Pharma Industry.pptx

8/14/2019 Pharma Industry.pptx

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PHARMA INDUSTRYVipul Murarka

Vibhuti Sharma



Global Pharma industry under serious pressure: large

no. of patent expiration, thin pipeline of new drugs,regulatory challenges and pricing pressures

Shifted focus on India along with China, Brazil &

Russia- spearhead growth

Growth in developed markets will slow down,emerging markets are promising

Global View



Evolution of Indian Pharma Industry





Segments





Contract Research andManufacturing Services (CRAMS)

Major Pharma companies outsource their manufacturingwork to low-cost centers such as India

To reduce cost while focusing on drug-discovery andmarketing themselves

Also outsource part of their research activities to some ofthe Indian pharma companies.

Over the last few years CRAMS has emerged as a majorfocus area for many of the Indian Pharma companies

Examples include companies like Divi’s Labs, Jubilant LifeSciences etc.



Formulations

APIs are responsible for medicinal effect of a drug, wecannot directly consume an API due to different reasons like

stability, taste, odour etc.

APIs are combined with certain substances called excipientsto form the final drugs or formulations which are suitable

for human consumption.

Continuing the example given above, Crocin is aformulation. Companies like Sun Pharma, Cipla, Dr.

Reddy’s etc. are examples of companies manufacturingformulations.



BioSimilars

Manufactured biopharmaceuticals that partially mimicproteins naturally present in the body

Result of biotechnology

Could potentially become important long-term growth

driver for the generic pharmaceuticals industry

Global annual sales opportunity rising to as much as $10 bnby 2015 (once patents for several biologics expire)



Where does India stand



The Indian pharmaceuticalsindustry revenues areexpected to rise at a CAGR of17.8 per cent to USD36 billionduring 2008–16

During the same period, therevenues from prescriptiondrugs are expected to expandat a CAGR of 18.2 per cent toUSD29 billion

Where does India stand



Generic Drugs

Drugs marketed under their chemical name withoutadvertising

Subject to the regulations of the governments of countrieswhere they are dispensed

Available once patent protections afforded to the originaldeveloper have expired

Once available, market competition often leads to reductionin prices to make available to mass market



OTC Drugs

Sold directly to a consumer without a prescription from a

healthcare professional

Elected by a regulatory agency to ensure that ingredientsare safe and effective when used without a physician's care

Usually regulated by active pharmaceuticalingredients (APIs), not final products.



Patented Drugs

Patents are issued on novel pharmacological compoundsquite early in the drug development process

Patent lifetime differs from country to country, and typicallythere is no way to renew a patent after it expires

Eg. In April 2013, the Supreme Court denied patentprotection to Novartis’s application covering a betacrystalline form of imatinib —the medicine Novartis brandsas Glivec, used to treat chronic myeloid leukaemia (CML)cancer.

On the grounds: modification by Novartis did not satisfy the

standard of inventiveness required under Indian patent law.



ExportsPatented

DrugsGenericsMarket

OTC Market Cost Efficiency Competency

Acceptability Accessibility Affordability

Epidemological

Factors

Government

Policy

Drivers of Pharma Industry



Exports

Pharma companies are capitalizingon exports in regulated and

semi regulated markets

India is the largest producer ofgenerics across the globe;

20% of global exports

Exports have increased at CAGR of26.1%to $10.1 bn during FY 06-13



Following introduction of product

patents, MNCs to launch patenteddrugs

Growth in number of lifestylediseases could boost the sale ofdrugs

Launch of Patented Drugs



Generics

India is the largest producer of generics across the globe;20% of global exports

Generics market expected to reach $26.1 bn by 2016.In 2011, it was $11.3 bn



In 2009, OTC market was worth $1.8 bn

By 2020, at a CAGR 0f 18%, expected to reach $11 bn

OTC Market

D R I V

E R S



Cost Efficiency

• Labour costs 50-55% cheaper

•

Cost of setting up a plant is40% lower



India has the largest number of FDA-approved plants

outside the US

India has 2,633 FDA –approved drug products

India has 546 FDA-approved company sites and 857companies having market authorization withUKMHRA

Competency



Rising level of education

Patients showing greater propensity to self-medicate;boosting OTC

Acceptance to biologics and preventive medicines

Surge in medical tourism

Acceptability



>$200bn to be spent on medical infrastructure in next

decade

New business models to penetrate tier-2 & tier-3 cities

Increasing access to lower income segments due togovt initiatives eg RSBY

Accessibility



Over 650 mn people to be covered by health

insurance by 2020

Govt-sponsored programs to provide health benefitsto >380mn people by 2017

By 2017, govt plans to provide free generic medicinesto half the population at an estimated cost of $5.4 bn

Affordability



Patient pool expected

to increase over 20%

Increasing prevalenceof lifestyle disorders

Epidemological Factors



Government Policy





Case Study - Cipla



CIPLA





Trends in Pharma Industry



Trends in Pharma Industry



Rural Market

The Opportunities are in



Initiatives by the MNCs



What needs to be done



How will it look in 2020



Documents

Pharma Industry.pptx