No one knows life sciences & healthcare like we do
India Overview 3
Segments of LSHC
13
rd
8
th
Largest by volume
Largest
1,000Cr
Testing Labs VC fund
by value
India Market Overview
GoI’S Pharma Vision 2020
LSHC landscape is dominated by Bio-tech, Pharmaceutical’s & Clinical Trial Industries
Making India a global manufacturing hub by incentivizing bulk manufacturers & reducing API Imports
Key off-shore market for Clinical Trials, Research & Development
Diagnostic Agents & Combination Products Implantable Devices Imaging, Diagnostics & Capital Equipment Consumables & Long Term Care Equipment, Wearables
PHARMACEUTICALS
MEDICAL DEVICES
LIFE SCIENCES & HEALTHCARE INDUSTRY
Organizations
Organizations
GLOBAL OVERVIEW
$
PHARMACEUTICAL
BIO-TECHNOLOGY
MEDICAL TECHNOLOGY
HEALTH CARE SPENDING
$959 BILLION
$232.5 BILLION
$349 BILLION
5.3% ANNUAL
10%
2.4% growth rate Leading area Oncology
9.6% growth rate Leading area Autoimmune infectious diseases
2.6% growth rate Leading area in-vitro diagnostics
Increase expected over next 5 years Comparative health care spend in Euros
increase in global population above 65 yrs. due to Increasing life expectancy
of global CAGR b/w generic exports 2015-2020
Generics Bio-tech & Vaccines Patented Pharma Animal Health Consumer Health
Launch of 1,000 Cr VC fund to support start-ups
Pharma market is the 3rd largest in terms of volume globally & 13th largest in terms of value
15%
Focus Areas
To set up 8 mini drug-testing laboratories
Production cost is 33% lower than US
20%
Focus Areas
0.27K 5K 4K 1.3K 1.1K India Germany OECD Russia Brazil
0.70K China
DEMOGRAPHICS
$100 BILLION
National Health Providers Public Hospitals Private Hospitals & Groups Insurers Home Care Consumer Health Care
HOSPITALS & HEALTH SERVICE
CLINICAL TRIALS
Pharmaceutical Companies Contract Research Central Labs Specialist Providers Diagnostic / Pathological Labs
Customers of LSHC
Indian Healthcare Market
Pharmaceutical Industry Overview
Health Care Industry Overview
World’s largest provider of generic medicines
Comprises hospitals, medical tourism, telemedicine and health insurance
Manufacturer of over 60,000 generic brands across 500 categories
Expected CAGR of 23%, to increase three fold to US $372 billion by 2022
PHARMACEUTICALS
MEDICAL DEVICES
BIO-TECHNOLOGY
DIAGNOSTICS
Accounts for 22% of USFDA approved plants
800+
30%
Bio-tech companies CAGR by 2025
15%
CAGR b/w 2009-2015
100% FDI
Bio-Tech Industry Overview
Medical Devices Industry Overview
Comprises bio-pharmaceuticals, bio-agriculture and bioinformatics
Imported products account for about 75% of total revenue
Expected to reach US $100 billion by 2025
800+ manufacturers & traders in India
In top 12 Biotech destinations of the world
To grow to US $50 billion by 2025
LSHC - Life Sciences & Healthcare Industry
For Internal Use Only
For Internal Use Only
PHASE-II Trials
Large studies with many participants. This phase compares the experimental drug or vaccine to a existing standard treatment.
PHASE-III Trials
Involves more people than Phase I as they assess the safety & efficacy of an experimental treatment. Can last several years.
1. Identifies area of investigation / disease / medical deficit. 2. Responsible for identifying hospitals, labs & patients for investigation. 3. Collects required information from patients. 4. Performs investigation / research on information collected & prepare data. 5. Analyze data received & make recommendation for drug development.
Lab Reports*
Medtech Company
Investigational Drug Distributor
2
Examples of the companies 1 - Pfizer, Cipla | 2 - Fisher, Catalent | 4 - Qunitiles, Eurofins | 5 - Icon, PPD
Clinical Research Organization
5
Drug Company/ Sponsor
1
Post-Launch
FDA Approved
(avg. 24 months)
2 months to 7 years
Approval
Testing Equipment, Consumables*
Investigational Drugs CTM (supplies) Returned Drugs*
*Supply chain where DHL Express plays a role For Internal Use Only
Central Laboratory
4
24-48 hrs
Diagnostic Samples Blood, Tissues Empty Diagnostic Kits*
< 72hrs
Hospitals/ Clinics (Patients)
3
For Internal Use Only
Drug's effectiveness & safety are monitored in large, diverse populations.
Trials take place after a regulatory health authority, such as the U.S. FDA approving the use of the drug or vaccine.
Approval & Post-Launch Phase
Clinical trials are scientific studies for durg discovery. They are conducted to screen, diagnose, prevent or treat diseases. Clinical Trials follow strict scientific standards which protect patients.
