Dr Reddy’s Laboratories is planning to launch injectable drug delivery soon, apart from other innovative injectable products, to make the most of the opportunity in the segment. Chief operating officer Abhijit Mukherjee, in an interview with BV Mahalakshmi, outlines the company’s plans. Excerpts:
How are you looking at the injectable space, given the current capabilities?
We are focusing strongly on injectables, given the large opportunity the segment offers, the capability we have built over the years and the success we have achieved in the face of unfulfilled needs we addressed with products, such as Fondaparinux, Azacitidine and Decitabine. Our US injectables business has scaled up to $280 million in three years. We continue to focus on complex injectables filings for the US market. We will focus on leveraging the complex injectable filings in Europe and emerging markets. We had acquired OctoPlus, the Netherlands-based injectables major in 2013, which is leading the development of cutting-edge, long-acting injectables and liposomal formulations. The company is building a world-class inventory of devices to support future portfolio for injectables (eg, Sumatriptan Auto Injector), supported by robust manufacturing systems and supply chain.
How big is the global market for injectables?
The global market for injectables is estimated to be around $300 billion in 2014, according to IMS 2014 data, and is expected to grow 7-8%. The US market, however, continues to be the biggest opportunity. Around 35% of $300-billion revenues is contributed by the global US market. The Indian market is estimated to be around $2 billion and has a high growth potential. This is a market where shortages are frequent and competition is relatively less intense because injectable products, by nature, are complex. Growth will likely be driven by both generic sterile injectables volume and emerging markets as well as devices and formulations in high entry barrier developed markets.
How many products have you lined up?
We have eight products already commercialised in the US market. We will be filing our first drug-delivery-based injectable soon. We have several innovative injectable products in the pipeline from both formulation as well as device perspectives. A major part of our business is in pure generics segment, where the focus is more on channels of sales than on therapeutic areas. Having said that, a sizeable chunk of our portfolio happens to be in the oncology area. Others cater to anti-infectives, cardio-vascular and CNS segments.
What are your research efforts in the New Drug Delivery System (NDDS)?
The industry has seen paradigm shift and is now moving towards self-injection devices that not only cure serious illnesses, but also have fewer serious side-effects. Self-injection devices, including auto injectors and pen injectors, are fast growing segments in the injectable drug delivery market. In recent years, the uptake and adoption of self-injection devices such as auto and pen injectors has grown substantially. We have different types of injections in the market. Even the innovator products are shifting to NDDS. This is due to the benefits it offers over conventional injection devices. Self-injection devices ensure better patient adherence to treatment, due to decreased risk of missed dose or medicine discontinuation, and reduced healthcare cost, as expensive hospital visits are curtailed. This has ignited the interest of device manufacturers who are, in turn, coming up with new variants of self-injection devices with advanced technological features.
What percentage of your revenues comes from this segment? How do you think it will shape up in future?
Considering the challenges because of high manufacturing cost and complex marketing and regulatory barriers for approval of devices, companies struggle to survive and keep pace with the industry’s growth. Currently, around 25% of our North America revenues come from injectables. We hope to see better numbers depending on approvals and new launches.