薬事アウトソーシング市場の規模、シェア、動向分析レポート：カテゴリー別（生物製剤、医療機器）、企業規模別（中規模、大規模）、適応症別、ステージ別、サービス別、エンドユーザー別、およびセグメント予測、2022年～2030年

Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Category (Biologics, Medical Devices), By Company Size (Medium, Large), By Indication, By Stage, By Services, By End Use, And Segment Forecasts, 2022 - 2030

レギュラトリー・アフェアーズ・アウトソーシング市場の成長・動向 Grand View Research, Inc.の最新レポートによると、規制関連業務のアウトソーシングの世界市場規模は、2030年までに139億米ドルに達し、予... もっと見る

出版社	出版年月	電子版価格	ページ数	言語
Grand View Research グランドビューリサーチ	2022年2月16日	US$5,950 シングルユーザーライセンスライセンス・価格情報注文方法はこちら	180	英語

日本語のページは自動翻訳を利用し作成しています。
実際のレポートは英文のみでご納品いたします。

サマリー

レギュラトリー・アフェアーズ・アウトソーシング市場の成長・動向

Grand View Research, Inc.の最新レポートによると、規制関連業務のアウトソーシングの世界市場規模は、2030年までに139億米ドルに達し、予測期間中に8.9%のCAGRを記録すると予想されています。トレーニング、技術、専門知識、施設など、薬事・業務活動に必要な社内リソースの固定費が大幅に増加していることが、薬事業務のアウトソーシングを促進しています。米国、欧州、アジアなどの主要市場において、各国の規制の課題や規制の絶え間ない変化に対応することが、これらのサービスに対する需要を生み出しています。現行の規制を遵守することはもちろんのこと、世界各国の動向を常に把握することは非常に困難な作業となっています。現行の規制の改正は、業界にとって規制の経路を簡素化する可能性がありますが、逆にヘルスケア製品の製造会社にとっては業務が複雑化することになります。

そのため、サービスプロバイダーへの薬事業務のアウトソーシングが進んでいます。2020年、COVID-19のパンデミック発生により、薬事更新を含む臨床試験活動が停止したため、市場は大きく減少した。サプライチェーンの混乱や研究開発拠点の閉鎖により、業界全体で2020年に大幅な収益減となった。しかし、パンデミックのため、様々なヘルスケア企業は、COVID-19の治療薬、ワクチン、デバイスにおける製品開発＆承認のスピードアップを推進し、より多くの規制当局のアドバイスを選択しています。COVID-19用の医療機器と治療法の緊急な必要性により、規制当局は大半の製品に緊急使用許可を与えています。このようなアクションは、2020年以降、これらのサービスの需要をさらに促進し、2021年以降、業界全体の売上高の好転を目撃することができます。

レギュラトリー・アフェアーズ・アウトソーシング市場のレポートハイライト

- 規制当局の執筆および出版サービスは、開発の初期段階から市販後の認可段階まで提供され、製品の成功に不可欠であるため、2021年には最大の売上シェアを占めた。

- 大企業向けセグメントは、予測期間中に最も速いCAGRを記録すると予測されます。多種多様なサービスが利用可能であり、これらのプロバイダーが様々な地域に存在することが、このセグメントの成長を促進する主な要因である

- 発展途上国での臨床試験需要の増加により、臨床試験段階セグメントが2021年に最大の市場シェアを占めた

- 製薬会社のエンドユーズセグメントは、オーファンドラッグや個別化治療などの進化した領域により、予測期間中に最も速い成長率を示すと予想されます。

- アジア太平洋地域は、経済効果の高い地域へのオフショアリングの増加や、インドや中国などの国におけるライフサイエンス企業の拡大により、2021年の世界市場で最大の売上シェアを占めています。

