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Anti Retrovirals Market the battle continues
As the spread of HIV in India continues unabated, drug manufacturers
search for innovative second line treatments. Arshiya Khan does a status
check on the anti retrovirals market
A growing infection …
 India
has entered a critical period in the fight against HIV/AIDS. The spread of the
virus appears to be stable or diminishing in some parts of the country, while
growing at modest rates in others. In terms of numbers, approximately six million
people are suffering from AIDS in India, According to other estimates, 40 million
people are HIV positive and 25 million people have died from AIDS.
After India's first case of HIV was detected in 1986, HIV rates first soared
among drug users and prostitutes before becoming visible in other sections of
the population. In Mumbai, home to one of the world's largest commercial sex
districts, the infection rate hit 64 percent by the late 1990s. Since then HIV
infection has been reported in all States and Union Territories.
As per Avert, an international AIDS charity, around 0.36 percent of India's
population is living with HIV. While this may seem a low percentage, India's
population is vast, so the actual number of people living with HIV/AIDS (PLHAs)
is remarkably high. To add to it, as there is no proper screening of patients
there may be a sizeable number dying without even getting diagnosed.
Market scenario
Amar Lulla,
Joint Managing Director,
Cipla |
The large number of HIV infected people translates into a
Rs 95 crore market for anti retrovirals (ARVs), with a growth rate of 9.86 percent
(as per IMS MAT figures). This is the only class of drugs capable of slowing
down the virus. According to a report by Market Research Company, the ARV market
is expected to increase from $7.1 billion in 2005 to $10.6 billion by 2015,
as new ARVs are launched and the number of HIV-positive people increases. Eleven
years after India's first HIV case was detected, access to treatment and care
has greatly increased. Two million people per year receive medication and care
via international and local support groups and NGOs.
If access to medication and care has improved, why is the disease still out
of control? According to Amar Lulla, Managing Director, Cipla, this is because
there is an increased resistance to the first line therapy of drugs. "Hence
there is a requirement for the second line therapy or a protease inhibitor or
a different combination therapy, " says Lulla.
This makes the treatment more expensive as most ARVs are highly priced. Therefore
treatment in regions where HIV has reached epidemic levels is funded by two
major funding agencies, namely, PEPFAR, (President Bush's Emergency Plan for
AIDS Relief, is a five-year, $15 billion US Government initiative to combat
the global HIV/AIDS epidemic), and Global Funds (created to fight AIDS, tuberculosis
and malaria, and to direct those resources to areas of greatest need. A partnership
between governments, civil society, the private sector and affected communities,
the Global Fund represents an innovative approach to international health financing).
Besides, the disease is most prevalent among those who can least afford it.
"The ARV segment is a low-end market, as the people who are affected are
usually from lower social strata, and a low-income group therefore they need
help, which only the state can provide", feels Lulla. To make matters worse,
the treatment has to be continued for an extended period and resistance increases
if the medication is taken in fits and starts.
Aloka Sengupta, Vice-President, (AIDS, TB, Malaria segment),
Strides Arcolabs, lists two other problems: grossly delayed payment with poor
and non- existent margins. India is better off compared to other countries,
as the country's vibrant domestic pharma industry plays an important role in
the fight against the disease by providing ARV drugs at low cost to the government.
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Recently there was a controversy on Cipla selling ARVs at a cheaper rate
in Africa than in India. On its website Dr Y K Hamied, CMD, Cipla, clarifies,
"There is an import duty factor of up to 15-20 percent on raw material
that goes into making active substances used in HIV/AIDS medicines in
India. When Cipla exports its ARV drugs, it is usually in response to
international tenders for large quantities. Prices are therefore lower.
The Indian government should remove all duties on raw material for ARV
drugs. Cipla has time and again requested for this, but no action has
been taken as of date. Meanwhile Lulla says, "It a myth created by
some people with vested interests who are trying to malign Cipla. There
is no difference in the prices of what we sell to the government of Africa
and the government of India."
