Evolution of a Powerful Diagnostic Technology

Evolution of a Powerful Diagnostic Technology

The market is shifting toward the acceptance of novel technology-based, cost-effective devices introduced by the key brands operating in the diagnostics industry.

Ultrasound imaging took some major steps forward in 2016, with innovative new systems and technologies debuting across multiple market segments. From new premium-tier systems to the expansion of handheld, point-of-care (POC) solutions, vendors focused on improvements in image quality, productivity, and ergonomics. The technology, which was discovered before other modalities such as MRI, took time to develop into the powerful diagnostic technology that it is today.

Ultrasound is constantly shifting toward greater mobility. Diagnostics as an industry is moving toward using non-ionizing technologies for imaging such as MRI and capsule endoscopy. There are an increasing number of companies that are introducing handheld and portable ultrasound equipment. Due to relative safety and its non-invasive nature, ultrasonic imaging has become one of the most rapidly advancing technologies. Companies are introducing wireless transducers that are able to send images of internal organs such as kidneys, heart, and lungs without worrying about troublesome cables or moving bulky machines around in a patient’s room. Looking to the boldness of small players in accessing international markets, it is sufficient to say the market is already highly competitive, and pricing new technology adequately so as to be accessible to large populations in emerging regions will guarantee significant capital returns.

Indian Market Dynamics

The Indian ultrasound systems market in 2016 is estimated at Rs.1212 crore. Trends suggest that the market for color ultrasound systems for the first time showed a decline. The decline could be attributed to the increase in customs duty by 7.3 percent to 18.94 percent in January 2016, coupled with foreign exchange volatility. The strict implementation of the Prenatal Diagnostic Tests Act, which prevents deliberate abortion of female fetus after determining the gender of the baby is discouraging purchase. Demonetization also played spoilsport in November and December.

The black-and-white ultrasound systems market is estimated to be steady at about 325 systems, valued at Rs.12 crore since the past couple of years, declining by 1–2 percent every year.

Global Market

The global ultrasound equipment market is segmented on the basis of product type, equipment display, portability, application, and geography. Based on product type, the market is categorized into diagnostic and therapeutic ultrasound equipment. Diagnostic ultrasound equipment generated the highest revenue in 2015, owing to increase in aging population, which requires frequent diagnostic examinations. The therapeutic ultrasound equipment segment is estimated to reach USD 353 million by 2020.

Based on the type of device display, the market is categorized into color ultrasound equipment and black-and-white (B/W) ultrasound equipment. The color ultrasound equipment accounted for the highest share in 2015 and is estimated to grow at a CAGR of 5.9 percent.

Based on device portability, the market is categorized into trolley/cart-based ultrasound equipment and compact/handheld ultrasound equipment. The trolley/cart-based ultrasound devices accounted for the largest share in 2015, whereas the compact/handheld ultrasound devices segment is the fastest growing segment with a CAGR of 7.4 percent. Although the compact/handheld ultrasound equipment segment is expected to grow at a high CAGR due to increased adoption of portable ultrasound devices for point-of-care applications, it cannot outpace the trolley/cart based ultrasound equipment as they offer more accurate diagnostic capabilities and high performance.

The global ultrasound devices market valued at Rs.38,500 crore in 2015 and it is projected to reach Rs.70,200 crore by 2022. Major factors boosting the market growth include technological advancements (such as advent of 3-D and 4-D ultrasound that provides detailed information about a known abnormality from different angles), rising incidences of chronic diseases, and increasing geriatric population worldwide. The rising number of application areas of ultrasound coupled with increasing adoption of ultrasound systems in obstetrics and gynecology field is set to boost the growth of the ultrasound market worldwide. Cost effectiveness, safety, high accessibility, and clinical value in preliminary diagnosis are strengthening the technologies value proposition in technological advancements in the ultrasound market. In addition, increase in the number of diagnostic imaging procedures and rising awareness for early diagnosis of clinical disorders are anticipated to further drive the demand for ultrasound devices. However, the dearth of skilled and experienced sonographers and technological limitations of ultrasound systems restrict the market growth.

