While there are many factors currently working in the favor of Indian CROs, proactive companies are still making strategic decisions rather than passively waiting to see benefits from the evolving market dynamics. For example, the global shift towards complex generics requires different capabilities on the part of contract research organizations, and the ones that are able to keep the pace with the transition by updating their offerings accordingly are best suited to attract these types of business opportunities.

“As our clients, both in India and globally, are increasingly moving onwards from simple generics towards complex generics, our focus has been to transition alongside them through offering the clinical development support they need,” said Ajay Tandon, managing director of Veeda Clinical Research, a global clinical development partner that acquired a majority stake in Bioneeds India in 2021 to amplify its preclinical capabilities. “Our investments into the preclinical space have proven helpful for our clients as they come to us for services such as additional toxicity tests or impurity qualification work for the development of novel generics before initiating clinical studies. Previously, we would have had to refer these clients to another preclinical company to do this work, but now Veeda, through Bioneeds, can assist them from this stage through to clinical studies.”

As the life sciences landscape shifts to accommodate more small and emerging biopharma companies, integrated service providers that can offer full-service capabilities are better able to take on this line of work without sacrificing the ability to meet the needs of larger players.

Regardless of size, many pharma and biopharma companies appreciate the opportunity to partner with the same service provider throughout the development and manufacturing process to avoid site and tech transfer complications. “We have clients come to us to co-develop a product from scratch,” said Bhaskar Krishna, managing director and CEO of Maiva Pharma, a sterile injectables CDMO. “It can be a challenge to find a CDMO with the capability to develop, license, and manufacture a product, and this is a strength of Maiva.”

Derren Healthcare, a CDMO that does general small volume parenteral (SVP) manufacturing, finds itself at an advantage when compared to other SVP manufacturing companies given its ability to assist with R&D along with production. “If a client has to develop something then do a tech transfer to another company then go to another supplier for commercial batches, this becomes costly and time consuming. When it comes to SVP in glass and vials, clients can come to Derren for development as well as the exhibit, engineer, or commercial batch all together,” commented the company’s director, Rahul Maheshwari.

In a similar vein, Jay Mandal, managing director of APDM Pharmaceuticals, acknowledges there is both a time and a cost standpoint associated with offering integrated services: “When services are provided under one umbrella, you are not dependent on several different service providers, and this helps both financially and from a time standpoint.”

Krishna Kanumuri, CEO and managing director of Sai Life Sciences, has found there are particular therapeutic areas in which clients stress the importance of having an integrated service provider from a speed perspective. “Especially with rare diseases and oncology, there is pressure to decrease the development and manufacturing timeline from 10 years down to five years,” Kanumuri said. “This need to get to market faster, gives companies very little time to move between service providers. The ability to provide high caliber, fully integrated CRO and CDMO services under one roof, saves time and avoids unnecessary bottlenecks.”

Just as forward-thinking contract research companies anticipate growth patterns in emerging sectors, such as Veeda with complex generics, Indian CDMOs are working overtime to keep their business strategies a step ahead of the curve.

“Around four years ago, we decided to expand the business through a niche segment of oncology services because we recognized this sector comprised roughly 20% of the world’s pharmaceutical market,” said Bikramjit Ghosh, head of strategy and business development at Sakar Healthcare, a CDMO formed in 2004 that has expanded its presence to over 60 countries worldwide.

Understanding the importance of cancer-related treatments, Sakar established its own API integrated oncology formulation and manufacturing unit. The company has since undertaken a joint development with a Greek company on a product that is, according to Ghosh, in the top 10 patented molecules in the oncology segment worldwide.

With an eye on the market growth potential for peptides, Piramal Pharma Limited, which demerged from Piramal Group in October 2022, acquired Hemmo Pharmaceuticals to add peptide API development and manufacturing capabilities to the company’s CDMO business. “We added Hemmo because they had been around for several decades and provided us with the ability to do development work for on-patent clients working with peptides,” commented the company’s CEO Peter DeYoung. “The company already had an established on-market generic portfolio and a pipeline of generics, meaning we can serve both the services segment and the generics segment for peptides, an area we believe is attractive and growing.”

According to Piramal Pharma’s estimates, there are over 80 approved peptides in the market in the US, about 250 under clinical development, and around 500 in preclinical development. According to DeYoung, even if Piramal Pharma takes on a small fraction of this peptide work, it has the potential to become a relevant player given the room to grow. “We see the space growing at roughly five to eight percent per year, and of that, two thirds is outsourced. As such, there is opportunity to grow a meaningful clinical development pipeline with our services business on top of the existing generic business Hemmo was already doing.”

Piramal Pharma has partaken in other recent inorganic activities as part of its growth strategy, including adding a new drug product facility in the US and a minority investment in a gene therapy and vaccine development company in Hyderabad.

While it may be the pharma and biopharma innovators that often make headlines, the behind-the-scenes activities of contract service providers are what enable the industry to develop at such a rapid pace.