市場調査レポート

商品コード

1726250

薬事申請の市場規模、シェア、動向分析レポート：サービス別、カテゴリー別、製品タイプ別、企業規模別、製品ステージ別、適応症別、最終用途別、地域別、およびセグメント動向：2025年～2030年

Regulatory Affairs Market Size, Share & Trends Analysis Report By Services (Regulatory Consulting, Legal Representation), By Categories, By Type, By Company Size, By Product Stage, By Indication, By End Use, By Region, And Segment Forecasts, 2025 - 2030

出版日: 2025年04月16日
発行: Grand View Research
ページ情報: 英文 200 Pages
納期: 2～10営業日

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全表示
概要
図表
目次

概要

サンプル依頼リストに入れる

薬事申請市場の成長と動向

Grand View Research, Inc.の最新レポートによると、世界の薬事申請市場規模は、2025～2030年にかけてCAGR 8.80%で拡大し、2030年には271億8,000万米ドルに達する見込みです。

同市場の成長に寄与すると予想される要因としては、事業活動や地域によって変化する規制要件、規制当局による承認の迅速化に伴う臨床検査や医薬品承認の増加、規制当局向けソフトウェアの技術進歩などが挙げられます。また、個別化医薬品の進化、企業が中核的な事業活動に集中する必要性の高まり、経済的・市場競争的圧力なども市場の成長に寄与している要因です。

COVID-19感染と闘うために必要なワクチンや医療製品を迅速に開発するために、製薬会社と規制当局が手を組みました。規制当局は、臨床検査中の患者や人員の安全を確保し、データの完全性や適正な実験室業務が維持されるよう、数多くの予防措置を講じています。バイオシミラー、希少疾病用医薬品、個別化医薬品、コンパニオン診断薬、適応検査デザインなどの市場の成長は、これらのセグメントにおける規制当局の専門性に対する需要を押し上げると予測されます。企業が新しいセグメントに進出するにつれて、規制を遵守する必要性が高まり、薬事業務の専門知識を有する専門サービスプロバイダへの需要が高まっています。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切れにより、バイオシミラーの需要と開発が増加しており、薬事サービスの需要に寄与しています。

個別化医療市場で主導権を握るため、複数の企業が提携や新製品開拓に積極的に取り組んでおり、薬事業務の支援が必要であることを示しています。例えば、2020年5月、Regeneron Pharmaceuticals, Inc.は、個別化医療とヒト遺伝学の進歩を設計するためにColorado Center for Personalized Medicineと提携しました。

薬事申請市場レポートハイライト

2024年にはアウトソーシング部門が59.05%のシェアを占め、市場を独占しました。このセグメントの成長は主に、製薬企業や医療機器企業が社内にない専門的な専門知識やリソースを利用できるアウトソーシングに注力するようになったためです。
レギュラトリーライティング＆パブリッシング部門は、2024年の市場で大きなシェアを占めています。同セグメントの成長は、複数の製薬・バイオ医薬品企業がコストを削減し、戦略的プロジェクトを優先し、スタッフのトレーニング時間を短縮し、全体的な効率を向上させ、より高い柔軟性を提供することに起因しています。
2024年の薬事申請市場は、医薬品セグメントが支配的でした。このセグメントの成長は、様々な規制と、プロセスに関わる各段階での関連する規制当局への申請/文書作成に起因しています。
2024年には、がん領域が市場を独占しました。このセグメントの成長は、効果的で安全な治療オプションを必要とするがんの有病率の増加によるものです。
臨床研究が2024年の市場を独占。慢性疾患の有病率の増加と新たな疾患の出現が相まって、より良い治療オプションへの需要が高まり、患者の増大するニーズに対応するために世界的に実施される臨床検査の数がさらに増加します。
2024年の市場規模は、中堅企業規模セグメントが支配的でした。同市場の成長は、主に非上場企業を中心とする中堅企業の存在感の大きさによるものです。
2024年の市場規模は製薬企業が圧倒的。このセグメントの成長は、承認医薬品数の増加と相まって研究開発活動が活発化していることによる。
アジア太平洋の薬事申請市場は世界市場を席巻し、2024年には38.03%のシェアを占めました。

セグメントダッシュボード
世界の薬事申請市場のカテゴリー変動分析
世界の薬事申請市場規模と動向分析（カテゴリー別、2018～2030年）
薬剤
- イノベーター
- ジェネリック医薬品
生物製剤
- バイオテクノロジー
- ATMP
バイオシミラー
医療機器
- 診断
- 治療

第6章薬事市場：適応症別、推定・動向分析

セグメントダッシュボード
世界の薬事申請市場の適応症変動分析
世界の薬事申請市場規模と動向分析（適応症別、2018～2030年）
腫瘍学
神経学
心臓病学
免疫学
その他

第7章薬事申請市場：製品ステージ別、推定・動向分析

セグメントダッシュボード
世界の薬事申請市場の製品ステージ変動分析
世界の薬事申請市場規模と動向分析（製品ステージ別、2018～2030年）
前臨床
臨床研究
市販前承認（PMA）

第8章薬事申請市場：タイプ別、推定・動向分析

セグメントダッシュボード
世界の薬事申請市場のタイプの変動分析
世界の薬事申請市場規模と動向分析（タイプ別、2018～2030年）
社内
アウトソーシング

第9章薬事申請市場：企業規模別、推定・動向分析

セグメントダッシュボード
世界の薬事申請市場の企業規模の変動分析
世界の薬事申請市場規模と動向分析（企業規模別、2018～2030年）
小
中
大

第10章薬事申請市場：最終用途別、推定・動向分析

セグメントダッシュボード
世界の薬事申請市場の最終用途変動分析
世界の薬事申請市場規模と動向分析（最終用途別、2018～2030年）
医療機器企業
製薬会社
バイオテクノロジー企業

第11章薬事申請市場：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
- 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
- ノルウェー
- オランダ
- スイス
- スウェーデン
アジア太平洋
- 日本
- 中国
- インド
- オーストラリア
- 韓国
- タイ
- インドネシア
- マレーシア
- シンガポール
- 台湾
ラテンアメリカ
- ブラジル
- アルゼンチン
- コロンビア
- チリ
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
- エジプト
- イスラエル
- クウェート

