Molecular diagnostics in India has moved far beyond its origins as a specialised capability concentrated within premier academic and reference laboratories. What was once largely an elite, infrastructure-intensive diagnostic discipline is increasingly becoming an integral part of clinical decision-making across a much broader healthcare ecosystem.
The transformation is being driven by three powerful forces: automation, decentralisation and indigenous manufacturing. Together, these developments are changing not only how molecular tests are performed, but also where they can be performed, who can perform them and how economically they can be deployed.
The larger shift is from centralised, manual molecular testing towards automated, sample-to-answer platforms capable of serving Tier-2, Tier-3 and rural healthcare ecosystems.
The old model: sophisticated science, limited access
Before 2020, molecular diagnostics in India faced several structural constraints.
More than 85% of molecular testing capacity was concentrated in premier institutes and metropolitan reference chains, including institutions such as AIIMS, Tata Memorial Centre and NIV Pune. This concentration reflected the complexity of molecular workflows and the infrastructure required to operate them.
Traditional molecular testing could require three-room physical segregation with negative airflow to minimise amplicon contamination. Nucleic acid extraction was often manual and labour-intensive, relying on silica spin-column extraction workflows.
The economics were equally challenging. Heavy dependence on imported closed platforms made routine applications such as HIV, HBV and HCV viral-load monitoring, as well as oncology panels, financially inaccessible to a large section of patients.
At the same time, early point-of-care molecular systems often had narrow menus, focusing predominantly on single-target qualitative screening, such as initial MTB detection, without the broader multiplexed resistance profiling increasingly required in modern clinical practice.
The result was a significant access gap: India possessed advanced molecular science, but molecular testing remained disproportionately concentrated in sophisticated laboratories and major urban centres.
COVID-19 created the infrastructure for the next phase
The COVID-19 pandemic fundamentally accelerated India’s molecular diagnostics ecosystem.
The rapid expansion of RTPCR testing created a much larger installed base of molecular infrastructure, laboratories and trained personnel. According to the source material, RT-PCR capacity expanded to more than 3,500 accredited facilities during the pandemic.
That expansion created something more important than temporary testing capacity: a foundation for decentralised molecular diagnostics.
The market could now begin addressing a different question. Instead of asking how to bring samples from smaller centres to a handful of specialised molecular laboratories, the industry could ask:
How can molecular testing itself be taken closer to the patient?
This is where automation and sample-to-answer technologies become strategically important.
Sample-to-answer: simplifying the molecular workflow
One of the most important technological shifts is the emergence of integrated sample-to-answer cartridge platforms.
Conventional molecular testing involves multiple sequential stages, each requiring infrastructure, trained personnel and quality controls. Modern cartridge-based systems increasingly integrate these steps within a closed workflow.
A single cartridge can combine:
- Automated sample lysis
- Magnetic-bead-based nucleic acid extraction
- Lyophilized reagent reconstitution
- Real-time molecular amplification and detection
- Multi-channel fluorescence detection
Advanced systems can employ multiple detection channels, including FAM, HEX, ROX and Cy5, enabling multiplexed detection within a single testing workflow.
The source material identifies integrated platforms capable of delivering this automated workflow in under 140 minutes, with walkaway simplicity. This is more than an incremental technology improvement; it changes the operational economics of molecular diagnostics.
Reducing manual intervention can reduce workflow complexity, dependence on specialised technical manpower and opportunities for handling related variability. This makes molecular testing more practical for a much wider range of laboratories.
In the next phase of molecular diagnostics, workflow simplicity will be as important as analytical sophistication.
Cold-chain independence: solving an overlooked challenge
Decentralisation also requires solving a less visible but critical problem: reagent logistics.
Sophisticated molecular technology cannot scale effectively into diverse geographies if its reagents depend on complex and uninterrupted cold-chain infrastructure.
Lyophilisation is helping address this challenge.
The use of lyoprotectant matrices such as Trehalose and Ficoll can enable PCR reagents to remain stable at room temperature within sealed cartridges. This can reduce dependence on cold-chain infrastructure and help overcome supply-chain vulnerabilities, particularly in tropical and geographically distributed healthcare environments.
From a technology perspective, this is a chemistry innovation.
From a market perspective, it is an access innovation.
A molecular platform that can operate with greater logistical flexibility has a fundamentally different scalability profile.
Policy is accelerating the molecular diagnostics market
Technology adoption does not happen in isolation. India’s public-health priorities are creating strong structural demand for molecular testing.
Under the National Tuberculosis Elimination Programme (NTEP), Universal Drug Susceptibility Testing promotes upfront molecular testing for presumptive TB cases, including simultaneous detection of Mycobacterium tuberculosis and Rifampicin resistance through the rpoB target.
The National Viral Hepatitis Control Programme (NVHCP) is driving the use of quantitative viral-load monitoring for Hepatitis B and Hepatitis C.