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Table of content

Chapter 1 Methodology and Scope
1.1 Market Segmentation & Scope
1.1.1 Services
1.1.2. Company Size
1.1.3. Category
1.1.4 Indication
1.1.5 Stage
1.1.6 End User
1.1.7 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
1.4 Information or Data Analysis
1.4.1 Data Analysis Models
1.5 Market Formulation & Validation
1.6 Region Wise Market Calculation
1.6.1 Region Wise Market: Base Estimates
1.6.2 Global Market: CAGR Calculation
1.7 List of Secondary Sources
1.8 Objectives
1.8.1 Objective - 1: Understanding market dynamics
1.8.2 Objective - 2: Understanding market estimates and forecasts
1.8.3 Objective - 3: Understanding attributes such as strategy framework and competitor categorization
1.8.4 Objective - 4: Understanding the key service and application scopes to conclude on the market size.
Chapter 2 Executive Summary
2.1 Market Outlook
Chapter 3 Regulatory Affairs Outsourcing Market: Variables, Trends, & Scope
3.1 Market Segmentation and Scope
3.2 Market Dynamics
3.2.1 Market Driver Analysis
3.2.1.1 Changing regulatory landscape
3.2.1.2 Entry of companies in 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 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 Penetration & Growth Prospect Mapping
3.4 Industry Challenges
3.4.1 Managing Relationships
3.5 Major Deals and Strategic Alliances Analysis
3.6 Regulatory Affairs: Market Analysis Tools
3.6.1 SWOT
3.6.2 Industry Analysis - Porter’s
3.6.3 PESTEL Analysis
Chapter 4 Regulatory Affairs Outsourcing Market: Service Segment Analysis
4.1 Regulatory Affairs Outsourcing Market: Service Market Share Analysis, 2020 & 2028
4.2 Regulatory Consulting
4.2.1 Regulatory Consulting Market, 2018 - 2030 (USD Million)
4.3 Legal Representation
4.3.1 Legal Representation Market, 2018 - 2030 (USD Million)
4.4 Regulatory Writing and Publishing
4.4.1 Regulatory Writing and Publishing Market, 2018 - 2030 (USD Million)
4.5 Product Registration and Clinical Trial Application
4.5.1 Product Registration and Clinical Trial Application Market, 2018 - 2030 (USD Million)
4.6 Other Services
4.6.1 Other Services Market, 2018 - 2030 (USD Million)
Chapter 5 Regulatory Affairs Outsourcing Market: Company Size Segment Analysis
5.1 Regulatory Affairs Outsourcing Market: Company Size Market Share Analysis, 2020 & 2028
5.2 Small Sized Companies
5.2.1 Small Sized Companies Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
5.3 Medium Sized Companies
5.3.1 Medium Sized Companies Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
5.4 Large Sized Companies
5.4.1 Large Companies Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
Chapter 6 Regulatory Affairs Outsourcing Market: Categories Segment Analysis
6.1 Regulatory Affairs Outsourcing Market: Categories Market Share Analysis, 2020 & 2028
6.2 Drugs
6.2.1 Drugs Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
6.2.2 Generics
6.2.2.1 Generics Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
6.2.3 Innovator
6.2.3.1 Innovator Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
6.3 Biologics
6.3.1 Biologics Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
6.3.2 Biotech
6.3.2.1 Biotech Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
6.3.3 ATMPs
6.3.3.1 ATMPs Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
6.3.4 Biosimilars
6.3.4.1 Biosimilar Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
6.4 Medical Devices
6.4.1 Medical Devices Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
6.4.2 Diagnostics
6.4.2.1 Diagnostics Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
6.4.3 Therapeutics
6.4.3.1 Therapeutics Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
Chapter 7 Regulatory Affairs Outsourcing Market: Stage Segment Analysis
7.1 Regulatory Affairs Market: Stage Market Share Analysis, 2020 & 2028
7.2 Preclinical
7.2.1 Preclinical-based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
7.3 Clinical
7.3.1 Clinical-based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
7.4 PMA
7.4.1 PMA-based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
