北米のバイオテクノロジーおよび製薬サービスアウトソーシングの市場規模、シェア、動向分析レポート：サービス別、最終用途別、国別、セグメント別予測、2024年～2030年

北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場の成長と動向：

Grand View Research, Inc.の最新レポートによると、北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場規模は2030年までに168億1,000万米ドルに達し、2024年から2030年までのCAGRは5.13%で成長すると予測されています。

より優れたROIで新規分子を上市するための競争の激化は、世界中でCROサービスプロバイダーの需要を高めると予想されます。製薬会社は、研究コストの増加とともに規制の複雑さに直面しており、多数のポートフォリオに関する専門知識の必要性が生じ、市場におけるアウトソーシングの必要性が高まっています。臨床試験の民営化が進む中、中核機能に集中するためにCROやCDMOへのアウトソーシングが増加しています。製薬企業やバイオテクノロジー企業は、複雑で厳格なスケジュール管理が必要な研究開発業務のアウトソーシングを開始しています。CROの機能は、顧客から与えられたスケジュール通りに新製品を市場に投入することです。CROは必要なインフラと熟練した専門知識を持っており、コスト、時間、効率に関連するいくつかの利点を提供します。節約されたコストは、スポンサーと患者にとって最高の節約を提供するのに役立ちます。

創薬と医薬品開発は、製薬会社やバイオテクノロジー企業が採用する不可欠な戦略です。慢性疾患や長期にわたる疾患の増加は、医薬品開発プロセスにおける広範な研究開発投資の需要増につながった。臨床試験の失敗率の増大は、医薬品開発コストの増大と相まって、メーカーにとって莫大な収益の損失につながります。臨床試験での挫折は、中小製薬会社の倒産につながった。多くの非公開会社は、新薬開発プロセスに支障をきたすと、ベンチャー・キャピタルからの支援が受けられなくなると判断しています。このような状況を回避し、実質的な投資収益率を得るために、製薬会社は現在、従来の臨床試験方法ではなく、計算生物学に基づく予測モデルを採用しており、予測期間中の市場成長を促進すると予想されます。専門家、研究開発幹部、臨床専門家から得られる洞察は、企業が研究開発に費やすことができる多額の費用を節約するのに役立ち、コンサルティングサービスの需要を押し上げます。

ヘルスケアアウトソーシング業界では最近、M&Aが急増しています。この分野の急成長と有望な可能性は、製薬会社、バイオテクノロジー企業、ベンチャーキャピタルから多額の投資を集めています。その結果、企業は戦略的買収を通じて自社のポートフォリオと能力を拡大し、新たなビジネスチャンスを生かして市場での競争力を強化しようとしています。例えば、2024年5月、ザルトリウスAGはエヌビディアとの協業を発表し、エヌビディアのAIを搭載したコンピューティングソフトウェアとプラットフォームを活用して、新たな治療法の開発を支援します。さらに、治療薬の開発に伴う複雑さと高コストは、業界内のコラボレーションと統合の増加につながっています。M&Aは企業に補完的な技術、専門知識、リソースを提供し、開発課題の克服、製品開発期間の短縮、製造能力の強化を可能にします。

