August 2015

Hope for Life

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Hope-for-LifeThe advent of new technologies and break- throughs in science having your own child is not a concern any more. The birth of world’s first test tube baby has given hopes to millions of in- fertile couples, fulfilling their dreams of becoming parents. The domestic and global IVF market is escalating and the reasons are manifold including growing awareness, avail- ability and the acceptance of the treatment.

Market Trends Infertility, in the 21st century, is a global issue with thou- sands of couples facing it worldwide. Over the past dec- ade, the concept of IVF has gained popularity at a swift pace in India. Given that this is a commonly found med- ical condition, the infertility treatment market is rapidly expanding. Besides the standard methods of treatment, which are surgical, drug and hormonal therapy, assisted reproductive treatments (ART), with technological ad- vancements, have opened new doors for providing solu- tions for the male and female infertility issues.

Indian IVF market is anticipated to be worth US$ 1 billion in the next three to five years and is expected to reach US$2 billion by 2018. As on date there are more than 20,000 infertility clinics in India and majority are in Mum- bai, at second place Bangalore, and at third place Delhi is there in India.

Hope-for-Life-1Among the large population of 1.28 billion people, around 15 per cent suffer infertility. The factors such as urbanisation, pollution, chemical exposure, stressful life, competitive work environment, late settlement in life, the urge to achieve maximum in a short time span etc leads to infertility. This escalates the infertility ratio expanding the IVF market. The country is becoming one of the powerful nations in the baby making business with the burgeoning fertility rate which is alarming.

Major players include Sun Pharmaceutical Industries Ltd, Lupin Pharma, Zydus-Cadila Healthcare Ltd, Intas Pharmaceuticals Ltd, CIPLA, Emecure House, Bharat Se- rums and Vaccines Ltd, Uni-Sankyo Limited, Serum Insti- tute of India, Alembic Limited. Other aggressive players include Lifemedicare, Svizera Laboratories Private Limit- ed, VHB Life Sciences Inc, Plethico Pharmaceuticals Lim- ited and Ferring BV.

Delayed pregnancy in women is one of the major driv- ers of the Indian IVF market, as the chances of conceiving lowers with age. Though the cost involved in the treatment stood as a limiting factor to the market growth as the pa- tient may not conceive in the first cycle of the procedure and many cycles have to be undergone by the patient to achieve pregnancy, which adds to the overall cost. The av- erage cost of this procedure is between US$ 10,000 – US$ 20,000. Major limitation stands in adoption of the technique for the people with lower income. The low awareness in the developing countries becomes a challenge in adoption of the technique. Awareness can be created through med- ical tourism and availability of low cost IVF treatments.

GROWTH DRIVERS

  • Rise in infertility rate
  • Changing lifestyle
  • Fertility disorders
  • Growing medical tourism

The market is poised to witness a remarkable growth, primarily due to technological advancements such as pre-implantation genetic diagnosis (PGD) and three par- ent IVF procedures. The lower cost for surrogacy is add- ing on to the booming surrogacy industry in India and the practice of reproductive tourism. Since the legalisation of surrogacy in 2002, India has become world’s largest sur- rogacy industry with estimated revenues at over half a billion dollars.

According to Dr. (Brig) R.K. Sharma, H.O.D IVF, Primus Super Specialty Hospital, IVF is the most common and most effective type of ART to help women become preg- nant. The liberal guidelines of ICMR, permitting egg dona- tion and surrogacy have expedited this. Also, the easy ac- cessibility of young and healthy egg donors and surrogates in India has further attracted more international patients.

Technological Advancements

New techniques offer the possibility of improving a pa- tient’s odds of having a baby through in-vitro fertilisation.

Screening chromosomes: The technique furthest along, and already used in select clinics around the world, is called pre-implantation genetic screening. In this pro- cedure, cells are removed from the embryo on day five to see if the normal amount of genetic material is present. An embryo should have 23 pairs of chromosomes; those with extra chromosomes or missing chromosomes are consid- ered less viable.

Chromosomal screening has shown promise in three small, randomised studies. A study co-authored by Dr. Scott, for instance, found that transferring a single embryo after chromosomal screening resulted in a similar rate of live births as transferring two untested embryos. The procedure costs about US$ 4,000—a hefty fee on top of an already expensive process that often is paid for out-of-pocket. The average IVF cycle costs about US$ 12,400, according to the Society for Assisted Reproductive Technology.

Monitoring cell division: Time-lapse imaging, which costs about US$ 1,500, is a less invasive method of evaluat- ing embryos. It’s already used in clinics around the world, but new types of time-lapse screening are just becoming available commercially. With time-lapse imaging, thou- sands of pictures are taken to record a fertilised egg cell dividing. Eggs dividing atypically are unlikely to survive. Companies are coming to market with products that use algorithms to automate the evaluation process. Currently most clinicians analyse time-lapse imaging subjectively. Time-lapse imaging may also work in tandem with chro- mosomal screening, since it provides information about an embryo’s metabolisms unavailable through genetic test- ing. An initial study was promising.

CHALLENGES

  • Cost involved in the treatment
  • Low level of awareness

Hope-for-Life-2The Bill

There is at present no law governing surrogacy in India, eventually the activity including renting a womb (commer- cial surrogacy) is considered legitimate. In the absence of any law the Indian Council of Medical Research (ICMR) in 2005 issued guidelines for accreditation, supervision and regulation of ART clinics in India. But the need for legis- lation became pressing with ICMR guidelines being often violated and reportedly rampant exploitation of surrogate mothers and even cases of extortion.

At the instance of the Indian government an expert committee has drafted a legislation known as Assisted Re- productive Technology (Regulation) Bill, 2010 for legalis- ing surrogacy. The proposed legislation earlier floated in 2008 envisages legalising commercial surrogacy as well.

The bill aims to regulate and supervise the ART pro- cedure happening throughout the country. It also recom-mends setting up State Boards and a National Advisory Board that will exercise the powers and duties con- ferred on them by the legislation. The ART bill also provides special guidelines for foreign nationals seek- ing surrogacy in India. Looking at all the constraints concerning the field, the ART Bill seems to be quiet fare and balanced. The positive part of the bill is that it states that ART bank and ART clinics should be separate entities. This is in order to promote more transparency; especially in cases that include egg donation and surrogacy.

Legal experts are of the view that the draft Bill is a step in right direction as it will end the present confusion and help regulate the functioning of the IVF centres and en- sure quality check and accountability of ART clinics.

There are worries too as to what impact it will have on the society in terms of commercialisation. Poor illiterate Indian women with the lure of money could be forced into repeated surrogate pregnancies risking their lives. There are also ethical and moral issues as well as the human dignity involved besides questions about the rights of sur- rogate mother.

As such the draft legislation on surrogacy needs to be debated threadbare in social, legal and political circles as well as by the civil society before it becomes a law.

Way Forward

The most important economic issues in contemporary IVF market are access to treatment and treatment success, as measured through birth rates and mul- tiple birth rates. These issues of access and quality are also the central concerns for Indian healthcare industry in general. Across the healthcare sector of the econo- my and in IVF market in particular, alter- ing the competitive structure of markets or the extent of insurance coverage can improve both access to care and quality. In the market for infertility treatment, man- datory insurance coverage is predicted to bring new patients into the market and reduce the incentive to transfer a dan- gerously high number of embryos during treatment, thereby increasing the quality of care. While price reducing competition is likely to improve access to IVF, there exist concerns that competing clinics will attempt to win new patients by inflating birth rates using treatments that also raise the risk of multiple births.

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