India is rising from a CDMO perspective when it comes to biologics

What are the top 3 biopharma trends that you have observed in 2024 with India as a focused region as well as looking at it locally?

I will start with global trends and then come to India trends.

Global trends: 

The emphasis on technology, AI, and generative AI is very strong within the biopharma sector, spanning areas like drug discovery, development, commercialisation, and the supply chain. For instance, these technologies are streamlining processes such as finding ways to take time and cost out of things like protocol optimisation in clinical trials, identifying druggable targets during the discovery phase, and advancing proof-of-concept pilots to broader adoption across the entire value chain. This trend is particularly evident given the significant advancements in generative AI over the past few years.

Another notable trend in global biopharma is the increasing scrutiny on access and pricing by health systems and governments worldwide. This is evident in the US with the IRA legislation, and in Europe through initiatives like the Joint Clinical Assessment, new EU pharmaceutical regulations, and recent changes in Germany. Consequently, there is a growing emphasis on building sustainable healthcare systems for aging populations while ensuring that new innovations entering the market are appropriately valued.

Personalised care is expanding, particularly in areas like cell and gene therapies, targeted medicines, and enhanced patient support to ensure adherence to effective treatments. This trend is fueled by the need to offer more tailored and effective solutions for patients.

India trends:

The power of AI and data analytics is ushering generative AI, along with AI and ML, into the Indian biopharma industry, contributing to areas such as disease understanding and vaccine development. India’s robust IT infrastructure and strong technology sector play a key role in streamlining clinical trial data. There is significant potential to harness these capabilities within the Indian economy to advance the biopharma sector, particularly in the development of drugs for domestic manufacturing companies.

India is streamlining processes for faster approvals of biologics and biosimilars, aiming to speed up access to effective therapies. New drug and clinical trial rules are being implemented to prioritise innovation and bring new products to Indian patients more quickly.

India has always been a stalwart of pharma manufacturing, particularly in the small molecule space. India is rising from a CDMO perspective when it comes to biologics. South Korea has been very active in the biologic space and China as well. But we are seeing India starting to stand up there and perhaps play a role in the future, the way it has played a role in the small molecule space.

How does ZS help clients cope with changes in the biopharma industry and turn challenges into opportunities?

The one area where we’ve been helping many organisations is applying AI/GenAI and analytics to business problems. Part of the challenge laid forth for pharma companies is to reduce their cost, to be more efficient, to bring new innovations faster. A lot of the work we’ve done in many years leading up to this and would be a big driver of 2025, is how do we really start seeing and feeling the impact of new technologies in the business? 

There’s two ways. We’ve always been able to help our clients in recent 10 years with increasingly personalising their promotion and discussions with healthcare practitioners when they’re making treatment decisions for patients. Maybe Doctor X responds better to information related to safety, but Doctor Y responds better to information about clinical efficacy or patient support services. Sequencing those promotions, looking at analytics to understand how our past promotions are resulting in more sales uplift or prescribing to get the right treatments to the right patients who will benefit.

Now technology is allowing us to go even further and faster. In recent years, it’s been more about understanding channel preferences, whether that’s a face-to-face discussion with a medical representative, emails, online portals, etc. Now it’s going even one step further. Applying classical AI to that problem helped us better optimise the promotional mix that our clients would bring to their mostly HCP customers or healthcare practitioner customers and that can generate top line sales lift to the order of 6-7 per cent over baseline. We are now seeing with increasing technology tools and generative AI the ability to further personalise the content for an individual customer in a way that he or she is going to be most responsive to it. We’re really having the ability now in a much more regulated framework and environment about what we can say in the pharma industry has to be on label.

ZS has been working on creating personalised content journeys for physicians in the commercial side. A lot of that innovation is driven right here from our offices in India. What’s driving another few per cent sales uplift is to take that engagement with customers to an even more personalised level. It will continue to be a trend in 2025. 

