In Vitro Diagnostics Market Size

ID: MRFR/MED/0659-CR

100 Pages

Kinjoll Dey

February 2021

In Vitro Diagnostics Market Research Report By Test Type (Clinical Chemistry, Microbiology, Immunology, Molecular Diagnostics, Hematology), By Product (Reagents, Instruments, Software, Quality Control Products, Consumables), By End User (Hospitals, Diagnostic Laboratories, Academic and Research Institutions, Home Care Settings), By Application (Infectious Diseases, Diabetes, Oncology, Cardiovas...

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In Vitro Diagnostics Size

In Vitro Diagnostics Market Growth Projections and Opportunities

In vitro diagnostics (IVD) is being impacted by the aging population for several reasons. Since chronic diseases become more common with age, diagnostic tests to monitor and treat them are needed. Diagnostic advances have a major influence on intravenous drug sales. Molecular tests, next-generation sequencing, and point-of-care testing are all better ways to diagnose diseases quickly and correctly. Diagnostic testing is being driven by a growing knowledge of preventative health care. More individuals are monitoring their health, which increases the demand for in vitro diagnostics that may identify and prevent infections early. The IVD sector is affected by global health issues like COVID-19. In vitro diagnostics is crucial during public health emergencies because thorough and quick testing is needed. IVD is heavily impacted by government rules and compliance. Manufacturers must follow regulations to assure diagnostic product safety and effectiveness. Market dynamics and new technology introduction are affected by this. Intravenous medication administration is growing due to customized treatment and innovative biomarkers. Diagnostic tests that discover biomarkers and tailor treatment approaches based on patient profiles are becoming increasingly important in the quickly changing healthcare environment. The rise of point-of-care testing drives the market. Point-of-care diagnostic instruments provide fast testing and instant findings to enhance patient care in clinics, emergency departments, and rural areas. Partnerships and cooperation between research organizations, healthcare providers, and diagnostic and research enterprises affect the IVD industry. These partnerships frequently lead to comprehensive diagnostic answers and advance medicine. In vitro diagnostics integrated with digital health platforms and connection-enabling technologies are affecting the market. Connected diagnostics provide direct monitoring, data exchange, and better doctor-patient communication. Economic variables and healthcare spending in different areas affect the IVD market. Economic expansion and healthcare infrastructure improvements have increased diagnostic technology and testing utilization. The intravenous drug manufacturing industry is affected by patient empowerment and self-testing. Home-based diagnostic kits and self-monitoring technologies empower people to control their health. Industry growth is boosted.

Market Highlights

Author

Kinjoll Dey

Research Analyst Level I

He is an extremely curious individual currently working in Healthcare and Medical Devices Domain. Kinjoll is comfortably versed in data centric research backed by healthcare educational background. He leverages extensive data mining and analytics tools such as Primary and Secondary Research, Statistical Analysis, Machine Learning, Data Modelling. His key role also involves Technical Sales Support, Client Interaction and Project management within the Healthcare team. Lastly, he showcases extensive affinity towards learning new skills and remain fascinated in implementing them.

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FAQs

What is the projected growth of the In Vitro Diagnostics (IVD) market?

The In Vitro Diagnostics (IVD) market is the expected increase in total market value of 133.3 USD billion over a defined forecast period 2025–2035. It is driven by factors such as demand trends, technological advances, regulatory changes, and geographic expansion.

What is the size of the In Vitro Diagnostics (IVD) market?

In Vitro Diagnostics (IVD) market size was valued at approximately 84.6 billion USD in 2024. This figure will reach 133.3 billion USD covering all regions (America, Europe, Asia, MEA and ROW), focusing its segments / services / distribution channels till 2035.

What is the CAGR of the In Vitro Diagnostics (IVD) market?

In Vitro Diagnostics (IVD) market is expected to grow at a CAGR of 4.22% between 2025 and 2035.

How much will the In Vitro Diagnostics (IVD) market be worth by 2035?

In Vitro Diagnostics (IVD) market is expected to be worth of 133.3 billion USD, reflecting growth driven by usage, technology and global demands by the end of 2035.

How will the In Vitro Diagnostics (IVD) market perform over the next 10 years?