Ultrasound equipment find their application in radiology/general imaging, obstetrics/gynecology, cardiology, urology, vascular, and other emergency clinical areas such as emergency medicine, anesthesiology, and musculoskeletal. Radiology/general imaging was the largest segment in 2015. Rise in demand for high-quality diagnostic and therapeutic imaging capabilities, as well as the rising awareness related to radiation dose concerns with other imaging modalities have driven the growth of this segment.

Asia-Pacific is expected to be the most potential market for the period 2015 to 2019, whereas Africa is estimated to be the slowest of the six regions and is anticipated to grow at a CAGR of 5.1 percent from 2015 to 2019. North America’s diagnostic industry traditionally relies greatly on CT and MRI modalities and is ranked slightly behind Europe’s in terms of global revenue generation. Demand for high-end and premium device segments is one of the primary growth drivers for the ultrasound technology in Europe and North America.

Technological Advancements

The past decade has witnessed significant developments in ultrasound technologies ranging from portable devices, wireless transducers to 3-D/4-D ultrasound imaging, and artificial intelligence. Researchers and scientists are endeavoring on developing technologies that simplify diagnostic procedures, improve efficiency of clinicians, and enhance image quality. These research and development activities focus on improving overall quality of patient care. In addition, manufacturers are emphasizing on implementing automation in premium-tier systems, portable devices, and point-of-care (POC) solutions. The prime focus of vendors will be on offering cost-effective devices with growing innovation and competition in the global industry.

The concerns regarding overexposure to radiation by conventional systems and other devices, including MRI or CT, have enabled manufacturers to concentrate their efforts on developing less radiation. The trend of using smart fusion technologies, i.e., acquiring images using a combination of ultrasound and MRI for interventional and therapeutic applications is also gaining momentum. Following are the technological advancements that are expected to shape the ultrasonic devices industry in the coming years.

3-D/4-D ultrasound technologies. Availability of better visualization owing to advancements in 3-D and 4-D ultrasound technologies has helped gynecologists to determine congenital birth defects. The golden-colored images offered by 3-D/4-D ultrasound aid in detecting defects distinctly as compared to grey-colored images delivered by 2-D ultrasound systems. So, congenital birth defects such as spina bifida, cleft palate, and others are easy to detect and conduct diagnostic procedures. In addition, cardiologists benefit from these technologies due to availability of real-time data and quantitative diagnostic information.

Different tools are available in 3-D technologies, such as multi-planar display, which helps in rendering orthogonal views for fetal brain and cavities. In addition, it also helps gynecologists to view baby’s face, hands, and other features through surface rendering and determine genetic syndromes. Maximum intensity projection is another tool that assists clinicians to view structures of bone, including skull or vertebra more distinctively. Thick slice scanning helps visualize toes, fingers and anomalies like cleft palate better. 3-D inversion mode is helpful in examining fluid-filled structures, including brain ventricles or fetal stomach.

3-D ultrasound helps in improving precision in fetal weight estimation by measuring fractional thigh volume. This, in turn, helps in assessment of prenatal nutritional status by assessment of soft tissues of fetal limbs. Wesley Lee, co-director, Texas Children’s Fetal Center, Texas Children’s Hospital Pavilion for Women, Houston, Texas, is conducting a research based on this method. Emphasizing the role of 3-D ultrasound in assessment of fetal limbs, he said, “We have to develop new ways and novel approaches for determining which babies are truly malnourished. That’s why we are using fractional limb volume as part of the fetal weight estimation procedure to assess the fetus before delivery.”

The examination of the moving heart and obtaining dynamic multi-planar views of the heart is possible with the help of spatial temporal image correlation (STIC) technique, which uses 4-D ultrasound. Benefits of 3-D and 4-D ultrasound technologies, such as practical, easy-to-use, safe, and shorter exam time give ultrasound a new life and increased relevance in medical imaging.

