India Pharma Outlook 2015: Accelerating Growth to the Next Level: Moving up the Value Chain Beyond Generics
Domestic sales improved in 2014, recovering from the slump in the 2013 caused by the market’s reaction to the new drug pricing policy. In 2015, growth is expected to continue to be healthy, as the momentum continues and improving economic growth allow more spending on healthcare. Sun Pharma acquisition of troubled Ranbaxy helped it to become the leading Indian pharma company in terms of domestic market share. Sun’s in-licensing of biologics from Merck also indicates, Indian companies willingness to advance its pipeline towards upper value chain. Though, US market remains the largest market for India generic exports, it is witnessing a slowdown in product approvals and channel consolidation which has impacted overall pricing and margin for the industry. The increase in audits by US FDA staff on the Indian plants of both multinationals and Indian companies have led to an increased number of issuance of warning letters. Indian Pharma companies are trying to diversify into other markets such as Brazil, Mexico, Venezuela and also in some East European markets to lower this growing dependency on the US.
Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, Government of India under ‘Make in India’ program has decided to declare the year 2015 as ‘Year of Active Pharmaceutical Ingredients (API).’ Under the ‘Make in India’ initiative, it is expected that the government will introduce many industry-friendly policies and incentives to give a major thrust to the growth of Indian bulk drug industry to make it a formidable force globally. State government of Telnagana has already announced many incentives for the bulk manufacturing units.
Indian companies are taking center stage in Complex Generics at US and EU markets. In Bio-similars, Indian companies will have perhaps the largest basket aimed at Emerging Countries in 2015-20 and later for Developed countries. Though few but is the beginning of NCE/mAb development by Indian companies is a sign of Indian Generics moving up in the chain. Biopharma/ biotech companies in India, S. Korea, China may have significant advantages of low-cost manufacturing, colossal markets, and healthy government support over potential peers from other regions. The cost barriers in the biosimilar market lead regulated marketed giants to tie up with Asian companies to gain access to these advantages and hedging their bets through a joint-venture strategy.
Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, Government of India under ‘Make in India’ program has decided to declare the year 2015 as ‘Year of Active Pharmaceutical Ingredients (API).’ Under the ‘Make in India’ initiative, it is expected that the government will introduce many industry-friendly policies and incentives to give a major thrust to the growth of Indian bulk drug industry to make it a formidable force globally. State government of Telnagana has already announced many incentives for the bulk manufacturing units.
Indian companies are taking center stage in Complex Generics at US and EU markets. In Bio-similars, Indian companies will have perhaps the largest basket aimed at Emerging Countries in 2015-20 and later for Developed countries. Though few but is the beginning of NCE/mAb development by Indian companies is a sign of Indian Generics moving up in the chain. Biopharma/ biotech companies in India, S. Korea, China may have significant advantages of low-cost manufacturing, colossal markets, and healthy government support over potential peers from other regions. The cost barriers in the biosimilar market lead regulated marketed giants to tie up with Asian companies to gain access to these advantages and hedging their bets through a joint-venture strategy.
AURBINDO PHARMA - RECOVERY SO FAR, SO GOOD
Strong Presence in US market – Channel consolidation has no Impact so far
Acquisition of commercial operations in Western Europe from Actavis
Domestic Business
Antiretroviral (ARV) Business
Table 1: Global Regulatory Filings
BIOCON - GLOBAL PARTNERSHIPS AND CREATING FURTHER VALUE OF CRAMS –FUTURE DRIVERS
Near term Growth Drivers
Long term growth Drivers
R&D Partnership Update
CADILA - NCE, BIO-SIMILARS, TRANSDERMAL AND COMPLEX GENERICS
US remains the key growth driver
NCE/NBE pipeline
Table 1: Key transdermal products and timelines for filing and approval
Table 2: colon targeted drugs –near to medium term growth driver of Cadila Healthcare
CAPLIN POINT - DEBT FREE COMPANY WITH STRONG MANAGEMENT – LATIN AMERICA INVESTMENT STRATEGY WILL PROVIDE CONSISTENT GROWTH
Formulation capabilities:
Financial status:
Export business:
Contract Manufacturing
CIPLA - FRESH LEADERSHIP TO START DELIVERING RESULTS SOON!
