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生物学的同等性試験の市場規模、シェア、動向分析レポート：分子タイプ別（低分子、高分子）、剤形別、治療領域別、地域別、セグメント予測、2023年～2030年

Bioequivalence Studies Market Size, Share & Trends Analysis Report By Molecule Type (Small Molecule, Large Molecule), By Dosage Form, By Therapeutic Area, By Region, And Segment Forecasts, 2023 - 2030
出版日: | 発行: Grand View Research | ページ情報: 英文 175 Pages | 納期: 2～10営業日

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価格
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生物学的同等性試験の市場規模、シェア、動向分析レポート：分子タイプ別（低分子、高分子）、剤形別、治療領域別、地域別、セグメント予測、2023年～2030年
出版日: 2023年06月07日
発行: Grand View Research
ページ情報: 英文 175 Pages
納期: 2～10営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

生物学的同等性試験市場の成長と動向

Grand View Research, Inc.の最新レポートによると、生物学的同等性試験の世界市場規模は2023年から2030年にかけてCAGR 8.3%で拡大し、2030年には12億7,220万米ドルに達すると予測されています。

希少疾患に関する研究開発活動の増加やジェネリック医薬品に対する需要の高まりが、生物学的同等性試験市場の成長を促す主な要因となっています。

生物学的同等性試験は、2つの製剤の生体内での生物学的同等性を分析するために使用されます。2つの医薬品が生物学的に同等であれば、生物学的利用率や薬物動態（PK）パラメータがあらゆる目的で等しく反映されると予想されます。市場の主要企業には、ProRelix Services LLP、IQVIA、ICON plc、Charles River Laboratories、Labcorp Drug Developmentなどがあります。

これらの企業は、医薬品開発に携わる研究機関、製薬会社、政府機関に対し、幅広い生物学的同等性およびバイオアベイラビリティ・サービスを提供しています。また、がん、神経学、免疫学などの疾患領域において、低コストのバイオシミラーやジェネリック医薬品の開発を目的とした臨床研究活動のペースが増加していることから、生物学的同等性試験の市場開拓が促進されると予想されます。

ジェネリック医薬品の上市率が高まっていることが、過去数年間における生物学的同等性試験の大きな需要を生み出しています。例えば、米国食品医薬品局（FDA）は、2022年1月現在、米国でFDAが承認したバイオシミラー医薬品は33品目あり、そのうち21品目が市場で市販されていると発表しました。

COVID-19の流行は生物学的同等性試験市場にマイナスの影響を与えました。しかし、この状況を緩和し、売上高を回復させるために、いくつかの企業が無機的な戦略を採用しました。さらに、ロシアとウクライナの間の地政学的戦争は、生物学的同等性試験業界全体の売上減少につながっています。これは米国など特定の経済に大きな影響を与えており、そのため2022年の市場全体の収益は緩やかに落ち込みました。

生物学的同等性試験市場レポートハイライト

  • 低分子セグメントは2022年に60.6%という最大の売上シェアを占めました。このセグメントは、低分子の大部分を占めるジェネリック医薬品の需要が着実に伸びていることが要因です。
  • 剤形別では、経口固形製剤が2022年に53.8%と最大の売上シェアを占めました。これは、経口固形製剤を最適な品質で製造する技術の革新別ものです。
  • がん領域は予測期間中に8.7%のCAGRを記録すると予想されます。これは、市場で承認される抗がん剤バイオシミラーの割合が増加しているためです。
  • アジア太平洋地域は、予測期間中に8.8%と最も高いCAGRを記録すると予測されます。インドや中国などのアジア諸国はジェネリック医薬品の主要輸出国であり、ジェネリック医薬品の生産が盛んであることから、生物学的同等性試験の需要が高まることが予想されます。