Over the next 10 years the In Vitro Diagnostics (IVD) market is expected to shift from usd billion 84.6 to 133.3 billion USD, led by adoption of advanced tech, demographic trends, regulatory approvals, with potential headwinds from 2025 to 2035.

What is the anticipated market size for the Global In vitro diagnostics (IVDs) market by 2035?

The anticipated market size for the In vitro diagnostics (IVDs) market by 2035 is expected to reach 120.0 USD Billion.

Which region is expected to have the largest market share of In vitro diagnostics (IVDs) market in 2024?

In 2024, North America is expected to have the largest market share, valued at 30.5 USD Billion.

How much is the Global In vitro diagnostics (IVDs) market in Europe expected to be valued at in 2035?

The Global In vitro diagnostics (IVDs) marketin Europe is expected to be valued at 38.0 USD Billion by 2035.

Who are the key players in the Global In vitro diagnostics (IVDs) market ?

Key players in the In vitro diagnostics (IVDs) market include Abbott Laboratories, Hologic, and Thermo Fisher Scientific among others.

What is the projected market size for Clinical Chemistry in 2035?

The projected market size for Clinical Chemistry in the Global In Vitro Diagnostics Market is expected to reach 45.0 USD Billion by 2035.

1. Market Overview

2. Market Trends

3. Market Segment Insights

4. Key Players and Competitive Insights

5. Industry Developments

6. Market Segmentation

7. Report Scope

8. Market Highlights

9. FAQs

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Market Summary

As per MRFR analysis, the In Vitro Diagnostics Market was estimated at 84.6 USD Billion in 2024. The In Vitro Diagnostics industry is projected to grow from 88.17 USD Billion in 2025 to 133.3 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 4.22 during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The In Vitro Diagnostics Market is poised for substantial growth driven by technological advancements and increasing demand for personalized healthcare solutions.

Technological advancements are revolutionizing diagnostic tools, enhancing accuracy and efficiency in testing.
North America remains the largest market, while Asia-Pacific is emerging as the fastest-growing region in the in vitro diagnostics sector.
Clinical chemistry continues to dominate the market, whereas molecular diagnostics is experiencing rapid growth due to its precision.
Rising prevalence of chronic diseases and growing awareness of personalized medicine are key drivers propelling market expansion.

In Vitro Diagnostics Market

CAGR

4.22%

Market Size & Forecast

2024 Market Size	84.6 (USD Billion)
2035 Market Size	133.3 (USD Billion)
CAGR (2025 - 2035)	4.22%
Largest Regional Market Share in 2024	North America

Major Players

Roche Diagnostics (CH), Abbott Laboratories (US), Siemens Healthineers (DE), Thermo Fisher Scientific (US), Danaher Corporation (US), Becton Dickinson and Company (US), bioMérieux (FR), Ortho Clinical Diagnostics (US), Hologic, Inc. (US)

Market Trends

The In Vitro Diagnostics Market is currently experiencing a transformative phase, driven by advancements in technology and an increasing emphasis on personalized medicine. The integration of artificial intelligence and machine learning into diagnostic tools appears to enhance accuracy and efficiency, potentially leading to improved patient outcomes. Furthermore, the growing prevalence of chronic diseases and the aging population are likely to fuel demand for innovative diagnostic solutions. As healthcare systems evolve, the focus on early detection and preventive care seems to be reshaping the landscape of in vitro diagnostics, encouraging the development of novel assays and testing methods. In addition, regulatory bodies are adapting to the rapid changes within the In Vitro Diagnostics Market, which may facilitate faster approvals for new products. This dynamic environment suggests that companies are increasingly investing in research and development to stay competitive. The rise of point-of-care testing is also noteworthy, as it offers convenience and immediate results, aligning with the needs of both healthcare providers and patients. Overall, the In Vitro Diagnostics Market is poised for substantial growth, driven by innovation and a shift towards more patient-centric approaches in healthcare.

Technological Advancements

The integration of cutting-edge technologies, such as artificial intelligence and machine learning, is revolutionizing the In Vitro Diagnostics Market. These innovations enhance the precision and speed of diagnostic tests, potentially leading to better patient management and outcomes.

