IVD industry – A rapidly expanding landscape

As rapid diagnostic technologies advance, the industry sets new standards for accuracy and efficiency in disease detection and management. From POC breakthroughs to AI-powered diagnostics, the IVD landscape is reshaping global healthcare, opening doors to faster, more precise patient care, and transforming the future of medicine.

The in vitro diagnostics (IVD) industry, essential to modern healthcare, is undergoing a dynamic transformation, blending innovation and expansion. IVD tests analyze biological samples – blood, tissues, and saliva – to diagnose and monitor various conditions, including infectious diseases, cancer, and genetic disorders. Over the years, the industry has incorporated advanced diagnostic technologies across clinical chemistry, immunoassays, molecular diagnostics, urinalysis, hematology, and microbiology, improving patient care.

Covid-19 sparked unprecedented demand for IVDs, particularly in molecular diagnostics and point-of-care testing (POCT). Technologies like PCR and NGS have enhanced the sensitivity and specificity of tests, enabling more accurate pathogen and mutation detection. As IVDs evolve, the industry moves beyond diagnosis to embrace personalized medicine, developing tests to identify biomarkers and genetic variants tailored to individual treatment plans.

Artificial intelligence (AI) and machine learning (ML) are emerging as transformative tools, particularly in biochemistry, where automation has enhanced precision, accuracy, and throughput. Immunochemistry continues to evolve with advancements in biomarker and trace analyte identification, improving workflows through innovations like multiplex assays, which combine multiple tests into a single panel for faster and more efficient processing.

As precision medicine and companion diagnostics gain traction, especially in oncology, the IVD industry remains at the forefront of healthcare innovation. These advancements are shaping the future of diagnostics, ensuring better patient outcomes through timely, accurate, and tailored medical interventions.

Indian dynamics
There has been a paradigm shift in the IVD sector in India in recent years. The emergence of infectious diseases has emphasized the need for molecular diagnostics results to be readily available. RT-PCR and other molecular tests, which have been restricted to referral laboratories for a long time, have become more decentralized. This has increased the demand for IVD equipment in smaller setups for tests like Covid-19, respiratory panels, and tuberculosis.

The National Health Mission has proposed the establishment of more hospitals and laboratories, which would further fuel the growth of diagnostics in smaller towns in India. With emphasis on faster turnaround time for early treatment initiation, the demand for devices and reagents for routine and specialized testing from more minor satellite laboratories will see a rise in the days ahead.

The demand for rapid, accessible diagnostic solutions has surged, especially post-pandemic. Technologies like liquid biopsy, digital pathology, and microfluidics are transforming diagnostics, emphasizing early detection and preventive care. This drive for faster, more accurate testing is significantly boosting the Indian IVD market, with the rise of POCT and expanded diagnostic capabilities leading the way. As global healthcare systems prioritize timely solutions, the IVD industry is evolving with innovative technologies and improved accessibility.

The government’s focus on Make in India has encouraged the development of indigenous instruments and reagents that are affordable, yet of optimum quality, and will go international in the coming years. They are already experiencing increasing acceptance amongst Indian laboratories. Global IVD companies are also expanding their operational footprint in India.

The Indian government’s decision to deny clinical trial waivers for IVDs approved in other countries presents several implications for the market, impacting both international players and local manufacturers. This policy introduces additional regulatory hurdles for foreign manufacturers, as they are now required to conduct clinical trials in India to validate the performance of their products within the Indian population. This not only slows the entry of new products into the market but also increases the cost and complexity of market access. Consequently, they may experience delays and higher prices as they absorb the added costs of local trials.

Indian manufacturers may stand to benefit from this decision. With international companies facing barriers to entry, local manufacturers can capitalize on their familiarity with the regulatory landscape and the specific healthcare needs of the Indian population. This could spur innovation within the domestic industry, with Indian manufacturers more likely to invest in developing IVD products tailored to the local market. Additionally, the short-term reduced competition from foreign players allows Indian companies to capture a more significant share of the growing demand.

The Indian IVD market is expected to experience significant growth. The rising demand for healthcare services, driven by a growing population and the increasing prevalence of lifestyle-related diseases, such as diabetes and cardiovascular conditions, continues to fuel the need for diagnostic solutions. Moreover, growing awareness of early diagnosis, preventive care, and expanded healthcare infrastructure further support market expansion. POCT and molecular diagnostics, which saw a surge during the Covid-19 pandemic, are expected to remain critical drivers of growth in the IVD sector.

Technological advancements in multiplex assays, digital pathology, and microfluidics are critical to shaping the market’s future. These innovations make testing faster, more accurate, and cost-effective, contributing to higher healthcare provider and patient adoption rates.