目次

第1章 調査手法と範囲

  • 市場セグメンテーションと範囲
    • セグメントの範囲
    • 地域範囲
    • 推定・予測のタイムライン
  • 調査手法
  • 情報調達
    • 購入したデータベース
    • GVRの内部データベース
    • 二次情報
    • 1次調査
    • 1次調査の詳細
  • 情報またはデータ分析
    • データ分析モデル
  • 市場の形成と検証
  • モデル詳細
    • 商品フロー解析（モデル1）
    • 出来高価格分析（モデル2）
  • 二次情報のリスト
  • 一次情報のリスト
  • 目的

第2章 エグゼクティブサマリー

  • 市場の見通し
  • セグメントの見通し
  • 競合考察

第3章 生物学的同等性試験の市場変数、動向、範囲

  • 市場系統の見通し
    • 親市場の見通し
    • 関連/補助的な市場見通し
  • 市場力学
    • 市場促進要因の分析
    • 市場抑制要因分析
    • 業界の課題
  • 生物学的同等性試験：市場分析ツール
    • 業界分析- ポーターズ
    • PESTEL分析
    • 主要取引と戦略的提携の分析
    • 市場参入戦略
    • COVID-19感染症の影響分析

第4章 生物学的同等性試験市場：分子タイプの推定・動向分析

  • 生物学的同等性試験市場：定義と範囲
  • 生物学的同等性試験市場：分子タイプ市場シェア分析、2022年および2030年
    • 低分子
    • 高分子

第5章 生物学的同等性試験市場：剤形の推定・動向分析

  • 生物学的同等性試験市場：定義と範囲
  • 生物学的同等性試験市場：剤形市場シェア分析、2022年および2030年
    • 固形経口投与量
    • 非経口製剤
    • 話題の商品
    • その他

第6章 生物学的同等性試験市場：治療領域の推定・動向分析

  • 生物学的同等性試験市場：定義と範囲
  • 生物学的同等性試験市場：治療領域の市場シェア分析、2022年および2030年
    • 腫瘍学
    • 神経内科
    • 代謝障害
    • 血液学
    • 免疫学
    • 整形外科
    • その他

第7章 生物学的同等性試験市場：段階の推定・動向分析

  • 生物学的同等性試験市場：定義と範囲
  • 生物学的同等性試験市場：段階市場シェア分析、2022年および2030年
    • ドラッグディスカバー
    • 前臨床研究
    • 臨床研究

第8章 生物学的同等性試験市場：地域の推定・動向分析

  • 地域市場シェア分析、2022年および2030年
  • 市場規模、予測、収益および傾向分析、2018年から2030年：
  • 北米
    • 市場推計・予測、2018-2030（金額）
    • 米国
    • カナダ
  • 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
  • アジア太平洋地域
    • 日本
    • 中国
    • インド
    • オーストラリア
    • タイ
    • 韓国
  • ラテンアメリカ
    • ブラジル
    • メキシコ
    • アルゼンチン
  • MEA
    • 南アフリカ
    • サウジアラビア
    • アラブ首長国連邦
    • クウェート

第9章 競合情勢

  • 企業の市場シェア分析、2022年
  • 企業プロファイル
    • CliniExperts
    • ICBIO Corporation
    • ProRelix Services LLP
    • PPD, Inc
    • Syneos Health
    • Labcorp Drug Development
    • IQVIA
    • Charles River Laboratories Inc.
    • Icon PLC
    • Intertek Group plc
図表

