Estimated pharmaceutical market growth 2015

The Indian Pharma Market

The Indian market projected to grow at a CAGR (compound annual growth rate) of 14-17 % over 2012-16 is now among the top five pharmaceutical emerging, or 'pharmerging' , markets. India is placed a tad lower in terms of growth rate to China, which is expected to register a 15-18 % growth.

The pharmerging markets including Brazil, Russia, Mexico , Turkey, India, China and others are expected to register a CAGR of 12-15 % over 2012-16 , slightly lower than that of the previous period (2008-12 ).

The year 2012 closed with a growth of 12%, lower than the previous year's growth of 16%, according to data culled from research
firm IMS Health. Overall, IMS has forecast that the pharma market will grow at a CAGR of 13.7% between 2011 and 2016, with this year's growth pegged between 11-15 %. Total spending on healthcare , which accounted for 4.1% of GDP in 2010, will continue to increase at double-digit rates, driven by a combination of rising incomes and a commitment to raise levels of public funding for the sector,

Global Pharma Arena

# India is an immerging market

Global Respiratory scenario The global respiratory therapeutics market was valued at $30.1 billion in 2010 and is expected to grow to $37.4 billion by 2017 at a Compound Annual Growth Rate (CAGR) of 3.1%.

In 2010, approximately 49 million patients received pharmacological treatment for respiratory disorders with the annual cost of therapy being $611 per year.
In addition, the annual cost of therapy for the respiratory disorders therapeutic area is expected to increase at a gradual rate over the following year.
The prescription respiratory world market value is Therapy area world market (MAT/Q3/11) ($bn)

$64.6 billion

Global Respiratory scenario

The drivers hence gives an opportunity for growth in the market whereas the restraints can be worked in to fill the gaps

The Global Burden of Respiratory Disease

Chronic respiratory diseases cause approximately 7% of all deaths worldwide and represent 4% of the global burden of disease; Lung diseases afflict people in every country and every socioeconomic group, but take the heaviest toll on the poor, the old, the young and the weak; Deadly synergies exist between diseases such as tuberculosis and HIV/AIDS, influenza and asthma, COPD and lung cancer; Diseases once primarily found in industrialized countries, such as asthma, COPD and lung cancer, are now major problems in low- and middle-income countries and threaten to overwhelm public health services; Pneumonia kills more than 2 million children under 5 each year one child every 15 seconds -despite the fact that it can be treated effectively and inexpensively;

Most of the 250,000 deaths from asthma each year can be attributed to lack of proper treatment.
Although COPD will be the 3rd leading cause of death worldwide by 2020, it is frequently not diagnosed;

Source : American thoracic society

BURDEN OF RESPIRATORY DISEASES IN INDIA

The two most common respiratory disorders which have been studied included asthma and chronic obstructive pulmonary disease (COPD). Using 2011 census data, an Indian study by S.K. Jindal estimated the national burden of asthma in adults as 17.23 million and 14.84 million for chronic bronchitis. One or more respiratory symptoms were present in 8.5% of individuals. The overall prevalence of asthma (in adults older than 15 years) was 2.05%; for chronic bronchitis (in adults older than 35 years), the prevalence was 3.49%.

Six states (Kerala, AP, HP, UP, Karnataka and WB) account for more than 68 percent of the acute respiratory burden with Kerala topping the list Asthma, COPD and pneumonia are the leading causes of hospitalization among patients with respiratory disorders

Top Global therapeutic classes vis-vis Respiratory scenario

Respiratory agents is the 6th largest therapeutic class Respiratory growth is constantly higher than the market reflecting a growing potential

Top 20 Global therapeutic Categories(2015)

Respiratory agents are expected to remain the third-biggest seller, with a $5 billion to $10 billion

Total spending on top Therapeutic Areas

http://www.forbes.com/sites/matthewherper/2012/07/12/the-global-drug-market-willswell-to-1-2-trillion-while-big-pharma-treads-water/