北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場レポートハイライト

• サービス別では、コンサルティング分野が2023年に最大の収益シェアを占めました。同分野が大きく成長した背景には、規制遵守、品質保証、改善課題、スポンサーによる戦略的コンサルティングの要件を満たすために、コンサルティングサービスの採用が拡大していることがあります。さらに、不正事例の増加、知的財産権（IPR）の齟齬、技術革新の高まりなど、製薬・バイオテクノロジー企業が直面する主要な課題により、規制コンサルティングサービスが広く利用されています。コンサルティング・サービスの需要を促進するもう1つの要因は、市場の統合化であり、合弁事業、買収、合併の増加につながります。このような要因が市場の成長を促進すると予想されます。
• 最終用途に基づくと、製薬企業セグメントは2023年に57.79%超の最大収益シェアを占めました。製薬企業の間で、臨床試験、データ管理、規制遵守、製造などの非中核業務をCROやCMOにアウトソーシングすることを好む傾向が強まっていることが、同セグメントの収益成長を押し上げると予想されます。CROやCMOへのアウトソーシングは、製薬企業が社内で大規模な能力を維持するのに比べ、費用対効果の高いソリューションを提供します。
• バイオテクノロジーおよび製薬サービスアウトソーシング市場では、米国が2023年に87.37%のシェアを獲得しています。同国の収益成長は、臨床試験に対する研究開発費の高さに起因しており、これも市場成長を促進すると予想される主要因です。例えば、2021年10月に米国FDAは11件の新たな臨床試験研究を承認し、その結果、今後4年間で2,500万米ドルを超える資金が提供されました。これらの助成金は、希少疾患の治療に特化した新しい医療製品の開発を支援することを目的としています。医薬品需要の増加に対応するため、製造能力を拡大するこれらの企業の存在感が高まっており、市場の成長を促進すると予想されます。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場の変数、動向、範囲

• 市場系統の見通し
• 市場力学
• テクノロジーの情勢
• 価格モデル分析
• GxPの概要
• 臨床試験ボリューム分析（2023年）
• R&D投資分析
• 北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場分析ツール
• COVID-19の影響分析

第4章 北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場：サービス別推定・動向分析

• セグメントダッシュボード
• 北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場：サービス別変動分析
• 北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場規模と動向分析、サービス別、2018～2030年
• コンサルティング
• 規制関連業務
• 製品設計と開発
• 監査と評価
• 製品メンテナンス
• トレーニングと教育
• その他

第5章 北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場：最終用途別推定・動向分析

• セグメントダッシュボード
• 北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場：最終用途別変動分析
• 北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場規模と動向分析、最終用途別、2018～2030年
• 製薬会社
• バイオテクノロジー企業

第6章 北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場：国別推定・動向分析、サービス別、最終用途別

• 国別ダッシュボード
• 北米のバイオテクノロジーおよび製薬サービスアウトソーシング市場：国別変動分析
• 米国
• カナダ
• メキシコ
• プエルトリコ

第7章 競合情勢

• 企業分類
  • 市場リーダー
  • 新興企業
• 企業市場シェア/評価分析、2023年
• サービスヒートマップ分析
• 企業プロファイル
  • Parexel International Corporation
  • The Quantic Group
  • IQVIA
  • Lachman Consultant Services, Inc.
  • GMP Pharmaceuticals Pty Ltd.
  • LabCorp
  • Charles River Laboratories
  • ICON plc.
  • Syneos Health
  • Lonza
  • Catalent Inc.
  • Samsung Biologics

