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Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU® (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation

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Each year in Europe more than 550,000 patients are diagnosed with breast cancer, of whom 70% have estrogen receptor (ER)-positive disease¹; more than 147,000 breast cancer patients in Europe die annually from the disease²If approved by the European Commission, ORSERDU would be the first and only treatment specifically indicated for patients with ER+, HER2- advanced or metastatic breast cancer tumors that harbor ESR1 mutationsESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers, and are a known driver of resistance to standard endocrine therapy, making these tumors more difficult to treatFLORENCE, Italy and NEW YORK, July 21, 2023 /PRNewswire/ — The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the approval of ORSERDU® (elacestrant) monotherapy, indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)–positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
 
The CHMP opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization for human medicines throughout the European Union (EU). If approved, Stemline and its affiliates will commercialize the product within Europe.  ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.  ESR1 mutations are acquired mutations that develop as a result of exposure to endocrine therapy, and they are found in up to 40% of patients with ER+, HER2- mBC.  ESR1 mutations are a known driver of resistance to standard endocrine therapy, and until now, the tumors that harbor these mutations have been more difficult to treat.
“Patients living with metastatic breast cancer are in need of efficacious and tolerable treatment options. ORSERDU may become the first product, if approved by the European Commission, indicated in ER+, HER2- advanced breast cancer with ESR1 mutations, which are a strong driver of resistance to treatment in up to 40% of patients in second line mBC. ORSERDU, if approved, will also provide a convenient daily oral treatment,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are proud of today’s positive CHMP opinion as it reflects our commitment to developing innovative solutions that address the greatest unmet needs in cancer treatment, and brings us one step closer to providing an important new option to the patients and families impacted by ESR1-mutated, ER+, HER2- metastatic breast cancer.”
The positive CHMP opinion for ORSERDU is supported by data from the Phase 3 EMERALD trial, which demonstrated statistically significant progression-free survival (PFS) with elacestrant versus standard-of-care (SOC), defined as investigator’s choice of an approved endocrine monotherapy.  The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations. In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months vs 1.9 months on the SOC, and reduced the risk of progression or death by 45% (PFS HR=0.55, 95% CI: 0.39, 0.77) vs SOC.
A post hoc subgroup analysis of the EMERALD PFS results, which were presented at the San Antonio Breast Cancer Symposium (SABCS) 2022, demonstrated that the duration of prior CDK4/6i treatment was positively associated with longer PFS on elacestrant but not with SOC.  For patients with ESR1 mutations who were treated with CDK4/6i for ≥12 months prior to randomization on EMERALD, elacestrant achieved a median PFS of 8.6 months versus 1.9 months on SOC, with a 59% reduction in the risk of progression or death (HR=0.41 95% CI: 0.26-0.63).³
“As an oncologist, it is remarkable that we are on the cusp of having the first treatment option for patients with advanced or metastatic ER+, HER2- breast cancer harboring ESR1 mutations, which occur in up to 40% of patients in the metastatic setting,” said Giuseppe Curigliano, MD, PhD, Professor of Medical Oncology at the University of Milano and the Head of the Division of Early Drug Development at the European Institute of Oncology, IRCCS, Italy.  “Elacestrant has demonstrated efficacy and a manageable safety profile, underscoring the potential benefit this therapy may soon bring to the patients we care for, and to the broader oncology community.” 
Safety data were consistent with previously reported results. Serious adverse reactions reported in ≥ 1% of patients included nausea, dyspnoea, and thromboembolism (venous).   The most common (≥ 10%) adverse reactions with ORSERDU were nausea, triglycerides increased, cholesterol increased, vomiting, fatigue, dyspepsia, diarrhoea, calcium decreased, back pain, creatinine increased, arthralgia, sodium decreased, constipation, headache, hot flush, abdominal pain, anaemia, potassium decreased, and alanine aminotransferase increased. The most common Grade ≥3 (≥2%) adverse reactions of elacestrant were nausea (2.7%), AST increased (2.7%), ALT increased (2.3%), anaemia (2%), back pain (2%), and bone pain (2%).
About the EMERALD Phase 3 Study (NCT03778931)
The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+, HER2- advanced/metastatic breast cancer patients. The study enrolled 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoints of the study were progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations.  In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months vs 1.9 months on the SOC, and reduced the risk of progression or death by 45% (PFS HR=0.55, 95% CI: 0.39, 0.77) vs SOC.