Personalized Medicine

There is a noticeable shift towards personalized medicine within the In Vitro Diagnostics Market. This trend emphasizes tailored treatment plans based on individual patient profiles, which may improve therapeutic efficacy and minimize adverse effects.

Point-of-Care Testing

Point-of-care testing is gaining traction in the In Vitro Diagnostics Market, offering rapid results and convenience for both patients and healthcare providers. This trend aligns with the growing demand for accessible and efficient diagnostic solutions.

In Vitro Diagnostics Market Market Drivers

Rising Prevalence of Chronic Diseases

The increasing incidence of chronic diseases such as diabetes, cardiovascular disorders, and cancer is a primary driver of the In Vitro Diagnostics Market. As healthcare systems strive to manage these conditions effectively, the demand for diagnostic tests that can provide timely and accurate results is surging. For instance, the World Health Organization has reported that chronic diseases account for approximately 70 percent of all deaths worldwide. This trend necessitates the development and deployment of advanced diagnostic tools, thereby propelling the In Vitro Diagnostics Market forward. Furthermore, the growing aging population, which is more susceptible to these diseases, is likely to further amplify the demand for in vitro diagnostic solutions.

Growing Awareness of Personalized Medicine

The rising awareness and adoption of personalized medicine are shaping the In Vitro Diagnostics Market. Personalized medicine, which tailors treatment based on individual patient characteristics, relies heavily on accurate diagnostic testing. As healthcare providers increasingly utilize genetic and biomarker testing to inform treatment decisions, the demand for in vitro diagnostics is expected to grow. Market analysis indicates that the personalized medicine market is projected to reach USD 2 trillion by 2025, which will likely drive the In Vitro Diagnostics Market as well. This trend underscores the importance of precision diagnostics in improving patient outcomes and optimizing therapeutic strategies.

Increasing Demand for Preventive Healthcare

The growing emphasis on preventive healthcare is significantly influencing the In Vitro Diagnostics Market. As healthcare providers and patients alike recognize the importance of early detection and prevention of diseases, the demand for diagnostic tests is expected to rise. Preventive diagnostics can lead to timely interventions, reducing the overall burden on healthcare systems. Market data suggests that the preventive healthcare market is anticipated to grow at a rate of 8 percent annually, which will likely bolster the In Vitro Diagnostics Market. This shift towards preventive measures is fostering a culture of health awareness, thereby increasing the utilization of diagnostic tests across various demographics.

Regulatory Support and Reimbursement Policies

Supportive regulatory frameworks and favorable reimbursement policies are crucial drivers of the In Vitro Diagnostics Market. Governments and regulatory bodies are increasingly recognizing the value of in vitro diagnostics in enhancing patient care and reducing healthcare costs. For instance, streamlined approval processes for new diagnostic tests can expedite their entry into the market, fostering innovation. Additionally, reimbursement policies that cover a wide range of diagnostic tests encourage healthcare providers to adopt these technologies. This supportive environment is likely to enhance the growth prospects of the In Vitro Diagnostics Market, as more stakeholders become willing to invest in advanced diagnostic solutions.

Technological Innovations in Diagnostic Tools

Technological advancements are revolutionizing the In Vitro Diagnostics Market, leading to the introduction of more sophisticated and efficient diagnostic tools. Innovations such as next-generation sequencing, microfluidics, and point-of-care testing devices are enhancing the accuracy and speed of diagnostic results. According to recent data, the market for molecular diagnostics alone is projected to reach USD 11 billion by 2026, reflecting a compound annual growth rate of over 10 percent. These innovations not only improve patient outcomes but also streamline laboratory workflows, making them essential in the evolving landscape of healthcare. As technology continues to advance, the In Vitro Diagnostics Market is expected to witness further growth driven by these cutting-edge solutions.

Market Segment Insights

In Vitro Diagnostics Market Test Type Insights

The Global In Vitro Diagnostics Market is experiencing notable growth within the Test Type segment, which encompasses various essential categories, including Clinical Chemistry, Microbiology, Immunology, Molecular Diagnostics, and Hematology. In 2024, the <a href="https://www.marketresearchfuture.com/reports/clinical-chemistry-analyzers-devices-market-16194">Clinical Chemistry </a>segment is valued at 30.0 USD Billion, positioning it as a leader in this market segment.

