Opportunities and Chalengges in Pharma Industry Development to Improve Indonesia Pharma Industry Competitiveness-GP Farmasi
Opportunities and Challenges in Pharma Industry Development
to Improve Indonesia Pharma Industry Competitiveness
06 October 2015
“It is Health that is Real
Wealth and not pieces of Gold
and Silver”
Mahatma Gandhi-
Why Developing Indonesia Pharma Industry?
Social Aspect
Availability, Independency,
and Sustainability of Supply
Economic Aspect
Medication Cost
Optimalization
Devisa Saving
Technology Aspect
Indonesia Herbal & Marine
Potency
Pharma Technology
Acquisition
Contribution to GDP
and Job Opportunity
Current Status Indonesian Pharma Industry
No. of Manufacturers
State Owned
Local
MNC
4
178
24
Value (IDR bio)
45,699
16,388
Share (%)
74.6%
25.4%
Growth vs. LY (%)
6.72%
15.3%
27% of total ASEAN pharmacy market and 73% dominated by local
industry, the only country in ASEAN which dominated by national industry
Source : Kemenkes 2014, IMS Report Q2 2015
Indonesia Pharma Market has hit >60 trillion
MAT Q2 2015: Growth 8.9% (value) or 9.7% (volume)
JKN Implementation
(Unbranded Generics
VOLUME )
Branded Generics &
OTC Price
JKN Implementation
(Unbranded Generics
PRICE )
Rp-USD
Exchange Rate
Source : IMS Report Q2 2015
Hospital Demand
New Product Launched
400
82
In mio IDR
500
80
78
76
300
74
72
200
70
68
100
66
-
64
Productivity Rate per Labor
Source: http://www.ieconomics.com
GDP per Capita
Life Expectancy
Years
Indonesia Expectation Heading 2025
Indonesia Health Care Expenditure as % of GDP
Total Health Expenditure as % of GDP
(2013)
Australia
9.2%
China
5.6%
Japan
9.3%
India
4.0%
Indonesia
2.7%
Thailand
4.1%
South Korea
7.7%
Singapore
4.9%
Malaysia
0.0%
3.8%
2.0%
4.0%
6.0%
8.0%
10.0%
Government shall increase Health Care Expenditure
to 5% of APBN
(Ref. UU Kesehatan No. 36/2009 pasal 171.1)
Source : Pharmaceutical & Healthcare Countries Report Q2 2014, Business Monitor International;
Economic 360 for Indonesia Healthcare Industry, 2011, Frost & Sullivan
Indonesia Health Care Expenditure per Capita
Source : Asia Pacific Healthcare Outlook 2014, Frost & Sullivan
Strong Industry Growth & Future Objective
Indonesia Pharmaceutical National Market Value
500
300
Value T IDR
400
450 T
Optimistic Annual Growth: 20%
GDP Contribution : 1.3-1.5% (2025)
Global
Top
20
200
100
147 T
from
Global
Top
15
2015
2020
2025
Value T IDR
Import Value : +/- IDR 21 T (2013),
dominated by raw material import
needed
Rp 215 T
Indonesia Pharmaceutical Export Value
200
ABCG
Investment
-
300
Commitment
250 T
100 T
Job Opportunity
100
2 million jobs
-
2015
2020
2025
Source: http://www.kemendag.go.id/id/economic-profile/indonesia-export-import/growth-of-non-oil-and-gas-export-sectoral
Rencana Induk Pengembangan Industri Nasional
Peraturan Pemerintah nomor 14 tahun 2015
12
Indonesia Pharma Industry Roadmap Journey
Kick Off Meeting
(16 Apr 14)
Presentation to Dirjen Binfar
(05 Sep 14)
Presentation to Kepala BPOM
(16 Sep 14)
Presentation to Menteri Kesehatan I
(10 Oct 14)
Indonesian Phar
maceutical Indu
2015 - 2025
stry Road Map
December 2014
Presentation in Rakor
Kemenko Perekonomian
(05 Aug 15)
PP 14/2015:
Pharma Industry as
National Industry Priority
(06 Mar 15)
Final version
(17 Dec 14)
Presentation to Menteri Kesehatan II
(12 Dec 14)
Rakor Kemenko Perekonomian – 05 August 2015
Participants: Menko Perekonomian, Menteri Kesehatan, Menteri RistekDikti; Dirjen Kemenkes, Kemenperin, Kementan, Kemenkeu, BKPM, etc
Conclusion:
1. Deputy V Kemenko Perekonomian will develop Peraturan Presiden draft to
support Pharma Industry Roadmap implementation.
The draft then will be distributed to relevant stake-holders for feedback.