AIUS. Clinicians face issues in reproduction of images in echocardiography as results vary based on the sonographer’s experience and techniques used. This issue was addressed by Philips Healthcare with the introduction of artificial intelligence software, Anatomically Intelligent Ultrasound (AIUS). The software collects image volume data with the help of 3-D echo, and optimal version of diagnostic views is created. Quantification measurements are computed from 3-D dataset and clinicians can carry out assessment of diseases and explore treatment options with highly reproducible images. AIUS also helps in saving time by obtaining dimensions three to six times faster as compared to manual methods. Advances in artificial intelligence technology help clinicians in workflow enhancement.

Point-of-care ultrasound solutions. Ultrasound has become ubiquitous in point-of-care (POC) solutions to determine and diagnose vascular and cardiac issues. Innovation in ultrasound devices gives rise to handheld, portable devices that are cost effective and save time of patients as well as of clinicians. Philips has introduced an app-based ultrasound system, Lumify. A smartphone turns into an ultrasound device by connecting Philips transducer through a USB port and using Lumify app. Smartphone screen works as a display and transducer performs all the functions regarding acquisition and image reconstruction processing. Linear and phased array transducers are available in this system.

Following the emergence of technologies and inclination of manufacturers toward innovation, the ultrasound devices will improve quality of patient care, enhance productivity of clinicians, and transform medical imaging. The last two decades have shaped the ultrasound market very well across the globe.

Industry Speak
Seeing More Innovations

The past couple of years have seen remarkable technological advancements hit the market. These innovations have not only made scanning easier for the end users, but have taken image resolutions to the next level. Scanning experience has been enhanced significantly. Zone sonography is one such innovation that has provided never-before resolution to the users. The traditional way ultrasound transducers obtain images is by scanning line-by-line. This often led to a trade-off between spatial resolution, frame rates, and tissue uniformity. Enhancing the performance of any one parameter led to deterioration in the performance of the other two. Thus images were always sub-par. Another challenge with traditional imaging was the channel data bottleneck. After a certain level the increase in number of channels does not increase the resolution. Zone sonography technology is a revolutionary, approach to acoustic data acquisition and image formation that breaks the barriers of conventional ultrasound imaging, based on innovative channel data processing methods. With the advent of Zone sonography, images are now obtained zone (multiple lines at a time) by zone. With this innovative approach, more information is gathered at higher frame rates, there is no trade-off between spatial resolution, frame rates, and tissue uniformity. Images are more homogenous.

Fat in the body, sub-cutaneous and visceral, offers high attenuation to ultrasound, thus imaging deeper structures poses big problems. Sound Speed Compensation is a latest technological advancement that overcomes this problem and makes imaging of obese patients easier. Sound Speed Compensation, with the press of a single button, detects the fat content in the target areas, and then adjusts the sound propagation speed accordingly providing higher penetration. Scanning of obese patients with ultrasound is now easier.

Touch is one of the five basic senses. With the advent of touch screens, man and machine interactions have become seamless and efficient. The new gesture- control touch panels on some ultrasound systems have taken this touch interface one step further. Machines can now be controlled with gestures. Machine control becomes easier and scanning becomes more enjoyable. I am filled with immense pride to be associated with the fastest-growing healthcare modality. Ultrasound imaging is seeing more innovations now than any other modality.

Punervasu Vyas
National Application Manager,
Mindray Medical India Private Limited


Industry Speak
Applications to Influence the Future Market Growth

Ultrasound continues to strengthen its value proposition in various healthcare systems in India due to its cost effectiveness, safety, high accessibility, and clinical value in preliminary diagnosis, and increasingly for a more definitive diagnosis. Bringing imaging to the patient rather than systematically taking the patient to imaging modalities enhances the clinical value of imaging across the healthcare system and opens up considerable new growth opportunities, from the frontline of emergency departments to the depth of subspecialties. Examples abound, and the list continues to expand, for relatively new uses of ultrasound across various clinical specialties and points of care, from image-guiding interventions and biopsies, to non-invasively diagnosing new conditions, to imaging in a war field and/or in sport settings.

