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Presentation at CPhI,Shanghaiby
ORS RaoCEO and DirectorCygnus Business Consulting & Research (www.cygnusindia.com)INDIA20th June 2007
Pharmaceutical Industry Pharmaceutical Industry in Indiain India
2
Agenda• Industry Segments
– Pharmaceuticals
– Biopharmaceuticals
– Bulk drugs and APIs
– Contract Research and Manufacturing Services (CRAMS)
• Other related Segments
– Traditional Systems of Medicine
– Healthcare Industry
– Dental Industry
• Major Players
• Mergers & Acquisitions
• Opportunities
• Issues and Challenges
• Future Outlook
• China and India - Competition or collaboration?
• About Cygnus
3
Industry Scenario
4
5.746.57
7.42
4.54 5.12
012345678
2002 2003 2004 2005 2006
USD
bn
0%
5%
10%
15%
Market size (LHS) Grow th rate (RHS)
Source: Cygnus Research
Indian Pharmaceuticals Industry over years
The industry has grown at a compounded annual growth rate (CAGR)of 13% during the last five years.
5
Pharmaceuticals Industry - 2006
• Amongst Global pharmaceutical producers, India ranks 4th in volume terms and 13th in value terms.
• Indian pharmaceutical market - USD7.42 billion in 2006 (Growth rate 12.9% over previous year).
• Domestic market contributed USD2.61 billion and exports touched USD 4.81 billion (65% of the market).
• About 65% of bulk drugs and 6% of formulations are imported and balance requirements met from domestic manufacturing.
• Out of the total formulation sales, about 90% is accounted by generics, balance being patented drugs.
• Generics segment grew by 13% to USD5.89 billion in 2006. Patented drugs sale was USD389.36m in 2006 growing at a rate of 18.9% over the previous year.
6
Production
Bulk Drugs
Growth – 19%
Formulations
Growth – 13%
Generics
Market Size-USD 5.89 bn
Growth – 13%
Patented Market Size-USD 390 mn
Growth – 19%
Exports -Products
Size- USD 4.81 bnGrowth – 17.5%
Bulk DrugsMarket Size-USD2.48 bn
Growth – 21%
FormulationsMarket Size-USD2.33 bn
Growth – 14%
Exports-Services
USD- 1030 mnGrowth – 45%
Contract ManufacturingMarket Size-USD 660 mn
Growth – 48%
Contract Research
Market Size-USD 140 mn
Growth – 45%
Clinical Trials& CDMSize-
USD 230 mnGrowth – 40%
Indian Pharmaceutical Industry
Market Size USD7.42 bnGrowth -12.9%
Pharmaceuticals Industry Value Chain
7
• In 2006, R&D expenditure of 50 major companies totaled USD495.19m , growth of 26% over previous year.
• FDI in pharma industry was USD172m in 2006, growing at a CAGR of 62.6% during the last four years.
• Contract Research (including clinical trials &CDM) during 2006 is estimated to be USD366 million, a growth of 45 % over previous year
• Contract manufacturing in 2006 was USD659 million and growing at 48% over pervious year
• Bio Pharma market is valued USD 1.3 million. Vaccines are the largest segment of Biopharma accounting for 50% of the sectoral revenue.
Indian Pharmaceuticals Industry - 2006
8
Anti-infectives14.70%
Dermatology5.40%
CNS5.40%
Gynaecology5.00%
Anti Diabetics4.60%
Vitamins / Food
supplements9.20%
Analgesics9.60%
Respiratory10.50%
Others13.80%
CVS11.10%
Gastro Intestinal10.70%
Therapeutic segmentation
Source: Cygnus Research
Anti-infectives,CVS and Gastro-intestinal- top 3
Indian Pharmaceuticals Industry - 2006
9
Top 5 market segments – India versus other regions
Anti-infectives dominate the Indian pharmaceutical market whereas lifestyle disorders dominate in other major markets
Country - wise major segmental Pharma market and contribution (%) to total market - 2006
7.8 10.5 8.614.3 14.7
18.820.0
17.2 9.1
13.9
11.1
13.614.1
14.6 18.7
16.5
10.7
9.411.8
9.6
10.5
9.6
22.83
8.2 16.09
12.27
15.35
8.88.4 11.59
27.5
38.5 35.1 33.8 33.0
43.4
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
US Japan Germany Mexico Brazil India
Anti-infectives CVS Alimentary/ Metabolism Respiratory Analgesics CNS Cytostatics Genito-Urinary Others
10
Indian Generic Market
• India has 6 Companies amongst top ten filers of ANDAs
• Over 80 US FDA approved facilities, largest outside of USA and 20 other certified plants
• Adopting Global Standards for growth and sustainability
• Investment in R&D increased from 3% of gross revenue to 10%
• Increase in capacities with focus on Vertical Integration
11
• Indian API manufacturing industry is the third largest in the world with sales of US$3.29 billion in 2006 , expected to touch USD6.5billion by 2010, at a CAGR of 19%.
