The global clinical trials support services market size was valued at USD 22.49 billion in 2023, driven by the rising demand for new and advanced drugs, treatment therapies, and medical devices across the globe. The market size is anticipated to grow at a CAGR of 7.1% during the forecast period of 2024-2032 to achieve a value of USD 41.70 billion by 2032. This significant growth trajectory underscores the critical role that clinical trial support services play in the pharmaceutical and biotechnology industries, facilitating the development and approval of innovative therapies that address unmet medical needs.
Global Clinical Trials Support Services Market Overview
Clinical trials support services encompass a wide range of activities that assist pharmaceutical, biotechnology, and medical device companies in conducting clinical trials efficiently and effectively. These services include clinical research organizations (CROs), data management, regulatory affairs, biostatistics, pharmacovigilance, and more. The primary objective is to ensure that clinical trials are conducted in compliance with regulatory standards, maintaining data integrity and patient safety.
Importance of Clinical Trials Support Services
Clinical trials are essential for the development of new medical treatments and therapies. They provide the necessary evidence to demonstrate the safety and efficacy of new drugs and medical devices before they reach the market. Support services streamline the clinical trial process, reducing time and costs while enhancing the quality of the trial outcomes. This efficiency is crucial in accelerating the availability of life-saving treatments to patients worldwide.
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Market Segmentation
The global clinical trials support services market is segmented based on service type, application, end-user, and region:
Service Type:
- Clinical Research Organizations (CROs)
- Data Management
- Regulatory Affairs
- Biostatistics
- Pharmacovigilance
- Other Services
Application:
- Pharmaceuticals
- Biotechnology
- Medical Devices
End-User:
- Pharmaceutical Companies
- Biotechnology Firms
- Medical Device Manufacturers
- Academic and Research Institutions
Region:
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa
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Global Clinical Trials Support Services Market Dynamics
Drivers
Rising Demand for New and Advanced Therapies: The continuous development of novel drugs and medical devices to address unmet medical needs is a primary driver. Innovations in areas such as oncology, neurology, and immunology require robust clinical trials to validate their efficacy and safety.
Increasing R&D Investments: Pharmaceutical and biotechnology companies are significantly investing in research and development (R&D) to discover and develop new treatments. This surge in R&D activities fuels the demand for comprehensive clinical trials support services.
Stringent Regulatory Requirements: Regulatory bodies like the FDA (Food and Drug Administration) and EMA (European Medicines Agency) have stringent guidelines for clinical trials. Compliance with these regulations necessitates specialized support services to navigate the complex regulatory landscape.
Globalization of Clinical Trials: The expansion of clinical trials to emerging markets in Asia-Pacific, Latin America, and other regions offers cost advantages and access to diverse patient populations. This globalization trend drives the need for localized clinical trials support services.
Technological Advancements: Innovations in data analytics, artificial intelligence (AI), and digital health technologies enhance the efficiency and accuracy of clinical trials. Advanced technologies enable better data management, patient monitoring, and trial design.
Restraints
High Costs of Clinical Trials: Conducting clinical trials is inherently expensive, with costs related to patient recruitment, data management, regulatory compliance, and site management. High costs can be a barrier, especially for smaller companies with limited budgets.
Complexity of Regulatory Approvals: Navigating the regulatory approval process is time-consuming and complex. Delays in approvals can hinder the progress of clinical trials and increase overall costs.
Patient Recruitment Challenges: Recruiting and retaining patients for clinical trials is a significant challenge. Low enrollment rates can lead to extended trial durations and increased expenses.
Data Privacy Concerns: Ensuring the privacy and security of patient data is paramount. Stringent data protection regulations, such as GDPR (General Data Protection Regulation) in Europe, impose additional compliance burdens on clinical trial support services.
Opportunities
Expansion in Emerging Markets: Emerging markets present substantial growth opportunities due to increasing healthcare infrastructure, rising R&D investments, and a growing patient pool.
Adoption of Decentralized Clinical Trials (DCTs): The shift towards decentralized or virtual clinical trials, which leverage digital technologies to conduct trials remotely, offers opportunities for innovation and efficiency in clinical trial support services.
Integration of AI and Machine Learning: AI and machine learning can optimize various aspects of clinical trials, including patient recruitment, data analysis, and predictive modeling. Integrating these technologies can enhance service offerings and improve trial outcomes.
