Global Pharmaceutical and Biotechnology Outlook 2014 - India Pharma
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 2014-16 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. The uncertainty of clinical and regulatory pathways in the US helps Asian biopharma and biotech companies to be in forefront in developing and marketing biosimilars. 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. Though reimbursement remains a concern as no countries provide full reimbursement – patient pay total cost out-of-pocket in India; with well defined regulatory pathways, we believe Indian biopharma companies keep leveraging their strength of low cost manufacturing along with skilled workforce which would support them to gain global recognition.
Factories at India continue to have lion’s share of US Generics market, despite a couple of plants at India facing scrutiny from US FDA. India has 526 USFDA units in which 403 intimations of violation (Form 483) of its manufacturing norms to Indian plants in the period from 2011 to Nov 2013. It is to be noted that one fourth of FDA inspection outside the US conducted in India. But Indian plants have received very less Import alerts/Warning letters by FDA which indicates strong quality consciousness of Indian Drug Manufacturers. Only 21 warning letters have been issued to Indian companies which is far less than other Ex-US countries (Mexico: 74%; Canada and British: 30% - Import alert).
With a robust outlook, companies continue to invest in sales force to target more doctors and more focus per brand. The implementation of quality norms with vigor has helped companies with better quality perception to charge high prices. Every company has invested in increasing the sales force to capture the market that has consolidated at the tail end. With tiny companies getting out of business importance of branding has increased drastically. Thus, all companies are trying to increase focus per brand. Policy makers in India to start the process of strict audit of marketing practices followed by pharma companies in India.
Our outlook 2014 on India Pharma covers overall business and market growth for Indian companies, ParaIV filing, NCE pipeline and biosimilar and NDDS development.
Key Topics Covered
1. Uniform Code on Sales and Marketing Practices in India
2. Issuance of warning letters to Indian facilities by USFDA: not a concern
3. Biosimilar perspective for Indian market
4. New drug discovery development in India
5. Biocon: Sits comfortable with its near and long term contributory products
6. Cadila Healthcare: NCE, Transdermal, Biosimilars and Complex generics launches thru 2016 – Eventful time ahead
7. Cipla: Major change in business model
8. Dr. Reddy’s Lab: Focus on Complex formulations and Biogenerics to intensify
9. Glenmark: US business, NCE and ParaIV will show significant growth
10. IPCA: Fine chemicals to formulation –Global leadership in select products
11. Lupin: US and Japan Business –Key for long term growth
12. Natco: Leveraging chemistry, formulation and IP strength – For Us and India Markets
13. Panacea Biotec: Financial trouble mounting, Acceptance of WHO prequalification and formulation business will revive the company
14. Shasun: On path to become fully integrated Pharma company
15. Shilpa Medicare: A leader in Oncology API, Expanding into Non-Onco, peptides and complex formulations
16. Sun Pharma: Strong Management Team - Absolute and Comparative Advantage
Factories at India continue to have lion’s share of US Generics market, despite a couple of plants at India facing scrutiny from US FDA. India has 526 USFDA units in which 403 intimations of violation (Form 483) of its manufacturing norms to Indian plants in the period from 2011 to Nov 2013. It is to be noted that one fourth of FDA inspection outside the US conducted in India. But Indian plants have received very less Import alerts/Warning letters by FDA which indicates strong quality consciousness of Indian Drug Manufacturers. Only 21 warning letters have been issued to Indian companies which is far less than other Ex-US countries (Mexico: 74%; Canada and British: 30% - Import alert).
With a robust outlook, companies continue to invest in sales force to target more doctors and more focus per brand. The implementation of quality norms with vigor has helped companies with better quality perception to charge high prices. Every company has invested in increasing the sales force to capture the market that has consolidated at the tail end. With tiny companies getting out of business importance of branding has increased drastically. Thus, all companies are trying to increase focus per brand. Policy makers in India to start the process of strict audit of marketing practices followed by pharma companies in India.
Our outlook 2014 on India Pharma covers overall business and market growth for Indian companies, ParaIV filing, NCE pipeline and biosimilar and NDDS development.
