Molbio Diagnostics

Molecular diagnostics is shifting from centralised PCR laboratories toward faster decentralised platforms that can operate nearer the patient. 1Lattice estimates the global molecular-diagnostics market to increase from USD 19.8 Bn in CY25 to USD 31.1 Bn by CY30 at 9.4% CAGR, while global POCT is expected to grow faster as healthcare systems prioritise speed, decentralisation and access

The key tailwinds are:

• India’s POCT total addressable market is estimated by 1Lattice at approximately INR 203.2 Bn in FY26 and INR 446.8 Bn by FY31, implying ~17.0% CAGR

• The Indian molecular-POCT infectious-disease market is estimated to grow from INR 61.6 Bn in FY26 to INR 152.1 Bn by FY31 at ~19.8% CAGR

• Truenat is designed for low-infrastructure, battery-operated use and returns molecular results in approximately one hour, aligning directly with the decentralisation trend

• The recurring test-kit model allows installed devices to translate utilisation growth into consumables demand.

TB remains a major global diagnostic gap and is particularly relevant to Molbio because Truenat’s earliest large-scale adoption has been in TB. The 1Lattice report estimates 10.7 million global TB cases in CY24, with only 8.3 million diagnosed, while India represented approximately 25% of global cases.

The key details are:

• Around 2.4 million global TB cases were undiagnosed or unreported in CY24, supporting continued expansion of case-finding infrastructure

• An estimated 150-200 million smear tests are conducted globally each year and may progressively shift toward molecular diagnostics

• India’s TB-diagnostics TAM is estimated to grow from INR 66.9 Bn in FY26 to INR 167.4 Bn by FY31 at ~20.1% CAGR

• Truenat has been integrated into India’s NTEP and had a leading share of incremental molecular installations in disclosed historical NTEP data.

India continues to build testing capacity through TB programmes, integrated public-health laboratories and broader health-infrastructure schemes. As testing becomes more decentralised, vendors with validated quality systems, regulatory clearances, service infrastructure and portable platforms can participate in a larger addressable network.

The key details are:

• 1Lattice notes a substantial increase in designated microscopy centres and molecular diagnostic installations, with further headroom to scale testing access

• Government health infrastructure and insurance programmes can increase patient access and diagnostic utilisation, although procurement remains tender-driven

• The Medical Devices Rules, 2017 and quality-system requirements raise formal compliance thresholds and favour manufacturers able to obtain and maintain approvals

• Molbio’s ISO 13485/MDSAP quality systems and multi-country regulatory strategy support expansion into more formalised diagnostic markets.

Molecular diagnostics is R&D intensive, regulated, technology-sensitive and dependent on consistent supply of specialised reagents and electronic components. Public-health procurement can create scale, but also introduces tender concentration, pricing pressure and slower payment cycles. New platforms must also win clinician and laboratory adoption while continuously maintaining performance and regulatory standards.

The key risks are:

• Government and aid-program dependence can create volume volatility if budgets, procurement rules, disease-program priorities or price caps change

• Regulatory approvals vary by country and assay; delayed clearances can slow commercialisation, while rapid technological change can make assays or platforms obsolete

• Molbio imported 42.0% of FY26 raw-material purchases; supply disruptions, currency moves and import duties can affect availability and cost

• The top 10 suppliers represented 58.5% of FY26 raw-material purchases, increasing vendor concentration risk

• Public-health payment cycles and tender execution can keep working capital high; private-sector adoption may also be slower due to switching costs and incumbent workflows.

Indian health policy broadly supports expansion of infectious-disease testing, decentralised public-health infrastructure and domestic medical-device capability. These programmes are demand enablers rather than guaranteed Company revenues and remain dependent on actual procurement and budget execution

The key policies are:

• The National Tuberculosis Elimination Programme promotes rapid molecular diagnosis and has already incorporated Truenat for TB testing

• Integrated Public Health Laboratories under public-health infrastructure initiatives expand district-level diagnostic capacity

• Ayushman Bharat / PM-JAY and related public-health spending can broaden utilisation of diagnostic services by improving access to care

• India’s healthcare budget allocation increased to approximately USD 12.6 Bn in FY26 according to 1Lattice, while healthcare expenditure remains low relative to GDP, leaving structural room for expansion

• The Medical Devices Rules, 2017 provide a formal regulatory framework for IVD and medical-device manufacturing and quality compliance.