 | • レポートコード：MRC2303B006 • 出版社/出版日：Mordor Intelligence / 2023年3月 • レポート形態：英文、PDF、113ページ • 納品方法：Eメール（受注後2-3営業日） • 産業分類：医薬品 |
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レポート概要
| Mordor Intelligence社の市場調査書では、世界の医薬品分析試験アウトソーシング市場規模が予測期間中（2022～2027年）に年平均8.7％上昇すると推測されています。本調査書では、医薬品分析試験アウトソーシングの世界市場を広く調査・分析をし、イントロダクション、調査手法、エグゼクティブサマリー、市場動向、サービス別（生物分析試験、方法開発・検証、安定性試験、その他）分析、エンドユーザー別（医薬品・バイオ医薬品企業、受託製造機関、その他）分析、地域別（アメリカ、カナダ、メキシコ、ドイツ、イギリス、フランス、イタリア、スペイン、中国、日本、インド、オーストラリア、韓国、中東、南アフリカ、ブラジル、アルゼンチン）分析、競争状況、市場機会・将来動向などを整理しています。また、本書には、SGS SA、Labcorp (Toxikon, Inc)、Eurofins Scientific、Pace Analytical Services, Inc.、Intertek Group Plc、Thermofischer Scientific (Pharmaceutical Product Development, LLC )、WuXi AppTec、Boston Analyticalなどの企業情報が含まれています。 ・イントロダクション ・調査手法 ・エグゼクティブサマリー ・市場動向 ・世界の医薬品分析試験アウトソーシング市場規模：サービス別 - 生物分析試験の市場規模 - 方法開発・検証の市場規模 - 安定性試験の市場規模 - その他サービスの市場規模 ・世界の医薬品分析試験アウトソーシング市場規模：エンドユーザー別 - 医薬品・バイオ医薬品企業における市場規模 - 受託製造機関における市場規模 - その他エンドユーザーにおける市場規模 ・世界の医薬品分析試験アウトソーシング市場規模：地域別 - 北米の医薬品分析試験アウトソーシング市場規模 アメリカの医薬品分析試験アウトソーシング市場規模 カナダの医薬品分析試験アウトソーシング市場規模 メキシコの医薬品分析試験アウトソーシング市場規模 … - ヨーロッパの医薬品分析試験アウトソーシング市場規模 ドイツの医薬品分析試験アウトソーシング市場規模 イギリスの医薬品分析試験アウトソーシング市場規模 フランスの医薬品分析試験アウトソーシング市場規模 … - アジア太平洋の医薬品分析試験アウトソーシング市場規模 中国の医薬品分析試験アウトソーシング市場規模 日本の医薬品分析試験アウトソーシング市場規模 インドの医薬品分析試験アウトソーシング市場規模 … - 南米/中東の医薬品分析試験アウトソーシング市場規模 南アフリカの医薬品分析試験アウトソーシング市場規模 ブラジルの医薬品分析試験アウトソーシング市場規模 アルゼンチンの医薬品分析試験アウトソーシング市場規模 … ・競争状況 ・市場機会・将来動向 |
The Pharmaceutical Analytical Testing Outsourcing Market is expected to register a CAGR of 8.7% during the forecast period, 2022-2027.
COVID-19 has 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 the 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 has seen a shift in site permissions from local to centralized. Previously, a prospective clinical trial location had to be approved by the local government. In other circumstances, the transition to a more centralized approval framework allowed more locations to be accepted for clinical trial testing more rapidly, cutting the period for site approval from months to days. 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, 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 the 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, according to the study published in the Iranian Journal of Medical Sciences in August 2021, titled “Expected Impact of Biosimilars on the Pharmaceutical Companies,” 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 the 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 rise in product development activities, growing research and development expenditures by the 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.
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 that require services throughout the drug development process, as well as contribute experience in drug-device combo products and extended-release injectable technologies. Such developments in the United States will lead to increased adoption of pharmaceutical analytical testing outsourcing services in this region, thereby driving the 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 2021, the funding in the United States for clinical trials and supportive activities for 2018, 2019, and 2020 was USD 5,207 million, USD 6,058 million, and USD 6,637 million, respectively. Therefore, the rise in research funding for such activities will lead to increased adoption of pharmaceutical analytical testing outsourcing services, driving the regional market growth.
Therefore, owing to the aforementioned factors, the market is anticipated to grow in the North American region.
Pharmaceutical Analytical Testing Outsourcing Market Competitor Analysis
The market for pharmaceutical analytical testing outsourcing is moderately competitive. The market is expected to drive due to the rise in key market strategies by the market players, such as partnerships with the pharmaceutical and biopharmaceutical companies, the rise in mergers and acquisitions among the market players, among others. 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
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 million)
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 Others
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 Others
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 Others
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
5.3.4.1 GCC
5.3.4.2 South Africa
5.3.4.3 Rest of Middle-East
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