VACCINE INDUSTRY
PRESENT AND FUTURE
INTRODUCTION
• 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 USD invested in childhood vaccine
save 18 USD
⬧ Increased life expectancy to economic
growth
Vaccines
• WHO:
 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
Pharmaceuticals
 Focus on prevention – not
patients, but healthy subjects
 Focus on treatment – patient
is 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 complexity
(Cold Chain Management,
complex biological
processes)
 Medium manufacturing and
supply chain complexity
(Easier to handle chemical
synthesis in most cases)
 Small
 Massive sales force
commitment
Regulatory
Vaccines
Marketing/ Sales
Vaccines vs Pharmaceuticals
 Major sales through
government
 Very few generic products
(Due to manufacturing
complexity)
 Sales through physician as
prescriber
 Increasing generic threat
A typical cold chain
• The system used for keeping and distributing
vaccines in good condition
• 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
A typical cold chain
Supply chain
• 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
condition
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 impacted
Stages of vaccine development
• A vaccine must be licensed first by the
appropriate authority for the use in the country
or WHO
• For licensing of a new vaccine, the vaccine
manufacturer should conduct the phase I, II
and III trials and must submit their results to
authority approval
• Good clinical practice (GCP) and ethical
guidelines are needed for approval
Stages of vaccine development
Stages of vaccine development
• Disease target is identified
• Antigen is identified
• Vaccine candidate is designed
• Vaccine is characterised
 Feasibility
 Formulation
 Identity
 Purity
 Stability
Stages of vaccine development
 Preclinical studies begin, testing for the
following:
 Potency
 Toxicology
Stages of vaccine development
 Manufacturing begins on a pilot scale, the
candidate is evaluated according to the
following controls:
 Good Clinical Practices
 Clinical Good Manufacturing Practices
(cGMP)
 Sterility
 Quality control
Stages of vaccine development
 Investigational New Drug (IND) application is
filed
 Phase I clinical testing begins
 Phase II clinical testing begins
 Phase III clinical testing begins
 Biologics License Application (BLA)
application is filed
 The authorities approve the candidate
 Phase IV clinical testing begins
Trial phases
• Clinical trials are governed by strict regulation
• The proceedings are monitored by
government authorities as well as
manufacturers’ own Global Safety Board
(GSB)
• At least three phases to clinical trials,
• A fourth phase might be necessary if
 The medicine can be improved
 To provide answers to questions from the
regulatory authorities
Phase 1
• The first time a new treatment or vaccine is
tested in humans
• Usually be given to a small group of healthy
volunteers
• In some cases – such as when a new
medicine is being tested as a treatment for a
terminal illness like cancer - it may be tested
on volunteers who have the condition
Phase 1
• The principle objectives in Phase I are to
 Make sure that the new vaccine presents no
major safety issues
 Clarify that it can reach the targeted body
area, and remain there long enough to
deliver its benefits
 Gain preliminary evidence that it could offer
therapeutic value, or prevent the disease or
condition
Phase 2
• A trial involving a larger group of people
• Usually (but not always) include patients who
have the condition the potential medicine is
targeting, and aim to establish
 Effectiveness in treating the condition
 Effectiveness in preventing the condition (if
the volunteer does not already have it)
 Appropriate dosing levels
Phase 2
• The performance of the medicine may be
compared against a group of patients
receiving a placebo
• A placebo: a treatment that looks the same as
the potential new medicine, but has no active
ingredients
• Neither the patients nor the researchers have
any idea which volunteers receive which
treatment (double-blinded placebo control)
Phase 3
• A much larger trial, often involving hundreds,
possibly thousands of participants coming
from a range of different countries
• The principle objectives in Phase III are to
 Demonstrate the safety and effectiveness of
the new medicine or vaccine in the typical
patient likely to use it
 Confirm effective dosing levels
Phase 3
• The principle objectives in Phase III are to
 Identify side effects or reasons why the
treatment should not be given to people with
the condition in question (known as
“contraindications”)
 Build knowledge of the benefits of the
medicine or vaccine and compare them with
any risks
 Compare results against any currently
achieved by existing treatments
Phase 3
• A new vaccine usually needs to offer the
prospect of better treatment for patients than
any treatments that are already available.
