Battle for control of human insulin begins

The anti-diabetics sector is witnessing stiff competition with the entry of new players.    

Eli Lilly and Company (India) Pvt Ltd reduced the price of its human insulin product (Huminsulin vials – a rDNA origin) on January 11, 2005. With this reduction, each vial of Huminsulin 100 IU/ml will now be cheaper by almost Rs 100, thus making it more affordable. The present price of the 100 IU/ml vial of Eli Lily's rDNA insulin is Rs 365.

Eli Lilly entered the Indian market in 1993 through a joint venture with Ranbaxy. Later it became a 100 percent subsidiary of Eli Lilly and Company. It introduced the rDNA insulin in India only in 1995, though it is the world's first player to have r-DNA human insulin. Novo Nordisk was the first to introduce rDNA insulin in India as early as in 1991. Besides Aventis Pharma too has been selling human insulin in India.

Despite they ruling the market, these companies slashed the prices on rDNA insulin products in India by 35-40 per cent in January 2003 to Rs 145-262 per unit. They anticipated price competition from Indian companies like Wockhardt and Biocon, which announced their intention to launch human insulin in India.

The stakes in this market are high and each of the players wants to maintain their stranglehold. The total market for diabetes therapy products in India is estimated at Rs 906 crore and growing at the rate of 14.4 percent. The insulin market is estimated at Rs 251 crore (growth rate 21.4 percent). Of this, human insulin has 10 times, the volume of animal insulin (value Rs 22.77 crore). The human insulin market is growing at the rate of 40.5 percent. The oral anti diabetic market is estimated at Rs 655 crore and is growing at the rate of 11.4 percent (Source: ORG -MAT September 2004).

This huge potential for the anti diabetic products in India has pulled the attention of the many pharmaceutical and biotechnology companies. Sensing the growth for anti diabetic products, the Indian companies invested a lot on R&D in developing indigenous human insulin and also entered into tie-ups with multinationals to market human insulin products in the country. In a period of just over a year, as many as three Indian companies launched rDNA insulin products under different brands in the price range of Rs 126-129 per 10 ml vial.

Mumbai-based Wockhardt launched its recombinant human insulin, Wosulin, at Rs 129 per 10 ml vial in September 2003. With this, it became the first Indian company to launch recombinant human insulin in Asia. Bangalore-based Biocon Ltd announced the launch of Insugen, a new generation bio-insulin in November 2004. Insugen was made available to the public in 10 ml vials of 40 iu/ml for an introductory price of Rs 126. Shreya Life Sciences Pvt Ltd, the Indian arm of Moscow-based Shreya Corporation too launched rDNA human insulin under the brand name Recosulin in December 2004 exactly a month after the launch of Biocon's Insugen in India. Shreya has launched Recosulin at Rs 128 per 10 ml vials (rate fixed by National Pharmaceutical Pricing Authority (NPPA) by importing the finished product from Bioton, Poland (manufactured using BTGC technology). It maintained that it would start producing rDNA human insulin at its Pune plant coming up at Hinjawadi Biotech Park.

It is good to note that the animal insulin makers in India-Cadila Pharma, Sarabhai, Glenmark Pharmaceuticals and other companies are planning to phase out their products from the market. This will boost the sale of human insulin in the near future. It was found by comparing the prices of rDNA products in Indian versus international market that most of the products are being sold at a much lower cost in India as compared to the average cost in developed countries (three to seven times). In addition to the huge domestic market, the Indian human insulin makers are looking at entering the developed countries like the US, the third leading country with maximum number of diabetes patients (17.7 million for 2000) after China with 20.8 million for the year 2000.

The Indian companies have a tough challenge ahead to capture the market amid stiff competition from the established multinational companies such as Novo Nordisk, Eli Lilly and Aventis. This is mainly because the diabetes patients have been using the brands of multinationals for many years. Even doctors who have stabilized patients on one brand of insulin prefer, for medical reasons, not to shift them to another without any demonstrable benefit. Novo Nordisk leads the domestic market as its sales during last year stood at Rs 110 crore, followed by Eli Lilly at Rs 57 crore and Wockhardt at about Rs 9 crore.

Although recombinant therapeutics are still not under any price control by the government, the Drug Price Control Order, 1995 (DPCO) lists insulin as one the bulk drugs for which the government can fix the maximum sale price. Since, the method of production of a bulk drug is not a parameter considered within DPCO, bulk insulin produced by recombinant technology also falls under the purview of the above order. If the government implements the order, then the chances are more that prices for rDNA insulin may drop further to the comfort of diabetes patients in India.

Narayan Kulkarni with inputs from Rolly Dureha in New Delhi