Key Topics Covered
1. Uniform Code on Sales and Marketing Practices in India
2. Issuance of warning letters to Indian facilities by USFDA: not a concern
3. Biosimilar perspective for Indian market
4. New drug discovery development in India
5. Biocon: Sits comfortable with its near and long term contributory products
6. Cadila Healthcare: NCE, Transdermal, Biosimilars and Complex generics launches thru 2016 – Eventful time ahead
7. Cipla: Major change in business model
8. Dr. Reddy’s Lab: Focus on Complex formulations and Biogenerics to intensify
9. Glenmark: US business, NCE and ParaIV will show significant growth
10. IPCA: Fine chemicals to formulation –Global leadership in select products
11. Lupin: US and Japan Business –Key for long term growth
12. Natco: Leveraging chemistry, formulation and IP strength – For Us and India Markets
13. Panacea Biotec: Financial trouble mounting, Acceptance of WHO prequalification and formulation business will revive the company
14. Shasun: On path to become fully integrated Pharma company
15. Shilpa Medicare: A leader in Oncology API, Expanding into Non-Onco, peptides and complex formulations
16. Sun Pharma: Strong Management Team - Absolute and Comparative Advantage
GROUND REALITY & THE IMPLICATIONS
Nothing Much Has Changed on the Ground Following the Issue of the Guidelines
More Sophisticated Ways of Bribing Invented
Different Companies Respond Differently in ‘Tackling’ the Guidelines
Gifting Policy Changed
Gifting Policy Changed
If Enforced Effectively – Uniform Codes Can Bring Signicant Changes on the Ground ‘Lack of Will’ and ‘Cut-Throat Competition’ are Bottlenecks in Implementing Ethical
Practices
Drug Sampling Policies– Most Improved ‘Uniform Codes’ Were Not Relayed Properly to the Field Force Strong Enforcement of
Guidelines May Hamper Revenues In Beginning, But Will Balanced Out In Long Run:
Doctors Become More Cautious In Dealing With Pharma Companies Following MCI And DOP
Guidelines, Yet A Mutual Understating With Pharma Cos ‘Matures’ and Finds Ways To ‘Reciprocate’ Business:
Table 1: Domestic Sales As Percent Of Total Sales
Table 2: Alleged Nexus Among Doctors & Pharma Cos: Complain Vs. Action Trend
Table 3: Uniform Code For Marketing Practices – Deliberations Vs. Ground Reality
Table 4: Various Promotional Ways To Incur As Expenses By Pharma Companies
Other No Table Developments in Indian Pharma
ISSUANCE OF WARNING LETTERS TO INDIAN FACILITIES BY USFDA: NOT A CONCERN
Table 5: India Pharma: Fda Warning Letter Review 2010-2013
BIOSIMILAR PERSPECTIVE FOR INDIAN MARKET
Table 6: Approved Biosimilars In India
Table 7: Select Biosimilars Collaborations Till Date
Indian ‘Similar Biologics’ Guideline: Overview
DRUG DISCOVERY DEVELOPMENT IN INDIA
Table 8: NCE-MAB PIPELINE INDIAN COMPANIES
SUN PHARMA - Strong Management Team – Absolute and Comparative Advantage
KEY THESIS
Domestic market – balanced portfolio, sustainable base
Table 1: Chronic Disease Focused Portfolio Leadership in Domestic Oncology Market is Likely to be Maintained Overseas Market Business – Solid Fundamentals
Promise Future Growth
Table 2: Year Wise Approvals In The Us Derma – A pro Table Segment with High entry barrier
Table 3: Therapy Wise Approvals In The Us A Decent Base in Europe Beyond Generics - Investing in Innovation
Improving Generics
True Innovation
Annexure 1: History Of Creating Value Through Executing Value Assets
CIPLA: Major Change in Business Model
KEY THESIS
Changing Leaderships, Changing Business Philosophies: Only Time will Unfold the Outcome
