医療関連業務アウトソーシングの世界市場

【英語タイトル】Healthcare Regulatory Affairs Outsourcing Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2017 - 2025

Future Market Insightsが出版した調査資料(FUMI809077)・商品コード:FUMI809077
・発行会社(調査会社):Future Market Insights
・発行日:2018年2月13日
・ページ数:140
・レポート言語:英語
・レポート形式:PDF
・納品方法:Eメール
・調査対象地域:グローバル
・産業分野:医療・医薬品・医療機器
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※本調査レポートでは、医療関連業務アウトソーシングの世界市場について調査・分析し、以下の構成でお届けいたします。
・医療関連業務アウトソーシングの世界市場の世界市場概観
・医療関連業務アウトソーシングの世界市場の世界市場規模
・医療関連業務アウトソーシングの世界市場の世界市場予測
・医療関連業務アウトソーシングの世界市場の世界市場:地域別市場分析
・医療関連業務アウトソーシングの世界市場のアメリカ市場規模
・医療関連業務アウトソーシングの世界市場のヨーロッパ市場規模
・医療関連業務アウトソーシングの世界市場のアジア市場規模
・医療関連業務アウトソーシングの世界市場の世界市場:セグメント別市場分析
・医療関連業務アウトソーシングの世界市場の世界市場:競争状況
・医療関連業務アウトソーシングの世界市場の世界市場:市場動向
・医療関連業務アウトソーシングの世界市場の世界市場:関連企業分析
【レポートの概要】

Mid-size pharmaceutical companies and biotechnology companies may compete in the global healthcare regulatory affairs outsourcing market

The global healthcare regulatory affairs outsourcing market is at a surge with the increase in demand for various services it offers. It includes medical writing and publishing of the regulatory documentation offered by experienced medical writers, quality control (QC) auditors and publishers that plays an important role to develop high-quality documents for clinical research projects. Then there are regulatory submissions which refer to the submission of any documentation or information on a healthcare product to a regulatory agency in order to get it reviewed. There are also outsourcing services like clinical trial applications, and regulatory consulting and legal representations. All these services are in high demand from end users like mid-size pharma companies, large pharma companies, biotechnology companies, medical device manufacturers and food & beverage companies.

The analysis of global healthcare regulatory affairs outsourcing market depicts that, among various end users in the market, the mid-size pharmaceutical companies are expected to dominate with a market value of over US$ 700 Mn by the end of 2025, growing at a CAGR of 13.8% during the forecast period. Biotechnology companies are expected to be a lucrative end user segment of the market with a significant demand expected during the forecast period of 2017-2025. The biotechnology companies segment is expected to grow at a CAGR of 13.2% during the forecast period, giving tough competition to mid-size pharmaceutical companies.

Increasing R&D activities and development of new products to boost the healthcare regulatory affairs outsourcing market

Various countries are gradually increasing their investments in the R&D departments. This has triggered development of new products in the industry. With the increasing strictness by the respective regulatory authorities worldwide, a growing collaboration between the drug developers and Clinical Research Organizations (CROs) and contract manufacturing organizations (CMOs) has been observed in order to mitigate risks. As CROs and CMOs help the companies in such risks, companies are able to focus on their core businesses. Therefore, increasing research and development activities along with patent expirations have been identified as the major factors fueling the growth of the regulatory affairs outsourcing market.

The rise in demand for services offered by healthcare regulatory affairs outsourcing market is also a result of increasing documentation during drug and device manufacturing. The mid or small size pharmaceutical companies, face problems like extensive documentation. The regulatory authorities, owing to their stringent policies, demand the need for trained and skilled regulatory professionals capable of efficiently handling registration, evaluation and compilation of scientific data. Subsequently, the pharmaceutical and biotechnology companies are seeking help of regulatory service providers, thereby driving the market’s growth.

Hidden costs and pricing fluctuations may discourage many end users from using services available in the healthcare regulatory affairs outsourcing market

There’s an increase in the instances where prices of the services are not stated clearly in the healthcare regulatory affairs outsourcing market. In addition, extra costs are said to be involved in the services with the increasing use of technological platforms such as software for the clinical data management, content management, database and document management. The use of such technologies results in hyped ultimate price for the services offered and this in turn would hamper the market’s growth. The technological advances no doubt improves the overall process but adds to the total costs as well. But makes the companies hesitant of spending high extra amounts. Many companies even confine themselves by outsourcing the regulatory activities to one destination country.