Some recent technological trends
As the healthcare landscape evolves, the IVD sector is on the brink of a technological renaissance driven by innovations that promise to enhance diagnostic accuracy, efficiency, and patient outcomes.

Point-of-care (POC) diagnostics revolutionize healthcare delivery, enabling immediate results that can significantly impact patient management. Portable testing devices and rapid diagnostic tests are enabling complex analyses in real time, even in remote or resource-limited settings. These advancements allow healthcare professionals to diagnose conditions quickly, facilitating timely treatment decisions. Microfluidics and biosensors are at the forefront of this evolution, ensuring high sensitivity and specificity while reducing the time and resources needed for testing. As these next-gen technologies continue to develop, we can anticipate a future where diagnostics become more accessible, streamlined, and integrated into routine patient care.

In addition, the fusion of AI and digital pathology redefines diagnostic capabilities, offering unprecedented opportunities for improving efficiency and accuracy. By converting traditional glass slides into digital whole slide images (WSIs), pathologists can now leverage AI algorithms to analyze and interpret complex tissue and cellular images with enhanced precision. This technology accelerates workflows and supports remote diagnoses and virtual collaboration among specialists.

Moreover, AI’s role in case prioritization and report generation enhances the pathologist’s ability to focus on critical cases, ultimately leading to better patient outcomes. As AI matures, its integration within image management systems (IMS) will foster seamless data flows, further optimizing diagnostic processes and ensuring that pathologists can rely on robust tools to augment their expertise.

Furthermore, histology and cytology are foundational pillars in diagnosing various diseases, including cancer. The introduction of novel techniques and technologies is set to transform these fields dramatically. Recent advancements, such as multiplexing reagents, allow for the simultaneous detection of multiple analytes, enhancing the comprehensiveness of diagnostic tests. Additionally, digital imaging technologies are revolutionizing how pathologists visualize and analyze samples, promoting integration with electronic medical records (EMR) for streamlined workflows.

FIBI, fluorescence-imitating brightfield imaging, and quantitative microscopy are pushing the boundaries of traditional histological methods, enabling rapid, accurate assessments without the lengthy processing times typically associated with sample preparation. These breakthroughs improve diagnostic capabilities and promise to increase access to critical diagnostics, especially in under-resourced areas.

The AI and precision medicine synergy
AI-powered diagnostics and pathology are revolutionizing the healthcare landscape by enhancing the precision of medical interventions and streamlining clinical workflows. The experts, including renowned figures in digital medicine, emphasized AI’s transformative potential, particularly in analyzing biomarkers and utilizing organ clocks to assess disease risks through blood tests and AI models. This capability enables earlier interventions, significantly improving patient outcomes.

In digitized pathology, advancements are particularly notable in oncology, where AI technologies maximize insights from single tissue samples. By employing machine learning classifiers, pathologists can quickly and accurately quantify cellular structures, enhancing their ability to inform patient care decisions. Furthermore, AI tools facilitate case prioritization, allowing clinicians to focus on the most urgent cases, and improve molecular testing by identifying the best areas for analysis, thus expediting personalized treatment strategies.

As healthcare professionals increasingly embrace these AI-driven innovations, they can reduce administrative burdens, enhance patient interactions, and ensure that the integration of AI into diagnostics and pathology leads to improved patient care outcomes. Overall, the synergy of AI and precision medicine is paving the way for a more effective, tailored approach to healthcare delivery, promising a brighter future for patients and providers.

IVD and global health
IVD is pivotal in enhancing global health outcomes by enabling faster, more accurate testing, directly impacting patient care. A prime example of IVD’s contribution is coagulation testing, crucial for diagnosing and managing bleeding disorders. One of the most widely used tests, the prothrombin time (PT) assay, assesses blood clotting ability and helps monitor patients on anticoagulants like warfarin, particularly those at high risk of complications, such as stroke or deep vein thrombosis. PT assays improve patient safety in clinical settings worldwide by ensuring timely dosage adjustments and preventing clotting issues.

The rising demand for coagulation tests is also linked to increased surgical procedures and post-surgical monitoring, especially as more advanced blood thinners, like Eliquis or Xarelto, require precise, less frequent testing.

As IVD technology evolves, the ability to perform rapid, reliable testing on a global scale helps healthcare systems manage cardiovascular health more effectively, improving treatment outcomes and reducing mortality associated with clotting disorders.

A new day is coming for the diagnostics industry, fueled by the expansion of at-home IVD test kits. As EDP Biotech and New Day Diagnostics merge, they are poised to revolutionize at-home testing. Their combined expertise enhances the accessibility and accuracy of direct-to-consumer (DTC) diagnostics, offering a more comprehensive range of tests, from early cancer detection to infectious diseases. With their innovative pipeline, the companies are on track to make affordable and fast diagnostic tests more readily available, empowering individuals to manage their health with greater autonomy. This merger marks a significant leap toward a future where at-home IVD testing becomes mainstream.

