We can help Pharma, Biotech and Biopharma companies reach newer heights with CAI’s proprietary operational readiness approach. Our expertise in manufacturing and supply chain base will help the market grow to newer heights. The Indian market is one of the strategic markets for us both from a manufacturing and support, disclosed John Vaughn, Vice President - Asia CAI, in an exclusive conversation with Hemant Arora, Editorial Head, Pharma Industrial India. John also discussed CAI's various product offerings, expansion plans, key customers, challenges in the Indian market, etc. Edited excerpts:
Question: Kindly share with Pharma Industrial India readers about the outlook of CAI in Asia for the short and medium term. Brief us on your road map for the next couple of years.
Answer: We are excited about India's growth prospects in the short and mid-term offerings. India has enormous growth potential in the pharma sector. We have seen a 10x increase in India’s pharma market. In 2000, the sector was a $4 billion market which in 2022 became a $42 billion market. The Indian government is projecting the sector to become a $130 billion market by 2030. CAI forecasts to increase the headcount to 100 in less than a year.
Our expertise in manufacturing and supply chain base will help the market grow to newer heights. With many pharma companies having a presence in this domain, there is a huge growth potential for CAI. CAI has a great team which is going to bring a lot of value to this sector.
Question: How do CAI's offerings and capabilities to pharmaceutical companies establish high standards of operational productivity and overall efficiency?
Answer: Across India, we are witnessing huge growth in the healthcare infrastructure and also in insurance coverage. The country has witnessed a 26 per cent growth in insurance coverage for Indian residents over the past five years and the sector is going to witness a 20 per cent growth in insurance coverage in the next five years to ten years.
India will have millions of people with access to drug therapies to help them have better lives and CAI is going to be a part of this growth story. CAI has been in this business for the last 25 years in other parts of the world and will deliver high value for the Indian pharma companies and for MNCs that manufacture API formulations in India.
One of the goals of the Indian government is to link the phrase Made in India with quality. This is where CAI can help pharma, biotech and biopharma companies reach newer heights with CAI’s proprietary operational readiness approach. CAI has brought on good talent and has a huge amount of support in the Indian and MNC markets.
Question: Post-COVID-19 pandemic, how has the business outlook for CAI changed over time?
Answer: The COVID-19 pandemic brought a sea change in how things were perceived by pharma companies when it came to manufacturing vaccines. Despite the odds, the period was good for CAI’s business and the operational readiness integrated approach has been proven to drive speed to the patient which has become critical to success in the pharma market.
Pharma companies were able to respond to the pandemic's needs rapidly and in a coordinated manner with regulatory agencies. The trends set by Covid treatments and vaccines will not go away. At CAI, the integrated approach is how we have always done business and now the industry is seeing the value.
The Indian government's growth strategy in the pharma market is commendable. There are four major arms, innovation and R&D, healthcare and delivery, manufacturing and supply chain and market access.
The manufacturing and supply chain approach was a big part of how the world was able to get so many vaccines to the market quickly. For CAI, now, we will help companies pivot to bring these solutions to the manufacture of other drug products. CAI’s expertise can help drive future growth for our pharma clients and CAI India.
Question: What will be the services offered in India? How challenging is the Indian market and what are its business opportunities?
Answer: A lot of the services offered directly translate to the goals set up by the Indian government and a lot of the pharma companies want to grow in this scenario. The generic market is huge and we are trying to tap this particular segment. CAI has a huge amount of experience in cell and gene space. In the US, we were able to provide our expertise to bring in a revolution in the cell and gene therapy space.
CAI has always focussed on an integrated approach to facility start-up and operation and has structured our services accordingly. Historically, we have been in the final step of project execution – commissioning and validating facilities, equipment, and processes. Over time, we recognized the need for project management services to deliver projects more effectively, on budget and on schedule. Noticing challenges with personnel development, we added human performance to develop SOPs, personnel training, and team leadership as well as other soft skills. Our quality, compliance and the regulatory group were added to deliver reasonable quality and compliance within the viewpoint of supporting the business objectives. This all is pulled together under our operational readiness umbrella, bringing the entire package of people, processes, and projects together to drive speed to patient and sustainability of operations.
Cell and gene therapy companies are mainly startups, and CAI has been able to help a lot of these clients in North America. We want to replicate the same business model in India. We are successful in operational readiness and want to bring the same experience to the Indian market.
Question: Is CAI offering CQV services with Kneat?
Answer: We are trusted Kneat service providers. Kneat is an electronic validation software solution. CAI has partnered with Kneat as a trusted services partner. Kneat is a great system, purposely built for the life sciences industry. It digitizes the entire validation lifecycle and allows the validation teams to author, review, approve tests, and manage executions that can be accessed anywhere with an Internet connection. I have worked with different software platforms over the years and am very happy to partner with Kneat.
We are helping Kneat implement the software that clients are looking for. CAI is the only services provider in the market that is 100 per cent validated with a full library of templates. That means we can walk into the facility and deploy the software and things get running with our Project Ready and Head Start options
We are making companies more efficient with our software and companies are eager to move into the 21st century with this validation software.
Question: Govt. of India offering support to the Indian pharma sector to become a global leader with its Make in India Initiative, how do you see this and what role can CAI play to make India a Global Pharma Manufacturing Hub?
Answer: Govt of India’s goal is to make ‘Made of India’ synonymous with high quality. CAI plays an important role from a quality perspective. With the Indian government strengthening the manufacturing supply chain, CAI knows we can support this ever-growing market with our expertise and thus drive value for companies in the long run.
The Indian market has changed over the years and has slowly shifted to a real quality focus. There is a change in the outlook in the past six and seven years. This perfectly aligns with how CAI conducts business and will drive our growth in India in the coming years.