Update : Pharma Industry as per the latest Economical survey

The pharma industry in the country has grown from mere Rs 1500 crore turnover in 1980 to over Rs 78,000 crore in 2008, with about 10 per cent share in the volume of global production, according to the latest Economic Survey which called for decontrolling of prices.

High growth has been achieved through the creation of required infrastructure, capacity building in complex manufacturing technologies of active ingredients (APIs) and formulations, entering into drug discovery through original and contract research and manufacturing (CRAM) and clinical trials and product specific strategies of acquisition and mergers. The domestic sector had a production turnover of Rs 47,241 crore from about 10,000 small-scale and 300 large and medium manufacturing units in 2008, the survey said.

The survey, presented by finance minister on Thursday in the Parliament, also said price control should be limited to essential drugs in which there are less than five producers. All others should be decontrolled.

Pharmaceutical exports have grown from Rs 6,256 crore in 1998-99 to Rs 30,759 crore in 2008. Exports of pharmaceuticals have been consistently outstripping the value of corresponding imports in the period 1996-97 up to 2007-08. Exports registered a growth rate of 25 per cent in 2007-08 over 2006- 07. The sector attracted FDI amounting to US$1,401.60 million during 2000-01 to September 2008, of which, US$125.30 million occurred during April- September 2008, according to the survey.

Investments in pharmaceutical sector are now expanding into areas of innovative R&D focused outsourcing opportunities like clinical trials, data management services, pharmaceutical informatics, lead discovery and optimization, pharmaco-kinetics and pharmaco-dynamics and pre-clinical drug discovery in combinatorial chemistry, chiral chemistry, new drug delivery systems, bioinformatics and phyto-medicines. "The Indian pharma industry is taking leaping strides in innovative drug discovery with clinical trials underway in 34 molecules. Consequently, the Indian drug discovery market has grown from US$ 470 million in 2005 to US$ 800 million in 2007," it said.

Dow to close 3 Plants in US

Dow Chemical is closing three US manufacturing plants, including an ethylene production unit in Hahnville, Louisiana in a further bid expand its specialty chemicals business. The other facilities earmarked for closure, a second in Hahnville and one in nearby Plaquemine, make ethylene derivatives for plastics manufacture, including for the production of pharmaceutical packaging.

Dow said that the closures will cost around $700m (€497m), but will allow it to save $100m a year over the longer term. It added that the 100 or so workers who staff the three plants will be offered jobs elsewhere in the company.

The Biosimilars- Future of cure

The future of pharmaceutical industry now seems lies with the biotechnology as there is a growing resistance to the use chemical based drugs world over. Biopharmaceuticals thus becoming the fastest growing segment of the pharmaceutical market today. Nearly a quarter of the top 100 drugs in 2007 were biologics and 13 of them achieved blockbuster status of more than $2 bn in worldwide sales. Both generic drug manufacturers and large pharma companies are angling for a share of this emerging niche in the $75 bn global market for biosimilars. Generic drug maker, Sandoz has already taken the lead on this segment with three biosimilars approved in Europe namely Omnitrope, Binocrit and Zarzio. Teva pharmaceuticals, a leading generics producer, has plans to become a major player in biosimilars. It has one product on the European market (Tevagrastim) and has improved its capabilities in biopharmaceuticals through the recent acquisitions of Barr Pharmaceuticals and CoGenesys in the US. Teva's strategic partnership with Lonza to jointly develop, manufacture and market biosimilars confirms its resolve to enter into biosimilar market in a big way. Merck & Co has recently established Merck BioVentures and agreed to purchase a portfolio of biosimilar candidates and commercial manufacturing facilities from US-based Insmed. Indian manufacturers such as Ranbaxy, Dr. Reddy's Lab, Biocon and Wockhardt, have also plans to venture into biosimilar market by taking approvals in Europe and, ultimately, in the US.

Biosimilar products do attract a lot of interest and controversy. Because, biological drugs are complicated and expensive and used to treat complex conditions. A key point for developers of biosimilars is the issue of interchangeability. This is going to be a hard sell in the regulated markets where prescribing of chemical generics is already unpopular. The task will be more difficult for biosimilars where worries over equivalence will be greater and less easy to counter. With a regulatory framework already in place in the European Union to address the safety of biosimilars, the opportunity represented by these products has been proven and is growing there. Over 10 biosimilars have been approved in Europe, using the EU's specially adapted approval procedure. In Japan, the first biosimilar has been submitted for review recently. But, the US, the largest pharmaceutical market, is yet to open up for biosimilars as the biotech industry there is strongly opposed to the entry of biosimilar products. Introduction of biosimilars in the US market should bring down the cost of medicine substantially for critical diseases and make them available to a wider population. And that depends on the US government. If the proposed legislation before the US Congress is passed without much changes it should alter the whole look of the global biopharmaceutical industry to the advantage of millions of patients who are now denied of the benefits of advanced but expensive biologics.

Pharmabiz