Chapter 8 Regulatory Affairs Outsourcing Market: Indication Segment Analysis
8.1 Regulatory Affairs Outsourcing Market: Indication Market Share Analysis, 2020 & 2028
8.2 Oncology
8.2.1 Oncology Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
8.3 Neurology
8.3.1 Neurology Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
8.4 Cardiology
8.4.1 Cardiology Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
8.5 Immunology
8.5.1 Immunology Indication Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (Usd Million)
8.6 Other Indications
8.6.1 Other Indication Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
Chapter 9 Regulatory Affairs Outsourcing Market: End-use Segment Analysis
9.1 Regulatory Affairs Outsourcing Market: End-use Market Share Analysis, 2020 & 2028
9.2 Medical Device Companies
9.2.1 Medical Device Companies Market, 2018 - 2030 (USD Million)
9.3 Pharmaceutical Companies
9.3.1 Pharmaceutical Companies Market, 2018 - 2030 (USD Million)
9.4 Biotechnology Companies
9.4.1 Biotechnology Companies Market, 2018 - 2030 (USD Million)
Chapter 10 Regulatory Affairs Outsourcing Market: Regional Analysis
10.1 Regulatory Affairs Outsourcing Market: Regional Market Share Analysis, 2020 & 2028
10.2 North America
10.2.1 North America Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.2.2 U.S.
10.2.2.1 U.S. Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.2.3 Canada
10.2.3.1 Canada Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3 Europe
10.3.1 Europe Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3.2 U.K.
10.3.2.1 U.K. Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3.3 Germany
10.3.3.1 Germany Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3.4 France
10.3.4.1 France Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3.5 Italy
10.3.5.1 Italy Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3.6 Spain
10.3.6.1 Spain Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3.7 Russia
10.3.7.1 Russia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3.8 Turkey
10.3.8.1 Turkey Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3.9 The Netherlands
10.3.9.1The Netherlands Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3.10 Switzerland
10.3.10.1 Switzerland Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3.11 Sweden
10.3.11.1 Sweden Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.3.12 CIS Countries
10.3.12.1 CIS Countries Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4 Asia Pacific
10.4.1 Asia Pacific Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4.2 Japan
10.4.2.1 Japan Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4.3 China
10.4.3.1 China Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4.4 India
10.4.4.1 India Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4.5 Australia
10.4.5.1 Australia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4.6 South Korea
10.4.6.1 South Korea Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4.7 Indonesia
10.4.7.1 Indonesia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4.8 Malaysia
10.4.8.1 Malaysia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4.9 Singapore
10.4.9.1 Singapore Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4.10 Thailand
10.4.10.1 Thailand Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4.11 Taiwan
10.4.11.1 Taiwan Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.4.12 CIS Countries
10.4.12.1 Taiwan Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.5 Latin America
10.5.1 Latin America Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.5.2 Brazil
10.5.2.1 Brazil Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.5.3 Mexico
10.5.3.1 Mexico Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.5.4 Argentina
10.5.4.1 Argentina Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.5.5 Colombia
10.5.5.1 Colombia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.5.6 Chile
10.5.6.1 Chile Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.6 MEA
10.6.1 MEA Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.6.2 South Africa
10.6.2.1 South Africa Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.6.3 Saudi Arabia
