In a series exploring trends across the APAC region, Norstella’s subject matter experts from key biopharma hubs delve into last year’s standout developments and share their outlook for 2025. Andrew Warmington, Manufacturing Editor at Citeline, spoke to Anju Ghangurde, Executive Editor, APAC, Citeline, and Vibha Ravi, Senior Editor, APAC, Citeline.
How would you describe the current clinical trial landscape in India? What major trends have you noticed in the last year?
Vibha Ravi: India is a large market for pharmaceutical products and presents companies with a large patient pool for trials and a very diverse set of indications. According to a white paper from Citeline on clinical trials in APAC, 580 Phase I-IV trials began in India during 2023.1 The compound annual growth rate (CAGR) from 2019 to 2023 fell by 1% but this fall was lower than that of other countries in the APAC region, other than China which grew very rapidly.
An interesting aspect is that academic-sponsored trials accounted for 48% of trials in India, much more than in other countries in the region. The domestic industry is also sponsoring more trials, but at the same time academia is also getting more interlinked with industry trials. During 2019-2023, the domestic industry sponsored 79% of trials in India, the other 21% was conducted outside India. The number of novel molecules being developed by Indian pharma companies is on the rise. We had a successful CAR T trial and India is developing more antibody-drug conjugates (ADCs). In addition, more Indian sites are being included in multi-regional clinical trials (MRCTs). This is driven not just by the size of the patient population but also by the requirement for more diversity in clinical trials.
The regulatory environment has been improving. India has not only simplified trial requirements but also shown flexibility in waiving them altogether in certain cases. In August 2024, the requirement for clinical trials in certain categories of drugs that have been approved in certain other countries was waived. In the previous year, the government removed a mandatory requirement for animal testing in drug development. The number of hospitals and hospital chains has also been growing, not just in the major cities but also in Tier 2 and 3 cities and tertiary networks. This is increasing the patient pool available to companies for trials.
What were the most significant Indian drug/device approvals or milestones reached in 2024?
Anju Ghangurde: I’d like to highlight a few key advances that underline the importance of partnerships as India moves up the innovation value chain. The striking one is the approval of immuno-oncology drug Toripalimab for the treatment of metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) for Dr. Reddy’s under a licence and commercialization agreement with Shanghai Junxi Biosciences. It came with a local Phase III trial waiver, subject to certain conditions. This is also an important debut because the drug was launched in India in the same year as the US launch. India is the third country after China and the US where this next-gen humanized programmed cell death protein 1 (PD-1) inhibitor is available.
Another is the go-ahead for MannKind Corporation’s Afrezza. MannKind has a partnership with Cipla in India, and this is the first inhaled insulin on the market. The other third key approval is the first indigenously developed macrolide antibiotic, nafithromycin, which was developed Wockhardt, backed by BIRAC, a unit of India’s Department of Biotechnology. This is important because it addresses community-acquired bacterial pneumonia, which is caused by drug-resistant bacteria.
2024 also saw India greenlight Immuneel’s autologous CD19 CAR-T cell therapy Qartemi, (varnimcabtagene autoleucel) for the treatment of relapsed and refractory non-Hodgkin’s lymphoma, the second CAR-T to get the go-ahead here. Immuneel acquired exclusive rights to it from two institutions in Spain, where it is approved, to develop, manufacture, and commercialize the therapy in India via technology transfer. Finally, Lilly’s tirzepatide got approval for Type 2 diabetes in India. All eyes are on the launch trajectory. The expert committee, which advises the Indian regulator, also gave a go-ahead for chronic weight management, subject to certain conditions being fulfilled.
How does India differentiate itself from other APAC regions in the clinical trial space?
Vibha Ravi: I wouldn’t call it a complete differentiator, but it’s an enabler that the regulator is making a more conscious effort to accelerate timelines for the approval of clinical trial applications. There’s also an attempt at more standardization and more clarity on the functioning of ethics committees, which is giving pharma companies more confidence in the overall regulatory environment.
India also has a large number of contract research, development and manufacturing organizations (CRDMOs), which are drawing more attention after the proposed BIOSECURE Act in the US. Indian CRDMOs are adding to the infrastructure available here. Several of them also have a base in the US, which adds to their attractiveness to biotechs.
In addition, graduates from internationally reputed institutes like the Indian Institutes of Technology (IITs) have driven leadership at various IT companies. The IITs are taking a keener interest in drug development now, and this could also help drive down drug costs. The cost of drug development in India is invariably lower than elsewhere, except maybe for China. As a case in point ImmunoACT, which was incubated in at IIT in Mumbai, has brought in a CAR-T cell therapy which is nearly 10% of the price of similar treatments.
Another point is that, given the increasing importance of artificial intelligence (AI) in the drug development landscape, the high number of data scientists coming out of various institutes could help fortify the drug development infrastructure and drive more opportunities to India. Many multinationals with global capability centres (GCCs), like Bristol-Myers Squibb and Lilly, are looking to conduct more trials in India.
What new or ongoing drug development challenges will Indian pharma and biotech companies face in 2025?