Acquisition of Medpro – A Signal Indicating Change in the Global Business Strategy Domestic market Business
Table 1: Respiratory CoverageSolid Base to Enter ‘Front-End’ Marketing In Overseas Markets
Capabilities in the Respiratory Area
Table 2: Strong Manufacturing To Cater To Global Markets
Table 3:Wide Technology Platform Base Initiatives to Bring Value to the Society Continue
Accelerated Efforts in HIV/AIDS Field
Cancer Palliative Care & Training Center alliance with ‘Drugs for Neglected Diseases initiative
ANNEXURE 1: CIPLA BUSINESS SUMMARY
DR REDDY’S LAB - Focus on Complex Formulation and Biogenerics to Intensify
KEY THESIS
Products continue to contribute US business:
Products expected to drive growth in future:
Russia/CIS – Momentum Continues
Table 1: Leadership Products In Russia
Table 2: Growth Of Otc Sales In RussiaDomestic Formulations
Table 3: Growth Of Otc Sales In Russia
ANNEXURE 1: INDIAN INC- DEPENDENCE ON DOMESTIC SALES
IPCA Laboratories- Fine Chemicals to Formulation – Global Leadership in Select Products
Key Thesis
Research and Development
Domestic Formulations – Steady Growth
Anti Malarial Tender Business – Strong Outlook
Export – Formulation
WHO Prequalied Anti Malarial Producers
IPCA LABORATORIES- FINE CHEMICALS TO FORMULATION – GLOBAL LEADERSHIP IN SELECT PRODUCTS
Key Thesis
Research and Development
Domestic Formulations – Steady Growth
Anti Malarial Tender Business – Strong Outlook
Export – Formulation
WHO Prequalied Anti Malarial Producers
LUPIN PHARMA - US AND JAPAN GENERIC BUSINESS – KEY FOR LONG TERM GROWTH
Key Thesis
Japan – Supplies from India to Improve Margins
Domestic – Disappointed
Branded business
Upcoming FTF Opportunities
Generic Business – Key Highlights
R&D Investments
NATCO PHARMA - LEVERAGING CHEMISTRY, FORMULATION AND IP STRENGTHS – FOR US AND INDIA MARKETS
Key Thesis
Domestic Formulations – Oncology Focused Portfolio
API Exports
NCE Pipeline
Key Oncology drugs in Domestic Market To Add Value In coming Years
Export Formulation
SHASUN CHEMICALS & DRUGS LIMITED - ON PATH TO BECOME A FULLY INTEGRATED PHARMA COMPANY
Key Thesis
CRAMS business
Biotechnology and Nanotechnology
New facility in Development
Shasun Pharma Solutions Limited, UK
SHILPA MEDICARE - A LEADER IN ONCOLOGY API, EXPANDING INTO NON-ONCO, PEPTIDES AND COMPLEX FORMULATIONS
Key Thesis
Oncology API in Pipeline
Anti-retro viral, low margin business, competitive but sustains the cash ow
Non-Oncology APIs Under Development
Manufacturing Facilities
Research and Development
Acquisitions so far
BIOCON – BIOCON SITS COMFOR Table WITH ITS NEAR & LONG TERM CONTRIBUTORY PRODUCTS
Key Thesis
Near term growth drivers
Long term growth drivers
Branded Formulations and Contract Research Services Growing Robustly
World's rst trastuzumab biosimilar (Canmab) from BIOS
R&D Partnership Update in Fy13
Review of NCE Pipeline from BIOS
Evertor (Everolimus)-No competition yet in India
Insulin Business Update
CADILA HEALTHCARE LTD: ONE NCE LAUNCHED AND FEW IN WAITING, BIO-SIMILARS, TRANSDERMAL AND COMPLEX GENERICS LAUNCHES THRU 2016– EVENTFUL TIME AHEAD
Key Thesis
Long term Outlook visible
US business expected to grow
Additional new products will revive JV business prospects in the near term
US approval of Two Transdermal products
Complex generics other than the transdermal opportunities
Mesalamine Franchise –– A low competition opportunity for CDH
Novel dual PPAR agonist: Saroglitazar outlook
No Table NCE/NBE Pipeline review including Biosimilar
