#US FDA’s 510(k)

[elexes]

US FDA’s 510(k) Submission & Review Process

510(k) submission is one of the essential steps of getting medical devices approved in the United States. A 510(k) is an FDA regulatory pathway for medical device clearance.

It's crucial as it allows manufacturers to demonstrate that their new device is substantially equivalent to an existing one already on the market, expediting approval. 

This process promotes innovation, reduces development costs, and ensures patient safety by evaluating similarities and differences between devices.

Before you start your 510(k) filing, you must consider the below-mentioned factors. In case you wish to get support for 510(k) submission, you must check out our 510(k) submission consulting services.

[covid-safer-hotties]

Also preserved on our archive

By Mary Van Beusekom, MS

As the country heads into the respiratory illness season, the US Food and Drug Administration (FDA) announced yesterday its marketing authorization of the first over-the-counter (OTC) rapid-antigen COVID-19/flu combination test outside of emergency use authorization.

The Healgen Rapid Check COVID-19/Flu A&B Antigen Test takes 15 minutes to detect proteins from both COVID-19 and influenza A and B in nasal swabs. It joins other OTC COVID-19/flu tests already available under emergency use authorization. The test is designed for use by people aged 14 years or older collecting and testing their own sample or those 2 and older with adult assistance.

Risk of false-negative results FDA review of data from people with signs and symptoms of COVID-19 and flu showed that the test correctly identified 99% of negative and 92% of positive SARS-CoV-2 samples, 99.9% of negative flu A and B samples, and 92.5% and 90.5% of positive influenza A and B samples, respectively. The FDA and the National Institutes of Health's Independent Test Assessment Program collected the validation data.

The FDA reminded users of the risk of false-negative test results with rapid-antigen tests. People who test negative and continue to have fever, cough, and/or shortness of breath may indeed have COVID-19, flu, or another respiratory disease and should visit their healthcare provider. Those who test positive for COVID-19 or flu should take appropriate precautions to avoid spreading the virus and seek follow-up care.

The agency is also establishing criteria called special controls that define the labeling and performance-testing for these tests, the statement said.

"When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type," it said. "This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s less burdensome 510(k) pathway."

[global-research-report]

Therapies Beyond Pills: Welcome to the Digital Age of Healthcare

The global digital therapeutics market size is expected to reach USD 32.52 billion by 2030, exhibiting a CAGR of 27.2% from 2024 to 2030, according to a new report by Grand View Research, Inc. The primary driver for expanding the market growth is the increased use of smartphones. The affordability of digital health technologies for healthcare providers & patients, rising demand for integrated healthcare systems, and care focusing on the patient are key factors fueling the market's growth. Furthermore, the growing globalization and shifts in lifestyle habits, such as higher rates of tobacco use, inadequate nutrition, insufficient physical activity, and rising alcohol consumption, increase the likelihood of chronic disease development. 

The market’s expansion is significantly influenced by the increasing adoption of digital therapeutics and the supportive initiatives by leading regulatory agencies such as the FDA. For instance, the U.S. FDA provided guidelines in April 2020 to enhance the reach of digital therapeutic devices for people suffering from psychiatric disorders. Furthermore, according to Kepios data, there's a 7.6% annual growth rate in the global internet user base, translating to around 900,000 new internet users daily. While developed and developing nations boast high smartphone and internet usage levels, areas such as Africa and South Asia need to catch up due to their economic limitations.

Increasing prevalence of chronic diseases is also driving the growth of the market. As per the CDC’s National Center for Chronic Disease Prevention and Health Promotion, 6 in 10 American adults suffer from a chronic disease, while 4 out of 10 adults have two or more chronic diseases. For instance, in February 2022, Teladoc Health, Inc. launched Chronic Care Complete, a chronic condition management solution to improve healthcare outcomes. Cardiovascular diseases, cancer, diabetes, chronic kidney disease, chronic lung disease, and Alzheimer’s have been identified as the leading causes of death and disability in the country. 