Clinical Trials â&#x20AC;&#x201C; Drug Development Study
Its starts with Drug Design & Drug discovery then proceeds to animal testing.
PHASE-I Trials
Involves a small group of people to evaluate safety, side effects and how the drug should be administered.
Scientists do experiments for a health condition to find right medical treatment.
Phase III
1,000-5,000
Phase II
100-500
Phase I
(avg. 5 years)
Phase III
20-100
2 to 10 years
Phase II
(avg. 18 months)
Phase I
1 to 3 years
Preclinical
Discovery & Preclinal Phase
Discovery
Drug Development Process & Phases
Sample Organogram Chairman & CEO
CFO
MD
EVP PP
EVP IPDO (R&D)
PresidentHR
COO
EVP FTO(MFG)
EVPEmerging Markets
EVPEmerging Markets
Pharmaceutical Segment Global OPS
• This industry discovers, develops, produces & market drugs or pharmaceutical drugs • Indian drugs are exported to 200+ countries worldwide • ~40.6% exports to the American continent, 19.7% to Europe, 19.1% to Africa & 18.8% to Asia
Director SCM
• Expected to be 6th largest pharma market globally by 2020 worth US $55 billion
Logistics Mgr. Engineering
AM-Logistic
A.D- SCM API
AD- SCM Formulations
AM-Logistics Imp
Manager SCM
Pharmaceutical
Active Pharmaceutical Ingredients/Bulk Drugs
Branded
Generics
Formulations
Branded
Generics
• Cardio Vascular • Anti-Diabetic • Gastro-Intestinal • Neurological
Supply Chain Opportunities in Contract Research Organizations (CROs) Support the Pharmaceutical, Biotechnology & Medical device industries in the form of research services Many CROs specifically provide clinical-study & clinical-trial support for drugs and/or medical devices Ranging from large, international full-service organizations to small, niche specialty groups Offer expertise service from new drug or device conception to FDA/EMA approvals
Structure of Indian Pharmaceutical Segment
Supply Chain Opportunities in Pharmaceuticals
Inbound
Outbound
Lab to Lab
Supplier
Dangerous Goods
Research & Development
Procurement
Information materials, Investigational Drug or Medical Device, Diagnostic Kit, Temperature Logger
Patient History Human sample, Specimen, Medical report
Consolidated Samples, Third Country movements
Dry Ice, Thermo Packaging
UN Category Shipments
Research Samples Documents
Raw materials Commercial Innovator Samples* Shipments Packaging materials (API – Small Weight & High Value Shipments) Pre Commercial Samples
For Internal Use Only
• Anti-infectives • Respiratory Pain • Gynecology
*Original approved drug created
Logistics
Marketing
Regulatory Affairs
Marketing Materials Dossiers Documents Samples (Filing) Samples
For Internal Use Only
Industry Challenges
• Valued at US $5.2 billion & contributes 4-5% to the Indian health care industry • India has about 750–800 medical device manufacturers in the country • Medical devices are regulated by the Food and Drug Administration (FDA)
Today’s LSHC Supply Chain are managing multiple challenges and priorities
Description / Intended Use
Medical Devices
Key Characteristics of Segment
Examples
Consumables/ Disposables
Long-Term Treatment and Equipment
Implantable Devices & Surgical Equipment
Diagnostic Agents & Combination Products
Imaging, Diagnostics & Surgery Capital Equipm.
Devices or supplies intended for one-time or temporary use for patient care/ treatment
Durable medical equipment used for patient care/ treatment for an extended time period
Surgically inserted or imbedded devices and equipment used in surgeries
Reagents and consumables used in the analysis of assays, as well as all combination products
Capital-intensive machinery, used for diagnosis, analysis of assays, or for surgery
Gloves, Syringes, etc.
Digital Displays, Tooth Implants, Monitoring Equip., etc. Metal rods, etc.
HIV Toolkit, Elize, etc.
Color Ultrasound, 3D Imaging, etc.
