Key Takeaways IQV is set to report Q4 results on Feb. 5, with revenues expected at $4.2B and EPS of $3.40, up 9% y/y.IQV TAS and R&D units will likely rise 6.9% and 7.7%, respectively, on drug launches and a solid RFP pipeline.IQV's geographic growth outlook indicates y/y Asia-Pacific revenue growth of 9.4% to $882.6M.IQVIA Holdings Inc. (IQV) is set to release fourth-quarter 2025 results on Feb. 5, before market open.IQV has a decent earnings surprise history, having surpassed the Zacks Consensus Estimate ...

白皮书 欧洲生物类似药竞争的影响 2026年1月 MAX 牛顿, 总裁，全球战略合作伙伴，IQVIA 凯莉·斯托达特， 资深顾问，全球供应商与协会关系，IQVIA 奥雷利奥·阿里亚斯 全球思想领袖总监，艾昆纬 目录 引言1 | IQVIA观察 | 2 | | --- | --- | | 1. 管道 | 4 | | 2. 商业吸引力 | 6 | | 3. 国际竞争力 | 9 | | 4. 获取不平等 | 10 | | 5. 高级计划 | 14 | | 方法论 | 16 | | 国家和产品细分KPI | 18 | | 粒细胞集落刺激因子 (GCSF) | 18 | | 抗肿瘤坏死因子（抗TNF） | 20 | | 胰岛素22 | | | 肿瘤学 | 24 | | 甲状旁腺激素（特立帕肽） | 26 | | 眼科 28 | | | 附录 | 30 | | EMA批准的生物类似药清单 | 30 | | ema 审批中的生物类似药列表 | 36 | | 参考文献 | 37 | 关于作者 38 了解更多 39 引言 欧洲生物类似药竞争影响报告第11版在去年的出版物观点的基础上构建，并提供了对欧 洲生物类似药竞争即将到来的 ...

Report Summary 1. Report Industry Investment Rating - Not provided in the content. 2. Core Viewpoints - The RDEP represents a significant evolution in FDA's approach to ultra - rare disease drug development, emphasizing scientific flexibility and innovation while maintaining strict evidence standards [22]. - Success under the RDEP depends on strategic integration of real - world evidence, strong confirmatory evidence, and careful cooperation with regulatory agencies [24]. 3. Summary by Related Catalog RDEP Introduction - In September 2025, the FDA released the Rare Disease Evidence Principles (RDEP), a new review process for ultra - rare, genetically - defined diseases, aiming to provide more clarity and predictability [3]. - RDEP is built on the precedent of the FDA's 2023 draft guidance, using a well - controlled clinical study to prove effectiveness and provide confirmatory evidence [4]. Comparison with Existing Pathways - RDEP formalizes the FDA's previous practices in rare - disease approvals, and it supplements existing mechanisms like accelerated approval, orphan drug designation, and RDEA pilot by clarifying evidence expectations [7][8]. Eligibility for RDEP - RDEP aims to support therapy developers for diseases that meet all of the following conditions: a sponsor can prove a well - controlled study with strong evidence to establish effectiveness; the disease is caused by a known congenital genetic defect; the situation is critical, rapidly progressing, and there is no disease - modifying treatment; and fewer than 1000 patients in the US are affected [8]. Role of RWE - Before accessing the RDEP process, RWE can be used to confirm the ultra - rare prevalence threshold of a disease by combining medical claims, EHRs, genomic databases, and patient registries, and AI - driven analysis can further refine these estimates [11][12]. - Once in the RDEP process, RWE plays a core role in natural history studies, patient registries, external comparator arms, and expanded access data and case reports [15]. Patient - Centered Development - In ultra - rare diseases, patient - centered drug development is crucial, and natural history studies and registries, especially those co - designed with advocacy groups, help identify important functional changes for patients and caregivers [18]. Time Considerations - Before starting a critical trial, sponsors should submit an application to their existing IND for each protocol they want to be reviewed under RDEP, including reasonable evidence to meet the inclusion criteria and prove the drug's safety and effectiveness [21]. Conclusion - RDEP provides a customized pathway for programs less likely to meet traditional requirements, and cooperation is key to accelerating treatment for patients in need [23][24].