Digital therapeutics have become an essential option for treating various health conditions, mainly due to customized treatment plans and strategic initiatives by leading companies in the industry. These actions include mergers and acquisitions, clearing regulatory approvals, introducing new products, and establishing partnerships. Moreover, the growing rates of chronic diseases such as cardiovascular disease, diabetes, and anxiety have driven critical players in the market to invest in digital solutions for treatment. Various companies are in the process of developing digital therapeutic products aimed specifically at managing anxiety, with many of these products in different phases of research and development. This presents a significant opportunity for market growth. For instance, In August 2023, Welldoc revealed it had obtained its 10th FDA 510(k) clearance for the BlueStar digital health solution for diabetes management. This clearance allows BlueStar to incorporate connected insulin dosing information into its customized recommendations for bolus insulin dosing.

Digital Therapeutics Market Report Highlights

Based on application, diabetes held a market share of 29.36% in 2023, owing to rapid technological advancements by market players in the segment. The segment is also expected to witness the fastest growth over the forecast period

The patients segment held the largest market share of 34.08% in 2023, owing to the growing number of patients suffering from chronic conditions. Digital therapeutics can also help improve access to care for people, especially those from rural and remote areas

North America dominated the global market in 2023 owing to the high demand for digital therapeutics in the region. These regional marketplaces are expected to show similar trends throughout the forecast period due to rising healthcare awareness coupled with increased use of digital health products over the forecast period

Digital Therapeutics Market Segmentation

Grand View Research has segmented the global digital therapeutics market based on application, end user, and region:

Digital Therapeutics Application Outlook (Revenue, USD Million, 2018 - 2030)

Diabetes

Obesity

CVD

Respiratory Diseases

Smoking Cessation

CNS Diseases

Others

Digital Therapeutics End Use Outlook (Revenue, USD Million, 2018 - 2030)

Patients

Providers

Payers

Employers

Others

Digital Therapeutics Regional Outlook (Revenue, USD Million, 2018 - 2030)

North America

US

Canada

Mexico

Europe

UK

Germany

France

Italy

Spain

Denmark

Sweden

Norway

Asia Pacific

China

Japan

India

Australia

South Korea

Thailand

Latin America

Brazil

Argentina

Middle East & Africa

South Africa

Saudi Arabia

UAE

Kuwait

Key Players

OMADA HEALTH, INC.

Welldoc, Inc.

2Morrow, Inc

Livongo Health, Inc. (Teladoc Health, Inc.)

Propeller Health (ResMed)

Fitbit LLC

Mango Health

CANARY HEALTH

Noom, Inc.

Pear Therapeutics, Inc.

Akili Interactive Labs, Inc.

HYGIEIA

DarioHealth Corp.

BigHealth

GAIA AG

Limbix Health, Inc.

Order a free sample PDF of the Digital Therapeutics Market Intelligence Study, published by Grand View Research.

[surgikartindia0]

SurgiKart: Your Trusted Partner Among Leading Surgical Instruments Manufacturers in India

In the ever-evolving field of healthcare, having reliable and high-quality surgical instruments is essential. SurgiKart India, based in New Delhi, is recognized as one of the most trusted surgical instruments manufacturers in India. With a strong focus on precision, innovation, and customer satisfaction, SurgiKart has set new benchmarks in the medical device manufacturing industry.

Excellence in Manufacturing

Cutting-Edge Facilities

SurgiKart’s modern manufacturing unit is equipped with controlled molding areas, a Class 10,000 clean room, and an ETO Gas Sterilization Plant. These facilities ensure that all products are manufactured under the most stringent conditions, maintaining the highest standards of quality and safety.

Adherence to International Standards

The company complies with ISO 13485:2003 standards, and many of its products bear the CE mark. Additionally, certain products have received approval through the US FDA 510(k) process, solidifying SurgiKart’s reputation as a global leader in the industry.

Diverse Range of Medical Instruments

As one of the leading surgical instruments manufacturers in India, SurgiKart offers an extensive range of products catering to various medical fields, including:

Cardiac Surgery SurgiKart specializes in instruments designed for cardiac surgery, ensuring precision and safety during critical procedures.

Infusion and Transfusion Therapy The company provides reliable solutions for infusion and transfusion therapy, focusing on efficiency and patient comfort.

Dialysis Equipment SurgiKart’s dialysis products are engineered to meet the specific needs of healthcare professionals, ensuring optimal performance.