List of Tables

  • Table 1 List of secondary sources
  • Table 2 List of Abbreviations
  • Table 3 North America Bioequivalence Studies market, by region, 2018 - 2030 (USD Million)
  • Table 4 North America Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 5 North America Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 6 North America Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 7 U.S. Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 8 U.S. Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 9 U.S. Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 10 Canada Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 11 Canada Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 12 Canada Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 13 Europe Bioequivalence Studies market, by region, 2018 - 2030 (USD Million)
  • Table 14 Europe Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 15 Europe Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 16 Europe Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 17 U.K. Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 18 U.K. Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 19 U.K. Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 20 Germany Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 21 Germany Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 22 Germany Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 23 France Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 24 France Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 25 France Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 26 Italy Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 27 Italy Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 28 Italy Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 29 Spain Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 30 Spain Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 31 Spain Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 32 Denmark Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 33 Denmark Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 34 Denmark Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 35 Sweden Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 36 Sweden Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 37 Sweden Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 38 Norway Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 39 Norway Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 40 Norway Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 41 Asia Pacific Bioequivalence Studies market, by region, 2018 - 2030 (USD Million)
  • Table 42 Asia Pacific Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 43 Asia Pacific Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 44 Asia Pacific Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 45 China Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 46 China Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 47 China Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 48 Japan Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 49 Japan Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 50 Japan Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 51 India Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 52 India Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 53 India Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 54 Australia Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 55 Australia Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 56 Australia Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 57 South Korea Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 58 South Korea Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 59 South Korea Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 60 Thailand Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 61 Thailand Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 62 Thailand Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 63 Latin America Bioequivalence Studies market, by region, 2018 - 2030 (USD Million)
  • Table 64 Latin America Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 65 Latin America Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 66 Latin America Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 67 Brazil Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 68 Brazil Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 69 Brazil Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 70 Mexico Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 71 Mexico Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 72 Mexico Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 73 Argentina Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 74 Argentina Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 75 Argentina Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 76 Middle East and Africa Bioequivalence Studies market, by region, 2018 - 2030 (USD Million)