It reflects its extensive use in routine laboratory testing, enabling healthcare professionals to diagnose and monitor numerous diseases effectively. Following closely, the Hematology category holds a valuation of 15.19 USD Billion, demonstrating its vital role in understanding blood disorders and systemic diseases, further contributing to the overall diagnostic approach within healthcare.

<a href="https://www.marketresearchfuture.com/reports/microbiology-testing-market-697">Microbiology </a>is also a significant player, valued at 15.0 USD Billion in 2024, ensuring that infectious diseases can be identified and treated promptly to prevent outbreaks. The Immunology segment, although relatively smaller at 9.0 USD Billion, plays a vital role in understanding the immune response and autoimmune conditions, allowing clinicians to make informed decisions about patient care.

In Vitro Diagnostics Market Product Insights

The Global In Vitro Diagnostics Market showcases a comprehensive range of products, including Reagents, Instruments, Software, Quality Control Products, and Consumables. Reagents play a pivotal role, serving as essential components in diagnostic testing, while Instruments facilitate the analysis and visualization of results. Software is increasingly critical for data interpretation and management, aiding in the streamlined workflows of laboratories.

Quality Control Products ensure the accuracy and reliability of test results, which is crucial for patient safety and effective healthcare delivery.Consumables, often utilized alongside these products, hold a significant share of the market, highlighting their necessity in daily diagnostic operations. The combined market growth is driven by advancements in technology, an increasing burden of chronic diseases, and a growing emphasis on early disease detection and personalized medicine. Furthermore, the market faces challenges such as stringent regulatory environments and the need for constant innovation to meet rising consumer demands.

Overall, the Global In Vitro Diagnostics Market segmentation indicates a robust and evolving landscape poised for growth fueled by innovations and heightened healthcare focus.

In Vitro Diagnostics Market End User Insights

The Global In Vitro Diagnostics Market plays a crucial role in the healthcare ecosystem, particularly in various End-user categories. Hospitals are significant players, being primary providers of diagnostic services, while Diagnostic Laboratories contribute extensively to accurate testing and analysis, driving efficiency in disease detection. Academic and Research Institutions are vital for innovation and development, focusing on new diagnostic technologies, thus shaping future market dynamics. Home Care Settings are gaining prominence, offering patients convenient testing options, especially in remote or underserved areas.

As the market progresses, these segments are influenced by advancements in technology, regulatory changes, and an increasing focus on personalized medicine, creating both opportunities and challenges for stakeholders. The continuous growth of the overall market industry, reinforced by supportive government policies and the rising prevalence of chronic diseases globally, emphasizes the importance of each category in enhancing patient outcomes and shaping the future landscape of the Global In Vitro Diagnostics Market.

In Vitro Diagnostics Market Application Insights

The Global In Vitro Diagnostics Market is projected to showcase substantial growth in the Application segment, with a market value reaching USD 81.19 Billion by 2024. This segment encompasses various critical areas such as Infectious Diseases, Diabetes, Oncology, Cardiovascular Diseases, and Genetic Testing, each playing a pivotal role in improving patient outcomes and public health.

Among these, Infectious Diseases diagnostics are increasingly vital, especially amid global health crises, addressing urgent needs for real-time disease detection.Diabetes management tools are also significant, offering essential tracking and monitoring that facilitate timely interventions. Additionally, the Oncology diagnostics segment is gaining momentum as cancer prevalence rises, showcasing advancements in personalized medicine and targeted therapies.

Cardiovascular Disease diagnostics continue to dominate as heart-related conditions remain the leading causes of mortality globally, necessitating preventive and diagnostic measures. Finally, Genetic Testing is on the rise due to its relevance in early disease detection and personalized healthcare approaches.The ongoing innovations in diagnostic technologies and the increasing awareness of preventive healthcare fuel the growth of these applications, establishing the Global In Vitro Diagnostics Market as a crucial aspect of contemporary healthcare services.

