Home to 140 crore people, it’s no wonder that India is one of the world's largest pharmaceutical and life sciences markets. Unsurprisingly, all the buzzwords like Digital Twin Technology, Precision Medicine, CRISPR Technology, Immunotherapy, Digital Health, and RNA Therapeutics are trending in the country's healthcare realm. According to statistics, India's pharma and life sciences industry is picking up significant momentum and is expected to reach $130 billion by 2030. However, when it comes to production volume, according to the Economic Survey 2022-23, India is ranked 3rd worldwide by volume and 14th by value. It is majorly driven by a large patient population, increasing healthcare needs, and a growing middle class.

On the other hand, the Indian clinical trials market size was valued at $2.1 billion in 2022 and is anticipated to grow at a CAGR of 8.3 percent till 2030. The opportunities in the segment are immaculate, and so are the challenges. Through an exclusive interview with CEO Insights, Sanjay Vyas, EVP, Global SBU Head-Clinical Logistics & Global Safety Services & Managing Director India, Parexel walks us through the life sciences trends-2024. Sanjay is an industry thought leader with more than three decades of experience. He joined Parexel—one of the leading global CRO and biopharmaceutical services companies—almost eight years ago. Below is an excerpt from the interview.

The pharmaceutical industry is at a unique inflection point with large-scale digital transformation underway. How does the supply chain benefit from this? 

There was a time, not so long ago, when tracing the origin of a drug and its chain of custody was arduous. But thanks to concepts like Serialization, Blockchain, track & trace with sensors, and enhanced barcode technologies, end-patients today can meticulously understand where the drug originated from and whether it is authentic. The global supply chain is widely adopting this concept beyond the pharmaceutical industry. For instance, in the food industry, combining these technologies allows consumers to understand a vegetable's origin by merely scanning a QR code.

Decentralized clinical trials are largely about taking the clinical study to the patient's home, using remote video monitoring, and powered by devices that track the data and transmit it to the EDC (Electronic Data Capture) systems that significantly help decision-making in the healthcare industry

On the other hand, the digital supply chain is transforming how the industry approaches Temperature Management in the Pharmaceutical supply chain. Every drug has to go through its highly sophisticated and sensitive temperature management life cycle involving a wide range of temperature settings. When a product reaches its destination, you either quarantine it or make it available for the patients for consumption. Today, the sensors attached to these drugs can capture and transmit various information, including the temperature ranges they have been through. It enables real-time determination of whether the product was temperature-compromised during its supply chain life cycle. It not only helps in quality control but also saves a lot of time. However, we have a long way to go in adopting these advantages.

How are clinical trials hosting the transformation? Also, how do the latest buzzwords like Generative AI come into the picture?

A major transformation is also happening in clinical trials—decentralized clinical trials are a great example. Decentralized clinical trials are largely about taking the clinical study to the patient's home, using remote video monitoring, and powered by devices that track the data and transmit it to the EDC (Electronic Data Capture) systems that significantly help decision-making in the healthcare industry. 

How do you perceive the industry's growth during and after this transformation, especially in a large healthcare market like India?

The Indian clinical trials market is expected to grow at a CAGR of around 8.5 percent between now and 2030 - largely driven by Phase-ii and Phase-iii trials. We're talking about achieving a market size between $3.8 to $4 billion by 2030. The regulatory landscape is looking good, the infrastructure landscape is improving from the tier-ii and tier-iii cities' perspectives, and the availability of talent contributes significantly to this growth. On the other hand, with the 1.3 billion patient population in India and the huge disease burden that comes along, it is becoming increasingly viable for multinational sponsors to look at India as a physical site to conduct their studies.

Another significant aspect of this growth is that Indian multinationals are investing heavily in biosimilars. Proactive investments are flowing into cell and gene therapy, biologicals, etc., as well. Simultaneously, R&D spending continues to grow because a lot of these pharma companies are now proactively looking at what's next, especially post-pandemic. Hence, immunomodulatory therapies, vaccines, and anything and everything related to respiratory diseases are gaining prominence in India. The focus lies on anything that can be brought faster into the market. Adjacently, the research around cancer, diabetes, and cardiovascular diseases continues to drive the market, while personalized healthcare and medication also seem to be a significant aspect of the future. 

India has the world's largest youth population, yet a significant talent shortage exists in the pharma and life sciences industry. How can the industry overcome this challenge?

I recently attended a CEO roundtable of about 110 CEOs. One of the major discussion points was that the dearth of talent is not a question mark confined to the life sciences industry but spreads across verticals. I believe there are a few things we can do to address this challenge. Delving deeper into this crater in the life sciences industry reveals an acute expectation gap. By the time students graduate, they have acquired a lot of theoretical knowledge but often lack practical know-how. Today, this long-ventilated industry-academia gap needs to be bridged more than ever before. The industry, academia, and the government must collaborate more and create a more favorable environment for the industry to train the students before their graduation.

I'll give you an example. Parexel has made a tie-up with Chitkara University (a private university in Chandigarh), launching a postgraduate program in clinical research and Pharmacovigilance. While the university still designs the main curriculum, students now go through a two-year course that includes 80 to 120 hours of practice labs conducted by our people. It covers a wide horizon of practical knowledge regarding everything from how to write a protocol to how the supply chain works and comprehending the entire case index. This provides the students with practical knowledge before they complete the fourth semester. They are subsequently provided with three to six months of internship. In the aftermath, they become industry-ready by the time they graduate. Even if Parexel can't hire all of them, the industry as a whole will benefit significantly. 

Another aspect of addressing the talent dearth challenge is employee retention. Today, GenZ is becoming a huge piece of this puzzle. They are pursuing jobs with a purpose - something that can keep them learning new skills, technologies, concepts, etc. Keeping them engaged should be a huge part of the retention strategy. I will give you an example. We recently conducted the Parexel India Conclave. We created an in-house tech talk, which saw an inflow of 65 abstracts from 5000 selected members of our workforce. We invited these 65 people to present their concepts to the entire Parexel population. The two-day event became an intriguing experience for the whole of the Parexel family, and we all learned a lot. Our people were overwhelmed by the fact that they were getting opportunities to learn within the organization, and they didn't have to look outside.

Give us a gist about how the future will pan out for the clinical trials segment, especially in improving safety.

One of the areas that is swiftly developing is the concept of digital twins. The industry is talking about creating the whole genome sequence of the human body digitally. With these digital twins, we will be able to test a product's safety and efficacy, even if it goes for the phase one trial. The physical trial will still be needed because finding out the reaction of a drug with human DNA should be proven in a real-life scenario. But digital twins will help improve the safety of that process by many folds.

CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), a technology that research scientists use to selectively modify the DNA of living organisms, is also gaining a lot of attention. Gene editing particularly helps in cancer treatment - avoiding tumor cells reproducing and growing back again.