2. Deputy V Kemenko Perekonomian will coordinate with Kementerian
Kesehatan, GP Farmasi Indonesia, and relevant stake-holders to form
a task-force to ensure and monitor the roadmap implementation.
National Pharma Pillars to realize the Transformation 2025
INDONESIA PHARMA INDUSTRY AS NATIONAL STRATEGIC INDUSTRY
Vision
1. To become Top 15 World Pharma in 2025 with IDR 700 T market value
Mission
1. To satisfy domestic drugs and medication market, including JKN & KIS
2. To contribute foreign exchange, export & import substitution
3. To master pharmaceutical technology, including R&D and talent pool
JKN & KIS:
Availability, Affordability, Accessibility
Bio-Pharma
15
Vaccine
Export Program & Import Substitution:
Foreign Exchange Contribution
Natural
Chem-API
Collaborative R&D
ABGC forum Alignment
Quality and efficient Manufacturing
Infrastructure to support industry growth
Regulation to support industry
Competent Human Resource
Transformation of Indonesian Pharma Industry
From Formulation to Integrated Pharma Industry
Current
Import (API & Excipient)
Formulation
Manuf.
Dist.
Formulation
Manuf.
Dist. &
Export
Future
R&D
16
Clinical
Trial
Intermediate
API
Pharma API R&D and Manufacturing Scenario 2015 - 2025
PERIOD
API
BIOPHARMACEUTICALS
VACCINE
NATURAL
2015-2018
•
•
•
•
•
•
•
•
•
EPO (Erythropoetin)
GCSF (Granulocyte Colony Stimulating Factor)
Probiotic
Insulin (utk diabetes)
Stem cell protein (Wound care and cosmetics)
Somatropin
EGF (Epidermal Growth Factor)
Enoxaparin (pengencer darah)
•
•
•
•
Dengue (Demam Berdarah)
MR (Measles Rubella)
HB (Hepatitis-B)
Hexavalent (dimulai)
•
•
•
•
Sabin IPV (Inactivated Polio Vaccine)
Rotavirus (dimulai)
Typhoid Vi-Conj
Rabies (dimulai)
•
•
•
•
•
•
•
Dehidro-di-Isoeugenol (Ekstrak Biji Pala)
Curcumin (terkadung dlm temulawak utk liver)
Gingerol (komponen kimia dalam jahe)
Phylantin (ekstrak daun meniran)
Piperin (ekstraksi lada hitam)
Steviosid (pemanis non kalori)
Xanthorhizol (komponen minyak atsiri khas
temulawak)
Zederone
•
2019-2022
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
2023-2025
Blood Fractionation (Albumin,
Immunoglobulin, Factor VIII, Factor IX)
Growth Hormone (hormon pertumbuhan)
Interferon (pelindung tubuh dari berbagai
virus)
Trastuzumab (antibodi monoklonal yang
dirancang untuk bekerja pada target
HER2 positive breast cancer)
Insulin
MAB (oncology)
•
•
MAB (Monoclonal Anti Body)
Insulin analogue
DTaP (Diphteri, Tetanus, acellular
Pertussis)
Hexavalent
MenACWY
New OPV type 2 (for stockpile)
Pneumococcal (vaksin pneumoni)
Rotavirus
Rabies
•
•
HPV (Human Papiloma Virus)
New TB Recombinant
Glucosamin (utk persendian dproduksi
dlm tubuh atau diekstrak melalui kulit
kepiting atau udang)
Omega-3
Resveratrol (anti oksidan alami)
Vinca alkaloid derivates
Isolat gandarusa (kontrasepsi pria dan
wanita)
Isolat alga coklat (wound care)
Isolat mikroba simbion karang laut
(antibiotik)
Isolat Guazuma longifolia
•
•
Andrographolide (anti malaria)
Etil-p-metoksi Sinamat (hasil isolasi
rimpang kencur utk pelindung kulit)
Ekstrak cacing tanah (thrombolisis)
•
Pharma API R&D and Manufacturing Scenario 2015 - 2025
PERIOD
API
NATURAL
CHEMICALS
2015-2018
•
•
•
•
•
•
•
•
2019-2022
Ekstrak sambung nyawa (antihiperkolesterolemia)
Ekstrak temulawak (antihiperkolesterolemia)
Ekstrak seledri (antihipertensi)
Ekstrak kumis kucing (antihipertensi)
Palm sugar
Ekstrak Cinnamomum burmanii
Fitoestrogen (Trigonella foenum-graceum)
Dermifix Wound Healing (Centella asiatica)
• Statin derivates (menurunkan kadar kolesterol:
Simvastatin, Atorvastatin, Rosuvastatin)
• Pantoprazole
• Clopidogrel
• ARV (Entecavir, Tenofovir)
• Beta-Lactam
(Amoxicillin)
• Pharma Salt (garam farmasi)
(NaCl pharma-grade)
• Dextrose pharma-grade
• Lyophilisation substances
• Pen-V
• Pen-G
• Magnesium stearate
• Paracetamol
•
•
•
•
•
•
Ascorbic Acid (vit. C)
Cephalosporin (7 – ACA)
7-AVCA
7-ACCA
7-ADCA
ARV (Entecavir,
Tenofovir)
2023-2025
Healthcare Sector Transform to Become Personalized, Predictive,
and Preventive
Genetic
Mapping
Patient
segmentation
tailored treatment
regimens
Advancements in
predictive and
preventive
medicine
Personalized
Medicine
Healthcare is becoming a precision-based industry...