Collaborations and Partnerships: Strategic alliances between CROs, technology providers, and pharmaceutical companies can drive innovation and expand service capabilities, fostering market growth.
Global Clinical Trials Support Services Market Trends
Decentralized Clinical Trials (DCTs)
Decentralized clinical trials involve conducting trials remotely, utilizing digital tools and technologies to engage participants outside traditional clinical settings. This approach increases accessibility, reduces participant burden, and accelerates trial timelines. The COVID-19 pandemic accelerated the adoption of DCTs, highlighting their potential to enhance flexibility and efficiency in clinical trials.
Artificial Intelligence and Machine Learning
AI and machine learning are transforming clinical trials by enabling predictive analytics, improving patient recruitment, and enhancing data management. These technologies facilitate the identification of suitable trial sites, optimize trial design, and streamline data analysis, leading to more efficient and cost-effective trials.
Personalized Medicine
The rise of personalized medicine, which tailors treatments based on individual genetic profiles and biomarkers, is driving the need for specialized clinical trial support services. Personalized clinical trials require sophisticated data management and analysis capabilities to handle complex genetic and molecular data.
Data Integration and Interoperability
Seamless integration and interoperability of data from various sources, including electronic health records (EHRs), wearable devices, and genomic databases, are critical for comprehensive data analysis in clinical trials. Advanced data integration solutions enhance data accuracy, reduce redundancies, and support real-time monitoring and decision-making.
Regulatory Harmonization
Efforts to harmonize regulatory standards across different regions are facilitating the globalization of clinical trials. Harmonized regulations streamline the approval process, reduce duplication of efforts, and enable more efficient trial execution across multiple jurisdictions.
Global Clinical Trials Support Services Market Segmentation
By Service Type
Clinical Research Organizations (CROs): CROs provide end-to-end management of clinical trials, including study design, site management, patient recruitment, data management, and regulatory compliance. They play a pivotal role in ensuring the successful execution of clinical trials.
Data Management: Data management services involve the collection, processing, and analysis of clinical trial data. These services ensure data integrity, accuracy, and compliance with regulatory standards.
Regulatory Affairs: Regulatory affairs services assist companies in navigating the complex regulatory landscape, ensuring compliance with local and international regulations, and facilitating the submission of regulatory documents.
Biostatistics: Biostatistics services provide statistical expertise for the design, analysis, and interpretation of clinical trial data. Accurate biostatistical analysis is crucial for determining the efficacy and safety of new therapies.
Pharmacovigilance: Pharmacovigilance services involve the monitoring and assessment of adverse events and side effects associated with clinical trial products. These services ensure patient safety and compliance with regulatory requirements.
Other Services: This category includes services such as project management, quality assurance, medical writing, and clinical trial logistics.
By Application
Pharmaceuticals: Clinical trials in the pharmaceutical sector focus on developing new drugs and therapies to treat various medical conditions. Support services in this sector ensure the successful development and approval of novel pharmaceuticals.
Biotechnology: Biotechnology clinical trials involve the development of biologic therapies, including monoclonal antibodies, gene therapies, and cell therapies. Specialized support services are required to handle the complexity of biologic data and regulatory requirements.
Medical Devices: Clinical trials for medical devices involve the testing of new devices to ensure their safety and efficacy. Support services in this sector include device testing, regulatory compliance, and data management.
By End-User
Pharmaceutical Companies: Pharmaceutical companies are major end-users of clinical trials support services, utilizing them to develop and bring new drugs to market.
Biotechnology Firms: Biotechnology firms rely on clinical trials support services to develop innovative biologic therapies and advanced medical treatments.
Medical Device Manufacturers: Manufacturers of medical devices utilize support services to conduct trials that validate the safety and effectiveness of their products.
Academic and Research Institutions: Academic and research institutions engage clinical trials support services for academic research, clinical studies, and collaborative projects with industry partners.
By Region
North America: North America dominates the global clinical trials support services market, driven by the presence of major pharmaceutical and biotechnology companies, advanced healthcare infrastructure, and favorable regulatory environments.
Europe: Europe is a significant market for clinical trials support services, supported by a robust pharmaceutical industry, stringent regulatory standards, and a strong emphasis on research and innovation.
