Line 338: | Line 338: | ||
</head> | </head> | ||
<body> | <body> | ||
− | <div class="container-fluid"> | + | <div class="container-fluid" id = "please"> |
<div class = "row" style ="background-color:#e2e2e2; margin-top:60px" align = "center"> | <div class = "row" style ="background-color:#e2e2e2; margin-top:60px" align = "center"> |
Revision as of 15:52, 1 November 2017
Barriers to Entry
Non-Financial
Permeability /10
Expected Financial
Cost ($US)
Scaling/Ongoing Cost?
Technical Barriers
Open-source
creation of a biosynthetic organism
8
5000
No
Design and
Engineering expertise required for fermentation/purification plant
8
10000
No
Open
Source Development of an insulin pump
8
10000
No
Cost Barriers
Clinical Trials I-IV
(for new analogue insulin)
8
~200 million
No
Biosimilar Clinical
Trials (for new generic/generic analogue)
5
~100 million*
No
Fermentation/Purification
Equipment and Testing (Small - Large Scale)
6
2 million - 200
million
Yes
Fermentation/Purification
Plant (Small - Large Scale)
6
4 million - 400
million
Yes
* Biosimilar clinical
trials yet to have enough data to generate an average expense
Market Barriers
Enormous
existing contracts between governments and pharmaceutical companies can be
used to leverage significant pressure to use a certain product in PBS
schemes.
5
USA, Europe,
Australia; ~100m+ to disturb the status quo. For most developing nations,
price/efficacy will be the major determining factor.
Yes
Economies
of scale favours existing manufacturers. Any new market entrant would be
vulnerable to a price war after investing significantly in setup.
6
^ See
Fermentation/Purification Plant and Equipment Costs
Yes
Existing distribution
systems are largely owned by competition
4
10 million + dependent
upon strategic partnerships
Yes
Legal Barriers
Existing
patents protecting analogue insulins
6
Litigation Risk
Possibly
Existing patents
protecting insulin manufacturing optimisations
6
Litigation Risk
Possibly
Existing patents for
insulin pump technologies
6
Litigation Risk
Possibly
Non-Financial
Permeability /10 |
Expected Financial
Cost ($US) |
Scaling/Ongoing Cost? |
|
Technical Barriers |
|||
Open-source
creation of a biosynthetic organism |
8 |
5000 |
No |
Design and
Engineering expertise required for fermentation/purification plant |
8 |
10000 |
No |
Open
Source Development of an insulin pump |
8 |
10000 |
No |
Cost Barriers |
|||
Clinical Trials I-IV
(for new analogue insulin) |
8 |
~200 million |
No |
Biosimilar Clinical
Trials (for new generic/generic analogue) |
5 |
~100 million* |
No |
Fermentation/Purification
Equipment and Testing (Small - Large Scale) |
6 |
2 million - 200
million |
Yes |
Fermentation/Purification
Plant (Small - Large Scale) |
6 |
4 million - 400
million |
Yes |
* Biosimilar clinical
trials yet to have enough data to generate an average expense |
|||
Market Barriers |
|||
Enormous
existing contracts between governments and pharmaceutical companies can be
used to leverage significant pressure to use a certain product in PBS
schemes. |
5 |
USA, Europe,
Australia; ~100m+ to disturb the status quo. For most developing nations,
price/efficacy will be the major determining factor. |
Yes |
Economies
of scale favours existing manufacturers. Any new market entrant would be
vulnerable to a price war after investing significantly in setup. |
6 |
^ See
Fermentation/Purification Plant and Equipment Costs |
Yes |
Existing distribution
systems are largely owned by competition |
4 |
10 million + dependent
upon strategic partnerships |
Yes |
Legal Barriers |
|||
Existing
patents protecting analogue insulins |
6 |
Litigation Risk |
Possibly |
Existing patents
protecting insulin manufacturing optimisations |
6 |
Litigation Risk |
Possibly |
Existing patents for
insulin pump technologies |
6 |
Litigation Risk |
Possibly |
Estimated Start Up Costs
|
Company A |
|
Company B |
|
Company C |
|
Building Related Expenses |
4,000,000.00 |
200,000.00 |
1,800,000.00 |
|||
Equipment + Installation |
1,000,000.00 |
980,000.00 |
300,000.00 |
|||
Engineering/Validation |
1,000,000.00 |
250,000.00 |
900,000.00 |
|||
Total ($CA) |
6,000,000.00 |
1,430,000.00 |
3,000,000.00 |
|||
Total ($US) |
4,680,000.00 |
1,115,400.00 |
2,340,000.00 |
|||
Annual GMP Compliance + Operating Expense
($CA)* |
925,000.00 |
454,000.00 |
720,000.00 |
|||
