ヘルスケア規制業務アウトソーシング市場 - 2031年の成長予測、統計および事実

  • Report Code : TIPRE00007611
  • Category : Healthcare IT
  • Status : Published
  • No. of Pages : 192
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[調査レポート] 医療規制業務アウトソーシング市場は、2021 年の 72 億 7,473 万米ドルから 2028 年までに 149 億 9,635 万米ドルに達すると予測されています。 2021 年から 2028 年にかけて 10.9 % の CAGR で成長すると予想されています。

ヘルスケア企業に対する規制の圧力が増大し、新製品の迅速な承認を求める需要が高まっています。しかし、熟練した専門家の不足により、医療規制業務アウトソーシング市場の成長が抑制されています。薬事アウトソーシングは、製薬、バイオテクノロジー、医療機器製造業界向けに提供されるサービスです。規制関連業務のアウトソーシング サービスは、規制当局の迅速な承認の実現に役立ちます。薬事アウトソーシング業界は、新製品の承認取得、臨床試験実施のためのプロトコールの作成、報告書の発行などを支援しています。薬事相談、メディカルライティング、薬事文書の発行、臨床試験申請書、治験申請書などのさまざまなサービスに対する需要が増加しています。規制コンサルティングと法的代理、特許出願、製品登録、臨床試験申請などの分野で、医療規制業務アウトソーシング ビジネスの採用が急増しています。


戦略的洞察< /h3>

医療規制業務アウトソーシング市場にとって有利な地域


市場洞察

ヘルスケア企業に対する規制圧力の増大 ヘルスケア規制業務アウトソーシング市場の成長

従来の医薬品開発アプローチの継続的なアップグレードと進歩により、ヘルスケア分野に重大な課題が生じています。製薬会社や医療団体には、運営コストが急増する一方で、処方薬のコスト削減を求める多大なプレッシャーがかかっています。規制要件の複雑さ、大ヒット薬の特許切れによる収益の減少、医療費削減を求める政府や医療保険会社からの圧力などが、医療業界にさらなる課題をもたらしています。こうした困難を考慮して、製薬会社は自社のリソースと専門的な外部ソースから提供される専門知識を活用する必要性を認識しています。多くのハイエンド規制コンサルティング会社は、製品ライフサイクル全体にわたって専門知識を提供しています。規制業務のアウトソーシングにより、スポンサーは経験を積み、コストを最適化し、生産性を向上できる可能性があります。規制アウトソーシング企業は、規制要件を評価する上で有利な立場にあり、最適なソリューションを選択できます。彼らは、規制出版システムの実装、運用、保守に関連する知識に精通しています。大手製薬会社やバイオテクノロジー会社のほとんどは、規制や医薬品安全性監視サービスのサポートも提供できるコンサルティング会社に注目しています。

規制申請の複雑さの増大により、CRO の専門知識に対する需要が強調されています。製品開発の初期段階で、製品固有の規制上のアドバイスと戦略を医療規制遵守対策とともに計画することは、製品の規制上の承認にとって非常に重要です。開発の初期段階でコンプライアンスに対処できなかった場合、不適切に提出された文書、製造上の見落とし、規制調査の省略、その他の規制要件を満たさないことにより、承認プロセスの遅延が発生することがよくあります。ヘルスケア企業は現在、生産性と業務効率を向上させるために、コアコンピタンスに重点を置き、非コア機能をアウトソーシングしています。通常、アジア太平洋地域や中東アフリカなどの新興市場で活動する CRO に規制機能をアウトソーシングすることで、運営コストを削減し、研究開発活動や既存製品などの中核機能への注力を強化することもできます。

サービス タイプに基づく洞察

サービス タイプに基づいて、医療規制事務アウトソーシング市場は規制および流通に分類されます。科学戦略開発、医療および科学科学的執筆、eCTD、および電子申請、データ管理サービス、ライフサイクル管理サービス、ファーマコビジランス、化学製造および化学品の製造および販売コントロール (CMC) サービス、規制ラベル、規制アートワーク サービス。医療と医療科学執筆部門は 2021 年にさらに大きな市場シェアを保持すると予想されており、ファーマコビジランス部門は予測期間中にさらに高い CAGR を記録すると予想されます。

ヘルスケア規制業務アウトソーシング市場、サービス タイプ別 - 2021 年と 2028 年

エンドユーザーベースの洞察

エンドユーザーに基づいた医療規制業務のアウトソーシング市場は製薬会社、バイオテクノロジー会社、医療機器会社に分割されています。 2021 年には、製薬会社セグメントがより大きな市場シェアを占めると予想されます。製薬会社セグメントの市場は、2021 年から 2028 年にかけてより高い CAGR で成長すると推定されています。

医療規制業務アウトソーシング市場で事業を展開する企業は、世界中で進化する顧客の需要に応えるための製品イノベーション戦略を採用しており、これにより世界市場でのブランド名を維持することも可能になります。

医療規制関連業務のアウトソーシング市場 –サービス タイプ別

  • 規制とサービス科学的戦略の開発
  • 医療と科学科学的執筆
  • eCTD と電子申請
  • データ管理サービス
  • ライフサイクル管理サービス
  • ファーマコビジランス
  • 化学製造および医薬品安全性監視コントロール (CMC) サービス
  • 規制ラベル表示
  • 規制アートワーク サービス

ヘルスケア規制業務アウトソーシング市場 –エンド ユーザー別

  • 製薬会社
  • バイオテクノロジー企業
  • 医療機器企業
    • 医療機器ソフトウェア (SaMD)
    • 医療機器材料および医療機器生体材料
    • 医療機器バイオマーカーおよび体外診断(IVD)
    • 物質ベースの医療機器
    • 複合製品(DDC)の医療機器
    • < /ul>

    医療規制業務アウトソーシング市場 –地理別

    • 北アメリカ
      • 米国
      • カナダ
      • メキシコ
    • < li>ヨーロッパ
      • フランス
      • ドイツ
      • イタリア
      • イギリス
      • スペイン
      • 残りヨーロッパ
    • アジア太平洋 (APAC)
      • 中国
      • インド
      • 韓国
      • 日本
      • オーストラリア
      • その他のアジア太平洋地域
    • 中東およびその他の地域
  • アフリカ (MEA)
    • 南アフリカ
    • サウジアラビア
    • UAE
    • 中東のその他の地域およびその他の地域アフリカ
  • 南部およびアフリカ中央アメリカ (SCAM)
    • ブラジル
    • アルゼンチン
    • その他の南中米 

会社概要

  • KLIFO
  • ProPharma Group
  • Arriello Ireland Ltd.
  • DRA CONSULTING OY
  • アスファリオン SL
  • パレクセル インターナショナル コーポレーション
  • IQVIA Inc.
  • Pharmalex Gmbh
  • ProductLife Group
  • Voisin Consulting Life Sciences (VCLS)
  • Azierta 契約科学サポート コンサルティング
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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