On the pursuit of transformative growth

2025 promises transformative growth in the IVD sector. Driven by ground-breaking innovations, this new era will enhance precision and broaden patient access to advanced diagnostic solutions.

In vitro diagnostics (IVDs) have emerged as an essential pillar of modern healthcare, influencing nearly 70 percent of clinical decisions. These diagnostic tools are vital in identifying infectious diseases, genetic disorders, and chronic conditions, enabling timely interventions and personalized treatment plans. The pandemic accelerated advancements in the field, spurring innovations in liquid biopsies, next-generation sequencing (NGS), and point-of-care (POC) diagnostics. Technologies, such as lab-on-a-chip devices and wearables, have revolutionized access to testing, delivering real-time, and actionable insights. At the same time, artificial intelligence (AI) has become integral to enhancing diagnostic precision by automating complex workflows and supporting data-driven decision making.

Regulatory landscapes have also shifted significantly, with the European Union’s In-Vitro Diagnostic Regulation (IVDR), introducing stricter quality and safety requirements. This shift has prompted nearly 90 percent of IVD devices to undergo rigorous third-party assessments, posing challenges for manufacturers navigating the certification process. Meanwhile, global supply chain constraints have highlighted the need for resilience in securing essential reagents and materials.

Looking ahead to 2025, the IVD sector is poised for transformative changes, driven by advancements in personalized medicine, the decentralization of testing, and deeper integration with public health strategies.

Remote and decentralized diagnostics
The remote and decentralized diagnostics market is experiencing unprecedented growth and is projected to reach USD 80.75 billion by the next decade. Driven by advancements in non-invasive devices, self-testing tools, and AI-enabled platforms, these technologies are making healthcare more accessible and patient-centric.

Offering quick, accurate results in non-clinical settings like homes and remote areas, they fill critical gaps in emergency and resource-limited environments. Innovations in biosensors, microfluidics, and telehealth are bridging the gap between patients and clinicians, enabling personalized care and efficient disease management.

Companies are setting benchmarks with app-based diagnostics integrating cloud-based AI and biosensors, offering real-time decision-making capabilities. These tools reduce healthcare costs while promoting early disease detection and equitable healthcare access.

Despite regulatory hurdles and accuracy concerns, collaborations between firms and healthcare providers accelerate speed-to-market for these revolutionary solutions. Remote diagnostics are poised to redefine healthcare delivery worldwide, ensuring inclusivity and efficiency in diagnostics.

Precision medicine and molecular diagnostics
Clinical and molecular diagnostic testing is advancing rapidly, with next-generation sequencing (NGS) revolutionizing the detection of genetic variations. NGS is recognized for its ability to provide highly accurate insights at increasingly lower costs. However, managing NGS workflows can be complex, involving multiple steps from sample accessioning to sequencing and reporting. Any delays within this process can significantly impact turnaround time (TAT), potentially delaying patient treatment. Since approximately 70 percent of medical decisions rely on lab results, and nearly 80 percent of labs report TAT complaints, optimizing efficiency is critical.

Several factors affect TAT, including sample volumes, data complexity, lab resourcing, and preanalytical errors. Clinical labs handle thousands of samples daily, requiring effective workflow management to prevent delays from minor mistakes. The complexity of NGS data demands meticulous handling, with any disruptions affecting the overall process. Lab resourcing challenges, such as staff shortages and high workloads, can lead to inefficiencies and increased errors. Preanalytical errors, accounting for up to 70 percent of TAT delays, often stem from incorrect sample labeling, faulty specimen collection, and transport.

Addressing these challenges requires solutions that streamline the entire diagnostic process. Modern, cloud-based laboratory information management systems (LIMS) can automate workflows, improve communication, and enhance sample tracking. By digitizing sample accessioning and integrating data from various sources, labs can reduce manual errors and speed up reporting. Clinician portals enable direct access to test ordering and results, fostering seamless communication between labs and healthcare providers. Additionally, automated reporting tools generate clinical reports based on integrated data, accelerating the final stages of diagnosis.

NGS and PCR technologies play pivotal roles in personalized medicine. NGS advancements, including whole-genome sequencing and targeted gene panels, have improved accuracy and accessibility. These innovations allow for comprehensive disease profiling, infectious disease surveillance, and pharmacogenomics applications. PCR innovations, such as digital PCR (dPCR) and real-time PCR (qPCR), enhance speed and precision, making them invaluable for rapid diagnostics and monitoring.