Source: Frost & Sullivan Analysis
Transformation in Health Sector
FROM
TO
One size fits all
APPROACH
Personalized Medicine
Fragmented, One way
INFORMATION FLOW
Integrated, Two Way
Provider centric
FOCUS
Patient Centric
Procedure – based
REIMBURSEMENT
Bundled, Capitated
Centralized, Hospital-based
LOCATION
Decentralized, Communitybased
Fragmented, Specialized
TREATMENT
Collaborative, Shared
Information
Based on Individual Expert
DECISION MAKING
Based on Protocols and
Analytics
Treating Sickness
OBJECTIVE
Preventing Sickness
(Wellness)
Source: Frost & Sullivan Analysis
Transformation in Health Sector
Global Healthcare Spend
100%
Monitor, 10%
90%
Monitor, 12%
Monitor, 16%
80%
Treat, 35%
60%
Treat, 70%
Treat, 60%
50%
40%
Diagnose, 27%
30%
20%
10%
Diagnose, 19%
Diagnose, 15%
0%
Global
Healthcare
Spend
Predict, 22%
Predict, 5%
Predict, 9%
2007
2012
Source: Frost & Sullivan Analysis
2025
The most advantageous
way to combat many
diseases,
such
as
diabetes or cancer is to
predict
susceptibility,
characterize and begin
preventive
treatment
before the onset of the
disease
Better health through
earlier diagnosis
Increasing Lifespan
70%
Screening and Localizing
diseases is the most
efficacious
and
cost
effective
approach
to
improving quality of life
The Five Selected Future Technologies
Natural
Bio-Tech
DDS
Diagnostic
Cell Therapy
Main Opportunity for Indonesia Pharma Industry
1. Future Economy Growth will Enlarge Pharma Market Significantly
• High growth in GDP per Capita will enhance people awareness to
their health. This may lead health expenditure to 4-5% of GDP
• Government commitment to support Pharma Industry as one of
their priority in next 20 years, will boost pharma investment
• Opportunity in export market, including to advanced countries, is not
yet explored optimally today
2. High Volume Growth for Generics
• JKN will endorse high volume growth for generic drugs demand,
and may slow-down branded-generic drugs growth
• The most efficient industry, both in raw material purchase price
and operational cost, will win JKN generic drugs market
3. “Out of Pocket” Market will be still Exist and Growing
Niece-market that not covered by JKN (e.g. for aesthetic purpose) and
for some treatment which ceiling compensation is relatively small
(e.g. for cataract-medication, etc); advanced medication, premium
treatment / service, and private insurance will be the main drivers for
future “out of pocket” market
Main Challenges for Indonesia Pharma Industry
1. Dependency on Raw Material Importation
• More than 95% raw materials (pharma-grade) are still imported,
mostly from China, India, and western Europe.
• Pharma product cost structure is vulnerable to Rp-USD exchange rate
fluctuation
• Generic product price, which regulated by government, become nonfeasible due to weakening Rp-USD exchange
2. Strangling Regulation
• As Indonesia joining PIC/s, industry must adopt PIC/s regulation to
comply cGMP. At the moment, most industries (and other supporting
industries) are not yet ready to fully adopt it, e.g. requirement to use
GMP-approved raw materials starting 2016.
• Government too focus on role to “supervise” industry, while their role
to “develop” industry was still minimum
Maturity of GMP Attitude and Compliance
5. GENERATIVE
9
Compliance is just part of how we do business
here (CAPA, QMS, QRM, MAI and CI)
4. PROACTIVE
We work sensibly on the problems that
we still find (CAPA, QMS, QRM, MAI?? and
CI?? )
3. CALCULATIVE
We have systems in place to manage
most compliance risks (CAPA, QMS and
QRM??)