Solid Base to Enter ‘Front-End’ Marketing In Overseas Markets
Capabilities in the Respiratory Area
Initiatives to Bring Value to the Society Continue
Table 1: Respiratory coverage
Table 2: Strong manufacturing to cater to global markets
Table 3: Wide technology platform base
Table 4: Wide technology platform base
DISHMAN - HIGH POTENT/ONCO CRAMS TO API: WILL THESE STRATEGIES WORK?
India CRAMS – Challenges Faced
New Initiative At Business Segments
Figure 1: Crams business – value chain
Table 1: Bulk API products - highly potent
Table 2: Bulk API products
DR. REDDY'S - ONCO GENERICS AND COMPLEX FORMULATION ARE NEW CATALYSTS FOR GROWTH
Rich Pipeline with ‘difficult to make’ products
Positioned Well to participate in Biosimilars opportunities
Russia/CIS – Momentum Continues:
Figure 1: Varieties of formulations in pipeline
Table 1: Expected new launches in next three years
Table 2: Select products launched by Dr. Reddys in past three years
Table 3: Leadership products in Russia
Table 4: Growth of sales in Russia
GLENMARK - MATURING NBE/NCE PIPELINE VISIBILITY TO INCREASE IN THE NEXT TWO YEARS
Buisness Segments
Junivia Case
India formulation
USA Formulation
Africa, Asia and CIS Region (ROW)
Europe Formulation
Latin America
API Business
Domestic Business
Further Value Creation
R & D pipeline Update
JUBILANT LIFE SCIENCE - INTEGRATED CRAMS BUSINESS - FINANCIAL RESTRUCTURING UNLIKELY SOLVE KEY ISSUE
Pharmaceutical Business De-growth to Impact Margin
Life Science Ingredients margin is not very attractive!
Geography wise Business and Long term Outlook
LUPIN - A TRUE GLOBAL INDIAN COMPANY – WILL ENTER NEW PHASE OF GROWTH
Solid Foundation in USA
Japanese success story is likely to be continued:
Increasing investments in R&D are strengthening the foundation:
Chart 1: Lupin: business split for fy 03/14
Table 1: upcoming ftf opportunities
Annexure 1: strategic initiatives and alliances in fy 03/14
NATCO - LEVERAGING CHEMISTRY, FORMULATION AND IP STRENGTHS – FOR US AND INDIA MARKETS
New Market Entry
Leading oncology player in domestic market
API Exports
NCE pipeline
CML Market position
Key Oncology in Domestic Market to Value in Coming Years
ORCHID - CDR IN PLACE BUT LOST CONFIDENCE ON MANAGEMENT
US Formulation Business, the Key Growth Driver, Strategy still a question?
From the ANDAs list, we see four products, where Orchid has meaningful opportunity –
DEPENDS ON THE PARTNER IT CHOOSES:
Facilities Post Hospira deals:
Table 1:Cephalosporin API Us DMF List
Table 2A: Us Antibiotic Consumption In Volume
Table 2B: Cephalosporin’s Consumption In Volume
Table 3: Key Andas And Competition
PANACEA BIOTECH: CDR APPROVED: TURNAROUND EXPECTED FROM FORMULATION BUSINESS
Panacea has shown confidence in rebuilding the business through research and strategy
Business Segments Review
Indian Market Position
International Markets Updates
Strategic Alliances
Joint Venture Partnerships with Global Companies
Panacea Biotec Research Capabilities
Formulation Platform technologies Developed
Manufacturing Facilities- Regulatory Approval
WHO and UNICEF Vaccine Business Update
Table 1: NDDS Pipeline
SHILPA MEDICARE: A LEADER IN ONCOLOGY API, EXPANDING INTO NON-ONCO, PEPTIDES AND COMPLEX FORMULATIONS – US MARKET THE NEXT TARGET!