Gastroenterology and Urology Instruments for gastroenterology and urology are crafted to support effective diagnosis and treatment in these specialized fields.

General Medical Disposables The company also offers a wide range of disposable medical products, designed to maintain hygiene and safety in healthcare settings.

Commitment to Quality and Innovation

SurgiKart’s commitment to quality is evident in every product it manufactures. The company follows a stringent quality assurance process to ensure that all instruments meet the highest safety and performance standards. Innovation is at the core of SurgiKart’s operations, with a dedicated team of experts continually developing new products to meet the dynamic needs of the healthcare industry.

As one of the leading surgical instruments manufacturers in India, SurgiKart not only focuses on creating high-quality products but also ensures that these products are accessible to healthcare providers across the globe.

A Vision for Excellence

SurgiKart’s mission is to enhance healthcare outcomes by providing world-class medical devices at competitive prices. The company strives to maintain its leadership position by focusing on:

Advanced manufacturing technologies

Customer-centric solutions

Continual improvement in product quality

By aligning its operations with this vision, SurgiKart has earned the trust of healthcare professionals in over 52 countries.

Expertise in Management and Operations

The company’s success is driven by a team of over 300 skilled professionals, working across departments such as production, quality assurance, marketing, and administration. Under the leadership of Director Sachin Chawla, who has over 20 years of experience in the medical device industry, SurgiKart has become a name synonymous with excellence.

The team’s dedication ensures smooth operations and the timely delivery of high-quality products, further solidifying SurgiKart’s position among the most reliable surgical instruments manufacturers in India.

Global Reach and Trust

SurgiKart’s products are trusted by healthcare providers worldwide, with a presence in more than 52 countries. This global reach reflects the company’s ability to meet diverse medical needs and its reputation for delivering reliable and innovative medical devices.

The overwhelming response from both domestic and international markets highlights SurgiKart’s excellence as one of the premier surgical instruments manufacturers in India.

Explore SurgiKart’s Offerings

When choosing a partner for surgical instruments, reliability, quality, and innovation are paramount. SurgiKart India excels in all these areas, making it a preferred choice for healthcare professionals and organizations. With a comprehensive range of products and a steadfast commitment to customer satisfaction, SurgiKart continues to lead as one of the top surgical instruments manufacturers in India.

Discover SurgiKart today and experience the quality and precision that define our products.

[top4allo]

Inogen expands US market with FDA approval

https://www.tipranks.com/news/company-announcements/inogen-expands-us-market-with-fda-clearance The latest announcement is out from Inogen ((INGN)). Inogen, Inc. announced that it has received FDA 510(k) clearance for its Simeox 200 device, designed to enhance airway clearance and improve bronchial drainage for patients with chronic respiratory diseases. The authorization allows Inogen to expand…

[haccpcertificationinseychelles]

FDA Certification : A Comprehensive Guide

In today’s competitive global market, compliance with regulatory standards is essential for businesses operating in industries such as pharmaceuticals, medical devices, food manufacturing, and cosmetics. The U.S. Food and Drug Administration (FDA) sets stringent guidelines to ensure the safety, quality, and efficacy of products entering the U.S. market. For South African companies aiming to export to the U.S., obtaining FDA certification is a critical step. This article delves into FDA Certification in South Africa, the services available to facilitate certification, and the role of FDA consultants in ensuring compliance.

FDA Implementation in South Africa

FDA certification involves adherence to specific regulations governing product safety, labeling, manufacturing processes, and quality control. In South Africa, businesses seeking FDA approval must align their operations with these requirements to gain access to the lucrative U.S. market.

The implementation process typically begins with understanding the applicable FDA regulations. These vary depending on the product category:

Pharmaceuticals and Biologics: These products must comply with Good Manufacturing Practices (GMP) outlined in the Code of Federal Regulations (CFR). South African pharmaceutical companies often need to update their facilities, processes, and documentation to meet FDA standards.

Medical Devices: Manufacturers must determine the device’s classification and whether it requires premarket notification (510(k)) or premarket approval (PMA). Adherence to Quality System Regulations (QSR) is also mandatory.

