의료 규제 업무 아웃소싱 시장 조사 – 규모, 점유율, 개발 및 미래 범위 2031

  • Report Code : TIPRE00007611
  • Category : Healthcare IT
  • Status : Published
  • No. of Pages : 192
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[연구보고서] 헬스케어 규제 업무 아웃소싱 시장은 2021년 72억 7,473만 달러에서 2028년 149억 9,635만 달러에 이를 것으로 예상된다. 2021년부터 2028년까지 연평균 성장률(CAGR) 10.9%로 성장할 것으로 예상됩니다.

의료 회사에 대한 규제 압력이 증가하고 신제품의 신속한 승인에 대한 수요가 높아지고 있습니다. 그러나 숙련된 전문가의 부족으로 인해 의료 규제 업무 아웃소싱 시장 성장이 제한되고 있습니다. 규제 업무 아웃소싱은 제약, 생명 공학, 의료 기기 제조 업계에 제공되는 서비스입니다. 규제 업무 아웃소싱 서비스는 신속한 규제 승인을 달성하는 데 도움이 됩니다. 규제 업무 아웃소싱 산업은 신제품 승인, 임상 시험 수행을 위한 프로토콜 준비, 보고서 게시 등을 지원하고 있습니다. 규제 상담, 의학 문서 작성 및 규제 문서 게시, 임상 시험 신청 및 기타 서비스와 같은 다양한 서비스에 대한 수요가 증가합니다. 규제 컨설팅 및 법률 대리, 특허 출원, 제품 등록, 임상 시험 신청으로 인해 의료 규제 업무 아웃소싱 비즈니스 채택이 급증했습니다.


전략적 통찰력< /h3>

의료 규제 업무 아웃소싱 시장에서 수익성이 높은 지역


시장 통찰력

의료 회사에 대한 규제 압력 증가 의료 규제 업무 아웃소싱 시장 성장

전통적인 약물 개발 접근 방식의 지속적인 업그레이드와 발전은 의료 부문에서 심각한 과제를 야기하고 있습니다. 제약회사와 의료 단체에는 처방약 비용을 줄여야 한다는 엄청난 압력이 가해지고 있는 반면 운영 비용은 치솟고 있습니다. 규제 요건의 복잡성, 블록버스터 약품의 특허 만료로 인한 수익 감소, 정부와 의료 보험사의 의료 비용 절감 압력으로 인해 의료 산업에 추가적인 과제가 제기되었습니다. 이러한 어려움을 감안하여 제약회사는 전문적인 외부 소스가 제공하는 전문 지식과 함께 자원을 활용할 필요성을 깨달았습니다. 많은 고급 규제 컨설팅 회사는 전체 제품 수명주기에 걸쳐 전문 지식을 제공하고 있습니다. 규제 업무를 아웃소싱하면 후원자는 경험을 쌓고 비용을 최적화하며 생산성을 향상시킬 수 있습니다. 규제 아웃소싱 회사는 규제 요구 사항을 평가할 수 있는 더 나은 위치에 있으므로 최상의 솔루션을 선택할 수 있습니다. 이들은 규제 출판 시스템의 구현, 운영 및 유지 관리와 관련된 이해에 정통합니다. 대부분의 대형 제약 및 생명공학 기업은 규제 및 약물 감시 서비스 지원도 제공할 수 있는 컨설팅 회사를 찾고 있습니다.

규제 서류 제출의 복잡성이 증가함에 따라 전문 CRO 전문 지식에 대한 수요가 더욱 커지고 있습니다. 제품 개발 초기 단계에서 의료 규제 준수 조치와 함께 제품별 규제 조언 및 전략을 계획하는 것은 제품의 규제 승인을 위해 매우 중요합니다. 개발 초기 단계에서 규정 준수 문제를 해결하지 못하면 부적절하게 제출된 문서, 제조 감독, 규제 연구 생략 및 기타 규제 요구 사항 충족 실패로 인해 승인 프로세스가 지연되는 경우가 많습니다. 이제 의료 기업은 핵심 역량에 집중하고 비핵심 기능은 아웃소싱하여 생산성과 운영 효율성을 향상시키고 있습니다. 그들은 일반적으로 아시아 태평양 및 MEA와 같은 신흥 시장에서 운영되는 CRO에 규제 기능을 아웃소싱하여 운영 비용을 절감하고 R&D 활동 및 기존 제품과 같은 핵심 기능에 대한 집중을 강화할 수 있습니다. 판매 및 유통.

서비스 유형 기반 통찰력

서비스 유형에 따라 의료 규제 업무 아웃소싱 시장은 규제 및 amp; 과학 전략 개발, 의료 & 과학 글쓰기, eCTD & 전자 제출, 데이터 관리 서비스, 수명주기 관리 서비스, 약물 감시, 화학 제조 및amp; 제어(CMC) 서비스, 규제 라벨링, 규제 삽화 서비스. 메디컬 & Scientific Writing 부문은 2021년에 더 큰 시장 점유율을 차지할 것으로 예상되며, 약물 감시 부문은 예측 기간 동안 더 높은 CAGR을 기록할 것으로 예상됩니다.

의료 규제 업무 아웃소싱 서비스 유형별 시장 – 2021년 및 2028년

최종 사용자 기반 통찰력

최종 사용자를 기반으로 의료 규제 업무 아웃소싱 시장은 제약 회사, 생명 공학 회사 및 의료 기기 회사로 분류됩니다. 제약 회사 부문은 2021년에 더 큰 시장 점유율을 차지할 것입니다. 제약 회사 부문의 시장은 2021년부터 2028년까지 더 높은 CAGR로 성장할 것으로 예상됩니다.