• 7 Indian Companies among top ten filers of DMFs in 2006 ( 30% by approvals and 58% by new applications ) and cumulative share in the global DMFs at over 14%
• India has 4354 manufacturing units which produce a range of formulations (top 200 – over 70% of market)
• 1333 bulk manufacturing units producing around 465 main bulk drugs. (top 100 –over 70%)
Indian Bulk drugs/API Industry- 2006
12
DMFs Filed in US by Leading Indian Companies in 2006
103 9987
8071
50
0
20
40
60
80
100
120
Dr.Reddy's
Aurobindo Cipla Ranbaxy Matrix Lupin
DM
Fs F
iled
in 2
006
13
Top Export Products in 2006
Russia, USA, Nigeria, Brazil, UK, Israel 24.1Ciprofloxacine in capsules and Tablets forms
10
USA, Russia, Germany, UK, Brazil 24.5Captopril, Enalapril, Lisinopril, Perindopril and Ramipril
9
Nigeria, Nepal, Brazil, Turkey, Angola 24.6Ampicillinein capsules, injections etc.8
Russia, USA, Brazil, Ukraine, Ireland 25Ciprofloxacin (Fluoroquinolones)7
UK, Ukraine, Malawi, Kazakhstan, Netherland 30Verapamil, Nifedipine, Amlodipine and Lacidipine
6
USA, UK, Ireland, Afghanistan, Russia 32Cimetidine, Rantidine, Nizatidine and Roxatidine
5
UK, Finland, Russia, Nigeria, Guinea 33Analgin with or without other compounds such as Paracetamol
4
UK, Nigeria, USA, South Africa, Ghana 54Ibuprofen with or without Paracetamolor Other Compounds
3
Russia, UK, Algeria, Bangladesh, Vietnam58Omeprazole and Lansoprazole2
USA , Nigeria, South Africa, Netherland, UK 755Amoxycyllinin capsules, injections etc.1
Top 5 DestinationsExport in 2006 (USD million)
Name of the DrugRank
14
Major players in India- 2006
05
1015202530354045
Ran
baxy
*
Dr.
Red
dy's
Cip
la
Lupi
n
Nic
hola
s Pi
ram
al
Sun
Phar
mac
eutic
als
GSK
Cad
ilaH
ealth
care
Auro
bind
o
Woc
khar
dt*
Turn
over
(Rs.
bn)
Source: Company Annual Reports FY2006-07, * Annual Reports 2006 Dec ending
15
Market structure
Raw materials/ Chemical intermediates manufacturers
API manufacturers
Formulation manufacturers
Distributor/ Dealer
C&F agents
HospitalsRetailers
Importers
Patients
Indian Pharmaceutical Market Structure
16
Bio-Pharmaceuticals• Bio Pharma market is valued USD 1.3 million in 2007.
• Vaccines is the largest segment of Biopharma accounting for 50% of the sectoral revenue.
• India is leader in global vaccine market (over 33% market as per E&Y 2007 report) . India is the largest producer of recombinant Hepatitis B vaccine in the world
• Vaccines market in India in 2007 was USD 0.65 million registering a 40.26% growth over the previous year.
• Diagnostics contributed 19% with USD 0.25 million market size in 2007 ,over 50% growth over previous year.
• Therapeutics, 3rd largest contributed 14% of the total biopharma sales –USD 0.18 million in revenues, growth of 28% in 2007.