Food Products: Compliance with the FDA’s Food Safety Modernization Act (FSMA) is crucial. This includes implementing hazard analysis and preventive controls to ensure food safety.

Cosmetics: These products must be safe for use and labeled accurately. While FDA approval isn’t mandatory for cosmetics, compliance with labeling and safety requirements is essential to avoid enforcement actions.

Businesses face unique challenges during implementation, such as navigating complex FDA Implementation in Bangalore requirements, bridging regulatory differences, and managing resource-intensive audits. However, with strategic planning and the right support, these challenges can be effectively addressed.

FDA Services in South Africa

South African companies can leverage a range of FDA-related services to streamline the certification process. These services are designed to help businesses navigate the complexities of FDA compliance and include:

FDA Registration and Listing: Companies must register their facilities and list their products with the FDA. This is a crucial first step for exporting goods to the U.S.

Regulatory Consulting: Experts provide guidance on FDA requirements specific to the product category, ensuring businesses understand their obligations.

Training and Workshops: Organizations offer training sessions on FDA regulations, such as GMP, FSMA compliance, and QSR requirements. These programs equip employees with the knowledge needed to maintain compliance.

Documentation Support: Preparing accurate and complete documentation is critical. FDA services include assistance with preparing regulatory submissions, such as Drug Master Files (DMFs), 510(k) applications, and food safety plans.

Audit Preparation and Mock Audits: Mock inspections help companies prepare for actual FDA audits, identifying areas of non-compliance and implementing corrective actions.

These services ensure that South African companies meet all FDA Services in Bahrain requirements, reducing the risk of non-compliance and facilitating smooth market entry.

FDA Consultants in South Africa

The expertise of FDA consultants is invaluable for South African businesses aiming for certification. These professionals possess in-depth knowledge of FDA regulations and offer tailored solutions to meet specific business needs. Here’s how they add value:

Gap Analysis: Consultants conduct a thorough review of existing processes, identifying gaps in compliance and recommending actionable improvements.

Custom Compliance Strategies: Based on the business’s goals and product category, consultants develop customized strategies to achieve FDA certification efficiently.

Regulatory Submission Assistance: Navigating FDA’s complex submission processes can be daunting. Consultants ensure that all submissions are accurate, complete, and compliant with regulatory standards.

Ongoing Support: Maintaining compliance is an ongoing process. FDA consultants provide continuous support to address regulatory updates, manage audits, and ensure adherence to best practices.

Choosing the right consultant is critical. South African businesses should look for professionals with proven experience, strong communication skills, and a track record of successful FDA certifications.

Conclusion

Achieving FDA Services in Uganda is a significant milestone for businesses seeking to expand into the U.S. market. By understanding the implementation process, utilizing specialized FDA services, and partnering with experienced consultants, companies can navigate the complexities of FDA compliance with confidence. With the right approach, South African businesses can unlock new opportunities and establish themselves as trusted exporters in the global marketplace.

[insightsresearch]

Printed & Flexible Sensors Market New Innovations Trends, Research, Global Share and Growth Factor

Analysis of Printed & Flexible Sensors Market Size by Research Nester Reveals the Market to Grow with a CAGR of 8.2% during 2025-2037 and Attain USD 29.5 billion by 2037

Research Nester assesses the growth and market size of the global printed & flexible market which is anticipated to be on account of the increasing demand for smartphones, laptops, and tablets.

Research Nester’s recent market research analysis on “Printed & Flexible Sensors Market: Global Demand Analysis & Opportunity Outlook 2037” delivers a detailed competitor’s analysis and a detailed overview of the global printed & flexible market in terms of market segmentation by printing technology, type, application, and by region.

Increased Integration in Biomedical Applications to Promote Global Market Share of Printed & Flexible Sensors

 The global printed & flexible sensors market is estimated to grow majorly due to the growing advancements and clinical approvals in biosensor technology. For instance, in May 2020, a global pioneer in health technology, Royal Philips, announced that the FDA approved its wearable biosensor, the Philips Biosensor BX100, under 510(k) to help monitor COVID-19 patients in hospitals, both proven and suspected. In the Philips patient deterioration detection system, the next-generation wireless wearable biosensor improves clinical monitoring to assist clinicians in identifying danger, allowing them to respond sooner and contributing to better patient care in lower acuity care areas. Because of their versatility and stretchability, flexible sensors have been utilized daily and have led to considerable breakthroughs, particularly in biomedical applications where they can adapt to complex geometries and be used on curved surfaces.