INDIAs top Therapy segment

TOP Global Brands

Rank Brand Name(s) Generic Name Sales Q3 2012 Change from Sales ($000) Q2 2012 Company(ies) Disease/Medical Use

1 2 3 4 5 6

Nexium Abilify Crestor

Esomeprazole Aripiprazole Rosuvastatin

1,420,907 1,405,226 1,245,527 1,158,353 1,152,261 1,148,611

2.93% 1.89% 10.74% 9.50% 13.45% 2.10%

AstraZeneca

Gastrointestinal disorders Otsuka Pharmaceutical, Bristol-Myers Psychosis, Squibb Depression AstraZeneca, Shionogi Cholesterol Eli Lilly and Company Abbott Laboratories GlaxoSmithKline Depression, Anxiety disorders Rheumatoid arthritis Asthma

Cymbalta Duloxetine Humira Advair Diskus, Seretide Enbrel Adalimumab Fluticasone + Salmeterol Etanercept

7 8

1,066,697 952,068

12.51% 2.02%

Amgen

Remicade Infliximab

9 10
14 23

Copaxone Glatiramer Neulasta

Spiriva Singulair

877,591 832,784
669,882 486,837

9.93% -1.17%
1.31% -62.20%

Filgrastim
Tiotropium Montelukast

Rheumatoid arthritis Johnson & Johnson, Merck & Co., Inc., Crohn's disease, Mitsubishi Tanabe Pharma Rheumatoid arthritis Teva Pharmaceutical Industries, Sanofi- Multiple sclerosis Aventis Amgen Neutropenia
Boehringer Ingelheim Merck & Co. Chronic obstructive pulmonary disease Asthma

TOP RESPIRATORY PRODUCTS,2012

Rank
1

Prodouct
Advair Diskus

Molecule
Fluticasone propionate+salmeterol inh

Manufacturer
GSK

US sales ($) in millions

$ 4887.7

2
3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Singulair
Spiriva Handihaler Symbicort Combivent ProAir HFA Nasonex Flovent HFA Budenoside Ventolin HFA Xolair Fluticasone propionate Pulmozyme Qvar Advair HFA Xopenex Tobi Revatio montelukast sodium Pataday Proventil HFA Asmanex twisthaler Pulmicort respules Atrovent HFA Patanol

Montelukast sodium
tiotropium bromide budenoside+formoterol albuterol sulphate inhalent momentasone furoate Fluticasone propionate albuterol sulphate inhalent omalizumab dornase alpha beclamethasone dipropionate Fluticasone propionate+ salmeterol levosalbutamol Tobramycin sidenafil citrate olopatadine albuterol sulphate inhalent momentasone furoate inhalation powder budenoside inhalation suspension inhalation aerosol

Merk
Boehringer Ingelheim Astra Zeneca Teva Merk GSK Generic GSK Genetech/Novartis Generic Genetech Teva GSK Sunovion Novartis Pfizer Generic Alcon Merk Merk Astra Zeneca Alcon

$3299.7
$2832.1 $ 1299.99 $1139.0 $ 1122.6 $ 1107.6 $1038.0 $ 944.4 $ 714.7 $ 707.4 $ 525.9 $ 458.2 $ 423.1 $ 362.4 $ 336.5 $332.1 $ 323.8 $300.2 $ 299.1 $ 230.9 $227.5 $222.9 $ 212.0 $211.1

ipratropium bromide+albuterol sulphate Boehringer Ingelheim

ipratropium bromide inhalation aerosol Boehringer Ingelheim

26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41

Dulera Albuterol Brovana Veramyst Azelastine HCL Xopenex HFA Astepro Clarinex Triaminoclone Pulmicort flexhalers Patanase levabuterol hydrochloride Perforomist Serevent Diskus Albuterol sulphate/ipratropium Adcirca

momentasaone furoate+ formeterol arformeterol tartarate solution Fluticasone furoate levabuterol tablets azelastine desloratidinetablets/ oral soution budenoside inhalation suspension olopatadine hydrochloride formoterol fumarate salmeterol xinafolate powder tadalafil tablets

