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1406991

藥物分析測試外包 -市場佔有率分析、產業趨勢/統計、成長預測，2024-2029 年

Pharmaceutical Analytical Testing Outsourcing - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts 2024 - 2029
出版日期: | 出版商: Mordor Intelligence | 英文 113 Pages | 商品交期: 2-3個工作天內

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簡介目錄

預計基準年藥品分析測試外包市場規模為71億美元，預測期間內複合年成長率為8.7%。

藥物分析測試外包-市場-IMG1

主要亮點

  • COVID-19 對藥物分析測試外包產生了重大影響。這縮短了核准流程並增加了臨床試驗地點的監管核准。例如，Ronan Brow 博士於 2021 年 3 月在《歐洲藥物評論》上發表的一篇論文發現，在大流行期間，製藥業和監管機構密切合作，以極快的速度提供診斷測試、治療方法和疫苗接種。此外，在製藥領域，臨床實驗場所的許可正在從地方當局轉移到中央當局。
  • 同樣，市場主要企業的舉措（例如協議）也有望促進市場成長。例如，2021 年 11 月，Alcami Corporation, Inc. 與 Novavax 簽訂了主實驗室服務協議。透過這項協議，Novavax 立即獲得了全職等效 (FTE) 資源，為使用 Matrix-M 佐劑的基於重組奈米顆粒蛋白的 COVID-19 候選疫苗提供分析測試支援。因此，所有這些因素都可能對大流行期間的市場成長產生積極影響。
  • 此外，推動該市場成長的因素包括研發費用的增加、對監管、安全和品質的日益關注、外包的價格優勢以及對生物學名藥、生物製藥和分析試劑的需求。技術、動力學方法和電化學技術。
  • 藥物分析測試外包提供者之間的收購和聯盟增加可能會推動該市場的成長。例如，2021 年 12 月，為製藥、生物技術和醫療技術領域提供專業服務的 PharmaLex Group 與 Pharmasol 合併，藥物安全檢測一家專門為藥物警戒提供 IT 和業務支援的生命科學公司。此外，SGS SA 於 2021 年 12 月收購了英國創新製劑研發服務供應商 Quay Pharmaceuticals Limited (Quay Pharma)。透過此次收購，SGS 將把 Quay Pharmaceuticals 的服務加入其全面的分析服務組合中。
  • 此外，對生物相似藥和生物製藥的需求不斷成長將顯著推動市場成長。例如，2021 年9 月發表在《伊朗醫學科學雜誌》上的一項研究發現，到2025 年，新型生物相似藥的開發可為消費者節省高達2500 億美元，並幫助超過120 萬名患者。預計將有更多機會獲得生物療法。這使得生物相似藥產品可供慢性病患者使用，對於以前不得不停止治療或依賴效果較差的藥物的患者來說，它們成為更便宜的選擇。生物相似藥生產的增加將增加藥物測試服務的外包，從而促進市場成長。因此，由於上述因素，預計市場在預測期內將會成長。
  • 然而，對不穩定的委託製造組織績效的日益依賴、對藥品製造中敏感資料的隱私/盜竊的日益擔憂以及公司的各種委託成本預計將阻礙所研究市場的成長。

藥物分析測試外包市場趨勢

製藥和生物製藥公司預計將在預測期內佔據主要市場佔有率

  • 從最終用戶來看，製藥和生物製藥公司預計在預測期內將佔據主要佔有率。其他活動，例如產品開發活動的活性化、公司研發支出的增加以及開發新治療方法的需要，預計將推動該區隔市場的成長。
  • 此外，主要市場參與者之間不斷增加的併購預計將進一步推動該領域的成長。
  • 例如，2022 年 2 月，Labcorp 收購了 Personal Genome Diagnostics Inc. (PGDx)，這是主要企業，擁有全系列液體活體組織切片和基於組織的解決方案。 PGD​​x 的技術補充並加速了 Labcorp 目前的液體活體組織切片能力，並擴展了 Labcorp 基於次世代定序(NGS) 的基因組分析能力的核心腫瘤學產品組合。這使得 Labcorp 處於改善腫瘤學患者治療效果的前線。
  • 此外，2021 年 12 月，Eurofins Scientific 與 Transgenic Inc. 簽訂了股票購買協議，收購 Genetic Lab，這是一家基於分子生物學的診斷、生物標記開發和藥物研發測試提供者。透過此次收購，Eurofins 網路將透過擴大其在日本的生物製藥和臨床測試服務範圍，進一步鞏固其在日本市場的地位。
  • 因此，由於上述因素，預計該區隔市場在預測期內將顯著成長。
藥物分析測試外包-市場-IMG2