10.6.3.1 Saudi Arabia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.6.4 UAE
10.6.4.1 UAE Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.6.5 Egypt
10.6.5.1 Egypt Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
10.6.6 Israel
10.6.6.1 Israel Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
Chapter 11 Company Profiles
11.1 Accell Clinical Research, LLC.
11.1.1 Company Overview
11.1.2 Service Benchmarking
11.1.3 Geographic Presence
11.1.4 Strategic Intiatives
11.1.5 SWOT
11.2 GenPact Ltd.
11.2.1 Company Overview
11.2.2 Financial Performance
11.2.3 Service Benchmarking
11.2.4 Geographic Presence
11.2.5 Strategic Initiatives
11.2.6 SWOT
11.3 Criterium, Inc.
11.3.1 Company Overview
11.3.2 Service Benchmarking
11.3.3 Geographic Presence
11.3.4 Swot
11.4 PRA Health Sciences
11.4.1 Company Overview
11.4.2 Financial Performance
11.4.3 Service Benchmarking
11.4.4 Geographic Presence
11.4.5 Strategic Initiatives
11.4.6 SWOT
11.5 Promedica International
11.5.1 Company Overview
11.5.2 Service Benchmarking
11.5.3 Geographic Presence
11.5.4 SWOT
11.6 WuXi AppTec, Inc.
11.6.1 Company Overview
11.6.2 Financial Performance
11.6.3 Service Benchmarking
11.6.4 Geographic Presence
11.6.5 Strategic Initiatives
11.6.6 SWOT
11.7 Medpace
11.7.1 Company Overview
11.7.2 Financial Performance
11.7.3 Service Benchmarking
11.7.4 Geographic Presence
11.7.5 Swot
11.8 Charles River Laboratories International, Inc.
11.8.1 Company Overview
11.8.2 Financial Performance
11.8.3 Service Benchmarking
11.8.4 Geographic Presence
11.8.5 Strategic Initiatives
11.8.6 SWOT
11.9 ICON plc
11.9.1 Company Overview
11.9.2 Financial Performance
11.9.3 Service Benchmarking
11.9.4 Geographic Presence
11.9.5 Strategic Initiatives
11.9.6 SWOT
11.10 Covance
11.10.1 Company Overview
11.10.2 Financial Performance
11.10.3 Service Benchmarking
11.10.4 Geographic Presence
11.10.5 Strategic Initiatives
11.10.6 SWOT
11.11 PAREXEL International Corporation, Inc.
11.11.1 Company Overview
11.11.2 Financial Performance
11.11.3 Service Benchmarking
11.11.4 Geographic Presence
11.11.5 Strategic Initiatives
11.11.6 SWOT
11.12 Freyr
11.12.1 Company Overview
11.12.2 Service Benchmarking
11.12.3 Geographic Presence
11.12.4 Strategic Initiatives
11.12.5 SWOT
11.13 Pharmalex GMBH
11.13.1 Company Overview
11.13.2 Service Benchmarking
11.13.3 Geographic Presence
11.13.4 Strategic Initiatives
11.13.5 SWOT
11.14 NDA Group AB
11.14.1 Company Overview
11.14.2 Service Benchmarking
11.14.3 Geographic Presence
11.14.4 SWOT
11.15 Pharmexon Consulting s.r.o
11.15.1 Company Overview
11.15.2 Service Benchmarking
11.15.3 SWOT
11.16 Qvigilance
11.16.1 Company Overview
11.16.2 Service Benchmarking
11.16.3 SWOT
11.17 BlueReg Group
11.17.1 Company Overview
11.17.2 Service Benchmarking
11.17.3 Geographic Presence
11.17.4 Strategic Initiatives
11.17.5 SWOT
11.18 Cambridge Regulatory Services
11.18.1 Company Overview
11.18.2 Service Benchmarking
11.18.3 SWOT
11.19 APCER Life Sciences, Inc
11.19.1 Company Overview
11.19.2 Service Benchmarking
11.19.3 Geographic Presence
11.19.4 Strategic Initiatives
11.19.5 SWOT
11.20 Real Regulatory Ltd.
11.20.1 Company Overview
11.20.2 Service Benchmarking
11.20.3 SWOT
11.21 Voisin Consulting Life Sciences
11.21.1 Company Overview
11.21.2 Service Benchmarking
11.21.3 Geographic Presence
11.21.4 Strategic Initiatives
11.21.5 SWOT
11.22 PrimeVigilance
11.22.1 Company Overview
11.22.2 Service Benchmarking
11.22.3 Geographic Presence
11.22.4 Strategic Initiatives
11.22.5 SWOT
11.23 ProPharma Group MIS Limited
11.23.1 Company overview
11.23.2 Service Benchmarking
11.23.3 Geographic Presence
11.23.4 Strategic Initiatives
11.23.5 SWOT
11.24 Regulatory Pharma Net srl
11.24.1 Company Overview
11.24.2 Service Benchmarking
11.24.3 Geographic Presence
11.24.4 SWOT
11.25 Zeincro Group
11.25.1 Company Overview
11.25.2 Service Benchmarking
11.25.3 Geographic Presence
11.25.4 Strategic Initiatives
11.25.5 SWOT
11.26 BioMapas
11.26.1 Company Overview
11.26.2 Service Benchmarking
11.26.3 Geographic Presence
11.26.4 Strategic Initiatives
11.26.5 SWOT
11.27 Dr. Regenold GmbH
11.27.1 Company Overview
11.27.2 Service Benchmarking
11.27.3 SWOT

