Molbio plans international growth after receiving USFDA approval for OptraScan

Molbio Diagnostics intends to expand its international operations through its US-based subsidiary, OptraScan. This decision comes amid the molecular diagnostics company's drive to diversify its revenue, which is predominantly dependent on public health programs related to tuberculosis.

OptraScan received approval from the U.S. Food and Drug Administration (USFDA) in July. This approval pertains to a system designed to assess HER2 status in breast cancer biopsy samples. OptraScan obtained 510(k) clearance for its OptraSCAN System for HER2 scoring, which is used to analyze digitized pathological tissue sections of the breast.

Indraneel Borkakoti, President of Corporate Strategy, Investor Relations, and M&A at Molbio Diagnostics, stated that OptraScan is negotiating with major laboratory networks to implement its digital pathology products across the United States. He declined to comment on how this will affect Molbio's domestic versus international revenue mix, citing restrictions related to the Initial Public Offering (IPO).

The company's financial results showed a 29.5 percent decline in foreign revenue, amounting to INR 139.04 crore in fiscal year 26, while domestic revenue increased by 58.7 percent, reaching INR 1,306.64 crore. Consequently, the share of foreign revenue dropped from 19.3 percent the previous year to 9.6 percent. Borkakoti attributed this fall to logistical disruptions rather than a structural weakening of export demand.

He clarified that the export decline mentioned in the performance report was a one-time event caused by logistics issues due to the situation in the Persian Gulf, leading to supply delays in Africa. Molbio acquired nearly 20 percent of OptraScan in October 2024 and increased its stake to 60 percent in October 2025, investing $30 million, part of which was secured as debt for the second tranche.

Borkakoti emphasized that the entire acquisition of OptraScan was made through a new equity infusion, and the funds are held by OptraScan. He noted that following the USFDA approval in July, these funds will be directed toward business development.

OptraScan reported a loss of INR 11.14 crore over five months of consolidation in fiscal year 26. Borkakoti described it as a startup whose primary objective last year was obtaining regulatory clearance for digital pathology technology. OptraScan machines scan pathological slides and convert them into digital images, and an artificial intelligence (AI) layer assists pathologists in interpreting and prioritizing slides requiring closer examination.

Expansion into the US market could provide Molbio with a new growth channel, as the company seeks to broaden its business, which is heavily focused on tuberculosis testing and government procurement. Tuberculosis accounted for 96.02 percent of the 17.56 million Truenat kits sold in fiscal year 26, generating INR 982.01 crore, representing 70.20 percent of finished product revenue. Truenat kits are disposable molecular diagnostic tests that operate exclusively on Molbio's portable Polymerase Chain Reaction (PCR) platform to detect tuberculosis and other infectious diseases near the point of care.

Molbio's largest client accounted for 56.52 percent of finished product revenue, while governments and international aid agencies collectively made up 84.56 percent. Shiva Shriram, President of Molbio Diagnostics, noted that such concentration reflects the priorities of public health for which Truenat was launched.

Shriram added that the issue is not about dependence on any single product or government, but about the influence the company exerts through its platform and global priorities. He mentioned that during the Covid pandemic, priorities shifted, and devices deployed under the tuberculosis control program were repurposed for Covid testing; however, the priority has now returned to tuberculosis, leading to a significant increase in tuberculosis test sales.

Molbio plans to extend its multi-disease platform to programs such as hepatitis testing and human papillomavirus (HPV) screening for cervical cancer. The company's portfolio includes 34 assays covering 22 additional infectious and non-infectious diseases. Shriram stated that the company's goal is to equip primary healthcare centers worldwide with as many devices as possible, enabling the treatment of multiple diseases and integrating with various treatment programs. He noted that this is already happening with diseases like hepatitis and HPV screening, although these programs are not yet as developed as the tuberculosis program.