Elacestrant is also being investigated in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108); and ELCIN (NCT05596409). Elacestrant is also planned to be evaluated in early breast cancer disease.
The Menarini Group obtained global licensing rights for elacestrant in July 2020 from Radius Health, Inc. The Menarini Group is now fully responsible for global registration, commercialization, and further development activities for elacestrant.
About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.4 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further information, please visit www.menarini.com.
About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. (“Stemline”) a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics.  Stemline commercializes ORSERDU® (elacestrant) in the United States, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.  Stemline also commercializes ELZONRIS® (tagraxofusp-erzs), a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the US and EU to date. Stemline also commercializes Nexpovio® in Europe, an XPO1 inhibitor for multiple myeloma. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers.
¹ Decision Resource Group / Clarivate Breast Cancer Landscape / Epidemiology – June 14, 2023
² International Agency for Research on Cancer, World Health Organization – Globocan – 2020
³ Bardia et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: Updated results by duration of prior CDK4/6i in metastatic setting. SABCS 2022. GS3-01 
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Dark Fiber Market Size to Grow USD 7594 Million by 2030 at a CAGR of 9.09% | Valuates Reports

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BANGALORE, India, Oct. 7, 2024 /PRNewswire/ — Dark Fiber Market is Segmented by Type (Single-Mode, Multi-Mode), by Application (Telecom, Oil & Gas, BFSI, Military & Defense, Medical, Railway, Others): Global Opportunity Analysis and Industry Forecast, 2024-2030.

The Global Dark Fiber Market was valued at USD 4475 million in 2023 and is anticipated to reach USD 7594 million by 2030, witnessing a CAGR of 9.09% during the forecast period 2024-2030.
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Major Factors Driving the Growth of Insect Dark Fiber Market:
The dark fiber market is experiencing robust growth due to the increasing demand for high-speed internet, data transfer, and secure communication infrastructure across various industries. Dark fiber refers to unused fiber-optic cables that are available for lease or purchase, allowing enterprises and service providers to establish private networks with dedicated bandwidth. The surge in data consumption, driven by cloud computing, 5G deployment, data centers, and IoT, has intensified the need for scalable and high-capacity networks, which dark fiber can provide. Additionally, sectors like telecom, IT, and healthcare are adopting dark fiber solutions to ensure better connectivity, network control, and security.
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TRENDS INFLUENCING THE GROWTH OF THE DARK FIBER MARKET
Single-mode fiber plays a crucial role in driving the growth of the dark fiber market due to its ability to support long-distance communication with minimal signal degradation. This fiber type offers high bandwidth and superior performance, making it ideal for telecommunication companies and data centers that require efficient transmission over extensive networks. The rapid increase in data consumption, driven by emerging technologies like 5G, cloud computing, and IoT, has intensified the demand for single-mode fiber. Its cost-effectiveness for long-haul applications further enhances its adoption, as it allows for higher transmission speeds and capacities over longer distances, making it a preferred choice for large-scale network expansion projects.
Multi-mode fiber is a key driver in the dark fiber market due to its efficiency in short-distance data transmission. Multi-mode fibers are particularly effective for data centers and intra-building communication networks where the focus is on high-speed connections over shorter distances. The demand for electric dark fiber, especially in urban infrastructure and renewable energy projects, has surged as these sectors require reliable, high-capacity data transfer solutions. Multi-mode fiber’s cost-effective installation and maintenance, along with its ability to handle high bandwidth over shorter distances, contribute significantly to the market’s growth, providing a reliable infrastructure for electric utilities and smart grid projects.
Telecom is one of the most significant sectors driving the growth of the dark fiber market due to the increasing demand for high-speed internet, large-scale network deployments, and seamless communication infrastructure. The rapid expansion of 5G networks, the need for backhaul connections, and the proliferation of data-intensive applications have all contributed to the growing adoption of dark fiber in the telecom industry. Telecom providers are leveraging dark fiber to reduce latency, enhance scalability, and increase network efficiency, which are critical for delivering enhanced customer experiences and supporting emerging digital services. As telecom networks continue to expand globally, the demand for dark fiber infrastructure is expected to rise.
