[Rapporto di ricerca] Si prevede che il mercato dell'outsourcing degli affari regolatori sanitari raggiungerà i 14.996,35 milioni di dollari entro il 2028 rispetto ai 7.274,73 milioni di dollari del 2021; si prevede che crescerà a un CAGR del 10,9% dal 2021 al 2028.
La crescente pressione normativa sulle aziende sanitarie e la crescente domanda di rapida approvazione di nuovi prodotti. Tuttavia, la carenza di professionisti qualificati sta frenando la crescita del mercato dell’outsourcing degli affari normativi nel settore sanitario. L'outsourcing degli affari regolatori è l'insieme dei servizi offerti ai settori farmaceutico, biotecnologico e manifatturiero di dispositivi medici. I servizi di outsourcing degli affari normativi aiutano a ottenere rapidamente approvazioni normative. Le industrie di outsourcing degli affari normativi stanno aiutando a ottenere l'approvazione per nuovi prodotti, preparando protocolli per la conduzione di una sperimentazione clinica, pubblicando rapporti, ecc. Un aumento della domanda di vari servizi come consulenza normativa, scrittura medica e pubblicazione della documentazione normativa, domande di sperimentazione clinica e consulenza normativa e rappresentanze legali, richieste di brevetti, registrazione di prodotti e richieste di sperimentazioni cliniche hanno portato a un'impennata nell'adozione di attività di outsourcing degli affari normativi nel settore sanitario.
Approfondimenti strategici< /h3>Regioni redditizie per il mercato dell'outsourcing degli affari normativi nel settore sanitario
Approfondimenti di mercato
Crescente pressione normativa sulle aziende sanitarie Affari normativi nel settore sanitario Crescita del mercato dell'outsourcing
I continui aggiornamenti e progressi negli approcci tradizionali allo sviluppo dei farmaci stanno creando sfide significative nel settore sanitario. C’è un’enorme pressione sulle aziende farmaceutiche e sul mondo medico affinché riducano il costo dei farmaci soggetti a prescrizione, mentre i loro costi operativi sono alle stelle. La complessità dei requisiti normativi, il calo dei ricavi dovuto alla scadenza dei brevetti di farmaci di grande successo e la pressione da parte dei governi e degli assicuratori sanitari per la riduzione dei costi sanitari hanno presentato ulteriori sfide alle industrie sanitarie. Date queste difficoltà, le aziende farmaceutiche hanno capito la necessità di sfruttare le proprie risorse insieme alle competenze fornite da fonti esterne specializzate. Molte società di consulenza normativa di fascia alta offrono la propria esperienza durante l'intero ciclo di vita del prodotto. L’esternalizzazione degli affari normativi può consentire agli sponsor di acquisire esperienza, ottimizzare i costi e aumentare la produttività. Le società di outsourcing normativo sono in una posizione migliore per valutare i requisiti normativi, il che consente loro di selezionare le soluzioni migliori. Sono esperti nella comprensione associata all'implementazione, al funzionamento e al mantenimento di un sistema di pubblicazione regolamentare. La maggior parte delle grandi aziende farmaceutiche e biotecnologiche cercano società di consulenza che possano anche offrire servizi di supporto normativo e di farmacovigilanza.
La maggiore complessità delle registrazioni normative sottolinea la domanda di competenze specialistiche CRO. Avere pianificato consulenza e strategie normative specifiche per il prodotto, insieme a misure di conformità normativa sanitaria, nelle fasi iniziali dello sviluppo del prodotto è estremamente importante per l'approvazione normativa dei prodotti. Il mancato rispetto della conformità nella fase iniziale dello sviluppo spesso porta a ritardi nel processo di approvazione a causa di documentazioni archiviate in modo inappropriato, sviste di produzione, studi normativi omessi e altri inadempimenti nel soddisfare i requisiti normativi. Le aziende sanitarie si stanno ora concentrando sulle proprie competenze chiave ed esternalizzando le funzioni non core per migliorare la produttività e l’efficienza operativa. Generalmente esternalizzano le funzioni normative a CRO operanti nei mercati emergenti, come l'Asia Pacifico e l'area MEA, il che consente loro anche di ridurre i costi operativi e rafforzare la concentrazione su funzioni principali come le attività di ricerca e sviluppo e i prodotti esistenti. vendite e distribuzione.