Molbio's IPO includes a new issuance of up to INR 200 crore and an offering of up to 9.166 million shares. The price range is set at INR 768–807 per share. Approximately INR 105 crore from the new proceeds will be allocated to fund an integrated Research and Development (R&D) center in Bengaluru, and about INR 72.5 crore will primarily be used for automation at test kit manufacturing sites in Goa and the device manufacturing facility in Visakhapatnam.

Molbio's R&D workforce grew from 69 employees in fiscal year 24 to 153 in fiscal year 26, although only one diagnostic assay was commercialized in fiscal year 26. Chandrashekhar Nair, CEO and CTO of Molbio Diagnostics, noted that R&D is aimed at building capacity over time until it becomes a platform capable of making a significant impact. He added that they are developing assays for the current platform and bringing them into regulated environments, including CE-IVDR and preliminary World Health Organization (WHO) qualification, which requires substantial evidence. Furthermore, they have created a technological base for building an entirely new suite of platforms that can increase revenue and open new avenues for growth.

business-standard.comJuly 30, 10:59

Piramal Pharma forecasts mid-decade revenue growth in FY2027, emphasizing organic expansion

The Chairman of Piramal Pharma, Nandini Piramal, stated that the company plans to sustain mid-decade revenue growth in the fiscal year 2027 and achieve a significant improvement in profitability. The company's priority is organic expansion rather than acquisitions.

First Quarter Financial Results

The company demonstrated a strong start to the fiscal year, noting a 17% year-on-year growth in consolidated revenue, reaching INR 2,270 crore in the quarter from April to June. Piramal noted that the operating leverage, driven by higher capacity utilization and improved execution, will continue to support margins.

During this quarter, the company increased its EBITDA by 72%, reaching INR 285 crore. Consequently, the EBITDA margin expanded by 400 basis points to 12.5%, compared to 8.5% the previous year. Despite increased depreciation and tax expenses, Piramal Pharma reported a net loss of INR 69 crore for the quarter, which is better than the INR 102 crore loss the previous year, excluding exceptional items.

Growth Across Business Segments

Piramal reported that all three business segments—Contract Development and Manufacturing Organization (CDMO), Complex Hospital Generics (CHG), and Consumer Healthcare—showed growth in the mid-to-upper part of the decade during the quarter. Management maintains the forecast for mid-decade revenue growth for the year, expecting EBITDA to grow faster than revenue, and net profit to improve significantly.

The CDMO business, which accounts for over half of the company's revenue, grew by 19%, reaching INR 1,187 crore. Piramal attributed this success to improved funding in the biopharmaceutical sector, broad growth both in India and abroad, and strengthened commercial execution following the expansion of the business development team. She added that most of the company's clients are biotechnology companies from the US, and demand in the US biopharma sector remains favorable as of October.

Technology and Market Developments

Despite strengthening demand, Piramal noted that customer decision-making timelines remain lengthy. Regarding new modalities such as Antibody-Drug Conjugates (ADC) and peptides, growth was uniform rather than concentrated in one segment. The company recently launched a commercial line of payload linkers at its Riverview facility in the US and continues work on expanding sterile injectable capacity in Lexington, expected to be operational by the end of 2027.

For peptides, the company is focused on contract manufacturing rather than large GLP-1 opportunities, as it currently lacks the scale to undertake large-scale work. Meanwhile, the peptide facility in Navi Mumbai shows healthy demand for niche peptide molecules.

Strategy and Risks

Despite improving profitability, Piramal emphasized that the company is not pursuing active acquisitions, focusing instead on organic growth and the expansion of new sites. In the complex hospital generics business, commercial supply of the drug Kenalog is expected to begin from the second quarter of the fiscal year 2027 as regulatory approvals transition across different markets. Price pressure persists in the US generics market, but the company has managed to maintain market share and margins.

Commenting on potential tariff risks following recent statements by US President Donald Trump, Piramal explained that the company's core products are largely protected because both Active Pharmaceutical Ingredients (APIs) and finished dosage forms are manufactured in the US, although some raw material components still originate from India and China.