“In­dia ac­counts for 60% of vac­cine sup­plies made to UNICEF”

Dr K Anand Ku­mar

BioSpectrum (India) - - BIO CONTENT -

Managing Direc­tor, In­dian Im­muno­log­i­cals Ltd

Un­doubt­edly, In­dia is the epi­cen­tre for vac­cine man­u­fac­tur­ing in the world. With many top vac­cine gi­ants sup­ply­ing ba­sic and ad­vanced vac­cines to nearly

150 coun­tries, In­dia, over the years, has emerged as the global vac­cines hub. In­dian vac­cine in­dus­try with many state-of-theart man­u­fac­tur­ing fa­cil­i­ties has earned In­dia the recog­ni­tion of hav­ing the largest global ca­pac­ity for WHO pre­qual­i­fied vac­cine man­u­fac­tur­ing. Along with other fac­tors, in­creased pub­lic aware­ness about vac­ci­na­tion and pub­lic im­mu­niza­tion pro­grams, cou­pled with govern­ment sup­port to de­velop new vac­cine act as key fac­tors driv­ing In­dia’s vac­cine in­dus­try. Speak­ing to Aish­warya Venkatesh of BioSpec­trum Asia Mag­a­zine,

Dr K Anand Ku­mar, Managing Direc­tor In­dian Im­muno­log­i­cals

Ltd & Direc­tor Pris­tine Bi­o­log­i­cals (NZ) Ltd, shared his views on chal­lenges and up­com­ing trends in In­dian vac­cine mar­ket.

Ex­cerpts of the interview

What ac­cord­ing to you are up­com­ing trends in In­dia’s vac­cine mar­ket?

The In­dian vac­cine mar­ket can be broadly be clas­si­fied as the Do­mes­tic Trade Mar­ket (DTM) and Govern­ment Busi­ness (GB) in­clud­ing UIP sup­plies. There is also an Ex­port Mar­ket that the In­dian man­u­fac­tur­ers tap into sup­ply­ing to UNICEF/GAVI by way of WHO PQ. The to­tal mar­ket size for vac­cines would be about a bil­lion USD. Value wise the Ex­port Mar­ket would be 50%, the trade mar­ket would be around 30% and the GB would be around 20%. There is grow­ing aware­ness on pre­ven­tive measures to fight against dis­eases in In­dia. While In­dian pharma in­dus­try is grow­ing at 10% over the past year, the vac­cine in­dus­try is grow­ing at 25% be­tween 2011- 2015.

The up­com­ing trends in the mar­ket space in­clude the fol­low­ing:

1. In­creased up­take of new gen­er­a­tion vac­cines such as Pneu­mo­coc­cal con­ju­gate vac­cine, Vari­cella vac­cine, Ro­tavirus vac­cine, HPV, ty­phoid con­ju­gate vac­cine in the trade seg­ment.

2. In­creased up­take of mul­ti­va­lent vac­cines such as the Hex­ava­lent vac­cine.

3. Large scale in­tro­duc­tion of vac­cines such as Pen­tava­lent vac­cine, in­ac­ti­vated po­lio vac­cine, MR vac­cine by the Govern­ment Busi­ness.

4. Ready to use pre­sen­ta­tion such as Pre­filled sy­ringes.

5. Nee­dle free de­liv­ery.

6. In­de­pen­dent clin­ics for vac­ci­na­tion pur­poses only.

7. More and more fo­cus on vac­cines for Zoonotic dis­eases.

8. More and more re­com­bi­nant vac­cines will be seen in the an­i­mal vac­cine seg­ment.

Please elab­o­rate on some on the key driv­ers of In­dia’s vac­cine busi­nesses?

There is more aware­ness now about the abil­ity of vac­cines to pre­vent dis­ease than ever be­fore. The Swach Bharat Mis­sion also has helped bring in sense of good hy­giene and clean­li­ness. It is in­evitable that the govern­ment in the com­ing years will spend sig­nif­i­cant amount on Health­care. Sim­i­larly the per capita govern­ment spend on rou­tine im­mu­niza­tion is also go­ing to in­crease with the ad­di­tion of vac­cines such as Pneu­mo­coc­cal con­ju­gate vac­cine, in­ac­ti­vated po­lio vac­cine etc. Sev­eral pro­grammes in­clud­ing the In­dia New born Ac­tion Plan launched in 2014 will in­crease the up­take of vac­cines to pre­vent death be­low the age of 5. This will drive more vol­ume.

The ed­u­cated and grow­ing mid­dle class seg­ment is

vary of the ben­e­fits of vac­ci­na­tion and will en­sure their chil­dren will get vac­ci­nated to as many pre­ventable dis­eases as pos­si­ble.

The trade mar­ket is cur­rently dom­i­nated by multi­na­tional com­pa­nies (GSK, Pfizer, MSD) as many of the In­dian man­u­fac­tur­ers have only con­ven­tional vac­cines in their prod­uct bas­ket at the present moment. In­dian man­u­fac­tur­ers have sev­eral prod­ucts in their R&D pipe­line and as they roll out, the dom­i­nance of the multi­na­tional com­pa­nies will sub­side in the com­ing years. With the in­tro­duc­tion of vac­cines by the In­dian man­u­fac­tur­ers, the mar­ket now will have a choice and pric­ing pres­sures will make it more af­ford­able than what is be­ing sold cur­rently.