2. REACTIVE
Compliance is important, so we do a lot
every time we have a problem (CA and PA??,
QMS?? No QRM)
1. PATHOLOGICAL
We haven’t ever been caught, so we
must be doing pretty good (No CAPA,
NO QMS and No QRM)
60
18
93
Continuous
Improvement (CI)
Monitoring,
Assessment and
Improvement (MAI)
35
28
14-20
Main Challenges for Indonesia Pharma Industry
3. “Jaminan Produk Halal” (JPH) Law Implementation
• UU no. 33 / 2014 requires all drugs should follow halal-certification
• UU JPH may potentially disturb products availability to support JKN
• Future pharma product will be dominated by biologic-products,
will be challenge to adopt halal-certification
• International Halal Pharma Summit (in CPhI Conference) stated
that NO international standard for halal pharma products.
4. Fast Demand Growth vs. Capacity Building
• High investment for new plant with relative low ROE, especially for
generics product
• Long lead-time to setup new production facility, dominated by permit
issuance (CPOB certification and product registration)
• Limited human-resources (Apoteker, Assisten Apoteker, Lab-Analyst)
to support Pharma industry growth, both in quantity and quality /
competency
• Threat of new MNC generic drugs player to enter the market
THANK YOU !
28
Rekomendasi Roadmap Industri Farmasi (1)
Memperkuat Struktur Industri Farmasi
• Kolaborasi industri farmasi (untuk R&D)
• Kolaborasi industri-akademisi-pemerintahkomunitas (Forum ABGC)
• Ketersediaan & kontinyuitas bahan awal dan bahan
penunjang lainnya
• Penyiapan kluster industri dan infrastruktur
• Peran Kemenkes, Kemenperin, Kemendag untuk
membina-mendukung industri farmasi
PIC: Kemenkes, Kemenperin, Kemendag, Kementan
Pengembangan Investasi
• Promosi investasi untuk industri farmasi
• Penyiapan infrastruktur dan peraturan untuk menarik dan
mempermudah investasi
• Evaluasi peraturan yang berpotensi menghambat investasi
(misalnya terkait fraksinasi darah, JPH)
• Penyediaan lahan/kluster industri dan infrastuktur
• Pengembangan industri penunjang (bahan kimia dasar,
budi daya tanaman / plant-tissue culture, dll)
PIC: Kemenkes, Kemenperin, Kementan, Kemenkeu, BPOM, BPKM
Rekomendasi Roadmap Industri Farmasi (2)
Insentif Fiskal, Pembiayaan
•
•
•
•
Harmonisasi tarif impor
Pembatasan kuota impor
Insentif pajak dan bea-masuk
Kemudahan akses pembiayaan, baik dalam & luar negeri)
PIC: Kemenperin, Kemenkeu, OJK
Teknologi dan Sumber Daya Manusia
• Pendanaan untuk penelitian dan start-up industry bahan
baku obat
• Mendorong transfer teknologi kefarmasian
• Memperkuat joint-research, baik dengan universitas
ataupun lembaga riset lainnya
• Memperjelas proses, timeline, dan screening paten
• Dukungan pengembangan SDM sesuai kebutuhan industri
farmasi
• Program pemanggilan kembali ilmuwan asal Indonesia
• Pembangunan pusat uji klinik dan CRO
PIC: Kemenkes, Kemenperin, Kemenristek-dikti, Kemenkumham, Kementan,
Kemenkeu, BPOM, BPPT, LIPI,
Rekomendasi Roadmap Industri Farmasi (3)
Pengawasan
•
•
•
•
Peredaran bahan baku obat (API), bahan penunjang, dan obat illegal
Pengendalian impor obat, khususnya suplemen dan produk herbal
HAKI
Peredaran obat melalui jalur non-konvensional, misalnya MLM dan on-line
shopping
• Implementasi peraturan yang mewajibkan industri farmasi asing
mendirikan industri berbasis riset di Indonesia
PIC: Kemenkes, Kemenperin, Kemendag, Kemenkumham, Kemenkeu, BPOM
Jaminan Penggunaan Hasil Produksi Industri
• Penggunaan untuk JKN melalui skema long-purchase
agreement
• Persyaratan bahan baku lokal untuk program pengadaan
obat pemerintah
• Pengendalian (buka-tutup) impor bahan baku obat
• Promosi ekspor dan menghilangkan hambatan ekspor
• Edukasi, pendampingan, prioritisasi oleh regulator untuk
perijinan dan registrasi produk
PIC: Kemenkes, Kemenperin, Kemendag, BPOM
Rekomendasi Roadmap Industri Farmasi (4)
Penunjang Lainnya
• Pendirian Biofarma Life Science Industry (BLSI) :
• Animal Laboratory Center (BSL 3)
• Research Center
• Manufacturing
• Bio-conservation
• Penyertaan Modal Negara (PMN) untuk lahan Jasinga
merupakan prerequisite pendirian BLSI
• Menyiapkan industri ADS (Auto Distract Syringe), cartridge,
prefilled syringe
• Menyiapkan infrastruktur cold chain
PIC: Kemenkes, Kemenperin, KBUMN, Kemenkeu
to Improve Indonesia Pharma Industry Competitiveness
06 October 2015
“It is Health that is Real
Wealth and not pieces of Gold
and Silver”
Mahatma Gandhi-
Why Developing Indonesia Pharma Industry?
