[Rapport de recherche]Le marché de l'externalisation des affaires réglementaires dans le domaine de la santé devrait atteindre 14 996,35 millions de dollars US d'ici 2028, contre 7 274,73 millions de dollars US en 2021 ; il devrait croître à un TCAC de 10,9 % de 2021 à 2028.
La pression réglementaire croissante sur les entreprises de soins de santé et la demande croissante d'approbation rapide de nouveaux produits. Cependant, la pénurie de professionnels qualifiés freine la croissance du marché de l'externalisation des affaires réglementaires de la santé. L'externalisation des affaires réglementaires est les services offerts aux industries pharmaceutiques, biotechnologiques et de fabrication de dispositifs médicaux. Les services d'externalisation des affaires réglementaires permettent d'obtenir des approbations réglementaires rapides. Les industries d'externalisation des affaires réglementaires aident à obtenir l'approbation de nouveaux produits, à préparer des protocoles pour la conduite d'un essai clinique, à publier des rapports, etc. Une augmentation de la demande pour divers services tels que la consultation réglementaire, la rédaction médicale et la publication de la documentation réglementaire, les demandes d'essai clinique et le conseil réglementaire et les représentations juridiques, les demandes de brevet, l'enregistrement de produits et les demandes d'essais cliniques ont entraîné une forte augmentation de l'adoption de l'externalisation des affaires réglementaires dans le domaine de la santé.
Perspectives stratégiques
Des régions lucratives pour Marché de l'externalisation des affaires réglementaires de la santé
Aperçu du marché
La pression réglementaire croissante sur les entreprises de santé Croissance du marché de l'externalisation des affaires réglementaires de la santé
Les mises à niveau et les progrès continus dans les approches traditionnelles de développement de médicaments créent des défis importants dans le secteur de la santé. Il y a une énorme pression sur les sociétés pharmaceutiques et la fraternité médicale pour réduire le coût des médicaments sur ordonnance, alors que leurs coûts opérationnels montent en flèche. La complexité des exigences réglementaires, la baisse des revenus due à la suppression du brevet des médicaments phares et la pression exercée par les gouvernements et les assureurs maladie pour réduire les coûts des soins de santé ont présenté des défis supplémentaires aux industries de la santé. Face à ces difficultés, les laboratoires pharmaceutiques ont pris conscience de la nécessité d'associer leurs ressources à l'expertise apportée par des sources externes spécialisées. De nombreuses sociétés de conseil en réglementation haut de gamme proposent leur expertise tout au long du cycle de vie du produit. L'externalisation des affaires réglementaires peut permettre aux promoteurs d'acquérir de l'expérience, d'optimiser les coûts et d'améliorer la productivité. Les entreprises d'externalisation réglementaire sont mieux placées pour évaluer les exigences réglementaires, ce qui leur permet de sélectionner les meilleures solutions. Ils connaissent bien la compréhension associée à la mise en uvre, à l'exploitation et à la maintenance d'un système de publication réglementaire. La plupart des grandes sociétés pharmaceutiques et biotechnologiques recherchent des sociétés de conseil qui peuvent également offrir des services de soutien en matière de réglementation et de pharmacovigilance.
La complexité accrue des dépôts réglementaires souligne la demande d'expertise spécialisée en CRO. Avoir planifié des conseils et des stratégies réglementaires spécifiques aux produits, ainsi que des mesures de conformité réglementaire en matière de soins de santé, à un stade précoce du développement du produit, est extrêmement important pour l'approbation réglementaire des produits. Le non-respect de la conformité au stade précoce du développement entraîne souvent des retards dans le processus d'approbation en raison de documents classés de manière inappropriée, d'oublis de fabrication, d'études réglementaires omises et d'autres manquements aux exigences réglementaires. Les entreprises de soins de santé se concentrent désormais sur leurs compétences de base et externalisent les fonctions non essentielles pour améliorer la productivité et l'efficacité opérationnelle. Ils externalisent généralement les fonctions réglementaires à des CRO opérant sur les marchés émergents, tels que l'Asie-Pacifique et la MEA, ce qui leur permet également de réduire leurs coûts opérationnels et de se concentrer davantage sur les fonctions essentielles telles que les activités de R&D et les produits existants’ ventes et distribution.