의료 규제 업무 아웃소싱 시장에서 활동하는 회사는 전 세계적으로 진화하는 고객 요구를 충족하기 위해 제품 혁신 전략을 채택하며 이를 통해 글로벌 시장에서 브랜드 이름을 유지할 수도 있습니다.

의료 규제 업무 아웃소싱 시장 – 서비스 유형별

  • 규제 및amp; 과학 전략 개발
  • 의료 및amp; 과학 글쓰기
  • eCTD & 전자 제출
  • 데이터 관리 서비스
  • 수명 주기 관리 서비스
  • 약물 감시
  • 화학 제조 및amp; 제어(CMC) 서비스
  • 규제 라벨링
  • 규제 삽화 서비스

의료 규제 업무 아웃소싱 시장 – 최종 사용자별

  • 제약 회사
  • 생명 공학 회사
  • 의료 기기 회사
    • 의료 기기 소프트웨어(SaMD)
    • 의료기기 재료 및amp; 생체재료
    • 의료기기 바이오마커 및 체외진단(IVD)
    • 물질 기반 의료기기
    • 복합 제품 의료기기(DDC)
    • < /ul>

    의료 규제 업무 아웃소싱 시장 – 지역별

    • 북미
      • 미국
      • 캐나다
      • 멕시코
    • < li>유럽
      • 프랑스
      • 독일
      • 이탈리아
      • 영국
      • 스페인
      • 나머지 유럽
    • 아시아 태평양(APAC)
      • 중국
      • 인도
      • 대한민국
      • 일본
      • 호주
      • 아시아 태평양 지역
    • 중동 및amp; 아프리카(MEA)
      • 남아프리카공화국
      • 사우디아라비아
      • UAE
      • 중동 및 기타 지역 아프리카
    • 남부 및amp; 중앙 아메리카(SCAM)
      • 브라질
      • 아르헨티나
      • 남미 및 중앙 아메리카 나머지 지역 

    회사 프로필

    • KLIFO
    • ProPharma Group
    • Arriello Ireland Ltd.
    • DRA CONSULTING OY
    • 아스팔리온 SL
    • 파렉셀 인터내셔널 코퍼레이션
    • IQVIA Inc.
    • Pharmalex Gmbh
    • ProductLife 그룹
    • Voisin Consulting Life Sciences(VCLS)
    • Azierta 계약 과학 지원 컨설팅
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What are healthcare regulatory affairs outsourcing?

Healthcare regulatory affairs mainly deal with the safety and efficacy of the product and other pharmaceutical agents. Medical writing and publishing of regulatory documentation prepared by experienced medical writers, quality control (QC) auditors, and publishers to develop high-quality documents for research projects regulatory submissions are among the services offered by healthcare regulatory affairs outsourcing. In addition, other regulatory outsourcing services include regulatory consulting, clinical trial applications, legal formalities, and guidelines, along with quality assurance and compliance.

What are the driving factors for the healthcare regulatory affairs outsourcing market across the globe?

Key factors that are driving the growth of this market are increasing regulatory pressure on healthcare companies and escalating demand for speedy approval of new products.

Which service type segment led the healthcare regulatory affairs outsourcing market?

The medical & scientific writing segment dominated the global anatomic pathology market and held the largest revenue share of 29.0% in 2021.

What are the restraining factors for the healthcare regulatory affairs outsourcing market across the globe?

Key factors that are restraining the growth of this market are dearth of skilled professionals and data breach and lack of calibration.

Which end user held the largest share in the healthcare regulatory affairs outsourcing market?

The pharmaceutical companies segment dominated the global healthcare regulatory affairs outsourcing market and accounted for the largest revenue share of 43.0% in 2021.

Who are the key players in the healthcare regulatory affairs outsourcing market?

The healthcare regulatory affairs outsourcing market majorly consists of the players such as Parexel International Corporation, IQVIA Inc., KLIFO, ProPharma Group, Arriello Ireland Ltd., DRA CONSULTING OY, Asphalion S.L, Pharmalex Gmbh, ProductLife Group, Voisin Consulting Life Sciences (VCLS), Azierta Contract Science Support Consulting among others.

What is the regional market scenario of healthcare regulatory affairs outsourcing?

Global healthcare regulatory affairs outsourcing market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa and South & Central America. In North America, the U.S. is the largest market for anatomic pathology. The US is estimated to hold the largest share in the healthcare regulatory affairs outsourcing market during the forecast period. The growth of the market can be because of rise in cases of chronic diseases such as cancer, and increase in healthcare expenditure in the country. In addition, presence of major market players coupled with large number of funding programs by the public agencies in the region stimulate the growth of healthcare regulatory affairs outsourcing market in North America. On the other hand, enormous number of ongoing developments and innovations in healthcare, and rising spending capabilities in the Asia Pacific is expected to account for the fastest growth of the region during the coming years.

The List of Companies - Healthcare Regulatory Affairs Outsourcing Market

  1. KLIFO
  2. ProPharma Group
  3. Arriello Ireland Ltd.
  4. DRA CONSULTING OY
  5. Asphalion S.L.
  6. Parexel International Corporation
  7. IQVIA Inc.
  8. Pharmalex Gmbh
  9. ProductLife Group
  10. Voisin Consulting Life Sciences (VCLS)
  11. Azierta Contract Science Support Consulting

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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