Social Aspect
Availability, Independency,
and Sustainability of Supply
Economic Aspect
Medication Cost
Optimalization
Devisa Saving
Technology Aspect
Indonesia Herbal & Marine
Potency
Pharma Technology
Acquisition
Contribution to GDP
and Job Opportunity
Current Status Indonesian Pharma Industry
No. of Manufacturers
State Owned
Local
MNC
4
178
24
Value (IDR bio)
45,699
16,388
Share (%)
74.6%
25.4%
Growth vs. LY (%)
6.72%
15.3%
27% of total ASEAN pharmacy market and 73% dominated by local
industry, the only country in ASEAN which dominated by national industry
Source : Kemenkes 2014, IMS Report Q2 2015
Indonesia Pharma Market has hit >60 trillion
MAT Q2 2015: Growth 8.9% (value) or 9.7% (volume)
JKN Implementation
(Unbranded Generics
VOLUME )
Branded Generics &
OTC Price
JKN Implementation
(Unbranded Generics
PRICE )
Rp-USD
Exchange Rate
Source : IMS Report Q2 2015
Hospital Demand
New Product Launched
400
82
In mio IDR
500
80
78
76
300
74
72
200
70
68
100
66
-
64
Productivity Rate per Labor
Source: http://www.ieconomics.com
GDP per Capita
Life Expectancy
Years
Indonesia Expectation Heading 2025
Indonesia Health Care Expenditure as % of GDP
Total Health Expenditure as % of GDP
(2013)
Australia
9.2%
China
5.6%
Japan
9.3%
India
4.0%
Indonesia
2.7%
Thailand
4.1%
South Korea
7.7%
Singapore
4.9%
Malaysia
0.0%
3.8%
2.0%
4.0%
6.0%
8.0%
10.0%
Government shall increase Health Care Expenditure
to 5% of APBN
(Ref. UU Kesehatan No. 36/2009 pasal 171.1)
Source : Pharmaceutical & Healthcare Countries Report Q2 2014, Business Monitor International;
Economic 360 for Indonesia Healthcare Industry, 2011, Frost & Sullivan
Indonesia Health Care Expenditure per Capita
Source : Asia Pacific Healthcare Outlook 2014, Frost & Sullivan
Strong Industry Growth & Future Objective
Indonesia Pharmaceutical National Market Value
500
300
Value T IDR
400
450 T
Optimistic Annual Growth: 20%
GDP Contribution : 1.3-1.5% (2025)
Global
Top
20
200
100
147 T
from
Global
Top
15
2015
2020
2025
Value T IDR
Import Value : +/- IDR 21 T (2013),
dominated by raw material import
needed
Rp 215 T
Indonesia Pharmaceutical Export Value
200
ABCG
Investment
-
300
Commitment
250 T
100 T
Job Opportunity
100
2 million jobs
-
2015
2020
2025
Source: http://www.kemendag.go.id/id/economic-profile/indonesia-export-import/growth-of-non-oil-and-gas-export-sectoral
Rencana Induk Pengembangan Industri Nasional
Peraturan Pemerintah nomor 14 tahun 2015
12
Indonesia Pharma Industry Roadmap Journey
Kick Off Meeting
(16 Apr 14)
Presentation to Dirjen Binfar
(05 Sep 14)
Presentation to Kepala BPOM
(16 Sep 14)
Presentation to Menteri Kesehatan I
(10 Oct 14)
Indonesian Phar
maceutical Indu
2015 - 2025
stry Road Map
December 2014
Presentation in Rakor
Kemenko Perekonomian
(05 Aug 15)
PP 14/2015:
Pharma Industry as
National Industry Priority
(06 Mar 15)
Final version
(17 Dec 14)
Presentation to Menteri Kesehatan II
(12 Dec 14)
Rakor Kemenko Perekonomian – 05 August 2015
Participants: Menko Perekonomian, Menteri Kesehatan, Menteri RistekDikti; Dirjen Kemenkes, Kemenperin, Kementan, Kemenkeu, BKPM, etc
Conclusion:
1. Deputy V Kemenko Perekonomian will develop Peraturan Presiden draft to
support Pharma Industry Roadmap implementation.
The draft then will be distributed to relevant stake-holders for feedback.
2. Deputy V Kemenko Perekonomian will coordinate with Kementerian
Kesehatan, GP Farmasi Indonesia, and relevant stake-holders to form
a task-force to ensure and monitor the roadmap implementation.