• Phase III trials may last several years
• If a new medicine or vaccine completes Phase
III with positive results → seek regulatory
approval to make it available in a range of
countries or regions
Phase 3
• In the case of a new medicine, regulators will
determine how it should be used, and which
patients should qualify for it, based on all the
evidence from clinical and pre-clinical studies
➔ A medicine/vaccine’s indication
Phase 4
• Done after a drug has been shown to work
and has been granted a license
• The main reasons for running phase 4 trials
are to find out
 More about the side effects and safety of the
drug
 What the long term risks and benefits are
 How well the drug works when it’s used
more widely
GLOBAL VACCINE INDUSTRY
• Global attitude in the vaccine industry: disease
prevention rather than treatment
• There are now 145 pure vaccines and 11
combination vaccines in clinical development
• Five major vaccine manufacturers:
GlaxoSmithKline, Merck, Sanofi, Pfizer,
Novartis
Global vaccine leaders (2019)
Global vaccine sales
Global vaccine market
Global vaccine market
• Newer and more expensive vaccines are
coming into the market faster than ever
before
• Growing concentration in OECD countries
but also newcomers (Pfizer, J&J,..)
• Vaccine development: increasing
investment
Global vaccine market
Global vaccine market
Worldwide immunisation coverage, 2014
Vaccine market gap
Industrialised countries
Population
82%
Developing countries
15%
85%
18%
Vaccine sales
Vaccines Market
• Segmentation by Region
Vaccines Market
• Segmentation by Type
Developing country market
80 % of population / less than 20% of global market
Regular and rapid growth in volume and dollar value
Emerging
economies and
markets
UN market
Private sector in
Low and Middle
income countries
UN market (in value)
2002
2011
%
UNICEF SD
$ 220 million
$ 1.03 Billion
+ 468%
PAHO RF
$ 120 million
$ 400 million
+ 333%
Total
$ 340 million
$1430 bilion
+ 420%
Around 7.5 % of total vaccine sales
Sources: our WHO estimates based on UNICEF SD and PAHO RF data
Vaccine segments
Human
vaccines
Pediatrics
Adolescents
Adults
Elderly
Top vaccines
Growth factor
Combination of :
• Importance of communicable diseases
and new threats
• Cost effectiveness of immunizations
• New funding opportunities (Gov, PPP,
donors, Foundations,..)
• New research techniques and
manufacturing technologies
Growth factor
Combination of :
• Increasing demand, new target
population, larger emerging markets
• Higher prices, improved profitability for the
industry (blockbuster vaccines..)
Managing the product life cycle
• On launch
⬧ Typically, only one producer, who owns
product and process intellectual property
⬧ Limited capacity, low demand, high
production costs and high prices
Managing the product life cycle
• Market penetration
⬧ New manufacturers will enter the market,
either through their own development efforts
or through licensing of the original
manufacturer’s patent
⬧ Capacity increase
⬧ Limited price tiering will be possible
Managing the product life cycle
• The product reaches maturity and the
intellectual property protection expires
⬧ Many manufacturers, both in the developing
as well as the industrialised world
⬧ Production costs are low and often there will
be overcapacity so that availability is high
and demand is global
⬧ Prices will be heavily tiered
Managing the product life cycle
Factor
New Product
Launch
Market Penetration
Product Maturity
High, industrialised
and developing
country
Number of
producers
One
Multiple, industrialised
countries
Capacity
Low
High
Potential surplus
Market
Low
High, industrialised
High, all markets
Cost
High
Medium
Low
Prices
High uniform
Tiered and high
average
Tiered and low
average
New trend
Demand side
Supply
Funding
• Vaccines and vaccinations : on the top of GoV and UN
agenda, unmet needs
• Accelerate uptake and increasing demand in LIC
• Middle Income countries including emerging Countries
• Increasing capacity
• Remaining tensions on products
• New production and supply strategies
• GoV resources
• Donors
• Private foundations
More players on demand, supply and
financing
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