北美佔據主要佔有率，預計在預測期內保持不變

  • 在預測期內，北美佔據藥物分析測試外包市場的主要佔有率。
  • 促進該地區成長的因素包括技術進步、主要市場參與者的強大立足點、慢性病盛行率的上升以及藥品研發和資金籌措的增加。
  • 例如，2021 年 10 月，Pace Analytical Services, LLC 收購了 Velesco Pharmaceutical Services, Inc.。 Velesco 是一家專門從事液體、半固態和口服固態劑型開發的 CDMO。此次收購增加了 Pace 在臨床前和臨床液體、固態和口服固態製劑開發方面的豐富經驗和專業知識，使 Pace 能夠在藥物開發過程中為越來越多的客戶提供支援。
  • 此外，2021 年 7 月，Pace Analytical Services 收購了 Drug Delivery Experts, LLC (DDE)。 DDE 也是一家 CDMO，專門從事複雜注射製劑和藥物器械組合產品的開發。透過此次收購，Pace 將能夠為越來越多在整個藥物開發過程中需要服務的客戶提供支持，並且還將能夠貢獻在藥物-器械組合產品和緩釋性注射技術方面的經驗。
  • 同樣，總部位於新罕布夏州塞勒姆的符合 cGMP 的分析實驗室 Boston Analytical 將於 2021 年 1 月在北卡羅來納州莫里斯維爾開設第二個實驗室。該地點提供的服務是取樣和測試服務。此類新興市場的開拓預計將促使該地區更多地採用藥物分析測試外包服務，並成為市場成長的驅動力。
  • 此外，美國臨床試驗和支持活動的研究經費增加預計也將有助於預測期內的市場成長。例如，根據美國美國衛生研究院（NIH）2022年6月發布的資料，2021年和2022年美國用於臨床試驗和支持活動的研究支出將分別為450億美元和510億美元。美元。因此，增加此類活動的研究經費將促使更多採用藥物分析測試外包服務，從而推動區域市場的成長。
  • 因此，由於上述因素，預計北美地區市場將會成長。

藥物分析測試外包產業概況

藥物分析測試外包的市場競爭溫和。由於市場參與企業關鍵市場策略的興起（例如與製藥和生物製藥公司的聯盟以及公司之間的併購）等因素，該市場預計將成長。該市場的一些主要企業包括 SGS SA、Labcorp (Toxikon, Inc.)、Eurofins Scientific、Pace Analytical Services, Inc.、Intertek Group Plc、WuXi AppTec 和 Boston Analytical。

其他福利：

  • Excel 格式的市場預測 (ME) 表
  • 3 個月的分析師支持

目錄

第1章簡介

  • 研究假設和市場定義
  • 調查範圍

第2章調查方法

第3章執行摘要

第4章市場動態

  • 市場概況
  • 市場促進因素
    • 日益關注監管、安全和品質
    • 外包的定價優勢
    • 對生物相似藥、生物製藥和分析藥物的需求不斷增加
  • 市場抑制因素
    • 對製藥生產中的隱私和敏感資料竊取的擔憂日益增加
    • 企業外包支出多元化
  • 波特五力分析
    • 新進入者的威脅
    • 買家/消費者的議價能力
    • 供應商的議價能力
    • 替代品的威脅
    • 競爭公司之間敵對關係的強度