• In 2007 Biopharma contributed USD 0.65 million worth exports.
17
Biopharmaceuticals industry – major players
• Serum Institute of India was the largest biopharma company recording revenue of USD 168 million in 2006. Major products include rubella, MMR and BCG vaccines .
• Biocon occupied the second position with a turnover of USD 164 million in 2006. However, in 2007 its turnover is Rs 208 million
• Panacea was the third largest company with revenues of USD 104 million
• Venkateshwara Hatcheries was the No 4 company with revenues of Rs 66million in 2006 and USD 100 million in 2007.
18
Contract Research and Manufacturing Services (CRAMS) in India
• Contract Research (including clinical trials and CDM) during 2006 is estimated to be USD 366 million, a growth of 45 % over previous year and is expected to scale up to USD 2.5billion by 2011
• Contract manufacturing in 2006 was USD 659 million and growing at 48% over pervious year and expected to be worth USD 2.5 billion in India by 2011.
19
CRAMS - Major Players
• Contract manufacturing:– Large Pharma companies - Ranbaxy, DRL, Wockhardt, Cipla, Nicholas Piramal
and Lupin – covering formulations, APIs, generics, NDDS, NCEs and biopharma– Medium sized companies - Focused contract mfg companies- Matrix Labs,
Shashun , Strides Arocolabs, Cadila, Jupiter biosciences, Jubilant Organosys, Orchid Pharmaceuticals, Dishman, IPCA, and Divis Labs - contract manufacturing of APIs for global MNCs.
• Contract Research:– Large Companies – dedicated units/companies – Medium sized CROs - Chembiotek (TCG Group), Reliance Research and
Development Services
• Integrated contract Research and contract mfg – synergy• Strategies followed
– International certifications of plants – FDA/MHRA– Acquisition of mfg plants abroad – for customer acquisition (Dr Reddys,Nicholas)
20
Clinical Trials - Major Players
• MNC CTOs ,like Quintiles
• Indian CTOs– Large Pharma companies – independent
units/companies- Wellquest (NPIL), Clingene(Biocon), SRL Ranbaxy, Lambda, (Intas)
– Corporate hospitals – Apollo, Manipal Acunova
– Independent/stand alone – Vimta Labs, Asian clinical Trials ,Metroplois
21
Clinical Data Management
• Management of clinical trial data• Needs multi-disciplinary skills (IT/Clinical
terminology/Physician)• Current market- USD 100 mn, growing 80% per
annum• Indian players
– IT companies ( IBM, TCS, Cognizant, Satyam, HCL, Infosys)– Clinical trial companies (Quintiles,Manipal Acunova)
22
Source: Cygnus Research
Traditional Medicine Market Size, 2004 (USD m)
333.3
0.59.5
57.2
Ayurveda
Homeopathy
Unani
Siddha
Indian Traditional Medicine System (ISM) -2006
• ISM market for products in India in 2006 – USD 400m, grew at 8%
• Over 82% of it - Ayurveda, 14% Homeopathy and balance by others.
23
Indian Healthcare Services
•Market is growing at an annual rate of 18%.
•The private sector accounts for 86% of the market while public sector accounts for the balance.
•The health tourism industry in India, worth US$333 million, is expected to rise to US$2,200 million by 2011.
Indian Healthcare market size
28.9 32.339.0
47.355.7
0
20
40
60
2002 2003 2004 2005 2006
USD
bn
Source: Cygnus Research
24
Indian dental care services market size
5.4
8.910.2
11.5
0
2
4
6
8
10
12
14
2003 2004 2005 2006
USD
m
Source: Cygnus Research
•The services market is growing at 12% annually
•The Indian dental equipments and appliances market size was US$66m in 2005.
•India is a net importer of dental equipments and supplies. India’s major dental products for import are dental furniture (US$9.76m in 2006) followed by dental cements (US$6.71m) and radiation apparatuses (US$5.39m).
