Biopharmaceutical industry or the biologic drugs sector is projected to be the key growth driver for the life sciences industry globally in the coming years. 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.

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.

Six years ago North America’s spending on biopharmaceutical R&D reached a record $55.2 billion and the US accounted for about three-quarters of global expenditure in this area, said Sujay Shetty executive director, PricewaterhouseCoopers (PwC).

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.

India’s biopharmaceutical sector is well differentiated as it has gained recognition of the global biotechnology and therefore referred to as the bio-economy. This is because biotechnology is now becoming an integral part of healthcare and evolving too, said  Kiran Majumdar-Shaw, chairperson, Vision Group on Biotechnology and chairman-managing director, Biocon Ltd.

While the global pharma market is expected to exceed US$ 1 trillion by 2015, biologics will attain market size of US $ 200 billion by 2015. The shift towards generics is expected to exceed US $ 440 billion by 2015 and the global biosimilars market expected to grow by eight times to touch US $ 2.5 billion by 2015. Indian biotechnology industry is $ 7.5 billion or Rs. 30,000 crore of which biopharma is $2.5 billion or Rs. 10,000 crore in 2012, she added.

High acceptance rate of biosimilars in Asia has helped garner 40 per cent global market share. India is a front runner in biosimilars. India has the R&D capabilities and bio-manufacturing infrastructure to be a key global player in biosimilars. India’s affordable biosimilars in the therapeutic category are anti EGFR, insulin Glargine, Filgastrim, EPO –Alpha and Rituximab Anti-CD-20 which indicate a price difference of 50 per cent to 80 per cent across categories, pointed out Shaw.

Dr. Satya Dash, former Chief Operating Officer, Association of Biotechnology Led Entrepreneurs (ABLE), who prepared the report on Indian Biotechnology :The Roadmap to the Next Decade and Beyond, said that one of the leading drivers for India to become a leading destination for innovation in biopharma will be the growth of its domestic market fuelled by overall GDP growth and increasing prosperity amongst the population, especially the growth of the middle class who can afford medicine and the changing profile of disease prevalence. These developments require the implementation of India - specific healthcare delivery models that take into account the evolving situation.

There is an aggressive shift by pharma majors like USV, Zydus, Cadila, Strides Arcolab, Hospira to enter the biotechnology space. We are now working to propel new growth avenues from this new trend of increasing bio pharma business, said M S Mahadevan, president and CEO Biozeen which is a bioprocess engineering major and a knowledge process outscoring (KPO).

Leading biopharma global companies are Amgen, Astra Zeneca, Bayer, Biogen Idec, Bristol Myers Squibb, CSL Behring, Eli Lily, GSK, Genzyme, Johnson & Johnson, Merck, Novo Nordisk, Pfizer, Roche, Sanofi- Aventis and  YM Biosciences. Some of these companies have collaborated with Indian bio pharma majors like Biocon, Dr. Reddy’s , Strides Arcolab, Panacea Biotech, Serum Institute, Shanta Biotechnics, Bharat Biotech, Reliance Life Sciences, Wockhardt and Intas Biopharmaceuticals.

“The typical strategy has been that while Indian companies handle the early stage clinical trials, global majors engaged in manufacturing a compound handle the late stage trial. At the same time the two companies share the research and development costs,” explained industry experts.

Biosimilars from India are Biocon’s Biomab (biosimilar nimotuzumab), Eripro (recombinant human erythropoietin (EPO) Insugen (recombinant human insulin), Myokinase (recombinant streptokinase) and Nufil (recombinant G-CSF). Dr. Reddy’s covers Cresp (Darbepoetin alfa), Grafeel (recombinant G-CSF) and Reditux (Rituximab.

Those from Intas are Epofit (recombinant EPO), Intalfa (recombinant human interferon alpha-2b), Neukine (recombinant G-CSF) and Neupeg (PEGylated G-CSF).

Reliance Lifesciences has Reliferon (recombinant interferon alpha 2b), ReliGrast (recombinant G-CSF) and Relipoietin (recombinant EPO). Shanta Biotec owned by Sanofi-Aventis has Shanferon (recombinant interferon alpha-2b), Shankinase (recombinant streptokinase), and Shanpoietin (recombinant EPO). Wockhardt products are Wepox (recombinant EPO) and Wosulin (recombinant insulin), informed Dr. Dash.

The biopharmaceutical giant US is now considering a proposal for a 12 year data exclusivity. Under this it will allow the USFDA to approve biosimilars which are off-patent only after 12 years have passed since the innovator drug comes out of patent. “This would see Indian companies to look at non-US markets like those of MENA (Middle East, North Africa) and BRC(Brazil Russia and China) and Asia Pacific region. While the US biosimilars market is estimated at $80 billion, the non-US markets are valued to be $1 billion and are growing at a healthy 30 per cent annually,” said  Shaw.

Industry experts are confident that there is no way for US to ignore India now. There is expertise, cost advantage and comprehension about biologics production which has led global pharma majors partner with many companies here, they point out.

For instance, till five years ago most biosimilar developing firms were contracting development of cell lines to USA and UK. Recently, however, this trend has changed with certain Indian firms, such as Reliance Lifesciences, Cipla and Biocon being able to develop cell lines in-house, says Dr. Dash.

While the US depends on China and South East Asia for outsourcing, there is a clear sign that despite the Euro crisis, several companies are coming up in the European Union for the production of biosimilars and are looking at India. The European Medicines Agency guidelines are already in place for biosimilars and vaccines for Indian companies to initiate the process, says Mahadevan.

The demand for biosimilars is likely to increase as Indians are becoming more affluent and healthcare insurance coverage widens. Moreover, considering the cost advantages that India can provide, the country has a great potential for future growth in the biosimilars market, informs Dr. Dash.

The high cost of biologics has contributed to the increasing and unsustainable overall health expenses throughout the world. In the US, 43% of the drug budget for Medicare Part B is consumed by 6 biologic drugs. This immense burden has led many countries to develop a regulatory framework which can approve biosimilars to provide entry of low cost alternatives to originator drugs, according to Dr. Reddy’s Biologics Devpt Centre.