第12章競合情勢

競合の分類
- マーケットリーダー
- 新興参入企業
企業市場シェア/評価分析、2024年
企業プロファイル
- Accell Clinical Research, LLC
- Genpact
- Criterium, Inc.
- ICON plc
- iuvo BioScience, LLC.
- WuXi AppTec
- Medpace
- Charles River Laboratories
- Laboratory Corporation of America Holdings
- Parexel International（MA）Corporation
- Freyr
- PHARMALEX GMBH
- SSI Strategy LLC
- Pharmexon
- Qvigilance
- BlueReg
- Cambridge Regulatory Services
- VCLS

図表

List of Tables

Table 1 List of Secondary Sources
Table 2 List of Abbreviations
Table 3 Global Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 4 Global Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 5 Global Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 6 Global Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 7 Global Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 8 Global Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 9 Global Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 10 Global Regulatory Affairs Market, by Region, 2018 - 2030 (USD Million)
Table 11 North America Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 12 North America Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 13 North America Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 14 North America Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 15 North America Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 16 North America Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 17 North America Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 18 U.S. Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 19 U.S. Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 20 U.S. Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 21 U.S. Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 22 U.S. Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 23 U.S. Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 24 U.S. Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 25 Canada Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 26 Canada Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 27 Canada Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 28 Canada Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 29 Canada Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 30 Canada Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 31 Canada Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 32 Mexico Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 33 Mexico Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 34 Mexico Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 35 Mexico Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 36 Mexico Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 37 Mexico Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 38 Mexico Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 39 Europe Regulatory Affairs Market, by Country, 2018 - 2030 (USD Million)
Table 40 Europe Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 41 Europe Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 42 Europe Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 43 Europe Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 44 Europe Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 45 Europe Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 46 Europe Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 47 Germany Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 48 Germany Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 49 Germany Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 50 Germany Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 51 Germany Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 52 Germany Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 53 Germany Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 54 UK Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 55 UK Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 56 UK Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 57 UK Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 58 UK Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 59 UK Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 60 UK Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 61 France Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 62 France Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 63 France Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 64 France Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 65 France Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 66 France Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 67 France Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 68 Italy Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 69 Italy Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 70 Italy Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 71 Italy Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 72 Italy Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 73 Italy Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 74 Italy Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 75 Spain Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 76 Spain Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 77 Spain Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 78 Spain Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 79 Spain Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 80 Spain Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 81 Spain Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 82 Denmark Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 83 Denmark Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 84 Denmark Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 85 Denmark Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 86 Denmark Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 87 Denmark Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 88 Denmark Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 89 Norway Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 90 Norway Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 91 Norway Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 92 Norway Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 93 Norway Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 94 Norway Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 95 Norway Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 96 Netherlands Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 97 Netherlands Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 98 Netherlands Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 99 Netherlands Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 100 Netherlands Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 101 Netherlands Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 102 Netherlands Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 103 Switzerland Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 104 Switzerland Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 105 Switzerland Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 106 Switzerland Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 107 Switzerland Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 108 Switzerland Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 109 Switzerland Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 110 Sweden Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 111 Sweden Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 112 Sweden Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 113 Sweden Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 114 Sweden Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 115 Sweden Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 116 Sweden Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 117 Asia Pacific Regulatory Affairs Market, by Country, 2018 - 2030 (USD Million)
Table 118 Asia Pacific Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 119 Asia Pacific Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 120 Asia Pacific Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 121 Asia Pacific Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 122 Asia Pacific Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 123 Asia Pacific Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 124 Asia Pacific Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 125 China Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 126 China Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 127 China Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 128 China Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 129 China Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 130 China Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 131 China Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 132 Japan Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 133 Japan Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 134 Japan Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 135 Japan Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 136 Japan Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 137 Japan Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 138 Japan Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 139 India Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 140 India Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 141 India Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 142 India Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 143 India Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 144 India Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 145 India Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 146 South Korea Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 147 South Korea Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 148 South Korea Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 149 South Korea Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 150 South Korea Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 151 South Korea Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 152 South Korea Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 153 Australia Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 154 Australia Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 155 Australia Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 156 Australia Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 157 Australia Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 158 Australia Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 159 Australia Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 160 Thailand Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 161 Thailand Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 162 Thailand Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 163 Thailand Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 164 Thailand Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 165 Thailand Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 166 Thailand Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 167 Indonesia Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 168 Indonesia Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 169 Indonesia Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 170 Indonesia Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 171 Indonesia Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 172 Indonesia Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 173 Indonesia Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 174 Malaysia Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 175 Malaysia Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 176 Malaysia Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 177 Malaysia Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 178 Malaysia Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 179 Malaysia Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 180 Malaysia Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 181 Singapore Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 182 Singapore Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 183 Singapore Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 184 Singapore Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 185 Singapore Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 186 Singapore Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 187 Singapore Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 188 Taiwan Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 189 Taiwan Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 190 Taiwan Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 191 Taiwan Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 192 Taiwan Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 193 Taiwan Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 194 Taiwan Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 195 Latin America Regulatory Affairs Market, by Country, 2018 - 2030 (USD Million)
Table 196 Latin America Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 197 Latin America Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 198 Latin America Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 199 Latin America Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 200 Latin America Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 201 Latin America Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 202 Latin America Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 203 Brazil Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 204 Brazil Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 205 Brazil Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 206 Brazil Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 207 Brazil Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 208 Brazil Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 209 Brazil Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 210 Argentina Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 211 Argentina Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 212 Argentina Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 213 Argentina Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 214 Argentina Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 215 Argentina Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 216 Argentina Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 217 Colombia Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 218 Colombia Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 219 Colombia Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 220 Colombia Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 221 Colombia Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 222 Colombia Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 223 Colombia Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 224 Chile Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 225 Chile Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 226 Chile Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 227 Chile Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 228 Chile Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 229 Chile Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 230 Chile Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 231 Middle East & Africa Regulatory Affairs Market, by Country, 2018 - 2030 (USD Million)
Table 232 Middle East & Africa Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 233 Middle East & Africa Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 234 Middle East & Africa Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 235 Middle East & Africa Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 236 Middle East & Africa Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 237 Middle East & Africa Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 238 Middle East & Africa Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 239 South Africa Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 240 South Africa Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 241 South Africa Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 242 South Africa Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 243 South Africa Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 244 South Africa Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 245 South Africa Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 246 Saudi Arabia Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 247 Saudi Arabia Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 248 Saudi Arabia Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 249 Saudi Arabia Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 250 Saudi Arabia Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 251 Saudi Arabia Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 252 Saudi Arabia Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 253 UAE Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 254 UAE Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 255 UAE Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 256 UAE Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 257 UAE Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 258 UAE Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 259 UAE Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 260 Egypt Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 261 Egypt Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 262 Egypt Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 263 Egypt Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 264 Egypt Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 265 Egypt Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 266 Egypt Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 267 Israel Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 268 Israel Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 269 Israel Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 270 Israel Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 271 Israel Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 272 Israel Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 273 Israel Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)
Table 274 Kuwait Regulatory Affairs Market, by Services, 2018 - 2030 (USD Million)
Table 275 Kuwait Regulatory Affairs Market, by Category, 2018 - 2030 (USD Million)
Table 276 Kuwait Regulatory Affairs Market, by Indication, 2018 - 2030 (USD Million)
Table 277 Kuwait Regulatory Affairs Market, by Product Stage, 2018 - 2030 (USD Million)
Table 278 Kuwait Regulatory Affairs Market, by Type, 2018 - 2030 (USD Million)
Table 279 Kuwait Regulatory Affairs Market, by Company Size, 2018 - 2030 (USD Million)
Table 280 Kuwait Regulatory Affairs Market, by End-Use, 2018 - 2030 (USD Million)