Indian Dental care Services
25
India Competitive Advantage
• Significant depth in engineering and science• Lower cost of innovation and highly motivated scientists.• Large pool of English speaking employees, a comfort for
international customers and regulatory agencies• Low cost scientific pool on shop floor leading to high
quality documentation and process understanding• Outsourcing services culture• Global business management skills (including patents
and legal aspects)
26
Trends in the Industry
• Research & Development – Indian companies are focusing on new product development by increasing the R&D spending on generics. In the next three years blockbuster drugs worth US$26.5billion are set to go off patent in US alone.
• Therapeutic coverage –Indian companies are enhancing the coverage of as many therapeutic areas as possible.
• Marketing – Large companies have been setting up sales operations / partnerships in developed markets
• M&A – Large companies have been acquiring companies in US, Latin America and Europe ,with a focus on customer acquisitions.
• Focus on services – Small/Medium sized companies focusing on niche services markets
27
Regulatory bodiesNational Pharmaceutical Pricing Authority (NPPA)Organization of the Government of India
• Established in 1997
• Revises the prices of controlled bulk drugs and formulations
• Enforces prices and availability of the medicines in the country
• Recovers amount overcharged by manufacturers for the controlled drugs from the consumers
• Monitors the prices of decontrolled drugs in order to keep them at reasonable levels
Central Drugs Standard and Control Organization(CDSCO)Functions under the Directorate General of Health Services
• Established in 1940
• Laying down standards of drugs, cosmetics, diagnostics and devices
• Laying down regulatory measures, amendments to Acts and Rules
• Regulates clinical trials & market authorization of new drugs
• Approve licenses to manufacture certain categories of drugs
• Regulate the standards of imported drugs
• Testing of drugs by Central Drugs Labs
• Publication of Indian Pharmacopoeia
Department of Chemicals & Petrochemicals (DCP)Functions under the Ministry of Chemicals & Fertilizers
• Established in 1991
• Responsible for the policy, planning, development, and regulation of the chemical, petrochemical, and pharmaceutical industries in India
28
Key regulations
Regulates the profession of pharmacy and deals with various pharmacy issues such as professional education and requirements for registration
The Pharmacy Act, 1948
Prohibits the advertising of remedies alleged to possess magic qualitiesDeals with levy and collection of taxes on medicinal and toilet preparations containing alcohol, opium, Indian hemp, or any other narcotic drug
The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954
DPCO, 1995 is an order issued by the GoI under Section 3 of the Essential Commodities Act, 1955 to regulate the prices of drugsCurrently 74 bulk drugs and their corresponding formulations areunder price control
The Drugs Price Control Order (DPCO), 1995
Regulates import, manufacture, distribution and sale of drugs and cosmetics whether imported or made in India
The Drugs and Cosmetics Act, 1940
Ministry of Health & Family WelfareDirectorate General of Health Services
Recognition of product patents for food, drug, and pharmaceuticals from January 1, 2005
Patents (Amendment) Rules, 2005
29
Recent Mergers and Acquisitions in Indian Pharma Industry
• Indian companies acquiring global firms to consolidate their overseas presence.
• Major giants like Ranbaxy, Dr.Reddy’s, Dishman and Wockhardt top the list with major acquisitions
• Major contracts are also signed in the CRAMS segment
• Acquisition of CROs in Europe to leverage on existing client relationships of acquired companies
• These acquisitions help in bridging the gaps in the services offered to become full service industry players.
• Industry benefited by acquisitions in terms of gaining access tonew technologies, platforms for improving custom synthesis, clinical research and working with new clients.