Medical biosensors are used in several instruments, including blood gas analyzers, pregnancy testing, blood glucose monitors, and cholesterol tastings. Proteins, nucleic acids, enzymes, and antibodies are some of the biological components that biosensors can detect and measure.

Some of the major growth factors and challenges that are associated with the growth of the global printed & flexible sensors market are:

Growth Drivers:

Growing technological advancements

Increased use in the production of sustainable energy

Challenges:

Conductive ink is cost-effective and easy to use compared to printed & flexible sensors. Also, the high costs of these sensors and inability to handle danger may impede the growth of printed & flexible sensors market.

Access our detailed report at: https://www.researchnester.com/reports/printed-and-flexible-sensors-market/6427

By printing technology, the global printed & flexible sensors market is segmented into flexographic, inkjet, and screen. The inkjet segment is expected to garner the highest revenue in 2037 at a significant CAGR over the forecast period. The expanding developments in inkjet printing technology and an increase in demand from various industries are responsible for the segment's expansion. For example, in July 2024, Ventec Giga Solutions, the value-added PCB equipment unit of Ventec, and Hi-Print worked together to launch the market's most cutting-edge inkjet printer for solder mask technology. With up to ten state-of-the-art printheads and the first-ever completely customizable three-color ink supply system, the Hi-Print SD11 Inkjet printer is a scalable, reconfigurable, modular, and adaptable system designed for PCB creation that will never go out of style. Furthermore, inkjet printing has several advantages when creating printed and flexible sensors, including the ability to create complex patterns, compatibility with a wide range of materials, and high resolution.

By region, the Europe printed & flexible sensors market is poised to generate the highest revenue by the end of 2037. The European automotive sector represents a significant market for printed and flexible sensors. These sensors offer functionalities such as touch-sensitive surfaces, driver assistance systems, and structural health monitoring, which are seamlessly integrated into the interiors of smart cars. The region's robust automotive manufacturing base, coupled with a strong emphasis on sustainability and connected vehicles, is driving the market demand for printed and flexible sensors.

Request Free Sample Copy of this Report @ https://www.researchnester.com/sample-request-6427

This report also provides the existing competitive scenario of some of the key players which includes the Canatu Oy, Interlink Electronics, Inc., Tekscan, Inc., Prophesee SA, Henkel AG & Co., KGaA, Peratech Holdco Limited, KWJ Engineering, T+Ink, Inc., Thin Film Electronics ASA, Renesas Electronics Corporation, and others.

Request for customization @ https://www.researchnester.com/customized-reports-6427

Research Nester is a leading service provider for strategic market research and consulting. We aim to provide unbiased, unparalleled market insights and industry analysis to help industries, conglomerates and executives to take wise decisions for their future marketing strategy, expansion and investment etc. We believe every business can expand to its new horizon, provided a right guidance at a right time is available through strategic minds. Our out of box thinking helps our clients to take wise decision in order to avoid future uncertainties.

Contact for more Info:

AJ Daniel

Email: info@researchnester.com

U.S. Phone: +1 646 586 9123

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[darkmaga-returns]

It has been over a decade since my late-wife, Dr. Amy Josephine Reed, was harmed and killed by a poorly regulated medical device, known as the Power Morcellator. The sheer force of Dr. Reed’s voice, as a Harvard Medical School faculty member and a physician-scientist — and the injustice it uncovered to countless other women like her — became a bellwether case that demonstrates an ongoing and severe safety failure operational in the medical device regulatory space at FDA.

Of course, this safety failure in the FDA’s medical device regulatory arm, the Center for Devices and Radiological Health (CDRH), is hardly unique to that center. Industry and conflicted academic “experts,” not patients, play an outsized role in governing and corrupting almost all of the FDA’s centers. But, certainly, the source of the safety failure at CDRH is crystallized in the dangerous regulatory regime that the agency center utilizes to clear the vast majority of medical devices for the US healthcare marketplace: The 510(k).

