OneSource goes for multi-modality to build a global pharma platform

OneSource Specialty Pharma Ltd is a new name in India’s pharmaceutical industry, but the businesses that make up the company are anything but new. Created through the demerger of the specialty pharmaceutical businesses of Strides Pharma Science Ltd, OneSource was listed on the NSE and BSE as an independent entity in January 2025 with a larger ambition: to build India’s first specialty pharma pure-play contract development and manufacturing organisation (CDMO) platform, offering global pharmaceutical and biotechnology companies multiple complex manufacturing capabilities through a single partner.

The Bengaluru-headquartered company, the demerged businesses of Strides Pharma, is being built around four principal modalities – drug-device combinations (DDCs), biologics, sterile injectables and softgel capsules. Together, these businesses are intended to create a multi-modality, end-to-end outsourcing platform covering much of the pharmaceutical product lifecycle, from development and scale-up to drug substance, drug product, sterile fillfinish, device assembly and commercial manufacturing.

The ambition is backed by significant investment. OneSource, which reported revenue of around Rs1,422 crore in FY26, is committing around $100 million towards expanding its DDC capabilities, primarily to cater to the growing demand for complex injectable products and GLP-1 therapies (a new generation of medicines that help people manage diabetes and obesity). It is also expanding its biologics, sterile injectable and softgel capacities as it builds a broader platform. About 80 per cent of the announced DDC capex programme has already been committed, with the second cartridge line entering commercial operations in Q2 FY27 and another Phase 2 line planned during FY27.

OneSource raised significant institutional capital as it built its specialty CDMO platform. Before the demerger, its predecessor, Stelis Biopharma, raised $195 million in 2021, while OneSource subsequently raised about $95 million in a pre-listing round in 2024, led by HBM Healthcare Investments and supported by a group of domestic institutional investors.

These investments are helping OneSource scale its capabilities at a time when the global pharmaceutical industry is shifting towards complex products and greater outsourcing. The rise of biologics, peptides, sterile injectables and sophisticated drug-delivery systems is creating demand for CDMOs with deeper technical capabilities, while pharmaceutical companies are increasingly looking to consolidate their supplier base and work with fewer but more capable partners.

“The idea of OneSource was basically to offer our customers a one-stop shop for their various CDMO requirements,” says Neeraj Sharma, CEO and Managing Director of OneSource Specialty Pharma. “Customers globally, whether they are big pharma companies or large generic companies, all want to reduce the complexity in their supply chains. They have so many supplier relationships when it comes to outsourcing, and they’re all looking at reducing this complexity.”

That is the strategic space OneSource is attempting to occupy. The origins of OneSource go back to Strides Pharma Science, which over the past three decades built a presence in global pharmaceuticals, with capabilities spanning regulated markets, contract manufacturing and specialised pharmaceutical technologies.

Headquartered in Bengaluru, Strides developed businesses across complex areas, including sterile injectables and softgels, while gradually adding capabilities in newer fields such as biologics and drug-device combinations.

As these businesses matured, however, the opportunity before them began to change. The global pharmaceutical industry was moving increasingly towards outsourcing complex manufacturing. Large pharmaceutical companies were looking for specialised partners without having to invest in every manufacturing technology themselves. At the same time, focused CDMO businesses were gaining strategic importance because of their potential for long-term customer relationships, recurring commercial revenues and high entry barriers.

A focused approach

Against this backdrop, the decision to separate the specialty pharmaceutical CDMO businesses from Strides was aimed at creating a focused platform that could allocate capital, management bandwidth and strategic attention exclusively to the outsourcing opportunity. For Strides, the demerger offered a way to unlock the value of a specialised business within a separate corporate structure. For OneSource, it provided the foundation to build a dedicated CDMO platform with its own capital allocation strategy and growth ambitions.

The businesses brought together under OneSource already had individual strengths. The opportunity was to combine them. The company therefore did not start as a greenfield CDMO. It began with manufacturing facilities, regulatory approvals, customer relationships and technical expertise, and is now attempting to turn these assets into a single integrated proposition.

OneSource’s strategy is based on a simple premise: pharmaceutical products are becoming more complex, making outsourcing increasingly attractive. But working with multiple specialised vendors creates its own challenges. A company developing a complex product may need separate partners for drug substance, drug product, sterile filling, device integration and packaging. Each additional vendor adds another layer of coordination, quality oversight, regulatory management and supply-chain risk.

OneSource wants to reduce that complexity. Its multi-modality approach allows a customer to access different capabilities through a single relationship. A biologics customer may require both drug substance and drug product manufacturing. A complex injectable may need sterile fill-finish and a pre-filled syringe. A GLP-1 developer may require cartridge filling, pen assembly and packaging. A pharmaceutical company with a softgel portfolio could potentially use the company’s injectable or biologics capabilities as well. The opportunity is therefore not only to win customers but also to deepen relationships with them.

