The API business at Lupin comprises both captive consumption as well as external sales, spread across 62 countries. This segment contributed 9% to the company’s revenue in FY21 and accounted for INR 13,823 million in sales, up 6.3% YoY.
We have supplemented a strong in-line product portfolio with a development pipeline of new products across a variety of therapy areas. In FY21, we were proud to emerge as industry leaders for our key APIs, each of them exceeding revenues of INR 1.5 billion.
According to Global Market Estimates, the Indian API Market is expected to grow rapidly at a CAGR of 8.57% during the 2020 to 2026 phase.
The government of India has initiated strong measures to achieve broader self-reliance in this sector. Accordingly, we have set in motion a series of initiatives, including portfolio expansion and bolstering our API production capacities, to be wellaligned with the changing dynamics of the industry.
Our API business is further forward integrated into the Global Institutional Business (GIB) as well as the Principal to Principal (P2P) business. The former aims to eradicate high burden diseases such as Tuberculosis (TB), HIV and Malaria through partnerships with government agencies and organizations across the globe, while the latter entails the introduction of first-to-market products in India and other developing geographies.
As one of the largest suppliers of first-line anti-TB finished product across the globe, our expertise in fermentation technology, which is required to manufacture products such as Rifampicin, Rifapentine and Rifabutin, enables us to be at the forefront in the battle against TB.
Six of our API manufacturing plants are prequalified by WHO and are aligned with global CGMP standards. In addition, our APIs as well as our formulations are prequalified by the World Health Organization (WHO) and are approved by leading regulatory authorities such as USFDA and SAHPRA (South Africa). Specific approvals by regulatory authorities in various countries in Africa, Asia and Latin America which are prone to TB enable us to be one of the largest supply partners of anti-TB drugs.
We consistently work towards strengthening our anti- TB portfolio by developing key solutions which are in line with the WHO guidelines and are recommended for the treatment of first line TB, multi-drug resistant (MDR) TB and latent TB.
With an overall market size of USD 1.8 billion, we have made conscious efforts over the last 5 years to ensure that our antiretroviral (ARV) portfolio is extensive and evolves with the ever-changing landscape of medical treatment.
Our development pipeline, significant filings and select approvals, enable us to address the ARV segment comprehensively and provide solutions which are accessible and affordable to patients.
By focusing on the development of new molecules and combinations which are attuned to the needs of the market, we make sure that our P2P business leverages our experience and expertise in API research and formulation development.
Aligned with this approach, we constantly work on strengthening our portfolio with unique new molecules and combination drugs.
Data Source: IQVIA MAT March 2021