第5章市場區隔

  • 依服務
    • 生物分析測試
      • 臨床試驗
      • 非臨床研究
    • 方法開發和驗證
      • 可萃取性/溶解度
      • 雜質法
      • 技術諮詢
      • 其他方法開發和驗證
    • 穩定性測試
      • 藥用物質
      • 穩定性指標驗證
      • 加速穩定性測試
      • 光穩定性測試
      • 其他穩定性測試
    • 其他服務
  • 依最終用戶
    • 製藥公司/生物製藥公司
    • 受託製造廠商
    • 其他最終用戶
  • 依地區
    • 北美洲
      • 美國
      • 加拿大
      • 墨西哥
    • 歐洲
      • 德國
      • 英國
      • 法國
      • 義大利
      • 西班牙
      • 其他歐洲國家
    • 亞太地區
      • 中國
      • 日本
      • 印度
      • 澳洲
      • 韓國
      • 其他亞太地區
    • 中東/非洲
      • GCC
      • 南非
      • 其他中東/非洲
    • 南美洲
      • 巴西
      • 阿根廷
      • 南美洲其他地區

第6章 競爭形勢

  • 公司簡介
    • SGS SA
    • Labcorp（Toxikon, Inc）
    • Eurofins Scientific
    • Pace Analytical Services, Inc.
    • Intertek Group Plc
    • Thermofischer Scientific（Pharmaceutical Product Development, LLC）
    • WuXi AppTec
    • Boston Analytical
    • Charles River Laboratories International, Inc
    • West Pharmaceutical Services Inc.
    • Element Group（Exova Group PLC）
    • Merck KGaA

第7章 市場機會及未來趨勢

簡介目錄
Product Code: 90467
Pharmaceutical Analytical Testing Outsourcing - Market - IMG1

The pharmaceutical analytical testing outsourcing market has a market size of 7.1 billion in the base year and is expected to register a CAGR of 8.7% during the forecast period.

Key Highlights

  • COVID-19 significantly impacted pharmaceutical analytical testing outsourcing due to the rise in the testing process to develop novel therapies for the disease. This has led to a rise in approvals from regulatory agencies on clinical trial sites by decreasing the time for the approval process. For instance, according to the article published in the European Pharmaceutical Review by Dr. Ronan Brow in March 2021, during the outbreak, the pharmaceutical sector and regulatory authorities worked closely together to create and provide diagnostic tests, treatments, and vaccinations at breakneck speed. In addition, the sector had seen a shift in site permissions from local to centralized.
  • Similarly, the initiative by key market players, such as agreements, was expected to increase market growth. For instance, in November 2021, Alcami Corporation, Inc. signed a master laboratory services agreement with Novavax. With this agreement, Novavax immediately secured full-time equivalent (FTE) resources to provide analytical testing support for its recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant. Thus, all these factors are likely to have a positive impact on the market growth over the pandemic phase.
  • Further, the factors driving the growth of this market include a rise in research and development expenditures, increasing focus on regulation, safety, and quality, pricing benefits of outsourcing, and a rise in the demand for biosimilars and biopharmaceutical products as well as for analytical drugs, availability of advanced analytical testing techniques such as hyphenated techniques; kinetic method of analysis, electrochemical techniques, among others.
  • Rising acquisitions and partnerships among pharmaceutical analytical testing outsourcing providers will drive the growth of this market. For instance, in December 2021, PharmaLex Group, a provider of specialist services for the pharmaceutical, biotech, and MedTech sectors, merged with Pharmasol, a life sciences corporation specializing in pharmacovigilance IT and business support. In addition, in December 2021, SGS SA acquired Quay Pharmaceuticals Limited (Quay Pharma), a UK-based provider of innovative formulation research and development services. With this acquisition, SGS will add Quay Pharmaceuticals services to its comprehensive portfolio of analytical services.
  • Furthermore, the rising demand for biosimilars and biopharmaceuticals will drive the market's growth significantly. For instance, the study published in the Iranian Journal of Medical Sciences in September 2021 stated that it is expected that the development of new biosimilars would save consumers up to USD 250 billion and make biological therapies more accessible to an extra 1.2 million patients by 2025. This increases the availability of such products to patients with chronic conditions and provides a more affordable option for those who previously had to discontinue therapy or rely on less effective medications. Such an increase in biosimilar manufacturing will increase the outsourcing of drug testing services, thereby boosting market growth. Therefore, owing to the aforementioned factors, the market is expected to grow over the forecast period.
  • However, a rise in the reliance on the performance of unstable outsourced manufacturing organizations, an increase in the concerns regarding the privacy/theft of confidential data for manufacturing pharmaceuticals, and varied outsourcing expenditures by companies, among others, are expected to hamper the growth of the market studied.