At the infrastructure level, PM-ABHIM is supporting the development of Integrated Public Health Laboratories across districts, creating further demand for compact and automated molecular platforms.
These initiatives demonstrate an important evolution in the role of molecular diagnostics.
It is no longer restricted to specialised clinical applications. Molecular testing is increasingly becoming part of large-scale disease-management and public health strategies.
The next frontier: AMR and syndromic testing
The next wave of molecular diagnostics is likely to be defined by increasingly sophisticated applications in antimicrobial resistance (AMR) and acute-care diagnostics.
Binary qualitative testing can answer whether a pathogen is present. The next generation of multiplex molecular diagnostics can potentially answer a more clinically meaningful question:
Which pathogen is present, and what resistance markers does it carry?
Syndromic panels for conditions such as sepsis and pneumonia can combine pathogen identification with detection of critical resistance markers.
The technical landscape includes markers such as:
- blaNDM
- blaKPC
- blaOXA-48
- mcr-1
Molecular testing is also expanding into second-line TB drug resistance, including markers associated with resistance to Fluoroquinolones and Bedaquiline.
The commercial implication is significant.
As molecular menus become broader and more clinically actionable, the value proposition shifts from simply selling a test to enabling faster clinical decision-making.
Oncology: Bringing actionable mutation testing closer to the patient
Oncology represents another major frontier.
Today, certain actionable mutation analyses can involve centralised testing pathways and relatively long turnaround times. The next generation of molecular platforms has the potential to bring selected mutation testing closer to routine diagnostic workflows.
The source material identifies EGFR Exon 19 deletion, L858R and T790M among actionable driver mutations that could be addressed through rapid molecular platforms.
Technologies such as ARMS (Amplification Refractory Mutation System) and PNA/LNA blocker chemistry can support targeted mutation detection on rapid, multi-channel cartridge platforms, potentially reducing dependence on longer 10–14 day NGS workflows for selected applications.
This does not mean molecular platforms will replace NGS across oncology.
Rather, it points towards a more differentiated diagnostic ecosystem in which rapid targeted molecular testing and comprehensive genomic profiling can serve complementary clinical needs.
From imported technology to indigenous precision engineering
Perhaps the most important transformation is taking place at the manufacturing level.
India’s molecular diagnostics market has historically depended substantially on imported technologies, platforms and components. The emergence of indigenous manufacturing is creating the possibility of a more locally responsive molecular diagnostics ecosystem.
The Medical Device PLI scheme and GeM procurement preferences are supporting domestic manufacturing capabilities, including precision moulded cartridges, automated optics and locally produced master mixes.
This is where Make in India becomes more than a manufacturing slogan.
Indigenous molecular diagnostics can potentially provide greater control over product development, localisation, supply chains and cost structures while allowing technologies to be designed around the specific requirements of Indian healthcare.
The competitive advantage will increasingly belong to organisations that can bring together molecular biology, reagent chemistry, microfluidics, optics, automation and manufacturing at scale.
The Erba Transasia perspective: Building for India’s diagnostic reality
For companies operating in this space, the opportunity is not simply to introduce another molecular analyser.
It is to build technology that addresses the realities of India’s diagnostic market: diverse geographies, variable infrastructure, manpower constraints, cost sensitivity and the growing need for faster clinical answers.
This is the direction being pursued by Transasia Bio-Medicals, which is scaling indigenous molecular diagnostics by combining ambient-stable, coldchain-free reagents with automated sample-to-result platforms.
By bringing together automated microfluidics and domestic manufacturing, the objective is to move precision molecular testing beyond its traditional metropolitan footprint and towards a more accessible nationwide model.
The significance of this approach lies in the combination.
- Automation addresses complexity
- Ambient stability addresses logistics
- Indigenous manufacturing addresses scalability and supply resilience
- Decentralisation addresses access.
Together, these elements can fundamentally alter the economics and reach of molecular diagnostics.
The next chapter is about access
India’s molecular diagnostics journey is entering a new phase.
- The first phase established the science.
- The second expanded infrastructure, particularly during COVID-19.
- The next phase is about scale.
Scale will require molecular diagnostics to become simpler without compromising sophistication, decentralised without compromising quality, and more affordable without compromising performance.
The technology already points in that direction: sample-to-answer cartridges, automated extraction, multiplex real-time detection, lyophilized reagents, ambient-stable chemistry, targeted molecular oncology, syndromic AMR panels and indigenous manufacturing.
The larger transformation is therefore not merely about developing better molecular tests.
It is about building a diagnostic ecosystem in which precision molecular testing can travel beyond the laboratory walls of India’s largest cities and become part of routine healthcare delivery across the country.
That is the real promise of the next generation of molecular diagnostics: not just more advanced testing, but more accessible precision.