Asia-Pacific: The Asia-Pacific region is experiencing rapid growth in the clinical trials support services market, fueled by increasing healthcare investments, a growing patient population, and expanding R&D activities.
Latin America: Latin America presents substantial growth opportunities due to improving healthcare infrastructure, rising R&D investments, and an increasing number of clinical trials conducted in the region.
Middle East & Africa: The Middle East & Africa region is emerging as a potential market for clinical trials support services, driven by investments in healthcare infrastructure and growing awareness of advanced medical treatments.
Global Clinical Trials Support Services Market Growth
Market Size and Forecast
The global clinical trials support services market was valued at USD 22.49 billion in 2023 and is projected to reach USD 41.70 billion by 2032, growing at a CAGR of 7.1% during the forecast period. This growth is driven by the increasing demand for new and advanced therapies, rising R&D investments, and the globalization of clinical trials.
Key Growth Drivers
Innovative Therapeutic Developments: The development of innovative therapies, including biologics, gene therapies, and personalized medicines, requires specialized clinical trials support services to ensure successful trial execution and regulatory compliance.
Expansion of Clinical Trial Sites: The expansion of clinical trial sites in emerging markets enhances the accessibility and diversity of patient populations, driving the demand for localized support services.
Adoption of Digital Technologies: The integration of digital technologies, such as electronic data capture (EDC), remote monitoring, and telemedicine, improves the efficiency and effectiveness of clinical trials, boosting the demand for advanced support services.
Collaborative Research Initiatives: Collaborative research initiatives between academic institutions, industry players, and government agencies foster innovation and drive the demand for comprehensive clinical trials support services.
Strategic Initiatives
Mergers and Acquisitions: Consolidation through mergers and acquisitions allows companies to expand their service offerings, enhance capabilities, and increase market share. For example, major CROs acquiring specialized firms to broaden their expertise in niche therapeutic areas.
Expansion of Service Offerings: Companies are continuously expanding their service portfolios to include end-to-end clinical trial management, data analytics, and regulatory consulting, catering to the evolving needs of their clients.
Investments in Technology: Significant investments in technology, including AI, machine learning, and data analytics platforms, enhance service efficiency and accuracy, driving market growth.
Recent Developments in Global Clinical Trials Support Services Market
Technological Innovations
Leading companies are investing in advanced technologies to streamline clinical trial processes. The adoption of AI and machine learning for predictive analytics, patient recruitment, and data management is enhancing the efficiency and accuracy of clinical trials.
Strategic Partnerships
Collaborations between CROs and technology firms are driving innovation in clinical trial support services. Strategic partnerships enable the integration of digital tools and data analytics capabilities, improving trial outcomes and operational efficiency.
Expansion into Emerging Markets
CROs are expanding their presence in emerging markets to capitalize on the growing demand for clinical trials in regions such as Asia-Pacific and Latin America. Establishing local offices and building regional expertise are key strategies for market expansion.
Regulatory Approvals
Regulatory bodies are continuously evolving their guidelines to facilitate faster approval processes for clinical trials. Streamlined regulatory pathways and harmonized standards are enhancing the ease of conducting multinational clinical trials, driving market growth.
Focus on Patient-Centric Trials
There is a growing emphasis on patient-centric clinical trials that prioritize patient convenience, engagement, and satisfaction. CROs are developing services that enhance patient recruitment and retention through personalized communication, remote monitoring, and flexible trial designs.
Global Clinical Trials Support Services Market Scope
Therapeutic Areas
Oncology: Oncology remains a major therapeutic area for clinical trials, driven by the high prevalence of cancer and the continuous development of targeted therapies and immunotherapies.
Cardiovascular Diseases: Clinical trials in cardiovascular diseases focus on developing treatments for heart disease, hypertension, and other related conditions, addressing a significant global health burden.
Neurology: Neurological disorders, including Alzheimer's disease, Parkinson's disease, and multiple sclerosis, are key areas for clinical trials, driven by the need for effective treatments and improved patient outcomes.
Infectious Diseases: The ongoing development of vaccines and therapies for infectious diseases, including COVID-19, drives the demand for clinical trials support services in this therapeutic area.