Pharmaceutical Analytical Testing Outsourcing Market Trends

Pharmaceutical and Biopharmaceutical Companies Segment is Expected to Garner a Major Share During the Forecast Period

  • By end user, the pharmaceutical and biopharmaceutical companies segment is expected to hold a significant share in the market studied over the forecast period. Factors such as the rise in product development activities, growing research and development expenditures by companies, and the need to develop novel therapies, among others, are expected to drive the growth of this segment.
  • In addition, rising mergers and acquisitions among the key market players are further expected to drive the growth of this segment studied.
  • For instance, in February 2022, Personal Genome Diagnostics Inc. (PGDx), a key player in cancer genomics with a range of complete liquid biopsy and tissue-based solutions, was acquired by Labcorp. PGDx's technology complements and accelerates Labcorp's current liquid biopsy capabilities, as well as expands Labcorp's leading oncology portfolio of next-generation sequencing (NGS)-based genomic profiling capabilities. This puts Labcorp at the forefront of improving patient outcomes in oncology.
  • Furthermore, in December 2021, Eurofins Scientific entered into a share purchase agreement with Transgenic Inc. to acquire Genetic Lab Co., Ltd., a molecular biology-based testing provider for diagnostics, biomarker development, and drug discovery. With this acquisition, the Eurofins network will further strengthen its position in the Japanese market by extending its service offering in biopharmaceutical services and clinical testing in Japan.
  • Therefore, owing to the above-mentioned factors, the segment is expected to witness significant growth over the forecast period.
Pharmaceutical Analytical Testing Outsourcing - Market - IMG2

North America Holds a Major Share and Expected to do Same in the Forecast Period

  • North America holds a major share in the pharmaceutical analytical testing outsourcing market during the forecast period.
  • The factors contributing to the growth of this region include advancements in technologies, the strong foothold of key market players, the rise in chronic cases, and the rise in pharmaceutical research and development and funding, among others.
  • For instance, in October 2021, Pace Analytical Services, LLC acquired Velesco Pharmaceutical Services, Inc. Velesco is a CDMO that specializes in liquid, semi-solid, and oral solid dose product development. This acquisition adds significant experience and expertise in the development of liquid, semi-solid, and oral solid dose products for pre-clinical and clinical use, allowing Pace to support a growing number of clients throughout the drug development process.
  • In addition, in July 2021, Pace Analytical Services acquired Drug Delivery Experts, LLC (DDE). DDE, also a CDMO, specializes in complex injectable drug formulations and combination drug-device product development. As a result of the acquisition, Pace will be able to assist a growing number of clients who require services throughout the drug development process, as well as contribute experience in drug-device combo products and extended-release injectable technologies.
  • Similarly, in January 2021, Boston Analytical, a cGMP-compliant analytical laboratory headquartered in Salem, NH, is now opening its second location in Morrisville, North Carolina. Services provided at this location will be sampling and testing services. Such developments in the United States will lead to increased adoption of pharmaceutical analytical testing outsourcing services in this region, thereby driving market growth.
  • Furthermore, a rise in research funding for clinical trials and supportive activities in the United States is also expected to contribute to the market growth over the forecast period. For instance, according to the National Institute of Health (NIH) data published in June 2022, the funding in the United States for clinical trials and supportive activities for 2021 and 2022 were USD 45 billion and USD 51 billion, respectively. Therefore, the rise in research funding for such activities will lead to increased adoption of pharmaceutical analytical testing outsourcing services, driving regional market growth.
  • Therefore, owing to the aforementioned factors, the market is anticipated to grow in the North American region.