One of the primary factors driving the growth of the dark fiber market is the exponential surge in global data consumption. With the widespread use of smartphones, connected devices, and the internet, data traffic has increased significantly. Streaming services, online gaming, video conferencing, and cloud computing are all fueling this growth. Dark fiber infrastructure is essential to accommodate this massive data flow, offering the bandwidth and capacity required to support such intensive usage. As businesses and consumers continue to generate more data, service providers rely on dark fiber networks to ensure faster, more reliable connections and to meet the growing demands for data transmission.
The growing adoption of cloud services by enterprises is another critical factor contributing to the growth of the dark fiber market. As businesses migrate their operations and data storage to the cloud, there is an increased need for high-speed, low-latency networks that can handle large volumes of data transmission. Dark fiber provides the necessary infrastructure for private, scalable, and secure network connectivity to the cloud. Enterprises across various industries, including healthcare, finance, and retail, are leveraging dark fiber to ensure seamless access to cloud applications, thus driving market growth. The continued shift toward cloud computing will likely increase demand for dark fiber solutions.
The rapid expansion of data centers worldwide is significantly boosting the dark fiber market. Data centers serve as critical hubs for storing and managing vast amounts of information. To ensure smooth operation, data centers require high-capacity, reliable, and secure fiber-optic networks. Dark fiber networks provide data centers with dedicated, high-performance connectivity, allowing them to scale their operations efficiently. The growth of edge computing and the need for real-time data processing have further intensified the demand for dark fiber connections in data centers. As the number of data centers grows, particularly in emerging markets, the need for dark fiber infrastructure will continue to rise.
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DARK FIBER MARKET SHARE ANALYSISThe dark fiber market shows varying growth trends across different regions, driven by factors like technological advancements and infrastructure investments. North America leads the market due to the rapid expansion of 5G networks, cloud computing adoption, and increasing data center construction. Europe follows closely, with countries investing in high-speed connectivity for smart cities and telecommunications. The Asia-Pacific region is witnessing significant growth, particularly in China, Japan, and India, driven by increased demand for internet services, telecom expansion, and government initiatives supporting digital infrastructure. Meanwhile, Latin America and the Middle East are also emerging as potential markets, propelled by growing data consumption and the need for improved connectivity in underdeveloped areas.
Key Players:
GTT CommunicationsUFINETVikram GroupDEPLUnite Private NetworksSterlite PowerColt Technology ServicesConsolidated CommunicationsCrown CastleNexGen NetworksSorrento NetworksFirstLightMicroscanWindstream Intellectual Property ServicesPurchase Chapters: https://reports.valuates.com/market-reports/QYRE-Auto-8O16959/global-dark-fiber/1
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AI Governance Market worth $5,776.0 million by 2029- Exclusive Report by MarketsandMarkets™

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DELRAY BEACH, Fla., Oct. 7, 2024 /PRNewswire/ — The AI Governance Market is anticipated to grow from USD 890.6 million in 2024 to USD 5,776.0 million by the year 2029 at a robust CAGR of 45.3% over the forecast period, according to a new report by MarketsandMarkets™.

Browse in-depth TOC on “AI Governance Market”
350 – Tables 50 – Figures450 – Pages
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Scope of the Report
Report Metrics
Details
Market size available for years
2019–2029
Base year considered
2023
Forecast period
2024–2029
Forecast units
USD (Million)
Segments covered
Product Type, Functionality, End User, and Region
Geographies covered
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America
Companies covered
Microsoft (US), IBM (US), Google (US), Salesforce (US), SAP (Germany), AWS (US), SAS Institute (US), FICO (US), Accenture (Ireland), Qlik (US), H2O.AI (US), Alteryx (US), DataRobot (UK), Dataiku (US), Domino Data Lab (US), SparkCognition (US), Collibra (US), OneTrust (US), Quest Software (US), Fiddler AI (US), Untangle AI (Singapore), 2021.AI (Denmark), Howso (US), Monitaur (US), Mind Foundry (UK), Credo AI (US), Holistic AI (UK), Fairly AI (Canada), Enzai (UK), ValidMind (US), FairNow (US), Mona Labs (US), Arthur AI (US), Trustible (US), Atlan (Singapore), ModelOp (US), Neptune AI (Poland), Patronus AI (US), and Datatron (US).
