Profil Industri Farmasi di

masa depan

Pengantar Farmasi Industri

 AGENDA
 Profil & tantangan Industri farmasi Dunia
 Key drivers of change
 Future Scenarios

 Profil & tantangan Industri farmasi Indonesia

 Indonesia Pharma Market trend
 Arah perkembangan industri farmasi
 Lean Manufacturing- PAT
 DDS, Innovative Dosage forms
 Improve Logistics and
Transportation effectiveness

DC Surabaya
DC Jakarta

Transportation Modes :
Biaya Delivery Menjadi
Land Sea Air Tinggi
 Improve Logistics and
Transportation effectiveness

• Availability
• Acessibility
• Affodarbility
 Peta Persebaran Industri
Improve Logistics and
Transportation
effectiveness
di Indonesia Distribution
Challenges
Kalimantan Sulawesi

3,75% 7,17%
Maluku & Papua

0,96%

Sumatera

12,54%

Jawa

67%
Bali, NTB, NTT

8,63%

Hingga tahun 2009, penyebaran industri Indonesia masih terpusat di Pulau Jawa
dimana mencapai 67% dari seluruh industri yang ada di Indonesia
5
Industri Farmasi : 95% di Jawa
Key Drivers of Change in World Pharma Industry

“Kegagalan”
Changing Consumer Lanndscape &
pharmaceutical R&D Hostile market conditions

Changing Technology Landscape

 Changing Consumer Landscape
 By 2015, the world’s population will be 7.2 billion (most are from
developing countries), … older, ……and more urbanized
 Share of people living below poverty line is decreasing (before USA
Crisis)……???
 New consumer groups are emerging, so are new trends

“Mom-fluentials”
The Ageing of Me, myself & I
Generation C
Population  Custom &
Young Ethnic Customer made
 Drug related Socio-cultural and Lifestyle issues (2)

Back to nature (Green Environment) Shifting from "Institutional help" to

"Self help"

A shift to newer and

more expensive drugs

An increase in therapeutic coverage

CHANGING CONSUMER LANDSCAPE

Global Environment
 Drug related to Regulation issues

Generic name must be Maximum retail price must Branded generic drugs price
specified on the package at be Legal
printed onissues
the packaging reduction
the size of at least 80% of
the brand name’s font size

Tighter regulations for traditional Price control

drugs and medications
 Changing Technology Landscape

Nanotechnology Key technology areas Information Technology

Material Science Genomic and

Biotechnology
• Material science
• biodegradable materials

• active / intelligent packaging

• Material science

• microencapsulation

• taste masking

Taste
• Particle engineering
• nanotechnology
 Applied Areas of Technology
• Biotechnology
Applied Areas of Technology
• Information Technology
• RFID in packaging
 “Kegagalan”
Pharmaceutical R&D
Hambatan Kemandirian Farmasi Nasional
Rantai Nilai Produk Farmasi Secara Keseluruhan

Terhambat Tidak maksimal

API (Bahan Distribution &

R&D Clinical trial Intermediate Baku) Formulation Manufacture Export

Iklim R&D yang tidak >95% bahan baku farmasi Produksi produk inovatif yang Ekspor farmasi
kompetitif impor tidak berkembang yang tidak
maksimal
 R&D Spending vs. NMEs Approved
 R&D productivity: Increasing R&D Spending,
Less NMEs & New Biologics Approved

Pharma R & D
product gap

Pharma R & D
Regulatory gap

Pharma R & D
 Global Market Overview

 Market shift:
 Reduced contribution of new products
 New product (+25-35 Billion) ≠ loss of patent protected
products (> USD 39 billion: 16 billion in 2007 + USD 23 billion
in 2006, incl. antipsychotics, calcium antagonists and beta-
blockers) → generic erosion.
 Fewer innovation, fewer NAS/NME
 Specialty and niche product → greater role.

 Further cost containment initiatives →

regulator/payers/consumers are more carefully weighing the
risk/benefit factors.

Pharma Market
Future product portfolio strategies (Biotech)

Pharma R & D
 Future Scenario
Global Pharma Industry

“Kegagalan”
Changing Consumer Lanndscape &
pharmaceutical R&D Hostile market conditions

