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Indian Positioning
Biosimilars : Global Trend
Contents
MTR -Highlight
Global Therapeutic Overview
0%
2%
4%
6%
8%
10%
12%
-10% -5% 0% 5% 10%
Anti-hyperlipidaemics
Anti-bacterials
Bronchodilators
Anti-hypertensive
Oncology
Anti-diabetics
Anti-rheumatics
Anti-virals
Bone-calcium regulators
vaccines
Key Drivers
Avastin, Rituxan (Roche),
Erbitux (BMS/LLY/ Merck KgaA)
Glivec (NVS).
Patent Expiries
Taxotere (SAN), Eloxatin (SAN),
Arimidex (AZN), Gemzar (LLY)
Key Drivers
HPV vaccines (GSK & MRK),
Pneumo. (WYE,NVS & GSK) &
Herpes zoster vaccine (MRK). Plus
strong influenza sales.
Key Patent Expiry
Angiotensin II antagonists segment
Diovan (NVS) in 2012, Cozaar (MRK)
2010, Avapro (BMY/ SAN) in 2012
Key Patent Expiry
Lipitor (PFE) in 2011
% Sales Growth: CAGR 2008-14
WW
Mark
et S
hare
%
Bubble = WW Sales in 2014
$70bn
$29bn
$23bn $26bn
$15bn $15bn
$28bn
$37bn
$34bn
Analysis of Top 10 Therapy Areas in 2014, Market Share & Sales Growth (2008-14)
Oncology potentially outperforming market by both volume & value growth in the space
Global Market : Size & Potential
Ma
rke
t P
ote
nti
al
In the worst-case scenario, with an estimated price erosion of biologics of up to 30% , potential market
worth ~$40bn remains very appealing & attractive spread across next five years
Year Estimated Revenue of Patented
Drugs Only Biologics
2010 $23bn $2bn
2011 $36bn $1bn
2012 $44bn $8bn
2013 $22bn $17bn
2014 $14bn $9bn
2015 $16bn $20bn
Total $155 $59bn
2010-2015 : Golden period of Biosimilars space to derive advantages from patent expiry
Mc Kinsey report
As per the latest report, Mc Kinsey & Co. expects the average patent expiry at $39.6bn per annum between 2010-2015 as
compared to just $14.2bn in last decade and $16.5bn per annum between 2016-2020. This indicates that 2010-2015 is a
golden period for Global Biosimilars space
Source : US FDA website, Bloomberg, HDFC Securities Institutional Research
Why Biosimilars : SWOT Analysis
Based upon India Brand Equity Foundation , www.ibef.org
The Biosimilars industry is fast-growing and has a strong economic value proposition . However, there are a number of competitive threats that make a well-developed strategy critical to any company wishing to develop in this sector
Weaknesses Cost of Biosimilars products to consumers in emerging markets is still relatively high unlike small molecules generics . Extensive funding is required due to emerging rigorous regulatory requirements. Lack of widespread awareness and credibility of industry.
Strengths Lower price point and similar effectiveness to originator products. Shorter time to market than originator products. Higher probability of Return on Investment (ROI) than with new product R&D. Due to rapidly increasing healthcare costs, there is high consumer demand for discounted high quality treatments
Opportunities Large and growing market for biosimilar products. Emerging regulatory frameworks provide structured approval guidelines. High-revenue bio-pharmaceutical projects that have less equivalent Biosimilar approved/available in their portfolio
Threats Future regulations for Biosimilars is still being defined Particularly in US ,few Biosimilars have been formally approved , resulting in little precedence for future rulings. The industry will require greater focus on new investments for future growth
Indian Positioning
Biosimilars : Global Trend
Contents
MTR -Highlight
Income Growth
Medical
Infrastructure
Insurance
Penetration
Increased
Prevalence
Others
40%
20%
14%
14%
12%
Ref: IMS world review , McKinsey India pharma demand model-best case
Biosimilars : Indian Positioning
Global pipeline at different clinical stages
Ref: From pipeline to market. R&D Directions.
2009;15(6):4-89.
20
25
25
25
32
38
38
46
82
9
6
20
13
19
31
13
32
68
Brazil
India
Italy
Canada
UK
Germany
China
France
Japan
2005
2015
Top 10 Pharma markets expt. US : 2015
Values in $billion
Drivers for 5X Growth from 2010
Ref. Mckinsey India pharma outlook 2015
Goldmine to be explored
Indian companies to add $20bn by 2015
Value will be
driven by -
Derma.
BloodDis
GI
Resp.
Meta.Dis.
Cardio
Pain,Infla
Infec.
CNS
Onco
66
83
97
137
166
191
204
229
329
831
With Indian : Save Time & Cost
Why – Outsourcing is beneficial?
Outsourcing is in demands in recent years, many major Pharma/Biotech companies have remodeled their traditional drug R&D operations to de-risking their R&D efforts
Latest New Technologies And Services
Pharma/Biotech companies are focusing more on new services such as biosimilar characterization and
antibody screening, and cell-line development primarily through collaboration with specialty biotech CROs.
