Indian biotech industry has come of age and is now a $7.5 billion sector. The sector is poised to touch $100 billion by 2025. Specifically with reference to bio-pharma, the growth contributors would be vaccines. India is fast emerging as a hub for biosimilar and biologicals manufacturing said Kiran Mazumdar-Shaw, CMD Biocon Ltd and chairperson Vision Group on Biotechnology, government of Karnataka.
The country’s bio-pharmaceutical sector is now is now working to strengthen its presence in the space. An acquisition by Strides Aroclab arm Agila Biotech which inked a joint venture pact with US-based Pfenex Inc recently indicates the aggressive efforts to develop and commercialize biosimalr drugs.
Proving its excellence in biosimilars another biopharma company Cipla went to launch the country’s first biosimilar anti - rheumatic drug Etannecept through a collaborative pact with China-based Shanghai CP Guojilan Pharmaceutical Co. Ltd.
Biocon Ltd which is India largest biotech company foresees a sustained pace of growth for itself from ramping up investments in R&D over the next four to five years. As a result, it expects its revenues, currently at Rs.2050 crore, to nearly double to Rs.4,000 crore by 2018.
A small promising start in this direction was already made this fiscal. “The 57 per cent rise in R&D during this fiscal is helping us drive research programmes like insulin and the novel molecules,” said Shaw.
Over the next five years, the biotechnology major has set sights on organic and inorganic growth. This will be driven by research services, small molecules covering active pharmaceutical ingredients, branded formulations and biosimilars. Now it is all set to scale new peaks in the global markets.
The governments of US and Japan are looking at high quality, affordable biosimilars. There is a huge opportunity for the same in the emerging markets of MENA (Middle East- North Africa) and BRIC (Brazil, India, Russia and China) The entire South East Asian region too unfolds bright prospects for insulin and branded formulations, Therefore, Biocon reflects growth momentum in R&D.
“We are literally investing in the future. R&D will be an integral part of our future focus. Right now all our research programmes are in key stages and if there is a concern on an increasing research spend, we view it as a positive indication,” she said.
There are several research programmes going into the clinical stage and the company needs to invest to deliver exponential growth in the future. As the company enter into the clinical research such expenditures would only increase, said Shaw.
"We are in advanced stages of finalizing our co-development agreement for IN-105 (oral insulin), initiated engagement with potential partners for out licensing Itolizumab an anti CD6 monoclonal antibody for psoriasis in the global markets. With Itolizumab, we are seeking market authorization from DCGI. Clinical trials will be initiated for indications like multiple sclerosis, Vitiligo and rheumatoid”, she said on the progress of the pipeline drugs.
“We have already identified strategic growth areas. It will be the active pharmaceutical ingredients (APIs) covering the statins and immunosuppresants, biosimilars, insulin and monoclonal antibodies which help us to accelerate the revenue generation. For instance, the small molecules led by the immunosuppressants can definitely do well in Latin America and US. APIs like fidaxomicin, orlistat and tacrolimus along with biosimilars and insulin are showing encouraging sales. We are working to be ready for product registrations in Europe in 2014-15 with insulin,” she said.
Among the branded formulations, under the diabetic category: Insugen, Basalog, oncology segment: Abraxane and BioMab EGFR, immunosuppressant basket: Psorid and Picon, is a reflection of a strong portfolio and the company will remain committed to offering differentiated products that provide best in class, affordable treatment to patients.
While the company has chalked out many partnerships at every stage of its research and entered into long-term supply agreements for commercial manufacturing and co-marketing, it has also tie-ups with AxiCorp, Pfizer and Amylin Pharmaceuticals. “These are part of a continuous research evolution," explained Shaw.
Coming to Cipla, the introduction of Etacept would help to offer an option to the patients suffering from rheumatic disorders at a lower cost. Etacept is available as a lyophilized powder to be given by subcutaneous injection. It is available with stockists across the country at Rs.6,150 and the recommended dose for adults is 25mg twice weekly by subcutaneous injection.
According to Dr Jaideep Gogtay, medical director, Cipla “The higher cost of biologics has been a major hindrance, limiting its affordability and accessibility to millions of patients. We believe that introducing Etacept at a lower cost (30 per cent lesser as compared to the innovator) will enable access of this drug to a greater number of patients in India. This can be enhanced further if we consider the results of a recent study that showed in patients who were successfully treated with Etanercept for six months, a 50 per cent reduced dose worked just as well as continuing the current dose.”
Currently there are DMARDs (Disease Modifying Anti-Rheumatic Drugs) which are considered to be the first line of treatment for rheumatic disorders. However, approximately 40 per cent of the patients are not controlled on these drugs. In such cases, biologics like Etanercept play a significant role in controlling the disease activity and make a positive difference in the lives of these patients.
Since biopharma sector is one of the largest components of the Indian biotech industry and the most promising, India needs to maximize its presence in the biotech space, aver industry leaders, said the Association of Biotechnology Led Entrepreneurs.
As emerging markets are surging ahead of the developed markets with 75 per cent of the worldwide growth coming out of these markets, Indian biopharma is poised to vault ahead, they rhapsodise.
Biologics or biopharmaceuticals are highly targeted drugs, proving to be more efficacious and with fewer side effects. The biologics are synthesized inside the human body. They have proven to be far more effective for the treatment of complex diseases including cancers and severe metabolic disorders. Biopharmaceutical drugs are therapeutic proteins, monoclonal bodies (MAbs) and vaccines, explains Dr. Reddy’s Laboratories’ Biologics Development Centre at Hyderabad.
Approximately, 30 per cent of the molecules in the pipeline are biologics. By 2016, 10 of the top selling 20 drugs will be biologics, according to the Datamonitor Report Pharmaceutical Key trends 2011- Prescription Pharmaceutical Sales 2011.
The prescription sale of top 50 pharmaceuticals companies indicate that growth in sales of small molecules is steadily declining whereas growth in the biologics sales is moving higher. Between 2010 and 2015, small molecules sales is forecast to drop by approximately $12 billion and biologics sales are projected to increase by $44billion, adds the Datamonitor report.
The small molecules accounted for $402 billion in 2012 but in 2013 it is expected to be $398 billion. In 2014 it is expected to be $ 399 and in 2015 at $ 401 billion. A steady increase is indicated in the case of therapeutic proteins which was $ 76 billion in 2012 growing to $79 in 2013 and estimated to be $81 billion in 2015. Similarly MAbs which registered a growth of $57 billion in 2012 would increase to $62 billion in 2013, $67 billion in 2014 and 71 billion in 2015. The vaccines had clocked revenues of $28 billion in 2012 and is expected to garner sales to the tune of $30 billion in 2013, $31billion in 2014 and $32 billion in 2015, says Datamonitor.
According to the Dr. Reddy’s Biologics Development Centre, several factors are responsible for the increase in biologics sales. These include growth in the incidence of the chronic and complex diseases which are best treated with biologics. Most biologics are still protected with patents. Biologics command a premium price, high entry barriers for competition and several markets such as the US have not put in place regulatory pathways for approval of generics competition.