List of Figures

Fig. 1 Regulatory Affairs Market segmentation
Fig. 2 Data analysis models
Fig. 3 Market formulation and validation
Fig. 4 Data validating & publishing
Fig. 5 Market research process
Fig. 6 Information procurement
Fig. 7 Primary research
Fig. 8 Value-chain-based sizing & forecasting
Fig. 9 QFD modelling for market share assessment
Fig. 10 Market formulation & validation
Fig. 11 Commodity flow analysis
Fig. 12 Market outlook
Fig. 13 Segment snapshot 1
Fig. 14 Segment snapshot 2
Fig. 15 Competitive landscape snapshot
Fig. 16 Market trends & outlook
Fig. 17 Porter's five force analysis
Fig. 18 PESTEL analysis
Fig. 19 Regulatory Affairs Market: Services outlook key takeaways
Fig. 20 Regulatory Affairs Market: Services movement analysis
Fig. 21 Regulatory consulting market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 22 Legal representation market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 23 Regulatory writing & publishing market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 24 Writing market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 25 Publishing market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 26 Product registration & clinical trial applications market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 27 Other services market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 28 Regulatory Affairs Market: Category outlook key takeaways
Fig. 29 Regulatory Affairs Market: Category movement analysis
Fig. 30 Drugs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 31 Innovator drugs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 32 Preclinical innovator drugs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 33 Clinical innovator drugs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 34 Pre-Market Approval (PMA) innovator drugs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 35 Generic drugs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 36 Preclinical generic drugs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 37 Clinical generic drugs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 38 Pre-Market Approval (PMA) generic drugs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 39 Biologics market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 40 Biotech market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 41 Preclinical biotech market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 42 Clinical biotech market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 43 Pre-Market Approval (PMA) biotech market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 44 ATMP market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 45 Preclinical ATMP market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 46 Clinical ATMP market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 47 Pre-Market Approval (PMA) ATMP market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 48 Biosimilars market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 49 Preclinical biosimilars market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 50 Clinical biosimilars market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 51 Pre-Market Approval (PMA) biosimilars market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 52 Medical Devices market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 53 Diagnostics market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 54 Preclinical diagnostics market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 55 Clinical diagnostics market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 56 Pre-Market Approval (PMA) diagnostics market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 57 Therapeutics market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 58 Preclinical therapeutics market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 59 Clinical therapeutics market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 60 Pre-Market Approval (PMA) therapeutics market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 61 Regulatory Affairs Market: Indication outlook key takeaways
Fig. 62 Regulatory Affairs Market: Indication movement analysis
Fig. 63 Oncology market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 64 Neurology market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 65 Cardiology companies market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 66 Immunology market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 67 Others market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 68 Regulatory Affairs Market: Product stage outlook key takeaways
Fig. 69 Regulatory Affairs Market: Product stage movement analysis
Fig. 70 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 71 Clinical studies market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 72 Pre-Market Approval (PMA) companies market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 73 Immunology market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 74 Regulatory Affairs Market: Type outlook key takeaways
Fig. 75 Regulatory Affairs Market: Type movement analysis
Fig. 76 In-house market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 77 Outsourced market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 78 Regulatory Affairs Market: Company size outlook key takeaways
Fig. 79 Regulatory Affairs Market: Company size movement analysis
Fig. 80 Small market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 81 Medium market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 82 Large market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 83 Regulatory Affairs Market: End-use outlook key takeaways
Fig. 84 Regulatory Affairs Market: End-use movement analysis
Fig. 85 Medical device companies market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 86 Pharmaceutical companies market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 87 Biotechnology companies market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 88 Regional marketplace outlook, 2024 & 2030 (USD Million)
Fig. 89 Regional marketplace: Key takeaways
Fig. 90 North America Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 91 Key country dynamics
Fig. 92 U.S. Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 93 Key country dynamics
Fig. 94 Canada Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 95 Key country dynamics
Fig. 96 Mexico Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 97 Key country dynamics
Fig. 98 Europe Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 99 Key country dynamics
Fig. 100 UK regulatory affairs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 101 Key country dynamics
Fig. 102 Germany Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 103 Key country dynamics
Fig. 104 France Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 105 Key country dynamics
Fig. 106 Italy Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 107 Key country dynamics
Fig. 108 Spain Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 109 Key country dynamics
Fig. 110 Denmark Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 111 Key country dynamics
Fig. 112 Norway Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 113 Key country dynamics
Fig. 114 Netherlands Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 115 Key country dynamics
Fig. 116 Switzerland Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 117 Key country dynamics
Fig. 118 Sweden Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 119 Asia Pacific Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 120 Key country dynamics
Fig. 121 Japan Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 122 Key country dynamics
Fig. 123 China Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 124 Key country dynamics
Fig. 125 India Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 126 Key country dynamics
Fig. 127 Australia Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 128 Key country dynamics
Fig. 129 South Korea Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 130 Key country dynamics
Fig. 131 Thailand Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 132 Key country dynamics
Fig. 133 Indonesia Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 134 Key country dynamics
Fig. 135 Taiwan Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 136 Key country dynamics
Fig. 137 Malaysia Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 138 Key country dynamics
Fig. 139 Singapore Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 140 Latin America Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 141 Key country dynamics
Fig. 142 Brazil Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 143 Key country dynamics
Fig. 144 Argentina Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 145 Key country dynamics
Fig. 146 Colombia regulatory affairs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 147 Key country dynamics
Fig. 148 Chile regulatory affairs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 149 Key country dynamics
Fig. 150 MEA Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 151 Key country dynamics
Fig. 152 South Africa Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 153 Key country dynamics
Fig. 154 Saudi Arabia Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 155 Key country dynamics
Fig. 156 UAE Regulatory Affairs Market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 157 Key country dynamics
Fig. 158 Egypt regulatory affairs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 159 Key country dynamics
Fig. 160 Israel regulatory affairs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 161 Key country dynamics
Fig. 162 Kuwait regulatory affairs market estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 163 Market participant categorization
Fig. 164 Regulatory affairs market share/assessment analysis, 2024
Fig. 165 Strategic framework