At a legislative level, CDRH’s 510(k) regulatory regime was not designed to ensure the safety or efficacy of the medical devices it regulates — a fact that is well known to most public health experts and FDA regulators themselves. CDRH’s 510(k) does not use anything even remotely resembling an “evidence-based” framework to provide clearance to thousands of new medical devices annually used in the care of patients across the US and abroad.

Even more problematic is that the medical device industry pays the FDA for the 510(k) clearances obtained. In other words, almost the entire 510(k) clearance apparatus at CDRH is literally funded by the medical device industry — the very industry that stands to gain the most from the 510(k) clearances it funds. This is a serious conflict of interest in the healthcare space, and should not pass ethical muster — even when the argument is that such payments from industry to government are saving taxpayer dollars. The moment the industry starts paying to keep the FDA’s centers’ lights on is when the industry, not the people, will have an outsized voice in governing the agency that is regulating it.

[drcare4u]

Acuitive Technologies Receives FDA 510(k) Clearance for CITREPORE™, A New Synthetic Bioactive Bone Void Filler for Orthopedic Procedures

ALLENDALE, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) — Acuitive Technologies, Inc. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market CITREPORE, a unique synthetic bioactive bone void filler, using their patented CITREGEN® biomaterial technology. Following placement in a bony void, CITREPORE is resorbed predictably and replaced by the patient’s…

[latestmarketresearchnews]

In Vitro Diagnostics (IVD) Industry Sales, Demand, Regional Outlook And Supply Chain Analysis till 2030

The global in vitro diagnostics (IVD) market reached an estimated size of USD 77.92 billion in 2023, with expectations for a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This market growth is primarily driven by the increasing use of IVD tools due to rising cases of infectious and chronic diseases worldwide. Automated IVD systems are becoming more common in hospitals and laboratories, as they provide accurate, fast, and error-free diagnoses, helping meet the growing demand for efficient healthcare services. Additionally, IVD market expansion is fueled by frequent product launches from key industry players. For example, in November 2023, ARUP Laboratories received a CE mark from the EU-IVDR for AAV5 DetectCDx, a companion diagnostic that helps identify eligibility for severe hemophilia Some patients to receive BioMarin’s gene therapy, Roctavian.

Major companies in the IVD market are employing various strategies to strengthen their position and bring more advanced and diverse products to their customers. New product launches and partnerships are among the most common tactics. For instance, in March 2023, BD received FDA 510(k) clearance for the BD Vaginal Panel on its BD COR System, a tool designed to detect infectious causes of vaginitis. In another instance, in August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These partnerships and product developments highlight how key players are focused on expanding their diagnostic offerings to meet growing healthcare needs.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Supportive initiatives from government and non-governmental bodies are also contributing to the market's growth by enhancing access to essential diagnostic tools. In October 2023, the World Health Organization (WHO) released an updated Essential Diagnostics List (EDL), a comprehensive catalog of vital IVD products that aids countries in making informed decisions on diagnostic tools. This list provides evidence-based recommendations, ensuring that essential diagnostic products are accessible to the people who need them most. Additionally, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to improve access to diagnostic tests across the African continent. Such initiatives are expected to further support the expansion of the IVD market, especially in regions with limited healthcare resources.

The global aging population, coupled with growing awareness of early disease detection, has led to an increase in routine check-ups. This trend is particularly relevant because the majority of deaths due to infections and chronic conditions occur in people over 75. According to the UK's Office for Budget Responsibility, healthcare costs have seen a significant rise, which can place economic strain on countries with rapidly aging populations. However, these increased expenditures are likely to boost the IVD market, as diagnostic testing becomes essential in managing the healthcare needs of older adults.

End-use Segmentation Insights:

Hospitals represented the largest revenue share in the IVD market in 2023, largely due to an increase in hospital admissions requiring rapid diagnostic support. The continuous development of healthcare infrastructure, supported by government initiatives, is further improving hospital facilities, thereby increasing demand for hospital-based IVD testing. IVD tests are frequently purchased by hospitals and are utilized in large volumes due to their critical role in providing fast, accurate results for patient care. In the U.S. alone, there are over 6,129 hospitals, all of which rely on IVD tests for essential decision-making in patient care.