Core Insights - Medical device companies are transitioning from hardware vendors to data-driven service organizations, creating new revenue opportunities and enhancing value for healthcare providers through advanced analytics and AI integration [1][2]. Group 1: Medtronic - Medtronic is leveraging data analytics and AI to improve clinical outcomes and operational insights, integrating these technologies into its product ecosystem [7][9]. - The company uses AI to provide procedure-level insights and personalized care, enhancing treatment plans and patient outcomes [8][9]. - Medtronic's investment in analytics infrastructure has unified data sources, improving decision-making and operational efficiency across its workforce [11][12]. - The integration of analytics into device offerings is expected to generate recurring revenue streams, moving beyond traditional hardware sales [13][14]. Group 2: IQVIA - IQVIA operates as a data-centric healthcare technology company, monetizing clinical data and analytics services for life sciences companies [15][21]. - The Connected Intelligence platform merges healthcare data with analytics to support strategic decisions in clinical development and commercialization [16][20]. - IQVIA's analytics capabilities include real-time data processing and AI-powered insights, which are essential for product development and market access strategies [19][20]. - The company has an expected revenue growth rate of 5.4% and an earnings growth rate of 8.4% for the current year [22]. Group 3: GE HealthCare - GE HealthCare combines its diagnostic imaging legacy with enterprise data infrastructure to enhance patient data management and insights [23][24]. - The Enterprise Data Hub consolidates various data sources, providing actionable insights that improve operational efficiency and clinical decision-making [24][26]. - GE HealthCare's analytics solutions are offered through subscription models, generating recurring revenue alongside traditional equipment sales [27][28]. - The company has an expected revenue growth rate of 4.3% and an earnings growth rate of 8.1% for the current year [28].

Core Insights - IQVIA Holdings Inc. is a leading global provider of advanced analytics, technology solutions, and clinical research services for the life sciences industry, headquartered in Durham, North Carolina [1] - The company has a market capitalization of $41.28 billion and operates across several countries, assisting pharmaceutical, biotechnology, and medical device companies through its core segments [2] Financial Performance - Analysts expect IQVIA to report a profit of $3.13 per share on a diluted basis for Q4 fiscal 2025, representing a year-over-year increase of 7.9% [4] - For the full fiscal year 2025, diluted EPS is expected to grow by 5.3% annually to $10.79, followed by an 8.7% improvement to $11.73 in fiscal 2026 [4] Stock Performance - Over the past 52 weeks, IQVIA's stock has gained 18.5%, while over the past six months, it has gained 48% [5] - In comparison, the broader S&P 500 Index has increased by 19.7% and 11.5% over the same periods, indicating that IQVIA has underperformed the broader market over the past year but outperformed over the past six months [5] Sector Comparison - The State Street Health Care Select Sector SPDR ETF has gained 12.7% over the past 52 weeks and 16.4% over the past six months, showing that IQVIA has outperformed its sector during these periods [6] Strategic Partnerships - Last month, IQVIA announced a partnership with Amazon Web Services (AWS), designating AWS as its Preferred Agentic Cloud Provider, which includes the provision of IQVIA's AI platform on AWS to enhance healthcare analytics [7]

Core Insights - IQVIA Holdings, Inc. (IQV) has outperformed the industry with a 25.5% increase over the past three months compared to the industry's 12.1% rise [1] - The company has a projected long-term EPS growth rate of 8.38%, with expected year-over-year earnings growth of 6.9% in 2025 and 8.4% in 2026 [1] Company Performance - IQVIA's R&DS backlog reached $32.4 billion in Q3 2025, reflecting a 4.1% year-over-year increase, with $8.1 billion expected to convert to revenues in the next 12 months [4][5] - The book-to-bill ratio was 1.15X in Q3 and 1.12X on a trailing-12-month basis, indicating that bookings are outpacing revenue recognition [5] - Net new bookings totaled $2.6 billion, with a 13% year-over-year growth in R&DS net bookings, alongside a 20% year-over-year increase in RFP activity, suggesting strong client demand [5][6] Strategic Partnerships - The collaboration with Amazon Web Services (AWS) as its Preferred Agentic Cloud Provider enhances IQVIA's capabilities in clinical trial automation and advanced analytics, positioning the company favorably in the life sciences and AI sectors [3] Shareholder Value - IQVIA has actively engaged in share repurchase programs, repurchasing $1.35 billion in 2024 and $1.03 billion over the nine months ending in 2025, which reduces the outstanding share count and signals management's confidence in the stock's intrinsic value [7]

