9%

of Global
sales

NaMuscla

EU expansion
ongoing

4th

in South Africa
by prescriptions

The Europe, Middle East and Africa (EMEA) region accounts for 26% of the global pharmaceutical market with an estimated market size of USD 300 billion. EMEA contributes 9% to Lupin’s overall sales.

The region offers significant opportunity for Lupin to grow its complex generics segment, especially with our unique range of long-acting injectables, biosimilars and inhalation products. In addition to our diverse generics’ portfolio, Lupin has entered the EMEA Specialty segment with the neurology orphan drug NaMuscla®. NaMuscla® is our proprietary product prescribed for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders, a severely debilitating neuromuscular condition. The company plans to comprehensively address Europe with this product before taking it to other geographies.

Europe

The pharmaceutical market in Europe is valued at USD 276 billion. The EU pharmaceutical market is expected to witness significant growth in the near future. In FY21, Lupin’s business in Europe registered a growth of 4% with sales of INR 6,685 million. The key contributors of growth included portfolio expansion in Hormosan Pharma, our German subsidiary, new product launches, and scale up of NaMuscla® beyond UK, Germany and France. Recent organization wide optimization efforts at our German subsidiary Hormosan proved to be essential in navigating FY21 in a very challenging environment of COVID-19 and inherent government restrictions.

The business has taken major efforts to deepen digital engagement with Health Care Practitioners and adopt digital channels for promotion.

Effective January 2021, Hormosan entered into a co-promotion agreement with Tilray, the market leader for medicinal cannabis in Germany, to promote its portfolio of full spectrum extracts. Medicinal cannabis is complementary to Hormosan’s pain therapy portfolio and will allow the company to provide attractive therapy options to German prescribers and patients.

In the UK, we continue to support reduction in HIV infection rates by maintaining our market leading position in the ARV segment. Negotiations for NaMuscla® reimbursement are ongoing, paving the growth path in existing markets while we continue exploring partnerships to expand our reach beyond the EU5 markets.

South Africa

The pharmaceutical market in South Africa is valued at USD 3.7 billion. While the market grew by 2.5% YoY, Lupin’s South African subsidiary Pharma Dynamics registered a growth of 6.2% with sales of ZAR 1,295 million, driven by continued strength in our key segments, including Cardiovascular and Central Nervous System as well as the OTC franchise. The benchmark-pricing band structures being used by medical aid funding agencies have been driving prices down. Pharma Dynamics’ compliance with the government’s Broad-Based Black Economic Empowerment (BBBEE) policy that seeks to advance the economic participation of the black population in the economy, ensures continued access to our products and puts us in a preferred status.

We continue to work with the South African Health Products Regulatory Authority (SAHPRA) and received 19 product approvals in FY21. Pharma Dynamics was the fastest growing pharma company overall as well as in the OTC/ CAMS segment in South Africa. The company also maintained its leadership in the CVS space, led by key brands including Amloc (Amlodipine), Fedaloc (Nifedipine) and Bilocor (Bisoprolol). The complementary medicines franchise and OTC segment was augmented by cough and cold brands, further fuelled by immune booster, EfferFlu product range.

Road Ahead

FY22 is poised to be a milestone year for Lupin’s EU business as we prepare to launch our first inhalation product generic Fostair® MDI and continue the expansion of NaMuscla®.

Our growth in South Africa will be driven by our strong market position, a robust portfolio in the CVS space, and launch of new products in the CNS segment. In the backdrop of COVID-19, we have revisited our commercial approach and focused on de-risking our supply chain. We have built contingencies into our new product launches, focused on leveraging digital to market our products and connect with the customers, while accelerating our pace towards digital transformation.

Data Source: IQVIA MAT February 2021

EMEA specialty segment