The Indian biologics market is the most significant contributor to the Indian biotechnology market, accounting for almost 72 percent of the revenue generated in 2005-06. Vaccines and recombinant therapeutics are the leading sectors driving the growth of the biotechnology industry in India. According to industry estimates, major share of the revenues is generated through exports accounting for almost 53 percent, over those from the domestic market, which are at a share of about 47 percent. With increasing consolidation of manufacturing and marketing capabilities by Indian companies, India has already achieved leadership position in the global vaccines market and is all set to grab the market opportunity in the global recombinant therapeutics market.
The Indian vaccines market was worth Rs. 1800 crore in 2005-06, and the human vaccines segment is the fastest growing segment in this sector. Prominent players include Serum Institute of India ltd, Panacea Biotec, Indian Immunologicals, Aventis Pharma, Glaxo SmithKline Ltd, Shantha Biotechnics ltd and others. Vaccine manufacturers like Serum Institute of India and Indian Immunologicals have a very strong global presence. Serum exports its vaccines to more than 140 different countries worldwide, whereas Indian Immunologicals is the largest supplier of foot and mouth disease.
Until a few years back the Indian vaccines market was suffering from cut throat competition, price erosions leading to reduced market shares and increasing market fragmentation. However due to active initiation on the part of the Government of India, and organizations like the WHO and UNICEF, players have gradually shifted focus towards the global markets. These organizations have engaged prominent players such as Serum Institute of India, Panacea Biotec and Shantha Biotechnics as pre-qualified Vaccine manufacturers and procure vaccines from them at highly competitive prices. The year 2005-06 has witnessed the launch of quadravalent vaccines by Serum Institute and Shantha Biotechnics. Some of the key initiatives that would significantly impact the landscape of the Indian Vaccines market include:
Indian company Bharat Biotech International Ltd, has partnered with Novavax, US to develop the Avian Influenza vaccine for India and other developing countries from South East Asia, This initiative is in close conjunction with the Government of India, Dept of Biotechnology, and will therefore be a significant step in the Public-private partnership development in public interest.
Major initiatives in India which are at various stages of development include Anthrax, HPV, HIV, Typhoid, Japanese Encephalitis, Malaria, Cholera, Rotavirus, HIB meningitis, and improved versions of TB vaccine, and others. These are being developed in close co-operation with premier research institutes like National Institute of Cholera & Enteric Diseases, Kolkata, National Institute of Immunology, Jawaharlal Nehru University and All India Institute of Medical Sciences, all in New Delhi, Central Drug Research Institute Lucknow, Institute of Microbial Technology, Chandigarh, Indian Institute of Science Bangalore, Centre for DNA Fingerprinting & Diagnostics Hyderabad, National AIDS Research Institute, and National Institute of Virology, both at Pune.
The Bill and Melinda Gates Foundation have pledged financial assistance and support for development of vaccines like Malaria, HPV, Hep B and Pneumococcus. They are also keen to see development of vaccines against diseases like TB and HIV. ICMR in India is already supporting development of 2 types of vaccines for HIV/AIDS- one undergoing clinical trials in Chennai and another one at NARI, Pune.
The recombinant therapeutics market in India was estimated to be Rs. 640 crore in 2005-06. There are about 14 different recombinant therapeutics that have gained market approval in India. Of these products seven are indigenously manufactured in India. Prominent products in this segment include the recombinant human insulin, recombinant human erythropoietin, granulocyte colony stimulating factor, interferon-alpha and interferon-beta, human growth hormone, human follicle stimulating hormone, recombinant streptokinase, and others.
All the seven products indigenously manufactured in India are generic versions of branded biopharmaceuticals. Until a few years back this segment was largely ruled by multinational players and predominant business models were importing and marketing the products rather than indigenous manufacturing. However recent years have witnessed not just emergence but rising dominance of domestic players
such as Wockhardt, Shantha Biotechnics, Biocon Indian and others. The biogenerics industry faces a lot of challenges such as
Tactics used by Innovator companies by introducing reformulated versions, Modified Drug Delivery systems or IP consolidation of the manufacturing processes
Lack of effective regulatory polices in Developed markets like the US and Europe Lack of awareness about Biogenerics among prescribers.
However with rising healthcare costs, spiraling population of aged persons particularly in developed countries, authorities worldwide have been forced to consider the cost-effective generic versions of branded biopharmaceuticals. According to industry estimates drugs worth more than $ 70 billion are expected to come off patent over the next few years.
The gradual streamlining of approval protocols for biogenerics especially in regulated markets will boost the international presence of biogenerics players from countries like India. Indian companies have already established market presence in prominent countries from South East Asia, Middle East and Africa. Similarly recent years have also witnessed a lot of cross-country alliances by Indian companies with local companies in a given market. Such alliances ease the barrier for entry caused due to lack of brand awareness in untapped markets and help to establish a local presence. With their excellent manufacturing capabilities of international standards and comparatively lower costs of manufacturing, Indian companies are all set to grab a significant share of the opportunity in the biogenerics space.
Future Trends
The Indian Biologics market currently stands at an interesting threshold, where the next few years shall witness emergence of new competitive therapies, and improved product portfolios that could change the dynamics of the existing market. In the recombinant vaccines segment, the next few years will witness emergence of multivalent vaccines with improved patient compliance and newer vaccines to meet the unmet medical needs of the people. Pricing dynamics will play a critical role and so will the active participation and support from the government.
In the recombinant therapeutics space, there will be emergence of new players who would pose formidable competition to existing players. This will lead to competitive pricing strategies and could lead to price erosions especially in the Erythropoietin, G-CSF and Insulin segments. The recombinant therapeutic segments will also witness emergence of drugs with Modified Drug Delivery systems like Pegylation, which could significantly impact the market shares of conventional products and could also significantly hamper the market entry strategies of emerging players. However with opening up of the global biogenerics market, players could shift focus from the restricted domestic market to the untapped potential in the international biogenerics market.
The next few years will also witness launch of newer therapies, prominent among these would be the monoclonal antibodies products, Stem Cell therapies, Growth factors and others. Biocon has already announced the availability of its monoclonal antibody product BioMAb EGFR. Similarly Reliance Life Sciences is also geared up to launch its recombinant products like Platelet derived Growth Factors and Epidermal Growth Factors. India slowly inching towards the leadership position for highest number of Diabetics, there is a huge potential for these products in areas such as Delayed wound healing and Diabetic foots. Similarly the Government has also pledged significant support for research, and commercial development of stem cell therapy. The first commercial products to hit the market are estimated in 2007. If stem cell therapy is indeed successful as an established, efficacious, safe and affordable therapy it will significantly impactthe future of the Indianbiopharma industry and change the face of India on the global biopharma map.
Jayashree Mapari is a Industry Analyst, Healthcare Practice, Frost & Sullivan.
Author can be contacted through Shwetha Thomas: sthomas@frost.com