The Indian cleanroom equipment industry which has seen considerable growth during the past 20-25 years, is poised to grow leaps and bounds in the the coming years, aver industry veterans.
With more than over 20,000 pharmaceutical plants and with 200 medium- and large-sized research and development companies, India holds a huge market for cleanroom equipment , they point out.
With liberalized rules and encouraging industrial environment, many global pharma majors are looking to outsource manufacturing from Indian companies, which has much lower costs (both capital and recurring) than their western counterparts.
Keeping the global market scenario in mind, many Indian companies have made their plants cGMP-compliant and today India has the largest number of USFDA-approved plants outside the US. Taking all these aspects into consideration, India will continue to grow and increase pharma cleanroom market share at the expense of Europe, they add.
Says P Narendran, General Manager , Isobuild , Beardsell Ltd "With the GMP systems being enforced and implemented in almost all major industries, like pharma, electronics, food processing , glass (lens) manufacturing, critical machinery assembly area and various other sectors, the cleanroom equipment industry is growing leaps and bounds in the country. The situation is quite promising and with our exposure to international developments in this field, the Indian industry is also trying to emulate and update the technology."
Acording to Ravi Thakur , Vice President Marketing , GMP Technical Solutions, the cleanroom equipment market has seen considerable growth during the past 20-25 years and there will be a robust requirement as more and more pharma/biotech /healthcare and electronics industries will have prime requirement of this technology in future.
"The Indian cleanroom equipment industry is moving towards manufacturing of critical equipment like aspetic isolators, containment system upto nanogram level, bio safety cabinets for BSL-3 & 4 applications and there is a huge opportunity for there equipment in Indian and international market .With our unique combination of good quality and competitive costs, we can definitely increase our global market share if we follow the international regulations and adhere to global quality standards', he points out..
Talking about the competitiveness of Indian products, he said today a considerable number of indigenous vendors operate in manufacturing of cleanroom equipment. Specialized and skilled personnel are available now and expertise for design and construction is available indigenously. The cost of construction is competitive and has major advantages compared to imported equipment. However for critical containment technologies and isolators, the quality of the components and workmanship has some scope for improvement and more R & D efforts are needed to achieve industry’s global ambitions.
According to Narendran, though the prospects are bright , problems persist because there is still no uniform specification product wise, industry- wise due to which there is a lot of variation in specifying the cleanroom products and specification by different consultants and architects. This needs to be addressed with proper co-ordination with users and manufacturers.
Despite the fact Indian products for cleanrooms are extreme ly competitive in comparison with international prices for similar products , due to excise duty and local tax, in some cases it becomes uncompetitive, particularly comparedwith Chinese products.
According to Ravi Thakur , in order to make our products more competitive, there is a serious need to constitute a national body, which can provide guidance for cleanroom equipment design and quality assurance programmes. This body should work in various aspects of formulation board based design specifications, introduction of local codes and standards to suit user requirement, implementation procedures, operational methodologies, maintenance and validation procedures, training and certifications of manpower to take up this jobs, conducting regular courses and lectures for various levels of management.
As the pharmaceutical and biotechnology industry are slowly setting up new bases in northern and southern parts of the country, the prospects are bright and the current scenario is also encouraging for the industry. In fact the pharma industry is major growth driver for the cleanroom industry.
In the coming days, new product and manufacturing trends will require adaptation by cleanroom manufacturers in the country. This is all the more important because demand for cleanroom equipment not only from the Indian domestic markets, but also from the overseas customers especially from Europe and America is also on the rise.
In the biotechnology sector there is a great potential for growth.In fact it is the fastest growing segment for cleanroom equipment. This industry requires cleanrooms not only to protect the products, but also to protect workers. For example, approximately five per cent of biotechnology plants currently utilize cells or products known to be pathogenic or derived from genetic engineering techniques.
Cleanrooms first appeared in the United States in the 1960s within the electronics industry, which required quality control of the production environment in order to reduce the rejection rate and thus increase productivity. Cleanrooms were subsequently adapted to the pharmaceutical and food-processing industries as well as the hospital sector. The basic cleanroom design, with control of airflow, air filtration, air velocity, air change rates and so on, has been a stable part of the preparation of pharmaceuticals for the past 50 years.
Though cleanroom technology did not advance greatly until the late 1990s, the pace of transformation has accelerated in recent years. In the 21st century, there have been a number of advances in new cleanroom technologies, which have helped to both reduce the risk of contamination and to streamline process operations. The majority of these technological developments have been orientated towards the manufacturing of sterile products, particularly aseptically filled products.
There has been a rise in opportunities in the cleanroom market, which can be attributed to rapid growth in emerging technology sectors. The growth of these newer markets, along with the steady flow of demand from traditional markets such as medical device production and aerospace composite manufacture, has led to the increased demand for cleanrooms.
The cleanroom equipment industry is very dynamic. The markets for cleanroom equipment changes rapidly with the invention of new products and procedures. Scientists and researchers are continuously evolving newer methods and processes which need equipment suiting those conditions.
As a result, products innovations are expected more than before.
“Providing timely, cost-effective solutions for the high performance needs of domestic market is a challenging job. We need to constantly adopt new changes and move according to the clients needs and requirements,” says Vishal Jaidka, Manager sales, Ayushi engineering services, Lucknow.
“To build and maintain a cleanroom is not an easy task, in fact it is a very complex exercise. Particulate count by different standards decides the cleanliness of cleanrooms. The particulate level has to be such that it will not affect sterility of the product in any way. Presence or absence of both viable and non-viable particles is detriment of successful cleanroom operations,” says Rajesh Jain, Director Kinetic polymers.
Keeping in mind the growing demand for the highest quality standards in the drug manufacturing industry, research bodies, laboratories and others involved in high end chemical and microbiological research are opting for most advanced and modern cleanroom equipment. And in order to meet the requirements of the industry, many manufactures are evolving new techniques and inventing innovative methods and developing most advanced cleanroom equipment.
Global cleanroom markets
Europe and United states still dominate the cleanroom equipment markets in the world. The US, including Puerto Rico, accounts for 40 per cent of the world’s pharma and biotech cleanroom space, while Europe contributes 34 per cent and rest of the world contributes 28 per cent.
During 1990 and 2004, R&D investment in the United States grew 4.5 times, while in Europe it only grew 2.7 times. Between 1993 and 2003, the US market grew by 11.9 per cent per annum.
Market revenues from bio/pharmaceutical cleanroom revenues in Europe represent more than 25 per cent of the world's cleanroom expenditure. The pharma industry is the largest contributor to the European trade balance in high-technology, research and development-intensive sectors. Important world players in cleanroom equipment segments like Anglo-Swedish AstraZeneca and Novartis of Switzerland have remained in the top tier by virtue of mergers.
In 2000, European pharma and biotechnology firms spent $128 million on new cleanrooms. By the year 2006, the cleanroom revenues in the pharma sector increased to $178 million.
Across the continent Europe still accounts for approximately 27 per cent of the global market. However, it is not really a single market. In health care, each member state operates its own pricing and regulatory framework, breaking the drugs market into smaller fragments.