The future of diagnostics is further bolstered by AI integration. AI-powered models analyze multi-omics data, enabling early disease prediction and tailored treatments. Proactive health monitoring systems combine genetic, lifestyle, and imaging data, representing a shift toward preventive care. As AI continues to evolve, its role in automating workflows, generating reports, and providing clinical insights will become integral to improving TAT and patient outcomes.

Digital innovations
IVD is transforming healthcare by enabling early disease detection, prevention, and management through advanced diagnostic tools. These tools analyze biological samples, such as blood, urine, and tissues outside the body, playing a pivotal role in nearly 70 percent of clinical decisions. As the world recovers from the Covid-19 pandemic, which underscored the critical importance of diagnostics, the IVD industry is experiencing remarkable advancements. Innovations in diagnostic technologies and evolving healthcare demands drive the global IVD market.

One significant factor fuelling growth is the rise of non-communicable diseases (NCDs) like cardiovascular diseases, diabetes, and cancer, which account for 74 percent of global deaths annually. Early detection through advanced IVD tools is essential to mitigate severe outcomes and reduce mortality rates, especially in low- and middle-income countries. The increasing aging population also amplifies the demand for IVD. With chronic diseases affecting over 80 percent of individuals aged 65 and older, advanced diagnostic solutions are essential for managing age-related health challenges.

Technological advancements in IVD are reshaping the diagnostic landscape, offering faster, more precise, and more accessible diagnostics. Liquid biopsies allow non-invasive monitoring of conditions like cancer, enabling timely interventions. Next-generation sequencing (NGS) identifies genetic mutations, paving the way for personalized treatments tailored to individual needs. POC testing, driven by wearable devices and lab-on-a-chip, provides real-time diagnostic results, reducing reliance on centralized laboratories and enhancing patient care in urgent and resource-limited settings.

The IVD industry’s digital transformation is revolutionizing healthcare delivery. Automation, digitization, and AI streamline diagnostic workflows, improve testing accuracy, and enable seamless lab integration. AI-powered tools assist in complex diagnostics, such as image analysis, enhancing laboratories’ efficiency, and empowering healthcare providers to make informed decisions. Cloud-based diagnostic platforms further enable secure data storage and analysis, fostering better collaboration across healthcare systems.

Emerging markets, particularly in Asia-Pacific, Latin America, and the Middle East, present immense opportunities for IVD growth. While these regions initially expanded due to Covid-19 testing, the focus is shifting toward decentralized testing, POC molecular diagnostics, and long-term investments in RT-PCR laboratory infrastructure. Regional players increasingly take the lead in infectious disease testing, emphasizing localization and tailored solutions. These regions also leverage digitization and AI to address staffing shortages and lab integration needs, highlighting the importance of adapting to localized demands.

Public and private investments play a critical role in advancing IVD technologies. Initiatives like the European Commission’s USD 203 million AGLYC project, which focuses on developing blood-based biomarkers for cardiovascular disease detection, are driving innovation and expanding the market. Such investments underscore the sector’s commitment to addressing global health challenges and ensuring the availability of cutting-edge diagnostics.

The IVD industry’s advancements extend beyond diagnostics, with broader implications for healthcare delivery and disease management. The clinical lab 2.0 model, emphasizing collaboration between labs, healthcare systems, and public health entities, exemplifies the shift toward value-based care. This model aims to improve outcomes, reduce costs, and enhance patient experiences by integrating diagnostics with population health management.

Moreover, advancements in life sciences, such as antibody-drug conjugates (ADCs) and cell and gene therapies (CGTs), complement IVD’s role in personalized medicine. AI-driven solutions are enhancing drug discovery and clinical trials, accelerating the development of innovative therapies. The Asia-Pacific region, particularly China, has emerged as a leader in clinical trials and biopharmaceutical innovation, attracting global investments and strategic partnerships.

Transforming diagnostics with AI
The integration of AI into diagnostics is fundamentally transforming healthcare by enhancing accuracy, efficiency, and speed across various sectors, including laboratory testing, imaging, and patient monitoring. AI’s ability to analyze vast datasets, including medical images, patient histories, and genomic information, is unlocking new potentials for early detection and personalized medicine.