Product Code: GVR-4-68039-065-9

Regulatory Affairs Market Growth & Trends:

The global regulatory affairs market size is expected to reach USD 27.18 billion by 2030, expanding at a CAGR of 8.80% from 2025 to 2030, according to a new report by Grand View Research, Inc. The factors expected to contribute to the growth of this market include changing regulatory requirements based on business activities and geographies, an increase in clinical trials & drug approvals along with accelerated regulatory approval, and technological advancement in regulatory software. Also, the evolution of personalized medicines, the increasing need for companies to focus on core business activities, and economic and competitive pressures are other factors that are contributing to the growth of the market.

The pharmaceutical and regulatory agencies joined forces to rapidly develop vaccines and medical products required to fight against the COVID-19 infection. The regulatory authorities take numerous precautions to ensure patient and personnel safety during a clinical trial, as well as data integrity and good laboratory practices are maintained. Growth in markets for biosimilars, orphan drugs, personalized medicines, companion diagnostics, and adaptive trial designs is projected to boost the demand for regulatory specialization in these areas. As companies venture into newer fields, the growing need to comply with regulations is boosting the demand for specialized service providers with expertise in regulatory affairs. 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.

Several companies are actively involved in collaborations and new product development to gain leadership in the personalized medicine market, indicating a need for supportive regulatory affairs. For instance, in May 2020, Regeneron Pharmaceuticals, Inc. collaborated with Colorado Center for Personalized Medicine to design advancements in personalized medicine and human genetics.

Regulatory Affairs Market Report Highlights:

The outsourcing segment dominated the market with a share of 59.05% in 2024. The growth of the segment is mainly due to the growing focus of the pharmaceutical and medical device companies to outsource their activities as it allows access to specialized expertise and resources that they may not have in-house.
The regulatory writing & publishing segment held a significant share of the market in 2024. The growth of the segment is attributed to several pharmaceutical or biopharmaceutical companies reducing costs, prioritizing strategic projects, reducing staff training time, and improving overall efficiency, as well as providing greater flexibility.
The drugs segment dominated the regulatory affairs market in 2024. The growth of the segment can be attributed to various regulations and related regulatory submissions/documentation at each of the steps involved in the process.
The oncology segment dominated the market in 2024. The growth of the segment is due to the increasing prevalence of cancer, which requires effective and safe treatment options.
Clinical studies dominated the market in 2024. The increasing prevalence of chronic diseases coupled with the emergence of new diseases will increase the demand for better treatment options, further growing the number of clinical trials conducted globally to meet the growing needs of the patients.
The medium company size segment dominated the market in 2024. The growth of the market is mainly due to the strong presence of several mid-sized established firms, mainly which are privately held.
The pharmaceutical companies segment dominated the market in 2024. The growth of the segment is due to growing research and development activities coupled with an increase in the number of approved pharmaceutical products.
The regulatory affairs market in Asia Pacific dominated the global industry and accounted for a 38.03% share in 2024.

Chapter 1. Methodology and Scope

1.1. Market Segmentation & Scope
- 1.1.1. Regional Scope
- 1.1.2. Estimates and Forecast Timeline
1.2. Market Definitions
1.3. Research Methodology
- 1.3.1. Information Procurement
- 1.3.2. Purchased Database
- 1.3.3. GVR's Internal Database
- 1.3.4. Secondary Sources
- 1.3.5. Primary Research
1.4. Information or Data Analysis
- 1.4.1. Information Analysis
- 1.4.2. Market Formulation & Data Visualization
- 1.4.3. Data Validation & Publishing
1.5. Model Details
- 1.5.1. Commodity Flow Analysis (Model 1)
- 1.5.2. Top Down Market Estimation (Model 2)
- 1.5.3. Value-Chain-Based Sizing & Forecasting (Model 3)
- 1.5.4. Multivariate Analysis (Model 4)
1.6. List of Secondary Sources
1.7. List of Abbreviations
1.8. Objectives

Chapter 2. Executive Summary

2.1. Market Outlook
2.2. Segment Snapshot
2.3. Competitive Insights Landscape

Chapter 3. Regulatory Affairs Market Variables, Trends & Scope

3.1. Market Lineage Outlook
- 3.1.1. Parent market outlook
- 3.1.2. Related/ancillary market outlook.
3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
  - 3.2.1.1. Changing regulatory landscape
  - 3.2.1.2. Entry of companies into the global market
  - 3.2.1.3. Life science companies focusing on their core competencies
  - 3.2.1.4. Economic and competitive pressures
  - 3.2.1.5. Demand for the faster approval process for breakthrough drugs and devices
  - 3.2.1.6. Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs
- 3.2.2. Market Restraint Analysis
  - 3.2.2.1. Risk Associated with Data Security
  - 3.2.2.2. Monitoring Issues and Lack of Standardization
3.3. Industry Market Analysis Tools
- 3.3.1. Industry Analysis - Porter's
- 3.3.2. PESTEL Analysis
- 3.3.3. COVID-19 Impact Analysis