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Table of Contents

Summary

Regulatory Affairs Outsourcing Market Growth & Trends

The global regulatory affairs outsourcing market size is expected to reach USD 13.9 billion by 2030, registering a CAGR of 8.9% over the forecast period, according to a new report by Grand View Research, Inc. Significant increase in the fixed costs of in-house resources for regulatory affairs & operation activities like training, technology, specialized knowledge, and facilities are driving outsourcing of regulatory affair functions. Addressing local regulatory challenges and constant changes in the regulations of the major markets, such as the U.S., Europe, and Asia, is creating demand for these services. Compliance with the current regulations has become an immense chore, leave alone trying to stay up to date with developments around the world. Amendments to current regulations are likely to simplify the regulatory pathway for the industry but in turn, complicate the operation for healthcare product manufacturing companies.

Thus, leading to the regulatory affairs outsourcing to service providers. The market witnessed a significant decline in 2020 due to the outbreak of the COVID-19 pandemic, as there was a halt in clinical trial activities including regulatory updates. Disruption in the supply chain and closure of R&D sites resulted in a significant loss of revenues in 2020 across the industry. However, due to the pandemic, various healthcare companies are opting for more regulatory advice, as companies push to speed up the product development & approvals in therapies, vaccines, & devices for COVID-19. Owing to the urgent need for medical devices and therapies for COVID-19, regulatory authorities are providing emergency use authorization for the majority of products. Such actions have further promoted the demand for these services post 2020 and the positive rebound of sales across the industry can be witnessed from 2021.

Regulatory Affairs Outsourcing Market Report Highlights

• The regulatory writing & publishing services segment dominated the market with the maximum revenue share in 2021as they are offered from the early stages of development to the post-marketing authorization phase and are vital for the success of a product

• The large companies segment is projected to witness the fastest CAGR during the forecast period. The availability of a wide variety of services and the presence of these providers in various geographies are the key factors driving the segment growth

• The clinical studies stage segment accounted for the largest market share in 2021 due to the increasing demand for clinical trials in developing countries

• The pharmaceutical companies end-use segment is anticipated to witness the fastest growth rate over the forecast period due to evolving areas, such as orphan drugs and personalized therapies

• Asia Pacific held the maximum revenue share of the global market in 2021 owing to higher off shoring of such services into regions of economic benefits and the expansion of life sciences companies in countries, such as India & China

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本レポートと同分野（生物学的製剤）の最新刊レポート

Grand View Research社の生物学的製剤分野での最新刊レポート

薬事申請市場規模、シェア、トレンド分析レポート：サービス別、カテゴリー別（生物製剤、医薬品）、適応症別、製品ステージ別、エンドユース別、サービスプロバイダー別、企業規模別、地域別、セグメント予測、2021年～2028年

本レポートと同じKEY WORD（biologics）の最新刊レポート

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ご注文は、お電話またはWEBから承ります。お見積もりの作成もお気軽にご相談ください。

本レポートと同分野（生物学的製剤）の最新刊レポート

Grand View Research社の生物学的製剤分野での最新刊レポート

本レポートと同じKEY WORD（biologics）の最新刊レポート

よくあるご質問

Grand View Research社はどのような調査会社ですか?

調査レポートの納品までの日数はどの程度ですか?

注文の手続きはどのようになっていますか?

お支払方法の方法はどのようになっていますか?

データリソース社はどのような会社ですか?