DiagnoTech fusion
IVD is crucial in enhancing remote diagnostics and telemedicine by enabling accurate, quick, and non-invasive testing that can be performed at home or in decentralized locations. With the rise of telemedicine, IVD devices, such as portable analyzers and at-home test kits, provide healthcare professionals with real-time patient health data without needing them to visit a healthcare facility. This supports early diagnosis, chronic disease management, and continuous health monitoring, making healthcare more accessible, especially in remote areas.

By combining IVD tools with telemedicine platforms, healthcare providers can remotely interpret test results, personalize treatment plans, and monitor ongoing conditions effectively, thus reducing the burden on hospitals and clinics while maintaining high-quality care.

Additionally, advancements in miniature robotics, coupled with the evolving landscape of IVD, are converging to shape the future of medical interventions. Both technologies address the growing demand for less invasive, more precise, and efficient medical procedures.

Miniature robotics offer the possibility of transporting surgical tools and delivering targeted therapies like drugs or fluids, a concept that resonates with the IVD trend of localized diagnostics and treatment.

IVD is also trending toward point-of-care diagnostics and personalized medicine, where portable and smart devices provide real-time, precise data to healthcare professionals. Miniature robots, equipped with sensors, could further expand IVD’s capabilities by integrating real-time sensing and sample collection directly within the body, providing diagnostic data during surgical interventions or drug administration.

Integrating miniature robotics in IVD could revolutionize remote diagnostics and minimally invasive surgeries, leading to enhanced precision, improved patient outcomes, and a more comprehensive array of applications in personalized healthcare. These trends show that both fields complement each other in the journey toward more sophisticated, less invasive, and patient-centered medical solutions.

The IVD quality control market includes quality-control products, external quality-assessment services, and data-management solutions, offered by companies for infectious diseases, cardiology, hematology, oncology, and other applications in hospitals and clinics, diagnostic laboratories, academic and research institutes, and blood banks.

Among the IVD quality controls commercially available, there is an increasing demand for multi-analyte and multi-instrument controls. Multi-analyte controls are designed to contain multiple analytes of interest, while multi-instrument controls are designed to be compatible with different types of laboratory instruments and testing platforms.

There is an increasing demand for multi-analyte controls as they eliminate the need to use separate controls for each analyte, streamlining the quality control process and saving time and resources. They are also cost-effective, as consolidating multiple analytes into a single control can be more cost-effective than purchasing separate controls for each analyte.

Some recent trends, by technology
Molecular diagnostics. In 2024, the MDx segment accounted for the largest share of the IVD market, driven by the growing adoption of rapid and POC testing. This technology utilizes advanced in-vitro biological assays to detect nucleic acids or proteins, even in low concentrations across samples. Such capabilities enable the identification of biomarkers, monitoring the disease’s progression over time, and guiding the selection of appropriate therapies.

MDx technologies have undergone continuous development, modification, and commercialization to analyze nucleic acids and proteins in situ and solution. By offering precise and sensitive detection capabilities, molecular diagnostics contribute significantly to advancing personalized medicine and optimizing patient care pathways.

The hematology segment emerges as the fastest-growing segment within IVD. These diagnostics encompass tests conducted on blood or tissue samples extracted from the human body. They serve the vital role of disease detection, monitoring overall health, and aiding in treating, curing, or preventing various conditions. IVD hematology parameters play a pivotal role in disease monitoring and treatment guidance.

Clinicians rely on these parameters, from anemia to leukemia to sepsis, to ensure optimal patient care. By providing comprehensive insights into blood-related disorders and conditions, IVD hematology parameters enable healthcare professionals to make informed decisions regarding treatment strategies, ultimately improving patient outcomes.

As advancements continue in this field, hematology diagnostics will further enhance their utility in disease management, contributing to the evolution of personalized medicine and healthcare delivery.

Integrating multiplex testing technologies in IVD has revolutionized diagnostic workflows, particularly in infectious disease detection. Multiplex assays allow the simultaneous identification of multiple pathogens from a single patient sample, increasing diagnostic efficiency and reducing the time required for critical care decisions. These tests are precious for distinguishing diseases like Covid-19, influenza, and RSV. With growing regulatory approvals and market adoption, multiplex testing is becoming preferred in clinical settings, improving patient outcomes through more precise and rapid diagnostics.

Immunoassays have become foundational in the IVD field due to their ability to accurately detect biomarkers, pathogens, and analytes critical for diagnosing various conditions like infections, cancers, and hormonal imbalances. Among the most widely used immunoassays are enzyme-linked immunosorbent assays (ELISA), chemiluminescent immunoassays (CLIA), and radioimmunoassays (RIA). Recent advancements in these technologies have improved these assays’ sensitivity, precision, and multiplexing capabilities, making them essential tools for disease diagnostics.

