“The company would also strategically look at in-licensing opportunities, alliances and partnerships to enhance its capabilities and product portfolio, gaining further legroom for growth in the US market,” Alkem Laboratories said in its Annual Report for 2020-21.
Despite the continuing challenges of price deflation owing to higher competition and evolving regulatory controls, the company is positive of countering them through regular and timely new product launches, the company informed its shareholders.
The drug firm said it has a healthy pipeline of over 150 abbreviated new drug applications (ANDAs) filed with the US Food and Drug Administration (USFDA) with a good mix of Para IV and first to file (FTF) opportunities, which gives it a good visibility of growth over the next few years.
Besides, in the medium to long term, the company’s investment in the areas of control substances from its US facilities and biosimilars through its subsidiary at Enzene will also help drive growth, it noted.
“We have a robust pipeline of biosimilars in the offing. This transformation in our product portfolio, while enabling us to deliver the products our patients need, also adds a longer-term growth avenue for our company with the uptake of biosimilars expected to increase in the coming years,” Alkem Laboratories MD Sandeep Singh said.
With a strong pipeline of filings pending for approval, there is considerable opportunity to scale up the company’s US business in the coming years, he added.
Elaborating on the observations received by its St. Louis-based plant from the US health regulator, Singh noted: “We are in the process of submitting our detailed response illustrating the corrective and preventive action being taken so that this plant can continue to remain compliant with the CGMP guidelines.”
He added that the company’s new manufacturing facility in Indore is awaiting pre-approval inspection by the USFDA.
Elaborating on other international markets, the company said it is strengthening its position by focusing on select markets and growing its operations by creating a strong local presence and offering differentiated products.
Alkem is also open to strategic acquisitions and partnership agreements for product in-licensing and out-licensing to capture greater market share, it added.
Acquisition of new customers, introduction of new products, and gaining commensurate market share in existing products will remain growth drivers, the drug maker said.
The company’s global footprint covers 40 international markets, besides India and the US, with its key markets being Chile, Australia, Kazakhstan, and the Philippines.
Over the past few years, the share of international business in the company’s overall revenue has increased significantly; it rose from 17.4 per cent in FY 2012-13 to 34.3 per cent in FY 2020-21.
One of the major growth drivers in international business has been the US market, which has more than doubled in the past four years, Alkem noted.
During FY 2020-21, the company’s US business registered revenue of Rs 2,466 crore as compared with Rs 2,200 crore in the previous financial year, recording a growth of 12.1 per cent.
Commenting on the domestic market, the drug firm noted that despite the near-term impact of the COVID-19 pandemic, the future looks promising for the Indian pharmaceutical industry.
“Favourable demographics, growing disposable incomes, sedentary lifestyle leading to rising incidences of lifestyle diseases, better access to healthcare facilities, and increasing penetration of medical insurance are key growth factors,” it said.
These, along with low-cost production, high R&D capabilities, and availability of skilled manpower, have the potential to catapult the industry to a higher level, the drug firm said.