Chapter 4. Regulatory Affairs Market: Services Estimates & Trend Analysis

4.1. Segment Dashboard
4.2. Global Regulatory Affairs Market Services Movement Analysis
4.3. Global Regulatory Affairs Market Size & Trend Analysis, by Services, 2018 to 2030 (USD Million)
4.4. Regulatory Consulting
- 4.4.1. Regulatory consulting market estimates and forecasts, 2018 - 2030 (USD Million)
4.5. Legal Representation
- 4.5.1. Legal representation market estimates and forecasts, 2018 - 2030 (USD Million)
4.6. Regulatory Writing & Publishing
- 4.6.1. Regulatory writing & publishing market estimates and forecasts, 2018 - 2030 (USD Million)
  - 4.6.1.1. Writing
    - 4.6.1.1.1. Writing market estimates and forecasts, 2018 - 2030 (USD Million)
  - 4.6.1.2. Publishing
    - 4.6.1.2.1. Publishing market estimates and forecasts, 2018 - 2030 (USD Million)
4.7. Product Registration & Clinical Trial Applications
- 4.7.1. Product registration & clinical trial applications market estimates and forecasts, 2018 - 2030 (USD Million)
4.8. Other Services
- 4.8.1. Other services market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 5. Regulatory Affairs Market: Category Estimates & Trend Analysis

5.1. Segment Dashboard
5.2. Global Regulatory Affairs Market Category Movement Analysis
5.3. Global Regulatory Affairs Market Size & Trend Analysis, by Category, 2018 to 2030 (USD Million)
5.4. Drugs
- 5.4.1. Drugs market estimates and forecasts, 2018 - 2030 (USD Million)
- 5.4.2. Innovator
  - 5.4.2.1. Innovator market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.4.2.2. Preclinical
    - 5.4.2.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.4.2.3. Clinical
    - 5.4.2.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.4.2.4. Pre-Market Approval (PMA)
    - 5.4.2.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
- 5.4.3. Generics
  - 5.4.3.1. Generics market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.4.3.2. Preclinical
    - 5.4.3.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.4.3.3. Clinical
    - 5.4.3.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.4.3.4. Pre-Market Approval (PMA)
    - 5.4.3.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
5.5. Biologics
- 5.5.1. Biologics market estimates and forecasts, 2018 - 2030 (USD Million)
- 5.5.2. Biotech
  - 5.5.2.1. Biotech market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.5.2.2. Preclinical
    - 5.5.2.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.5.2.3. Clinical
    - 5.5.2.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.5.2.4. Pre-Market Approval (PMA)
    - 5.5.2.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
- 5.5.3. ATMP
  - 5.5.3.1. ATMP market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.5.3.2. Preclinical
    - 5.5.3.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.5.3.3. Clinical
    - 5.5.3.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.5.3.4. Pre-Market Approval (PMA)
    - 5.5.3.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
5.6. Biosimilars
- 5.6.1. Biosimilars market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.6.1.1. Preclinical
    - 5.6.1.1.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.6.1.2. Clinical
    - 5.6.1.2.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.6.1.3. Pre-Market Approval (PMA)
    - 5.6.1.3.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
5.7. Medical Devices
- 5.7.1. Medical devices market estimates and forecasts, 2018 - 2030 (USD Million)
- 5.7.2. Diagnostics
  - 5.7.2.1. Diagnostics market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.7.2.2. Preclinical
    - 5.7.2.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.7.2.3. Clinical
    - 5.7.2.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.7.2.4. Pre-Market Approval (PMA)
    - 5.7.2.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
- 5.7.3. Therapeutics
  - 5.7.3.1. Therapeutics market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.7.3.2. Preclinical
    - 5.7.3.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.7.3.3. Clinical
    - 5.7.3.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  - 5.7.3.4. Pre-Market Approval (PMA)
    - 5.7.3.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 6. Regulatory Affairs Market: Indication Estimates & Trend Analysis

6.1. Segment Dashboard
6.2. Global Regulatory Affairs Market Indication Movement Analysis
6.3. Global Regulatory Affairs Market Size & Trend Analysis, by Indication, 2018 to 2030 (USD Million)
6.4. Oncology
- 6.4.1. Oncology market estimates and forecasts, 2018 - 2030 (USD Million)
6.5. Neurology
- 6.5.1. Neurology market estimates and forecasts, 2018 - 2030 (USD Million)
6.6. Cardiology
- 6.6.1. Cardiology market estimates and forecasts, 2018 - 2030 (USD Million)
6.7. Immunology
- 6.7.1. Immunology market estimates and forecasts, 2018 - 2030 (USD Million)
6.8. Others
- 6.8.1.1. Others market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 7. Regulatory Affairs Market: Product Stage Estimates & Trend Analysis

7.1. Segment Dashboard
7.2. Global Regulatory Affairs Market Product Stage Movement Analysis
7.3. Global Regulatory Affairs Market Size & Trend Analysis, by Product Stage, 2018 to 2030 (USD Million)
7.4. Preclinical
- 7.4.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
7.5. Clinical studies
- 7.5.1. Clinical studies market estimates and forecasts, 2018 - 2030 (USD Million)
7.6. Pre-Market Approval (PMA)
- 7.6.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 8. Regulatory Affairs Market: Type Estimates & Trend Analysis

8.1. Segment Dashboard
8.2. Global Regulatory Affairs Market Type Movement Analysis
8.3. Global Regulatory Affairs Market Size & Trend Analysis, by Type, 2018 to 2030 (USD Million)
8.4. In-house
- 8.4.1. In-house market estimates and forecasts, 2018 - 2030 (USD Million)
8.5. Outsourced
- 8.5.1. Outsourced market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 9. Regulatory Affairs Market: Company Size Estimates & Trend Analysis