One notable advancement is using CLIA (chemiluminescent immunoassays) technology in diagnostics. CLIA offers enhanced sensitivity and better detection limits than traditional methods like ELISA. A key innovation in CLIA is the integration of AMPPD (adamantyl 1,2-dioxetane phosphate) substrates with alkaline phosphatase (ALP) enzymes.

Combining immunoassays and advanced chemiluminescent technology, such as CLIA-AMPPD ALP, revolutionizes the IVD sector by enhancing diagnostic speed, accuracy, and scalability. This allows healthcare providers to deliver better patient outcomes through earlier and more precise disease detection.

The latest developments in urinalysis reflect significant advancements in IVD integration, focusing on automation and precision. Introducing pediatric measurement modes in the LabUMat 2 and UriSed 3 PRO devices addresses diverse patient needs. At the same time, the research use only (RUO) feature in the UriSed mini expands analytical capabilities, now including body fluid measurement. Their adaptive sip and spit mixing technology ensures consistent urine sediment distribution, providing reliable and operator-independent results. These innovations streamline urine analysis, offering rapid and accurate diagnostics essential for detecting conditions like UTIs and kidney diseases.

Rapid, accurate diagnostics in small, easy-to-use devices is now possible with the increasing popularity of LAMP, FIA, and CLIA analyzers. These solutions are designed for real-time testing in decentralized settings, such as clinics and remote areas, making advanced diagnostics more convenient and widely available. This marks a shift toward more user-friendly and practical diagnostic tools in IVD.

So far, the reagents and kits segment has accounted for the largest share in the global IVD market. This segment’s substantial market share is due to the frequent use of reagents and kits to detect a variety of chronic diseases and the wide availability of a diverse range of reagents and consumables for diagnosing different conditions.

Opportunities for new entrants
The IVD market presents numerous lucrative opportunities for new entrants, driven by several key factors. Firstly, the rising demand for diagnostic services is a significant catalyst, as a global emphasis on early disease detection and personalized medicine creates an urgent need for innovative diagnostic solutions. Consequently, new companies can capitalize on this trend by offering unique and tailored IVD products that address specific healthcare needs.

In addition to technological opportunities, the focus on personalized medicine is also a driving force. As healthcare increasingly shifts toward customized treatment approaches, a growing market for diagnostics provides insights tailored to individual patient profiles. New entrants can strategically position themselves in this niche by developing IVD solutions integrating genomics and biomarker analysis.

Furthermore, investment in emerging markets is a significant growth opportunity. Rapidly expanding healthcare infrastructure in these regions presents a favorable landscape for new companies.

Partnerships and collaborations also play a crucial role in facilitating market entry and development. By collaborating with established pharmaceutical and biotech companies, new entrants can access valuable resources, expertise, and distribution channels, enhancing their market presence.

Finally, various governments’ regulatory support and incentives encourage innovation in the IVD sector. Initiatives, such as grants and streamlined regulatory pathways, can significantly benefit new companies by accelerating product development and market entry.

Post-pandemic vaccination and IVD
The global market for preventive vaccines has experienced a remarkable boost, with growth attributed to a renewed focus on non-Covid-19 vaccines as routine immunizations and wellness visits resume.

According to Kalorama report, the market value more than doubled from USD 34 billion in 2017 to USD 77 billion in 2023, reflecting increases in several vaccine segments, including shingles, HPV, meningitis, rotavirus, and RSV vaccines, as well as travel and endemic vaccines. This growth is expected to continue through 2028, driven by favorable demographic trends, new product launches, and rising vaccination rates, particularly in countries like China and India.

However, challenges, such as vaccine safety concerns, availability in developing countries, and public hesitancy, pose significant hurdles to sustaining this growth.

IVD technologies play a crucial role in supporting the non-Covid vaccine market. They enhance vaccine development through advanced diagnostic tools that assess immune responses and safety in clinical trials. Additionally, IVD solutions facilitate monitoring immunization programs by tracking vaccine uptake and effectiveness, thereby identifying immunity gaps in populations. Rapid POCT solutions also enable timely interventions, particularly in resource-limited settings. Furthermore, IVD technologies support surveillance of vaccine-preventable diseases, aiding public health efforts to evaluate vaccination campaigns.

Outlook
IVDs are revolutionizing the healthcare industry by providing precise, quick, and reliable diagnostic results. The IVD market is poised for significant growth, driven by technological advancements and increasing demand for early disease detection. With the ongoing innovations in molecular diagnostics, POCT, and AI-powered tools, the future of healthcare diagnostics looks promising. Investors have substantial opportunities to capitalize on this growing market, which is shaping the next generation of healthcare.