In December 2023, the American Hospital Association advocated to the FDA that regulatory requirements for devices should not apply to hospitals' laboratory-developed tests (LDTs), which could allow hospitals greater flexibility in their use of in-house diagnostic tools. Meanwhile, the homecare segment is anticipated to see high growth from 2024 to 2030, driven by the aging population and increasing demand for at-home diagnostic devices. There is a particular need for novel molecular diagnostic and immunoassay platforms that enable patients to perform self-tests conveniently at home. For example, in February 2023, the FDA granted Emergency Use Authorization (EUA) to the first over-the-counter (OTC) home diagnostic test capable of distinguishing between influenza A, influenza B, and SARS-CoV-2 (the virus causing COVID-19). This authorization demonstrates the shift towards providing individuals with more autonomy in managing their health through accessible at-home testing solutions.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

[researchreportinsight]

In Vitro Diagnostics (IVD) Industry Growth Analysis & Forecast Research Report, 2030

The global in vitro diagnostics (IVD) market reached an estimated size of USD 77.92 billion in 2023, with expectations for a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This market growth is primarily driven by the increasing use of IVD tools due to rising cases of infectious and chronic diseases worldwide. Automated IVD systems are becoming more common in hospitals and laboratories, as they provide accurate, fast, and error-free diagnoses, helping meet the growing demand for efficient healthcare services. Additionally, IVD market expansion is fueled by frequent product launches from key industry players. For example, in November 2023, ARUP Laboratories received a CE mark from the EU-IVDR for AAV5 DetectCDx, a companion diagnostic that helps identify eligibility for severe hemophilia Some patients to receive BioMarin’s gene therapy, Roctavian.

Major companies in the IVD market are employing various strategies to strengthen their position and bring more advanced and diverse products to their customers. New product launches and partnerships are among the most common tactics. For instance, in March 2023, BD received FDA 510(k) clearance for the BD Vaginal Panel on its BD COR System, a tool designed to detect infectious causes of vaginitis. In another instance, in August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These partnerships and product developments highlight how key players are focused on expanding their diagnostic offerings to meet growing healthcare needs.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Supportive initiatives from government and non-governmental bodies are also contributing to the market's growth by enhancing access to essential diagnostic tools. In October 2023, the World Health Organization (WHO) released an updated Essential Diagnostics List (EDL), a comprehensive catalog of vital IVD products that aids countries in making informed decisions on diagnostic tools. This list provides evidence-based recommendations, ensuring that essential diagnostic products are accessible to the people who need them most. Additionally, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to improve access to diagnostic tests across the African continent. Such initiatives are expected to further support the expansion of the IVD market, especially in regions with limited healthcare resources.

The global aging population, coupled with growing awareness of early disease detection, has led to an increase in routine check-ups. This trend is particularly relevant because the majority of deaths due to infections and chronic conditions occur in people over 75. According to the UK's Office for Budget Responsibility, healthcare costs have seen a significant rise, which can place economic strain on countries with rapidly aging populations. However, these increased expenditures are likely to boost the IVD market, as diagnostic testing becomes essential in managing the healthcare needs of older adults.

End-use Segmentation Insights:

Hospitals represented the largest revenue share in the IVD market in 2023, largely due to an increase in hospital admissions requiring rapid diagnostic support. The continuous development of healthcare infrastructure, supported by government initiatives, is further improving hospital facilities, thereby increasing demand for hospital-based IVD testing. IVD tests are frequently purchased by hospitals and are utilized in large volumes due to their critical role in providing fast, accurate results for patient care. In the U.S. alone, there are over 6,129 hospitals, all of which rely on IVD tests for essential decision-making in patient care.

