Team:SDU-Denmark/Tour33
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Business
Market Analysis
The market has to be evaluated to determine how many batches P. A. S. T. should be able to produce per year. The analysis of the market is based on the competitors of iGEM 2014, these teams are at the forefront of synthetic biology and therefore it is assumed, that they represent the future of the field. Every team who has succeeded in making their wiki has been taking into account. The results can be viewed in pdf (Market analysis iGEM 2014). The market is presumed to be worldwide, since no problem has presented itself in shipping. The distribution of teams, which can be viewed in the chart, shows an even distribution in all but one region. This underrepresentation by Latin America can be caused by several factors, but for now it is considered a future market, and no correlations will be made.
It has also been investigated, how many teams used antibodies in their 2014 project in regards to the regions, the result is represented in the chart. It is seen, that though Europe only represents 28% of the total teams, these team use antibodies significantly more at 55% out of all teams. Whereas North American teams used antibodies in their project half as much as the total representation of teams.
Figure 2:
There could be several reasons for this under- and overrepresentation. If it is assumed, that all teams producing proteins could potentially use antibodies, it is a possibility that projects on this subject is more common in Europe than in North America, in the chart it can be seen that this is not the case. North American and European teams producing protein are distributed with 34% and 37% respectively. Therefore another reason must responsible for the uneven usage of antibodies in the regions.
Figure 3:
To identify these reasons the production of proteins has been compared to the usage of antibodies, this is presented in the chart. This chart clearly shows, that the usage of antibodies is far less common than the production of proteins. Since it has already been assumed that all teams producing proteins could potentially use antibodies, the market should be evaluated by the protein production not the antibody usage.
The reasons that antibodies are rarely used are plenty. Teams might not have reached a point in their research, where antibodies can be applied to the experiments. This should not be considered in the evaluation of the market, since it is assumed that research projects normally have more time to evolve. It is more likely that the cause is the expense or the long delivering time of antibodies that are not readily available.
Figure 4:
Therefore it is estimated that the market includes all teams producing proteins. In all 123 teams where
involved in such projects, and on average the teams used two types of antibodies per project. Therefore a
production of approximately 246 varieties of peptide aptamers is presumed appropriate.
Though this estimates the number of batches per year, each project will only buy a small amount of the
production. Therefore it should be evaluated if, it is reasonable to assume that the rest of the production
can be sold as well. To reach a conservative estimate the European market has been evaluated, as this is
the region where most antibodies where used by iGEM teams from 2014. There were 63 universities
represented at iGEM 2014 out of approximately 4000 academic institutions in Europe.
Reference:
European Union. The role of universities in the Europe of knowledge. (Link) (Accessed August 21st 2015).
Taking these numbers into account
iGEM 2014 represents 1.6% of the market. This is assuming that only one research project per university is
using antibodies, which is unlikely. This evaluation reinforces the assumption, that the remaining product
can be sold. In some instances this will not be the case, due to the specialized nature of production or
property rights on the protein targetet, therefore it is estimated that 30% of the production will be lost.
Cost analysis
The evaluation of the cost and profitability of production is key in determining, whether this project should be carried on after iGEM. These estimates shows if our presumption of the competitiveness are wrong rather than right. The analysis is used to approximate the pricing of the product, since it does not exist on the market as of yet. The aim is to reduce prices by half in comparison to the price of monoclonal antibodies, which leaves an acceptable margin between reality and estimates.
To estimate how much capital is needed to build the plant, the model Busche (1995) with modifications has been used. Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 The size of the factory has to be estimated before costs can be calculated, therefore it is necessary to evaluate the number of units needed. As established under entrepreneurship it has been decided to produce several small batches, and the market analysis estimated the amount of batches to be 250 [batches/yr]. According to the timeline a batch cycle is 63.5 [h], and the next batch can begin after a flash sterilization of the fermenter, after 42.5 [h] from the start of the batch. This will say, that the cycle time for two batches is 106 [h]. It is assumed that the plant is closed for 4 [weeks/yr] and a work week consists of 5 days (120 [h]). Which means that 3 set-ups is needed. This assumption leaves a time buffer in case of unforeseen maintenance or orders.
| Result [million USD] | Source: | |
| Total bare-module investment | 7.6 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 chapter 22.3 |
| Simulation Aspen Plus, method BK10 | ||
| Reference: E-mail from GE lifescienses linear extrapolation of price development | ||
| Cost of site preparation | 1.1 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 chapter 22.3 |
| Cost of service facilities | 0.6 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 chapter 22.3 |
| Allocated costs for utility plants and related facilities | 2.9 |
Reference:
Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and
Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010
chapter 22.3; table 22.12 Simulation Aspen Plus, method BK10 |
| Total direct permanent investment (CDPI) | 12.2 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 chapter 22.3 |
| Cost of contingencies and contractor’s fee | 2.2 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 chapter 22.3 |
| Total depreciable capital (CTDC) | 14.4 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 chapter 22.3 |
| Cost of land | 0.3 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 chapter 22.3 |
| Cost of plant startup | 3.6 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 chapter 22.3 |
| Total permanent investment (CTPI) | 21.6 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 chapter 22.3 |
| Working capital | 3.2 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 chapter 22.3 |
| Total captital investment (CTCI) | 24.9 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 chapter 22.3 |
This calculation shows that an investment of 24.9 [million USD] is needed to get the plant up and running. From this amount 14.4 [million USD] is depreciable.
