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Latest trends in medical technology and IVD

In today’s healthcare delivery system, MedTech is beginning to take a primary role for diagnosis and treatment. Developments in wearable technology, artificial intelligence (AI), data analytics, robotics, computing, and communication technology have largely been responsible for this trend, especially during the pandemic period.

The applications of AI in medicine have aided clinicians for early and accurate diagnosis. Researchers have proved that COVID-19 could be detected with more than 90 percent accuracy from chest CT scans of asymptomatic patients, and this could be distinguished from other viral infections with high specificity. Patient CT images can be analyzed and AI tools can predict the incidence of lung cancer with high accuracy at a very early stage of the disease. It is customary to screen women for breast cancer using digital mammography systems. But for women with dense breasts, there are challenges with sensitivity using this technique, and AI tools have been developed to overcome this and detect tumors at an early stage. Similarly, using MR image data and with machine learning and AI tools, assessment and characterization of abnormal breast tissue is possible with greater accuracy non-invasively. Typically, coronary calcium scoring is a biomarker for predicting cardiovascular events and requires dedicated cardiac CT studies, with and without contrast. But now, using AI tools, coronary calcium scoring is possible with standard non-contrast low-dose chest CT scans, thus avoiding extensive testing to detect high-risk patients. Incidence of diabetes has been growing worldwide, and as a consequence many of these patients are also affected by diabetic retinopathy. AI tools are now available to analyze images from a fundus camera and automatically predict this condition at early onset to save the patient’s eye sight. In order to determine blood flow disorders in the brain, neurovascular imaging of the brain is performed in an interventional suite. A transcranial doppler ultrasound system is used to measure blood flow velocities. These ultrasound images can be combined with AI tools to assess the brain’s blood vessels and predict the onset of stroke and other brain disorders caused by blood flow issues without any extensive invasive studies. AI tools are being used by smart watches to provide ECG traces and also blood pressure information so that any cardiac eventuality can be notified to the wearer and improve their quality of life. AI applications in digital pathology have helped histopathologists provide their reports more accurately and quickly. As DP images can be stored in common access locations, this is particularly useful for hospitals in remote towns without their own histopathologists.

Robotic surgery has progressed to perform minimally invasive surgeries in multiple disciplines. Intuitive Surgical has been a leader worldwide since several years. At Apollo Group Hospitals, ten of their units are being used for about a decade. Recently, Medtronic has received CE approval for their robotic surgical system and Apollo has been the first hospital to procure their system in India. Considering that accuracy and precision are critical for spine surgeries, Globus Medical has developed a navigation-assisted robotic spine surgical system to perform several spinal procedures. The system has capability of real-time monitoring of accuracy and active navigation tracking throughout the procedures. Medtronic have acquired Mazor Robotics, who have many installations worldwide of their spine robotic systems. For carrying out percutaneous interventional procedures, cardiologists and their patients have always been exposed to radiation from the cathlab in addition to mechanical fatigue at the table. To overcome these shortcomings, Corindus has developed the Corpath GRX robotic-assisted system for carrying out interventional work with more precision in stent placements, and less radiation levels in the interventional suite. The cardiologist can carry out the procedures from the console room, using joystick controls. A Swiss-based company, Hocoma, has since two decades developed robotic-assisted rehabilitation equipment to help improve the mobility for a wide range of patients. They have dedicated products to cater to pediatric and geriatric patients for upper or lower limb rehabilitation, gait and balance training, and so on. Radiation treatment has been given to treat cancer patients for more than a century. Robotic technology has been applied in the Cyberknife radiosurgical system about two decades ago to treat tumors throughout the body for the first time with utmost precision and accuracy in 1 to 5 sessions. This system also has capability to treat moving tumors like lung, liver, etc., with minimal radiation exposure to normal tissue surrounding the tumor. In addition to clinical robotic applications, this technology has also been utilized for disinfection of critical areas like ICU, OT, wards using UVC radiation by companies like Mediland and Diversey. This is especially very useful and safe during the current pandemic times.

Due to its high demand, accuracy and utility, in-vitro diagnostic solutions defined as medical devices and reagents, used to examine specimens derived from the human body, such as blood, tissues, and other body fluids, to detect diseases, conditions, and infections have piqued the curiosity of the healthcare ecosystem. IVD tests can be performed in a stand-alone laboratory, hospital-based laboratory, and point-of-care (POC) centers, and typically include polymerase chain reaction (PCR), microarray techniques, sequencing technology, and mass spectrometry, which are used for test sample preparation.