Vaccines
Vaccine Market Drivers
• Breakthroughs with new products to address
unmet medical needs
• Contingency planning for pandemic infections
• Growing income in the developing world
markets
• Rising demand for better healthcare
infrastructure and high awareness levels of the
benefits of immunisation
• Threat from bioterrorism
Vaccine Market Drivers
• 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 investment
Vaccine Market Drivers
• Ex: The advent of Gardasil (Merck/SA) and
Cerverix (GSK) in the prevention of cervical
cancer, precancerous genital lesions and
genital warts due to human papillomavirus
(HPV)
⬧ A turning point in the history of vaccines
⬧ Compete for market penetration and
market share in a totally new
⬧ Create huge demand among the
population at risk
Vaccine Market Drivers
• Ex: The advent of Gardasil (Merck/SA) and
Cerverix (GSK) in the prevention of cervical
cancer, precancerous genital lesions and
genital warts due to human papillomavirus
(HPV)
⬧ Public organisation like WHO, UNICEF,
GAVI (a public-private alliance) are
constantly working for spreading awareness
and increasing the coverage of
immunisation
Challenges for the vaccine market
• Failing realisation for mass vaccination
(Hepatitis B)
• Funding
• High maintenance
• Slow regulatory approval
• Dependence on government
SWOT ANALYSIS
• Strengths
• Weaknesses
• Opportunities
• Threats
SWOT ANALYSIS
• Only two to three vaccine manufacturers
compete for each disease (except influenza)
• 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
Strengths
• Prevent disease
• Vaccines are widely available, and programs
have reduced cost as a barrier to vaccination
• Vaccines will not face significant generic
competition
Weaknesses
• Vaccine research and development is lengthy
and expensive
• Less awareness
• Vaccine manufacturing : High cost
• High maintenance products
• Regulatory approvals
• Funding to new enterprises
Opportunities
• Vaccines for diseases currently without a
vaccine
• Improved vaccines for partially vaccine –
preventable diseases
• Global recognition of the benefits of
immunisation
• Combination vaccines (therapeutic vaccines,
vaccines effective against more strains,
universal influenza vaccine…) – way ahead
Threats
• Only strong players so intense competition
• Domestic companies depend on government
procurement to push volumes
• Gestation period is long
• Ageing of their product basket
• Vaccine distribution networks
• The anti-vaccine movement
FUTURE PERSPECTIVE
• The main future opportunities: the
pneumococcal, meningococcal and HPV
vaccine sectors → 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
Future vaccines
Vaccine
Dengue
Malaria
Estimated annual burden
of disease
10,000-20,000 deaths
500,000 severe cases
1.1 to 2.7 million deaths,
300-500 million cases
At risk population
2.5 billion people are at
risk, with a strong trend
upwards
2 billion people in endemic
regions
children under 5
Tuberculosis
1.6 million deaths; 8 million
cases
Endemic regions including
Africa, Asia and S. America.
Individuals infected with
Multidrug resistant TB
HIV/AIDS
Almost 3 million deaths; 38
– 42 million cases
High risk groups Continent
of Africa
Future vaccines
• Diabetes
• Cancer
• Smoking
• Obesity
• Asthma
• Allergy
FUTURE DEVELOPMENTS
• 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
FUTURE DEVELOPMENTS
Adjuvants
Conjugate vaccines
• Substances that helps
vaccine to produce a
stronger immune response
• Faster response
• Broad immunity
• Conjugation of sugar
molecules present on
bacteria to a strong
immunogenic carrier protein
• Can stimulate cell mediated
long lasting memory
To increase and prolong the immune response to the
vaccine antigen
To increase vaccine efficacy in the elderly population
Nucleic acid vaccines
• Injection of DNA encoding the antigen
• Involves transfection of DNA plasmid
containing antigen coded gene into target cells
which results in immune response
• Ease of manipulation
• Simple manufacturing
• More stable
• Targeting a specific organ
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
CONCLUSION
• 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 industry