Fermentation technology, as mentioned in the literary texts, is more than 3000 years in India. The fermentation technology employed a variety of processes and was put to a large number of uses. It also laid the foundation of alchemy and chemistry.
The term fermentation is derived from the Latin word Fermentum that stands for boiling. Fermentation is the process of digesting certain substances that leads to chemical conversion of organic substances into simpler compounds. Fermentation technology began with sweet substances (vegetable or animal) in different parts of the world. The process of fermentation was probably discovered by observing the changes in the juices of several fruits and other substances that had been kept for a day or more. It appears that fermentation technology started simultaneously with settled agriculture during the neolithic period.
Fermentation as we know today started roughly towards beginning of second half of 20th century. The term "Fermentor" as used by US manufacturers meaning that it is a cell culture system designed for growing highly aerobic bacteria, yeast and fungi. The term "Bioreactor" on the other hand refers to a cell culture system designed for growing mammalian and insect cells.
Current market scenario
The biotechnology sector has grown by 21.5 percent in 2010-11, to cross the US$ 4 billion mark, as revealed by an annual survey conducted by BioSpectrum and Association of Biotech Enabled Enterprises (ABLE). India's biotechnology industry is expected to reach US$ 10 billion, in terms of revenue from the current US$ 4 billion, by 2015. There was an economic downturn in the year 2009 that continued until the first half of 2010. However, thereafter due to investments and increased funding in the fermentation and cell culture segment the market has picked up and is currently growing at an impressive rate of over 40 per cent.
Expanding market opportunities and growth drivers
There are a lot of reasons to suggest that the growth story of fermentors and bioreactors is expected to continue. The government and industry are now focusing on biofuels as an alternate source of energy. There is an increase in demand for vaccines with the increase in population and an increase in activities in biopharma and clinical research. There is a spurt in the probiotic products in the Indian market Companies are buying more and more systems to enhance their production throughputs. The Indian market for biosimilar products is estimated to be huge (about Rs,2,500 crore) and is further growing. Pharma companies have witnessed rural market sales doubling on the back of aggressive marketing initiatives. India's rural drug market has grown by 18.8 percent in the 12 month period ending April 2011 as compared with 10.9 per cent in the previous year. With the expansion of bioengineering market in India both in research and industry, the chances for sale of fermentors have improved further. There is an emphasis on the role of biochemist - microbiologist in establishing the fundamental components of fermentation process i.e. organism, substrate and process conditions.
Market segments
The market segments for fermentors and bio-reactors can be broadly classified as academic, industry and contract research organizations (CROs). Academic continues to be a major growth driver especially for bench scale fermentors.
The demand is particularly high in universities wherein these are being increasingly purchased as "Technology Demonstrators" for the student community. At the research level, more sophisticated instruments depending on the user applications like microcarrier cultures; developing high yield secreted products from anchorage dependent or suspension cultures in perfusion; cell lines requiring high oxygen mass transfer rates (KLA); gentle mixing with minima! cell damage etc. are being purchased. For algal cultures, fermentors with photosynthetic accessories are being procured.
At the Industry level both laboratory scale and SIP (Sterilizable-in-Place) kind of fermentors and bio-reactors (especially for volumes of 20 lit and above) are being procured. The laboratory scale instruments are commonly used as "seed vessels" and serve as inoculum for the higher volume vessels.
There is another upcoming trend wherein other countries are now beginning to outsource their work in India. This has resulted in CRO players growing five-fold in three years, from around 20 in 2005. The number is expected to reach 150-200 by 2012. According to an estimate the Indian contract research and manufacturing services (CRAMS) sector is expected to almost double to US$ 7.6 billion in 2012, up from US$ 3.8 billion in 2010. The sector is estimated to capture a considerable portion of the global outsourcing by 2012, as per a report by ICRA Ltd. Further, the segment is estimated to grow at a global high, 41.4 percent compounded annual growth rate (CAGR) during the fiscal year 2010-12. India's high-skill and low-cost advantage is said to have helped in gaining export contracts and clinical research bioservices.
There is yet another fast growing market for biosimilar products, such as insulin, hormones, vaccines and plasma proteins. It is currently estimated to be about Rs 2,500 crores wherein a lot of fermentors and biore-actors can be expected to be purchased.
Significant developments
Single Use Bioreactor Technology (also popularly known as Disposable Bioreactors) is increasingly gaining acceptance especially in GMP compliant facilities. Use of this technology does not require vessel cleaning, autoclaving or assembling and hence the requirement of any revalidation is minimized. The set-up is quick and the turn-around time between runs is reduced. The vessels are pre-sterilized and ready for use. This technology is available with companies like Sartorius, Applikon, GE and New Brunswick Scientific.
Biotech firms like Serum Institute, Panacea Biotec and Bharat Biotech have independently agreed to supply pentavalent which combines five different vaccines in one, and rotavirus vaccines for infants at discounted rates to global health NGO GAVI Alliance.
The Department of Biotechnology (DBT) has received necessary approvals for setting up the National Biotechnology Authority which was expected to come for Parliament approval in the next session, as per Dr M K Bhan, Secretary, Department of Biotechnology.
Leading players
There is no single player that is dominating the Indian market as of now. The sale is happening more on the existing customer relationships and after sales services being provided by different companies.
The main players are:New Brunswick Scientific (NBS), now an eppendorf company manufactures fermentors with a volume range of 1.3 lit (400 ml to 1 lit working volume) to 3000 lit (upto 2400 lit working volume). Bioreactors with a volume range of 1.3 lit (400 ml to 1 lit working volume) to 650 lit (upto 520 lit working volume) too are available with NBS. NBS also manufactures Stirred Tank Bioreactors that makes use of single-use vessel technology. These are available in volume range of 5 lit (1.25-3.75 lit working volume) to 14 lit {upto 10.5 lit working volume).
Sartorius India Pvt. Ltd. plays a key role within Sartorius group as one among four system manufacturing facilities for Sartorius worldwide (the other three are located in the US, Germany and Italy). Sartorius India designs and produces fermentors and peripheral systems. For laboratory applications, Sartorius supplies autoclavable and in situ sterilizable equipment, sensors and software.
Applikon, a Netherlands based company supplies mini bioreactors; single-use bioreactors; autoclavable and In situ Bioreactors through its dealers in India.
BioEngineering AG, a Swiss company manufactures and supplies a wide volume range of fermentors and bioreactors under the category of autoclavable laboratory fermentors and cell fermentors. Infers, another Swiss company, supplies bench top and pilot scale bioreactors.
Besides these there are a host of other local and International players in the market especially for laboratory scale fermentors. The most notable among the local players is Scigenics (India) Pvt. Ltd, a Chennai-based company.
Trends and opportunities
The estimated size of the Indian market for imported fermentors and bioreactors in the range of 400ml to 2400 lit working volume would be approx. US$ 15-20 million and is further expected to grow in excess of 20 per cent for the next 3-5 years.
The author is working as National Manager with
the Eppendorf India Ltd.
(Courtesy:Indian Analytical Instruments Association)