Informations basées sur le type de service
En fonction du type de service, le marché de l'externalisation des affaires réglementaires de la santé est segmenté en développement de stratégie réglementaire et scientifique, rédaction médicale et scientifique, eCTD et Soumissions électroniques, services de gestion des données, services de gestion du cycle de vie, pharmacovigilance, services de fabrication et de contrôle des produits chimiques (CMC), étiquetage réglementaire, services d'illustrations réglementaires. Le segment de la rédaction médicale et scientifique devrait détenir une plus grande part de marché en 2021, et le segment de la pharmacovigilance devrait en outre enregistrer un TCAC plus élevé au cours de la période de prévision.
Marché de l'externalisation des affaires réglementaires en santé, par type de service - 2021 et 2028
Insights basés sur l'utilisateur final
En fonction de l'utilisateur final, le marché de l'externalisation des affaires réglementaires de la santé est segmenté en sociétés pharmaceutiques, sociétés de biotechnologie et Entreprises de dispositifs médicaux. Le segment des sociétés pharmaceutiques représenterait une part de marché plus importante en 2021. Le marché du segment des sociétés pharmaceutiques devrait croître à un TCAC plus élevé de 2021 à 2028.
Entreprises opérant sur le marché de l'externalisation des affaires réglementaires en santé adopter la stratégie d'innovations de produits pour répondre à l'évolution des demandes des clients dans le monde entier, ce qui leur permet également de maintenir leur marque sur le marché mondial.
Marché de l'externalisation des affaires réglementaires dans le domaine de la santé - par type de service
- Développement de la stratégie réglementaire et scientifique
- Rédaction médicale et scientifique
- eCTD & e-Submissions
- Services de gestion des données
- Services de gestion du cycle de vie
- Pharmacovigilance
- Services de fabrication et de contrôle des produits chimiques
- Étiquetage réglementaire
- Services d'illustrations réglementaires
li>
Marché de l'externalisation des affaires réglementaires dans le domaine de la santé - par utilisateur final
- Sociétés pharmaceutiques< /li>
- Entreprises de biotechnologie
- Entreprises de dispositifs médicaux
- Logiciels pour dispositifs médicaux (SaMD)
- Matériaux et biomatériaux pour dispositifs médicaux
- Médical Biomarqueurs de dispositifs et diagnostics in vitro (IVD)
- Dispositif médical basé sur une substance
- Dispositif médical de produit combiné (DDC)
- Amérique du Nord
- États-Unis
- Canada
- Mexique
- Europe
- France
- Allemagne
- Italie
- Royaume-Uni
< li>Espagne - Reste de l'Europe
- Asie-Pacifique (APAC)
- Chine
- Inde
- Corée du Sud
- Japon
- Australie
- Reste de l'Asie-Pacifique
- Moyen Est et Afrique (MEA)
- Afrique du Sud
- Arabie saoudite
- EAU
- Reste du Moyen-Orient et Afrique
- Amérique du Sud et centrale (SCAM)
- Brésil
- Argentine
- Reste de l'Amérique du Sud et centrale
Marché de l'externalisation des affaires réglementaires dans le domaine de la santé - par zone géographique
Profils d'entreprise
- KLIFO
- Groupe ProPharma
- Arriello Ireland Ltd.
- DRA CONSULTING OY
- Asphalion SL
- Parexel International Corporation
- IQVIA Inc.
- Pharmalex Gmbh
- ProductLife Group
- Voisin Consulting Life Sciences (VCLS)
- Azierta Contract Science Support Consulting
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
This text is related
to country scope.
Frequently Asked Questions
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.
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.
The medical & scientific writing segment dominated the global anatomic pathology market and held the largest revenue share of 29.0% in 2021.
Key factors that are restraining the growth of this market are dearth of skilled professionals and data breach and lack of calibration.
The pharmaceutical companies segment dominated the global healthcare regulatory affairs outsourcing market and accounted for the largest revenue share of 43.0% in 2021.
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.
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
- KLIFO
- ProPharma Group
- Arriello Ireland Ltd.
- DRA CONSULTING OY
- Asphalion S.L.
- Parexel International Corporation
- IQVIA Inc.
- Pharmalex Gmbh
- ProductLife Group
- Voisin Consulting Life Sciences (VCLS)
- 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.
- 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.
- 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:
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.
- 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.
- 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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