developed economies, has significantly increased the development of orphan drugs. Patent expiration of biologics, such as Simulect, Vectibix, Mircera, and Kineret, is increasing the demand and development of biosimilars, thereby contributing to the demand for regulatory services in this segment.

Biologics Regulatory Affairs Outsourcing Market Report Highlights:

• The regulatory writing & publishing segment held the largest market share in 2024. The high segment growth is owing to the increasing complexity of biologics requiring precise and comprehensive documentation, stringent global regulatory requirements demanding thorough submissions, and the need for specialized expertise to ensure compliance. The rapid pace of innovation in biologics, such as gene therapies and biosimilars, necessitates up-to-date knowledge of evolving regulations is anticipated overall market growth
• The clinical phase segment accounted for the largest share in 2024. The high segmental revenue growth can be attributed to the increasing number of clinical trial registrations over the past few years
• The monoclonal antibodies (mAbs) segment accounted for the largest revenue share in 2024. The segmental growth is owing to rapid advancements in mAb technology, including novel delivery methods and therapeutic targets, which require updated and precise regulatory strategies leading to overall market growth potential
• The Asia Pacific biologics regulatory affairs outsourcing market held the largest revenue share of 40.94% in 2024 and is expected to grow at the fastest CAGR over the forecast period.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
  • 1.1.1. Regional Scope
  • 1.1.2. Estimates and Forecast Timeline
• 1.2. Research Methodology
• 1.3. Information Procurement
  • 1.3.1. Purchased Database
  • 1.3.2. GVR's Internal Database
  • 1.3.3. Secondary Sources
  • 1.3.4. Primary Research
• 1.4. Information or Data Analysis
  • 1.4.1. Data Analysis Models
• 1.5. Market Formulation & Validation
  • 1.5.1. Region Wise Market: Base Estimates
  • 1.5.2. Global Market: CAGR Calculation
• 1.6. Model Details
  • 1.6.1. Commodity Flow Analysis (Model 1)
  • 1.6.2. Value-Chain-Based Sizing & Forecasting (Model 2)
  • 1.6.3. QFD Model Sizing & Forecasting (Model 3)
  • 1.6.4. Bottom-Up Approach (Model 4)
• 1.7. Market Definitions
• 1.8. List of Secondary Sources
• 1.9. List of Abbreviations
• 1.10. Objectives
  • 1.10.1. Objective - 1:
  • 1.10.2. Objective - 2:
  • 1.10.3. Objective - 3:
  • 1.10.4. Objective - 4:

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. Biologics Regulatory Affairs Outsourcing Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Growing Number of Clinical Trials
    • 3.2.1.2. Increasing Adoption of the Personalized Medicine and Novel Therapeutics
    • 3.2.1.3. Rising R&D Investment in the Healthcare Industry
    • 3.2.1.4. Advancements in the Regulatory Affairs Market
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Compliance Issues While Outsourcing
    • 3.2.2.2. Managing Relationships
• 3.3. Technological Advancements
  • 3.3.1. Existing and Emerging Use of Technology and Preferred Tools
  • 3.3.2. Differentiating In-House Tools Vs Widely Available
  • 3.3.3. Key Technology Pillars
    • 3.3.3.1. Digital Transformation and Data Integrity
    • 3.3.3.2. Artificial Intelligence, Machine Learning/Automation
    • 3.3.3.3. Data Analysis and Predictive Modeling
    • 3.3.3.4. Automation of Routine Tasks
    • 3.3.3.5. Compliance Monitoring
    • 3.3.3.6. Discovery and Development
    • 3.3.3.7. Regulatory Guidelines Related to AI/ML
  • 3.3.4. Big Data and Analytics
  • 3.3.5. RTP, Text Processing and Analytics
  • 3.3.6. Speech and Video Analytics
  • 3.3.7. IoT (Internet Of Things)
  • 3.3.8. AI Tools
• 3.4. Pricing Model Analysis
• 3.5. Clinical Trials Volume Analysis, 2024
  • 3.5.1. Total Number of Clinical Trials, by Region (2024)
  • 3.5.2. Total Number of Clinical Trials, by Phase (2024)
  • 3.5.3. Total Number of Clinical Trials, by Study Design (2024)
  • 3.5.4. Total Number of Clinical Trials, by Key Therapeutic Area (2024)
• 3.6. Market Analysis Tools
  • 3.6.1. Porter's Five Forces Analysis
  • 3.6.2. PESTEL Analysis
  • 3.6.3. COVID-19 Impact Analysis