Get more detailed insights about In-Vitro Diagnostics [IVD] Market Research Report – Forecast to 2035

Regional Insights

North America : Market Leader in Diagnostics

North America is the largest market for in vitro diagnostics, holding approximately 45% of the global share. Key growth drivers include advanced healthcare infrastructure, increasing prevalence of chronic diseases, and a strong focus on personalized medicine. Regulatory support from agencies like the FDA further catalyzes innovation and market expansion. The U.S. is the primary contributor, followed by Canada, which is experiencing significant growth due to rising healthcare investments. The competitive landscape is characterized by the presence of major players such as Abbott Laboratories, Thermo Fisher Scientific, and Roche Diagnostics. These companies are investing heavily in R&D to develop innovative diagnostic solutions. The market is also witnessing a trend towards point-of-care testing, driven by the need for rapid and accurate results. This shift is expected to enhance patient outcomes and streamline healthcare delivery.

Europe : Regulatory Framework and Innovation

Europe is the second-largest market for in vitro diagnostics, accounting for approximately 30% of the global market share. The region's growth is driven by an aging population, increasing healthcare expenditure, and a robust regulatory framework that encourages innovation. The European Union's In Vitro Diagnostic Regulation (IVDR) aims to enhance patient safety and ensure high-quality diagnostic products, further stimulating market growth. Leading countries in this region include Germany, France, and the UK, which are home to several key players like Siemens Healthineers and bioMérieux. The competitive landscape is marked by a strong emphasis on technological advancements and partnerships among companies to enhance product offerings. The presence of well-established healthcare systems facilitates the adoption of innovative diagnostic solutions, making Europe a vital hub for market expansion.

Asia-Pacific : Emerging Market Potential

Asia-Pacific is rapidly emerging as a significant player in the in vitro diagnostics market, holding approximately 20% of the global share. The region's growth is fueled by increasing healthcare investments, rising awareness of preventive healthcare, and a growing population with chronic diseases. Countries like China and India are leading this growth, supported by government initiatives aimed at improving healthcare access and quality. The competitive landscape in Asia-Pacific is evolving, with both multinational corporations and local players vying for market share. Key players such as Danaher Corporation and Becton Dickinson are expanding their presence through strategic partnerships and acquisitions. The region is also witnessing a surge in demand for point-of-care testing, driven by the need for rapid diagnostics in remote areas, further enhancing market dynamics.

Middle East and Africa : Untapped Market Opportunities

The Middle East and Africa represent an emerging market for in vitro diagnostics, holding approximately 5% of the global share. The growth in this region is driven by increasing healthcare investments, rising prevalence of infectious diseases, and a growing focus on improving healthcare infrastructure. Countries like South Africa and the UAE are leading the market, supported by government initiatives aimed at enhancing healthcare access and quality. The competitive landscape is characterized by a mix of local and international players, with companies like Ortho Clinical Diagnostics and Hologic, Inc. making significant inroads. The region is witnessing a growing demand for innovative diagnostic solutions, particularly in point-of-care testing, which is crucial for addressing healthcare challenges in remote and underserved areas. This presents significant opportunities for market expansion and investment.

Key Players and Competitive Insights

The Global In Vitro Diagnostics Market has become increasingly competitive as technological advancements and rising healthcare demands reshape the landscape. These market dynamics are driven by major players who strive to innovate and expand their product offerings in response to the evolving needs of healthcare providers and patients worldwide. Players within the market are leveraging research and development to enhance the performance of diagnostic tests while striving to gain market share in regions experiencing growth, such as North America, Europe, Asia, and emerging markets.

The competitiveness in this sector is also influenced by factors such as regulatory changes, pricing pressures, and the constant introduction of novel diagnostic solutions. The focus on personalized medicine and point-of-care diagnostics is amplifying competitive strategies as companies position themselves to cater to an increasingly informed consumer base and healthcare professionals.Abbott Laboratories stands out in the Global In Vitro Diagnostics Market due to its extensive experience and diverse portfolio that includes a wide range of diagnostic products and systems. The company’s strengths are rooted in its commitment to innovation, which is evident through constant investments in research and development.

Abbott’s diagnostics division has maintained a robust presence worldwide, supported by its comprehensive offerings that span various disciplines, including immunoassay, molecular diagnostics, and point-of-care testing. The company’s ability to integrate its diagnostics with digital technologies also enhances its market position, making it competitive in delivering timely and accurate results to healthcare providers. Moreover, Abbott’s established global distribution network enables it to remain accessible in various healthcare settings, thus reinforcing its stature in the market.