List of Tables

• Table 1 List of Secondary Sources
• Table 2 List of Abbreviations
• Table 3 North America Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
• Table 4 North America Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
• Table 5 North America Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
• Table 6 North America Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
• Table 7 North America Biotechnology and Pharmaceutical Services Outsourcing by Auditing and Assessment, 2018 - 2030 (USD Million)
• Table 8 North America Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)
• Table 9 North America Biotechnology and Pharmaceutical Services Outsourcing by Region, 2018 - 2030 (USD Million)
• Table 10 North America Biotechnology and Pharmaceutical Services Outsourcing by Country, 2018 - 2030 (USD Million)
• Table 11 North America Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
• Table 12 North America Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
• Table 13 North America Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
• Table 14 North America Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
• Table 15 North America Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)
• Table 16 U.S. Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
• Table 17 U.S. Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
• Table 18 U.S. Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
• Table 19 U.S. Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
• Table 20 U.S. Biotechnology and Pharmaceutical Services Outsourcing by Auditing and Assessment, 2018 - 2030 (USD Million)
• Table 21 U.S. Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)
• Table 22 Canada Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
• Table 23 Canada Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
• Table 24 Canada Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
• Table 25 Canada Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
• Table 26 Canada Biotechnology and Pharmaceutical Services Outsourcing by Auditing and Assessment, 2018 - 2030 (USD Million)
• Table 27 Canada Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)
• Table 28 Mexico Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
• Table 29 Mexico Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
• Table 30 Mexico Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
• Table 31 Mexico Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
• Table 32 Mexico Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)
• Table 33 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
• Table 34 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
• Table 35 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
• Table 36 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
• Table 37 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by Auditing and Assessment, 2018 - 2030 (USD Million)
• Table 38 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Information Procurement
• Fig. 2 Primary Research Pattern
• Fig. 3 Market Research Approaches
• Fig. 4 Value Chain-Based Sizing & Forecasting
• Fig. 5 Market Formulation & Validation
• Fig. 6 North America Biotechnology and Pharmaceutical Services Outsourcing, Market Segmentation
• Fig. 7 Market Driver Relevance Analysis (Current & Future Impact)
• Fig. 8 Market Restraint Relevance Analysis (Current & Future Impact)
• Fig. 9 SWOT Analysis, By Factor (Political & Legal, Economic and Technological)
• Fig. 10 Porter's Five Forces Analysis
• Fig. 11 Regional Marketplace: Key Takeaways
• Fig. 12 North America Biotechnology and Pharmaceutical Services Outsourcing, for Consulting, 2018 - 2030 (USD Million)
• Fig. 13 North America Biotechnology and Pharmaceutical Services Outsourcing, for Regulatory Consulting, 2018 - 2030 (USD Million)
• Fig. 14 North America Biotechnology and Pharmaceutical Services Outsourcing, for Clinical Development Consulting, 2018 - 2030 (USD Million)
• Fig. 15 North America Biotechnology and Pharmaceutical Services Outsourcing, for Strategic Planning & Business Development Consulting, 2018 - 2030 (USD Million)
• Fig. 16 North America Biotechnology and Pharmaceutical Services Outsourcing, for Quality Management Systems Consulting, 2018 - 2030 (USD Million)
• Fig. 17 North America Biotechnology and Pharmaceutical Services Outsourcing, for Others, 2018 - 2030 (USD Million)
• Fig. 18 North America Biotechnology and Pharmaceutical Services Outsourcing, for Regulatory Affairs, 2018 - 2030 (USD Million)
• Fig. 19 North America Biotechnology and Pharmaceutical Services Outsourcing, for Legal Representation, 2018 - 2030 (USD Million)
• Fig. 20 North America Biotechnology and Pharmaceutical Services Outsourcing, for Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
• Fig. 21 North America Biotechnology and Pharmaceutical Services Outsourcing, for Product Registration & Clinical Trial Applications, 2018 - 2030 (USD Million)
• Fig. 22 North America Biotechnology and Pharmaceutical Services Outsourcing, for Regulatory Submissions, 2018 - 2030 (USD Million)
• Fig. 23 North America Biotechnology and Pharmaceutical Services Outsourcing, for Regulatory Operations, 2018 - 2030 (USD Million)
• Fig. 24 North America Biotechnology and Pharmaceutical Services Outsourcing, for Others, 2018 - 2030 (USD Million)
• Fig. 25 North America Biotechnology and Pharmaceutical Services Outsourcing, for Product Design & Development, 2018 - 2030 (USD Million)
• Fig. 26 North America Biotechnology and Pharmaceutical Services Outsourcing, for Research, Strategy, & Concept Generation, 2018 - 2030 (USD Million)
• Fig. 27 North America Biotechnology and Pharmaceutical Services Outsourcing, for Concept & Requirements Development, 2018 - 2030 (USD Million)
• Fig. 28 North America Biotechnology and Pharmaceutical Services Outsourcing, for Detailed Design & Process Development, 2018 - 2030 (USD Million)
• Fig. 29 North America Biotechnology and Pharmaceutical Services Outsourcing, for Design Verification & Validation, 2018 - 2030 (USD Million)
• Fig. 30 North America Biotechnology and Pharmaceutical Services Outsourcing, for Process Validation & Manufacturing Transfer, 2018 - 2030 (USD Million)
• Fig. 31 North America Biotechnology and Pharmaceutical Services Outsourcing, for Production & Commercial Support, 2018 - 2030 (USD Million)
• Fig. 32 North America Biotechnology and Pharmaceutical Services Outsourcing, for Auditing and Assessment, 2018 - 2030 (USD Million)
• Fig. 33 North America Biotechnology and Pharmaceutical Services Outsourcing, for General Auditing, 2018 - 2030 (USD Million)
• Fig. 34 North America Biotechnology and Pharmaceutical Services Outsourcing, for Gap Assessments, 2018 - 2030 (USD Million)
• Fig. 35 North America Biotechnology and Pharmaceutical Services Outsourcing, for Due Diligence Assessments, 2018 - 2030 (USD Million)
• Fig. 36 North America Biotechnology and Pharmaceutical Services Outsourcing, for Mock Audits/Inspections, 2018 - 2030 (USD Million)
• Fig. 37 North America Biotechnology and Pharmaceutical Services Outsourcing, for Inspection/Audit Management and Support, 2018 - 2030 (USD Million)
• Fig. 38 North America Biotechnology and Pharmaceutical Services Outsourcing, for Others, 2018 - 2030 (USD Million)
• Fig. 39 North America Biotechnology and Pharmaceutical Services Outsourcing, for Product Maintenance, 2018 - 2030 (USD Million)
• Fig. 40 North America Biotechnology and Pharmaceutical Services Outsourcing, for Training & Education, 2018 - 2030 (USD Million)
• Fig. 41 North America Biotechnology and Pharmaceutical Services Outsourcing, for Others, 2018 - 2030 (USD Million)
• Fig. 42 North America Biotechnology and Pharmaceutical Services Outsourcing, for Pharmaceutical Companies, 2018 - 2030 (USD Million)
• Fig. 43 North America Biotechnology and Pharmaceutical Services Outsourcing, for Biotech Companies, 2018 - 2030 (USD Million)
• Fig. 44 Country Outlook, 2023 & 2030
• Fig. 45 U.S. Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 46 Canada Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 47 Mexico Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 48 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)