Changing Technology Landscape

Global Pharma Market - Future Scenarios
 Global Pharma Market
~ Future Scenarios
1 2
 Scenario 1: Age of the Super Companies
 Dominance through M&A and by ‘sweeping up’ innovations
 Only large companies can afford to compete for the most
expensive marketing channels
 Few biotech are allowed to grow maturity & mid-tier
companies struggle to survive in niche markets
 Scenario 2: Pharmacos Turn to Consumers
 NP development & launch but cost containment worsen &
payers refuse to pay high prices for NP
 Rely on high priced blockbusters to maintain size → have to
seek alternative payers: patients
 Consumer-oriented marketing becomes critical.
 3 4 Global Pharma Market
~ Future Scenarios
 Scenario 3: Biotech Take Control
 Pharmacos fail to procure sufficient numbers of NP to maintain
current sales levels → increasingly reliant on biotechs to
supply R&D, but biotechs are becoming more independent →
pharmacos are reduces to being marketing partners to the
biotechs.
 Scenario 4: Death of Big Pharma
 Unable to launch sufficient numbers of new products → profit
& stock price 
 Unable to make sufficient investments in new R&D & return on
existing products 
 Pharmacos fail as R&D engines and are unable to adapt to the
challenges of the new marketing environment
 Current situation and trends
(Resume)

 “mega-blockbuster” strategy is unsustainable due to: off patent,

generic competition and fewer new “mega-blockbuster”
 Difficulty in generics due to price erosion & increased levels of
competition
TRENDS
 DDS:
Targeted medicine: oncology
New drug technologies: biochips, anti-sense tech., Nanotech
 Biotech is the fastest growing sector in the drug industry
 Personalized medicine will radically transform the nature of
pharmaceutical industry
Gene Therapy, Stemcell

Pharma R & D
 Indonesia
Pharma Industry
Global Pharma R&D, The Biggest
Spend Across Industries

Global pharma R&D

Rp 2.237 T spend 2016

CAGR
+2.4% 2016-2022

Biaya menemukan
Rp 36 T molekul baru
 Uji Klinik Adalah Biaya Terbesar Dari Seluruh
Rangkaian R&D di Bidang Farmasi

(3)
 Peluang menuju Industri Farmasi HULU
Perlu insentif pendorong TANPA mengganggu ketersediaan

Obat yang Beredar Obat di JKN

32
16.484 KELAS TERAPI

OBAT

603
ZAT AKTIF
1.058
ZAT AKTIF
1.043
BENTUK
SEDIAAN
Pharma Market (2005)-Bill.US$
400 365

300

200
World market
100 Indonesia Market
2,59
0
2005
World market 365
Indonesia 2,59
Market

Pharma Market
 Pharma market Indonesia (Rp.Triliun)

30

25

20

OTC
15
Ethical
10

0
2003 2004 2005 2006* 2007*
OTC 6,637 8,159 9,014 9,206 9,619
Ethical 10,763 12,657 14,681 13,957 14,747
Growth : +13,2% +19,6% +13,8% - 2,2% + 5,2 %
Pharma Market
 Indonesian Market Overview
Total Market
Pharma Market by Segments

30,000,000

25,000,000

20,000,000

MIDR
15,000,000

10,000,000

5,000,000

0
MAT ~ 03/2003 MAT ~ 03/2004 MAT ~ 03/2005 MAT ~ 03/2006 MAT ~ 03/2007
Periods

TOTAL PHARMA Ethical OTC

Pharma Market
 Indonesian Market Overview
Total Market
Pharma Market by Corporations

4,000,000

3,500,000

3,000,000

2,500,000

MIDR
2,000,000

1,500,000

1,000,000

500,000

0
MAT ~ 03/2003 MAT ~ 03/2004 MAT ~ 03/2005 MAT ~ 03/2006 MAT ~ 03/2007

Periods
KALBE GROUP SANBE DEXA MEDIC A GROUP TEMPO GROUP PFIZER GROUP
SOHO GROUP KIMIA FARMA GROUP SANOFI-AVENTIS GRP BAYER GLAXOSMITHKL GROUP

Pharma Market
 TIPE NEGARA INDUSTRI FARMASI

A Negara yang memiliki industri farmasi skala besar dan terintegrasi

Berbasis riset yang kuat dan innovative

B Negara yang memiliki industri farmasi skala menengah

Berbasis riset kuat dan innovative, pemasaran utamanya lisensi

Negara yang memiliki industri farmasi dengan skala kecil

Tidak punya infrastruktur untuk R&D, hanya melakukan manufaktur
C produk yang ditemukan oleh negara industri tipe A&B
C1: Dapat membuat bahan baku
C2: Tidak Dapat membuat bahan baku