Merk Generic sunovion GSK Generic Sunovion Meda Merk Generic Astra Zeneca Alcon Generic Dey GSK Generic Lung LLC

$ 209.2 $188.0 $173.0 $141.4 $141.3 $ 140.2 $126.2 $121.3 $116.2 $116.0 $109.8 $108.6 $98.8 $86.0 $82.4 $77.5

42
43 44 45 46 47 48 49 50

Daliresp
Foradil Aeroliise Ipratropium bromide Rhinocort Aqua Flovent Diskus Zyflo CR Alvesco Levocetrizine dih Alrex

rofulimast
formoterol fumarate budenoside inhaler fluticasone propionate Zileuton ciclesonide inhalation aerosol oteprednol

Forest
Merk Generic Astra Zeneca GSK Cornerstone Sunovion Generic Bausch&Lomb

$71.4
$68.6 $63.5 $60.2 $58.5 $56.9 $54.9 $48 $45.4

Domestic Respiratory Landscape

Respiratory Landscape :Respiratory ailments

Cortecosteroids, Bronchodilators

Asthma, Bronchitis, COPD

Anti-coagulants, Thrombolytics

Obstructive lung diseases Restrictive lung diseases

Lung Surfactants

Pulmonary embolism, hypertenssion, edema

Pulmonary vascular diseases

ILD,ILF,Sarcoidosis

Effusion, Thorascopy, Thoractomy

Pneumothoraxm, Pleural efusion

Pleural cavity diseases

Respiratory tract infections Respiratory tumors

Upper (Common cold, Sinusitosis, Pharyngitis, Tonsillitis, ear infection, Laryngitis Lower- Bronchitis, Pneumonia, TN Otitis media
Anti-histamines, Cold & Cough, Antibiotics

Anticancer, Cancer Chemotherapy

Malignant, Benign

Respiratory Landscape Respiratory ailments Core Respiratory therapy

Cortecosteroids, Bronchodilators

Asthma, Bronchitis, COPD

Anti-coagulants, Thrombolytics

Obstructive lung diseases Restrictive lung diseases

Lung Surfactants

Pulmonary embolism, hypertenssion, edema

Pulmonary vascular diseases

Infant RDS

Effusion, Thorascopy, Thoractomy

Pneumothoraxm, Pleural efusion

Pleural cavity diseases

Respiratory tract infections Respiratory tumors

Upper (Common cold, Sinusitosis, Pharyngitis, Tonsillitis, ear infection, Laryngitis Lower- Bronchitis, Pneumonia, TN Otitis media
Anti-histamines, Cold & Cough, Antibiotics

Anticancer, Cancer Chemotherapy

Malignant, Benign

Respiratory Landscape: Core Respiratory Therapy

Val - 19133 mio ; Gr 20% ; CAGR-11%

Cold & Cough preparations

Val 0.10 mio, CAGR: 37% Val 10835 mio ; Gr 16% ; CAGR-15%

Lung surfactant

Anti asthma

Core Respirator y Therapy

Anti histamine combinations

Val - 814 mio ; Gr-42% ; CAGR- 31%

Sys Corticosteroid s
Val - 4655 mio ; Gr 10% ; CAGR13%

ASTHMA AROUND THE WORLD

The five countries with the highest prevalence of clinical asthma were Australia (21.5%), Sweden (20.2%), UK (18.2%), Netherlands (15.3%), and Brazil (13.0%)

Burden of Asthma in India

Prospect of Asthma in India

Asthma medication
Controllers Steroids, LABA, Theophylline, Leukotriene receptor antagonist,cromones

Relievers: SABA,anticholinergics,theophylline,sh ort course oral steroids

Maintenance therapy- ICS

Beclomethasone,Budenoside,
Fluticasone Source: GINA guidelines

Therapy map for Asthma

Mild Asthmatics

LABA or patient dependent treatment low dose inhaled ICS Leukotriene modifiers

Moderate Asthmatics

Low dose ICS+LABA medium or high dose ICS low dose ICS+ leukotriene modifier low dose ICS plus sustained release theophylline High dose ICSLABA LTRA Theophylline oral steroids Anti- IgE treatment

Severe Asthmatics

Source: GINA guidelines Indian guidelines

Chronic Obstructive Pulmonary Disorder

India also contributes a significant and growing percentage of COPD mortality estimated to be amongst the highest in the world; i.e. more than 64.7 estimated age standardized death rate per 100,000 amongst both sexes as mentioned in the WHO Global Infobase Updated on 20th January 2011 (India 102.3 and China 131.5).