Focusing On Emerging Markets/CRO
The new model of "more achievements for less cost" has forced many drug companies to investment into
these emerging countries especially true in India and China .
The global Pharma outsourcing industry will experience fast growth in the next five years, $85 B in 2011 to as much as $150B by 2015 with a CAGR of about 12% .
Total CRO market value, which is about $40.5B in 2011 will grow up to $65B by 2015 with a
CAGR of about 13% . The biology-related services, preclinical and clinical development will
account for about 75% of total outsourcing .
Financial Outlook
Focusing On CRO
1.Vertical growth, partnerships (including joint ventures) or
2. Acquisitions with major Pharma/Biotech players .
Indian Positioning
Biosimilars : Global Trend
Contents
MTR -Highlight
Challenges for Sponsor & Strategy via MTR
Challenges Strategy
High development cost
Clinical complexity
Stringent guidelines
Partnership for cost effective development
Well designed trials & protocols
Strong developmental capabilities in India
Development
Sponsor alone
Sponsor with MTR
High promotional spend
Uptake by stakeholders
Market competition
Patent Barriers
Regulatory Barriers
Competition from Brands
Enter marketing agreements
Right product for right indication
Low cost manufacturing
Gain legal expertise
strong product positioning
Gain experience in emerging
markets
Profitability
Marketing
Strengths meter
Technical Barriers
Lack of Manufacturing facilities
Cost Barriers
Early planning & analysis
Team up with companies having expertise
Access to GMP facilities
Manufacturing
Based upon qualitative analysis on dynamics of developed markets
Corporate Office & Biosimilars Research Centre
S
e
r
v
i
c
e
s
Company Overview
MTR was founded in 2005, in Chennai, India.
MTR having a dedicated team of around 150
+ Scientist for R&D, Analytical & Bioanalytical,
Preclinical , Clinical trail for Biosimilars .
MTR is a world’s class global contract
research organization (CRO) dedicated
exclusively to R&D, Pre-clinical, Bioanalytical
and Clinical services for large molecule.
MTR is already a well-established, recognized
CRO in India.
MTR have conducted more than 150 Pre-
Clinical Trial , 12 Clinical trial projects and
750 BA/BE studies for Biopharmaceutical
Products and supported around 180
successful FDA/WHO/EMEA/ANVISA/TPD-
Canada submissions.
CHENNAI - PADI
CHENNAI - PADI
Our R&D centre is spreads over 16,000 square feet for Biosimilar services
CHENNAI - SELAIYUR
Our Selaiyur Corporate/R&D centre
spreads over 45,000 square feet, one stop
centre for Clinical & Bioanalytical services.
CHENNAI - PADI
BioPharmaceutical Services
Specialist Services for:
• Recombinant Proteins & Glycoproteins
• Monoclonal Antibodies
• Antibody-Drug Conjugates
• Biosimilars
• Oligonucleic Acid Therapeutics
• Vaccine
Spectrum of Services
SPECTRUM OF SERVICES
RESEARCH & DEVELOPMENT
PRECLINICAL
BIOANALYTICAL
CLINICAL SPECTRUM
OF SERVICES
R & D
BIO ANALYTICAL
PRECLINICAL
CLINICAL
Ensuring the purity, identity, safety and quality of your biopharmaceutical product is critical to success.
CHENNAI - PADI
Research & Development
Develop to Outsource
Out-license biosimilars after establishing the POC
Synthesis of Biosimilars (Monoclonal antibody, Insulin)-
Structure Identification
Purification
Heterogeneity
Activity
Stability
Manufacturing Process- (Should be optimized to minimize differences between the biosimilar
and innovator) Up-stream process
Downstream process
Develop & Out-license after POC (establish proof of concept and outsource fully or look partnership
for Clinical phase trail & commercialization)
CHENNAI - PADI
Bioanalytical Services
1) Biosimilar Comparability Studies 2) Protein Analysis 3) Stability Testing of Biologics and Biosimilars 4) Biopharmaceutical Process and Product Related
Impurities Analysis 5) Biologics and Biosimilar Product Release Testing
Structural Characterization
Physicochemical Properties
Comparability Studies
Process Residuals Determination
Product Related Impurities
Aggregation Studies
Immunochemistry
Potency Testing
Extractables / Leachables
QC Release Testing
ICH Stability Studies
Method Development & Validation
INSTRUMENTS
Waters Alliance HPLC systems with UV & PDA.
Gas chromatography-Mass spectrometry (GC-MS)
Horizontal gel electrophoresis units of various sizes
Vertical electrophoresis for PAGE & Western blotting analysis
PCR machine; General and Gradient PCR with RAMP rate
Stability chambers.