D Negara yang tidak memiliki industri farmasi, pengadaan obat hanya

dengan trading (import obat jadi)
 Tipe Negara Industri Farmasi Dunia

Tipe A TIPE B TIPE C1 TIPE C2 TIPE D

Aktifitas indust: Aktifitas Indust: Aktifitas Indust: Aktifitas Indust: Aktifitas Ind:
Discovery Discovery
Development
Development Raw Mat’l Raw Mat’l
Raw mat’l Manuf Manuf
manuf Formulation Formulation Formulation Marketing/
Formulation Marketing/Distr. Marketing/Distr. Marketing/Distr. Dist
Marketing/distr.
Contoh negara : Contoh Negara : Contoh Negara : Contoh Negara : Contoh Neg :
Spanyol Cina Malaysia Bahrain
Usa Argentina India Brunei Qatar
Jepang Canada Brazilia Nigeria Suriname
Inggris Australia Cuba Srilangka
Jerman Rusia Indonesia
Cina
Perancis
India
 Indonesia(Future)

Indonesia(Now)
 Arah Strategi Industri Farmasi Indonesia

Industri Produk Baru

Farmasi • Formulasi “me too”, BA/BE
• Pengembangan Produk lisensi
• OTC, Natural Prod, Health food
• DDS /Innovative Dosage Form
• New Molekul??

• UU Paten Process Produksi

•Harmonisasi • Lean Factory- PAT
•Price control • Toll Manufacturing
•CGMP
Merger & Going
Regional
Lean Factory approach

•Lean Approach
•PAT
•New Equipment
 The Changes in
Pharma Manufacturing

 In the 70s the main challenges was the volume increases,

nowadays cost cutting is the top issue
 Nowadays companies strive for economy of scale
 Until lately Rx-, Generics-, OTC- and Contract-Manufacturing
have been performed under the same roof, nowadays separation
is the goal
 The future was supposed to provide us with highly automated
unmanned ghost-factories, in fact the beauty of simplicity is
emerging instead

Reference/source :Symposium : German Technology for The Pharmaceutical Industry

Singapore, November 22-23, 2001
 “ Lean Factory” Approaches (1)
The future will ask for “dedicated” facilities :
 Every factory plays it’s specific roles
 Dedication means focusing, or : the “one fits all” -
approach is out
 Dedication means also : Specializing on one or two
basic dosage forms and thus reaching economies of
scale
 Cost issues are the drivers in the future rather than
unlimited flexibility or GMP
Reference/source :Symposium : German Technology for The Pharmaceutical Industry
Singapore, November 22-23, 2001 Pharma technology trend
 “Lean Factory” Approaches (2)

 Dosage form dedicated (solids, liquids, etc)

 Product range dedicated (OTC, Generics, Rx)
 Volume dedicated (large / small volume)
 Production step dedicated (formulation,
packaging)

Reference/source :Symposium : German Technology for The Pharmaceutical Industry

Singapore, November 22-23, 2001 Pharma technology trend
 Vertical or Horizontal ?

 In SDF manufacturing there was a revolution ongoing :

“The gravity flow concept”

 It was not only the gravity approach, but also the higher degree of
automation / mechanization which was introduced compared to previous
concept
 Vertical or Horizontal ?
the majority of the new factories for manufacturing tablets and
capsules have been planned and realized in a vertical model

WHY ?
 Gravity flow is a key issue in this context
 Dust-free handling is another item
 Minimizing the GMP-area is a goal, and
 Cleaning efforts are either trigger or consequence
A cross-check vertical vs horizontal
with dedication approaches
Dedication Horizontal Vertical
approach

Product range Generics OTCs

Volume Small Large

Conclusion vertical vs horizontal
Go vertical ... for Go horizontal ... for
 new  existing
 large scale  small scale
 mono product  flexible
 common substance  highly potent
... facilities ... facilities
 Few innovation in production equipment ?

Which “ground breaking” innovation has come up in our industry

in the last 10 years ? Not many!
 Single-Pot Granulation + Microwave drying
 Weighing automation is introduced (AZO)
 Tablet-presses are washable (Fette, Ima)
 Fast change over : detachable turret, tool-less setting down/up
 Continuous techniques for granulation (Gerteis) and
coating are coming up and ... dying away

Pharma technology trend

Process Analysis Technology
(PAT)
Non destructive in process Control
(on-Line)
Shift the Manufacturing Paradigm – Process Analytical
Technology

Process C ontrol Philosophy - Paradigm Shift

Conventional approach - lab based
End of phase testing of quality, to reduce the risk in
m oving to the next stage

O btain raw Mix active and Press tablets Package

m aterials excipeints

P.A.T approach - process based, at-line or on-line

O btain raw Mix active and Press tablets Package

m aterials excipeints

Continuously or m ore frequently test quality during each

phase, to rem ove the risk in m oving to the next stage

Pharma technology trend

 Benefits of PAT
 Conventional methods give product which is fit for
intended use, but…
 Advanced control gives
 better batch to batch consistency
 better quality (less impurities)
 fewer reworks/rejects
 better productivity
 lower cost
 improved process understanding
 faster response times