30
Recent Mergers and Acquisitions in Indian Pharma Industry
Source: Cygnus Research
Jun-05263Docpharma (Belgium)Matrix
Nov-0559Roche's API Business (Mexico)Dr. Reddy's
Active pharmaceutical ingredient (API)
Aug-0510Valeant Pharma (2 facilities) (Hungary, US)
Dec-0524Able Laboratories (US)Sun Pharma
Branded formulation
Oct-0534Target Research Associates (US)Jubilant Organosys
Feb-0613Milpharma (UK)Aurobindo
Mar-06-Allen Spa (Italy)Ranbaxy
Mar-06-Ethimed NV (Spain)Ranbaxy
Mar-06324Terapia (Romania)Ranbaxy
Feb-06574Betapharm (Germany)Dr. Reddy's
Generics
DateValue USD millionTargetAcquirer
Major acquisitions by Indian companies
31
Major Agreements Signed in CRAMS Segment
Source: Pharma Summit 2006/KPMG
CCS for 3 moleculesEli LillyJubilant Organosys
API for AcyclovirGSKMatrix
API for CephalosporinsDSMLupin
Two intermediates for PantaprazoleIntermediates for 8 oncology products
AltanaMayne
Cadila (through JV)
API for Eposaratan MesylateIntermediates for EsomeparzoleIntermediates for 3 productsIntermediates for 3 products
SolvayAstraZenecaGSKMerck
Dishman
NAAbbottDivi's Lab
API for RanitidineAPIs for Nizatidine and CyclosorineAPI for Ibuprofen
GSKEli LillyBoots Plc
Shasun Chemicals
Neutralizing tabletsAPIFormulations for many productsAPIs & Intermediates for many productsAPIs for many productsAPIs/formulations for Veterinary productsAPIs & Intermediates for many products
AMOAllerganFortune 500 companyAstra ZenecaGlobal hospital products companyPfizerAstraZeneca
Nicholas Piramal
AreaInnovatorCompany
32
Opportunities
33
Pharmaceuticals
• Growing Generics – A strong generic market in India is a favouable destination for many MNCs
• Low- Cost Manufacturing Skills – Indian manufacturers offer low cost in producing complex synthesis within short frame of time. The sharp decline in generic prices raises the importance of low-cost manufacturing even further.
• World class practices – Majority of the Indian firms comply with cGMP standards. India has the largest number of USFDA approved manufacturing sites (about 80) outside the US
• EMR in US - Indian companies have been able to win rights on blockbuster drugs. For instance Ranbaxy received 180 day exclusivity (80gm.) for Simvastatin and Dr.Reddy's became the authorized generic for Merck for Zocor.
34
CRAMS & Clinical Trials
• India is fast becoming a leading destination for CRAMS with advantages like cGMP and FDA compliant facilities, manufacturing capabilities, R&D base, superior information technology capability, cost efficiency and pool of skilled personnel.
• There is an increasing visibility in the Contract Research and Manufacturing Services (CRAMS) space, which is being considered as the next emerging and scalable opportunity for the Indian pharma industry.
• India is fast becoming a hub of pharmaceutical outsourcing thanks to its cost and quality advantage. Not only manufacturing, but research contracts and clinical trials are coming into India.
35
India’s advantage as a clinical trials center
Cardiovascular disease and stroke cause three million deaths peryear in India. Incidence of diabetes, lung cancer, and oral cancer are also rising, while a wide variety of infectious diseases are endemic
Variety of diseases carried by population
Data, from trial patients who are already taking drugs for the condition, is difficult to interpret. Patients on drugs for other conditions may also suffer from drug interactions, again complicating data analysis. Patients in India rarely fit these descriptions, providing a more specific and qualified patient pool.
Treatment-naïve population
Highly qualified principal investigators and trained clinical research staff are available.
Qualified human resources
The high population density facilitates speedy recruitment of patients into trials, which shortens the entire trial process.
Rapid recruitment process
Several ethnic populations coexist in India, allowing greater insights into genetic components of disease.
Diverse ethnic pool
A trial in India leads to cost savings of over 60% compared to US and European trials.
Low CostBenefits Parameter
36
Issues and Challenges
37
Pharmaceuticals
• Domestic market – price controls on several drugs. The draft New Drug Policy intends to bring an additional 354 drugs under price control. Drug prices in India are already amongst the lowest in the world
• Sustainability of growth in exports: in the face of competitive pricing pressures , high cost of international marketing and increasing salaries of employees
• Logistics infrastructure : under pressure
• R&D Expenses: Continuous rise in R&D expenditure puts pressure on the industry to increase productivity.
• Dominating generic drugs: Indian companies are more focused on generics whereas branded drugs market is yet to be fully captured
38
Bio Pharmaceuticals
• Human Resources - Biopharma is an emerging knowledge-driven industry and requires specific skill sets for product development and marketing .
• Products - Identifying the right unmet need of products and alliances is challenge. Faster commercialization of the product is very important.