By automating routine tasks, such as image analysis, AI significantly reduces human error and accelerates decision making, leading to quicker diagnoses and tailored treatment options. For instance, in radiology, AI algorithms can detect anomalies in images, such as CT scans or MRIs, with remarkable precision, often identifying conditions that may be missed by human eyes.

Moreover, AI-powered diagnostic tools are being integrated with laboratory information management systems (LIMS) and laboratory information systems (LIS) to streamline workflows, ensuring the seamless capture, analysis, and storage of data. These systems not only manage the increasing volumes of medical data but also facilitate remote monitoring and analysis, providing real-time insights into patient conditions. In molecular diagnostics, AI applications are refining diagnostic accuracy and paving the way for more personalized approaches to treatment, particularly in oncology and genetic disorders.

Furthermore, AI’s role in POC diagnostics is revolutionizing patient care by enabling rapid, on-site testing in diverse environments, from emergency rooms to remote clinics. Through predictive algorithms, AI is helping clinicians make informed decisions quickly, leading to faster interventions and improving patient outcomes. The rise of AI in diagnostics is also fostering innovation in the development of new biomarkers and diagnostic technologies, driving growth in sectors, such as IVD, medical imaging, and digital health.

Sustainability, ESG, and gender-inclusive innovation in manufacturing
Sustainability, ESG (environmental, social, and governance) principles, and gender-inclusive innovation are becoming central tenets of industry growth and transformation. The healthcare sector is increasingly tasked with integrating ESG frameworks into its operational strategies, aligning sustainability with social responsibility and strong governance practices. As environmental concerns intensify and societal inequalities grow, healthcare organizations, particularly those in the IVD sector, are expected to lead the way in adopting these principles to improve both patient outcomes and the industry’s environmental footprint.

Companies are also encouraged to prioritize the use of environmentally friendly products and adopt green manufacturing technologies. This not only aligns with global sustainability goals but also provides a competitive edge as consumers and investors increasingly value eco-conscious practices. For example, the European Commission’s commitment to carbon neutrality underscores the importance of sustainable manufacturing processes in the MedTech and IVD sectors. By embracing sustainability, companies can achieve cost savings while supporting broader environmental goals, positioning themselves as leaders in both market competitiveness and regulatory compliance.

The social aspect of ESG within IVD manufacturing emphasizes diversity and inclusion, particularly gender-inclusive innovation. Diverse leadership teams contribute to better decision making and foster innovation, which is crucial for developing inclusive healthcare solutions. As more IVD companies embrace gender diversity, they are driving forward the development of diagnostics that address a broader range of health conditions and patient needs. This approach not only helps in producing more effective healthcare solutions but also improves organizational performance by drawing from a wider pool of perspectives.

For instance, pharmaceutical and life sciences companies that prioritize diversity in leadership often lead the charge in developing innovative therapies and diagnostic tools that cater to underserved populations. This trend is gaining traction in the IVD sector, as organizations increasingly recognize the value of gender-inclusive approaches in fostering a more equitable healthcare ecosystem.

Effective governance is vital to the successful implementation of ESG initiatives. Transparent reporting, clear accountability structures, and adherence to regulatory standards are critical for gaining trust of patients, employees, and investors.

As the European Union’s Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) continue to impose stringent compliance requirements, IVD manufacturers must invest in robust governance frameworks that ensure both regulatory adherence and the ethical execution of sustainability initiatives.

Additionally, the adoption of advanced technologies, such as AI and machine learning, can streamline operations and improve compliance management, but they also require careful oversight to ensure their ethical use.

As the IVD sector navigates these challenges, leveraging frameworks like the global reporting initiative (GRI) and the United Nations sustainable development goals (SDGs) can help organizations align their sustainability efforts with global objectives. Embracing technology is also a key component in advancing ESG goals, from optimizing supply chains to enhancing the precision of diagnostics. Digital health technologies, such as AI-driven data analysis, cloud storage, and the Internet of Things (IoT), not only improve operational efficiency but also contribute to sustainability by reducing waste and energy consumption.

Furthermore, integrating these technologies helps IVD manufacturers offer more personalized and timely healthcare solutions, improving patient outcomes and expanding access to care.

In addition, evolving regulations are reshaping the global IVD landscape. These frameworks reflect an increased emphasis on patient safety, product reliability, and rigorous standards for market approval. For instance, the IVDR mandates that IVD devices undergo third-party evaluations by notified bodies instead of relying on self-certification, setting a higher bar for quality assurance across Europe.

