Vaccine industry overview
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  • The system used for keeping and distributing vaccines in good condition is called the 'cold chain‘…This consists of a series of storage and transport links, all of which are designed to keep the vaccine at the correct temperature until it reaches the user
  • Risks to vaccines of exposure to extremes in Temperature Compliance with vaccine manufacturer Assurance/confidence in potent product Ensuringmaximum benefit from immunisation
  •  it’s not just about developing safe and effective vaccines. It’s about getting vaccines to the right place, at the right time, in the right conditionThe 6 listed vaccines are sold at between Re 1 and Rs 1.50. For vaccine companies, big and small alike, making money at such price points, after high import duties on raw materials, most of which have to be imported, and an expensive production and distribution process, is getting to be a near impossible proposition. Thermostable vaccines
  • there is a global shift in attitudes in the Pharma industry toward disease prevention, rather than treatment.
  • A vaccine must be licensed first by the appropriateauthority for the use in the country. The vaccines/drugs licensing authority in India, i.e. NationalRegulatory Authority (NRA) is Drugs ControllerGeneral of India (DCGI) which is approved byWHO also. For licensing of a new vaccine, thevaccine manufacturer should conduct thephase I, II,and III trials and must submit their results to NRA forits approval.There are both central and state licensingauthorities. Good clinical practice (GCP) and ethicalguidelines (by ICMR) for approval exist. Licensingof products in India is by the Central LicensingApproval Authority (CLAA). The Drug TechnologyAdvisory Board (DATB) approves introduction ofvaccines into the immunization services, while allvaccine approval and clinical trials is by the CLAA.The state licensing authority inspects and grantslicensing for retail.
  • Long being regarded as an unattractive market, vaccines have re-emerged as successful growth driver for Big Pharma. The launch and rapid uptake of novel, high-price products such as Wyeth's Prevnar or Merck & Co's Gardasil, along with the emergence of novel vaccine technologies and favourable legislation have brought vaccines back into the main focus of pharmaceutical and biotech companies.
  • On launch, there is typically only one producer, who owns product and processintellectual property. This phase will have limited capacity, low demand, highproduction costs and high prices. During market penetration, new manufacturers willenter the market, either through their own development efforts or through licensing ofthe original manufacturer’s patent, and capacity will increase. Limited price tieringwill be possible. Once the product reaches maturity and the intellectual propertyprotection expires, there may be many manufacturers, both in the developing as wellas the industrialized world. Production costs are low and often there will beovercapacity so that availability is high and demand is global. Prices will be heavilytiered. 30
  • Wyeth and shanthabiotechnics
  • 2 things to notice—R&D , top product
  • India represents one of thr fastest growing vaccines market in the worldIt is currently the centre of attraction for all leading pharma majorsBirth of 24 million babies each year provides a big market for vaccinesGrowth more than traditional medicines
  • An estimated two out of every three immunised children in the world have received a vaccine manufactured by the Serum Institute. As the risk of global pandemics grows, so does the potential market for new vaccines
  • Small no of companies
  • 6 in one..reduces the number of vaccines the child has to take…tetanus, pertussis, hep b, polio, influenza, diphtheria
  • Cadi 05 skin cancer
  • New methods of vaccine delivery needle free patches, edible vaccine, nasal
  • The advent of Gardasil (Merck/sanofiaventis) and Cerverix (GSK) in the prevention of cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV), are a turning point in the history of vaccines. After Wyeth’s success with Prevnar, the first ever vaccine blockbuster, Gardasil (and second-in-line Cervarix from GSK) will compete for market penetration and market share in a totally new area in which itconfers 100% protection and hence create huge demand among the population at riskPublic organization like WHO, UNICEF as well as public-private alliances like GAVI are constantly working for spreading awareness and increasing the coverage of immunization.Emerging diseases like HPV, rotavirus, pneumococcal and meningococcal diseases are one of the major driving force of the market.Global funding mechanisms like Internatinal Finance Facility for Immunization and Advance market commitments have accelarated the development and manufacture of vaccines in developing countries
  • Regulation --NRA
  • With the exception of influenza, only two to three vaccine manufacturers compete for each disease. This lack of competition combined with public health requirements to guarantee a stable supply of vaccines has resulted in a recent upward shift of vaccine prices for specialty vaccines.
