Mercado global de outsourcing de assuntos regulamentares – Tendências do setor e previsão para 2030

Análise e dimensão do mercado de outsourcing de assuntos regulamentares

Um aumento significativo dos custos fixos de recursos internos para assuntos regulamentares e atividades operacionais como formação, tecnologia, conhecimento especializado e instalações é o principal fator impulsionador para o mercado de externalização de assuntos regulamentares. O número crescente de ensaios clínicos é também um fator impulsionador para o mercado de externalização de assuntos regulamentares. A melhoria do processo com foco nas atividades de pré e pós-marketing e a redução do custo dos serviços regulamentares é uma oportunidade para o mercado de outsourcing de assuntos regulamentares.

O risco associado à segurança dos dados e ao acesso ao sistema é um grande desafio para o mercado de outsourcing de assuntos regulamentares. No entanto, a perda de controlo e os avanços tecnológicos que levam a flutuações de preços são a principal restrição no crescimento do mercado de externalização de assuntos regulamentares durante o período de previsão.          

A Data Bridge Market Research analisa que o mercado de outsourcing de assuntos regulamentares, que era de 9.389,20 milhões de dólares em 2022, subiria para 15.312,19 milhões de dólares até 2030, e deverá passar por um CAGR de 10,66% durante o período de previsão. A “oncologia” domina o segmento de indicação do mercado de externalização de assuntos regulamentares devido ao aumento da prevalência do cancro. Além dos insights sobre cenários de mercado, tais como valor de mercado, taxa de crescimento, segmentação, cobertura geográfica e grandes players, os relatórios de mercado com curadoria da Data Bridge Market Research incluem também análise especializada aprofundada, epidemiologia de pacientes, análise de pipeline, análise de preços, e quadro regulamentar.

Âmbito e segmentação do mercado de outsourcing de assuntos regulamentares

Definição de mercado

A externalização de assuntos regulamentares são os serviços utilizados pelas empresas farmacêuticas, de biotecnologia e pelos fabricantes de dispositivos médicos para obter aprovações regulamentares rápidas de várias organizações. A regulamentação envolve principalmente testes extensivos de um determinado produto para garantir a proteção da saúde pública, autorização de comercialização, importação e distribuição e atender à segurança e desempenho do produto, o participante do mercado garante que o produto cumpre todos os requisitos regulamentares.

Dinâmica do mercado de outsourcing de assuntos regulamentares

Motoristas

• Aumento da complexidade regulatória

Os requisitos regulamentares em indústrias como a farmacêutica, a biotecnologia e os dispositivos médicos estão a tornar-se mais complexos e diversificados. Esta complexidade leva as empresas a procurarem conhecimentos regulamentares especializados junto de parceiros de outsourcing para garantir a conformidade e navegar eficientemente pelas regulamentações em evolução.

• Rápidos avanços tecnológicos

Industries such as pharmaceuticals and medical devices continuously introduce innovative products and technologies. To keep up with the pace of innovation, companies rely on outsourcing partners with specialized knowledge to navigate regulatory hurdles efficiently and bring new products to market faster.

• Focus on Core Competencies 

Companies are increasingly recognizing the importance of focusing on their core competencies, such as research and development, manufacturing, and marketing. By outsourcing regulatory affairs, they can delegate regulatory tasks to experts and allocate more resources to their primary business activities.

• Flexibility and Scalability

The outsourcing model provides flexibility and scalability to adapt to changing regulatory needs. Companies can scale their regulatory operations up or down based on project requirements, allowing for efficient resource allocation.  

Opportunities

• Expanding Pharmaceutical and Healthcare Industries

The pharmaceutical and healthcare sectors are experiencing rapid growth globally, driven by an aging population, increasing healthcare expenditures, and the development of innovative therapies and medical devices. This growth creates a substantial opportunity for regulatory affairs outsourcing as companies seek efficient ways to navigate complex regulatory landscapes and bring products to market faster.

• Adoption of Advanced Technologies

The adoption of advanced technologies, such as artificial intelligence (AI) and data analytics, can enhance regulatory affairs processes. Outsourcing providers can leverage these technologies to streamline regulatory data management, submissions, and compliance, offering innovative solutions to clients.

