The current global market for biopharmaceuticals is a little over $25 billion and is expected to touch $40 billion within next couple of years. In India, the biopharmaceuticals market is an emerging market with about 30 players currently. With a host of activities happening, this market is likely to almost double in terms of its revenue turnover by 2004.
The major advantage of entering this market is the short timelines needed to develop a product and make it available in the market.
Monoclonal antibodies or MABs is another area of interest amongst pharmaceutical companies. MABs have been in use for quite sometime now, especially for basic research and purification. They find their application in a variety of places - starting from basic research to diagnostics to therapy. Currently, only two MABs are available for therapeutic use - for the treatment of cancer. While one is used for the treatment of chronic myeloid leukemia, the other is used for a subset of breast cancer patients.
The potential of the biopharmaceuticals market in India is large. Many of the products in this market are imported, which is why they are expensive. However, a number of Indian companies have already entered or are planning to enter this market. They are expected to introduce products at much lower prices. This is likely to result in larger volumes by the end of the forecast period.
The total Biopharmaceuticals market is worth Rs. 2800.1 million in 2001. Revenues are expected to reach to Rs. 4028.3 million by 2004. This represents a CAGR of 15 percent between 2000 and 2004. Most of the present revenues stem from recombinant products.
The challenges affecting the biopharmaceutical products market are 1) Small biotech start-ups find marketing of products difficult; 2) Moderate success rates daunts research activities and myths and misconception surrounding biopharmaceutical products.
The factors which work in favour of biopharmaceutical market are 1) Large scale production leads to lowering of production costs 2) Inadequacy of traditional drugs to fulfill a need and perception of the value and safety of the therapy and 3) unlimited production to ensure constant supply.
The demand for recombinant products is huge in India. The following section discusses the demand analysis for the following categories:
Insulins: Insulin extracted from pigs and cattle has long been the source of worldwide usage. However, it is now believed that some of the side effects that have occurred with continued long-term use of insulin could be due to additional contaminating compounds present in the animal insulin. Recombinant human insulin appears not to have such problems and is increasingly having the largest market share of sales worldwide. Production is unlimited and free from market shortage of animals and all the problems associated with earlier production methods. However in India, the concept of using recombinant insulin is still in the nascent stage.
Hepatitis B Vaccine: Of the 350 million cases of chronic hepatitis B in the world, 40 million cases are estimated to be there in India alone. Besides, there are many more hepatitis B virus carriers in the country as well. To add to this, the falling prices of the vaccine and the mass awareness of the disease are likely to result in mass vaccination against hepatitis B.
Erythropoetin: is mainly used to treat anaemia resulting from chronic renal failure and chemotherapy. The renal failure cases in India are estimated to be higher than those in the west. Some of the risk factors for renal failure are diabetes, malaria, malnutrition, abuse of certain antibiotics, painkillers and hypertension. All these factors are rampant in India. Other factors responsible for this higher incidence include hot climate (resulting in peripheral vasodilatation), which in conjunction with excessive sweating predisposes to hypovolemia. A high prevalence of glucose 6- phosphatase dehydrogenase (G6PD) enzyme deficiency in certain ethnic groups predisposes them to hemolysis when exposed to certain drugs and infections. In addition, the endemic malnutrition predisposes the population to a variety of infections secondary to its well-known effects on the immune system.
Interferon: have generated a lot of interest of late because of their ability to inhibit cancer in experimental animals. Two sources of interferon are currently available. The first is from human diploid fibroblasts. The second source is from bacteria in which the gene for human fibroblast interferon has been inserted into a plasmid in such a manner that interferon is synthesized and can then be extracted and purified. Since only minute amounts of interferon are produced within cells, they have been very difficult to extract and separate them from other cellular proteins. In other words, recombinant interferon seems to have a huge demand both from a therapeutic as well as an experimental perspective.
Monoclonal Antibodies (MABs): Conventional treatment of chemotherapy and radiation therapy often results in relapse and such patients ultimately die either from their cancer or from complications of the therapy. The development of monoclonal antibodies for these disorders have been studied to improve the therapies and minimize the toxicities associated with standard therapies. Monoclonal antibodies are designed to demonstrate efficacy with low toxicity and are expected to reduce overall treatment and hospitalization costs associated with the side effects and opportunistic infections, which can result from chemotherapy or radiation therapy.
Currently, two such MABs are available in India. They are Mabthera (rituximab) and Herceptin (transtuzumab). Both are marketed by Nicholas Piramal/Roche. Mabthera is indicated for relapsed/refractory low-grade B-cell non-Hodgin's Lymphoma (NHL). It was the first monoclonal antibody to receive approval for a cancer indication in 1997. The product was made available in India in January 2001. The parent company for developing this drug - IDEC, is also developing a murine version of Mabthera, Zevalin, which is linked to a radioisotope for refractory B-cell NHL. Coulter Pharmaceutical's Bexxar is a similar product that targets the same antigen on B-cells but is conjugated to a different radioisotope.
Herceptin is used for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 (human epidermal growth factor receptor2) protein and who have received one or more chemotherapy regimens for their metastatic disease.
There are several advantages that India has in the biopharmaceuticals arena. For one, the huge genetic pool could serve as a research base. Secondly, with manpower costs being much lower here than elsewhere abroad, coupled with the large number of Indian scientists involved in research in molecular biology, the foundation stone for a biotech boom seems to be set in India. India is slowly and steadily waking up to the challenges of biotechnology.
Realizations that emphasis should be more on technology transfer, influx of funds by private sector (like venture capitalists) and strengthening of links between the pharmaceutical industry, academia and government institutions are gradually dawning. These will boost the capabilities of market participants and strengthen their efforts in competing at a global level.