Annual GMP Compliance + Operating Expense
($US)* |
721,500.00 |
354,120.00 |
561,600.00 |
Risk Assessment Matrix
Potential Risks for Our Model
Potential Risk |
Risk Matrix |
Price war from competitors |
9 |
GMP failure, dangerous product |
10 |
Escape/Release of GMO organism |
2 |
Manufacturing Injuries |
2 |
Insufficient Liquidity |
8 |
Exclusionary contracts prevent entrance to
certain markets |
7 |
Cure for Diabetes |
5 |
Superior Analogue enters market |
6 |
Inefficient secretion pathway |
6 |
Inefficient Purification |
6 |
Local - High Australian Wages |
2 |
Carbon Emissions Target |
2 |
Nickel-Agarose Price Inflation |
2 |
Electricity Inflation |
2 |
Competitive advertising |
2 |
Government overregulation |
8 |
Economies of Scale |
9 |
Natural Disaster |
4 |
Manufactory Fire |
4 |
Internal Corruption |
4 |
Patent Infringement Lawsuits |
3 |
High Employee Turnover |
2 |
Export/Import Restrictions |
8 |
Unforeseen Circumstances |
5 |
An analysis of various business models that can profit from this industry without pricing individuals out of the market.
In response to our various talks with various professionals throughout our project, we thought it we should consider the possibility of continuing with a standard business model. Below you will read through some potential business models which summarise the information we processed in response to these conversations.
Open-source research and development has revolutionised the Technology Sector and is quickly making its impact known on the Deep Tech Sector. Just as novel financial tools like ‘Freemium’ changed the way consumers interact with online businesses, open-source research offers new and unique ways to approach monetisation of Intellectual Property (IP).
- Intellectual Property Tools - Platforms to empower individual researchers with the sharing and application of their work.
- Design + characterisation of genetic sequences for protein (e.g. insulin) manufacturing - Competitions like iGEM showcase the excellent talent of researchers, while businesses such as AddGene provide simple sharing of plasmids for a novel fee.
- Design + characterisation of expression systems for protein (e.g. insulin) manufacturing - Further focus on the downstream requirements to optimise protein expression is already entering the open-source market, expanding the options of small-time researchers to develop technologies with a big impact.
- Manufacturing plant design and optimisation - Often held as trade-secrets rather than patented, the secrets of high-efficiency protein manufacturing are rarely shared between agents in the market. Improved clarity within this industry would be to the benefit of all.
- Open-source Clinical Trials - Potential investors that wish their money to contribute to the development of essential medications and treatment are currently forced to purchase stock in a major pharmaceutical company. A financial platform can be designed that offers the chance to invest in the clinical trials of a new open-source drug, pledging money alongside other potential investors until sufficient capital is obtained to proceed with Stage I, II, III or IV clinical trials. Rather than the return on IP contributing to a single pharmaceutical company's profit margin, it can instead be divided between clinical trial investors and the developer of the IP.
- Return-on-Investment would have to scale with the relative risk of the drug not finishing clinical trials, however this could still be significantly less than the ROI expected by public corporations.
- Some legal protection would have to be established to prevent manufacturing of approved open-source drugs without contributing to the investors that helped get it approved.
- Open-source Manufacturing Investment - Like open-source clinical trials, this financial tool would allow investors to direct their capital towards necessary manufacturing facilities for setup and GMP approval of protein manufacturing facilities.
- Could be combined with public investment to better overcome the challenge of economies-of-scale.
- All about helping the market respond more effectively to supply shortages.
- Utilising Open-Source tools to carve out a market niche: The open-source tools listed above have the potential to make a tidy profit to the business that facilitates their creation.