Restraints/Challenges

• Confidentiality and Data Security Concerns

Regulatory affairs often involve sensitive and confidential data, including proprietary product information and clinical trial data. Companies may be hesitant to outsource these activities due to concerns about data security, confidentiality breaches, and intellectual property protection.

• Quality Control Challenges

Maintaining consistent quality standards and oversight can be challenging when outsourcing regulatory affairs. Companies may worry about the level of control they have over regulatory processes and whether outsourced providers can maintain the same quality and compliance standards.

• Changing Regulatory Landscapes

Regulatory environments are constantly evolving, with new regulations and guidelines being introduced in various regions and industries. Keeping up with these changes and ensuring compliance across multiple jurisdictions can be a significant challenge for outsourcing providers and their clients.

• Data Privacy and Security

Handling sensitive regulatory data, including clinical trial information and patient data, requires strict adherence to data privacy regulations like GDPR in Europe. Ensuring the security and privacy of data across borders and during the outsourcing process is a complex challenge.

This regulatory affairs outsourcing market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the regulatory affairs outsourcing market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Development

• In February 2021, ICON plc acquired PRA Health Sciences, Inc. in a cash and stock transaction valued at approximately USD 12 billion. This acquisition has strengthened the medical affairs service offering of the company
• In August 2021, ProPharma Group acquired India-based iSafety Systems. This acquisition is expected to strengthen ProPharma Group’s position as the prime global provider of regulatory and compliance consulting, pharmacovigilance, clinical research services, and medical information

Global Regulatory Affairs Outsourcing Market Scope

The regulatory affairs outsourcing market is segmented on the basis of service outlook, size, category, indication, stage and end-user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Service Outlook

• Regulatory Consulting
• Legal Representation
• Regulatory Writing and Publishing
• Product Registration
• Clinical Trial Applications
• Other Services

Size

• Small
• Medium
• Large

Category

• Drugs
• Generics
• Innovators
• Biologics
• Biotech
• ATMPs
• Medical Devices
• Therapeutic
• Diagnostic

Indication

• Oncology
• Neurology
• Cardiology
• Immunology
• Others

Stage

• Preclinical
• Clinical
• PMA (Post Market Authorization)

End-User

• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies

Regulatory Affairs Outsourcing Market Regional Analysis/Insights

The regulatory affairs outsourcing market is analysed and market size insights and trends are provided by service outlook, size, category, indication, stage and end-user as referenced above.

The countries covered in the regulatory affairs outsourcing market report are U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia- Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, U.A.E., Egypt, Israel, Rest of Middle East and Africa.

North America is likely to lead the regulatory affairs outsourcing market. The regional market has been driven by the low costs of labour increased availability of a skilled workforce and increasing number of clinical trials and a rising number of companies trying to enter markets. However, growing market with new players is the main factor propelling the growth of the regional market. The market in Asia-Pacific is expected to exhibit a substantial growth rate during the forecast period 2023 to 2030 due to growing number of regulatory affairs out-sourcing companies and availability of skilled workforce.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and up-stream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Competitive Landscape and Regulatory Affairs Outsourcing Market Share Analysis

The regulatory affairs outsourcing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the company’s focus related to regulatory affairs outsourcing market.

Some of the major players operating in the regulatory affairs outsourcing market are:

• Accell Clinical Research, LLC (U.S.)
• Genpact (U.S.)
• CRITERIUM, INC. (U.S.)
• PRA Health Sciences (U.S.)
• Promedica International(U.S.)
• WuXiAppTec (China)
• Medpace (U.S.)
• PPD Inc. (U.S.)
• Charles River Laboratories (U.S.)
• ICON plc (U.S.)
• Covance (U.S.)
• Parexel International Corporation. (U.S.)
• Freyr, Navitas Clinical Research, Inc. (U.S.)
• Medelis, Inc. (U.S.)
• Sciformix (U.S.)
• Tech Tammina(U.S.)
• Acorn Regulatory Consultancy Services Ltd. (Ireland)
• BIOMAPAS (Lithuania)
• REGULATORY PROFESSIONALS (Australia)
• CompareNetworks, Inc. (EUA),    

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