  • Table 77 Middle East and Africa Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 78 Middle East and Africa Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 79 Middle East and Africa Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 80 South Africa Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 81 South Africa Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 82 South Africa Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 83 Saudi Arabia Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 84 Saudi Arabia Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 85 Saudi Arabia Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 86 UAE Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 87 UAE Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 88 UAE Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)
  • Table 89 Kuwait Bioequivalence Studies market, by Dosage Form type, 2018 - 2030 (USD Million)
  • Table 90 Kuwait Bioequivalence Studies market, by Molecule Type, 2018 - 2030 (USD Million)
  • Table 91 Kuwait Bioequivalence Studies market, by Therapeutic Area, 2018 - 2030 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information procurement
  • Fig. 3 Market research approaches
  • Fig. 4 QFD modelling for market share assessment
  • Fig. 5 Market formulation & validation
  • Fig. 6 Commodity flow analysis
  • Fig. 7 Primary research pattern
  • Fig. 8 Primary interviews in North America
  • Fig. 9 Primary interviews in Europe
  • Fig. 10 Primary interviews in Asia Pacific
  • Fig. 11 Primary interviews in Latin America
  • Fig. 12 Primary interviews in MEA
  • Fig. 13 Market Snapshot
  • Fig. 14 Segment Snapshot
  • Fig. 15 Segment Snapshot
  • Fig. 16 Competitive Landscape Snapshot
  • Fig. 17 Bioequivalence Studies market segmentation
  • Fig. 18 Parent market outlook (2022)
  • Fig. 19 Related/ancillary market outlook (2022)
  • Fig. 20 Market driver relevance analysis (Current & future impact)
  • Fig. 21 Current shared services and outsourcing usage levels
  • Fig. 22 Market restraint relevance analysis (Current & future impact)
  • Fig. 23 Porter's five forces analysis
  • Fig. 24 SWOT analysis, by a factor (political & legal, economic and technological)
  • Fig. 25 Bioequivalence Studies Market Molecule Type outlook: Segment dashboard
  • Fig. 26 Bioequivalence Studies: Molecule Type movement analysis
  • Fig. 27 Small Molecule market, 2018 - 2030 (USD Million)
  • Fig. 28 Large Molecule market, 2018 - 2030 (USD Million)
  • Fig. 29 Bioequivalence Studies Market Dosage Form type outlook: Segment dashboard
  • Fig. 30 Bioequivalence Studies: Dosage Form movement analysis
  • Fig. 31 Solid Oral Dosage market, 2018 - 2030 (USD Million)
  • Fig. 32 Parenteral Formulations market, 2018 - 2030 (USD Million)
  • Fig. 33 Topical Products market, 2018 - 2030 (USD Million)
  • Fig. 34 Others market, 2018 - 2030 (USD Million)
  • Fig. 35 Bioequivalence Studies market Therapeutic Area outlook: Segment dashboard
  • Fig. 36 Bioequivalence Studies market: Therapeutic Area movement analysis
  • Fig. 37 Oncology market, 2018 - 2030 (USD Million)
  • Fig. 38 Neurology market, 2018 - 2030 (USD Million)
  • Fig. 39 Metabolic Disorders market, 2018 - 2030 (USD Million)
  • Fig. 40 Hematology market, 2018 - 2030 (USD Million)
  • Fig. 41 Immunology market, 2018 - 2030 (USD Million)
  • Fig. 42 Others market, 2018 - 2030 (USD Million)
  • Fig. 43 Regional marketplace: Segment dashboard
  • Fig. 44 Regional outlook, 2022 & 2030
  • Fig. 45 North America market, 2018 - 2030 (USD Million)
  • Fig. 46 U.S. market, 2018 - 2030 (USD Million)
  • Fig. 47 Canada market, 2018 - 2030 (USD Million)
  • Fig. 48 Europe market, 2018 - 2030 (USD Million)
  • Fig. 49 Germany market, 2018 - 2030 (USD Million)
  • Fig. 50 UK market, 2018 - 2030 (USD Million)
  • Fig. 51 France market, 2018 - 2030 (USD Million)
  • Fig. 52 Italy market, 2018 - 2030 (USD Million)
  • Fig. 53 Spain market, 2018 - 2030 (USD Million)
  • Fig. 54 Denmark market, 2018 - 2030(USD Million)
  • Fig. 55 Sweden market, 2018 - 2030 (USD Million)
  • Fig. 56 Norway market, 2018 - 2030 (USD Million)
  • Fig. 57 Asia Pacific market, 2018 - 2030 (USD Million)
  • Fig. 58 China market, 2018 - 2030 (USD Million)
  • Fig. 59 Japan market, 2018 - 2030 (USD Million)
  • Fig. 60 India market, 2018 - 2030 (USD Million)
  • Fig. 61 Australia market, 2018 - 2030 (USD Million)
  • Fig. 62 South Korea market, 2018 - 2030 (USD Million)
  • Fig. 63 Thailand market, 2018 - 2030 (USD Million)
  • Fig. 64 Latin America market, 2018 - 2030 (USD Million)
  • Fig. 65 Brazil market, 2018 - 2030 (USD Million)
  • Fig. 66 Mexico market, 2018 - 2030 (USD Million)
  • Fig. 67 Argentina market, 2018 - 2030 (USD Million)
  • Fig. 68 Middle East & Africa market, 2018 - 2030 (USD Million)
  • Fig. 69 South Africa market, 2018 - 2030 (USD Million)
  • Fig. 70 Saudi Arabia market, 2018 - 2030 (USD Million)
  • Fig. 71 UAE market, 2018 - 2030 (USD Million)
  • Fig. 72 Kuwait market, 2018 - 2030 (USD Million)
目次
Product Code: GVR-4-68040-084-1