North America Biotechnology and Pharmaceutical Services Outsourcing Market Growth & Trends:

The North America biotechnology and pharmaceutical services outsourcing market size is expected to reach USD 16.81 billion by 2030, according to a new report by Grand View Research, Inc., growing at a CAGR of 5.13% from 2024 to 2030.

Increasing competition to launch novel molecules with better RoI is expected to heighten the demand for CRO service providers across the globe. Pharmaceutical companies face complexity in regulations along with increased research costs, creating a need for expertise in numerous portfolios and driving the need for outsourcing in the market. With increasing clinical trial privatization, there has been an increase in outsourcing functions to CROs and CDMOs to focus on core capabilities. Pharmaceutical and biotechnology companies have started outsourcing R&D activities, which are complex and need a strict timeline to follow up. A CRO's function is to bring new products to the market as per the timeline given by the client. CROs have the required infrastructure and skilled expertise, which provides several advantages associated with cost, time, and efficiency. The cost saved helps in offering the best savings for sponsors and patients.

Drug discovery and development is an integral strategy adopted by pharmaceutical and biotechnology companies. An increase in the prevalence of chronic and long-term diseases led to a rise in the demand for extensive R&D investments in the drug development process. Growing clinical trial failure rates coupled with increasing drug development costs lead to huge losses in revenue for manufacturers. Setbacks faced in clinical studies have led smaller pharmaceutical companies to go bankrupt. Many private investors have been observed to withdraw venture capital support from startup drug companies, considering their investments would suffer if there were a disruption in the drug development process. To circumvent these situations and gain a substantial return on investment, pharmaceutical companies are now adopting computational biology-based predictive models over traditional methods of clinical trials, which are expected to drive market growth during the forecast period. Insights gained from subject-matter experts, R&D executives, and clinical professionals help a company save a large amount, which can be spent on R&D, thereby boosting demand for consulting services.

The healthcare outsourcing industry has recently witnessed a surge in mergers and acquisitions. The sector's rapid growth and promising potential have attracted significant investment from pharmaceutical companies, biotech firms, & venture capitalists. As a result, companies seek to expand their portfolios and capabilities through strategic acquisitions to capitalize on emerging opportunities and strengthen their competitive position in the market. For instance, in May 2024, Sartorius AG announced a collaboration with NVIDIA to help the development of new therapies, leveraging NVIDIA's AI-powered computing software and platform. Moreover, the complexity and high costs associated with developing therapeutics are leading to increased collaboration & consolidation within the industry. Mergers & acquisitions offer companies complementary technologies, expertise, and resources, enabling them to overcome development challenges, accelerate product development timelines, and enhance manufacturing capabilities.