Emerging technologies like next-generation sequencing (NGS) are also under scrutiny, as these advanced diagnostics are increasingly integrated into clinical workflows. By requiring enhanced certification and clinical trial data, the IVDR ensures these innovations deliver accurate and dependable results. Such regulatory tightening aims to minimize risks associated with diagnostic errors, support clinical decision-making, and establish a robust framework for the adoption of cutting-edge diagnostics worldwide.

India’s recent regulatory shift, mandating clinical trials for all IVDs, is a significant move toward aligning with global standards like the IVDR and CE-IVD. The CDSCO’s decision to eliminate clinical trial waivers will ensure that diagnostic products entering the Indian market undergo a more thorough evaluation process. This shift aligns with global best practices, reflecting a growing demand for more reliable, region-specific diagnostics. While this regulation may lead to challenges, particularly in terms of certification timelines and the availability of low-risk products, it provides an opportunity for Indian manufacturers to innovate and create solutions tailored to the country’s unique healthcare needs.

On a global scale, the harmonization of regulatory standards will foster greater confidence in the reliability of diagnostic tools. It will also drive innovations in diagnostics, particularly in genomics and personalized medicine, by ensuring that emerging technologies, such as NGS, undergo stringent evaluations. Products like the twist precision Dx line, which are IVDR-compliant, streamline the validation process for clinical NGS workflows, providing laboratories with reliable tools to ease the transition to compliance.

As regulations evolve in both Europe and India, they will set a new benchmark for IVDs worldwide, ensuring that diagnostics are not only accurate but also safer and more effective for diverse populations. The global IVD market is likely to experience significant growth, driven by the increasing importance of precision medicine and personalized diagnostics. However, the industry must navigate the complexities of adapting to these regulations, particularly the growing demands of certification and clinical trials, which will shape the future of diagnostics and patient care.

Innovations in reagents
The future of IVD is driven by remarkable advancements in reagents and lab materials. High-performance reagents, such as ultra-sensitive antibodies and advanced nucleic acid probes, are enhancing diagnostic accuracy for conditions like cancer and infectious diseases. Sustainable lab materials, including eco-friendly consumables, are reducing environmental footprints. Automation-compatible reagents streamline workflows with next-generation analyzers, boosting speed and precision. Innovations in biomarkers and companion diagnostics are paving the way for personalized medicine, enabling targeted treatments. Collectively, these advancements promise a transformative leap in diagnostic efficiency, accessibility, and sustainability.

Companion diagnostics (CDx) in genomic testing
The field of genomic medicine is driving a transformative era in healthcare, with companion diagnostics (CDx) playing a critical role in advancing precision medicine. These specialized diagnostic tools identify specific genetic or molecular markers that predict how a patient will respond to a targeted therapy, ensuring treatments are tailored to individual profiles. This alignment reduces trial-and-error prescribing, minimizes adverse effects, and enhances therapeutic efficacy.

CDx has gained particular prominence in oncology, enabling clinicians to select therapies based on tumor biomarkers, such as HER2 for breast cancer or EGFR for lung cancer. Beyond oncology, it is expanding into areas like cardiology, rare genetic disorders, and infectious diseases, offering solutions that align with the unique genetic landscapes of patients.

Advancements in genetic testing technologies, including next-generation sequencing (NGS), are accelerating CDx development. By uncovering actionable genetic variations, NGS empowers researchers to design more effective and personalized treatment strategies. For instance, CDx supports the development of targeted drugs for conditions like cystic fibrosis and specific cardiovascular diseases, where conventional therapies often fall short.

The role of CDx extends beyond clinical outcomes. It is revolutionizing drug development by streamlining clinical trials and enabling faster approvals. Pharmaceutical companies now rely heavily on CDx to stratify patient populations, ensuring that only those most likely to benefit are enrolled. This not only improves trial efficiency but also reduces the cost of developing new therapies.

Despite its potential, challenges persist. Regulatory complexities, high development costs, and the need for robust data integration with electronic health records remain as hurdles. Collaboration among diagnostic developers, pharmaceutical companies, and regulatory bodies is essential to navigate these challenges and expand access to CDx globally.

As genomic medicine continues to evolve, companion diagnostics is poised to redefine healthcare by enabling early disease detection, precision treatment, and improved patient outcomes. By bridging the gap between diagnostics and therapeutics, CDx is unlocking a future where personalized medicine becomes the standard of care.