  • Prevent disease- reduces future cost, cost effective
  • The DCGI is the Central Licensing Approving Authority (CLAA) under the MinistryVaccine park in chennai
  • therapeutic vaccines, newer adjuvants Vaccines Effective Against More Strains, Towards a Universal Influenza Vaccine,The Need for an Improved Tuberculosis Vaccine
  • Khhannamgardasilapbarodacervarix rural areas Misinformation about Side-Effects of Vaccines Controversy Surrounding Mercury-Containing VaccinesCampaigns Against Cervical Cancer Vaccines
  • The main future opportunities lie in the pneumococcal, meningococcaland HPV vaccine sectors, where there is a large medical need for better products. For pneumococcal and HPV vaccines, candidates offering a higher subtype coverage than existing products can be expected to yield excellent returns
  • A lot of advancements are taking place in the field of biotechnological research and manufacturing technologies which will play a dominating role further developments of this industry.
  • Adjuvants are substances that help avaccine to produce a strong protective response. They can also reduce thetime the body takes to mount a protective response and can make the immuneresponse more broadly protective against several related pathogensMany vaccines are formulated with adjuvants, which help modulate and stimulate the immune response (9). These compounds bind to the vaccineand aid retention at the site of injection or delivery to the lymph nodes. As a result, the release of the antigens to the surrounding tissues is slowed and a stronger immune response is achieved than would be generated by the vaccine alone. The predominant adjuvants are ‘alum’- based, containing a mixture of aluminum salts. However, there are novel adjuvants under investigation that can provide benefits over alum, such as the technology developed by Antigenics: QS-21, an adjuvant derived from tree bark (10). conjugation allows scientists to link (conjugate) the sugar moleculeson the outer envelopes of certain bacteria – such as the pneumococcus, themeningococcus, and the Hib bacterium – to strongly immunogenic “carrier” proteins.e.g. Prevnar (Wyeth), Menactra (Sanofi Pasteur)
  • An alternative to conventional vaccines is DNA vaccines, of which there is currently several in development.
  • Immunizations in India are currently restricted to a limited public vaccination schedule, with the insufficient healthcare infrastructure in rural areas contributing to low coverage rates. Commercial opportunities lie in providing premium vaccines to the emerging private sector and in partnering with domestic players.

Vaccine industry overview Vaccine industry overview Presentation Transcript

  • VACCINE INDUSTRY : PRESENT AND FUTURE Naveen Kumar
  • Flow of Presentation  Introduction  Vaccine Industry: An Overview  Growth Drivers  Challenges and Issues  SWOT  Company watch  Future Perspective  Further Developments  conclusion2
  • 3
  •  Every year 3 million deaths are prevented and 750,000 children are saved from disability by vaccines(WHO)  Why do we need vaccine?  Common communicable diseases  Geographic variation in disease spread  Every 1$ invested in childhood vaccine save 18$  Increased life expectancy to economic growth4
  • VACCINES  “A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. Vaccines include, for example, suspensions of killed or attenuated microorganisms, or products or derivatives of microorganisms.”- WHO.5
  • Vaccines vs Pharmaceuticals Vaccines Pharmaceuticals Regulatory Focus on prevention – not patients,  Focus on treatment – patient is but healthy subjects generally sick Key role for the government agencies  Key role for healthcare players  Very low acceptance of side effects  Acceptance of side effects varies by severity of disease Manufacturing  High manufacturing and supply chain  Medium manufacturing and supply complexity chain complexity (Cold Chain Management, complex (Easier to handle chemical synthesis biological processes) in most cases) Marketing/ Sales  Small Massive sales force commitment  Major sales through government Sales through physician as prescriber  Very few generic products Increasing generic threat (Due to manufacturing complexity)6