This would translate into approximately 556,000 in case of India (>20%) and 1,354,000 cases in China (about 50%) out of a world total of 2,748,000 annually

Increasing Burden of Diseases and Injuries: Change in Rank Order

Burden of COPD in India

Though Asthma is prevalent, It can be seen that the burden of COPD Is increasing proportionately.

Increasing burden of COPD

Therapy map for COPD

Patient Group
Low risk Less Symptoms

1st Choice
Ipratropium

2nd Choice
Tiotropium OR Salmeterol / Formoterol OR Ipratropium + Levosalbutamol

Alternative
Doxophylline

GOLD 1 or 2 OR Exacerbation 1/yr Levosalbutamol mMRC 0-1 CAT score < 10 Low risk More Symptoms

Tiotropium GOLD 1 or 2 OR Exacerbation 1/yr Salmeterol / mMRC 2 Formoterol

CAT score 10 Higher risk Less Symptoms

Tiotropium + Salmeterol / Formoterol

Levosalbutamol AND/OR Ipratropium Doxophylline Roflumilast Levosalbutamol AND/OR Ipratropium Doxophylline

ICS + LABA GOLD 3 or 4 OR Exacerbation 2/yr Tiotropium

mMRC CAT score 0-1 < 10

Tiotropium + Salmeterol / Formoterol ICS + Tiotropium OR ICS + Salmeterol / Formoterol + Tiotropium OR ICS + Salmeterol / Formoterol + Roflumilast OR Tiotropium + Roflumilast

High risk More Symptoms

ICS + LABA GOLD 3 or 4 OR Exacerbation 2/yr Tiotropium

mMRC CAT score 2 10

Carbocysteine Levosalbutamol AND/OR Ipratropium Levosalbutamol

COPD market is more lucrative

It is forecasted that by 2019 the asthma patients(drug treated) will increase from 31% to 32.4% whereas that of COPD is expected to rise 17.9% in 2009 to 23.9%.

Molecules Of potential

Olopatadine Currently, these molecules have not been launched Top global molecules In India for currently indication of COPD not in and asthma but India occupy a space in the global top 50 Loteprednol Respiratory products

Dornase

alpha

Rofulimast

Zileuton

More Than 50 medicines in Pipeline in COPD

IosmapimodOral p38 kinase inhibitor Formeterol/ fluticasone fixed dose combination

Intense research work is been carried in treatment of COPD.

More than 50 drugs are in pipeline which avails a bigger market in future.

Some molecules in the clinical trials

Canakinuma bmonoclonal antibody

IbudilastPD4 inhibitor

Paclitaxe l loaded stent

Bedoradrin e-SABA

Vilanter olLABA

Interstitial Lung diseases

Allergic Rhinitis Asthma COPD indication is the DARK HORSE of respiratory market

Pleural effusion RESPIRATORY Tuberculosis DISEASES

Summary

Asthma and COPD incidences will be on the rise in India and these markets will be the

growth drivers for Respiratory therapy

Ranbaxy is relaunching its pure respiratory portfolio because of a strong presence in

Anti-biotics forte. Ranbaxy is ranked low in antihistamines and has virtually no presence in the high value cough and cold market
New products are driving growth in the respiratory market Cipla maintains its No 1 position in the bronchodilator inhalation market and Lupin is

No 2
Bronchodilator & Antiasthma solids market has shown a revival in the past few years

after the launch of Deflazacort ,Doxophylline and focus on Montelukast combination