National Pharma Pillars to realize the Transformation 2025
INDONESIA PHARMA INDUSTRY AS NATIONAL STRATEGIC INDUSTRY
Vision
1. To become Top 15 World Pharma in 2025 with IDR 700 T market value
Mission
1. To satisfy domestic drugs and medication market, including JKN & KIS
2. To contribute foreign exchange, export & import substitution
3. To master pharmaceutical technology, including R&D and talent pool
JKN & KIS:
Availability, Affordability, Accessibility
Bio-Pharma
15
Vaccine
Export Program & Import Substitution:
Foreign Exchange Contribution
Natural
Chem-API
Collaborative R&D
ABGC forum Alignment
Quality and efficient Manufacturing
Infrastructure to support industry growth
Regulation to support industry
Competent Human Resource
Transformation of Indonesian Pharma Industry
From Formulation to Integrated Pharma Industry
Current
Import (API & Excipient)
Formulation
Manuf.
Dist.
Formulation
Manuf.
Dist. &
Export
Future
R&D
16
Clinical
Trial
Intermediate
API
Pharma API R&D and Manufacturing Scenario 2015 - 2025
PERIOD
API
BIOPHARMACEUTICALS
VACCINE
NATURAL
2015-2018
•
•
•
•
•
•
•
•
•
EPO (Erythropoetin)
GCSF (Granulocyte Colony Stimulating Factor)
Probiotic
Insulin (utk diabetes)
Stem cell protein (Wound care and cosmetics)
Somatropin
EGF (Epidermal Growth Factor)
Enoxaparin (pengencer darah)
•
•
•
•
Dengue (Demam Berdarah)
MR (Measles Rubella)
HB (Hepatitis-B)
Hexavalent (dimulai)
•
•
•
•
Sabin IPV (Inactivated Polio Vaccine)
Rotavirus (dimulai)
Typhoid Vi-Conj
Rabies (dimulai)
•
•
•
•
•
•
•
Dehidro-di-Isoeugenol (Ekstrak Biji Pala)
Curcumin (terkadung dlm temulawak utk liver)
Gingerol (komponen kimia dalam jahe)
Phylantin (ekstrak daun meniran)
Piperin (ekstraksi lada hitam)
Steviosid (pemanis non kalori)
Xanthorhizol (komponen minyak atsiri khas
temulawak)
Zederone
•
2019-2022
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
2023-2025
Blood Fractionation (Albumin,
Immunoglobulin, Factor VIII, Factor IX)
Growth Hormone (hormon pertumbuhan)
Interferon (pelindung tubuh dari berbagai
virus)
Trastuzumab (antibodi monoklonal yang
dirancang untuk bekerja pada target
HER2 positive breast cancer)
Insulin
MAB (oncology)
•
•
MAB (Monoclonal Anti Body)
Insulin analogue
DTaP (Diphteri, Tetanus, acellular
Pertussis)
Hexavalent
MenACWY
New OPV type 2 (for stockpile)
Pneumococcal (vaksin pneumoni)
Rotavirus
Rabies
•
•
HPV (Human Papiloma Virus)
New TB Recombinant
Glucosamin (utk persendian dproduksi
dlm tubuh atau diekstrak melalui kulit
kepiting atau udang)
Omega-3
Resveratrol (anti oksidan alami)
Vinca alkaloid derivates
Isolat gandarusa (kontrasepsi pria dan
wanita)
Isolat alga coklat (wound care)
Isolat mikroba simbion karang laut
(antibiotik)
Isolat Guazuma longifolia
•
•
Andrographolide (anti malaria)
Etil-p-metoksi Sinamat (hasil isolasi
rimpang kencur utk pelindung kulit)
Ekstrak cacing tanah (thrombolisis)
•
Pharma API R&D and Manufacturing Scenario 2015 - 2025
PERIOD
API
NATURAL
CHEMICALS
2015-2018
•
•
•
•
•
•
•
•
2019-2022
Ekstrak sambung nyawa (antihiperkolesterolemia)
Ekstrak temulawak (antihiperkolesterolemia)
Ekstrak seledri (antihipertensi)
Ekstrak kumis kucing (antihipertensi)
Palm sugar
Ekstrak Cinnamomum burmanii
Fitoestrogen (Trigonella foenum-graceum)
Dermifix Wound Healing (Centella asiatica)
• Statin derivates (menurunkan kadar kolesterol:
Simvastatin, Atorvastatin, Rosuvastatin)
• Pantoprazole
• Clopidogrel
• ARV (Entecavir, Tenofovir)
• Beta-Lactam
(Amoxicillin)
• Pharma Salt (garam farmasi)
(NaCl pharma-grade)
• Dextrose pharma-grade
• Lyophilisation substances
• Pen-V
• Pen-G
• Magnesium stearate
• Paracetamol
•
•
•
•
•
•
Ascorbic Acid (vit. C)
Cephalosporin (7 – ACA)
7-AVCA
7-ACCA
7-ADCA
ARV (Entecavir,
Tenofovir)
2023-2025
Healthcare Sector Transform to Become Personalized, Predictive,
and Preventive
Genetic
Mapping
Patient
segmentation
tailored treatment
regimens
Advancements in
predictive and
preventive
medicine
Personalized
Medicine
Healthcare is becoming a precision-based industry...