“When we launched OneSource, we had not one customer who was common across platforms,” says Sharma. “Now we already have customers who are common across services.” That shift is strategically important. Instead of relying entirely on acquiring new customers, OneSource can potentially grow by increasing its share of existing customers’ outsourcing requirements. This is the foundation of its end-to-end strategy.

Sharma has more than 30 years of experience in the pharmaceutical industry, with a career spanning India, Southeast Asia, Latin America and Europe. He began his career with Ranbaxy and later spent time at Sun Pharma, where he was responsible for the generics business in Western Europe. He joined the OneSource group in 2021 and previously served as CEO of Steriscience. Sharma became Managing Director of OneSource in March 2024. He holds a bachelor’s degree in Instrumentation and Control Engineering from the University of Delhi and a postgraduate diploma in Business Management from IMT Ghaziabad.

An integrated partner

The OneSource proposition goes beyond manufacturing capacity. The company is attempting to participate across the product lifecycle: from development and scale-up to regulatory support and commercial production. That can create longer customer relationships. A project may begin as a development programme, move into clinical manufacturing and, if successful, eventually become a commercial product. Once approved, the relationship can continue for years as the customer scales sales. This model is particularly relevant in complex pharmaceutical categories, where manufacturing processes are difficult to replicate and regulatory approvals create significant switching costs.

OneSource today operates five manufacturing facilities with approvals from global regulatory agencies, including the US FDA, European regulators and Australia’s Therapeutic Goods Administration. It has more than 1,600 employees, over 80 global customers and more than 220 successful audits.

The proposition, therefore, is not simply that OneSource has manufacturing capacity. It is that the company can combine technology, regulatory expertise, infrastructure and customer relationships across multiple modalities. That is where it sees its competitive moat.

Sharma identifies three critical barriers to entry in complex CDMO manufacturing: capability, capacity and compliance. “Capability, capacity and compliance – these three Cs are the entry barriers,” he says.

The first is capability. Complex pharmaceutical products require specialised scientific and technical expertise. Developing a manufacturing process is different from scaling it up, and both are different from maintaining consistent commercial production. OneSource has accumulated experience across these areas. Its sterile injectables business has more than two decades of experience, while its DDC capabilities have been developed over several years. The company has also built an integrated biologics platform covering both drug substance and drug product.

The second barrier is capacity. Complex manufacturing facilities require substantial upfront investment and long lead times. A new facility must be constructed, equipment installed, processes qualified and regulatory approvals obtained before commercial production can begin. OneSource estimates that a new entrant starting a greenfield DDC facility today could take around 5 years before generating its first dollar of revenue. This creates an advantage for companies that already have infrastructure and regulatory approvals.

The third is compliance. A CDMO serving global pharmaceutical companies must meet stringent regulatory standards across multiple markets. For customers, the regulatory record of their manufacturing partner is critical because any compliance issue can disrupt product supplies.

OneSource has maintained a strong track record, with more than 220 successful audits. During Q1 FY27, it also received EU GMP and TGA GMP approvals across two sites. “Compliance track record, especially as you have seen in India, has so many challenges that companies keep getting into,” says Sharma. “We have had a very, very strong track record. We have a very strong quality and compliance DNA.”

The combination of capability, capacity and compliance is what OneSource believes will allow it to compete for long-term relationships rather than short-term manufacturing contracts.

The company’s strategy is particularly relevant as the pharmaceutical industry shifts towards complex products, with GLP-1 therapies among the most visible examples. The explosive growth of semaglutide and other obesity and diabetes treatments has created a significant opportunity for companies involved in their development and manufacturing. For OneSource, the opportunity is especially relevant because of the complexity of the delivery systems involved.

Many GLP-1 products require specialised drug-device combinations, including cartridges, pens, sterile filling and assembly. This plays directly into OneSource’s DDC capabilities. Its Bengaluru facility is being expanded to meet the opportunity. The second cartridge line entered commercial operations in Q2 FY27, while a further Phase 2 line is planned during FY27. The company expects the expansion to double sterile production days initially and eventually triple them by FY28. About 80 per cent of the announced $100 million capex programme is already committed.

Expanding portfolio

OneSource now has more than 20 customers across its DDC portfolio. Its platform has supported three G7 semaglutide approvals, while it has also secured two first-to-file opportunities in tirzepatide through two customers.

The company has begun commercialising semaglutide programmes in India and Canada and is working with Hikma Pharmaceuticals to commercialise generic semaglutide in the MENA region, with OneSource manufacturing and supplying the product.

The significance of these partnerships extends beyond individual products. They demonstrate the company’s ability to combine complex manufacturing with partners that bring regulatory and commercial capabilities in different markets. The GLP-1 opportunity is therefore an early test of the OneSource model. The company is not simply supplying a molecule. It is providing an integrated manufacturing platform around a complex product.