In­dian man­u­fac­tur­ers have the tech­ni­cal ex­per­tise to pro­duce sev­eral vac­cines at an af­ford­able price. In­dian man­u­fac­tur­ers ac­counted for 60% of sup­plies made to UNICEF. Hav­ing tasted suc­cess sev­eral com­pa­nies have ex­panded fa­cil­i­ties to cater to the global mar­kets to get a bet­ter price.

In­dian man­u­fac­tur­ers have the tech­ni­cal ex­per­tise to pro­duce sev­eral vac­cines at an af­ford­able price. Hav­ing tasted suc­cess, sev­eral com­pa­nies have ex­panded fa­cil­i­ties to cater to the global mar­kets to get a bet­ter price.

Where do you see the vac­cine in­dus­try heading; five years from now?

The ex­ist­ing vac­cine man­u­fac­tur­ers will con­sol­i­date their po­si­tion and with new prod­uct in­tro­duc­tions will con­tinue to dom­i­nate the do­mes­tic and UNICEF/GAVI mar­kets. The cur­rent mar­ket of USD 1 bil­lion could eas­ily dou­ble to USD 2 bil­lion in less than 5 years.

Sev­eral fac­tors at the present moment may see new en­trants in the form of big pharma houses enter into the vac­cine busi­ness. Fac­tors in­clude a higher CAGR of the vac­cine busi­ness than the pharma busi­ness, con­stant USFDA woes, NPPA and erod­ing mar­gins, at­trac­tive­ness of few play­ers in the vac­cine busi­ness etc. Given the huge cap­i­tal costs and long lead times, this busi­ness is not for small time play­ers and en­trepreneurs.

Part­ner­ships with vac­cine com­pa­nies abroad to ac­cess the In­dian mar­ket will be­come com­mon. In order to shorten reg­u­la­tory time lines, com­pa­nies may ex­plore the pos­si­bil­ity of im­port­ing the bulk of an ap­proved prod­uct for fill/fin­ish in In­dia. Sim­i­larly In­dian com­pa­nies will also look at ex­port­ing bulk vac­cines for fill fin­ish in other mar­kets.

Sev­eral new vac­cines would be in­tro­duced by do­mes­tic play­ers for sev­eral dis­eases such as Pneu­mo­nia, Vari­cella, Hep­ati­tis A, IPV, Chikun­gunya etc.

In your opinion what are the most dif­fi­cult chal­lenges in vac­cine busi­ness in In­dia?

The chal­lenges are:

 Vac­cine man­u­fac­tur­ing in­volves huge cap­i­tal in­vest­ment up­front and sub­se­quently the reg­u­la­tory ap­proval process for li­cen­sure i.e from con­duct­ing Pre Clin­i­cal Tox­i­col­ogy (PCT) stud­ies to ob­tain­ing Mar­ket­ing Au­tho­riza­tion may take 5 years. Added to that if sup­plies are to be made to the govern­ment, some states re­quire 3 year mar­ket stand­ing. Based on the above cash flows will hap­pen sev­eral years af­ter in­vest­ment is made.

 Vac­cine man­u­fac­tur­ing is a com­plex process that in­volves sev­eral up­stream and down stream pro­cess­ing steps. Through­out man­u­fac­tur­ing sev­eral in process con­trol tests are em­ployed. The fi­nal vac­cine test­ing in some cases may take upto 3 months. All vac­cines sold must be cleared by the Cen­tral; Test­ing Lab in Kasauli and this fur­ther adds to the timeline. All this can add to in­ven­tory build up.

 Get­ting In­dus­try ready can­di­dates from ed­u­ca­tional in­sti­tu­tions is a chal­lenge. Most can­di­dates have lim­ited prac­ti­cal knowl­edge and the com­pany has top spend al­most a year in train­ing them.

 Ma­jor­ity of the vac­cines are for govern­ment sale and is pro­cured based on ten­ders. If one fails to win a bid, the fa­cil­i­ties and peo­ple will re­main idle till the next ten­der.

 The na­ture of some dis­ease such as Swine fever, Flu are un­pre­dictable. An­tic­i­pat­ing de­mand at times would lead to ex­cess in­ven­tory which may re­main un­con­sumed.

 Get­ting qual­ity epi­demi­o­log­i­cal and sur­veil­lance data is also a chal­lenge. Ac­cu­rate in­ci­dence re­port­ing and bur­den of dis­ease es­ti­mates are all in in­fancy.

Many deadly dis­eases like Zika still do not have an ap­proved vac­cine. In your opinion what could be the rea­sons?

There are mil­lions of micro­organ­isms that ex­ist in na­ture. Based on en­vi­ron­men­tal con­di­tions and ge­netic changes some of these or­gan­isms may ex­ert higher lev­els of vir­u­lence at some pe­riod of time. It is eco­nom­i­cally un­vi­able to de­velop vac­cines in an­tic­i­pa­tion when the dis­ease man­i­fests at a low level and only in cer­tain re­gions. I do not see any tech­ni­cal chal­lenge in de­vel­op­ing a vac­cine for Zika, it’s just that like any other vac­cine can­di­date it has to go through a long journey to es­tab­lish safety and ef­fi­cacy cre­den­tials as a part of li­cen­sure.

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Dr K Anand Ku­mar Managing Direc­tor In­dian Im­muno­log­i­cals Ltd

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