North America Biotechnology And Pharmaceutical Services Outsourcing Market Report highlights

• Based on service, the consulting segment held the largest revenue share in 2023. The large segment growth is owing to the growing adoption of consulting services to meet regulatory compliance, quality assurance, remediation challenges, and strategic consulting requirements by sponsors. Furthermore, regulatory consulting services are widely used owing to increasing fraud cases, discrepancies in Intellectual Property Rights (IPR), and rising technological innovation, which are some of the major challenges faced by pharmaceutical and biotechnology companies. Another factor driving the demand for consulting services is the consolidated nature of the market, which leads to an increase in the number of joint ventures, takeovers, acquisitions, and mergers. Such factors are anticipated to drive the market growth.
• Based on end use, the pharmaceutical companies segment held the largest revenue share of over 57.79% in 2023. The segment growth is owing to an increasing preference for outsourcing non-core activities such as clinical trials, data management, regulatory compliance, and manufacturing to CROs and CMOs among pharmaceutical companies is anticipated to boost segment revenue growth. Outsourcing to CROs and CMOs provides pharmaceutical companies with cost-effective solutions compared to maintaining extensive in-house capabilities.
• The U.S. dominated the biotechnology and pharmaceutical services outsourcing market with a share of 87.37% in 2023. The country's revenue growth is owing to high R&D spending on clinical trials, which is another major factor expected to fuel market growth. For instance, in October 2021, the U.S. FDA approved 11 new clinical trial research, resulting in over USD 25 million in funding over the next four years. These grants aim to support the development of new medical products specifically for treating rare diseases. The growing presence of these companies expanding their manufacturing capabilities to cater to the rising demand for pharmaceuticals is anticipated to propel market growth.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased Database
  • 1.4.2. GVR's Internal Database
  • 1.4.3. Secondary Sources
  • 1.4.4. Primary Research
• 1.5. Details of primary research
• 1.6. Market Formulation & Validation
• 1.7. Country-wise Market Calculation
  • 1.7.1. Country Wise Market: Base Estimates
  • 1.7.2. CAGR Calculation
  • 1.7.3. Country Based Segment Share Calculation
• 1.8. Model Details
  • 1.8.1. Commodity flow analysis (Model 1)
  • 1.8.2. Value Chain-Based Sizing & Forecasting (Model 2)
  • 1.8.3. QFD Model Sizing & Forecasting (Model 3)
  • 1.8.4. Bottom-up Approach (Model 4)
• 1.9. Research Scope and Assumptions
• 1.10. List of Secondary Sources
• 1.11. List of Primary Sources
• 1.12. List of Abbreviations
• 1.13. Objectives
  • 1.13.1. Objective 1
  • 1.13.2. Objective 2
  • 1.13.3. Objective 3
  • 1.13.4. Objective 4

Chapter 2. Executive Summary

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

Chapter 3. North America Biotechnology and Pharmaceutical Services Outsourcing Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Increasing Outsourcing of R&D Activities
    • 3.2.1.2. Changing Regulatory Landscape
    • 3.2.1.3. Increasing Focus on Core Competencies by Pharmaceutical and Biotechnology Companies
    • 3.2.1.4. Growing Drug Development Costs Coupled With High Clinical Development Failure Rates
    • 3.2.1.5. Increasing Mergers and Collaborations
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Monitoring Issues and Lack of Standardization
    • 3.2.2.2. Loss of Control
    • 3.2.2.3. Data Security Issues
• 3.3. Technology Landscape
• 3.4. Pricing Model Analysis
• 3.5. GxP Overview
  • 3.5.1. Good Manufacturing Practices (GMP)
  • 3.5.2. Current Good Manufacturing Practices (cGMP)
  • 3.5.3. Good Laboratory Practices (GLP)
  • 3.5.4. Good Clinical Practices (GCP)
  • 3.5.5. Good Distribution Practices (GDP)
• 3.6. Clinical Trials Volume Analysis (2023)
  • 3.6.1. Total Number of Clinical Trials, by Country
  • 3.6.2. Total Number of Clinical Trials, by Phase
  • 3.6.3. Total Number of Clinical Trials, by Study Design
  • 3.6.4. Total Number of Clinical Trials, by Key Therapeutic Area
• 3.7. R&D Investment Analysis
• 3.8. North America Biotechnology and Pharmaceutical Services Outsourcing Market Analysis Tools
  • 3.8.1. Porter's Five Forces Analysis
  • 3.8.2. PESTEL Analysis
• 3.9. COVID-19 Impact Analysis