【レポートの目次】

Table Of Content
1. Global Healthcare Regulatory Affairs Outsourcing Market – Executive Summary

2. Research Methodology

3. Assumptions and Acronyms Used

4. Global Healthcare Regulatory Affairs Outsourcing Market Overview

4.1. Introduction

4.1.1. Healthcare Regulatory Affairs Outsourcing Market Taxonomy

4.1.2. Healthcare Regulatory Affairs Outsourcing Market Definition

4.2. Global Healthcare Regulatory Affairs Outsourcing Market Size and Forecast

4.2.1. Global Healthcare Regulatory Affairs Outsourcing Market Y-o-Y Growth

4.2.2. Global Healthcare Regulatory Affairs Outsourcing Market Absolute $ Opportunity

4.3. Global Healthcare Regulatory Affairs Outsourcing Market Dynamics

4.3.1. Macro-economic Factors

4.3.2. Drivers

4.3.2.1. Supply Side

4.3.2.2. Demand Side

4.3.3. Restraints

4.3.4. Opportunities

4.3.5. Trends

4.3.6. Forecast Factors – Relevance and Impact

5. Global Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By Services

5.1. Introduction

5.1.1. Basis Point Share (BPS) Analysis By Services

5.1.2. Y-o-Y Growth Projections By Services

5.2. Market Size (US$ Mn) and Forecast By Services

5.2.1. Regulatory Writing and Publishing

5.2.2. Regulatory Submissions

5.2.3. Clinical Trial Applications and Product Registrations

5.2.4. Regulatory Consulting and Legal Representation

5.2.5. Other Regulatory Affairs

5.3. Market Attractiveness Analysis By Services

6. Global Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By End User

6.1. Introduction

6.1.1. Basis Point Share (BPS) Analysis By End User

6.1.2. Y-o-Y Growth Projections By End User

6.2. Market Size (US$ Mn) and Forecast By End User

6.2.1. Mid-Size Pharmaceutical Companies

6.2.1. Large Pharmaceutical Companies

6.2.2. Biotechnology Companies

6.2.3. Medical Devices Companies

6.2.4. Food & Beverage Companies

7. Global Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By Region

7.1. Introduction

7.1.1. Basis Point Share (BPS) Analysis By Region

7.1.2. Y-o-Y Growth Projections By Region

7.2. Market Size (US$ Mn) and Forecast By Region

7.2.1. North America

7.2.2. Latin America

7.2.3. Europe

7.2.4. Asia Pacific

7.2.5. Middle East & Africa

7.3. Market Attractiveness Analysis By Region

8. North America Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast

8.1. Introduction

8.1.1. Basis Point Share (BPS) Analysis By Country

8.1.2. Y-o-Y Growth Projections By Country

8.2. Market Size (US$ Mn) and Forecast By Country

8.2.1. U.S.

8.2.2. Canada

8.3. Market Size (US$ Mn) and Forecast By Services

8.3.1. Regulatory Writing and Publishing

8.3.2. Regulatory Submissions

8.3.3. Clinical Trial Applications and Product Registrations

8.3.4. Regulatory Consulting and Legal Representation

8.3.5. Other Regulatory Affairs

8.4. Market Size (US$ Mn) and Forecast By End user

8.4.1. Mid-Size Pharmaceutical Companies

8.4.2. Large Pharmaceutical Companies

8.4.3. Biotechnology Companies

8.4.4. Medical Devices Companies

8.4.5. Food & Beverage Companies

8.5. Market Attractiveness Analysis

8.5.1. By Country

8.5.2. By Services

8.5.3. By End user

9. Latin America Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast

9.1. Introduction

9.1.1. Basis Point Share (BPS) Analysis By Country

9.1.2. Y-o-Y Growth Projections By Country

9.2. Market Size (US$ Mn) and Forecast By Country

9.2.1. Brazil

9.2.2. Mexico

9.2.3. Rest of Latin America

9.3. Market Size (US$ Mn) and Forecast By Services

9.3.1. Regulatory Writing and Publishing

9.3.2. Regulatory Submissions

9.3.3. Clinical Trial Applications and Product Registrations

9.3.4. Regulatory Consulting and Legal Representation

9.3.5. Other Regulatory Affairs

