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Transcript of Global Pharma
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CH428:Drug Design and
DevelopmentChallenges and Opportunities for the PharmaceuticalSector: Global and India
Akshay Rao07012202
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Intro to Pharma
Develops, produces, and markets drugslicensed for use as medicationsAre allowed to deal in generic and/or
brand medications and medical devicesAre subject to a variety of laws andregulations regarding the patenting, testingand ensuring safety and efficacy andmarketing of drugs.Often considered a defensive sector dueto high level of regulation
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Whats likely to happen?
By 2020, the E7 (Brazil, China, India,Indonesia, Mexico, Russia and Turkey)could account for as much as one-fifth of
global sales
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Can we capitalize?
Current functioning not good enough
Lack of productivity in the lab
Spends far more on research anddevelopment (R&D) and produces farfewer new molecules than it did 20 yearsago
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Other Challenges
Increasing expenditure on sales andmarketing
Deteriorating financial performance
Damaged reputation
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But we have Technology!......Right?
At the start of the decade, many peoplethought that science would come to theindustrys rescue and that molecular geneticswould reveal numerous new biologicaltargetsBut the human genome has provedotherwise
It is no longer the speed at which scientificknowledge is advancing but the healthcareagenda of companies that is dictating howPharma evolves
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In India
The Indian pharmaceutical industry is theworld's second-largest by volumeIndia is currently ranked as the fourth
largest pharmaceutical market in the Asiapacific region behind Japan, China andSouth Korea.The Indian pharma industry is expectedto be ranked the 10th largest market of all the markets in the world by 2015.
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In India (contd.)
The Indian pharmaceutical drug productionaccounts to around 10% of the global drugproduction
The Indian pharma industry revenued US$ 16billion in 2009 and is expected to reach US$ 40billion by 2014India ranks 3rd in Asia in clinical trails witharound 350 clinical studies behind China and
Japan.The Indian clinical trials market was estimated tobe US$ 400 million in 2006
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Indian Pharma: SWOT
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Indian Pharma: Growth Drivers
The Indian growing and aged population isexpected to reach more than 1.4 billionby 2020
The population in India is even forecast tobecome larger than China (today 1.3 billion)after 2035, thus becoming the worlds mostpopulous country with 1.6 billion Indians.
The percentage of people aged 65 andabove will increase from 4.3% to 6.3% till2020.
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Indian Pharma: Growth Drivers
The healthcare expenditure in India isexpected to increase at around 20% perannum ( it was US$ 44 billion in 2009)
Indias per capita spending a year onmedicine is expected to increase fromUS$ 15 in 2009 to US$ 31 in 2014.
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Indian Pharma: Future DriversThe future growth is expected to be primarilydriven by five fundamental drivers Demographic Factors
Population growth; Literacy rate; Awareness levels Penetration Factors % access to medicine
Connectivity; Electrification; Rural telephony; Doctor reach;Chemist channel
Macroeconomic Factors Healthcare ExpenditureGDP growth; Health Insurance; Affordability; Willingness
Epidemiology Factors Acute : Chronic ratioPrevalence; Age profile; Gender dispersion; Life expectancy
Innovation Factors Novel drugs and technologyPrice premium; Preventive v/s curative
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Global Challenges
Failing growth
Organic R & D is increasingly beingviewed as not delivering value
Weaker New Drug pipeline and shorterperiods of exclusivity
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Global Challenges
Challenging times ahead of drug patentexpirations
Increasing operational costs
Increasing regulatory pressures
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Global Challenges: CreatingOpportunities for Indian Pharma
Improving R&D productivity, a high priority for InnovatorPharma Companies Looking for effective solutionsExploring opportunities for expanding pipeline whileaddressing costs
Testing the watersOutsourcing of non-core activities on an experimental basis Expanding collaborative strategic alliances / partnerships
Drug discovery experimental programs in various countries
Looking for new business approaches based on Leading disease categories Key health issues through demographic dataIndian companies are setting up internal drug discoveryprograms as well as exploring partnerships with large &medium innovator companies
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Global IssuesFrom 3 rd world to 1 st world
The diseases of the developing world increasingly resemblethose of the developed world, and greater affluence is makingsome countries much more attractive markets
The markets of the developing world are heterogeneous, andPharma must understand their specific needs
R&D Productive ? Pharma must improve its R&D productivity, if it is to meet the
worlds unmet medical needs and capitalise on the marketopportunities now emerging
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Global Issues
Patents and Laws The legal framework in which Pharma
operates must be altered to promote
innovation and discourage imitationNew Strategic Approach The investment model used by the capital
markets does not work very well for anindustry that works to timelines of 10 yearsor more , and is unlikely to do so unlessPharma re-sets market expectations
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Global IssuesPrice Control
Pharma will have to participate in the debate on healthcarefunding and demonstrate the value of its products or risk coming under huge pressure to cut the prices of many mass-market medicines
Disease Prevention as New Business Vaccines for cocaine addiction, hypertension, Alzheimers
disease,nicotine withdrawal etc Oncology is by far the most significant new therapeutic
area(around 90 therapeutic vaccines for cancer in the pipeline,and more than 2/3 rds of them are in late-stage development)
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Global Issues: Non-compliance
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Global Issues: Patient Adherence
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Pharma Reputation
Unless Pharma improves its reputation, its political,commercial and clinical credibility will be eroded, withserious implications for its future success 22
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R&D: Molecular Fallout
In one recent analysis of 73 molecules thatfailed in Phase III, 50% of the compounds thatfailed did so because they could not be provedeffectiveCompounds with novel mechanisms of actionfailed more than twice as often as those usingestablished ones
Such studies show that the industry is sinkinglarge sums of money in developing moleculeswhose pharmacological impact it does notcomprehend in sufficient detail beforehand
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Process Change: Making TheEducated Guess
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The Future??
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Removing Present Roadblocks
Advent of a comprehensive yet leansupply chain
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Removing Present Roadblocks:Technical Perspective
New Development Technologies Biologics in a Bottle:Insulin, JAK inhibitors etc
New Manufacturing Technologies
Modular production Continuous processing and Automation
Micro-containers with embedded superparamagnetic nano-particles can be treated with an alternating magnetic field torelease materials encapsulated in bubbles within the materialand thus converted into micro-reactors for the efficientproduction of thousands of individual doses of tailoredbiological products
Transgenic Production
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Removing Present Roadblocks:Technical Perspective
New Distribution Technologies Bokode, Dna Fingerprinting
New Patient interface Technologies Proteus Biomedical has developed a miniature digestible chip which can be
attached to a conventional medicine and used to monitor patient compliance.The chip sends a signal to a sensing device worn on the skin, which records thetime and date at which the medicine has been ingested as well as measuringcertain vital signs. The information is then forwarded, via wireless technology, tothe patients doctor. Novartis has previously tested the chip on 20 patients whoare taking its blood pressure treatment Diovan, with impressive results; thecompany reported that compliance could be improved from 30% to80% in sixmonths
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References
www.wikipedia.com The Indian Pharma Industry:Danish IntlBusiness Development group
Pharma 2020: The vision (PWC SectorReport and Analysis)Pharma 2020: Supplying the Future (PWCSector Report and Analysis)
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Thank You