Regulatory pressure and demands for compliance are driving the AI Governance Market as governments around the world roll out tougher regulations related to AI. For example, the European Union’s AI Act had subjected risk assessments and compliance audits to AI systems, particularly in high-risk sectors like health and finance, thereby increasing demand for the governance framework. Organizations also run the risk of facing reputational damages linked with prejudiced or harmful AI output. A notable example is the controversy caused by OpenAI GPT models, which flagged misinformation and biased data concerns, making businesses adopt robust AI guard rails. On similar note, Amazon’s discontinuation of its biased AI recruiting tool demonstrate the reputational and financial risks of ungoverned AI. Another major reason for market expansion is the uptick in AI adoption across highly regulated industries, especially BFSI and healthcare. Industries operating in these sectors are under immense regulatory pressure to comply with dynamic regulations, leading to increased affinity towards AI governance tools.
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By product type, data governance tools will account for largest market share in 2024 owing to robust data provenance and lineage capabilities.
Data governance tools are poised to account for the largest market share in the AI Governance Market, as these tools help an organization track data quality, provenance, and bias within AI development training data. This is important in order to prevent bias results being generated from AI systems. For example, data governance tools may apply profiling techniques to the dataset in order to ensure fairness, and also put in place data lineage to indicate potential problems with data sourcing. As an increasing number of AI regulations call for documentation, tracking and record keeping especially on the data that feeds AI systems, data governance has become paramount. Data governance also assists enterprises in compliance with regulations through robust AI data traceability and accuracy. Additionally, the metadata repository feature in data governance tools offer centralized catalogs and controls of metadata for data visibility across an organization to ensure trustworthy and responsible AI implementation.
The demand for ethical AI use across ML platforms and generative AI models will push software & technology providers as the fastest growing end user segment during the forecast period
Software & technology providers are poised to become the fastest growing end user segment in the AI Governance Market, buoyed by rapid adoption of AI governance tools to make their AI systems trustworthy and ethical. The rising regulatory scrutiny and the expanding reach of data privacy laws like GDPR and CCPA has also accelerated governance frameworks being adopted across such players. For instance, Microsoft has created an internal AI ethics working group to implement strong ethical guardrails across its AI offerings. On a similar note, Google has formed AI governance framework for developing fair, explainable, and ethical AI solutions. There are also expectations from stakeholders who demand that technology companies create AI responsibly. With AI regulations likely to disrupt every software vendor, incorporating ethical norms and regulation is now of extraordinary importance for technology businesses to maintain the brand’s trust and growth.
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North America is set to hold the largest market share in 2024, fueled by a strong regulatory environment and increasing investments in responsible AI deployment
North America has emerged as the largest regional market for AI government adoption. Federal funding on AI governance in North America crossed USD 1 billion in 2023, indicating a growing interest in responsible AI research. Industries with strict regulations such as healthcare and banking are leading in the implementation of governance, with 45% of healthcare providers mentioning regulatory compliance as a key business requirement. Businesses are forced to implement governance frameworks due to rising regulatory requirements like NIST’s AI Risk Management Framework and the California Consumer Privacy Act (CCPA). More than half of businesses expect more stringent AI rules in the next five years, with 62% citing data privacy compliance as a main factor for implementing governance. Also important is consumer confidence, as 78% of American consumers favor brands that utilize ethical AI. Businesses such as Google and Microsoft are implementing governance to guarantee transparency and establish trust. Additionally, organizations are prioritizing fairness in their AI systems and have turned to tools like IBM’s AI Fairness 360 to address the need to mitigate AI bias, with 56% of businesses doing so. Moreover, financial institutions are particularly focused on risk management, giving priority to governance for addressing AI-related risks.
Top Key Companies in AI Governance Market:
The major players in the AI Governance Market include Microsoft (US), IBM (US), SAS Institute (US), DataRobot (UK), and Dataiku (US), along with SMEs and startups such as Fiddler AI (US), 2021.AI (Denmark), Monitaur (US), Credo AI (US), and Fairly AI (Canada).
Browse Adjacent Markets: Artificial Intelligence (AI) Market Research Reports & Consulting
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Access Control as a Service (ACaaS) Market worth $3.06 billion by 2029 – Exclusive Report by MarketsandMarkets™

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DELRAY BEACH, Fla., Oct. 7, 2024 /PRNewswire/ — The global access control as a service market is expected to be valued at USD 1.34 billion in 2024 and is projected to reach USD 3.06 billion by 2029; it is expected to grow at a CAGR of 17.9% from 2024 to 2029 according to a new report by MarketsandMarkets™. Accelerated urbanization in emerging markets is fueling the demand for advanced access control solutions. Growing adoption of cloud-based Access Control as a Service (ACaaS) is transforming security management systems. Increasing integration of access control systems with employee management and HR platforms is enhancing operational efficiency in the access control as a service market. Increasing shift toward subscription-based business models is fostering recurring revenue streams for security service providers. Growing demand to manage global security operations from centralized locations is pushing the adoption of unified security platforms in the access control as a service market.