9.1. Segment Dashboard
9.2. Global Regulatory Affairs Market Company Size Movement Analysis
9.3. Global Regulatory Affairs Market Size & Trend Analysis, by Company Size, 2018 to 2030 (USD Million)
9.4. Small
- 9.4.1. Small market estimates and forecasts, 2018 - 2030 (USD Million)
9.5. Medium
- 9.5.1. Medium market estimates and forecasts, 2018 - 2030 (USD Million)
9.6. Large
- 9.6.1. Large market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 10. Regulatory Affairs Market: End-use Estimates & Trend Analysis

10.1. Segment Dashboard
10.2. Global Regulatory Affairs Market End-use Movement Analysis
10.3. Global Regulatory Affairs Market Size & Trend Analysis, by End-use, 2018 to 2030 (USD Million)
10.4. Medical Device Companies
- 10.4.1. Medical device companies market estimates and forecasts, 2018 - 2030 (USD Million)
10.5. Pharmaceutical Companies
- 10.5.1. Pharmaceutical companies market estimates and forecasts, 2018 - 2030 (USD Million)
10.6. Biotechnology Companies
- 10.6.1. Biotechnology companies market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 11. Regulatory Affairs Market: Regional Estimates & Trend Analysis

11.1. Regional Market Share Analysis, 2024 & 2030
11.2. Regional Market Dashboard
11.3. Market Size & Forecasts Trend Analysis, 2018 to 2030 (USD Million)
11.4. North America
- 11.4.1. North America Market Estimates and Forecasts 2018 to 2030, (USD Million)
- 11.4.2. U.S.
  - 11.4.2.1. Key country dynamics
  - 11.4.2.2. Competitive scenario
  - 11.4.2.3. Regulatory scenario
  - 11.4.2.4. U.S. market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.4.3. Canada
  - 11.4.3.1. Key country dynamics
  - 11.4.3.2. Competitive scenario
  - 11.4.3.3. Regulatory scenario
  - 11.4.3.4. Canada market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.4.4. Mexico
  - 11.4.4.1. Key country dynamics
  - 11.4.4.2. Competitive scenario
  - 11.4.4.3. Regulatory scenario
  - 11.4.4.4. Mexico market estimates and forecasts, 2018 - 2030 (USD Million)
11.5. Europe
- 11.5.1. Europe Market Estimates and Forecasts 2018 to 2030 (USD Million)
- 11.5.2. UK
  - 11.5.2.1. Key country dynamics
  - 11.5.2.2. Competitive scenario
  - 11.5.2.3. Regulatory scenario
  - 11.5.2.4. UK market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.5.3. Germany
  - 11.5.3.1. Key country dynamics
  - 11.5.3.2. Competitive scenario
  - 11.5.3.3. Regulatory scenario
  - 11.5.3.4. Germany market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.5.4. France
  - 11.5.4.1. Key country dynamics
  - 11.5.4.2. Competitive scenario
  - 11.5.4.3. Regulatory scenario
  - 11.5.4.4. France market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.5.5. Italy
  - 11.5.5.1. Key country dynamics
  - 11.5.5.2. Competitive scenario
  - 11.5.5.3. Regulatory scenario
  - 11.5.5.4. Italy market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.5.6. Spain
  - 11.5.6.1. Key country dynamics
  - 11.5.6.2. Competitive scenario
  - 11.5.6.3. Regulatory scenario
  - 11.5.6.4. Spain market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.5.7. Denmark
  - 11.5.7.1. Key country dynamics
  - 11.5.7.2. Competitive scenario
  - 11.5.7.3. Regulatory scenario
  - 11.5.7.4. Denmark market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.5.8. Norway
  - 11.5.8.1. Key country dynamics
  - 11.5.8.2. Competitive scenario
  - 11.5.8.3. Regulatory scenario
  - 11.5.8.4. Norway market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.5.9. Netherlands
  - 11.5.9.1. Key country dynamics
  - 11.5.9.2. Competitive scenario
  - 11.5.9.3. Regulatory scenario
  - 11.5.9.4. Netherlands market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.5.10. Switzerland
  - 11.5.10.1. Key country dynamics
  - 11.5.10.2. Competitive scenario
  - 11.5.10.3. Regulatory scenario
  - 11.5.10.4. Switzerland market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.5.11. Sweden
  - 11.5.11.1. Key country dynamics
  - 11.5.11.2. Competitive scenario
  - 11.5.11.3. Regulatory scenario
  - 11.5.11.4. Sweden market estimates and forecasts, 2018 - 2030 (USD Million)
11.6. Asia Pacific
- 11.6.1. Asia Pacific Market Estimates and Forecasts 2018 to 2030 (USD Million)
- 11.6.2. Japan
  - 11.6.2.1. Key country dynamics
  - 11.6.2.2. Competitive scenario
  - 11.6.2.3. Regulatory scenario
  - 11.6.2.4. Japan market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.6.3. China
  - 11.6.3.1. Key country dynamics
  - 11.6.3.2. Competitive scenario
  - 11.6.3.3. Regulatory scenario
  - 11.6.3.4. China market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.6.4. India
  - 11.6.4.1. Key country dynamics
  - 11.6.4.2. Competitive scenario
  - 11.6.4.3. Regulatory scenario
  - 11.6.4.4. India market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.6.5. Australia
  - 11.6.5.1. Key country dynamics
  - 11.6.5.2. Competitive scenario
  - 11.6.5.3. Regulatory scenario
  - 11.6.5.4. Australia market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.6.6. South Korea
  - 11.6.6.1. Key country dynamics
  - 11.6.6.2. Competitive scenario
  - 11.6.6.3. Regulatory scenario
  - 11.6.6.4. South Korea market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.6.7. Thailand
  - 11.6.7.1. Key country dynamics
  - 11.6.7.2. Competitive scenario
  - 11.6.7.3. Regulatory scenario
  - 11.6.7.4. Thailand market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.6.8. Indonesia
  - 11.6.8.1. Key country dynamics
  - 11.6.8.2. Competitive scenario
  - 11.6.8.3. Regulatory scenario
  - 11.6.8.4. Indonesia market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.6.9. Malaysia
  - 11.6.9.1. Key country dynamics
  - 11.6.9.2. Competitive scenario
  - 11.6.9.3. Regulatory scenario
  - 11.6.9.4. Malaysia market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.6.10. Singapore
  - 11.6.10.1. Key country dynamics
  - 11.6.10.2. Competitive scenario
  - 11.6.10.3. Regulatory scenario
  - 11.6.10.4. Singapore market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.6.11. Taiwan
  - 11.6.11.1. Key country dynamics
  - 11.6.11.2. Competitive scenario
  - 11.6.11.3. Regulatory scenario
  - 11.6.11.4. Taiwan market estimates and forecasts, 2018 - 2030 (USD Million)
11.7. Latin America
- 11.7.1. Latin America Market Estimates and Forecasts 2018 to 2030 (USD Million)
- 11.7.2. Brazil
  - 11.7.2.1. Key country dynamics
  - 11.7.2.2. Competitive scenario
  - 11.7.2.3. Regulatory scenario
  - 11.7.2.4. Brazil market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.7.3. Argentina
  - 11.7.3.1. Key country dynamics
  - 11.7.3.2. Competitive scenario
  - 11.7.3.3. Regulatory scenario
  - 11.7.3.4. Argentina market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.7.4. Colombia
  - 11.7.4.1. Key country dynamics
  - 11.7.4.2. Competitive scenario
  - 11.7.4.3. Regulatory scenario
  - 11.7.4.4. Colombia market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.7.5. Chile
  - 11.7.5.1. Key country dynamics
  - 11.7.5.2. Competitive scenario
  - 11.7.5.3. Regulatory scenario
  - 11.7.5.4. Chile market estimates and forecasts, 2018 - 2030 (USD Million)
11.8. MEA
- 11.8.1. MEA Market Estimates and Forecasts 2018 to 2030 (USD Million)
- 11.8.2. South Africa
  - 11.8.2.1. Key country dynamics
  - 11.8.2.2. Competitive scenario
  - 11.8.2.3. Regulatory scenario
  - 11.8.2.4. South Africa market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.8.3. Saudi Arabia
  - 11.8.3.1. Key country dynamics
  - 11.8.3.2. Competitive scenario
  - 11.8.3.3. Regulatory scenario
  - 11.8.3.4. Saudi Arabia market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.8.4. UAE
  - 11.8.4.1. Key country dynamics
  - 11.8.4.2. Competitive scenario
  - 11.8.4.3. Regulatory scenario
  - 11.8.4.4. UAE market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.8.5. Egypt
  - 11.8.5.1. Key country dynamics
  - 11.8.5.2. Competitive scenario
  - 11.8.5.3. Regulatory scenario
  - 11.8.5.4. Egypt market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.8.6. Israel
  - 11.8.6.1. Key country dynamics
  - 11.8.6.2. Competitive scenario
  - 11.8.6.3. Regulatory scenario
  - 11.8.6.4. Israel market estimates and forecasts, 2018 - 2030 (USD Million)
- 11.8.7. Kuwait
  - 11.8.7.1. Key country dynamics
  - 11.8.7.2. Competitive scenario
  - 11.8.7.3. Regulatory scenario
  - 11.8.7.4. Israel market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 12. Competitive Landscape