- Facilitating efficiency of distribution of Human Insulin and Analogues: [1]
- The global pharmaceutical distribution market is a maze of intermediaries, each adding a small profit margin to the final price. Remodelling this will require public and private entities operating at all stages of the supply chain.
- E.g. A click-and-mortar business that matches a diabetic’s insulin requirements to a specific wholesaler - cutting out all intermediaries and claiming a portion of the profit margin.
The sheer scale of the insulin market (600m+ potential patients) allows economies of scale to play a major role in the competitiveness of individual players. Without enormous investment capital, any new manufacturing facility will be too small to make a significant impact on the insulin market and may be unable to produce at a low enough cost to survive a price war.* As such, new market entrants will most likely be large pharmaceutical corporations looking to share in this industry’s profits.
- Large-scale Manufacturing Facilities
- Expected cost: Minimum of US$100m for a medium-scale facility [2]
- Research and Development of Single-Chain Insulin Analogues:
- xpected cost: Upwards of $US50m for initial approval. Ongoing expense of 20-25% annual operating costs to ensure compliance. [3] Expense here can scale infinitely with risk aversion.
Governments provide a functional alternative to corporate manufacturing, as they can justify investment in research and manufacturing that offers a lower potential profit margin (or even a loss). Analysis of trends and forces within the international ‘Active Pharmaceutical Ingredient’ (API) manufacturing market exemplifies two nations already investing heavily in expanding local insulin manufacturing;
- ndia - The brands ‘Biocon’ and ‘Wockhardt’ already hold a larger portion of the global market share than any other brands outside the ‘Big 3’ and are poised to take greater advantage of economies of scale. If the Indian government were to implement a ‘maximum price’ on insulin, these two could operate locally without fear of competition.
- China - Companies with close ties to the national government such as “Tonghua Dongbao Pharmaceutical” and “Zhuhai United Laboratories” are building enormous manufacturing facilities which could majorly restructure the current market layout.
- Tsai, A. (2016). The Rising Cost of Insulin. [online] Diabetes Forecast. Available at: http://www.diabetesforecast.org/2016/mar-apr/rising-costs-insulin.html?referrer=https://www.google.com.au/ [Accessed 25 Oct. 2017].
- Basu, P., Joglekar, G. and Rai, S. (2008). Analysis of Manufacturing Costs in Pharmaceutical Companies. [online] Available at: http://moodle.univ-lille2.fr/pluginfile.php/28162/mod_resource/content/0/Analysis%20of%20Manufacturing%20Costs%20in%20pharma%202008.pdf [Accessed 25 Oct. 2017].
- Bruttin, F. and Dean, D. (2017). Managing the Cost of Compliance in PharmaceuticalOperations. [online] Available at: https://www.scribd.com/document/137906487/Managing-the-Cost-of-Compliance-in-Pharmaceutical-Operations [Accessed 25 Oct. 2017].
Strength, Weakness, Opportunity and Threat Analysis
S.W.O.T Analysis
Click on the Segments in the Pie Chart to learn about the Strengths, Weaknesses, Opportunities and Threats to the Insulin Market!
Strengths
• Reduces technological barrier to entry for new manufacturers.
• Able to disrupt the insulin supply market – new suppliers will not have to mitigate R&D expenses and can focus on lower prices than the established brands.
• Open-source registration of Single-Chain Analogue prevents patent hoarding by large corporations.
Weaknesses
• Does not generate a revenue stream by itself.
• Requires willing manufacturers to invest in equipment.
• Complete success requires public support and legislative changes, which are notoriously hard to achieve.
Opportunities
• Chance to expand open-source protein manufacturing beyond insulin to other expensive biopharmaceuticals.
• Plenty of generic manufacturers that would willingly enter the insulin market if it was ‘easy’.
• The Indian and Chinese governments stand to gain a lot from this business model – increasing the chance of public support!
Threats
• New manufacturers using our bacteria will still be vulnerable to a price war after setup.
• ‘Big 3’ pharmaceutical companies may be forced to attempt to shut down distribution if it threatens their profit margin.
• FDA/EMA biosimilar approval is extremely expensive and can be drawn out for years.