Rare Diseases: Clinical trials for rare diseases require specialized support services due to the unique challenges associated with patient recruitment, trial design, and regulatory compliance.
Geographic Scope
The global clinical trials support services market has a widespread geographic presence, with varying levels of adoption and growth across different regions. North America and Europe are mature markets with established healthcare infrastructures, while Asia-Pacific and other emerging regions offer significant growth opportunities due to expanding healthcare systems and increasing R&D investments.
End-Use Segments
Pharmaceutical Companies: Pharmaceutical companies are the primary end-users, leveraging clinical trials support services to develop and commercialize new drugs and therapies.
Biotechnology Firms: Biotechnology firms utilize support services to develop innovative biologic therapies and advanced medical treatments.
Medical Device Manufacturers: Medical device manufacturers engage clinical trials support services to validate the safety and efficacy of new devices.
Academic and Research Institutions: Academic and research institutions collaborate with industry partners, utilizing clinical trials support services for academic research and clinical studies.
Global Clinical Trials Support Services Market Analysis
Market Size and Forecast
With the market valued at USD 22.49 billion in 2023, the global clinical trials support services market is projected to reach USD 41.70 billion by 2032, growing at a CAGR of 7.1%. This robust growth is driven by the increasing demand for new and advanced therapies, technological advancements, and the globalization of clinical trials.
Competitive Landscape
The clinical trials support services market is highly competitive, characterized by the presence of numerous established CROs and emerging service providers. Key players are focusing on strategic initiatives such as mergers and acquisitions, partnerships, and technological innovations to enhance their service offerings and expand their market presence.
Key Players
IQVIA: IQVIA is a leading global CRO providing comprehensive clinical trial support services, including data analytics, technology solutions, and regulatory consulting.
LabCorp (Covance): LabCorp’s Covance division offers extensive clinical trial services, encompassing drug development, diagnostic services, and laboratory testing.
Parexel International: Parexel is a prominent CRO known for its expertise in clinical research, regulatory consulting, and data management services.
ICON plc: ICON provides a wide range of clinical trial support services, including site management, patient recruitment, and biostatistics.
PPD (Pharmaceutical Product Development): PPD offers end-to-end clinical trial services, from early-phase development to post-market surveillance.
Syneos Health: Syneos Health combines CRO services with commercialization expertise, providing integrated solutions for clinical trials and market access.
Charles River Laboratories: Charles River specializes in preclinical and clinical trial services, supporting drug discovery and development.
Medpace: Medpace offers comprehensive clinical trial management services, focusing on therapeutic expertise and operational excellence.
SWOT Analysis
Strengths:
- Extensive service portfolios covering all aspects of clinical trials.
- Strong global presence and established client relationships.
- Advanced technological capabilities enhancing trial efficiency.
Weaknesses:
- High operational costs associated with maintaining global infrastructure.
- Dependence on a limited number of large clients for revenue.
Opportunities:
- Expansion into emerging markets with growing clinical trial activities.
- Adoption of innovative technologies such as AI and machine learning.
- Diversification of service offerings to include specialized therapeutic areas.
Threats:
- Intense competition from both established CROs and new entrants.
- Regulatory changes and compliance challenges.
- Economic uncertainties impacting R&D budgets and clinical trial investments.
Porter's Five Forces Analysis
Threat of New Entrants: Moderate
- High barriers to entry due to the need for specialized expertise, regulatory compliance, and significant capital investments.
- However, technological advancements and the rise of niche CROs lower the barriers to entry for specialized services.
Bargaining Power of Suppliers: Low
- Suppliers mainly include technology providers and data management firms. The presence of multiple suppliers reduces their bargaining power.
Bargaining Power of Buyers: High
- Pharmaceutical and biotechnology companies have significant bargaining power due to their size and the critical nature of clinical trials support services.
Threat of Substitutes: Low to Moderate
- Limited substitutes exist for comprehensive clinical trials support services. However, in-house clinical trial capabilities can act as substitutes for some companies.
Industry Rivalry: High
- The market is highly competitive with numerous players vying for market share. Competition drives innovation but can also lead to price pressures.
COVID-19 Impact Analysis
The COVID-19 pandemic had a profound impact on the global clinical trials support services market, influencing both demand and operational dynamics.