Pharmaceutical Analytical Testing Outsourcing Industry Overview

The market for pharmaceutical analytical testing outsourcing is moderately competitive. The market is expected to grow due to factors such as a rise in key market strategies by the market players, such as partnerships with pharmaceutical and biopharmaceutical companies and mergers and acquisitions among the players. Some of the major players operating in this market include SGS SA, Labcorp (Toxikon, Inc.), Eurofins Scientific, Pace Analytical Services, Inc., Intertek Group Plc, WuXi AppTec, and Boston Analytical, among others.

Additional Benefits:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Increasing focus on Regulation, Safety and Quality
    • 4.2.2 Pricing Benefits of Outsourcing
    • 4.2.3 Rise in the Demand for Biosimilars and Biopharmaceutical Products as well as for Analytical Drugs
  • 4.3 Market Restraints
    • 4.3.1 Increase in the Concerns Regarding Privacy/Theft of Confidential Data of Manufacturing Pharmaceuticals
    • 4.3.2 Varied Outsourcing Expenditures by Companies
  • 4.4 Porter's Five Forces Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market size in USD)

  • 5.1 By Services
    • 5.1.1 Bioanalytical Testing
      • 5.1.1.1 Clinical
      • 5.1.1.2 Non-clinical
    • 5.1.2 Method Development and Validation
      • 5.1.2.1 Extractable & Leachable
      • 5.1.2.2 Impurity Method
      • 5.1.2.3 Technical Consulting
      • 5.1.2.4 Other Method Development and Validations
    • 5.1.3 Stability Testing
      • 5.1.3.1 Drug Substance
      • 5.1.3.2 Stability Indicating Method Validation
      • 5.1.3.3 Accelerated Stability Testing
      • 5.1.3.4 Photostability Testing
      • 5.1.3.5 Other Stability Testings
    • 5.1.4 Other Services
  • 5.2 By End-User
    • 5.2.1 Pharmaceutical And Biopharmaceutical Companies
    • 5.2.2 Contract Manufactuing Organizations
    • 5.2.3 Other End-Users
  • 5.3 Geography
    • 5.3.1 North America
      • 5.3.1.1 United States
      • 5.3.1.2 Canada
      • 5.3.1.3 Mexico
    • 5.3.2 Europe
      • 5.3.2.1 Germany
      • 5.3.2.2 United Kingdom
      • 5.3.2.3 France
      • 5.3.2.4 Italy
      • 5.3.2.5 Spain
      • 5.3.2.6 Rest of Europe
    • 5.3.3 Asia-Pacific
      • 5.3.3.1 China
      • 5.3.3.2 Japan
      • 5.3.3.3 India
      • 5.3.3.4 Australia
      • 5.3.3.5 South Korea
      • 5.3.3.6 Rest of Asia-Pacific
    • 5.3.4 Middle-East and Africa
      • 5.3.4.1 GCC
      • 5.3.4.2 South Africa
      • 5.3.4.3 Rest of Middle-East and Africa
    • 5.3.5 South America
      • 5.3.5.1 Brazil
      • 5.3.5.2 Argentina
      • 5.3.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 SGS SA
    • 6.1.2 Labcorp (Toxikon, Inc)
    • 6.1.3 Eurofins Scientific
    • 6.1.4 Pace Analytical Services, Inc.
    • 6.1.5 Intertek Group Plc
    • 6.1.6 Thermofischer Scientific (Pharmaceutical Product Development, LLC )
    • 6.1.7 WuXi AppTec
    • 6.1.8 Boston Analytical
    • 6.1.9 Charles River Laboratories International, Inc
    • 6.1.10 West Pharmaceutical Services Inc.
    • 6.1.11 Element Group (Exova Group PLC)
    • 6.1.12 Merck KGaA

7 MARKET OPPORTUNITIES AND FUTURE TRENDS