1. What is the status of the CDMO market landscape in India? How Lupin is planning to use this trend as a growth opportunity?

India’s CDMO market is at an inflection point, projected to grow significantly, driven by shifts in global supply chains and strategic realignments. Bain predicts a rise in India’s CDMO market share by over 6% until 2026, underscoring the potential of Indian CDMOs to become reliable partners in global drug development. With the BioSecure Act in the U.S., India is emerging as a preferred partner, offering competitive advantages in quality, cost, and reliability over other regions. Established pharma CDMO players in India, including Lupin Manufacturing Solutions (LMS), are stepping up to meet this demand.

LMS is ideally positioned to leverage this trend. With Lupin’s established expertise in development and manufacturing, we bring strong foundations in both scale and technical sophistication. Our deep talent pool and cost-efficient operations position us to capture market share in clinical assets development, particularly for small and mid-sized pharma. Furthermore, our capabilities in handling complex chemical entities and niche technologies make us a partner of choice for companies seeking sophisticated solutions. LMS aims not only to participate in this market but to lead it, setting benchmarks for quality, innovation, and client satisfaction.

2. What are some of the key areas that Lupin is focusing on as part of its CDMO business?

At LMS, we’re crafting a flexible yet robust approach to meet the evolving needs of the pharma industry. For small molecules, we bring a vast array of technological expertise, from complex chemical synthesis to high-potency manufacturing. For biologics, we offer CDMO services for large molecules, including monoclonal antibodies and fusion proteins. Our expertise spans diverse platforms—peptides, iron-based formulations, fermentation (non-recombinant and recombinant) technologies, and advanced chemistries, such as hydrogenation and low-temperature transformations.

Our approach is platform-agnostic, allowing us to cater to clients’ needs across the spectrum while continuing to expand capabilities in a phased manner. We are particularly poised to add value in areas like Antibody Drug Conjugates, a rapidly growing modality. Additionally, Lupin’s established presence across therapeutic areas like anti-TB, anti-diabetic, and anti-malarial APIs , with over 100 APIs sold in 70+ countries, strengthens LMS’ foundation. We have capabilities to enable industry-leading market share in numerous therapeutic areas backed by strong R&D capabilities with more than 170 DMFs till date (5-6 new DMF filings per year, on average), combined manufacturing capacity of 4100 metric tons, and global compliance certifications and regulatory approvals from FDA, EMEA, TGA, Korea, Russia, China, among others. Such an extensive portfolio and infrastructure ensure that LMS is equipped to offer both scale and specialization, tailored to our clients’ needs.

3. What are some of the challenges that the Indian CDMO market is facing? How is it different from the Global landscape?

India’s CDMO landscape is unique, given the relatively low domestic healthcare spend (less than 3% of GDP). This places Indian CDMOs in a position where global clients become a primary focus, demanding stringent adherence to international standards, especially in environmental sustainability, diversity, and compliance.

Globally, sustainability has become more than a requirement; it’s a qualifier. Western clients increasingly seek partners with strong ESG credentials. Moreover, access to renewable energy and automation technologies are pressing challenges, as modern manufacturing requires seamless integration of AI and automation for scalability and efficiency. Unlike China, which has developed a robust CDMO ecosystem with advanced infrastructure, India must invest in similar improvements, from transportation to education and high-value technology hubs.

India’s cost advantage is compelling, yet to realize our full potential, we need to foster a resilient ecosystem that encompasses all facets, from ground transportation to incentives for R&D and high-value job creation. LMS, with its global outlook, intends to overcome these barriers by creating a sustainable, future-ready framework aligned with the needs of an international client base.

4. How are you tackling these challenges? What are your upcoming business plans?

To navigate these challenges, LMS is implementing a multi-faceted strategy:
• Global Presence: We are building a global organization , establishing commercial and program management functions in our target geographies to meet client needs in real-time.
• Scale and Capabilities: We recognize that scale is critical to compete globally. We are continuously expanding our technological and manufacturing capacities to deliver competitive advantages at scale.
• ESG Leadership: Lupin and LMS are dedicated to sustainability. This is reflected in Lupin’s industry-leading S&P Global score, which rose from 68 to 76 this year. Investing in ESG is not just a commitment; it’s a strategic advantage that differentiates us in this market.
• Integrated Offerings: Our clients, particularly smaller companies, often seek comprehensive solutions. As part of Lupin, we offer end-to-end capabilities — from bench to commercial scale — streamlining workflows and ensuring accountability.
• Talent Development: Access to skilled talent is a key priority. Through partnerships with leading universities, we are investing in the future of our workforce, equipping our teams with technical and leadership skills essential for a globally competitive CDMO business.

5. Could you share some insights with respect to Lupin’s approach on development, manufacture, and sale of APIs?

LMS takes a strategic, end-to-end approach to API development, prioritizing quality, scalability, and regulatory compliance. With over 170 Drug Master Files (DMFs) filed and an annual filing rate of 5-6 DMFs, we are committed to continuously expanding our portfolio. Our APIs span therapeutic areas critical to global health, including anti-TB, anti-diabetic, and anti-malarial treatments, with 100+ APIs marketed in 70 countries.

Our manufacturing philosophy is rooted in operational excellence and quality compliance. We have achieved global certifications from the FDA, EMEA, TGA, and other leading authorities. This ensures that we consistently meet the highest international standards, further positioning LMS as a trusted partner in the global API market.

6. What are your upcoming plans with respect to disease portfolio, partnerships, and molecule discovery and manufacturing in FY25 and upcoming financial year?

LMS plans to expand its therapeutic footprint and strengthen partnerships that align with our core capabilities in complex molecules and high-demand disease areas. We are exploring strategic partnerships with global innovators in oncology, metabolic disorders, and infectious diseases, where our expertise in both API manufacturing and complex drug formulations can be leveraged to commercialize new molecules. Additionally, we are actively investing in R&D for novel formulations and treatment modalities. Our R&D team is pursuing innovations in high-potency molecules and exploring ADCs and bioconjugates, paving the way for groundbreaking treatments. With each step, LMS aims to be a strategic partner driving advances in healthcare.

7. Anything else that you would like to add?

Lupin Manufacturing Solutions is rapidly growing, supported by two large-scale manufacturing facilities in Dabhasa and Vizag, and a world-class R&D center in Pune. Our development and manufacturing capabilities across various platforms make LMS a unique partner, offering over 25 generic APIs registered across major markets. Looking ahead, we are exploring both organic and inorganic growth opportunities, with investments in future technologies that will shape the next era of pharmaceutical manufacturing. As we build on Lupin’s legacy, LMS is committed to setting new standards for excellence, sustainability, and client success in the global CDMO and API markets. We look forward to bringing our clients solutions that are as innovative as they are impactful, driving the future of healthcare forward together.

This interview was first published in the Financial Express Healthcare on 12th November 2024