Global Pharma

7/31/2019 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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http://www.wikipedia.com/http://www.wikipedia.com/


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Thank You

Global Pharma

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