GLENMARK: COMPLEX GENERICS AND NDDS (TRANSDERMAL) WILL SHOW SIGNICANT GROWTH
Key Thesis
Business Segments Review
Indian Market Position and US and RoW Business review
Glenmark Research Capabilities
R&D Pipeline Update
PANACEA BIOTEC LTD: FINANCIAL TROUBLE MOUNTING, ACCEPTANCE OF WHO PRE-QUALICATION AND FORMULATION BUSINESS WILL REVIVE THE COMPANY
Key Thesis
Panacea has the ability to revive
Business segments review: India and International Business
Strategic Alliances
Research Capabilities
Formulation Platform Technologies Developed
Manufacturing Facilities- Regulatory Approval
WHO and UNICEF Vaccine Business Update
Nothing Much Has Changed on the Ground Following the Issue of the Guidelines
More Sophisticated Ways of Bribing Invented
Different Companies Respond Differently in ‘Tackling’ the Guidelines
Gifting Policy Changed
Gifting Policy Changed
If Enforced Effectively – Uniform Codes Can Bring Signicant Changes on the Ground ‘Lack of Will’ and ‘Cut-Throat Competition’ are Bottlenecks in Implementing Ethical
Practices
Drug Sampling Policies– Most Improved ‘Uniform Codes’ Were Not Relayed Properly to the Field Force Strong Enforcement of
Guidelines May Hamper Revenues In Beginning, But Will Balanced Out In Long Run:
Doctors Become More Cautious In Dealing With Pharma Companies Following MCI And DOP
Guidelines, Yet A Mutual Understating With Pharma Cos ‘Matures’ and Finds Ways To ‘Reciprocate’ Business:
Table 1: Domestic Sales As Percent Of Total Sales
Table 2: Alleged Nexus Among Doctors & Pharma Cos: Complain Vs. Action Trend
Table 3: Uniform Code For Marketing Practices – Deliberations Vs. Ground Reality
Table 4: Various Promotional Ways To Incur As Expenses By Pharma Companies
Other No Table Developments in Indian Pharma
ISSUANCE OF WARNING LETTERS TO INDIAN FACILITIES BY USFDA: NOT A CONCERN
Table 5: India Pharma: Fda Warning Letter Review 2010-2013
BIOSIMILAR PERSPECTIVE FOR INDIAN MARKET
Table 6: Approved Biosimilars In India
Table 7: Select Biosimilars Collaborations Till Date
Indian ‘Similar Biologics’ Guideline: Overview
DRUG DISCOVERY DEVELOPMENT IN INDIA
Table 8: NCE-MAB PIPELINE INDIAN COMPANIES
SUN PHARMA - Strong Management Team – Absolute and Comparative Advantage
KEY THESIS
Domestic market – balanced portfolio, sustainable base
Table 1: Chronic Disease Focused Portfolio Leadership in Domestic Oncology Market is Likely to be Maintained Overseas Market Business – Solid Fundamentals
Promise Future Growth
Table 2: Year Wise Approvals In The Us Derma – A pro Table Segment with High entry barrier
Table 3: Therapy Wise Approvals In The Us A Decent Base in Europe Beyond Generics - Investing in Innovation
Improving Generics
True Innovation
Annexure 1: History Of Creating Value Through Executing Value Assets
CIPLA: Major Change in Business Model
KEY THESIS
Changing Leaderships, Changing Business Philosophies: Only Time will Unfold the Outcome
Acquisition of Medpro – A Signal Indicating Change in the Global Business Strategy Domestic market Business
Table 1: Respiratory CoverageSolid Base to Enter ‘Front-End’ Marketing In Overseas Markets
Capabilities in the Respiratory Area
Table 2: Strong Manufacturing To Cater To Global Markets
Table 3:Wide Technology Platform Base Initiatives to Bring Value to the Society Continue
Accelerated Efforts in HIV/AIDS Field
Cancer Palliative Care & Training Center alliance with ‘Drugs for Neglected Diseases initiative
ANNEXURE 1: CIPLA BUSINESS SUMMARY
DR REDDY’S LAB - Focus on Complex Formulation and Biogenerics to Intensify
