[Forschungsbericht]Der Outsourcing-Markt für regulatorische Angelegenheiten im Gesundheitswesen wird bis 2028 voraussichtlich 14.996,35 Millionen US-Dollar erreichen, gegenüber 7.274,73 Millionen US-Dollar im Jahr 2021; Von 2021 bis 2028 wird ein durchschnittliches jährliches Wachstum von 10,9 % erwartet.
Der zunehmende regulatorische Druck auf Gesundheitsunternehmen und die zunehmende Nachfrage nach einer schnellen Zulassung neuer Produkte. Allerdings bremst der Mangel an qualifizierten Fachkräften das Wachstum des Outsourcing-Marktes für regulatorische Angelegenheiten im Gesundheitswesen. Beim Outsourcing von Regulatory Affairs handelt es sich um Dienstleistungen, die der Pharma-, Biotech- und Medizingeräteindustrie angeboten werden. Outsourcing-Dienstleistungen für regulatorische Angelegenheiten helfen dabei, schnelle behördliche Genehmigungen zu erhalten. Die Outsourcing-Branche für regulatorische Angelegenheiten hilft dabei, die Zulassung neuer Produkte zu erhalten, Protokolle für die Durchführung klinischer Studien vorzubereiten, Berichte zu veröffentlichen usw. Die Nachfrage nach verschiedenen Dienstleistungen wie regulatorischer Beratung, medizinischem Schreiben und Veröffentlichung der regulatorischen Dokumentation, Anträgen für klinische Studien usw. steigt Regulierungsberatung und Rechtsvertretung, Patentanmeldung, Produktregistrierung und Anträge auf klinische Studien haben zu einem Anstieg der Akzeptanz des Outsourcing-Geschäfts für regulatorische Angelegenheiten im Gesundheitswesen geführt.
Strategische Einblicke
Lukrative Regionen für Markt für Outsourcing von regulatorischen Angelegenheiten im Gesundheitswesen
Markteinblicke
Zunehmender regulatorischer Druck auf Unternehmen im Gesundheitswesen Outsourcing-Markt für regulatorische Angelegenheiten im Gesundheitswesen Wachstum
Kontinuierliche Verbesserungen und Fortschritte bei traditionellen Arzneimittelentwicklungsansätzen stellen den Gesundheitssektor vor große Herausforderungen. Der Druck auf die Pharmaunternehmen und die Ärzteschaft ist enorm, die Kosten für verschreibungspflichtige Medikamente zu senken, während ihre Betriebskosten in die Höhe schießen. Die Komplexität der regulatorischen Anforderungen, rückläufige Einnahmen aufgrund des Patentschutzes für Blockbuster-Medikamente und der Druck von Regierungen und Krankenversicherern, die Gesundheitskosten zu senken, haben die Gesundheitsbranche vor zusätzliche Herausforderungen gestellt. Angesichts dieser Schwierigkeiten haben Pharmaunternehmen die Notwendigkeit erkannt, ihre Ressourcen zusammen mit dem Fachwissen spezialisierter externer Quellen zu nutzen. Viele erstklassige regulatorische Beratungsunternehmen bieten ihr Fachwissen über den gesamten Produktlebenszyklus hinweg an. Die Auslagerung regulatorischer Angelegenheiten kann es Sponsoren ermöglichen, Erfahrungen zu sammeln, Kosten zu optimieren und die Produktivität zu steigern. Regulatorische Outsourcing-Unternehmen sind besser in der Lage, regulatorische Anforderungen einzuschätzen und so die besten Lösungen auszuwählen. Sie verfügen über umfassende Kenntnisse im Zusammenhang mit der Implementierung, dem Betrieb und der Wartung eines regulatorischen Veröffentlichungssystems. Die meisten großen Pharma- und Biotechnologieunternehmen suchen nach Beratungsunternehmen, die auch unterstützende Regulierungs- und Pharmakovigilanzdienstleistungen anbieten können.
