biotechpharmamarketjuly2009-12529086537122-phpapp01

Opportunities in the Pharma/ Biotech Sector 2009
- Market Analysis

by

Napoleon Samarasam

SUB-SECTORS :: MARKET SHARE :: GROWTH TRAJECTORY

Imbued with Passion... Muscled by Reason!!!

Plans fail for lack of counsel,
but with many advisers they succeed


Sub-sectors of the
Pharma / Biotech Industry.


List of Sub-sectors

Pharmaceuticals sector (Small Molecule Drug Companies)

2. Bio-pharma (Bio-drug Companies)

3. CRAMS (Contract Research & Manufacturing Organizations) Custom Research

4. Biotech Companies working on Industrial Enzymes


Sub SectorsContd..

5. Agri Biotech Companies

6. Bio-informatics Companies

7. Diagnostics Kit Development (Biomedical Assays etc)

8. Lab Research Chemicals & Equipments (Bio-Suppliers Category)


Drugs - Classification

DRUGS CLASSIFICATION :: MARKET SEGMENTATION

Drugs

Ethical Drugs

(Patented

Small Molecule Drugs)

Biologics

( Biotech Drugs

Very Expensive )

Generics

( Patent

expired

Drugs offered at

low prices )

Drug Types Global Market Segmentation


Global Pharma/Biotech Market - $770 billion in 2008
2007 Sales 663.5 B$


Breakup of the Global Pharma Market
$ 770 Billion

Small Molecule drugs accounted for $ 570 billion

biotechnology drugs/biologics accounted for $120 billion

generics for $80 billion of the global market


Top Three Therapeutic categories - Global

The three top therapeutic categories were

CNS drugs at $118 billion,

Cardiovascular drugs at $ 105 billion and

Cancer drugs at $70 billion of sales.

The list of therapeutic categories is quite long a separate one for each type of disease & disorder.


Top Therapeutic Categories - India

Top therapeutic segments:

gastro-intestinal

cardiac therapies.

Opthologicals,

cardiovascular,

anti-diabeticand

neurological drugs.

anti-infective,

neurology,

Cardiovascular

anti-diabetic segments

THERAPEUTIC CATEGORIES

Biotech Drug Types - Global

In Biologics top three categories were

monoclonal antibodies at $33 billion,

Vaccines at $24 billion and

TNF inhibitors at $18 billion sales in 2008.

DRUGS CLASSIFICATION :: MARKET SEGEMENTATION

Global rank of Biologics among top 20 drugs -
( 2008 - 2009 )

Four biologics made the top ten best selling list and seven biologics made the top twenty lists in 2008 ( A very positive trend for bio-drugs)

GOOD NEWS .!!!


The Prognosis::Global Pharma Market 2008- 2012

The global pharmaceutical market is forecast to grow to $929 billion in 2012, an equivalent CAGR of 5.5% over the next four years


An Interlude

A Peek into the different stages of Drug Development

PHASES OF DRUG DEVELOPMENT

Different Phases of Drug Development

Domains Involving Biological/Biomedical Research

Image Source: Biocon Inc

PHASES OF DRUG DEVELOPMENT

Image Source: Jubilant Biosys

Drug Discovery Phase of Drug Development

DRUG DISCOVERY SEQUENCE

Drug Discovery Sequence

Source: Biocon Inc

DRUG DISCOVERY SEQUENCE

1. Core Pharma Industry

Core Pharma companies are involved in making Small molecule drugs.

The Indian pharmaceutical market value will reach as high as US $25 billion by 2015 .

Current exports of top ten Pharma companies alone accounts to US $5.8 billion.

SMALL MOLECULE PHARMA INDUSTRY :: INDIAN SCENARIO

Small Molecule Drug Companies

Around 270 large R&D based pharmaceutical companies in India, including MNCs, government and private companies.

Around 3,000 companies are involved in pharmaceutical production to cater to the market needs. (not all of them are up to international standards though)


Brand Name drugs Vs Generics drugs

Brand Name drugs have to carry out extensive R & D (pre-clinical drug discovery assays, Clinical trials [ Phases 14 ] testing) to test the efficacy/toxicity of the drugs.

Generics drugs are drugs manufactured after a patent expires and are NOT required to do Pre clinical trials . They just directly perform Bioavailability /Bio-equivalent studies (i.e. Phase I of Clinical Trials).


FDA -ANDA (Generics) Approvals for Indian Companies

Year Number

2002 - 21

2003 - 26

2004 - 25

2005 - 52

2006 - 74

2007- 124

2008 - 134

2009 50 (Q1 )

FDA Approval for Indian Drugs on the rise!!!


India Generics Future (A News Excerpt )

PATENT EXPIRY: RICH PICKINGS AHEAD

A boost for the Indian generic industry will come from the significant number of blockbuster branded products many of them first-line therapies that will lose patent protection in the next 5 years in the US. Over 49 such products will be affected by the end of 2013, including Topamax, Effexor XR, Lipitor, Plavix and Cymbalta.

Source : Research Study


Biological Drug Testing in Core Pharma (small molecule drug companies)

Core Pharma developing small molecule drugs perform Biological Testing & Validation as a part of the Pre-Clinical Testing.

Fertile ground for Bioscience research.


2. CRAMS :: Bio-Services

CRAMS - Contract Research and Manufacturing Services.