Core Insights - IQVIA Holdings is positioned as a leader in healthcare information, real-world evidence collection, and AI-enabled trials and commercialization, distinguishing itself from traditional contract research organizations (CROs) [1] Group 1: Company Overview - IQVIA Holdings operates beyond the scope of a typical large CRO, emphasizing its extensive capabilities in healthcare information and advanced trial methodologies [1] Group 2: Investment Perspective - The company is viewed as a resilient investment opportunity, appealing to investors focused on long-term growth and income generation through a blend of dividend-paying equities and selective growth strategies [1]

Group 1 - IQVIA Holdings is positioned as a leader in healthcare information, real-world evidence collection, and AI-enabled trials and commercialization, distinguishing itself from traditional contract research organizations (CROs) [1] - The company operates in a competitive landscape where other CROs are vying for market share, but IQVIA's scale and capabilities provide a significant advantage [1] Group 2 - The investor profile mentioned indicates a focus on building a resilient, income-generating portfolio with a long-term growth mindset, blending dividend-paying equities, REITs, and selective growth opportunities [1] - The investment strategy emphasizes disciplined, fundamentals-driven investing, prioritizing capital preservation while compounding returns over time [1]

Core Insights - IQVIA Holdings Inc. is a significant player in the life sciences industry, providing clinical research services and healthcare intelligence, with a market cap of $38.4 billion [1][2] Company Overview - The company operates through three main segments: Technology & Analytics (TAS), Research & Development (R&DS), and Contract Sales & Medical Solutions (CSMS) [1] - IQVIA is categorized as a large-cap stock, reflecting its substantial size and influence in the diagnostics and research industry [2] Stock Performance - IQVIA's stock reached a 52-week high of $234.29 on November 25 and is currently trading 3% below that peak [3] - Over the past three months, IQVIA's stock prices have increased by 23.1%, outperforming the S&P 500 Index, which gained 6.2% during the same period [3] - Year-to-date, IQVIA's stock has gained 15.6%, while over the past 52 weeks, it has increased by 13%, compared to the S&P 500's gains of 16.5% and 13.2%, respectively [4] Financial Performance - Following the release of better-than-expected Q3 results on October 28, IQVIA's stock saw a slight uptick [5] - The company reported a 5.2% year-over-year growth in topline revenue, reaching $4.1 billion, which exceeded market expectations [5] - Adjusted EPS grew by 5.6% year-over-year to $3.00, surpassing consensus estimates by 1.4% [5] Competitive Position - IQVIA has outperformed its peer Agilent Technologies, Inc., which recorded 11.1% gains year-to-date and 7.2% returns over the past year [6]

Core Insights - IQVIA Holdings Inc. is valued at $37.6 billion and provides healthcare research services, including analytics, technology solutions, and clinical research to the life sciences industry, aimed at improving healthcare outcomes for patients [1] Performance Overview - Over the past year, IQV shares have gained 12.2%, underperforming the S&P 500 Index, which increased by nearly 13.7% [2] - In 2025, IQV's stock rose 10%, while the S&P 500 saw a 13.4% rise on a year-to-date basis [2] - Compared to the Health Care Select Sector SPDR Fund (XLV), which gained about 7% over the past year, IQV's performance is relatively better, although the ETF's 10.3% year-to-date returns outshine IQV's gains [3] Financial Results - For Q3, IQV reported an adjusted EPS of $3, exceeding Wall Street expectations of $2.96, and revenue of $4.10 billion, beating forecasts of $4.07 billion [4] - The company expects full-year adjusted EPS to be in the range of $11.85 to $11.95 and revenue between $16.2 billion and $16.3 billion [4] Analyst Expectations - Analysts project IQV's EPS to grow by 5.1% to $10.77 for the current fiscal year ending in December [5] - Among 22 analysts covering IQV, the consensus rating is a "Strong Buy," with 16 "Strong Buy" ratings, one "Moderate Buy," and five "Holds" [5] - A month ago, the bullish sentiment increased, with 15 analysts suggesting a "Strong Buy" [6] Price Targets - BMO Capital initiated coverage of IQV with an "Outperform" rating and a price target of $260, indicating a potential upside of 20.3% from current levels [6] - The mean price target is $244.38, representing a 13.1% premium to current prices, while the highest price target of $265 suggests an upside potential of 22.6% [6]