Sub-Saharan Africa is more heavily affected by HIV and AIDS than any
other region of the world. An estimated 24.5 million people were living
with HIV at the end of 2005. "Cheaper drugs are definitely a high
priority requirement in that continent. However, considering the growing
statistics in India, India too requires the same amount of attention,"
opines Thacker.
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Access and availability
Ashwin Thacker, Chairman and Managing Director, Flamingo Pharmaceuticals
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The availability of HIV/AIDS drugs, like others, depends upon
at least three main factors—sustainable financing for drug procurement
at the national level, national and local health infrastructure for delivering
drugs and monitoring patient compliance and affordable drug prices. India and
Brazil are the world's two major ARV producers.
As ARVs date back to the pre-TRIPS era, there are no restrictions
on manufacturing copycat versions of these drugs. As a consequence of this,
ARVs are on average 80 percent cheaper in countries like India, than in countries
which recognised patents. Hence, "Availability of drugs is not an issue
in India anymore, it's the price that is the major problem," says Ashwin
Thacker, Chairman and Managing Director, Flamingo Pharmaceuticals.
Policy moves
T Vijayakumar,
Senior Manager, Export Formulations, Aurobindo Pharma |
Many developing countries are exploring the possibility of
dealing with policies related to drug sales and intellectual property rights
(IPRs) within the legal framework of the World Trade Organisation (WTO). Governments
have another tactic against patent-protected drugs: compulsory licensing. South
Africa has taken a lead on this issue. However Indian AIDS NGOs, community groups
and policy makers have yet to take steps to facilitate local production of essential
anti-HIV medication in India. The government of India has not issued any compulsory
licenses. The WHO and UNAIDS have just completed a review of the patent rights
on 24 drugs of interest to people with HIV infection. Drugs in this list can
be manufactured under the compulsory licensing provision.
Innovator pharma companies should continue to compete with generic manufacturers
in market. "To guarantee that this competition will remain possible, it
is essential that the provision on compulsory licensing in the TRIPS agreement
be preserved and enshrined in national law, in particular in developing country
markets where patents for HIV pharmaceuticals/medication will be requested and
HIV is a significant problem," opines T Vijayakumar, Senior Manger, Export
Formulations, Aurobindo Pharma. As making drugs affordable to those who need
them is a formidable challenge, governments must ensure sufficient financing
for procurement and adequate health system capacity to support care for people
with HIV/AIDS.
Market restraints
The problems in distribution of ARV drugs to various treatment centres include
hurdles such as check points, road permits, lack of communication between the
procurement agency and the treatment centre. The Indian regulatory and patent
uncertainties further constrain development of generic and bio generic drugs
in developed countries. "With end users of prescription drugs seeking to
pay less for medication, generic and biogenerics are poised for strong growth,
especially in developing nations," informs Vijayakumar.
Indian drug manufacturers are adept at re-engineering drugs,
thanks to the previous process patent regime, but under this system, there was
no focus on the quality of the final product. Today, these same manufacturers
have to meet global quality norms and need to upgrade their production and quality
systems accordingly. "Several Asian generics producers have faced similar
difficulties and one recent example is the removal of two generic HIV drugs
produced by a prominent Indian pharma company from the WHO list of approved
medications meant specifically for patients in Africa", informs Vijayakumar.
Though generic and biogeneric drugs are emerging as strong
contenders to branded medications, a number of consumers in developed nations
have a perception that branded products are more effective than unbranded ones.
Certain patient popu-lations tend to view healthcare benefits as entitlements
rather than privileges and resist shifting from more expensive to less expensive
options. Even when they are compelled to switch drugs, they shift from one brand
to another, popularly known as a 'brand name shift', despite the availability
of low-cost generics. This is one challenge that generic drug manufacturers
are likely to find hard to overcome in their quest to extend market reach.
At the same time, as more people are becoming resistant to
first line therapies, the demand for the second line treatment is increasing,
which is more expensive than the first line therapy. This is a huge hurdle.
And ARV drugs are still not accessible to vast majority of Indian PLHAs. "The
price of ARV drugs in India is Rs 14,400 per annum, which is about 120 percent
more than the price the Clinton Foundation is procuring it at," says Thacker.