• Early stage funding – Non availability of large VC/angel funding
39
Quick adoption ofnew technology
High chemistryand processreengineeringskills
Low costmanufacturing
Fast changinglifestyles
Matured Industry / Large home market
Strength
Highly fragmentedindustry
Investments in R&D
Characterized by low margins
Lack of productpatents
Lack of pricingpower impactsgrowth
Weakness
Establish as a global sourcing hub
Large number of drugs going off patent
Opening of OTCsegment
Product patentprotection from 2005
Emerging biologics opportunities – India gearing up.
Changing demographicand socio economicprofile
Potential to absorb high priced products
Opportunities
Internal fragmentation
Non tariff barriersChina
2005 IPR regime implies drying up ofproduct pipeline forIndian companies
Threats
Indian Pharmaceutical Industry
40
Future Outlook
41
Indian Pharmaceutical Market Projections
8.47
12.9414.70
9.77
11.26
0
5
10
15
20
2007 2008 2009 2010 2011
USD
bn
Source: Cygnus Estimates
42
Indian Pharmaceuticals by 2011…• Expected to double to USD14.7billion
• Domestic market driven by :– Aging population,
– Increase in consumption of life style disorder drugs,
– Improving healthcare awareness of the economically growing population
– New product launches
• Exports to grow at 20% CAGR .
• Contract research to India to grow to US$2 -3 billion (2-3% of global R$D spend)
43
Generics Segment• Mergers of Pharmacies, wholesalers – increasing bargaining
power, Corporate mergers, Restructuring of product sourcing / supply chain .
• Value to drift towards cost efficient, low cost countries.
• Significant business in less regulated market or old generics -with scale and technology superiority
• New Generic opportunities are becoming highly complex and the business shall migrate to strong India R&D players
• The diversity of product dosage forms, strengths, packaging and regulatory challenge across continents offers a competitive advantage for modern Indian companies.
44
Biopharmaceuticals
• India's fledging biotech industry is expected to grow still further to reach a value of approximately USD5.37 billion in 2010
• Revenues of Indian Biopharmaceuticals are expected to reach approximately US$3.90 billion by 2010
• Monoclonal antibodies, human and animal biologics will be the limelight products in the future.
• The areas of clinical trials, contract research and government support will be the future growth drivers for the industry.
45
CRAMS
• Contract Manufacturing and Contract Research are expected to scale up to USD2.5billion and USD1.5billion respectively by the same period
• Growth in Contract Research will be driven by the vast pool of abundant English-speaking manpower skilled in chemistry and biotechnology.
• A sharp increase in Clinical Trials activities due to large subject pools in all major therapeutic areas, improved healthcare infrastructure, increased awareness of the ICH Guidelines for Good Clinical Practice (GCP) and availability of specialized pool of research investigators.
46
China and India – competition or co-operation?
Focus onEarly Stage intermediatesLarge Volume API mfg Expertise in Fermentation
•Large scale production capacities•Low cost production•Better logistics infrastructure
Focus onLate stage IntermediatesComplex Synthetic APIs(Custom Synthesis)Dosage Form Manufacture
•R&D led generics industry•Global Sales organisations•M&A capability
ChinaIndia
China is an important source of chemical and APIs , whereas India is stronger on the finished product / formulation side.
•India - second largest export destination for bulk drugs/APIs for China (after US) and exports to India grew at 42% in 2006 ,whereas exports to US grew at 9%
•China and India can collaborate - CHINDIA can lead the world pharma market !!!
47
About us• Cygnus in Latin means “SWAN” - a symbol of purity and
swiftness. As per Hindu mythology, it is the heavenly bird that separated milk from water.
• Cygnus stands for :*Quality *Speed *Innovation * Satisfaction of its
stakeholders (Employees and customers)• A Knowledge Products/services Organization
– focused on : Knowledge creation, dissemination and deployment– for profitable growth of its customers
• Market, People and Process driven • 4 years old ,95 employees and 9 offices in India • Over 600 customers across the globe• Growing @ CAGR of over 50% (last 3 years)
48
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Company: Cygnus Progress – Indian Company Intelligence on 2500 listed Indian companies Company profiles (Top 200 Pharma companies)
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KNOWLEDGE PRODUCTS
49
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50
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