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Browse in-depth TOC on “Access Control as a Service (ACaaS) Market” 162 – Tables64 – Figures226 – Pages
Access Control as a Service (ACaaS) Market Report Scope:
Report Coverage
Details
Market Revenue in 2024
$ 1.34 billion
Estimated Value by 2029
$ 3.06 billion
Growth Rate
Poised to grow at a CAGR of 17.9%
Market Size Available for
2020–2029
Forecast Period
2024–2029
Forecast Units
Value (USD Million/Billion)
Report Coverage
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered
By Service Type, Cloud Deployment Model, Vertical, and Region
Geographies Covered
North America, Europe, Asia Pacific, and Rest of World
Key Market Challenge
Unauthorized Access and Data Breach
Key Market Opportunities
Unauthorized Access and Data Breach
Key Market Drivers
Increased adoption of IoT-based security systems and cloud computing platforms
Commercial vertical to hold the highest market share during the forecast period.
Commercial vertical will account for the largest market share in the ACaaS market during the forecast period. This can be attributed to the increasing need for secure access management solutions across commercial buildings, offices, and retail spaces. Scalability, cost-effectiveness, and even remote access management abilities are making cloud-based ACaaS increasingly attractive within this segment. With increasing urbanization and infrastructure development, coupled with the trend of smart buildings, demand for advanced security systems is rising in the commercial segment, which is further basing its strength in the ACaaS market.
By Service Type, Hybrid segment is projected to grow at a high CAGR of Acalas industry during the forecast period.
A hybrid access control service may be marked as a combination of both hosted and managed access control. In this type of access control, a certain part of the access control system is handled by the end user while the rest of the function is outsourced to a third-party vendor. In this model, permissions are not directly associated with the attributes or the roles. In dynamic role assignment, roles are assigned to users based on the attributes provided by the user, which are then adopted for authentication purposes. Once the roles are assigned, authorization starts whereby the user is granted access based on the assigned roles. The hybrid access control service will act as a catalyst in driving better threat visibility, rapid and effective attack response, minimizing cyber security risks, and being compliant with the latest regulations and standards.
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Asia Pacific will account for the highest CAGR during the forecast period.
In Asia Pacific, China is amongst the largest countries in the world and one of the largest manufacturers and producers of industrial goods. Agaas has grown and developed immensely in the recent years as, to address margin-related issues that Chinese suppliers have been causing, lately manufacturers are adopting cloud-based solutions. The large-scale industrialization of the country has given birth to the growing need for security systems. Thirdly, consistent R &D expense resulted in the innovation of highly sophisticated systems that can meet the diversified user needs. In government sectors, access control system had been employed to raise security measures and take instantaneous action against looming threats. AcaaS – The software and data are retained at vast data centres instead of being retained locally on on-premises servers. Hardware systems remain the same, similar to those in an access control system. Hence, Acaas save the operational costs of institutions considerably with no compromise on the standards of security. In residential areas too, the demand for Acaas is tremendous, thanks to the ever-growing requirement of securing personal properties.
Key Players
Key companies operating in the ACaaS companies are Johnson Controls Inc. (Ireland), Honeywell International Inc. (US), Thales (France), ASSA ABLOY Group (Sweden), dormakaba Group (Switzerland), Identiv, Inc. (US), Kastle Systems (US), AMAG (US), Brivo Systems, LLC. (US), and Cloudastructure Inc. (US) among others.
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Browse Adjacent Market: Semiconductor and Electronics Market Research Reports &Consulting
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VSaaS Market Size, Share & Industry Growth Analysis by Type (Hosted, Managed, Hybrid), Feature (AI-enabled VSaaS, Non-AI VSaaS), AI Visual Analysis (Object Detection & Recognition, Intrusion Detection, Facial Recognition, Anomaly Detection), Vertical & Region – Global Forecast to 2029
Access Control Market by Offering (Hardware-Card-based, Biometric, & Multi-technology Readers, Electronics Locks, Controllers; Software; Services), ACaaS (Hosted, Managed, Hybrid), Vertical and Region – Global Forecast to 2029
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