KEY THESIS
Products continue to contribute US business:
Products expected to drive growth in future:
Russia/CIS – Momentum Continues
Table 1: Leadership Products In Russia
Table 2: Growth Of Otc Sales In RussiaDomestic Formulations
Table 3: Growth Of Otc Sales In Russia
ANNEXURE 1: INDIAN INC- DEPENDENCE ON DOMESTIC SALES
IPCA Laboratories- Fine Chemicals to Formulation – Global Leadership in Select Products
Key Thesis
Research and Development
Domestic Formulations – Steady Growth
Anti Malarial Tender Business – Strong Outlook
Export – Formulation
WHO Prequalied Anti Malarial Producers
IPCA LABORATORIES- FINE CHEMICALS TO FORMULATION – GLOBAL LEADERSHIP IN SELECT PRODUCTS
Key Thesis
Research and Development
Domestic Formulations – Steady Growth
Anti Malarial Tender Business – Strong Outlook
Export – Formulation
WHO Prequalied Anti Malarial Producers
LUPIN PHARMA - US AND JAPAN GENERIC BUSINESS – KEY FOR LONG TERM GROWTH
Key Thesis
Japan – Supplies from India to Improve Margins
Domestic – Disappointed
Branded business
Upcoming FTF Opportunities
Generic Business – Key Highlights
R&D Investments
NATCO PHARMA - LEVERAGING CHEMISTRY, FORMULATION AND IP STRENGTHS – FOR US AND INDIA MARKETS
Key Thesis
Domestic Formulations – Oncology Focused Portfolio
API Exports
NCE Pipeline
Key Oncology drugs in Domestic Market To Add Value In coming Years
Export Formulation
SHASUN CHEMICALS & DRUGS LIMITED - ON PATH TO BECOME A FULLY INTEGRATED PHARMA COMPANY
Key Thesis
CRAMS business
Biotechnology and Nanotechnology
New facility in Development
Shasun Pharma Solutions Limited, UK
SHILPA MEDICARE - A LEADER IN ONCOLOGY API, EXPANDING INTO NON-ONCO, PEPTIDES AND COMPLEX FORMULATIONS
Key Thesis
Oncology API in Pipeline
Anti-retro viral, low margin business, competitive but sustains the cash ow
Non-Oncology APIs Under Development
Manufacturing Facilities
Research and Development
Acquisitions so far
BIOCON – BIOCON SITS COMFOR Table WITH ITS NEAR & LONG TERM CONTRIBUTORY PRODUCTS
Key Thesis
Near term growth drivers
Long term growth drivers
Branded Formulations and Contract Research Services Growing Robustly
World's rst trastuzumab biosimilar (Canmab) from BIOS
R&D Partnership Update in Fy13
Review of NCE Pipeline from BIOS
Evertor (Everolimus)-No competition yet in India
Insulin Business Update
CADILA HEALTHCARE LTD: ONE NCE LAUNCHED AND FEW IN WAITING, BIO-SIMILARS, TRANSDERMAL AND COMPLEX GENERICS LAUNCHES THRU 2016– EVENTFUL TIME AHEAD
Key Thesis
Long term Outlook visible
US business expected to grow
Additional new products will revive JV business prospects in the near term
US approval of Two Transdermal products
Complex generics other than the transdermal opportunities
Mesalamine Franchise –– A low competition opportunity for CDH
Novel dual PPAR agonist: Saroglitazar outlook
No Table NCE/NBE Pipeline review including Biosimilar
GLENMARK: COMPLEX GENERICS AND NDDS (TRANSDERMAL) WILL SHOW SIGNICANT GROWTH
Key Thesis
Business Segments Review
Indian Market Position and US and RoW Business review
Glenmark Research Capabilities
R&D Pipeline Update
PANACEA BIOTEC LTD: FINANCIAL TROUBLE MOUNTING, ACCEPTANCE OF WHO PRE-QUALICATION AND FORMULATION BUSINESS WILL REVIVE THE COMPANY
Key Thesis
Panacea has the ability to revive
Business segments review: India and International Business
Strategic Alliances
Research Capabilities
Formulation Platform Technologies Developed
Manufacturing Facilities- Regulatory Approval
WHO and UNICEF Vaccine Business Update