Pharma technology trend

On- line NIR bin blender

Battery RF Module

Fibre optic

NIR Instrument

Reading Head

Pharma technology trend

 Automated tablet analysis
Weight
Thickness
Hardness
Dr S Pharmatron

NIR
Identity
Potency
Uniformity
Bruker
INNOVATIVE DOSAGE
FORM- DDS
•Oral Drug Delivery
•Inhaled Drug Delivery
• Injectable Drug Delivery
•Transmucosal Drug Delivery
•Transdermal Drug Delivery
Drivers of DDS Innovation
1.ORAL DRUG DELIVERY
Safest, most convenient and most economical method of drug delivery, Tends to be applied
across a wider range of indications than other technologies
Major therapeutic applications : cardiovascular, CNS, respiratory, oncology

 Main types of oral technologies :

1.rapid dissolving & taste masking tablets to overcome patients’

difficulties in tablet administration (e.g Zydis technology)
2.controlled, sustained and chronomodulated release tablets (e.g
SkyePharma
Geomatrix technology, ALZA’s OROS delivery system)
3.enhanced absorption technology, used for oral delivery of macromolecule

Pharma technology trend

 1.a. Fast Dissolving Tablets
 Fast dissolve (< 1 minute, without water), good taste
 Target :
 children, elderly and patients who have difficulty swallowing tablets or liquids
 patients with persistent nausea, vomit, who are traveling or who have no access to water

Pharma technology trend

1.b. Soluble Film Technology

 Good prospect in the nutraceutical industry

 wide range of film technologies, from quick dissolve strips to
slower dissolving strips (up three hours)
 Great application:
 pain relief
 diet product  contained an ingredient providing satiation & also
made mouth feel fresh

Pharma technology trend

2.Inhaled drug delivery
 Number of patients using inhaled treatment 50 million
 current application : local ( treatment of respiratory condition )
 Future application : systemic pain management, cystic fibrosis, diabetes,
neurogical condition,multiple sclerosis, Cancer, infection and
inflammatory disease (macromolecules peptide and protein ).
Device for inhaled drug :
1. Nebulizer
2. Metered dose Inhaler
3. Drug powder Inhaler

Pharma technology trend

Selected leading product utilizing
inhaled drug delivery system

Pharma technology trend

 3.Injectable Drug Delivery

 Injectable DDS is the only viable drug delivery method for

large molecular weight compounds of low potency (e.g.
monoclonal antibodies).
 Injectable Formulation :
 Needleless injection
 Long acting/sustained release injection
(matrix, PEGylation, depot)
 Liposomal injection

 Major therapeutic Applications :

anti-infectives, anti-cancer, anesthetics

Pharma technology trend

Selected leading product utilizing injectable
drug delivery system

Pharma technology trend

 4.Transmucosal Drug Delivery

 Advantages : avoiding hepatogastrointestinal clearance,

increased bioavailability compared with transdermal
drug delivery, ability to start and stop administration
quickly.
 Transmucosal formulations : buccal, nasal, pulmonary,
rectal, vaginal.
 Exciting innovations in buccal delivery is Generex’s
system, a drug is administered via metered dose oral
spray for absorption through the mucous membranes.
 Oralin is the first transoral insulin to be launched.
 The development of nasal vaccines is a promising
approach to the prevention of infectious disease.

Pharma technology trend

 Selected leading product utilizing
Transmucosal drug delivery system

Pharma technology trend

 5.Transdermal Drug Delivery
 Delivery route : local and systemic
 Advantages :
Reduces dosing frequency to provide better compliance
Easy to remove if no longer needed
Prevents any dose-dumping possibility
Easy to terminate administration and has less side effects than oral dosage
forms
• Transdermal formulation :
Passive : reservoir with rate controlling membrane, drug-in adhesive systems,
solid matrix
Active : iontophoresis, sonophoresis, electroporation, heat or thermal energy,
microneedles
 Major therapeutic applications :
Hormone Replacement (testosterone, estradiol), Angina (nitroglycerin), Pain
relief (fentanyl), Hypertension (clonidine), Motion sickness (scopolamine),
Smoking cessation (nicotine), Depression (selegiline), ADHD (methylphenidate),
CNS disorder (rotigotine).

Pharma technology trend

 Future Technologies :
Niche and emerging drug delivery

 Gene delivery : viral based vector and non-viral vector (cationic

lipid based).

 Pulmonary drug delivery : as a way to deliver gene based

therapies.

 Advance topical drug delivery : development of improved

absorption enhancer.

 Implantable drug delivery : usage of bioerodible technology, iMEDD

(nanoporous silicon membranes).

 ‘Smart’ Microchips for controling release of therapeutic substances