Commercial Space Transportation Study

Appendix F New Missions Appendix

F.1 Business Park User Market

F.1.1 Principal Microgravity Uses

1. Improved quality and size of protein crystals
2. Improved Separation Process (electrophoresis)
3. Improved capability for drug testing (rats)
4. Growth of replacement tissues for transplants
5. Improved quality of semi-conductor crystals

F.1.2 Pharmaceuticals

The principal customers for micro-gravity processing are pharmaceutical companies and microprocessor producers. Among the pharmaceuticals there are eight small research companies which focus on structure base drug design, thirty worldwide major pharmaceuticals with drug design departments and approximately one hundred biotechnology companies that currently conduct research, development, and commercialization. These potential users are listed below:

There are several steps that require protein crystals: protein molecule solution in order to discover the location and composition of the active site; heavy metal doping to clarify and amplify the active site; and the testing of many possible drug compounds. The production of crystals that have sufficient size and clarity is a time consuming process.

The protein crystals need to be produced on a regular basis for a period of years and this is very expensive process. It is estimated that $15,000 to $40,000 per month is spent growing crystals of one protein in order to meet the requirements of the drug development process.

This assumption is based on data from Eli Lilly who spent approximately $965M in R&D in 1992A-1, of which 67%A-2 is spent on pre-clinical discovery and drug development. This amounts to approximately $54M per month of which 5% - 15% is spent on growing crystals. This leads to an estimate of a conservative medium probability market for crystal growing of $5M to $8M per year per major company.

A large pharmaceutical company will have 100 or more drugs undergoing some phase of clinical testA-2. During this process the most intensive effort is to search for side effects and unexpected short and long term complications. Having a better characterization of the active site of the protein means the drug molecule will be much more accurately tailored.

This minimizes the problem of bonding of the drug to the active sites of other proteins and hence reduces the side effects and complications of drug use. The result is that on average each drug undergoing clinical tests will see a reduction in the cost of testing of approzimately $700,000. This is based upon the assumption that 33% of the $965M is spent on clinical trials of which 20% is saved through better understanding of the drug. This saving amounts to $3.2M per year per drug.

Of all the drugs tested, the few that are successful undergo a lengthy development and qualification process, Often competing companies are in a race to reach market first and obtain substantial marketing advantage. Using protein crystals grown in micro-gravity results in an average reduction of the total development process of approximately one yearA-3.

Also the costs of these drugs during their pre-clinical development consissts mostly of the cost of capital that must be invested by the company before a return on the investment is realized. If the developemnt time is reduced by a year then the time for recovery of the cost of development is reduced accordingly. The savings to each of ten successful drugs would be in excess of $8MA-2.

When a pharmaceutical company has a more accurate tool for the development of drugs, such as micro-gravity protein crystal growth, the opportunity for additional successful drugs exists. Micro-gravity processing allows for a closer analysis of the structure of the protein and different perspectives of the protein due to additional morphologies which presents new opportunities for the use of small molecule drugs. Statistically, this would result in the addition of a new successful drug to the companies inventory. conservatively, this would be an additional value to the company of $50MA-2.

A-2. Cost of Innovation in the Pharmaceutical Industry, 1991.

A-3. Conversations with Dr. Larry DeLucal, UAB Center for Macromolecular Crytallography, 1992.

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