12.1. Competition Categorization
- 12.1.1. Market Leaders
- 12.1.2. Emerging Players
12.2. Company Market Share/Assessment Analysis, 2024
12.3. Company Profiles
- 12.3.1. Accell Clinical Research, LLC
  - 12.3.1.1. Company overview
  - 12.3.1.2. Financial performance
  - 12.3.1.3. Service benchmarking
  - 12.3.1.4. Strategic initiatives
- 12.3.2. Genpact
  - 12.3.2.1. Company overview
  - 12.3.2.2. Financial performance
  - 12.3.2.3. Service benchmarking
  - 12.3.2.4. Strategic initiatives
- 12.3.3. Criterium, Inc.
  - 12.3.3.1. Company overview
  - 12.3.3.2. Financial performance
  - 12.3.3.3. Service benchmarking
  - 12.3.3.4. Strategic initiatives
- 12.3.4. ICON plc
  - 12.3.4.1. Company overview
  - 12.3.4.2. Financial performance
  - 12.3.4.3. Service benchmarking
  - 12.3.4.4. Strategic initiatives
- 12.3.5. iuvo BioScience, LLC.
  - 12.3.5.1. Company overview
  - 12.3.5.2. Financial performance
  - 12.3.5.3. Service benchmarking
  - 12.3.5.4. Strategic initiatives
- 12.3.6. WuXi AppTec
  - 12.3.6.1. Company overview
  - 12.3.6.2. Financial performance
  - 12.3.6.3. Service benchmarking
  - 12.3.6.4. Strategic initiatives
- 12.3.7. Medpace
  - 12.3.7.1. Company overview
  - 12.3.7.2. Financial performance
  - 12.3.7.3. Service benchmarking
  - 12.3.7.4. Strategic initiatives
- 12.3.8. Charles River Laboratories
  - 12.3.8.1. Company overview
  - 12.3.8.2. Financial performance
  - 12.3.8.3. Service benchmarking
  - 12.3.8.4. Strategic initiatives
- 12.3.9. Laboratory Corporation of America Holdings
  - 12.3.9.1. Company overview
  - 12.3.9.2. Financial performance
  - 12.3.9.3. Service benchmarking
  - 12.3.9.4. Strategic initiatives
- 12.3.10. Parexel International (MA) Corporation
  - 12.3.10.1. Company overview
  - 12.3.10.2. Financial performance
  - 12.3.10.3. Service benchmarking
  - 12.3.10.4. Strategic initiatives
- 12.3.11. Freyr
  - 12.3.11.1. Company overview
  - 12.3.11.2. Financial performance
  - 12.3.11.3. Service benchmarking
  - 12.3.11.4. Strategic initiatives
- 12.3.12. PHARMALEX GMBH
  - 12.3.12.1. Company overview
  - 12.3.12.2. Financial performance
  - 12.3.12.3. Service benchmarking
  - 12.3.12.4. Strategic initiatives
- 12.3.13. SSI Strategy LLC
  - 12.3.13.1. Company overview
  - 12.3.13.2. Financial performance
  - 12.3.13.3. Service benchmarking
  - 12.3.13.4. Strategic initiatives
- 12.3.14. Pharmexon
  - 12.3.14.1. Company overview
  - 12.3.14.2. Financial performance
  - 12.3.14.3. Service benchmarking
  - 12.3.14.4. Strategic initiatives
- 12.3.15. Qvigilance
  - 12.3.15.1. Company overview
  - 12.3.15.2. Financial performance
  - 12.3.15.3. Service benchmarking
  - 12.3.15.4. Strategic initiatives
- 12.3.16. BlueReg
  - 12.3.16.1. Company overview
  - 12.3.16.2. Financial performance
  - 12.3.16.3. Service benchmarking
  - 12.3.16.4. Strategic initiatives
- 12.3.17. Cambridge Regulatory Services
  - 12.3.17.1. Company overview
  - 12.3.17.2. Financial performance
  - 12.3.17.3. Service benchmarking
  - 12.3.17.4. Strategic initiatives
- 12.3.18. VCLS
  - 12.3.18.1. Company overview
  - 12.3.18.2. Financial performance
  - 12.3.18.3. Service benchmarking
  - 12.3.18.4. Strategic initiatives