Acquisitions so far
Table 1: Select Key Oncology API And Their DMF Status
Table 2: Select Non-Onco API And Their DMFStatus
Table 3: Select API Under Development
STRIDE ARCOLAB: HONEYMOON PHASE ON- POST MERGER WITH SHASUN
Complementary Business- Shasun and Strides
Malaria and HCV opportunity are future growth drivers--
Notable acquisitions with Stride Arcolab
Biotech/Biosimilar- Long term Drivers- Stelis Biopharma
Hedging Risk in biosimilar/biologics
SUN PHARMA,: LARGEST INDIAN GENERIC COMPANY VENTURING INTO BIOLOGIC INNOVATION
Domestic market – balanced portfolio, sustainable base
Leadership in Domestic Oncology Market is Likely to be Maintained:
Overseas Market Business
Rest of the world formulation business:
Acquisition & Collaboration and its impact on the company’s growth
Table 1: Domestic Chronic Disease Focused Portfolio
Table 2: Year Wise Approvals In The Us
Table 3: Therapy Wise Approvals In The Us
Annexure 1: History Of Creating Value By Executing Value Assets
CONNEXIOUS - CONNEXIOS HAS HAD A BUMPY RIDE LIKE MOST RISING STARS/DRUG DISCOVERY COMPANIES IN THE BIOTECH SECTOR
Technology Platform
Therapy Focus—Diabetes/Metabolic Disorder and Non Alcoholic Steatohepatitis (NASH)
Key Milestones
Figure 1: PRODUCTS IN PIPELINE- DIABETES
Figure 2: PRODUCTS IN PIPELINE FOR NASH
Figure 3: OTHER PROGRAMS
Appendix 1: Network Biology Platform for Diabetes and fibrosis
Appendix:2 Novel GPR40 agonist
CNX-103: Whole body improvement of metabolic health
Table 1: Differences Between G-Protein Coupled receptor agonists
Table 2: Pipeline Of Gpr Agonist For Treatment Of Type 2 Diabetes
CELLWORKS - CELLWORKS (CW) HAS EVOLVED FROM A SERVICE BASED COMPANY TO A DRUG DISCOVERY /DEVELOPMENT COMPANY ON THE STRENGTH OF ITS PROPRIETARY VIRTUAL PROTOTYPING PLATFORM THAT ALLOWS SIMULATION OF CELL TYPES//DISEASE IN SILICO.
Technology Platform
Pipeline
Figure 1: Simulation Based personalization
Figure 2: Cellworks Therapeutic Programs
BUGWORKS - BUGWORKS IS A VALIDATION OF CELLWORKS SIMULATION IN SILICO TECHNOLOGY PLATFORM WHERE ITS BUGWORKS MICROBIAL PLATFORM (BMP) COMBINES FUNCTIONAL PROTEOMICS WITH SOPHISTICATED SEMICONDUCTOR DESIGNE ENGINEERING TO MODEL AND MANIPULATE VARIOUS BACTERIAL SYSTEMS.
Therapy focus- Serious Hospital Infection
Technology Platform
Need of the Hour- New Targets= New Antibiotic Class
The GAIN Act
Figure 1: Drug Development Success For Tb
Figure 2: Going Way Froward: focus: Helathcare Associated Infections
TERGENE - TERGENE’S FIRST PRODUCT IN DEVELOPMENT IS A VACCINE FOR PNEUMONIA CAUSED BY, STREPTOCOCCUS PNEUMONIA (PNEUMOCOCCOUS). THE AVAILABLE VACCINE THE PNEUMOCOCCAL POLYSACCHARIDE VACCINES (PPV)
Development Strategy and Status-
Long term plans-
Vaccine Market-
Figure 1: sales of currently available vaccines for streptococcus pneumonia
Figure 2: Ww Demand Forecast Of Vaccines For Streptococcus Pneumonia
Figure 3: Vaccine Market
Strong Presence in US market – Channel consolidation has no Impact so far
Acquisition of commercial operations in Western Europe from Actavis
Domestic Business
Antiretroviral (ARV) Business
Table 1: Global Regulatory Filings
BIOCON - GLOBAL PARTNERSHIPS AND CREATING FURTHER VALUE OF CRAMS –FUTURE DRIVERS
Near term Growth Drivers
Long term growth Drivers
R&D Partnership Update
CADILA - NCE, BIO-SIMILARS, TRANSDERMAL AND COMPLEX GENERICS
US remains the key growth driver
NCE/NBE pipeline
Table 1: Key transdermal products and timelines for filing and approval
Table 2: colon targeted drugs –near to medium term growth driver of Cadila Healthcare
CAPLIN POINT - DEBT FREE COMPANY WITH STRONG MANAGEMENT – LATIN AMERICA INVESTMENT STRATEGY WILL PROVIDE CONSISTENT GROWTH
Formulation capabilities:
Financial status:
Export business:
Contract Manufacturing
CIPLA - FRESH LEADERSHIP TO START DELIVERING RESULTS SOON!