Bioequivalence Studies Market Growth & Trends

The global bioequivalence studies market size is expected to reach USD 1,272.2 million by 2030, expanding at a CAGR of 8.3% from 2023 to 2030, according to a new report by Grand View Research, Inc. The increasing R&D activities pertaining to rare diseases and growing demand for generics are the key factors driving the growth of the market for bioequivalence studies.

Bioequivalence studies are used to analyze the desired in vivo biological equivalence of two formulations of drug products. If two drugs are bioequivalent, then they would be anticipated to reflect equal rates of bioavailability and pharmacokinetic (PK) parameters for all intents and purposes. Some of the major players in the market include ProRelix Services LLP, IQVIA, ICON plc, Charles River Laboratories, and Labcorp Drug Development, among others.

These companies offer a wide range of bioequivalence and bioavailability services to research institutes, pharmaceutical companies, and government agencies involved in drug development. In addition, the increasing pace of clinical research activities with an aim to develop low-cost biosimilars and generics across disease areas such as cancer, neurology, immunology, etc., is anticipated to boost the market growth for bioequivalence studies.

The growing rate of generics launches has helped to create a significant demand for bioequivalence studies over the past few years. For instance, the U.S. Food and Drug Administration (FDA) announced that as of January 2022, there are 33 FDA-approved biosimilars in the U.S., among which 21 are commercially available in the market.

The COVID-19 pandemic negatively impacted the market for bioequivalence studies. However, several players adopted inorganic strategies to mitigate this situation and rebound their sales figures. Additionally, the geopolitical war between Russia and Ukraine has led to a drop in revenue across the bioequivalence industry, as clinical trials outsourced across the war-infected countries have been halted until further notice. This has greatly impacted certain economies, such as the U.S., due to which the overall market witnessed a moderate dip in its revenue during 2022.

Bioequivalence Studies Market Report Highlights

  • The small molecule segment accounted for the largest revenue share of 60.6% in 2022.The segment is driven by the steadily growing demand for generics, which constitute a vast portion of small molecules
  • Based on the dosage form, the solid oral dosage segment accounted for the largest revenue share of 53.8% in 2022, owing to innovations in the technology involved in manufacturing oral solids at an optimal quality
  • The oncology segment is anticipated to register the fastest CAGR of 8.7% during the forecast period. This is due to the growing rate of anti-cancer biosimilars being approved in the market
  • Asia Pacific is anticipated to witness the highest CAGR of 8.8% during the forecast timeframe. The expected high growth is primarily since Asian countries such as India and China are major exporters of generic drugs, which also suggests that they have a stronghold in the production of generic drugs, thereby supporting demand for bioequivalence studies

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
    • 1.1.1. Segment Scope
    • 1.1.2. Regional scope
    • 1.1.3. 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
    • 1.3.5. Details of primary research
      • 1.3.5.1. Data for primary interviews in North America
      • 1.3.5.2. Data for primary interviews in Europe
      • 1.3.5.3. Data for primary interviews in Asia Pacific
      • 1.3.5.4. Data for primary interviews in Latin America
      • 1.3.5.5. Data for Primary interviews in MEA
  • 1.4. Information or Data Analysis
    • 1.4.1. Data analysis models
  • 1.5. Market Formulation & Validation
  • 1.6. Model Details
    • 1.6.1. Commodity flow analysis (Model 1)
      • 1.6.1.1. Approach 1: Commodity flow approach
    • 1.6.2. Volume price analysis (Model 2)
      • 1.6.2.1. Approach 2: Volume price analysis
  • 1.7. List of Secondary Sources
  • 1.8. List of Primary Sources
  • 1.9. Objectives
    • 1.9.1. Objective 1
    • 1.9.2. Objective 2

Chapter 2. Executive Summary

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

Chapter 3. Bioequivalence Studies 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
    • 3.2.2. Market restraint analysis
    • 3.2.3. Industry challenges
  • 3.3. Bioequivalence Studies: Market Analysis Tools
    • 3.3.1. Industry Analysis - Porter's
      • 3.3.1.1. Supplier power
      • 3.3.1.2. Buyer power
      • 3.3.1.3. Substitution threat
      • 3.3.1.4. Threat of new entrant
      • 3.3.1.5. Competitive rivalry
    • 3.3.2. PESTEL Analysis
      • 3.3.2.1. Political landscape
      • 3.3.2.2. Technological landscape
      • 3.3.2.3. Economic landscape
    • 3.3.3. Major Deals & Strategic Alliances Analysis
    • 3.3.4. Market Entry Strategies
    • 3.3.5. COVID-19 Impact Analysis