Die zunehmende Komplexität von Zulassungsanträgen unterstreicht die Nachfrage nach spezialisierter CRO-Expertise. Für die behördliche Zulassung der Produkte ist es äußerst wichtig, bereits in einem frühen Stadium der Produktentwicklung produktspezifische regulatorische Ratschläge und Strategien sowie Maßnahmen zur Einhaltung gesetzlicher Vorschriften im Gesundheitswesen zu planen. Wenn die Einhaltung der Konformität nicht in der frühen Entwicklungsphase berücksichtigt wird, führt dies oft zu Verzögerungen im Genehmigungsprozess aufgrund von nicht ordnungsgemäß eingereichten Dokumentationen, Versäumnissen bei der Herstellung, unterlassenen behördlichen Studien und anderen Versäumnissen bei der Erfüllung der behördlichen Anforderungen. Gesundheitsunternehmen konzentrieren sich jetzt auf ihre Kernkompetenzen und lagern nicht zum Kerngeschäft gehörende Funktionen aus, um die Produktivität und betriebliche Effizienz zu verbessern. Sie lagern Regulierungsfunktionen im Allgemeinen an CROs aus, die in Schwellenmärkten wie dem asiatisch-pazifischen Raum und der MEA tätig sind. Dadurch können sie auch ihre Betriebskosten senken und sich stärker auf Kernfunktionen wie F&E-Aktivitäten und bestehende Produkte konzentrieren. Vertrieb und Vertrieb.
Servicetypbasierte Einblicke
Basierend auf dem Servicetyp ist der Outsourcing-Markt für regulatorische Angelegenheiten im Gesundheitswesen in regulatorische und wissenschaftliche Strategieentwicklung, medizinisches und wissenschaftliches Schreiben, eCTD & E-Einreichungen, Datenverwaltungsdienste, Lebenszyklusmanagementdienste, Pharmakovigilanz, Chemistry Manufacturing & Controls (CMC)-Dienste, behördliche Kennzeichnung, behördliche Grafikdienste. Es wird erwartet, dass das Segment Medical & Scientific Writing im Jahr 2021 einen größeren Marktanteil halten wird, und das Segment Pharmakovigilanz wird voraussichtlich im Prognosezeitraum eine höhere CAGR verzeichnen.
Outsourcing-Markt für regulatorische Angelegenheiten im Gesundheitswesen, nach Dienstleistungstyp 2021 und 2028
Endbenutzerbasierte Erkenntnisse
Basierend auf dem Endbenutzer ist der Outsourcing-Markt für regulatorische Angelegenheiten im Gesundheitswesen in Pharmaunternehmen, Biotechnologieunternehmen und unterteilt Unternehmen für medizinische Geräte. Das Segment Pharmaunternehmen würde im Jahr 2021 einen größeren Marktanteil ausmachen. Es wird geschätzt, dass der Markt für das Segment Pharmaunternehmen von 2021 bis 2028 mit einer höheren CAGR wachsen wird.
Unternehmen, die im Outsourcing-Markt für regulatorische Angelegenheiten im Gesundheitswesen tätig sind übernehmen die Produktinnovationsstrategie, um den sich entwickelnden Kundenanforderungen weltweit gerecht zu werden, was ihnen auch ermöglicht, ihren Markennamen auf dem globalen Markt zu behaupten.
Outsourcing-Markt für regulatorische Angelegenheiten im Gesundheitswesen nach Servicetyp
- Entwicklung regulatorischer und wissenschaftlicher Strategien
- Medizinisches und wissenschaftliches Schreiben
- eCTD & elektronische Einreichungen
- Datenmanagement-Dienste
- Lebenszyklus-Management-Dienste
- Pharmakovigilanz
- Chemistry Manufacturing & Controls (CMC)-Dienste
- Regulatorische Kennzeichnung
- Regulatorische Grafikdienstleistungen
Markt für Outsourcing regulatorischer Angelegenheiten im Gesundheitswesen nach Endbenutzer
- Pharmaunternehmen< /li>
- Biotechnologieunternehmen
- Unternehmen für medizinische Geräte
- Software für medizinische Geräte (SaMD)
- Materialien und Biomaterialien für medizinische Geräte
- Medizin Gerätebiomarker und In-vitro-Diagnostik (IVD)
- Medizinprodukt auf Substanzbasis
- Medizinprodukt oder Kombinationsprodukt (DDC)
- Nordamerika
- USA
- Kanada
- Mexiko
- Europa
- Frankreich
- Deutschland
- Italien
- Großbritannien
< li>Spanien - Restliches Europa
- Asien-Pazifik (APAC)
- China
- Indien
- Südkorea
- Japan
- Australien
- Übriger Asien-Pazifik
- Mitte Osten und Afrika (MEA)
- Südafrika
- Saudi-Arabien
- VAE
- Übriger Naher Osten und Afrika
- Süd- und Mittelamerika (SCAM)
- Brasilien
- Argentinien
- Übriges Süd- und Mittelamerika
Outsourcing-Markt für regulatorische Angelegenheiten im Gesundheitswesen nach Geografie
Unternehmensprofile
- KLIFO
- ProPharma Group
- 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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