Chapter 4. North America Biotechnology and Pharmaceutical Services Outsourcing Market: Service Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. North America Biotechnology and Pharmaceutical Services Outsourcing Market: Service Movement Analysis
• 4.3. North America Biotechnology and Pharmaceutical Services Outsourcing Market Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
• 4.4. Consulting
  • 4.4.1. Consulting Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.2. Regulatory Consulting
    • 4.4.2.1. Regulatory Consulting Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.3. Clinical Development Consulting
    • 4.4.3.1. Clinical Development Consulting Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.4. Strategic Planning & Business Development Consulting
    • 4.4.4.1. Strategic Planning & Business Development Consulting Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.5. Quality Management Systems Consulting
    • 4.4.5.1. Quality Management Systems Consulting Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.6. Others
    • 4.4.6.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Regulatory Affairs
  • 4.5.1. Regulatory Affairs Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.2. Legal Representation
    • 4.5.2.1. Legal Representation Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.3. Regulatory Writing & Publishing
    • 4.5.3.1. Regulatory Writing & Publishing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.4. Product Registration & Clinical Trial Applications
    • 4.5.4.1. Product Registration & Clinical Trial Applications Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.5. Regulatory Submissions
    • 4.5.5.1. Regulatory Submissions Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.6. Regulatory Operations
    • 4.5.6.1. Regulatory Operations Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.7. Others
    • 4.5.7.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.6. Product Design & Development
  • 4.6.1. Product Design & Development Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.2. Research, Strategy, & Concept Generation
    • 4.6.2.1. Research, Strategy, & Concept Generation Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.3. Concept & Requirements Development
    • 4.6.3.1. Concept & Requirements Development Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.4. Detailed Design & Process Development
    • 4.6.4.1. Detailed Design & Process Development Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.5. Design Verification & Validation
    • 4.6.5.1. Design Verification & Validation Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.6. Process Validation & Manufacturing Transfer
    • 4.6.6.1. Process Validation & Manufacturing Transfer Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.7. Production & Commercial Support
    • 4.6.7.1. Production & Commercial Support Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.7. Auditing and Assessment
  • 4.7.1. Auditing and Assessment Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.7.2. General Auditing
    • 4.7.2.1. General Auditing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.7.3. Gap Assessments
    • 4.7.3.1. Gap Assessments Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.7.4. Due Diligence Assessments
    • 4.7.4.1. Due Diligence Assessments Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.7.5. Mock Audits/Inspections
    • 4.7.5.1. Mock Audits/Inspections Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.7.6. Inspection/Audit Management and Support
    • 4.7.6.1. Inspection/Audit Management and Support Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.7.7. Others
    • 4.7.7.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.8. Product Maintenance
  • 4.8.1. Product Maintenance Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.9. Training & Education
  • 4.9.1. Training & Education Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.10. Others
  • 4.10.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. North America Biotechnology and Pharmaceutical Services Outsourcing Market: End-Use Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. North America Biotechnology and Pharmaceutical Services Outsourcing Market: End-Use Movement Analysis
• 5.3. North America Biotechnology and Pharmaceutical Services Outsourcing Market Size & Trend Analysis, by End-Use, 2018 to 2030 (USD Million)
• 5.4. Pharmaceutical Companies
  • 5.4.1. Pharmaceutical Companies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.5. Biotech Companies
  • 5.5.1. Biotech Companies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. North America Biotechnology and Pharmaceutical Services Outsourcing Market: Country Estimates & Trend Analysis, by Service, by End-Use

