As healthcare shifts towards personalisation and digitalisation, diagnostics allow individuals to receive vital information with increased accuracy, specificity, and speed. In a bid to get closer to the end user, manufacturers are leveraging data and building intelligence into their products. This practice places prevention ahead of treatment and cure, thereby giving patients greater control over their care.
The healthcare market in India is expected to reach US$372 billion by 2022, while the medical devices market is expected to cross USD 11 billion by 2022*. Rising incomes, greater health awareness, lifestyle diseases, and increasing access to insurance will contribute to this growth. Besides developing India as a global healthcare hub, the Government of India aims to increase healthcare spending to 3 per cent of the Gross Domestic Product (GDP) by 2022.
With increasing urbanisation and problems related to modern-day living in urban settings, currently, about 50 per cent of spending on in-patient beds is for lifestyle diseases. Ageing populations and changing lifestyles are causing an increase in conditions like cancer, diabetes and heart disease, thereby leading to growth in demand for diagnostic services. This has increased the demand for specialised care. Further, the medical fraternity is educating the general population on the benefits of early diagnosis to increase the chances of a positive outcome, help improve the lives of patients and save costs of further treatment.
In-vitro Diagnostics (IVDs) form a crucial part of modern medicine: laboratory-based tests performed on biological samples provide vital information that is key for the prevention, treatment and management of disease. Reagents and analysers used in IVDs must ensure precise and reliable results. They can be used in a variety of areas ranging from sophisticated techniques performed in specialised clinical laboratories to userfriendly devices that are used by medical professionals, as well as simple self-tests that patients can use at home.
Rapid change in business models immensely impacts the medical device industry. Today, consolidation, integration and outsourcing are areas that larger players are exploring to create a better business environment. As medical research advances, newer tests are needed for accurate diagnosis. In order to ensure that the test menu remains comprehensive and updated, laboratories outsource the tests not being processed in-house. Consolidation and integration catalyse the process of smaller labs joining hands with bigger ones. This allows more comprehensive test menus, increases the reach and accessibility of services, ensures better standardisation of services and allows greater cost benefits to be passed on to patients.
The concept of core laboratory is soon catching up in India. Core laboratories collect, process, and analyse data from multi-centres through a single platform to prevent inter- and intravariability by following standardised protocols. Unified and standardised data collection with strict quality control methods facilitates easy central review by physicians and reduction in errors and meets expectations and approval of regulatory authorities.
Innovative developments in the IVD field are currently driven by four major trends: point-of-care testing, automation, digitalisation and the concept of personalised medicine.
PoCT: Various digital technologies will improve the point-of-care testing (PoCT) options of pathology departments in the future. Just as portable diagnostic devices are making it possible to diagnose patients wherever they are, such tools enable the examination of tissues, fluids and other samples near the patient’s location, in the surgery or clinic at the time of consultation to facilitate prompt clinical decision making regarding patient management. Various blood glucose meters, urine test strips, pregnancy tests fall into the category of PoCT, but their range will significantly widen in the future.
Molecular diagnostics: Molecular analysis will enable more precise diagnosis in the future, and revolutionise how we define several diseases. It will also give precious information on how patients respond to treatment and what the prognosis is. The pathologist will help interpret the results and choose which molecules to be evaluated.
Nex-Gen Sequencing (NGS) is another growing trend in molecular diagnostics. An analysis of the genetic information from the sample will help diagnose a disease well in advance, even before a patient actually starts presenting symptoms of a disease. It can thus be used to detect levels of TB, malaria and other diseases which all the other tests would miss. In the near future, NGS will be considered by many laboratories for routine diagnostic use.
Automation: With the introduction of various government schemes, the healthcare delivery system in India is undergoing a paradigm shift. Speaking particularly of the diagnostic industry, laboratories will have to think out-ofthe-box to handle the huge workload and at the same time maintain the quality, affordability and accuracy of the tests. This is where automation can play a significant role. Over the last few years, automation is proving to be the biggest growth driver for this segment. From a manual, hands-on process for a simple test menu to an instrumentcentric, high-volume set-up, automation has become indispensable to meet the increasing demand for high productivity and cost reduction. Infact, it is now a multi-billion market consisting of several manufacturers of integrated and workflow systems and components as well as software to improve the overall process efficiency.
Additionally, automation is enabling healthcare companies to meet regulatory compliance and data consolidation. Most of the latest systems are equipped with reagent and sample barcode reader having HIS / LIS connectivity. Integrating the systems to the HIS/LIS interface, has drastically reduced analytical errors. Automation combined with cloudbased technology is helping laboratories streamline daily operations, troubleshooting and better management of patient information.