In December 2023, the American Hospital Association advocated to the FDA that regulatory requirements for devices should not apply to hospitals' laboratory-developed tests (LDTs), which could allow hospitals greater flexibility in their use of in-house diagnostic tools. Meanwhile, the homecare segment is anticipated to see high growth from 2024 to 2030, driven by the aging population and increasing demand for at-home diagnostic devices. There is a particular need for novel molecular diagnostic and immunoassay platforms that enable patients to perform self-tests conveniently at home. For example, in February 2023, the FDA granted Emergency Use Authorization (EUA) to the first over-the-counter (OTC) home diagnostic test capable of distinguishing between influenza A, influenza B, and SARS-CoV-2 (the virus causing COVID-19). This authorization demonstrates the shift towards providing individuals with more autonomy in managing their health through accessible at-home testing solutions.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

[marketanalysisdata]

In Vitro Diagnostics (IVD) Industry Size, Trends, Value, Sales and Forecast 2030

The global in vitro diagnostics (IVD) market was valued at approximately USD 77.92 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This growth can be attributed to several factors, including the increasing adoption of IVD technologies due to the rising prevalence of infectious and chronic diseases. The development and integration of automated IVD systems in laboratories and hospitals, which aim to deliver more efficient, accurate, and error-free diagnoses, are also expected to significantly drive market growth. Additionally, the continuous introduction of new IVD products by key industry players contributes to this positive trend. For instance, in November 2023, ARUP Laboratories obtained a CE mark under the EU-IVDR for the AAV5 DetectCDx, a companion diagnostic test that determines the eligibility of patients with severe hemophilia A for BioMarin's gene therapy, Roctavian.

Technological advancements in IVD systems, particularly improvements in accuracy, portability, and cost-effectiveness, are among the high-impact factors influencing this market. Innovations in highly accurate clinical laboratory tests are fostering global adoption of novel IVD diagnostics. For example, in June 2023, Japan's Ministry of Health, Labour, and Welfare granted marketing approval to Toray Industries, Inc. for its Toray APOA2-iTQ, a diagnostic tool used for pancreatic cancer detection. Similarly, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory blood test for Traumatic Brain Injury (TBI). These developments highlight the increasing approval of IVD tests targeting life-threatening diseases, which is expected to create significant opportunities in untapped market segments.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Leading companies in the IVD market are adopting diverse strategies to strengthen their positions, often introducing new products and forming partnerships to attract more customers and meet evolving diagnostic needs. For instance, in March 2023, BD received 510(k) clearance from the U.S. FDA for its BD Vaginal Panel on the BD COR System, aimed at detecting infectious causes of vaginitis. In August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These strategic collaborations and product launches are critical for companies seeking to leverage cutting-edge technologies in diagnostics.

Product Segmentation Insights:

In terms of products, the reagents segment accounted for the largest market share, representing 65.88% of total revenue in 2023. This segment is expected to maintain its dominance, growing at the fastest CAGR from 2024 to 2030. The growth of the reagents segment is driven by extensive research and development (R&D) efforts by key players aimed at developing novel reagents and test kits. For example, in February 2023, BD received market approval for its BD Onclarity HPV Assay, which is used with the ThinPrep Pap Test in the U.S. Ongoing R&D efforts focused on faster cancer detection and precision medicine are prompting companies to concentrate on specialized, profitable areas of the IVD market. In March 2023, QIAGEN formed a partnership with Servier to develop a companion diagnostic test for TIBSOVO, which is indicated for the treatment of acute myeloid leukemia, a type of blood cancer.

The growing demand for precision medicine is expected to further boost the overall demand for these novel reagents and consumables. The instruments segment held the second-largest share of the IVD market in 2023. Increasing approvals of novel IVD instruments are likely to contribute to the segment's growth. For instance, in April 2023, bioMérieux SA submitted a 510(k) application to the U.S. FDA for VITEK REVEAL, a rapid antimicrobial susceptibility testing (AST) system. Moreover, companies are aligning their instrument launches to meet the increasing demand for genetic tests globally. In March 2022, Thermo Fisher Scientific introduced the Ion Torrent Genexus Dx Integrated Sequencer for both research and diagnostic purposes, showcasing the alignment of technological advancements with the growing needs of genetic testing.

In conclusion, the global IVD market is poised for substantial growth, driven by the increasing incidence of infectious and chronic diseases, rising demand for precision medicine, and ongoing advancements in diagnostic technologies. Companies are continuously innovating, launching new products, and forming strategic partnerships to meet the evolving needs of healthcare providers and patients, which will further accelerate market expansion.

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