Positive Impacts
Increased Demand for Clinical Trials: The urgent need for COVID-19 vaccines and treatments led to a surge in clinical trial activities, boosting demand for support services.
Acceleration of Digital Transformation: The pandemic accelerated the adoption of digital tools and technologies, such as virtual trials and remote monitoring, enhancing operational efficiency.
Enhanced Regulatory Flexibility: Regulatory bodies introduced expedited approval processes and flexible guidelines to facilitate the rapid development and approval of COVID-19 therapies and vaccines.
Global Collaboration: The pandemic fostered unprecedented global collaboration among pharmaceutical companies, CROs, and regulatory agencies, driving innovation and accelerating clinical trial timelines.
Negative Impacts
Operational Disruptions: Lockdowns, travel restrictions, and workforce shortages disrupted clinical trial operations, causing delays and increasing costs.
Supply Chain Challenges: Disruptions in the supply chain affected the availability of essential materials and equipment, impacting trial continuity.
Shift in Priorities: Non-COVID-19 related clinical trials faced delays as resources and attention were redirected towards pandemic-related research.
Economic Uncertainty: Economic downturns and budget constraints affected R&D investments, potentially limiting the initiation of new clinical trials.
Long-Term Implications
The pandemic has left a lasting imprint on the clinical trials support services market, leading to sustained changes in operational models and regulatory frameworks. The increased adoption of decentralized clinical trials, enhanced digital capabilities, and strengthened global collaborations are expected to shape the future trajectory of the market.
Key Players in the Global Clinical Trials Support Services Market
IQVIA
Overview: IQVIA is a global leader in clinical trials support services, offering a comprehensive range of solutions that integrate data, technology, and expertise. The company's extensive network and advanced analytics capabilities enable efficient and effective trial execution.
Key Services:
- Clinical trial management
- Data analytics and management
- Regulatory consulting
- Patient recruitment and engagement
Recent Developments: IQVIA has expanded its technology platform to incorporate AI and machine learning, enhancing its data analytics capabilities and improving trial outcomes.
LabCorp (Covance)
Overview: LabCorp’s Covance division is a prominent CRO providing end-to-end clinical trial support services. Covance leverages its global presence and extensive laboratory capabilities to deliver high-quality services.
Key Services:
- Drug development
- Laboratory testing
- Diagnostic services
- Clinical trial management
Recent Developments: Covance has invested in expanding its laboratory infrastructure and enhancing its diagnostic services to support a broader range of clinical trials.
Parexel International
Overview: Parexel is a leading CRO known for its expertise in clinical research and regulatory consulting. The company focuses on delivering innovative solutions that accelerate drug development and market access.
Key Services:
- Clinical trial management
- Regulatory affairs
- Data management
- Biostatistics
Recent Developments: Parexel has formed strategic partnerships with technology firms to integrate advanced digital tools into its clinical trial processes, enhancing efficiency and data accuracy.
ICON plc
Overview: ICON is a global CRO providing a wide array of clinical trial support services. The company is recognized for its innovative approach and commitment to improving trial efficiency and patient outcomes.
Key Services:
- Site management
- Patient recruitment
- Biostatistics
- Data management
Recent Developments: ICON has expanded its service offerings to include specialized solutions for decentralized clinical trials, catering to the evolving needs of the market.
PPD (Pharmaceutical Product Development)
Overview: PPD is a prominent CRO offering comprehensive clinical trial services from early-phase development to post-market surveillance. The company is dedicated to delivering high-quality, efficient, and compliant trial support.
Key Services:
- Clinical trial management
- Data analytics
- Regulatory consulting
- Pharmacovigilance
Recent Developments: PPD has invested in enhancing its data management capabilities, incorporating advanced analytics to support data-driven decision-making in clinical trials.
Syneos Health
Overview: Syneos Health is a leading CRO that combines clinical trial services with commercialization expertise. The company provides integrated solutions that span the entire drug development lifecycle.
Key Services:
- Clinical trial management
- Market access
- Data analytics
- Regulatory consulting
Recent Developments: Syneos Health has expanded its global footprint through strategic acquisitions, enhancing its service offerings and market reach.
Charles River Laboratories
Overview: Charles River Laboratories specializes in preclinical and clinical trial services, supporting drug discovery and development. The company is known for its comprehensive testing and laboratory services.