Approfondimenti basati sul tipo di servizio
In base al tipo di servizio, il mercato dell'outsourcing degli affari normativi nel settore sanitario è segmentato in Regolamentazione e distribuzione. Sviluppo di strategie scientifiche, medicina e specializzazione Scrittura scientifica, eCTD & invii elettronici, servizi di gestione dei dati, servizi di gestione del ciclo di vita, farmacovigilanza, produzione chimica e amp; Servizi di controlli (CMC), etichettatura normativa, servizi di grafica normativa. Il Medical & Si prevede che il segmento della scrittura scientifica deterrà una quota di mercato maggiore nel 2021 e si prevede inoltre che il segmento della farmacovigilanza registrerà un CAGR più elevato durante il periodo di previsione.
Outsourcing per gli affari normativi nel settore sanitario Mercato, per tipo di servizio: 2021 e 2028
Approfondimenti basati sull'utente finale
In base all'utente finale, l'outsourcing degli affari normativi nel settore sanitario il mercato è segmentato in aziende farmaceutiche, aziende di biotecnologia e aziende di dispositivi medici. Il segmento delle aziende farmaceutiche rappresenterebbe una quota di mercato maggiore nel 2021. Si stima che il mercato per il segmento delle aziende farmaceutiche crescerà a un CAGR più elevato dal 2021 al 2028.
Le aziende che operano nel mercato dell'outsourcing degli affari regolatori sanitari adottano la strategia di innovazione dei prodotti per soddisfare le richieste in continua evoluzione dei clienti in tutto il mondo, il che consente loro anche di mantenere il proprio marchio nel mercato globale.
Mercato dell'outsourcing degli affari normativi nel settore sanitario: per tipo di servizio
- Normativa e di regolamentazione Sviluppo di strategie scientifiche
- Sviluppo medico e di ricerca Scrittura scientifica
- eCTD & invii elettronici
- Servizi di gestione dei dati
- Servizi di gestione del ciclo di vita
- Farmacovigilanza
- Produzione chimica e amp; Servizi di controllo (CMC)
- Etichettatura normativa
- Servizi di grafica normativa
Mercato dell'outsourcing degli affari normativi nel settore sanitario - per utente finale
- Aziende farmaceutiche
- Aziende di biotecnologia
- Aziende di dispositivi medici
- Software per dispositivi medici (SaMD)
- Materiali e amp; per dispositivi medici Biomateriali
- Biomarcatori di dispositivi medici e diagnostica in vitro (IVD)
- Dispositivi medici basati su sostanze
- Dispositivi medici di prodotti combinati (DDC) < /ul>
Mercato dell'outsourcing degli affari normativi nel settore sanitario: per area geografica
- Nord America
- Stati Uniti
- Canada
- Messico
< li>Europa - Francia
- Germania
- Italia
- Regno Unito
- Spagna
- Resto dell'Europa
- Asia Pacifico (APAC)
- Cina
- India
- Corea del Sud
- Giappone
- Australia
- Resto dell'Asia Pacifico
- Medio Oriente e Asia Africa (MEA)
- Sudafrica
- Arabia Saudita
- Emirati Arabi Uniti
- Resto del Medio Oriente e dell'Africa. Africa
- Sud e Africa America Centrale (SCAM)
- Brasile
- Argentina
- Resto dell'America centrale e meridionale
Profili aziendali
- KLIFO
- Gruppo ProPharma
- Arriello Ireland Ltd.
- DRA CONSULTING OY
- Asphalion SL
- Parexel International Corporation
- IQVIA Inc.
- Pharmalex Gmbh
- ProductLife Group
- Voisin Consulting Life Sciences (VCLS)
- Consulenza di supporto scientifico Azierta Contract
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
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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.
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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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