Source: Frost & Sullivan Analysis
Transformation in Health Sector
FROM
TO
One size fits all
APPROACH
Personalized Medicine
Fragmented, One way
INFORMATION FLOW
Integrated, Two Way
Provider centric
FOCUS
Patient Centric
Procedure – based
REIMBURSEMENT
Bundled, Capitated
Centralized, Hospital-based
LOCATION
Decentralized, Communitybased
Fragmented, Specialized
TREATMENT
Collaborative, Shared
Information
Based on Individual Expert
DECISION MAKING
Based on Protocols and
Analytics
Treating Sickness
OBJECTIVE
Preventing Sickness
(Wellness)
Source: Frost & Sullivan Analysis
Transformation in Health Sector
Global Healthcare Spend
100%
Monitor, 10%
90%
Monitor, 12%
Monitor, 16%
80%
Treat, 35%
60%
Treat, 70%
Treat, 60%
50%
40%
Diagnose, 27%
30%
20%
10%
Diagnose, 19%
Diagnose, 15%
0%
Global
Healthcare
Spend
Predict, 22%
Predict, 5%
Predict, 9%
2007
2012
Source: Frost & Sullivan Analysis
2025
The most advantageous
way to combat many
diseases,
such
as
diabetes or cancer is to
predict
susceptibility,
characterize and begin
preventive
treatment
before the onset of the
disease
Better health through
earlier diagnosis
Increasing Lifespan
70%
Screening and Localizing
diseases is the most
efficacious
and
cost
effective
approach
to
improving quality of life
The Five Selected Future Technologies
Natural
Bio-Tech
DDS
Diagnostic
Cell Therapy
Main Opportunity for Indonesia Pharma Industry
1. Future Economy Growth will Enlarge Pharma Market Significantly
• High growth in GDP per Capita will enhance people awareness to
their health. This may lead health expenditure to 4-5% of GDP
• Government commitment to support Pharma Industry as one of
their priority in next 20 years, will boost pharma investment
• Opportunity in export market, including to advanced countries, is not
yet explored optimally today
2. High Volume Growth for Generics
• JKN will endorse high volume growth for generic drugs demand,
and may slow-down branded-generic drugs growth
• The most efficient industry, both in raw material purchase price
and operational cost, will win JKN generic drugs market
3. “Out of Pocket” Market will be still Exist and Growing
Niece-market that not covered by JKN (e.g. for aesthetic purpose) and
for some treatment which ceiling compensation is relatively small
(e.g. for cataract-medication, etc); advanced medication, premium
treatment / service, and private insurance will be the main drivers for
future “out of pocket” market
Main Challenges for Indonesia Pharma Industry
1. Dependency on Raw Material Importation
• More than 95% raw materials (pharma-grade) are still imported,
mostly from China, India, and western Europe.
• Pharma product cost structure is vulnerable to Rp-USD exchange rate
fluctuation
• Generic product price, which regulated by government, become nonfeasible due to weakening Rp-USD exchange
2. Strangling Regulation
• As Indonesia joining PIC/s, industry must adopt PIC/s regulation to
comply cGMP. At the moment, most industries (and other supporting
industries) are not yet ready to fully adopt it, e.g. requirement to use
GMP-approved raw materials starting 2016.
• Government too focus on role to “supervise” industry, while their role
to “develop” industry was still minimum
Maturity of GMP Attitude and Compliance
5. GENERATIVE
9
Compliance is just part of how we do business
here (CAPA, QMS, QRM, MAI and CI)
4. PROACTIVE
We work sensibly on the problems that
we still find (CAPA, QMS, QRM, MAI?? and
CI?? )
3. CALCULATIVE
We have systems in place to manage
most compliance risks (CAPA, QMS and
QRM??)
2. REACTIVE
Compliance is important, so we do a lot
every time we have a problem (CA and PA??,
QMS?? No QRM)
1. PATHOLOGICAL
We haven’t ever been caught, so we
must be doing pretty good (No CAPA,
NO QMS and No QRM)
60
18
93
Continuous
Improvement (CI)
Monitoring,
Assessment and
Improvement (MAI)
35
28
14-20
Main Challenges for Indonesia Pharma Industry
3. “Jaminan Produk Halal” (JPH) Law Implementation
• UU no. 33 / 2014 requires all drugs should follow halal-certification
• UU JPH may potentially disturb products availability to support JKN
• Future pharma product will be dominated by biologic-products,
will be challenge to adopt halal-certification
• International Halal Pharma Summit (in CPhI Conference) stated
that NO international standard for halal pharma products.