Chapter 4. Bioequivalence Studies Market: Molecule Type Estimates & Trend Analysis

  • 4.1. Bioequivalence Studies Market: Definition & Scope
  • 4.2. Bioequivalence Studies Market: Molecule Type Market Share Analysis, 2022 & 2030
    • 4.2.1. Small Molecule
      • 4.2.1.1. Small Molecule Market estimates and forecast 2018 to 2030 (USD Million)
    • 4.2.2. Large Molecule
      • 4.2.2.1. Large Molecule Market estimates and forecast 2018 to 2030 (USD Million)

Chapter 5. Bioequivalence Studies Market: Dosage Form Estimates & Trend Analysis

  • 5.1. Bioequivalence Studies Market: Definition & Scope
  • 5.2. Bioequivalence Studies Market: Dosage Form Market Share Analysis, 2022 & 2030
    • 5.2.1. Solid Oral Dosage
      • 5.2.1.1. Solid Oral Dosage Market estimates and forecast 2018 to 2030 (USD Million)
    • 5.2.2. Parenteral Formulations
      • 5.2.2.1. Parenteral Formulations Market estimates and forecast 2018 to 2030 (USD Million)
    • 5.2.3. Topical Products
      • 5.2.3.1. Topical Products Market estimates and forecast 2018 to 2030 (USD Million)
    • 5.2.4. Others
      • 5.2.4.1. Others Market estimates and forecast 2018 to 2030 (USD Million)

Chapter 6. Bioequivalence Studies Market: Therapeutic Area Estimates & Trend Analysis

  • 6.1. Bioequivalence Studies Market: Definition & Scope
  • 6.2. Bioequivalence Studies Market: Therapeutic Area Market Share Analysis, 2022 & 2030
    • 6.2.1. Oncology
      • 6.2.1.1. Oncology market estimates and forecast 2018 to 2030 (USD Million)
    • 6.2.2. Neurology
      • 6.2.2.1. Neurology Market estimates and forecast 2018 to 2030 (USD Million)
    • 6.2.3. Metabolic Disorders
      • 6.2.3.1. Metabolic Disorders Market estimates and forecast 2018 to 2030 (USD Million)
    • 6.2.4. Hematology
      • 6.2.4.1. Hematology Market estimates and forecast 2018 to 2030 (USD Million)
    • 6.2.5. Immunology
      • 6.2.5.1. Immunology Market estimates and forecast 2018 to 2030 (USD Million)
    • 6.2.6. Orthopedics
      • 6.2.6.1. Orthopedics Market estimates and forecast 2018 to 2030 (USD Million)
    • 6.2.7. Others
      • 6.2.7.1. Others Market estimates and forecast 2018 to 2030 (USD Million)

Chapter 7. Bioequivalence Studies Market: Phase Estimates & Trend Analysis

  • 7.1. Bioequivalence Studies Market: Definition & Scope
  • 7.2. Bioequivalence Studies Market: Phase Market Share Analysis, 2022 & 2030
    • 7.2.1. Drug Discover
      • 7.2.1.1. Drug Discover Market estimates and forecast 2018 to 2030 (USD Million)
    • 7.2.2. Preclinical Studies
      • 7.2.2.1. Preclinical Studies Market estimates and forecast 2018 to 2030 (USD Million)
    • 7.2.3. Clinical Studies
      • 7.2.3.1. Clinical Studies Market estimates and forecast 2018 to 2030 (USD Million)

