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Active
Active Pharmaceutical Ingredients (API) Business
The COVID-19 pandemic continued to affect business across countries in FY22 and we are still witnessing the impact of post-COVID effects on the market demand for antibiotic pharmaceutical products. The demand for oral cephalosporin antibiotics has declined across markets in the last two years though we expect it to bounce back in FY23.
The market has also witnessed huge Increases in the cost of key raw materials, intermediates, energy and other utilities, and this is contributing to an increase in the cost of manufacture of products across the API industry. The price of Penicillin-G, for example, the raw material used to manufacture certain cephalosporin antibiotics, has increased exponentially and the end market has not yet been able to absorb this increase.
These are new market realities and Lupin has reoriented its market approach with the current market environment. We have leaned on our experience in process chemistry including fermentation technology and refocused our efforts to mitigate the impact of headwinds in the market place and manage the situation optimally. Most importantly, our client base remained strong during these challenging times.
API contributed about 6% percent of the total sales of the firm with sales of INR 9,904 Mn.
We are developing a robust portfolio of new API products to meet the needs of numerous therapies. Introducing new products to different markets will pave the way for sustainable growth of API business over the next five years.
Further, the Indian government has launched a noteworthy initiative under the Production-Linked Incentive (PLI) scheme to achieve broader selfreliance in the API sector and reduce reliance on imports for key products. We have set in motion a series of initiatives in response to this important initiative, which includes the expansion of our API production capacities and the introduction of new products in our portfolio.
By leveraging our extensive experience in API research and formulation development, our valueadded formulation P2P business focuses on the development of new molecules and combinations which are tailored to meet the needs of the market. In FY22, the P2P business has commercialized 2 new and novel formulations in the cardiovascular segment and received approval of 1 product in gastrointestinal therapy.
GIB Business
As part of our Global Institutional Business (GIB), we partner with global and national public health organizations to coordinate the fight against tuberculosis and HIV.
For many years, Lupin has been leading the fight against Tuberculosis and providing affordable, highquality medicines to underserved communities. We are one of the very few vertically integrated companies engaged in the manufacture and supply of key first line anti-TB drugs. Today, our products are available in more than 50 countries across Africa, Latin America, CIS, and Asia. As a result of our relentless commitment to the fight against TB, we are one of the world’s largest suppliers of first-line anti-TB drugs.
The development of new drugs for treating multidrugresistant tuberculosis (MDR-TB) is underway. Backward integration enables us to manufacture vital APIs in-house. This ensures reliable supplies and availability of APIs, enabling patient access to qualityassured medications at affordable prices. The pandemic has significantly impacted TB eradication programs across TB burdened nations, resulting in a significant decrease in TB notification rates. Globally, TB notification rates dropped by 18% worldwide during the peak of COVID-19 period in 2020, with high burden countries such as India experiencing a drop of almost 41%. The intense focus of various countries on the management of COVID-19 diverted the focus of public health infrastructure towards pandemic-affected individuals. According to the Global TB report 2021, the impact of COVIDrelated disruptions on TB incidence is likely to persist for much longer periods unless rigorous efforts are undertaken by respective stakeholders and governments to reactivate and intensify TB eradication programs. It is expected that this scenario will continue to improve through FY23.
Outlook
There has been an increased focus on the prevention of TB in high-risk individuals, such as those living with HIV or having close contact with TB patients. The preventive TB regimen uses a fermentation-based product called Rifapentine. Lupin’s fermentation expertise, combined with our large API/formulation manufacturing capabilities, gives us a strong head start for growth. In our efforts to maximize access, we are looking to register our formulations with the national drug regulatory authority in more than 20 high disease burden countries to support the fight towards eradication of TB.
We are excited about our association with international and national public health organizations in the treatment of HIV patients in low and middleincome countries. As with TB, we are backwardly integrated to manufacture new anti-retroviral (ARV) drugs and offer high quality medications at affordable prices, while mitigating the risk of disruption in supply. We have received product approval from the US FDA and WHOPQ for a few key ARV products and have begun commercial supplies. Lupin is well-poised to be able to garner significant market share in the ARV segment in the access countries as we have the fundamental requisites of being backward integrated and of having large manufacturing capacities to meet global demand. In FY22, we received the approval under the PEPFAR route of US FDA for our TLD, the key first-line drug used currently in the management of HIV/AIDS.. To date, we are having more than 120 regulatory dossier submissions globally for our ARV medicines of which 30 approvals have already been received.