Vibha Ravi: Intellectual property (IP) has been a sticking point for quite a while now. Global companies have emphasized that effective and enforceable patents and the introduction of regulatory data production protection (RDP) will encourage more innovation. Now, as Indian companies increasingly develop novel molecules, support for IP protection has increased, but at the same time affordability and access are two prongs of the Indian healthcare system that cannot be ignored. Striking a balance between these two is an ongoing challenge.
During an interview with a large CRO, Parexel, I was told about the challenges of gathering real world data (RWD). RWD is becoming a big aspect of drug development. The opportunity for it in India is huge, but challenges exist, like elsewhere, because of data quality and disparity. A lot of data is generated, but it’s not always collected optimally. Creating electronic health records (EHRs) would help, but then we have the challenge of data integrity and privacy. Privacy needs to be tackled first before we can get to the stage of assuring the patient that his data is not going to be shared in a way that he didn’t intend.
The third challenge is patient literacy, because, despite being a vast market for clinical trials, the numbers compared to the total percentage of population in India is still low. That also boils down to trust. The rules have been amended, and ethics committees were created to ensure proper conduct and transparency in trials. But just to overcome this hesitancy, transparency needs to be increased, keeping the patients interests in mind and compliance with set standards should be ensured so that patients can trust the sponsor and the process more. Lastly, clinical trials in India are predominantly driven by hospitals and investigators, so digital platforms could be accessed or created and democratized to increase access to trials.
What Indian M&A deals is the industry most anticipating in the year ahead?
Anju Ghangurde: 2024 saw a range of deals. The highlights among the domestic large domestic buyouts included Mankind Pharma acquiring Bharat Serums & Vaccines for $1.6 billion in the largest disclosed transaction at the time in India. Then there was Eris’s acquisition of Biocon Biologics’ branded formulations business in India and Swiss Parenterals.
On the outbound front, some key ones were Dr. Reddy’s snapping up Haleon’s global portfolio of consumer health brands in the nicotine replacement therapy category outside the US. Dr. Reddy’s went on to acquire MenoLabs, a women’s health and dietary supplement branded portfolio, from Amyris under the Chapter 11 sales process. The other interesting bit, given all the activity on the biosimilars front is Intas’s acquisition of Udenyca, a Neulasta biosimilar, from Coherus. That is an important one because it perhaps shows where the industry is heading in terms of ‘buy’ versus ‘develop’. That equation seems to be changing.
There has also been rising investor interest in the health tech and medical devices segment. With that background, where could we see more action this year? I spoke to some investment bankers who said they expect Indian companies to target outbound deals in the $50-250 million range initially. There could be some brand deals, like in 2024. There could be more interest in the CDMO space and consolidation is anticipated in the domestic formulation space. There has been long running speculation about deal interest in Cipla, which is among the top five companies in the country. If that translates into a deal, it could be a defining transaction.
How do you see the Indian pharma market growing over the next year? What would you say is the top priority for this sector?
Anju Ghangurde: The Indian pharma market was valued at $50 billion for the 2023-2024 financial year and projections show that it could reach about $130 billion by 2030. Some estimates project spending on medicines to reach $38-42 billion by 2028, which reflects a CAGR of 7-10% between 2024 and 2028. This overall upbeat tenor is driven by a number of factors. These include a shift in consumption patterns fueled by a middle class with rising income. What is important is that this consumption growth story is seen beyond the major cities.
Then there is expanding health coverage; more people are coming into the treatment net, thanks to the government run-health assurance scheme and private insurance should also pick up. The government is aware that the Indian pharma sector is important to health security and there is plenty of policy support coming along for the industry. The top priorities for the sector would likely be a sustained effort to keep the quality slate clean across the board, because a large part of the world depends on Indian generics. The other bit would be strict enforcement of compliance norms. And finally, it’s really high time that we made some big strides in delivering cutting-edge innovation. After all, this is a country that has managed to carry out a soft landing on the South Pole of the Moon!
How can partnering with Norstella help organizations gain a competitive edge in the Indian market?
Anju Ghangurde: I would say our Insights business and all the publications are not just covering news; it’s really news you can use. It encapsulates on-the-ground insights and flavors; it brings you the trends, with exclusive C-suite interviews. And it comes from a team rich in experience and has seen various waves in pharma over the years. For example, on GLP-1s we not only cover the headline news around the blockbusters, we’ll tell you about the R&D developments, the trends in the space, how things are shaping up in markets from the US to Japan to India, all the regulatory stuff rolled in, views from key opinion leaders. It’s a global lens that reflects both local and global considerations on all key developments. We are bringing a complete value proposition.
Vibha Ravi: As an organization, we have commercial and regulatory insights from our various publications and, apart from helping companies from pipeline to patient with intelligence and recruiting solutions, data solutions from Pharmaprojects and Evaluate and advisory services from Dedham also help companies face other challenges. For example, we have written about the likely impact of the BIOSECURE Act, identifying gaps that could be created, listing Indian companies that could help fill this gap and articles on the size of market opportunities, presenting them in easy-to-consume forms like infographics. We bring insights across the spectrum, from trials to market access. Our Asia focus is something that many other organizations don’t have, because we’re committed on the ground with a whole team covering Asia.
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