The growing trend of miniaturization and increasing trust in portable systems has led to a significant increase in the market of hand-carried ultrasound systems in recent years. In the traditional ultrasound systems market, color Doppler equipment with 3-D/4-D capabilities accounts for a major chunk, while black-and-white scanners are now beginning to slowly fade out. The major technological trends in recent times include advent of fusion imaging wherein real-time ultrasound images are fused with the high-resolution contrast-enhancing images produced by modalities like computerized tomography scans and magnetic resonance imaging. Another recent medical innovation is the use of intravascular ultrasounds to assess vascular diseases like stenotic blood vessels by placing an ultrasound probe on the tip of a tiny catheter that is inserted into the lumen of the vessel.

Manufacturers would have to adapt medical devices to be effectively used in local context, e.g., designing devices which can withstand hot and dusty climate and operate effectively in areas with insufficient electricity supplies. Ultrasound being one of the modalities used in almost all health centers, mobile hospitals, and medical camps the machine requires to be robust, all-weather/terrain, reliable, and consistent in providing diagnosis. The goodness of ultrasound technology has been overshadowed by its misuse. As a result, there has been a conscious/controlled growth of this modality, especially in India, where illegal sex determination is rampant. However, the use of ultrasound in other areas such as emergency medicine, cardiology, anesthesiology, urology, and veterinary and musculoskeletal applications apart from OB/GYN has shown the importance of this modality. This variety of applications of ultrasound may significantly influence the market growth in future.

Nitin Gupta
Country Manager-India,
Fujifilm Sonosite India


Second Opinion
Advancement in Ultrasound Imaging

Medical imaging is showing fast growth in technology to keep pace with the rapidly growing population. Manufacturers are focusing on expanding ultrasound use in radiology as it is most cost-effective, fast, and efficacious. Its applications are no longer limited to 2-D images and have thus expanded to cover all specialties including radiology, cardiology, OB/GYN, urology, vascular, breast, guidance for interventional procedures, emergency medicine, and many more.

With 3-D/4-D technology, there is significant increase in accuracy and efficacy and easy guidance in interventional procedures, cancer detection in prostate and breast, etc. Portable handheld units are getting more popular for point-of-care diagnosis, increasing clinicians’ acceptability with processing units now packed into smaller devices. Wireless probes have eased their use further. With advancement in computational power, there is enhanced image reconstruction and display. This breakthrough in computing power is similar in technology to imaging modalities, which use principle of increasing number of transistors on integrated circuits (ICs). Another quality of miniaturization of device has been achieved with Windows PC-based architecture.

Elastography, earlier used for liver, has expanded to include thyroid, prostate, breast, pancreas, and cervix, and is growing to cover other organs where stiffness measurements can be diagnostic. Real-time imaging in ultrasound and faster acquisition time with a rate of 30 volumes per second and portability compared to MRI or CT is a significant advancement which holds excellent futuristic applications making complex surgical procedures a lot easier. Ultrasound contrast agents were introduced in the market few years back and were used for enhanced detection of lesions, and were suitable for patients who could not be given CT and MRI contrast as these contrast agents could seriously increase morbidity. Ultrasound contrast was the safest in these patients; however, ultrasound could not be used for functional imaging earlier like PET for a long time. Now its functional activities after contrast development have inspired scientists to explore potential for measuring events as a function of time in decay of contrast agents in vivo. This could be a breakthrough in safety and efficacy standards in near future.

Dr Vivek Sharma
Senior Consultant-Radiology,
Medanta the Medicity, Gurgaon

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