Solid Base to Enter ‘Front-End’ Marketing In Overseas Markets
Capabilities in the Respiratory Area
Initiatives to Bring Value to the Society Continue
Table 1: Respiratory coverage
Table 2: Strong manufacturing to cater to global markets
Table 3: Wide technology platform base
Table 4: Wide technology platform base
DISHMAN - HIGH POTENT/ONCO CRAMS TO API: WILL THESE STRATEGIES WORK?
India CRAMS – Challenges Faced
New Initiative At Business Segments
Figure 1: Crams business – value chain
Table 1: Bulk API products - highly potent
Table 2: Bulk API products
DR. REDDY'S - ONCO GENERICS AND COMPLEX FORMULATION ARE NEW CATALYSTS FOR GROWTH
Rich Pipeline with ‘difficult to make’ products
Positioned Well to participate in Biosimilars opportunities
Russia/CIS – Momentum Continues:
Figure 1: Varieties of formulations in pipeline
Table 1: Expected new launches in next three years
Table 2: Select products launched by Dr. Reddys in past three years
Table 3: Leadership products in Russia
Table 4: Growth of sales in Russia
GLENMARK - MATURING NBE/NCE PIPELINE VISIBILITY TO INCREASE IN THE NEXT TWO YEARS
Buisness Segments
Junivia Case
India formulation
USA Formulation
Africa, Asia and CIS Region (ROW)
Europe Formulation
Latin America
API Business
Domestic Business
Further Value Creation
R & D pipeline Update
JUBILANT LIFE SCIENCE - INTEGRATED CRAMS BUSINESS - FINANCIAL RESTRUCTURING UNLIKELY SOLVE KEY ISSUE
Pharmaceutical Business De-growth to Impact Margin
Life Science Ingredients margin is not very attractive!
Geography wise Business and Long term Outlook
LUPIN - A TRUE GLOBAL INDIAN COMPANY – WILL ENTER NEW PHASE OF GROWTH
Solid Foundation in USA
Japanese success story is likely to be continued:
Increasing investments in R&D are strengthening the foundation:
Chart 1: Lupin: business split for fy 03/14
Table 1: upcoming ftf opportunities
Annexure 1: strategic initiatives and alliances in fy 03/14
NATCO - LEVERAGING CHEMISTRY, FORMULATION AND IP STRENGTHS – FOR US AND INDIA MARKETS
New Market Entry
Leading oncology player in domestic market
API Exports
NCE pipeline
CML Market position
Key Oncology in Domestic Market to Value in Coming Years
ORCHID - CDR IN PLACE BUT LOST CONFIDENCE ON MANAGEMENT
US Formulation Business, the Key Growth Driver, Strategy still a question?
From the ANDAs list, we see four products, where Orchid has meaningful opportunity –
DEPENDS ON THE PARTNER IT CHOOSES:
Facilities Post Hospira deals:
Table 1:Cephalosporin API Us DMF List
Table 2A: Us Antibiotic Consumption In Volume
Table 2B: Cephalosporin’s Consumption In Volume
Table 3: Key Andas And Competition
PANACEA BIOTECH: CDR APPROVED: TURNAROUND EXPECTED FROM FORMULATION BUSINESS
Panacea has shown confidence in rebuilding the business through research and strategy
Business Segments Review
Indian Market Position
International Markets Updates
Strategic Alliances
Joint Venture Partnerships with Global Companies
Panacea Biotec Research Capabilities
Formulation Platform technologies Developed
Manufacturing Facilities- Regulatory Approval
WHO and UNICEF Vaccine Business Update
Table 1: NDDS Pipeline
SHILPA MEDICARE: A LEADER IN ONCOLOGY API, EXPANDING INTO NON-ONCO, PEPTIDES AND COMPLEX FORMULATIONS – US MARKET THE NEXT TARGET!