New analytical technologies, extended data processing and advanced means of integration and interpretation of laboratory findings are greatly influencing the IVD industry.
Business process improvement:
While there has been a large focus on patient-facing aspects of digitalisation, it is also a powerful tool to reduce costs and time on the back-end, resulting in improved levels of service and increased profits from efficiency gains in R&D through supply chain management, sales and marketing. Internet of Things (IoT) has brought in a new wave of digital transformation. Manufacturers of medical devices in particular, are adopting IoT as a tool to improve operational efficiency and offer realtime insights based on patient data.
Devices fitted with IoT sensors can provide information on the usage of the instrument. This is particularly relevant for a diagnostic laboratory that is faced with a major challenge of optimising capacities of capital equipments. Likewise, IoT data can be used to track the usage, expiry and consumption of reagents for each test, to allow efficient management of lab inventory and utilisation. Alerts can be sent for replenishment, when there is depletion.
Product service innovation:
Experts estimate that 87 per cent global healthcare organisations will soon be adopting IoT. The entire ecosystem—including caregivers, patients, and manufacturers — is experiencing a new level of engagement; that arises from the need to increase operational efficiency (through predictive maintenance and remote access), to enhance patient outcomes (through predictive healthcare). Healthcare organisations are moving more towards cloud-based IT infrastructure, to better automate processes. Infact, IoT enabled medical devices can now be remotely monitored 24x7 to predict possible problems and proactively resolve them thereby improving the uptime.
Besides this, data analytics is being leveraged to track the manufacturing process, allowing a more accurate and consistent output of high-quality products.
The medical laboratory professionals will also need to reflect on future relationships with stakeholders outside the realm of the classical health care professional. Specifically, concepts like ‘the patient-oriented laboratory medicine’ and ‘the empowered patient’ will have a greatly extended meaning in the era of digitalisation and need to be addressed. The future will require us to set and adjust standards in education and training programmes in order to attract the young generation of professionals with an interest in our multifaceted field of technical, analytical and medical expertise.
While telemedicine is currently spreading it wings to encompass all segments of healthcare, there is a special focus on telepathology, as laboratory diagnosis forms the basis of all treatment modalities. Telepathology services help in transferring superior quality imagerich pathological data for education, research, and patient diagnosis and are useful for emergency services, obtaining expert opinion on referral cases, patient diagnosis at remote locations, meetings and conferences, quality assurance, and educational purposes.
The global telepathology service market was valued at US$637 million in 2018 and is expected to generate USD 1,786mn by 2027, at a CAGR of 12 per cent between 2019 and 2027**. Speaking of the Indian scenario, the telepathology market is expected to touch US$2 billion by 2020***.
While North America and Europe contribute to the highest share in the global telepathology market, Asia-Pacific is projected to register the highest CAGR in the near future, owing to the growing availability of healthcare facilities, rising investments for telepathology, and increasing prevalence of life-hreatening diseases. The growing demand for enhanced patient management services, and government support especially in China, Japan, and India, is projected to fuel the Asia-Pacific telepathology service market in the future.
The challenges India is facing today include meeting the growing healthcare demand; bringing together pathologists, biochemists, and microbiologists under one virtual umbrella; making use of technology to bridge the delivery gap; and ensuring that quality and accuracy remains uncompromised. An alarming statistic; there are approximately 1 lakh diagnostic labs in the country but only 1per cent of these are accredited. For every 1 lakh people, there are just about eight diagnostic labs and 70 per cent of the industry functions by sharing the services of pathologists,biochemists or microbiologists or at times in even their absence. This obviously poses a challenge for ensuring quality services. Telepathology can play a very important role, as it allows for consultation as well as interactive peer discussions. It ensures accessibility to qualified pathologists round-the-clock, thereby ensuring real-time reporting during emergency, a boon for tier II, III and IV cities and towns. It can prove to be beneficial for smaller labs, in implementation of uniform protocols and standardisation of reports.
As a country, we are in the midst of one of the most challenging times in healthcare history, facing growing and ageing populations, the rise of chronic diseases and global resource constraints, and the transition to value-based care. These challenges demand leading healthcare players to use technology to shift from treatment and cure to prevention through integrated smart services.
Digitalisation of pathology laboratories makes the specialty more efficient and the work of pathologists less cumbersome. Both physicians and patients will benefit from this transformation. With better tools, medical professionals will have more chance to save lives and patients will have more chance to survive.