Overseas Companies have started to outsource their work to cut their cost from 40 70%.

India A favored destination.

~98 Contract Research Organizations (both domestic & global) having operations in India.

CRAMS :: INDIAN SCENARIO

CRAMS :: WORLD MARKET A PROGNOSIS

Involves Biological Testing & Validation

CRAMS :: MARKET SEGEMENTATION

CRAMS market value - India

$0.5bn - 2005

$0.9bn - 2006

$2.7bn - 2010

Currently,80% of the contract work undertaken consists APIs and intermediates manufacturing.

India has managed to attract $360m in drug discovery investment (expected to grow in the near future.)

CRAMS :: INDIAN SCENARIO

Clinical Trials - Drug testing Market

India is a growing clinical trial destination, for MNCs to get approvals to test their new drugs in the country.

No of applications for conducting Clinical trials

100 - 2005

170 - 2006

200 - 2007

350 - 2008

CROs :: INDIAN SCENARIO

Biotechnology in India :: Few Perspectives

The Indian biotechnology sector is one of the fastest growing knowledge-based sectors in India.

Currently, India holds two per cent share of the global market.

BIOTECH INDUSTRY :: INDIAN SCENARIO

Comparative advantages of India

R&D facilities

knowledge

skills, and

cost effectiveness


Indian Biotech market

The Indian biotech market was estimated at $ 2.80 billion USD in 200708

Likely grow at a compound annual growth rate (CAGR) of 30 per cent.

Ranked 4 th in the Asia Pacific region behind Japan, China & Australia.

The sector is poised to generate US$ 1316 billion by 2015.


Biotech Categories Indian Market

Bio-Pharma

Agri-biotech

Bio-informatics

Bio-industrial and

Bio-services

The first three are the most important segments according to their revenue contribution.

BIOTECH INDUSTRY :: CATEGORIES

3. Bio-Pharma industry - India

The bio-pharma industry accounted for almost 70 per cent (of the 2.8 Billion USD) of the overall revenues in 2007-08

Likely to touch US$ 4.60 billion by 2012-13.

Currently more than 40 % of the total 325 biotech companies in India are in the bio-pharma segment.

Products from Fermentation/Animal Cell cultures etc

Growth is expected in the Bio-Generics space

BIO-PHARMA INDUSTRY :: INDIAN SCENARIO

4. Bio-Industrial Segment - India

Includes industry involved in the production of enzymes, and other products for agriculture, nutrition etc.

Industry Size $ 101 Million USD

BIO-INDUSTRIAL SEGMENT :: INDIAN SCENARIO

5. Agriculture Biotech

One of the fastest growing sectors in the industry.

India became the fourth largest adopter of biotech crop in the world, by planting Bt cotton on 7.6 million hectares

The companies that come in the top 20 are all involved in developing Bt hybrid varieties.

Current Size - $ 318 Million USD

AGRI-BIOTECH INDUSTRY :: INDIAN SCENARIO

6. Bioinformatics Companies

A small section is involved in Bio-informatics approaches to help in drug discovery. (studying Structure Activity Relationship of drug-target etc)

$47 Million USD.

Expected to grow considering Indias IT strength

BIO-INFO INDUSTRY :: INDIAN SCENARIO

7. Diagnostics Kit Development

1. Diagnostic Kit Development
Biochemical AssaysMolecular Biology Applications
2. Bio medical Instruments used for Diagnosis like CT,MRI,PET
Not a lot of R & D right now, but expected to Grow.Currently a billion dollar industry . Diagnostics subsectors are Heavily Fragmented.
DIAGNOSTICS :: INDIAN SCENARIO

8.Lab Research Chemicals & Equipments

Customers: Industry & Academia

Current Size:- 3,621 crores (0.94 Billion USD)

Source: Biospectrum

BIO-SUPPLIERS :: INDIAN SCENARIO

Summary :: Indian Industry Market Size (08-09)

Core Pharma Industry 12.3 Billion USD (55K crores)

CRAMS Over 1 Billion USD

Biotech 2.8 Billion USD

Diagnostics 1.19 Billion USD

Bio-Suppliers 0.94 Billion USD

SUMMARY :: INDIAN MARKET

Overall Size ~ 18 Billion USD

Summary :: Indian Industry

Core Pharma Industry

Huge Domestic Market.

Increasing international presence in the Generics space.

Appreciable consolidation across the globe in the last few years.

Ranked 4 th in terms of Volume & 11 th in terms of Global Value share.

CRAMS Increasing Growth in the coming years due to outsourcing & cost reduction by 40 70%.


Summary :: Indian Industry

Biotech A sunrise Industry, Picking up with a growth rate of 30% every year.

Diagnostics Heavily Fragmented. A 25% annual growth rate is expected in the coming years.

Bio-suppliers Domestic & MNCs catering to the growing industry & economy.


Inputs & Suggestions plz

Thank You !!!


Hi,

This is just my small effort to understand the Biotech/Pharma Market in India. I am eagerly looking forward to your feedback. Please do email me your comments at [email protected]

Thanks.

S.M.Napoleon

biotechpharmamarketjuly2009-12529086537122-phpapp01

Documents

market share

market segmentationbreakup

global pharma market

global pharmaceutical

cardiovascular drugs

years drugs classification

cancer drugs

billionsmall molecule