The COVID-19 pandemic has changed the contours of healthcare, and has particularly prompted seismic shifts within the IVD industry. As the pandemic gathered momen­tum, demand grew for not only faster testing but also testing in higher volumes, with molecular assays, parti­cularly the reverse-transcription polymerase chain reaction (RT-PCR), being regarded as the gold standard, and the optimal confirmatory test for diagnosing the prevalence, rate, and cyclicity of viral load. In Europe and the United States alone, the demand for molecular-diagnostic tests rose 20-fold between March and October 2020.

The volume of POC testing has predictably risen during the pandemic due to a rise in demand for faster on-site screening wherein COVID-19 testing singularly added USD 9000 million to the IVD market’s value, mostly from RT-PCR testing.

While the cases of COVID-19 continue to plateau globally, the demand for such in vitro diagnostics is likely to keep growing, making it a champion within the medical devices industry.

The medical devices market in India is growing at a staggering pace and the country is poised to become a global manufacturing hub in the medical devices space, with 100-percent FDI allowance under the automatic route for both brownfield and greenfield setups adding to its growth and resilience.

The Indian IVD market was valued at USD 1240 million in 2019, and is projected to reach USD 2060 million by 2027, registering a CAGR of 7.5 percent from 2020 to 2027.

The major factors that are driving the growth of the Indian IVD market are the high prevalence of chronic diseases, increasing use of POC diagnostics, and rising awareness and acceptance of personalized medicine and companion diagnostics. According to the Globocan factsheet, in 2020, the number of prevalent cancer cases in five years was found to be 2,720,251 among all age groups in India. Additionally, as per the International Agency for Research on Cancer (IARC), the incident cases in India are estimated to rise from 1.15 million in 2018 to 1.9 million in 2040. Similarly, according to the National Diabetes and Diabetic Retinopathy Survey report 2015–2019, there are 11.8 percent prevalent cases of diabetes in India. As diabetic is a major risk factor for many diseases, it is expected to have significant growth of the market over the forecast period.

Furthermore, emerging technological innovations in health­care, such as bio-sensors, lab-on-a-chip, wearable devices, and POC diagnostics are increasingly becoming an important part of the healthcare landscape. POC testing helps bring testing closer to the patients, and obtain results quickly for the healthcare provider to expedite diagnoses and subsequent treatment. This is likely to increase the adoption of IVD in India.

However, stringent regulatory policies and lack of sufficient reimbursement policies are projected to hamper the market growth of IVD market.

Molecular diagnostics segment is expected to grow with a CAGR of 7.12 percent.

Molecular diagnostic devices are used to analyze biological markers in the genome and proteome to detect pathogens or mutations. On the basis of technology used, molecular diagnostic devices can be segmented into chips and microarrays, mass spectroscopy, next-generation sequencing (NGS), polymerase chain reaction (PCR)-based methods, cytogenetics, and molecular imaging.

Factors, such as large outbreaks of bacterial and viral epidemics in India, increasing demand for POC diagnostics, and rapidly evolving technology, are driving the growth of the molecular diagnostics segment. Also, advancements in molecular diagnostics and new product launches in India are projected to boost the segment growth over the forecast period. For instance, in January 2020, CO-Diagnostics, Inc. and Cosara have launched CoSara tests for tuberculosis, malaria, hepatitis B, hepatitis C, and human papillomavirus.

Moreover, with the advent of COVID-19, many of the companies are focused on developing effective molecular diagnostics for the disease. In March 2020, Co-Diagnostics Inc. announced that its joint venture, CoSara Diagnostics Pvt. Ltd., had received the license from the Central Drugs Standards Control Organization (CDSCO) to manufacture RT-PCR COVID-19 test kits. Similarly, Mylab Discovery Solutions, which is a Pune-based molecular diagnostics company, launched its Compact XL to automate the manual processes of molecular diagnostic tests, such as RT-PCR tests for COVID-19.

The technological advancements in this segment have been significant, and the cost of these molecular diagnostic tests have decreased steadily, to make them accessible to more patients suffering from genetic diseases and infectious diseases. Additionally, the outbreak of COVID-19 in the region has increased the demand for molecular diagnostics, which is boosting the market growth.