[Informe de investigación] Se proyecta que el mercado de subcontratación de asuntos regulatorios de atención médica alcanzará los 14.996,35 millones de dólares en 2028, desde los 7.274,73 millones de dólares de 2021; se espera que crezca a una tasa compuesta anual del 10,9 % de 2021 a 2028.
La creciente presión regulatoria sobre las empresas de atención médica y la creciente demanda de aprobación rápida de nuevos productos. Sin embargo, la escasez de profesionales capacitados está frenando el crecimiento del mercado de subcontratación de asuntos regulatorios de atención médica. La subcontratación de asuntos regulatorios son los servicios que se ofrecen a las industrias farmacéutica, biotecnológica y de fabricación de dispositivos médicos. Los servicios de subcontratación de asuntos regulatorios ayudan a lograr aprobaciones regulatorias rápidas. Las industrias de subcontratación de asuntos regulatorios están ayudando a obtener la aprobación de nuevos productos, preparando protocolos para realizar un ensayo clínico, publicando informes, etc. Un aumento en la demanda de diversos servicios como consultas regulatorias, redacción médica y publicación de documentación regulatoria, solicitudes de ensayos clínicos y La consultoría regulatoria y las representaciones legales, la solicitud de patentes, el registro de productos y las solicitudes de ensayos clínicos han dado como resultado un aumento en la adopción de negocios de subcontratación de asuntos regulatorios de atención médica.
Perspectivas estratégicas< /h3>regiones lucrativas para el mercado de subcontratación de asuntos regulatorios de atención médica
Perspectivas del mercado
Aumento de la presión regulatoria sobre las empresas de atención médica Asuntos regulatorios de atención médica Crecimiento del mercado de subcontratación
Las continuas actualizaciones y avances en los enfoques tradicionales de desarrollo de medicamentos están creando desafíos importantes en el sector de la salud. Existe una tremenda presión sobre las compañías farmacéuticas y la comunidad médica para que reduzcan el costo de los medicamentos recetados, mientras sus costos operativos se están disparando. La complejidad de los requisitos regulatorios, la disminución de los ingresos debido a la pérdida de patente de medicamentos de gran éxito y la presión de los gobiernos y de las aseguradoras de salud para reducir los costos de la atención médica han presentado desafíos adicionales para las industrias de la salud. Dadas estas dificultades, las empresas farmacéuticas se han dado cuenta de la necesidad de aprovechar sus recursos junto con la experiencia proporcionada por fuentes externas especializadas. Muchas empresas de consultoría regulatoria de alto nivel ofrecen su experiencia a lo largo de todo el ciclo de vida del producto. La subcontratación de asuntos regulatorios puede permitir a los patrocinadores ganar experiencia, optimizar costos y mejorar la productividad. Las empresas de subcontratación regulatoria están en mejor posición para evaluar los requisitos regulatorios, lo que les permite seleccionar las mejores soluciones. Están bien versados en la comprensión asociada con la implementación, operación y mantenimiento de un sistema de publicación regulatorio. La mayoría de las grandes empresas farmacéuticas y de biotecnología buscan empresas de consultoría que también puedan ofrecer servicios regulatorios y de farmacovigilancia de apoyo.
La creciente complejidad de las presentaciones regulatorias subraya la demanda de experiencia especializada en CRO. Tener planificados consejos y estrategias regulatorias específicas del producto, junto con medidas de cumplimiento regulatorio de atención médica, en las primeras etapas del desarrollo del producto es extremadamente importante para la aprobación regulatoria de los productos. No abordar el cumplimiento en la etapa inicial de desarrollo a menudo conduce a retrasos en el proceso de aprobación debido a documentación presentada incorrectamente, descuidos de fabricación, estudios regulatorios omitidos y otras fallas en el cumplimiento de los requisitos regulatorios. Las empresas de atención médica ahora se están centrando en sus competencias básicas y subcontratando las funciones no esenciales para mejorar la productividad y la eficiencia operativa. Por lo general, subcontratan funciones regulatorias a CRO que operan en mercados emergentes, como Asia Pacífico y MEA, lo que también les permite reducir sus costos operativos y fortalecer su enfoque en funciones centrales como actividades de I+D y productos existentes. ventas y distribución.
Información basada en el tipo de servicio
Según el tipo de servicio, el mercado de subcontratación de asuntos regulatorios de atención médica se segmenta en Regulatory & Desarrollo de estrategias científicas, médicas y científicas. Escritura científica, eCTD y Envíos electrónicos, servicios de gestión de datos, servicios de gestión del ciclo de vida, farmacovigilancia, fabricación y fabricación de productos químicos. Servicios de Controles (CMC), Etiquetado Regulatorio, Servicios de Arte Regulatorio. El médico y Se espera que el segmento de Escritura científica tenga una mayor participación de mercado en 2021, y se anticipa además que el segmento de Farmacovigilancia registre una CAGR más alta durante el período de pronóstico.
Externalización de asuntos regulatorios de atención médica Mercado, por tipo de servicio: 2021 y 2028
Información basada en el usuario final
Basada en el usuario final, la subcontratación de asuntos regulatorios de atención médica El mercado está segmentado en empresas farmacéuticas, empresas de biotecnología y empresas de dispositivos médicos. El segmento de empresas farmacéuticas representaría una mayor participación de mercado en 2021. Se estima que el mercado para el segmento de empresas farmacéuticas crecerá a una tasa compuesta anual más alta de 2021 a 2028.
Las empresas que operan en el mercado de subcontratación de asuntos regulatorios de atención médica adoptan la estrategia de innovación de productos para satisfacer las cambiantes demandas de los clientes en todo el mundo, lo que también les permite mantener su marca en el mercado global.
Mercado de subcontratación de asuntos regulatorios de atención médica: por tipo de servicio
- Reglamentario y Desarrollo de estrategias científicas
- Medical & Escritura científica
- eCTD & Presentaciones electrónicas
- Servicios de gestión de datos
- Servicios de gestión del ciclo de vida
- Farmacovigilancia
- Fabricación y fabricación de productos químicos Servicios de controles (CMC)
- Etiquetado regulatorio
- Servicios de ilustraciones regulatorias
Mercado de subcontratación de asuntos regulatorios de atención médica: por usuario final
- Empresas farmacéuticas
- Empresas de biotecnología
- Empresas de dispositivos médicos
- Software para dispositivos médicos (SaMD)
- Materiales y materiales para dispositivos médicos Biomateriales
- Biomarcadores de dispositivos médicos y diagnóstico in vitro (IVD)
- Dispositivo médico basado en sustancias
- Dispositivo médico de producto combinado (DDC) < /ul>
Mercado de subcontratación de asuntos regulatorios de atención médica: por Geografía
- América del Norte
- Estados Unidos
- Canadá
- México
< li>Europa - Francia
- Alemania
- Italia
- Reino Unido
- España
- Resto de Europa
- Asia Pacífico (APAC)
- China
- India
- Corea del Sur
- Japón
- Australia
- Resto de Asia Pacífico
- Medio Oriente y Asia África (MEA)
- Sudáfrica
- Arabia Saudita
- EAU
- Resto de Medio Oriente y África África
- Sur y África Centroamérica (SCAM)
- Brasil
- Argentina
- Resto de Sudamérica y Centroamérica
Perfiles de empresas
- KLIFO
- Grupo 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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