Low volume, low value items
Medium price with varying product sizes
Small size at relatively high price
Small size with varying price levels
Large devices with very high price levels
Delivery to hospital warehouses
Urgent shipments uncommon
Extremely high inventory costs due to
Need for increased transparency due to
Delivery to ward more common
- Consignment stock model
Need for temperature control (frozen/ cooled/ ambient)
Aftermarket needs ((emergency) spare parts logistics, technical service)
- Numerous stock points in hospital
Some spare parts and return logistics required
- Kits & implants of various sizes
- High no. of orders
Global Presence
Subcontracting & Relying on Third Party
Mergers
Shift in Product Mix
Creating supply chain complexity and need to enter new markets
Relying on third party viz Airlines, Pickup agents, CHA’s increases transit time for delivery
Opportunity for Suppy Chain integration and process harmonization
Translates in multiple SC requirements including cold chain
Special handling for hazardous & fragile goods
Supply Chain Opportunities in Medical Devices Delivery
Urgent Shipments
Repair & Return
Procurement
Direct To Room/ Hospitals, Ad-hoc urgent shipments, Direct to end customers, Consolidation/ Break-bulk, Cross-dock solutions
Delivery to be made on weekend, Faster clearance
Damaged parts, Raw materials (JIT), Damaged products, Innovator Samples Replenish urgent parts for repairs
No Visibility
Increase of Direct-to Models
Intensifying Regulation
Lack of Visibility, Track & Trace reduces Planning capability
Entering consumer space and shortening order to cash cycle
Is driving need for compliance and control
Dangerous Goods
UN Category Shipments
For Internal Use Only
For Internal Use Only
For Internal Use Only
*SDU - Same Day Uplift
3
<50K INR shipments SDU >50K INR, SDU+1
NIL
CTM – Clinical Trial Materials
IPDO – Integrated Product Development Organization
CAGR – Compound Annual Growth Rate
JIT – Just in Time
CRAMS – Contract Research and Manufacturing Services
OPS – Operations
FTO – Finish to Order
NIL
GOI – Government of India
OECD Countries – Organization for Economic Cooperation & Development (35 countries) SCM – Supply Chain Management VC – Venture Capitalist
Glossary Active Pharmaceutical Ingredient – Any substance or combination of substances used in a finished pharmaceutical product. API’s are manufactured from raw materials thru’ chemical and physical means Assay – An investigative procedure for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity. Eg. Level of thyroid Autoimmune diseases – Condition in which your immune system mistakenly attacks your body instead of guarding against germs like bacteria and viruses Branded – A branded medicine is the original product that has been developed by a pharmaceutical company Biosimilars – It is an identical copy of the original FDA approved product. They are officially approved versions & can be manufactured when the original product’s patent expires Bioinformatics – The science of collecting, classifying , storing, & analyzing of biochemical and biological information. Its done by using software tools & computer for understanding biological data Cryo Cans – Stainless steel container carrying liquid nitrogen Dossier – Detailed collection of administrative, chemical, pre-clinical & clinical information of a pharmaceutical product Note – Information as available in public domain / website
All shipments under cargo mode (SDU+1 day uplift)
FDA – Food & Drug Administration
Mon-Sat Mon-Sat Working hours Mon–Sat: 08:30–21:00 Controlled Ambient Controlled Ambient Controlled Ambient (+15 to +25), (+15 to +25), (+15 to +25), Cold (+2 to + 8) , Cold (+2 to + 8) , Range of TCL Solutions Cold (+2 to + 8) & Frozen (-80 to -20), Frozen (-80 to -20), Frozen (-80 to -20) Cryo Cans(upto -200) Cryo Cans(upto -200) 15 8 TAPA Certification 15 Goods Distribution Practises Goods Distribution Practises (secured network) (GDP Certificate) (GDP Certificate) All shipments under All shipments under <50K INR shipments SDU Customs Clearance cargo mode cargo mode >50K INR, SDU+1 (SDU+1 day uplift) (SDU+1 day uplift) 8 NIL NIL Hubs & Gateways (incl. 4 tertiary gateways) Customer Support
API – Active Pharmaceutical Ingredient
EMA – European Medicines Agency
NIL
Controlled Ambient (+15 to +25), Cold (+2 to + 8) & Frozen (-80 to -20)
Standard Tariffs for Non-TCL Spot Rates for TCL Customer Care Mon–Sat: 09:00–21:00
Premium Tariff for Non-TCL Premium Tariff for TCL Customer Care 24*7 Controlled Ambient (+15 to +25), Cold (+2 to + 8) , Frozen (-80 to -20), Cryo Cans(upto -200) Premium Tariff for Non-TCL Premium Tariff for TCL Premium Tariff for Non-TCL Premium Tariff for TCL
Standard Tariffs for Non-TCL Premium Tariff for TCL Dedicated TCL desk 24*7 Pricing Support
3 3 1 6 5 Cold Rooms in India
200 Niche Markets 150 50+ 232 Wide Coverage (Countries & Territories)
Competitive Advantage
Abbreviations
Formulations – Process involved in combining various chemical substances & active drugs to produce a final medicinal product Generics – drugs for medical use, which are produced by many companies, rather than by the companies that invented them Oncology – Study and treatment of tumors Reagents – A substance or mixture for use in chemical analysis or other reactions Specimen – A part of being (humans, animal, plants) taken to perform a study Vitro diagnostics (IVD) – Medical devices and accessories used to perform tests on samples, (e.g., blood, urine and tissue that has been taken from the human body) For Internal Use Only
DHL Express (India) Ltd. 8th Floor, Unit – 801-A Silver Utopia Cardinal Gracias Road Andheri (East), Mumbai – 400099 Maharashtra, India Information provided is strictly For Internal Use Only LSHC Sell Sheet Ver 1.0 / Dec 2018