Opportunities in the Pharma/ Biotech Sector 2009 - Market Analysis

by Napoleon Samarasam

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

SUB-SECTORS :: MARKET SHARE :: GROWTH TRAJECTORY

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

SUB-SECTORS :: MARKET SHARE :: GROWTH TRAJECTORY

Sub-sectors of the Pharma / Biotech Industry.

SUB-SECTORS :: MARKET SHARE :: GROWTH TRAJECTORY

List of Sub-sectors

1.

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
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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)

SUB-SECTORS :: MARKET SHARE :: GROWTH TRAJECTORY

Drugs - Classification

Drugs

Ethical Drugs (Patented Small Molecule Drugs)

Biologics ( Biotech Drugs Very Expensive )

Generics ( Patent expired Drugs offered at low prices )

DRUGS CLASSIFICATION :: MARKET SEGMENTATION

Drug Types Global Market Segmentation

DRUGS CLASSIFICATION :: MARKET SEGMENTATION

2007 Sales 663.5 B$

Global Pharma/Biotech Market - $770 billion in 2008

DRUGS CLASSIFICATION :: MARKET SEGMENTATION

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

DRUGS CLASSIFICATION :: MARKET SEGMENTATION

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.

DRUGS CLASSIFICATION :: MARKET SEGMENTATION

Top Therapeutic Categories - India

Top therapeutic segments: gastro-intestinal cardiac therapies. Opthologicals, cardiovascular, anti-diabetic and 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 .!!!

DRUGS CLASSIFICATION :: MARKET SEGEMENTATION

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

DRUGS CLASSIFICATION :: MARKET SEGEMENTATION

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

Drug Discovery Phase of Drug Development

Image Source: Jubilant Biosys

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)

SMALL MOLECULE PHARMA INDUSTRY :: INDIAN SCENARIO

Brand Name drugs Vs Generics drugs

Brand Name drugs have to carry out extensive R & D (preclinical 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).

SMALL MOLECULE PHARMA INDUSTRY :: INDIAN SCENARIO

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!!!

SMALL MOLECULE PHARMA INDUSTRY :: INDIAN SCENARIO

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

SMALL MOLECULE PHARMA INDUSTRY :: INDIAN SCENARIO

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.

SMALL MOLECULE PHARMA INDUSTRY :: INDIAN SCENARIO

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

BIOTECH INDUSTRY :: INDIAN SCENARIO

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 INDUSTRY :: INDIAN SCENARIO

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 Assays Molecular 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 Overall Size ~ 18 Billion USD
SUMMARY :: INDIAN MARKET

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 MARKET

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.

SUMMARY :: INDIAN MARKET

Thank You !!!

Inputs & Suggestions plz
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 smnapoleon@gmail.com Thanks. S.M.Napoleon
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