Chapter 8. Bioequivalence Studies Market: Regional Estimates & Trend Analysis

  • 8.1. Regional market share analysis, 2022 & 2030
  • 8.2. Market Size, & Forecasts, Revenue and Trend Analysis, 2018 to 2030:
  • 8.3. North America
    • 8.3.1. Market estimates and forecast, 2018 - 2030 (Value)
    • 8.3.2. U.S.
      • 8.3.2.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.3.3. Canada
      • 8.3.3.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
  • 8.4. Europe
    • 8.4.1. U.K.
      • 8.4.1.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.4.2. Germany
      • 8.4.2.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.4.3. France
      • 8.4.3.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.4.4. Italy
      • 8.4.4.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.4.5. Spain
      • 8.4.5.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.4.6. Denmark
      • 8.4.6.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.4.7. Sweden
      • 8.4.7.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.4.8. Norway
      • 8.4.8.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
  • 8.5. Asia Pacific
    • 8.5.1. Japan
      • 8.5.1.1. Market estimates and forecast, 2018 - 2030 (USD Billion, Volume, Thousand)
    • 8.5.2. China
      • 8.5.2.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.5.3. India
      • 8.5.3.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.5.4. Australia
      • 8.5.4.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.5.5. Thailand
      • 8.5.5.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.5.6. South Korea
      • 8.5.6.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
  • 8.6. Latin America
    • 8.6.1. Brazil
      • 8.6.1.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.6.2. Mexico
      • 8.6.2.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.6.3. Argentina
      • 8.6.3.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
  • 8.7. MEA
    • 8.7.1. South Africa
      • 8.7.1.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.7.2. Saudi Arabia
      • 8.7.2.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.7.3. UAE
      • 8.7.3.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)
    • 8.7.4. Kuwait
      • 8.7.4.1. Market estimates and forecast, 2018 - 2030 (Value & Volume)

Chapter 9. Competitive Landscape

  • 9.1. Company Market Share Analysis, 2022
  • 9.2. Company Profiles
    • 9.2.1. CliniExperts
      • 9.2.1.1. Company overview
      • 9.2.1.2. Financial Performance
      • 9.2.1.3. Product benchmarking
      • 9.2.1.4. Strategic initiatives
    • 9.2.2. ICBIO Corporation
      • 9.2.2.1. Company overview
      • 9.2.2.2. Financial performance
      • 9.2.2.3. Product benchmarking
      • 9.2.2.4. Strategic initiatives
    • 9.2.3. ProRelix Services LLP
      • 9.2.3.1. Company overview
      • 9.2.3.2. Financial performance
      • 9.2.3.3. Product benchmarking
      • 9.2.3.4. Strategic initiatives
    • 9.2.4. PPD, Inc
      • 9.2.4.1. Company overview
      • 9.2.4.2. Financial performance
      • 9.2.4.3. Product benchmarking
      • 9.2.4.4. Strategic initiatives
    • 9.2.5. Syneos Health
      • 9.2.5.1. Company overview
      • 9.2.5.2. Financial performance
      • 9.2.5.3. Product benchmarking
      • 9.2.5.4. Strategic initiatives
    • 9.2.6. Labcorp Drug Development
      • 9.2.6.1. Company overview
      • 9.2.6.2. Financial performance
      • 9.2.6.3. Product benchmarking
      • 9.2.6.4. Strategic initiatives
    • 9.2.7. IQVIA
      • 9.2.7.1. Company overview
      • 9.2.7.2. Financial performance
      • 9.2.7.3. Product benchmarking
      • 9.2.7.4. Strategic initiatives
    • 9.2.8. Charles River Laboratories Inc.
      • 9.2.8.1. Company overview
      • 9.2.8.2. Financial performance
      • 9.2.8.3. Product benchmarking
      • 9.2.8.4. Strategic initiatives
    • 9.2.9. Icon PLC
      • 9.2.9.1. Company overview
      • 9.2.9.2. Financial performance
      • 9.2.9.3. Product benchmarking
      • 9.2.9.4. Strategic initiatives
    • 9.2.10. Intertek Group plc
      • 9.2.10.1. Company overview
      • 9.2.10.2. Financial performance
      • 9.2.10.3. Product benchmarking
      • 9.2.10.4. Strategic initiatives