薬事申請の市場規模、シェア、動向分析レポート：サービス別、カテゴリー別、製品タイプ別、企業規模別、製品ステージ別、適応症別、最終用途別、地域別、およびセグメント動向：2025年～2030年

Regulatory Affairs Market Size, Share & Trends Analysis Report By Services (Regulatory Consulting, Legal Representation), By Categories, By Type, By Company Size, By Product Stage, By Indication, By End Use, By Region, And Segment Forecasts, 2025 - 2030

薬事申請市場の成長と動向

薬事申請市場レポートハイライト

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章薬事申請市場の変数、動向、範囲

第4章薬事申請市場：サービス別、推定・動向分析

第5章薬事申請市場：カテゴリー別、推定・動向分析

第6章薬事市場：適応症別、推定・動向分析

第7章薬事申請市場：製品ステージ別、推定・動向分析

第8章薬事申請市場：タイプ別、推定・動向分析

第9章薬事申請市場：企業規模別、推定・動向分析

第10章薬事申請市場：最終用途別、推定・動向分析

第11章薬事申請市場：地域別、推定・動向分析

第12章競合情勢

List of Tables

List of Figures

Regulatory Affairs Market Growth & Trends:

Regulatory Affairs Market Report Highlights:

Table of Contents

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. Regulatory Affairs Market Variables, Trends & Scope

Chapter 4. Regulatory Affairs Market: Services Estimates & Trend Analysis

Chapter 5. Regulatory Affairs Market: Category Estimates & Trend Analysis

Chapter 6. Regulatory Affairs Market: Indication Estimates & Trend Analysis

Chapter 7. Regulatory Affairs Market: Product Stage Estimates & Trend Analysis

Chapter 8. Regulatory Affairs Market: Type Estimates & Trend Analysis

Chapter 9. Regulatory Affairs Market: Company Size Estimates & Trend Analysis

Chapter 10. Regulatory Affairs Market: End-use Estimates & Trend Analysis

Chapter 11. Regulatory Affairs Market: Regional Estimates & Trend Analysis

Chapter 12. Competitive Landscape

薬事申請の市場規模、シェア、動向分析レポート：サービス別、カテゴリー別、製品タイプ別、企業規模別、製品ステージ別、適応症別、最終用途別、地域別、およびセグメント動向：2025年～2030年

Regulatory Affairs Market Size, Share & Trends Analysis Report By Services (Regulatory Consulting, Legal Representation), By Categories, By Type, By Company Size, By Product Stage, By Indication, By End Use, By Region, And Segment Forecasts, 2025 - 2030

薬事申請市場の成長と動向

薬事申請市場レポートハイライト

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 薬事申請市場の変数、動向、範囲

第4章 薬事申請市場：サービス別、推定・動向分析

第5章 薬事申請市場：カテゴリー別、推定・動向分析

第6章 薬事市場：適応症別、推定・動向分析

第7章 薬事申請市場：製品ステージ別、推定・動向分析

第8章 薬事申請市場：タイプ別、推定・動向分析

第9章 薬事申請市場：企業規模別、推定・動向分析

第10章 薬事申請市場：最終用途別、推定・動向分析

第11章 薬事申請市場：地域別、推定・動向分析

第12章 競合情勢

List of Tables

List of Figures

Regulatory Affairs Market Growth & Trends:

Regulatory Affairs Market Report Highlights:

Table of Contents

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. Regulatory Affairs Market Variables, Trends & Scope

Chapter 4. Regulatory Affairs Market: Services Estimates & Trend Analysis

Chapter 5. Regulatory Affairs Market: Category Estimates & Trend Analysis

Chapter 6. Regulatory Affairs Market: Indication Estimates & Trend Analysis

Chapter 7. Regulatory Affairs Market: Product Stage Estimates & Trend Analysis

Chapter 8. Regulatory Affairs Market: Type Estimates & Trend Analysis

Chapter 9. Regulatory Affairs Market: Company Size Estimates & Trend Analysis

Chapter 10. Regulatory Affairs Market: End-use Estimates & Trend Analysis

Chapter 11. Regulatory Affairs Market: Regional Estimates & Trend Analysis

Chapter 12. Competitive Landscape

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章薬事申請市場の変数、動向、範囲

第4章薬事申請市場：サービス別、推定・動向分析

第5章薬事申請市場：カテゴリー別、推定・動向分析

第6章薬事市場：適応症別、推定・動向分析

第7章薬事申請市場：製品ステージ別、推定・動向分析

第8章薬事申請市場：タイプ別、推定・動向分析

第9章薬事申請市場：企業規模別、推定・動向分析

第10章薬事申請市場：最終用途別、推定・動向分析

第11章薬事申請市場：地域別、推定・動向分析

第12章競合情勢