• 6.1. Country Dashboard
• 6.2. North America Biotechnology and Pharmaceutical Services Outsourcing Market: Country Movement Analysis
• 6.3. U.S.
  • 6.3.1. Key Country Dynamics
  • 6.3.2. Competitive Scenario
  • 6.3.3. Regulatory Framework
  • 6.3.4. U.S. Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.4. Canada
  • 6.4.1. Key Country Dynamics
  • 6.4.2. Competitive Scenario
  • 6.4.3. Regulatory Framework
  • 6.4.4. Canada Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.5. Mexico
  • 6.5.1. Key Country Dynamics
  • 6.5.2. Competitive Scenario
  • 6.5.3. Regulatory Framework
  • 6.5.4. Mexico Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.6. Puerto Rico
  • 6.6.1. Key Country Dynamics
  • 6.6.2. Competitive Scenario
  • 6.6.3. Regulatory Framework
  • 6.6.4. Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Company Categorization
  • 7.1.1. Market Leaders
  • 7.1.2. Emerging Players
• 7.2. Company Market Share/Assessment Analysis, 2023
• 7.3. Service Heat Map Analysis
• 7.4. Company Profiles
  • 7.4.1. Parexel International Corporation
    • 7.4.1.1. Company Overview
    • 7.4.1.2. Financial Performance
    • 7.4.1.3. Service Benchmarking
    • 7.4.1.4. Strategic Initiatives
  • 7.4.2. The Quantic Group
    • 7.4.2.1. Company Overview
    • 7.4.2.2. Financial Performance
    • 7.4.2.3. Service Benchmarking
    • 7.4.2.4. Strategic Initiatives
  • 7.4.3. IQVIA
    • 7.4.3.1. Company Overview
    • 7.4.3.2. Financial Performance
    • 7.4.3.3. Service Benchmarking
    • 7.4.3.4. Strategic Initiatives
  • 7.4.4. Lachman Consultant Services, Inc.
    • 7.4.4.1. Company Overview
    • 7.4.4.2. Financial Performance
    • 7.4.4.3. Service Benchmarking
    • 7.4.4.4. Strategic Initiatives
  • 7.4.5. GMP Pharmaceuticals Pty Ltd.
    • 7.4.5.1. Company Overview
    • 7.4.5.2. Financial Performance
    • 7.4.5.3. Service Benchmarking
    • 7.4.5.4. Strategic Initiatives
  • 7.4.6. LabCorp
    • 7.4.6.1. Company Overview
    • 7.4.6.2. Financial Performance
    • 7.4.6.3. Service Benchmarking
    • 7.4.6.4. Strategic Initiatives
  • 7.4.7. Charles River Laboratories
    • 7.4.7.1. Company Overview
    • 7.4.7.2. Financial Performance
    • 7.4.7.3. Service Benchmarking
    • 7.4.7.4. Strategic Initiatives
  • 7.4.8. ICON plc.
    • 7.4.8.1. Company Overview
    • 7.4.8.2. Financial Performance
    • 7.4.8.3. Service Benchmarking
    • 7.4.8.4. Strategic Initiatives
  • 7.4.9. Syneos Health
    • 7.4.9.1. Company Overview
    • 7.4.9.2. Financial Performance
    • 7.4.9.3. Service Benchmarking
    • 7.4.9.4. Strategic Initiatives
  • 7.4.10. Lonza
    • 7.4.10.1. Company Overview
    • 7.4.10.2. Financial Performance
    • 7.4.10.3. Service Benchmarking
    • 7.4.10.4. Strategic Initiatives
  • 7.4.11. Catalent Inc.
    • 7.4.11.1. Company Overview
    • 7.4.11.2. Financial Performance
    • 7.4.11.3. Service Benchmarking
    • 7.4.11.4. Strategic Initiatives
  • 7.4.12. Samsung Biologics
    • 7.4.12.1. Company Overview
    • 7.4.12.2. Financial Performance
    • 7.4.12.3. Service Benchmarking
    • 7.4.12.4. Strategic Initiatives