ACTIVITY
Bioanalysis Services in line with ICH guidelines
CHENNAI - PADI
Bioanalytical Services
Expertise in Protein Analysis
•Immunochemistry Services •Immunochemistry Assays •Ligand-Binding Assays
Bioanalytical Services (cont)
Protein Sequencing by Mass Spectrometry
N-Terminal Protein Sequencing by Mass Spectrometry
Peptide mapping (Xevo TQMS or Q-TOF)
INSTRUMENTS
INSTRUMENTS SPECIFICATION NO OF INSTRUMENTS
LC-MS/MS ( Waters Xevo TQMS, Quattro Micro Mass, API –5500,4000,3200& 3000)
16
ICPMS 01
AB Sciex-Q-TOF 01
GC-MS/HS
01
CHENNAI - PADI
Bioanalytical Services (cont)
MTR has Validated nearly 160 molecules at our Bio-analytical facility which includes
challenging Biopharmaceutical molecules like
Molecules Method Diseases Mechanism Albumin Colorimetric General
Bismuth ICP-MS Minerals
Calcium ICP-MS Minerals
Cholecalciferol LC-MS/MS Health Supplement
Cholesterol Enzymatic Lipid
Estradiol and its metabolite LC-MS/MS Steroid
Ethinyl Estradiol LC-MS/MS Steroid
Growth Hormone Human ELISA Hormone
Hormonal drugs LC-MS/MS Hormone
Niacin LC-MS/MS Vitamin
Omega 3 –Fatty Acids and Esters LC-MS/MS Fatty Acids
Potassium ICP-MS Minerals
Progesterone LC-MS/MS Hypertension
Testosterone GC-MS/MS Steroid
Vitamin D3 and its metabolite- LC-MS/MS Vitamin
19
Preclinical facility in a total area of 7500 Sq.ft .Completed more than 150 studies in compliance
with guidelines.
Registered with )nstitutional Bio Safety Committee – Ministry of Science and Technology,
department of Biotechnology.
Registered with Committee for the Purpose of Control and Supervision of Experiments on
Animals CPCSEA . Ministry of Environment & Forests, Government of India .
ADME Assays Non GLP pharmacokinetics studies Effect of food and Gender difference on pharmacokinetics studies Solubility studies Permeability studies Plasma Protein binding Metabolic stability Plasma stability CYP inhibition/induction studies
Microbiological Studies Microbial Limit Test (MLT) Sterility Test Antibiotics Microbial Assays Antimicrobial Activity Test Time Kill Assay
Preclinical Services
20
Toxicology GLP IND submission package studies Non-GLP discovery studies Acute/Sub acute / Sub chronic
studies In vitro and in vivo genotoxicity Toxicokinetics studies Medical device testing Biological assay.
Pharmacology
In vivo efficacy studies Inflammation & autoimmune disease Metabolic disorders Transfer and validation of new efficacy
models
Bioanalytical Method development & validation Cassette analysis ADME assay screening High throughput LCMS-MS analysis
Preclinical Services (cont)
21
Clinical Services
THERAPEUTIC AREAS OF EXPERTISE
Oncology
Cosmetology
Dermatology
Cardiology
Obstetrics and Gynecology
Diabetology
Gastroenterology
Endocrinology and
Metabolic Disorders
OUR STRENGTH
Investigator Selection
Study conduct
Clinical study monitoring
Clinical trial co-ordination
Clinical trial site training
Submission and approval from DCGI for trials in India
Investigational Product and Material accountability
Tie-up with major hospitals all over India to conduct clinical Trials.
Oncology;
60%
Cosmetology ; 25%
Cardiology; 10%
Others; 5%
Quality Compliance * Quality Assurance systems are supported by our Quality Policy and Quality Manual
Robust SOPs.
Adhere to ISO and GCP compliance
Prompt follow up & resolution
Highly qualified, well trained, dedicated & experienced QA department.
Focused Leadership*
Competent
Cope with rapid growth
Flexibility to undertake out-of-scope activity
Values in MTR that Sponsor Looks For
Communications to Sponsor*
Accurate, Timely
Effective Project Management
Regulatory*
Responsibility / Ownership and Authority
Accreditation from local & Global Regulatory Bodies
Dedicated Research & Development team under
professional leadership
Nationally and Internationally accredited
Central Lab Facility
Experience the true sense of Business
partnership
Helps Sponsor to obtained various NOC from
Regulatory Authorities
Advantage MTR
Transparent systems with sponsors, still maintaining utmost confidentiality
MTR has effectively undergone numerous audits and certificated by various
global regulatory bodies
MTR provide intergraded services for Biopharmaceuticals as well as
customized services depending on the clients need
Contact Us
CORPORATE OFFICE & MAIN SITE
MICRO THERAPEUTIC RESEARCH LABS PRIVATE LIMITED
Rajam Bhavanam, Door No.6,
Kamarajar Salai, Selaiyur, East Tambaram, Chennai – 600 059.Tamilnadu, India
Tel: (91 44) 22390070,71,72 & 64625721
Fax: 044-22390069
Email:info@microtheraps.com
www.microtheraps.com
Research Centre CHENNAI - PADI
Door No.50,51, Balaji Nagar, 3rd Street, Padi. Chennai – 600 050, India. Tel: (91 44) 26548475
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