When you’re designing and then beginning to execute a clinical trial, you must author about 90 documents for that trial. Not least of which is the clinical trial protocol which describes the endpoints we’re going after the inclusion-exclusion criteria. With the advent of generative AI tools, we can push it even further. Some of these documents can take months to create with human medical writers. 

The opportunity there is to shorten that timeline considerably from a few months to a couple of weeks and by leveraging the past documents – all of the major manufacturers have done hundreds of clinical trials – how do we leverage that to create for the medical writer a strong first draft that includes the details for this new asset that we’re putting into a clinical trial and to give them a great first draft, leveraging technology to create consistency and quality across these documents and try to cut months out of the time from when we decide to go forward with a Phase 2 or Phase 3 trial. Those are a couple of areas where we will continue to see impact coming through in the marketplace this year.

We do quite a lot of work in what we call the value and access space, related to value propositions, engaging healthcare systems, drug pricing, drug access. ZS is helping our clients try to stay ahead of understanding the impact of the different things that are happening. For instance, what will be the impact of the European Joint clinical assessment, what might be the impact of IRA (Inflation Regulation Act) in the US and drug pricing evolution over time, predicting what that will look like in the future. Does it impact the products that we invest in? Could it impact their advocacy agenda or the customers they focus on? Maybe they focus more on healthcare systems than individual healthcare providers or move that balance, etc.

Some of our clients are also looking at the developed markets. The growth opportunity maybe is more constrained. How can they have success in low- and middle-income countries? Increasingly, we see some of our multinational clients asking that question. There’s commercial opportunities in some markets or philanthropic opportunities but trying to find out if there are more of those commercial opportunities, where at the right price point or with secondary brand names or partnerships with local or domestic distributors and manufacturers, we can create value in bringing our drugs to more people. It not only perhaps drives some incremental growth for our client organisations, but also helps them fulfil the societal commitments they’re making in their ESG around the number of patients they’re touching worldwide and helping to bend the curve on a particular disease.

What regions does ZS operate in, and what is the contribution of the Indian market to its overall revenue?

Our largest market is North America. We have around 2,000 employees in the US. We’ve got about 400-500 folks across Europe operating in various countries. We have offices and teams in Shanghai, China, Japan, Osaka, Tokyo, and Singapore as well, where we cover Southeast Asia. India for us is a large capability, innovation and expertise center that drives and supports our clients all around the world. We have about 9,000 of our 13,000 ZS employees here in India, across our offices in Bangalore, Pune, and Delhi NCR as well as more.

In terms of our revenue split, that’s not something we necessarily disclose as a private company. Most of our work in India is not really in the domestic India industry as of today. We do support our multinational clients in India. Most of our work historically has been more with multinationals supporting them. We have increasingly over the past few years started to work with some of the domestic manufacturers. I can’t mention names or products.

One of the exciting areas is some of the domestic manufacturers focus on cell and gene therapies particularly trying to get to autologous cell therapies so that you can democratise these therapies that are very expensive and see potential innovations here in the Indian domestic industry. Perhaps cell therapies can get to hundreds of thousands of people in need because some of the more complicated therapies, which require extracting the patient cells, manufacturing them, and bringing them back can be quite difficult. Those allogeneic therapies versus autologous therapies are seeing investment and we’ve engaged some manufacturers on such topics on advanced therapies in the Indian marketplace. We’re finding that our expertise as a firm is quite resonant with those manufacturers.

What is the growth potential of the Indian market for ZS?

Most multinationals are focused on driving growth. When you look at the markets that are on the rise and developing, India is becoming more and more prominent. Many are seeing India as a very interesting and large opportunity for the future. As India becomes wealthier, as the GDP increases, as median incomes increase, and especially as you look at broad therapies like the obesity drugs. Those kinds of categories will see lots of advancement and investment in cardiovascular drugs. Some of the future portfolios are lending themselves to growth in India as well.

viveka.r@expressindia.com 

viveka.roy3@gmail.com