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CH428:Drug Design and Development

Challenges and Opportunities for the Pharmaceutical Sector: Global and India

Akshay Rao 07012202

Intro to Pharma
Develops, produces, and markets drugs licensed for use as medications Are allowed to deal in generic and/or brand medications and medical devices Are subject to a variety of laws and regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs. Often considered a defensive sector due to high level of regulation

Subsections
R&D Product Approval Patents and generics Marketing Mergers, acquisitions, and co-marketing of drugs (Business Development)

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

Can we capitalize?

Current functioning not good enough Lack of productivity in the lab Spends far more on research and development (R&D) and produces far fewer new molecules than it did 20 years ago
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Other Challenges

Increasing expenditure on sales and marketing Deteriorating financial performance Damaged reputation

But we have Technology!......Right?

At the start of the decade, many people thought that science would come to the industrys rescue and that molecular genetics would reveal numerous new biological targets But the human genome has proved otherwise It is no longer the speed at which scientific knowledge is advancing but the healthcare agenda of companies that is dictating how Pharma evolves
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In India
The Indian pharmaceutical industry is the world's second-largest by volume India is currently ranked as the fourth largest pharmaceutical market in the Asia pacific region behind Japan, China and South Korea. The Indian pharma industry is expected to be ranked the 10th largest market of all the markets in the world by 2015.

In India (contd.)
The Indian pharmaceutical drug production accounts to around 10% of the global drug production The Indian pharma industry revenued US$ 16 billion in 2009 and is expected to reach US$ 40 billion by 2014 India ranks 3rd in Asia in clinical trails with around 350 clinical studies behind China and Japan. The Indian clinical trials market was estimated to be US$ 400 million in 2006

Indian Pharma: SWOT

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Indian Pharma: Growth Drivers

The Indian growing and aged population is expected to reach more than 1.4 billion by 2020
The population in India is even forecast to become larger than China (today 1.3 billion) after 2035, thus becoming the worlds most populous country with 1.6 billion Indians.

The percentage of people aged 65 and above will increase from 4.3% to 6.3% till 2020.
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Indian Pharma: Growth Drivers


The healthcare expenditure in India is expected to increase at around 20% per annum ( it was US$ 44 billion in 2009) Indias per capita spending a year on medicine is expected to increase from US$ 15 in 2009 to US$ 31 in 2014.

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Indian Pharma: Future Drivers

The future growth is expected to be primarily driven by five fundamental drivers


Demographic Factors Penetration Factors % access to medicine
Population growth; Literacy rate; Awareness levels

Macroeconomic Factors Healthcare Expenditure Epidemiology Factors Acute : Chronic ratio


Price premium; Preventive v/s curative GDP growth; Health Insurance; Affordability; Willingness

Connectivity; Electrification; Rural telephony; Doctor reach; Chemist channel

Innovation Factors Novel drugs and technology

Prevalence; Age profile; Gender dispersion; Life expectancy

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Global Challenges

Failing growth Organic R & D is increasingly being viewed as not delivering value Weaker New Drug pipeline and shorter periods of exclusivity

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Global Challenges

Challenging times ahead of drug patent expirations Increasing operational costs Increasing regulatory pressures

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Global Challenges: Creating Opportunities for Indian Pharma

Improving R&D productivity, a high priority for Innovator Pharma Companies


Looking for effective solutions Testing the waters

Exploring opportunities for expanding pipeline while addressing costs


Expanding collaborative strategic alliances / partnerships
Drug discovery experimental programs in various countries Outsourcing of non-core activities on an experimental basis

Looking for new business approaches based on


Leading disease categories Key health issues through demographic data

Indian companies are setting up internal drug discovery programs as well as exploring partnerships with large & medium innovator companies
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Global Issues

From 3rd world to 1st world


The diseases of the developing world increasingly resemble those of the developed world, and greater affluence is making some countries much more attractive markets The markets of the developing world are heterogeneous, and Pharma 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 market opportunities 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 imitation

New Strategic Approach


The investment model used by the capital markets does not work very well for an industry that works to timelines of 10 years or more , and is unlikely to do so unless Pharma re-sets market expectations
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Global Issues

Price Control
Pharma will have to participate in the debate on healthcare funding and demonstrate the value of its products or risk coming under huge pressure to cut the prices of many massmarket 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 2/3rds 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, with serious implications for its future success

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R&D: Molecular Fallout

In one recent analysis of 73 molecules that failed in Phase III, 50% of the compounds that failed did so because they could not be proved effective Compounds with novel mechanisms of action failed more than twice as often as those using established ones Such studies show that the industry is sinking large sums of money in developing molecules whose pharmacological impact it does not comprehend in sufficient detail beforehand
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Process Change: Making The Educated Guess

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The Future??

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Removing Present Roadblocks

Advent of a comprehensive yet lean supply 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 nanoparticles can be treated with an alternating magnetic field to release materials encapsulated in bubbles within the material and thus converted into micro-reactors for the efficient production of thousands of individual doses of tailored biological 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 the time and date at which the medicine has been ingested as well as measuring certain vital signs. The information is then forwarded, via wireless technology, to the patients doctor. Novartis has previously tested the chip on 20 patients who are taking its blood pressure treatment Diovan, with impressive results; the company reported that compliance could be improved from 30% to80% in six months

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References
www.wikipedia.com The Indian Pharma Industry:Danish Intl Business Development group Pharma 2020: The vision (PWC Sector Report and Analysis) Pharma 2020: Supplying the Future (PWC Sector Report and Analysis)

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Thank You

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