Acquisitions so far
Table 1: Select Key Oncology API And Their DMF Status
Table 2: Select Non-Onco API And Their DMFStatus
Table 3: Select API Under Development
STRIDE ARCOLAB: HONEYMOON PHASE ON- POST MERGER WITH SHASUN
Complementary Business- Shasun and Strides
Malaria and HCV opportunity are future growth drivers--
Notable acquisitions with Stride Arcolab
Biotech/Biosimilar- Long term Drivers- Stelis Biopharma
Hedging Risk in biosimilar/biologics
SUN PHARMA,: LARGEST INDIAN GENERIC COMPANY VENTURING INTO BIOLOGIC INNOVATION
Domestic market – balanced portfolio, sustainable base
Leadership in Domestic Oncology Market is Likely to be Maintained:
Overseas Market Business
Rest of the world formulation business:
Acquisition & Collaboration and its impact on the company’s growth
Table 1: Domestic Chronic Disease Focused Portfolio
Table 2: Year Wise Approvals In The Us
Table 3: Therapy Wise Approvals In The Us
Annexure 1: History Of Creating Value By Executing Value Assets
CONNEXIOUS - CONNEXIOS HAS HAD A BUMPY RIDE LIKE MOST RISING STARS/DRUG DISCOVERY COMPANIES IN THE BIOTECH SECTOR
Technology Platform
Therapy Focus—Diabetes/Metabolic Disorder and Non Alcoholic Steatohepatitis (NASH)
Key Milestones
Figure 1: PRODUCTS IN PIPELINE- DIABETES
Figure 2: PRODUCTS IN PIPELINE FOR NASH
Figure 3: OTHER PROGRAMS
Appendix 1: Network Biology Platform for Diabetes and fibrosis
Appendix:2 Novel GPR40 agonist
CNX-103: Whole body improvement of metabolic health
Table 1: Differences Between G-Protein Coupled receptor agonists
Table 2: Pipeline Of Gpr Agonist For Treatment Of Type 2 Diabetes
CELLWORKS - CELLWORKS (CW) HAS EVOLVED FROM A SERVICE BASED COMPANY TO A DRUG DISCOVERY /DEVELOPMENT COMPANY ON THE STRENGTH OF ITS PROPRIETARY VIRTUAL PROTOTYPING PLATFORM THAT ALLOWS SIMULATION OF CELL TYPES//DISEASE IN SILICO.
Technology Platform
Pipeline
Figure 1: Simulation Based personalization
Figure 2: Cellworks Therapeutic Programs
BUGWORKS - BUGWORKS IS A VALIDATION OF CELLWORKS SIMULATION IN SILICO TECHNOLOGY PLATFORM WHERE ITS BUGWORKS MICROBIAL PLATFORM (BMP) COMBINES FUNCTIONAL PROTEOMICS WITH SOPHISTICATED SEMICONDUCTOR DESIGNE ENGINEERING TO MODEL AND MANIPULATE VARIOUS BACTERIAL SYSTEMS.
Therapy focus- Serious Hospital Infection
Technology Platform
Need of the Hour- New Targets= New Antibiotic Class
The GAIN Act
Figure 1: Drug Development Success For Tb
Figure 2: Going Way Froward: focus: Helathcare Associated Infections
TERGENE - TERGENE’S FIRST PRODUCT IN DEVELOPMENT IS A VACCINE FOR PNEUMONIA CAUSED BY, STREPTOCOCCUS PNEUMONIA (PNEUMOCOCCOUS). THE AVAILABLE VACCINE THE PNEUMOCOCCAL POLYSACCHARIDE VACCINES (PPV)
Development Strategy and Status-
Long term plans-
Vaccine Market-
Figure 1: sales of currently available vaccines for streptococcus pneumonia
Figure 2: Ww Demand Forecast Of Vaccines For Streptococcus Pneumonia
Figure 3: Vaccine Market