  • A Typical Cold Chain7
  • 8
  • Problems in supply chain  Tight price competition  Damage to vaccines during transportation - Storage problems  Due to less financial incentive from govt. to manufacturers – insufficient doses  Demand uncertainty  Manufacturing interruptions - required to maintain cGMP standards so high product rejection rate - supply can be impacted9
  • Vaccine MRP, in `, Price offered Discount in Percentage 2008 (A) to physicians, `(A-B) Margin of in ` (B) profit for the physician (A- B)*100/ BPentaxim 2066 1446 620 42.9Imovax Polio 365 280 85 30.4Tripacel 1211 762 449 58.9Okavax 1468 986 482 48.9Avaxim 80 952 665 287 43.2TetractHib 504 305 199 65.2ActHib 10 426 251 175 69.7
  • 11
  • STAGES OF VACCINE DEVELOPMENT Total time of development 12 - 15 years (Total Investment US$ 500mn – 1bn)12
  •  76 US-FDA approved vaccines  There are now 145 pure vaccines and 11 combination vaccines in clinical development  Five major players–GlaxoSmithKline, Merck, Sanofi-Aventis, Pfizer and Novartis  Vaccines approved by FDA in 2010 : Provenge, Prevnar 13, and Menveo13
  • Vaccine segments Human vaccines Pediatrics Adolescents Adults Elderly14
  • Global vaccine sales($ billion) 30 25 20 15 28 26 24 10 18 5 0 2007 2008 2009 201015
  • Major markets Country Sales, 2008 Market share ($ mn) 2008(%) US 4741 42.7 Germany 1755 15.8 Japan 911 8.2 France 835 7.5 Italy 303 2.7 Spain 198 1.8 UK 176 1.616 Source : Business insights, 2008
  • Global vaccine leaders(2010) Company Sales($ billion) GSK 6.50 SA 5.14 Pfizer 3.7 Merck 3.5 Novartis 2.9 SP-MSD 1.217 Source : Global Vaccine Market 2010 , Krishan Maggon
  • Global vaccine leaders Others GSK SP-MSD 21% 23% 4% Novartis 10% SA 17% Merck 12% Pfizer 13%18
  • Top vaccines Brand name Company Sales($ billion) 2010 Prevnar(13) Pfizer 3.6 Fluarix GSK 1.85 Fluzone SAP 1.75 Gardasil Merck 1.35 IPOL SAP 1.3319 Source : Global Vaccine Market 2010 , Krishan Maggon
  • Managing the product life cycle Factor New Product Market Product Maturity Launch Penetration Number of One Multiple, High, producers industrialized industrialized and countries developing country Capacity Low High Potential surplus Market Low High, High, all markets industrialized Cost High Medium Low Prices High uniform Tiered and high Tiered and low average average20
  • Overview of major vaccine related acquisitions Target Company Acquiring Investment Date Company Made Announced Wyeth Pfizer $68 bn Jan 2009 MedImmune AstraZenecea $15.6 bn April 2007 Chiron Novartis $5.1 bn Oct 2005 Crucell Johnson & Johnson $2.6 bn Sep 2009 ID Biomedical GSK $1.4 bn Sep 2005 Shantha Sanofi Aventis $781 mn July 2009 Biotechnics Acambis Sanofi Aventis $549 mn July 2008 Intercell Novartis $363 mn July 2007 Corixa GSK $300 mn May 2005 PowderMed Pfizer $230 mn Oct 2006 Coley Pfizer $214 mn Nov 200721 Source: VacZine Analytics
  • 2010 2015(F) Sales (millions) $67791 $64532 Research & $9338 $7212 Development Net Income $17983 $17430 EPS $2.23 $3.00 Top product Lipitor ($10773) Prevnar($5624)22 Source: Forbes
  • 23
  • The Indian Market for Vaccines  Indian market : US$ 524 million  Vaccine industry will continue to grow at a CAGR in the range of 10-13% over the next 10 years to reach a size of between US$1.4 billion and US$1.8 billion by 2020  India produces about 40-70% of the WHO demand for DPT and BCG, and almost 90% of the demand for measles  The largest vaccine producer in India is the Serum Institute of India, it is the world’s largest24 producer of measles and DPT vaccines
  • The Indian Market for Vaccines ,0 Animal vaccines, 107 Domestic, 238 Export, 179 Source: Biospectrum (June 2010)25 Figures in US$ mn
  • Increased vaccine sales in 2009-1026
  • Major players MNCs Local manufacturers • GSK • Serum institute of • Sanofi Pasteur India • Novartis • Shantha Biotechnics • Wyeth • Bharat Biotech • Merck • Panacea Biotech • Bio-Med27
  • Company watch : GSK  Market share 28%  10% of total sales  24% growth vs 2009 Vaccine India launch Rotarix 2008 Cervarix 2009 Infanrix Hexa 2009 Synflorix 201028