9.4. Market Size (US$ Mn) and Forecast By End user

9.4.1. Mid-Size Pharmaceutical Companies

9.4.2. Large Pharmaceutical Companies

9.4.3. Biotechnology Companies

9.4.4. Medical Devices Companies

9.4.5. Food & Beverage Companies

9.5. Market Attractiveness Analysis

9.5.1. By Country

9.5.2. By Services

9.5.3. By End user

10. Europe Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast

10.1. Introduction

10.1.1. Basis Point Share (BPS) Analysis By Country

10.1.2. Y-o-Y Growth Projections By Country

10.2. Market Size (US$ Mn) and Forecast By Country

10.2.1. Germany

10.2.2. France

10.2.3. U.K.

10.2.4. Italy

10.2.5. Spain

10.2.6. Rest of Europe

10.3. Market Size (US$ Mn) and Forecast By Services

10.3.1. Regulatory Writing and Publishing

10.3.2. Regulatory Submissions

10.3.3. Clinical Trial Applications and Product Registrations

10.3.4. Regulatory Consulting and Legal Representation

10.3.5. Other Regulatory Affairs

10.4. Market Size (US$ Mn) and Forecast By End user

10.4.1. Mid-Size Pharmaceutical Companies

10.4.2. Large Pharmaceutical Companies

10.4.3. Biotechnology Companies

10.4.4. Medical Devices Companies

10.4.5. Food & Beverage Companies

10.5. Market Attractiveness Analysis

10.5.1. By Country

10.5.2. By Services

10.5.3. By End user

11. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast

11.1. Introduction

11.1.1. Basis Point Share (BPS) Analysis By Country

11.1.2. Y-o-Y Growth Projections By Country

11.2. Market Size (US$ Mn) and Forecast By Country

11.2.1. China

11.2.2. India

11.2.3. Japan

11.2.4. ASEAN

11.2.5. Australia & New Zealand

11.2.6. Rest of Asia Pacific

11.3. Market Size (US$ Mn) and Forecast By Services

11.3.1. Regulatory Writing and Publishing

11.3.2. Regulatory Submissions

11.3.3. Clinical Trial Applications and Product Registrations

11.3.4. Regulatory Consulting and Legal Representation

11.3.5. Other Regulatory Affairs

11.4. Market Size (US$ Mn) and Forecast By End user

11.4.1. Mid-Size Pharmaceutical Companies

11.4.2. Large Pharmaceutical Companies

11.4.3. Biotechnology Companies

11.4.4. Medical Devices Companies

11.4.5. Food & Beverage Companies

11.5. Market Attractiveness Analysis

11.5.1. By Country

11.5.2. By Services

11.5.3. By End user

12. Middle East & Africa (MEA) Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast

12.1. Introduction

12.1.1. Basis Point Share (BPS) Analysis By Country

12.1.2. Y-o-Y Growth Projections By Country

12.2. Market Size (US$ Mn) and Forecast By Country

12.2.1. GCC Countries

12.2.2. South Africa

12.2.3. Rest of MEA

12.3. Market Size (US$ Mn) and Forecast By Services

12.3.1. Regulatory Writing and Publishing

12.3.2. Regulatory Submissions

12.3.3. Clinical Trial Applications and Product Registrations

12.3.4. Regulatory Consulting and Legal Representation

12.3.5. Other Regulatory Affairs

12.4. Market Size (US$ Mn) and Forecast By End user

12.4.1. Mid-Size Pharmaceutical Companies

12.4.2. Large Pharmaceutical Companies

12.4.3. Biotechnology Companies

12.4.4. Medical Devices Companies

12.4.5. Food & Beverage Companies

12.5. Market Attractiveness Analysis

12.5.1. By Country

12.5.2. By Services

12.5.3. By End user

13. Competitive Landscape (Revenue, Product Offerings, Highlights)

13.1. PAREXEL International Corporation

13.2. Quintiles IMS Holdings Inc.

13.3. Clinilabs, Inc.

13.4. Accell Clinical Research, LLC.

13.5. Freyr Solutions

13.6. The Weinberg Group Inc.

13.7. Covance, Inc., (LabCorp)

13.8. Pharmaceutical Product Development LLC

13.9. ICON plc

13.10 Sciformix Corporation



【レポートのキーワード】

医療関連業務アウトソーシング

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