3. Global Biotech Industry
• $90 billion market size.
• Growing 2x faster pace than small chemical
entities (CAGR = 18%).
– 2009: $90 billion vs $650 billion.
– 2010: 50% of approved pharma products will be
biologics.
– 2011: 25% of total pharma sales in US.
– 1/3rd of pipeline products are biologics.
Cancer Antibodies = $18
billion
EPO = $10 billion
Interferon = $8 billion
G-CSF = $5 billion
4. SA Biotech Industry (Medical)
• Import all Biological Therapeutics (No total market
size defined)
– Insulin
– EPO (R140 million/year)
– G-CSF (R40 million/year)
– Antibodies (Cancer)
– Antibodies (Viral)
– Interferons (Influenza)
– Growth Hormones/Hormone Replacement
All imported as final product (Little SA capacity for biological
formulation and filling)
5. SA Biotech Industry (Medical)
• As a result lag not only vs. US, Europe,
China, India but also:
– Brazil
– Cuba
– South Korea
– Malayasia
All of the above have well
developed local manufacturing
of biologics
All have API
Manufacturing
Capacity (75% of cost
of medicine)
6. SA Biotech Industry (Medical)
• Given high cost, not used as first
line treatment despite proven
therapeutic benefits.
• Seen as therapeutics targeting
developed market diseases.
• BUT Diabetes and Cancer
increasing dramatically in
developing markets.
• South Africa and Africa need access
to biologics.
7. Bioclones Group
– Only South African ( & Sub-Saharan African)
manufacturer of Biopharmaceuticals
including API.
– Product Portfolio:
• Repotin® (EPO - Renal Failure/Cancer)
• G-CSF (Cancer)
– Research and Development (Global Patents)
• Personalized Medicine (Forefront of
therapeutic Technology)
• Vaccines (Improved supply and adherence
attributes)
– Significant experience in biological
development (including antibodies) clinical
trials, registration, specialist marketing +
global Biotech network
8. Bioclones Group
• Employment: 16 (4 PhD graduates)
• Skill Set: Majority are tertiary institute
graduates in science (microbiology,
biochemistry, biotech, pharmacy,
engineering)
• Many scientists emigrating because of no
prospects.
• Those that stay enter SA Academia
• Developed Biotech industry provides
alternative skills usage
9. Bioclones Group
• Growth Prospects
– Local manufacture of majority of
biologics (in-licensing).
– Revenue invested in R&D of SA
generated novel technology.
• Personalised Medicines
• Vaccines
• Incremental/next generation biologics (US =
3rd generation)
– SA product launch first as product
needs to be registered in SA first.
10. Contribution to SA Economy
• Employment creation:
Scientists/Pharmacists (Medium level given
automation but not as low as straight
pharma).
• Skills development: Development,
Commercialisation, Manufacture in growing
global industry.
• GDP Contribution: Full local manufacture
= >30 cents per rand sold!
• Access to much needed medicines at SA
costs.
• Security of Supply
11. Challenges
• DoH and Treasury
– Almost exclusively support Multi-
nationals
– E.g RT297 EPO component (R40
million):
– Multinational: 99% (Fully imported)
– Bioclones 1% (Cheaper/Equal Price
despite no volumes – MNC loss
leader?)
EXPLANATION:
– DoH - Doctors requirements
– Treasury – DoH Decision
– No acknowledgement of local status other than
6 points
12. Challenges
• India products next to penetrate market.
– Compete on price (Subsidized products)
– Further eliminate SA manufacturers.
– Destroy SA capacity, know how, SA developed
technology.
– Skills loss (further disincentive for scientists)
SA will never compete in Biotech BUT
biopharmaceuticals seen as medium term future of
medicine, country WILL need biologics as front line
treatment .
Result = Continued trade deficit for pharmaceuticals
13. What Next?
• Export (developing) market becomes more
attractive than SA.
• G-CSF – fully locally manufactured but
uncertain sales uptake given Repotin ®
experience.
• Other biologics – do we bother to buy in
technology and develop infrastructure
when no support from DoH or Treasury
• R&D – Rely on export market revenue for
investment (but this is SA state of the art
technology)
14. Conclusion
• Bioclones remains committed to local
manufacturing and providing SA with life improving
and saving biologics at SA manufactured prices.
• DST and DTI continue to show extensive support.
• DoH and Treasury significantly reducing growth
opportunities and hindering development of local
industry.
Bioclones believes that simply through the
preferential procurement of SA manufactured
biologics, a Biotech industry can be developed
within 5 - 10 years that not only buys in
technology but has established a platform for
SA developed novel technologies with both
local and export potential.