"Therefore government intervention in pricing is required," he adds.
| In many regions of the world, new HIV infections
are heavily concentrated among young people. Health experts have observed
the same trend in India as well, where the incidence of infection in adolescents
is said to be rising steadily. What is worrying is that even though India
has the largest number of infections in Asia, governments continue to shy
away from incorporating sex education in school curricula. As per an IPS
report, as many as 11 of India's 29 state governments have either banned
or are in the process of dropping sex education from school curricula. "In
India everything takes a political colour. Sex education, which is needed,
has now taken a back seat because there are some people who believe that
sex education means promiscuity," informs Lulla. Overall, though, sex
education is scant, while young people receive an ever-increasing diet of
sexual innuendo through TV channels and movies.
Educating people about HIV/AIDS and how it can
be prevented is complicated in India, as a number of major languages and
hundreds of different dialects are spoken within its population. This
means that, although some HIV/AIDS prevention and education can be done
at the national level, many of the efforts have to be carried out at the
state and local level. Each state has its own AIDS Prevention and Control
Society, which carries out local initiatives with guidance from National
AIDS Control Organisation (NACO). Under the second stage of the government's
National AIDS Control Programme, which finished in March 2006, state AIDS
control societies were granted funding for youth campaigns, blood safety
checks, and HIV testing among other things. Various public platforms were
used to raise awareness of the epidemic—concerts, radio dramas, a
voluntary blood donation day and TV spots with a popular Indian film-star.
Messages were also conveyed to young people through schools. Teachers
and peer educators were trained to teach about the subject, and students
were educated through active learning sessions, including debates and
role-playing.
Hospital staff and health professionals, much like
the rest of the Indian population, are often unaware of the facts about
HIV. This leads to unnecessary fears and, in some cases, causes them to
stigmatise HIV positive people and discriminate against them, including
testing them without consent. Laws should ensure that privacy of an individual
is maintained when diagnosis is complete. Awareness campaigns need to
be widespread and communicable.
Now it is the state that has to intervene and see that
those patients need to be helped in terms of drugs. People have to be
counseled on how to handle social issues related to HIV. The treatment
is expensive unless they are told that there are free drugs, which are
being distributed by NACO. "The government is doing its bit but I
think they need to speed up and give it more depth," feels Lulla.
"Doctors have to be educated as they are mostly unclear on how handle
the patients and what are the treatments and the medicines," he adds.
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Opportunities
The global emergence and resurgence of epidemics such as AIDS, tuberculosis
and malaria is expected to translate into a $2 billion opportunity for Indian
generic players, particularly early movers such as Cipla, Aurobindo and Lupin.
The average available global funding per annum is slated to be around $4 billion
over the next four years (2006-10), with the generic opportunity pegged around
an equivalent amount. Assuming Indian companies will capture 50 percent market
share, it will translate into a $2 billion opportunity for Indian firms. This
is in comparison to the $5 billion domestic formulation market annually, according
to a report by Edelweiss, a financial services company based in Mumbai.
The fact that more people are becoming resistant to first line therapy also
translates into an opportunity. This creates the need for newer, innovative
and more effective therapies. Research indicates that patients are developing
resistance to more than one class of drugs that are in general use. There is
an increased level of drug resistance even in drug-naive patients. Estimates
show that up to 78 percent of patients are now failing to respond to ARVs. In
1999, an eight percent hike in resistance was recorded in treatment-naive individuals
and the figure has alarmingly risen to 20 percent. "This can lead to a
condition where patients are less likely to reach suppressed levels of HIV due
to undet-ectable levels when they start treatment," says Vijayakumar.
Therefore these older generation drugs are being replaced
by products with lower pill burdens, enhanced potency and reduced side effects.
Hence, compounds that are effective against multi-drug resistant strains currently
dominate the clinical development scene and are likely to drive the future growth
of this industry. "These opportunities can be doubled if the existing ARV
suppliers are able to balance their prices such that the common man can afford
them," adds Vijayakumar.
arshiya.khan@expressindia.com
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