Chapter 4. Biologics Regulatory Affairs Outsourcing Market: Service Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 4.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
  • 4.3.1. Regulatory Consulting
    • 4.3.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 4.3.1.2. Strategy & Development Planning
      • 4.3.1.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 4.3.1.3. QA Consulting
      • 4.3.1.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 4.3.1.4. Agent Services
      • 4.3.1.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 4.3.1.5. Others
      • 4.3.1.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.2. Legal Representation
    • 4.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.3. Regulatory Writing & Publishing
    • 4.3.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.4. Product Registration & Clinical Trial Applications
    • 4.3.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.5. Regulatory Submissions
    • 4.3.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.6. Regulatory Operations
    • 4.3.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.7. Other Services
    • 4.3.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 5. Biologics Regulatory Affairs Outsourcing Market: Phase Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 5.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, by Phase, 2018 to 2030 (USD Million)
  • 5.3.1. Preclinical
    • 5.3.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.3.2. Clinical
    • 5.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 5.3.2.2. Phase I
      • 5.3.2.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 5.3.2.3. Phase II
      • 5.3.2.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 5.3.2.4. Phase III
      • 5.3.2.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 5.3.2.5. Phase IV
      • 5.3.2.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 6. Biologics Regulatory Affairs Outsourcing Market: Modality Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 6.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, by Modality, 2018 to 2030 (USD Million)
• 6.4. Monoclonal Antibodies (mAbs)
  • 6.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.5. Recombinant Proteins
  • 6.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.6. Vaccines
  • 6.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.7. Cell & Gene Therapies
  • 6.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.8. Biosimilars
  • 6.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.9. Others
  • 6.9.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 7. Biologics Regulatory Affairs Outsourcing Market: Phase by Service Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 7.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, Phase by Service, 2018 to 2030 (USD Million)
  • 7.3.1. Preclinical
    • 7.3.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.2. Regulatory Consulting
      • 7.3.1.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.3. Legal Representation
      • 7.3.1.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.4. Regulatory Writing & Publishing
      • 7.3.1.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.5. Product Registration & Clinical Trial Applications
      • 7.3.1.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.6. Regulatory Submissions
      • 7.3.1.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.7. Regulatory Operations
      • 7.3.1.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.8. Other Services
      • 7.3.1.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.3.2. Clinical
    • 7.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.2. Regulatory Consulting
      • 7.3.2.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.3. Legal Representation
      • 7.3.2.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.4. Regulatory Writing & Publishing
      • 7.3.2.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.5. Product Registration & Clinical Trial Applications
      • 7.3.2.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.6. Regulatory Submissions
      • 7.3.2.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.7. Regulatory Operations
      • 7.3.2.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.8. Other Services
      • 7.3.2.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 8. Biologics Regulatory Affairs Outsourcing Market: Phase by Modality Estimates & Trend Analysis

• 8.1. Segment Dashboard
• 8.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 8.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, Phase by Modality, 2018 to 2030 (USD Million)
  • 8.3.1. Preclinical
    • 8.3.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.2. Monoclonal Antibodies (mAbs)
      • 8.3.1.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.3. Recombinant Proteins
      • 8.3.1.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.4. Vaccines
      • 8.3.1.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.5. Cell & Gene Therapies
      • 8.3.1.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.6. Biosimilars
      • 8.3.1.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.7. Others
      • 8.3.1.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 8.3.2. Clinical
    • 8.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.2. Monoclonal Antibodies (mAbs)
      • 8.3.2.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.3. Recombinant Proteins
      • 8.3.2.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.4. Vaccines
      • 8.3.2.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.5. Cell & Gene Therapies
      • 8.3.2.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.6. Biosimilars
      • 8.3.2.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.7. Others
      • 8.3.2.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 9. Biologics Regulatory Affairs Outsourcing Market: Modality by Service Estimates & Trend Analysis