  • Vaccines currently under development by Indian companies Vaccine Company Status of development Rotavirus vaccine Bharat Biotech Phase 3 Rotavirus vaccine Shantha Biotechnics Phase 2 Cadi-05 Cadila Phase 3 Malaria vaccine Bharat Biotech Phase 1 H1N1 influenza Bharat Biotech, Phase 2/3 (Swine flu) vaccine Panacea Biotech, SII Conjugated typhoid Bharat Biotech Phase 3 vaccine29 Source : Biospectrum, April 2010
  • Trends in vaccine industry Major players looking to develop flu vaccines Increase exports Increase focus on adult vaccines Increase in conjugation vaccines Novel methods of vaccine administration Vaccines30 Source: PwC
  • Vaccine Market Drivers  Breakthroughs with new products to address unmet medical needs  ‰ Contingency planning for pandemic infections  Growing income in the developing world markets  Threat from bioterrorism  Potential for therapeutic vaccines  Continued interest and investment from major pharma players  Education and awareness about disease prevention  Participation by government in terms if improving PSUs and investment31
  • Challenges for the Indian vaccine market  Failing realization for mass vaccination(Hepatitis B)  Funding  High maintenance  Slow regulatory approval  Dependence on government32
  • 33
  • Strengths  Prevent disease  Vaccines are widely available and programs have reduced cost as a barrier to vaccination  Vaccines Will Not Face Significant Generic Competition34
  • Weaknesses  Vaccine Research and Development is Lengthy and Expensive  Less awareness  Vaccine Manufacturing : High cost  High maintenance products  Regulatory approvals  Funding to new enterprises35
  • Opportunities  Vaccines for Diseases Currently Without a Vaccine  Improved Vaccines for Partially Vaccine- Preventable Diseases  Global recognition of the benefits of immunization  Combination vaccines – way ahead36
  • Threats  Only strong players so intense competition  Domestic Indian companies depend on government procurement to push volumes  Gestation period is long  Ageing of their product basket  Vaccine Distribution Networks  The Anti-Vaccine Movement37
  • 38
  • 39
  • Future vaccines Vaccine Estimated annual burden of At risk population disease Dengue 10,000-20,000 deaths 2.5 billion people are at 500,000 severe cases risk, with a strong trend upwards Malaria 1.1 to 2.7 million deaths, 2 billion people in endemic 300-500 million cases regions children under 5 Tuberculosis 1.6 million deaths; 8 million Endemic regions including cases Africa, Asia and S. America. Individuals infected with Multidrug resistant TB HIV/AIDS Almost 3 million deaths; 38- High risk groups Continent 42 million cases of Africa40
  • And more…  Diabetes  Cancer  Smoking  Obesity  Asthma  Allergy  HTN41
  • 42
  • Adjuvants Conjugate vaccines • Conjugation of sugar molecules• Substances that helps vaccine to present on bacteria to a strong produce a stronger immune immunogenic carrier protein response • Can stimulate cell mediated long• Faster response lasting memory• Broad immunity To increase and prolong the immune response to the vaccine antigen Adjuvant and conjugate vaccines may help to increase vaccine efficacy in the elderly population43
  • DNA vaccine Advantages Technique Ease of manipulation • Injection of DNA encoding the antigen Simple manufacturin • Involves transfection of g DNA plasmid containing antigen coded gene into More stable target cells which results in immune Targetting a response specific organ44
  • Conclusion  Vaccine industry has been proved to be one of the fastest growing sectors of the past decade and is forecasted to do so in future also  Driven by novel, high-price vaccines, the 7MM’s paediatric and adolescent vaccines market will almost quadruple in size by 2016  Due to ageing populations, the emergence of new technologies and the increasing awareness for vaccine-preventable diseases, adults and the elderly are coming into focus as an attractive target population for future vaccine development  Advancement in the molecular biology and vaccine delivery systems will be the key for further development of this industry45
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