4. Fast Demand Growth vs. Capacity Building
• High investment for new plant with relative low ROE, especially for
generics product
• Long lead-time to setup new production facility, dominated by permit
issuance (CPOB certification and product registration)
• Limited human-resources (Apoteker, Assisten Apoteker, Lab-Analyst)
to support Pharma industry growth, both in quantity and quality /
competency
• Threat of new MNC generic drugs player to enter the market
THANK YOU !
28
Rekomendasi Roadmap Industri Farmasi (1)
Memperkuat Struktur Industri Farmasi
• Kolaborasi industri farmasi (untuk R&D)
• Kolaborasi industri-akademisi-pemerintahkomunitas (Forum ABGC)
• Ketersediaan & kontinyuitas bahan awal dan bahan
penunjang lainnya
• Penyiapan kluster industri dan infrastruktur
• Peran Kemenkes, Kemenperin, Kemendag untuk
membina-mendukung industri farmasi
PIC: Kemenkes, Kemenperin, Kemendag, Kementan
Pengembangan Investasi
• Promosi investasi untuk industri farmasi
• Penyiapan infrastruktur dan peraturan untuk menarik dan
mempermudah investasi
• Evaluasi peraturan yang berpotensi menghambat investasi
(misalnya terkait fraksinasi darah, JPH)
• Penyediaan lahan/kluster industri dan infrastuktur
• Pengembangan industri penunjang (bahan kimia dasar,
budi daya tanaman / plant-tissue culture, dll)
PIC: Kemenkes, Kemenperin, Kementan, Kemenkeu, BPOM, BPKM
Rekomendasi Roadmap Industri Farmasi (2)
Insentif Fiskal, Pembiayaan
•
•
•
•
Harmonisasi tarif impor
Pembatasan kuota impor
Insentif pajak dan bea-masuk
Kemudahan akses pembiayaan, baik dalam & luar negeri)
PIC: Kemenperin, Kemenkeu, OJK
Teknologi dan Sumber Daya Manusia
• Pendanaan untuk penelitian dan start-up industry bahan
baku obat
• Mendorong transfer teknologi kefarmasian
• Memperkuat joint-research, baik dengan universitas
ataupun lembaga riset lainnya
• Memperjelas proses, timeline, dan screening paten
• Dukungan pengembangan SDM sesuai kebutuhan industri
farmasi
• Program pemanggilan kembali ilmuwan asal Indonesia
• Pembangunan pusat uji klinik dan CRO
PIC: Kemenkes, Kemenperin, Kemenristek-dikti, Kemenkumham, Kementan,
Kemenkeu, BPOM, BPPT, LIPI,
Rekomendasi Roadmap Industri Farmasi (3)
Pengawasan
•
•
•
•
Peredaran bahan baku obat (API), bahan penunjang, dan obat illegal
Pengendalian impor obat, khususnya suplemen dan produk herbal
HAKI
Peredaran obat melalui jalur non-konvensional, misalnya MLM dan on-line
shopping
• Implementasi peraturan yang mewajibkan industri farmasi asing
mendirikan industri berbasis riset di Indonesia
PIC: Kemenkes, Kemenperin, Kemendag, Kemenkumham, Kemenkeu, BPOM
Jaminan Penggunaan Hasil Produksi Industri
• Penggunaan untuk JKN melalui skema long-purchase
agreement
• Persyaratan bahan baku lokal untuk program pengadaan
obat pemerintah
• Pengendalian (buka-tutup) impor bahan baku obat
• Promosi ekspor dan menghilangkan hambatan ekspor
• Edukasi, pendampingan, prioritisasi oleh regulator untuk
perijinan dan registrasi produk
PIC: Kemenkes, Kemenperin, Kemendag, BPOM
Rekomendasi Roadmap Industri Farmasi (4)
Penunjang Lainnya
• Pendirian Biofarma Life Science Industry (BLSI) :
• Animal Laboratory Center (BSL 3)
• Research Center
• Manufacturing
• Bio-conservation
• Penyertaan Modal Negara (PMN) untuk lahan Jasinga
merupakan prerequisite pendirian BLSI
• Menyiapkan industri ADS (Auto Distract Syringe), cartridge,
prefilled syringe
• Menyiapkan infrastruktur cold chain
PIC: Kemenkes, Kemenperin, KBUMN, Kemenkeu