Now it needs to be approximated how much it will cost PAST to run production annually, this is achieved by usage of a model, Busche (1995) with modifications. Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010
| Result [million USD/yr] | Source: | |
| Total Feedstock | 3.5 | Entrepreneurship |
| Reference: Available at: [Sigma-Aldrich] (accessed: 10.09.2015) Sigma-Aldrich | ||
| Reference: Available at: [NEB] (accessed: 13.09.2015) NEB | ||
| Electricity | 0.3 | Simulation Aspen Plus, methods BK10 and Water |
| Cooling water | 0.00004 | Simulation Aspen Plus, methods BK10 and Water |
| Process water | 0.003 | Entrepreneurship |
| Total utilities | 0.32 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Direct wages and benefits | 1.09 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Equation 23.2 and table 23.3 |
| Direct salaries and benefits | 0.16 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Operating supplies and services | 0.07 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Technical assistance to manufacturing | 0.02 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Control laboratory | 0.02 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Total labor-related Operations (O) | 1.4 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Wages and benefits | 0.6 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Salaries and benefits | 0.2 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Materials and services | 0.6 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Maintenance overhead | 0.03 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Total Maintenance (M) | 1.5 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| General plant overhead | 0.1 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Mechanical department services | 0.05 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Employee relations department | 0.1 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Business services | 0.2 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Total operation overhead | 0.47 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Property taxes and insurance (t) | 0.3 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Direct plant | 0.88 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Allocated plant | 0.21 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Total depreciation (D) | 1.08 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Total cost of manufacturing (COM) | 8.6 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
| Total general expenses (GE) | 0.2 | Reference: Available at: (accessed: 15.09.2015) Rand Corporation |
| Total cost of production (C) | 8.8 | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 Chapter 23.2 |
This concludes that according to this model, it will cost 8.8 [million USD/yr] for PAST to produce 250 batches.
The challenge of biotech companies is to price a product that is of yet not on the market. This has to be an evaluation of the costs estimated above and the investments needed for maturing the concept on the one hand. On another how much customers are willing to pay. PAST aims to replace mAbs, and it must be assumed that though there are concerns of animal welfare, the customers will be inclined to keep using mAbs, if the price of the peptide aptamers are not considerably lower. Therefore an average of the price mAbs has been estimated by 50 products from Sigma-Aldrich, details can be viewed in pdf. Showing an average price of 1.7 [million USD/g]. This method of pricing presupposed that the peptide aptamers have the same affinity and specificity as mAbs. The definition of sales can be viewed in equation 1, it should be noted, that it is assumed that 30 % of production is lost. Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010
S=Price x 0.70Production (1)
In the figure the development of sales and net earnings in relation to a price of 1-100% of that of mAbs can be viewed. Net earnings has been calculated from equation 2. Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010
Net earnings = (1 - t)(S - C) (2)
Figure 1: development of sales and net earnings
This confirms the assumption, that this production method can render profit at a price lower than that of mAbs. Though it does not take into account the investments in the plant. Therefore three different methods are used for estimating the profitability, see table. These methods cannot be compared directly, but if all shows profitability, it must be assumed, that grounds to work further with the idea is established. Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010
| Method | Equation | Source |
| Return of investment | ROI=(1-t)(S-C)/CTCI | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 table 22.5 |
| Payback period | PBP=CTDC/((1-t)(S-C)+D) | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 table 22.5 |
| Venture profit | VP=(1-t)(S-C)-imin CTCI | Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010 table 22.5 |
The goal is to sell the peptide aptamers at least at 50% of the price of mAbs, therefore the methods are used for a price range between 1-50 %. Parameters for profitability of the three methods are: ROI>0 %, PBP<2 [yr] and VP>0 [million/yr]. Results can viewed in figure. Reference: Seider, Seader, Lewin and Widagoo. Product and Process Design Principles - Synthesis, Analysis, and Evaluation; Third Edition - International Student Version; John Wiley & Sons, Inc.; 2010
Figure 2: Evaluation of profitability
The evaluation shows, that P. A. S. T. will be profitable at a price above 4 % that of mAbs, which corresponds to a price of 0.07 [million USD/g]. It is most unlikely that investors can be paid back at this price, and should be taken as an indication of the margin in pricing. In this estimate it will be possible to raise prices by 44% before exceeding the goal. Another uncertainty is the validity of the estimate, since this is only an approximation of reality. Therefore the same calculations were done, if the cost turns out to be double. This showed profitability at a price set at 8% that of mAbs, which corresponds to a price of 0.13 [million USD/g]. This leads to the conclusion, that there is a good possibility of making a profitable enterprise, and it should be encourage to keep working towards more accurate estimates and finally the realization of P. A. S. T.