OneSource, however, does not want to become dependent on a single therapeutic category. Its second major growth pillar is biologics. The company has built capabilities across microbial and mammalian systems and is expanding both drug-substance and drug-product capacity. Current capacity includes 1 KL microbial and 4 KL mammalian systems, with planned additions of 5 KL and 4 KL respectively. The biologics strategy is focused on three areas: biosimilars, animal health and innovative biologics.

In biosimilars, the company has announced two major partnerships. In animal health, it has a strategic partnership with a top-three global player. The innovator pipeline is being developed through discussions with potential US and European customers. The opportunity is significant as biologics account for an increasing share of new drug development. “More than 50 per cent of the new drugs which are coming out are biologic drugs,” says Sharma.

For pharmaceutical companies, developing and manufacturing biologics internally requires substantial investment in specialised facilities and expertise. Outsourcing can therefore provide greater flexibility, particularly as product pipelines evolve. OneSource’s integrated biologics platform is designed to address this need. The company’s biologics RFP funnel is at an all-time high, supported by biosimilar opportunities, patent expiries and global supply-chain diversification. Over time, biologics could become as important to OneSource as DDCs are today.

The newer growth engines are being built on established businesses. Sterile injectables have been part of the company’s capabilities for more than two decades. The business serves specialised categories and is expanding into areas such as pre-filled syringes, high-viscosity products and lyophilisation. Softgels provide another established technology. OneSource has expanded softgel capacity nearly threefold over the past 12 to 18 months, according to Sharma. Existing capacity stands at around 2.4 billion capsules, with another 1.6 billion targeted for addition.

The strategy is to move beyond captive or intellectual-property-led demand and increase third-party CDMO business. “We are looking at adding customers to fill that capacity,” says Sharma.

Together, these businesses provide diversification. DDCs and GLP-1s are expected to drive near-term growth; biologics represent a longer-term opportunity; and sterile injectables and softgels provide an established base. The result is a platform with multiple growth cycles rather than dependence on a single technology or product.

OneSource’s financials reflect a period of transition. FY25 revenue grew 30 per cent to around Rs1,445 crore, while PAT rose sharply. In FY26, revenue slipped marginally to around Rs1,422 crore and adjusted PAT stood at Rs73.9 crore, as the company continued investing in its platform and semaglutide commercialisation took longer than expected.

The recovery became visible in Q4, when revenue rose 47 per cent sequentially to around Rs428 crore. Momentum continued into Q1 FY27, with revenue up 37 per cent year on year to Rs449 crore and adjusted PAT rising 72 per cent to around Rs64 crore, signalling a potential inflexion in the company’s growth trajectory.

Ramping up clientele

OneSource has more than 80 global customers, while its RFP funnel has grown fourfold since FY25. The company had more than 70 active RFPs and reported multiple new wins and launches across modalities in Q1 FY27. The opportunity, however, is not simply to win more customers. It is to build deeper relationships with existing ones.

A relationship that begins with softgels could potentially extend into sterile injectables. A customer working with OneSource on a biologics programme could eventually use its drug-product capabilities. A GLP-1 customer may require not just drug manufacturing but also cartridge filling, device assembly and packaging.

The more of these requirements OneSource can address, the greater the opportunity to increase its share of the customer’s outsourcing spend. This is perhaps the most important test of the OneSource strategy. The company has invested heavily in building multiple capabilities, but the value of that investment will increase substantially if customers begin using more than one. “The more capabilities we have, the more opportunities we have to engage with the same customer,” says Sharma.

This is the real strategic value of the demerger. The individual businesses had capabilities before OneSource was created. What the new structure is attempting to add is connectivity between them.

The company now has a clear financial ambition against which its strategy will be measured. OneSource is targeting $400 million in organic revenue by FY28 and a steady-state EBITDA margin of around 40 per cent.

Achieving these targets will require more than a favourable cycle in GLP-1s. It will require the successful commercialisation of its DDC investments, continued growth in biologics, higher utilisation of sterile injectable and softgel capacity and, most importantly, the ability to deepen relationships with existing customers. The company has already made the capital commitments, started commissioning new capacity, expanded its regulatory infrastructure and built a growing customer pipeline. The task now is to convert these investments into a scaled, integrated business.

The OneSource story is ultimately about more than the separation of a business from Strides. The demerger created the opportunity to take a group of specialised pharmaceutical businesses and give them a singular identity and a focused growth strategy. The real transformation is taking place at the platform level. OneSource is attempting to bring together capabilities that historically existed as separate businesses and turn them into a single proposition for customers. That proposition is becoming increasingly relevant to the global pharmaceutical industry. As medicines become more complex, pharmaceutical companies need partners that can do more than manufacture a product at scale. This is where OneSource hopes its multi-modality model will create an advantage.