Whereas saving time, money and energy, process control and automation techniques are playing an increasingly important role in a broad range of industries nowadays. Basically, all companies, including pharmaceutical companies, endeavor to minimize their costs in order to maximize their profit. They are intended to reduce their costs with optimal technological parameters in a controlled environment. This demand required different specific process control solutions and later, as the result of this improvement the Process Analytical Technology was born. However PAT is not obligated yet, companies have an increasing need for PAT solutions, because they realized that the more appropriately controlled processes with good parameters they have, the better product they got back in return.
In the pharmaceutical industry, the Food & Drug Administration (FDA) regulates the introduction of new drugs. It requires that manufacturers perform extensive testing to prove that products are safe and effective before it will sanction commercial sale. The U.S. rigorous approval process is respected around the world.
The Biotech Industry within the last 5 years has seen a significant influx of capital into their firms due to their cutting edge technologies and a wave of new biologic drug product approvals by the FDA. PAT is already recommended by the FDA, but PAT will probably be obligated for companies in the pharma industry in the coming 5-10 years, as the modern quality management didn’t spread like in case of other industry fields (i.e. the electronic and car industry), and the FDA is convinced that PAT will encourage innovation in pharmaceutical manufacturing and quality assurance.
Based on the 2009 survey of the European Federation of Pharmaceutical Industries and Associations (EFPIA), there are more than 2500 pharma and biotech companies in the USA and Europe (not to mention the rapidly developing Asian countries). The numbers of European pharmaceutical companies are shown in the attached diagram in accordance with the European countries.
For the last 5 years, the number of pharma companies has been continuously growing, and according to the EFPIA, further sharp development is expected. According to the 2011 global biotech report of Ernst & Young, global biotech industry revenues for publicly-held companies are estimated at more than $80 billion, and IMS Health estimated that global drug sales will reach $1 trillion for the first time in 2014.
These companies will need an appropriate product that supports both their process control system and service, so thus the PAT “industry” continues to grow.
Considering the USA and Europe, more than 1100 companies would like to implement a PAT system in the present. 74% of pharma manufacturers say they either already have or will have in the next 30 months a PAT/QbD initiative. (Source: 2010 AMR survey)
The size of the PAT market depends on the number of sold PAT licenses. In 2008, 1000 new licenses and in 2009, about 3500 licenses were sold for an average of $130,000/license by the potential competitors (ABB, Siemens and Symbion) on the market. The total pharmaceutical and biotech market is more than $450 billion and this is expected to increase by 7.4% annually in the next 5 years. (Source: 2011 BCC Research survey)
We would like to achieve PAT market penetration with our newly developed, IT combined PAT system. Our target is to reach about 5-10% of the biopharma market within the next 5 years.
We would also like to extend the range of our products and services in the future. (i.e. creation of the
Neural Network Integrated PAT.)
Market and Competition
According to the 2010 international AMR survey, 29% of the pharmaceutical companies already have a PAT/QbD system and 64% of companies are intended to have the PAT/QbD system within 5 years. Our purpose is to persuade as many companies as possible to purchase and use our product and services.
We try to convince those companies who have no proposal to implement PAT that their investment will be returned if they use our product and services. Furthermore, our purpose is to “conquest” companies that have the PAT system of competitors to use our utterly unique software, as well.
To achieve the objectives mentioned above, a considered, effectively and appropriately used strategy is needed to further increase the size of the market.
We already started negotiations with 4 pharmaceutical companies:
Mylan Inc. (Komárom, HU), Gedeon Richter Ltd. (Budapest, Debrecen, HU), TEVA Pharmaceutical
Industries Ltd. (Debrecen, HU) and Novartis International AG (Basel, CH) are all interested. Although no contracts have been signed yet, we already had a verbal agreement with the contact persons, that they all want to participate in the testing of the prototype, and are interested in the purchase, as well.
Besides these, our plan is to negotiate with a lab device vendor is who can recommend our BIOMIPAT system to their measuring equipment. Furthermore, we plan to contact a process control device distributor company and a fermentor manufacturer, too, who can give our test laboratory some new devices to facilitate the software development. In the future, our activities and customer base should be extended to pharmaceutical counselor organizations and technological transfer organizations to achieve improved market position.
'Biotech industry 2011 revenue $80 billion...'
(Ernst&Young)
'Biopharma market size $450 billion, 7.4% annual growth until 2015...'
(BCC Research)
'Drug sales reach $1 trillion for 1st time in 2014...'
(IMS Health)
Our system should be made available and known by entering the international market. Increased marketing strategy and more advertising are required, and if it is necessary, we can extend our PAT system’s availability for other segments of biotechnological industry, and thus acquiring a larger market share.