Key Services:
- Preclinical testing
- Clinical trial support
- Laboratory services
- Diagnostic testing
Recent Developments: Charles River has expanded its laboratory capabilities and invested in advanced testing technologies to support a broader range of clinical trials.
Medpace
Overview: Medpace is a global CRO offering comprehensive clinical trial management services. The company is committed to delivering high-quality, efficient, and compliant trial support tailored to client needs.
Key Services:
- Clinical trial management
- Data management
- Regulatory consulting
- Patient recruitment
Recent Developments: Medpace has enhanced its service offerings by integrating digital tools and advanced analytics, improving trial efficiency and data accuracy.
Other Notable Players
- Covance Inc.
- PPD, Inc.
- Parexel International Corp.
- Charles River Laboratories International, Inc.
- ICON plc
- Syneos Health Inc.
- Medpace Holdings, Inc.
- Worldwide Clinical Trials
- WuXi AppTec Co., Ltd.
These companies play a significant role in shaping the clinical trials support services market through continuous innovation, strategic partnerships, and extensive service portfolios.
Frequently Asked Questions (FAQs)
What are clinical trials support services?
Clinical trials support services encompass a range of activities and services provided to facilitate the planning, execution, and management of clinical trials. These services include clinical research organizations (CROs), data management, regulatory affairs, biostatistics, pharmacovigilance, and more, aimed at ensuring the efficient and compliant conduct of clinical trials.
Why are clinical trials support services important?
Clinical trials support services are crucial for the successful development and approval of new drugs and medical devices. They ensure that clinical trials are conducted efficiently, comply with regulatory standards, maintain data integrity, and prioritize patient safety. These services help accelerate the development process, reduce costs, and enhance the quality of trial outcomes.
What factors are driving the growth of the clinical trials support services market?
Key growth drivers include the rising demand for new and advanced therapies, increasing R&D investments by pharmaceutical and biotechnology companies, stringent regulatory requirements, globalization of clinical trials, and technological advancements such as AI and machine learning.
What are the major challenges faced by the clinical trials support services market?
Major challenges include the high costs associated with conducting clinical trials, complex regulatory approval processes, difficulties in patient recruitment and retention, and data privacy concerns. Additionally, operational disruptions caused by events like the COVID-19 pandemic can hinder market growth.
How has the COVID-19 pandemic impacted the clinical trials support services market?
The COVID-19 pandemic had both positive and negative impacts on the clinical trials support services market. It increased the demand for clinical trials related to COVID-19 therapies and vaccines, accelerated the adoption of digital technologies, and enhanced regulatory flexibility. However, it also caused operational disruptions, supply chain challenges, and delays in non-COVID-19 related trials.
What are biosimilars, and how do they impact the clinical trials support services market?
Biosimilars are biologic products that are highly similar to already approved biologics, with no significant differences in safety, purity, or potency. The development and approval of biosimilars drive the demand for clinical trials support services as companies conduct comparative studies to demonstrate biosimilarity and regulatory compliance.
Which regions are expected to witness the highest growth in the clinical trials support services market?
The Asia-Pacific region is expected to witness the highest growth due to increasing healthcare investments, a growing patient population, and expanding R&D activities. North America and Europe will continue to dominate the market, supported by advanced healthcare infrastructures and a strong presence of pharmaceutical and biotechnology companies.
Who are the key players in the clinical trials support services market?
Key players include IQVIA, LabCorp (Covance), Parexel International, ICON plc, PPD (Pharmaceutical Product Development), Syneos Health, Charles River Laboratories, and Medpace. These companies lead the market through innovation, strategic partnerships, and comprehensive service offerings.
What is the future outlook for the clinical trials support services market?
The clinical trials support services market is poised for robust growth, driven by ongoing advancements in biotechnology, increasing R&D investments, and the globalization of clinical trials. The adoption of digital technologies, decentralized trial models, and personalized medicine will further enhance market dynamics and create new opportunities for service providers.
How do clinical trials support services enhance patient recruitment and retention?
Clinical trials support services enhance patient recruitment and retention through targeted recruitment strategies, patient engagement programs, and the use of digital tools to streamline the enrollment process. Effective communication, personalized approaches, and flexible trial designs contribute to higher enrollment rates and better patient retention.
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