Focus on non-invasive diagnostics
In the rapidly evolving landscape of IVD, non-invasive diagnostic methods are gaining significant attention and traction, with promising developments expected in 2025. These methods are increasingly seen as game-changers for their ability to enhance patient comfort, reduce diagnostic risks, and improve accessibility to critical healthcare. Technologies, such as liquid biopsy, saliva-based testing, and breath analysis, are at the forefront of this revolution, enabling earlier and more accurate disease detection with minimal patient intervention.

One of the key drivers behind this trend is the demand for early-stage disease detection and monitoring, particularly in fields like oncology, infectious diseases, and genetic disorders. Liquid biopsy, for example, is making significant strides in cancer diagnostics. This non-invasive approach can identify cancers at earlier stages when treatments are more effective, improving prognosis and patient outcomes.

Saliva-based testing is also gaining attention due to its potential in detecting a wide range of diseases, including viral infections, genetic disorders, and even certain types of cancer. As an easy-to-collect biological sample, saliva offers a convenient and cost-effective alternative to more invasive methods like blood draws, making it particularly attractive for widespread use in clinical and at-home testing scenarios.

Another exciting development in non-invasive diagnostics is breath analysis, which can potentially detect diseases, such as lung cancer, infections, and metabolic disorders, through the detection of biomarkers in exhaled breath. This approach could provide a quick and painless way to monitor patient health, detect early-stage diseases, and even assess the effectiveness of ongoing treatments in real-time.

The continued integration of AI and advanced sensor technologies further enhances the capabilities of non-invasive diagnostics. AI-powered algorithms can analyze complex biological data from non-invasive samples, improving the accuracy and reliability of test results. Additionally, integrating multi-omics data, which combines information from genomics, proteomics, metabolomics, and other biological fields, can offer deeper insights into disease progression, treatment responses, and individual health risks.

By 2025, non-invasive diagnostic approaches are expected to play an increasingly central role in IVD, offering faster, more reliable, and patient-friendly solutions for detecting and monitoring a wide array of diseases.

Challenges
The IVD industry in 2025 faces several challenges that could hinder its growth and innovation. A major obstacle is the complex regulatory landscape, with varying regulations across countries making it difficult for manufacturers to navigate and comply with all requirements. The slow approval processes for new devices further delay market entry and limit innovation.

Additionally, data security and patient confidentiality remain pressing concerns, as the increasing use of digital health records and connected devices heightens the risk of data breaches.

Interoperability between healthcare systems and devices is also a challenge, as seamless data exchange is essential for effective diagnostics and treatment.

Collaboration within the industry is another challenge, as siloed approaches among healthcare providers, manufacturers, and researchers can stifle innovation.

Intellectual property disputes also continue to impede progress, creating barriers to technological advancements.

Lastly, the high costs of research and development (R&D), combined with uncertainties about market demand, create significant financial risks for companies investing in new IVD technologies.

Preparing for 2025 and beyond
As we look ahead to 2025, both the global and Indian MedTech and IVD industries stand on the precipice of a transformative era. The strides being made in the medical devices and diagnostics sectors are a testament to the power of collaboration, innovation, and a relentless focus on patient-centric care. From enhancing patient input and advancing decentralized trials to streamlining regulatory processes, these developments lay the groundwork for a healthcare ecosystem that is more inclusive, transparent, and efficient than ever before.

In India, the sector is poised to follow in the footsteps of its pharmaceutical counterpart, consolidating its position in the domestic market and expanding its influence globally. With robust regulatory frameworks, an emphasis on quality standards, and growing capabilities in international certifications, Indian companies are well-positioned to lead the global diagnostics revolution. The government’s commitment to diagnostics, alongside the push for universal health coverage, will pave the way for a more accessible, proactive healthcare system.

As the focus shifts toward early detection, preventive care, and innovative diagnostic technologies like POC solutions and connected health data, the future of healthcare is not only more responsive but also more connected. By embracing these advancements, the industry is not just enhancing healthcare within the country, but they are also setting the stage for a global leadership role in shaping the future of healthcare worldwide.

The journey ahead is one of immense opportunity, marked by a clear vision for innovation and progress. With sustained collaboration, investment, and a patient-focused approach, the sectors are on track to redefine healthcare delivery, offering a beacon of hope and a model of success for the global community. The horizon is bright, and the time for India to take its place as a leader in global healthcare innovation has arrived.