Hologic is another significant player in the Global In Vitro Diagnostics Market, renowned for its focus on women's health and related diagnostic solutions. The company offers a range of products, including molecular diagnostic tests and blood screening assays that cater to specific health conditions affecting women. Hologic's market presence is bolstered by its strategic focus on delivering innovative technologies that improve health outcomes while enhancing patient care.

The strength of Hologic lies in its commitment to research and development, leading to numerous advancements in diagnostic capabilities. The company has been proactive in mergers and acquisitions, allowing it to strengthen its product portfolio and expand its market share rapidly. Hologic's reputation for quality and reliability makes it a trusted name among healthcare professionals, positioning it favorably against competitors in the global market landscape.

Key Companies in the In Vitro Diagnostics Market market include

Industry Developments

Abbott Laboratories

May 2025: Abbott announced it received CE Mark to the IVD Directive (98/79/EC) for its laboratory-based serology blood test for the detection of the1 IgG antibody, which identifies if a person has had COVID-19.

Roche Diagnostics (F. Hoffmann-La Roche Ltd)

June 2025: Access Medical Labs, a subsidiary of Empresas Aries, completed a full transition from Siemens to Roche Diagnostics systems in under 6 months, increasing its daily diagnostic capacity fivefold.
May 2025: Roche announced a new collaboration with Broad Clinical Labs to accelerate the adoption of cutting-edge SBX sequencing technology.
May 2025: Roche received FDA approval for the VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify non-squamous non-small cell lung cancer patients eligible for treatment with Emrelis.

Recent developments in the Global In Vitro Diagnostics Market have seen significant growth, particularly amid the ongoing demand for advanced testing solutions in response to public health needs. Companies such as Abbott Laboratories and Thermo Fisher Scientific continue to innovate, with expanded product offerings focusing on molecular diagnostics and infectious disease testing. In September 2023, Hologic announced the release of new PCR technology aimed at enhancing testing efficiency and accuracy.

Notably, Danaher Corporation's acquisition of GE Healthcare's biomanufacturing business in October 2023 is expected to strengthen its portfolio in molecular diagnostics. The market is also experiencing upward valuation trends, driven by increased funding for Research and Development initiatives among key players like Roche Diagnostics and Siemens Healthineers, which are investing heavily in digital health technologies.

Current affairs highlight the growing regulatory support for rapid diagnostic tests, particularly for respiratory illnesses, emphasizing the need for innovation. Over the past two to three years, the market has also seen robust expansion in regions like North America and Europe, propelled by increasing healthcare expenditures and advancements in laboratory automation, reinforcing the importance of ongoing collaboration and strategic partnerships to address emerging healthcare challenges.

Future Outlook

In Vitro Diagnostics Market Future Outlook

The In Vitro Diagnostics Market is projected to grow at a 4.22% CAGR from 2024 to 2035, driven by technological advancements, increasing prevalence of chronic diseases, and rising demand for personalized medicine.

New opportunities lie in:

Development of point-of-care testing devices for rapid diagnostics.
Expansion into emerging markets with tailored diagnostic solutions.
Integration of AI and machine learning for enhanced data analysis in diagnostics.

By 2035, the In Vitro Diagnostics Market is expected to be robust, driven by innovation and strategic expansions.

Market Segmentation

Report Scope

MARKET SIZE 2024	84.6(USD Billion)
MARKET SIZE 2025	88.17(USD Billion)
MARKET SIZE 2035	133.3(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR)	4.22% (2024 - 2035)
REPORT COVERAGE	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR	2024
Market Forecast Period	2025 - 2035
Historical Data	2019 - 2024
Market Forecast Units	USD Billion
Key Companies Profiled	Market analysis in progress
Segments Covered	Market segmentation analysis in progress
Key Market Opportunities	Integration of artificial intelligence in diagnostic processes enhances accuracy and efficiency in the In Vitro Diagnostics Market.
Key Market Dynamics	Technological advancements and regulatory changes are reshaping competitive dynamics in the In Vitro Diagnostics Market.
Countries Covered	North America, Europe, APAC, South America, MEA