• 9.1. Segment Dashboard
• 9.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 9.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, Modality by Service, 2018 to 2030 (USD Million)
  • 9.3.1. Monoclonal Antibodies (mAbs)
    • 9.3.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.2. Regulatory Consulting
      • 9.3.1.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.3. Legal Representation
      • 9.3.1.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.4. Regulatory Writing & Publishing
      • 9.3.1.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.5. Product Registration & Clinical Trial Applications
      • 9.3.1.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.6. Regulatory Submissions
      • 9.3.1.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.7. Regulatory Operations
      • 9.3.1.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.8. Other Services
      • 9.3.1.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 9.3.2. Recombinant Proteins
    • 9.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.2. Regulatory Consulting
      • 9.3.2.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.3. Legal Representation
      • 9.3.2.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.4. Regulatory Writing & Publishing
      • 9.3.2.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.5. Product Registration & Clinical Trial Applications
      • 9.3.2.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.6. Regulatory Submissions
      • 9.3.2.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.7. Regulatory Operations
      • 9.3.2.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.8. Other Services
      • 9.3.2.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 9.3.3. Vaccines
    • 9.3.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.2. Regulatory Consulting
      • 9.3.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.3. Legal Representation
      • 9.3.3.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.4. Regulatory Writing & Publishing
      • 9.3.3.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.5. Product Registration & Clinical Trial Applications
      • 9.3.3.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.6. Regulatory Submissions
      • 9.3.3.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.7. Regulatory Operations
      • 9.3.3.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.8. Other Services
      • 9.3.3.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 9.3.4. Cell & Gene Therapies
    • 9.3.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.2. Regulatory Consulting
      • 9.3.4.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.3. Legal Representation
      • 9.3.4.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.4. Regulatory Writing & Publishing
      • 9.3.4.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.5. Product Registration & Clinical Trial Applications
      • 9.3.4.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.6. Regulatory Submissions
      • 9.3.4.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.7. Regulatory Operations
      • 9.3.4.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.8. Other Services
      • 9.3.4.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 9.3.5. Biosimilars
    • 9.3.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.2. Regulatory Consulting
      • 9.3.5.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.3. Legal Representation
      • 9.3.5.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.4. Regulatory Writing & Publishing
      • 9.3.5.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.5. Product Registration & Clinical Trial Applications
      • 9.3.5.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.6. Regulatory Submissions
      • 9.3.5.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.7. Regulatory Operations
      • 9.3.5.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.8. Other Services
      • 9.3.5.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 9.3.6. Others
    • 9.3.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.2. Regulatory Consulting
      • 9.3.6.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.3. Legal Representation
      • 9.3.6.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.4. Regulatory Writing & Publishing
      • 9.3.6.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.5. Product Registration & Clinical Trial Applications
      • 9.3.6.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.6. Regulatory Submissions
      • 9.3.6.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.7. Regulatory Operations
      • 9.3.6.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.8. Other Services
      • 9.3.6.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 10. Biologics Regulatory Affairs Outsourcing Market: Regional Estimates & Trend Analysis

• 10.1. Regional Market Dashboard
• 10.2. Global Regional Market Snapshot
• 10.3. Market Size & Forecasts Trend Analysis, 2018 to 2030:
• 10.4. North America
  • 10.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.4.2. U.S.
    • 10.4.2.1. Key Country Dynamics
    • 10.4.2.2. Competitive Scenario
    • 10.4.2.3. Regulatory Framework
    • 10.4.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.4.3. Canada
    • 10.4.3.1. Key Country Dynamics
    • 10.4.3.2. Competitive Scenario
    • 10.4.3.3. Regulatory Framework
    • 10.4.3.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.4.4. Mexico
    • 10.4.4.1. Key Country Dynamics
    • 10.4.4.2. Competitive Scenario
    • 10.4.4.3. Regulatory Framework
    • 10.4.4.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.5. Europe
  • 10.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.2. UK
    • 10.5.2.1. Key Country Dynamics
    • 10.5.2.2. Competitive Scenario
    • 10.5.2.3. Regulatory Framework
    • 10.5.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.3. Germany
    • 10.5.3.1. Key Country Dynamics
    • 10.5.3.2. Competitive Scenario
    • 10.5.3.3. Regulatory Framework
    • 10.5.3.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.4. France
    • 10.5.4.1. Key Country Dynamics
    • 10.5.4.2. Competitive Scenario
    • 10.5.4.3. Regulatory Framework
    • 10.5.4.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.5. Italy
    • 10.5.5.1. Key Country Dynamics
    • 10.5.5.2. Competitive Scenario
    • 10.5.5.3. Regulatory Framework
    • 10.5.5.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.6. Spain
    • 10.5.6.1. Key Country Dynamics
    • 10.5.6.2. Competitive Scenario
    • 10.5.6.3. Regulatory Framework
    • 10.5.6.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.7. Denmark
    • 10.5.7.1. Key Country Dynamics
    • 10.5.7.2. Competitive Scenario
    • 10.5.7.3. Regulatory Framework
    • 10.5.7.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.8. Sweden
    • 10.5.8.1. Key Country Dynamics
    • 10.5.8.2. Competitive Scenario
    • 10.5.8.3. Regulatory Framework
    • 10.5.8.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.9. Norway
    • 10.5.9.1. Key Country Dynamics
    • 10.5.9.2. Competitive Scenario
    • 10.5.9.3. Regulatory Framework
    • 10.5.9.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.6. Asia Pacific
  • 10.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.2. China
    • 10.6.2.1. Key Country Dynamics
    • 10.6.2.2. Competitive Scenario
    • 10.6.2.3. Regulatory Framework
    • 10.6.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.3. Japan
    • 10.6.3.1. Key Country Dynamics
    • 10.6.3.2. Competitive Scenario
    • 10.6.3.3. Regulatory Framework
    • 10.6.3.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.4. India
    • 10.6.4.1. Key Country Dynamics
    • 10.6.4.2. Competitive Scenario
    • 10.6.4.3. Regulatory Framework
    • 10.6.4.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.5. Australia
    • 10.6.5.1. Key Country Dynamics
    • 10.6.5.2. Competitive Scenario
    • 10.6.5.3. Regulatory Framework
    • 10.6.5.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.6. South Korea
    • 10.6.6.1. Key Country Dynamics
    • 10.6.6.2. Competitive Scenario
    • 10.6.6.3. Regulatory Framework
    • 10.6.6.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.7. Thailand
    • 10.6.7.1. Key Country Dynamics
    • 10.6.7.2. Competitive Scenario
    • 10.6.7.3. Regulatory Framework
    • 10.6.7.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.7. Latin America
  • 10.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.7.2. Brazil
    • 10.7.2.1. Key Country Dynamics
    • 10.7.2.2. Competitive Scenario
    • 10.7.2.3. Regulatory Framework
    • 10.7.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.7.3. Argentina
    • 10.7.3.1. Key Country Dynamics
    • 10.7.3.2. Competitive Scenario
    • 10.7.3.3. Regulatory Framework
    • 10.7.3.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.8. MEA
  • 10.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.2. South Africa
    • 10.8.2.1. Key Country Dynamics
    • 10.8.2.2. Competitive Scenario
    • 10.8.2.3. Regulatory Framework
    • 10.8.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.3. Saudi Arabia
    • 10.8.3.1. Key Country Dynamics
    • 10.8.3.2. Competitive Scenario
    • 10.8.3.3. Regulatory Framework
    • 10.8.3.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.4. UAE
    • 10.8.4.1. Key Country Dynamics
    • 10.8.4.2. Competitive Scenario
    • 10.8.4.3. Regulatory Framework
    • 10.8.4.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.5. Kuwait
    • 10.8.5.1. Key Country Dynamics
    • 10.8.5.2. Competitive Scenario
    • 10.8.5.3. Regulatory Framework
    • 10.8.5.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 11. Competitive Landscape

