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市場調查報告書
藥事申請 (RA) 業務外包市場:2020年∼2025年Healthcare Regulatory Affairs Outsourcing Market (2020 - 2025) |
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| 出版商 | IndustryARC | 商品編碼 | 978853 | ||||
| 出版日期 | 內容資訊 | 英文 108 Pages 商品交期: 2-3個工作天內 |
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| 藥事申請 (RA) 業務外包市場:2020年∼2025年 Healthcare Regulatory Affairs Outsourcing Market (2020 - 2025) | ||
| 出版日期: 2020年10月05日 | 內容資訊: 英文 108 Pages |
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藥事申請 (RA) 業務外包的市場規模，從2019年的24億美元，到2025年達到33億7,000萬美元，在2020年∼2025年的預測期間內以7.2％的年複合成長率成長。市場成長主要起因於研究開發活動的成本增加伴隨，專利到期數增加。
本報告提供全球藥事申請 (RA) 業務外包調查分析，市場概要，市場規模、預測，各市場區隔的市場分析，各地區的市場分析，競爭情形等相關的系統性資訊。
Healthcare Regulatory Affairs Outsourcing Market size is valued at $2.40 Bn in 2019, and is estimated to reach $3.37 Bn by 2025, growing at CAGR of 7.2% during the forecast period of 2020-2025. Healthcare regulatory affairs outsourcing are the regulatory policies that are implemented to ensure that companies obey with certain performance standards in relation to their business. These policies aim to protect public health and well-being by ensuring the safety of healthcare and pharmaceutical products. Outsourcing of healthcare regulation includes the medical writing and publication of regulatory documents provided by quality control and experienced medical writers and publishers who play a vital role in developing high-quality documentation for clinical research projects. The global Healthcare Regulatory Affairs Outsourcing Market growth is primarily attributed to the rising number of patent expiration along with growing costs of research and development activities. The service providers have been shifting their focus to outsource healthcare regulatory activities for reducing costs and focusing on core competencies, which helps to increase the growth of the Global Healthcare Regulatory Affairs Outsourcing Market over the forecast years 2020-2025.
Healthcare Regulatory Affairs Outsourcing Market Report Coverage
The report: "Healthcare Regulatory Affairs Outsourcing Market Forecast (2020-2025)", by Industry ARC, covers an in-depth analysis of the following segments of the Healthcare Regulatory Affairs Outsourcing Market.
By Service Type: Clinical Trial Applications and Product Registrations, Regulatory Consulting and Legal Representation, Regulatory Submissions, Regulatory Writing and Publishing, and others.
By End User: Biotechnology Companies, Medical Device Companies, and Pharmaceutical Companies.
By Geography: North America, Europe.
Key Takeaways:
Healthcare Regulatory Affairs Outsourcing Market Segment Analysis - By Service Type
The global Healthcare Regulatory Affairs Outsourcing Market based on Mode of Service Type, can be further segmented into Clinical Trial Applications and Product Registrations, Regulatory Consulting and Legal Representation, Regulatory Submissions, Regulatory Writing and Publishing, and others. Regulatory Writing and Publishing segment registered for the highest revenue of $865m in 2019 and is estimated to grow at highest CAGR of 7.5% over the forecast years 2020-2025. This is owing to the growing demand for the regulatory writing and publishing services to develop the regulatory filing documents in comprehensive, standard, reliable, and convincing manner, which drives the growth of the segment. However, the increasing need for high-quality documents to support timely drug approvals in developing countries is estimated to boost the demand for the segment over the forecast period 2020-2025.
Healthcare Regulatory Affairs Outsourcing Market Segment Analysis - By End User
The global Healthcare Regulatory Affairs Outsourcing Market based on End User, can be further segmented into Biotechnology Companies, Medical Device Companies, and Pharmaceutical Companies. The Pharmaceutical Companies segment registered for highest revenue of $947m in 2019 and projected to grow at the highest CAGR of 6.3% during the forecast period 2020-2025 owing to the increasing need for efficient development and manufacturing of pharmaceutical products, which subsequently increases the adoption of full-time regulatory affairs outsourcing models to minimize the overall manufacturing cost. The Pharmaceutical companies are actively working to improve productivity and efficiency, streamline clinical trials, and meet strict healthcare regulatory outsourcing and quality assurance requirements to keep pace with the high competition, which is driving the segment.
Healthcare Regulatory Affairs Outsourcing Market Segment Analysis - By Geography
The global Healthcare Regulatory Affairs Outsourcing Market based on Geography, can be further segmented into North America, Asia-Pacific, Europe, and Rest of World. North America registered for the highest revenue of $1.30 Bn in 2019 and is set to grow at highest CAGR of 7.7% over the forecast period 2020-2025 owing to the increasing number of R&D activities in the field of drug discovery carried out in the region. It have a large presence of multinational biotech and pharma companies which carry out a large number of clinical trials and also has the well developed and advanced healthcare infrastructure. However, Europe is estimated to outpace all the regions by clocking the highest CAGR of 7.3% during the forecast period 2020-2025 owing to the health care needs and government funding towards research activities. Moreover, many biotech and pharma companies have started outsourcing their drug development services to various countries like Italy, Germany, and France which is further boosting the market growth for healthcare regulatory affairs outsourcing market.
Healthcare Regulatory Affairs Outsourcing Market Drivers
Increasing the number of patent expirations
The global Healthcare Regulatory Affairs Outsourcing industry growth is primarily attributed to the rising number of patent expiration along with growing costs of research and development activities. Biopharmaceutical and healthcare organizations are likely to team up with many outsourcing companies for getting their devices and drugs approved but the approval time of a drug or device is expensive, long time procedure, and is also a documentation centric procedure. So, the service providers have been shifting their focus to outsource healthcare regulatory activities for reducing costs and focusing on core competencies which helps to increase the growth of the Global Healthcare Regulatory Affairs Outsourcing Market over the forecast years 2020-2025.
Healthcare Regulatory Affairs Outsourcing Market Challenges
Fluctuations in Prices
There is an increase in the instances where prices of the services are not clearly stated in the healthcare regulatory affairs outsourcing market, which is acting as a challenge to the market. Besides, the additional 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, and database & document management. The technological advances no doubt improves the overall process but adds to the total costs as well which are restraining the market growth during the forecast period 2020-2025.
Product launches, mergers and acquisitions, joint ventures, and geographical expansions are key strategies adopted by players in the Healthcare Regulatory Affairs Outsourcing Market. Key companies of this market Accell Clinical Research, LLC, Charles River Laboratories International, Inc, Clinilabs Inc, Criterium Inc, Covance Inc, Cardinal Health, Freyr, ICON PLc, IQVIA, and Medpace, Inc.