• 11.1. Market Participant Categorization
  • 11.1.1. Market Leaders
  • 11.1.2. Emerging Players
• 11.2. Competitive Market share/Assessment Analysis, 2024
• 11.3. Company Profiles
  • 11.3.1. Lonza AG
    • 11.3.1.1. Company Overview
    • 11.3.1.2. Financial Performance
    • 11.3.1.3. Service Benchmarking
    • 11.3.1.4. Strategic Initiatives
  • 11.3.2. Wuxi Apptec Inc.
    • 11.3.2.1. Company Overview
    • 11.3.2.2. Financial Performance
    • 11.3.2.3. Service Benchmarking
    • 11.3.2.4. Strategic Initiatives
  • 11.3.3. Thermo Fisher Scientific Inc.
    • 11.3.3.1. Company Overview
    • 11.3.3.2. Financial Performance
    • 11.3.3.3. Service Benchmarking
    • 11.3.3.4. Strategic Initiatives
  • 11.3.4. Eurofins Scientific SE
    • 11.3.4.1. Company Overview
    • 11.3.4.2. Financial Performance
    • 11.3.4.3. Service Benchmarking
    • 11.3.4.4. Strategic Initiatives
  • 11.3.5. Freyrsolutions
    • 11.3.5.1. Company Overview
    • 11.3.5.2. Financial Performance
    • 11.3.5.3. Service Benchmarking
    • 11.3.5.4. Strategic Initiatives
  • 11.3.6. Catalent Inc.
    • 11.3.6.1. Company Overview
    • 11.3.6.2. Financial Performance
    • 11.3.6.3. Service Benchmarking
    • 11.3.6.4. Strategic Initiatives
  • 11.3.7. Piramal Group
    • 11.3.7.1. Company Overview
    • 11.3.7.2. Financial Performance
    • 11.3.7.3. Service Benchmarking
    • 11.3.7.4. Strategic Initiatives
  • 11.3.8. AGC Biologics
    • 11.3.8.1. Company Overview
    • 11.3.8.2. Financial Performance
    • 11.3.8.3. Service Benchmarking
    • 11.3.8.4. Strategic Initiatives
  • 11.3.9. ICON Plc.