Grow­ing pharma mar­ket driv­ing CRO in­dus­try in APAC

BioSpectrum (Asia) - - BIO CONTENT - Aish­warya Venkatesh aish­warya.venkatesh@mmac­

At 31 per cent of the to­tal, Asia Pa­cific has the se­cond largest share of the CRO pro­duc­tion mar­ket. Much of this growth is driven by phar­ma­ceu­ti­cal and biotech­nol­ogy com­pa­nies in the United States and West­ern Europe in­creas­ingly out­sourc­ing their core re­search ac­tiv­i­ties to

CROs in de­vel­op­ing coun­tries in or­der to con­tain costs. It is seen that many multi­na­tional CROs are them­selves now ex­pand­ing their op­er­a­tions to de­vel­op­ing coun­tries in Asia Pa­cific, tak­ing ad­van­tage of lower costs for con­duct­ing clin­i­cal tri­als in these re­gions com­pared to the US and Euro­pean coun­tries. Speak­ing to BioSpec­trum Asia Magazine, Karen Chu, Cor­po­rate Vice Pres­i­dent, Global Clin­i­cal Op­er­a­tions, PAREXEL and Chang Lee, Vice Pres­i­dent, PAREXEL Con­sult­ing APAC elab­o­rated on op­por­tu­ni­ties, growth and chal­lenges of the APAC CRO mar­ket. Edited ex­cerpts;

In your opin­ion, what are the big­gest chal­lenges CROs in the APAC re­gion face to­day?

Karen Chu: In the APAC re­gion, a small tal­ent pool con­tin­ues to be the big­gest chal­lenge CROs are fac­ing as the phar­ma­ceu­ti­cal R&D mar­ket grows in this area. Both China and Ja­pan are ex­pe­ri­enc­ing a lack of tal­ent in the drug de­vel­op­ment in­dus­try. In China, due to the most re­cent reg­u­la­tory change and sig­nif­i­cant in­vest­ment into small to mid-sized biotech/phar­ma­ceu­ti­cal com­pa­nies, tal­ent is needed in re­search and de­vel­op­ment, project man­age­ment, reg­u­la­tory strat­egy, and clin­i­cal op­er­a­tions. With the China Na­tional Drug Ad­min­is­tra­tion (CDA) adopt­ing ICH-GCP, the work­force need to be well-versed in these pro­ce­dures and be able to op­er­ate at a more ad­vanced level.

In con­trast, Ja­pan’s R&D is much more wellestab­lished and ro­bust, es­pe­cially in the last decade, and reg­u­la­tions have also been more sta­ble. As a re­sult, in Ja­pan there is greater need for tal­ent with a re­gional and global project man­age­ment skillset. English-speak­ing abil­ity is also a manda­tory com­po­nent. In ad­di­tion, as si­mul­ta­ne­ous global tri­als are run­ning in Ja­pan, the coun­try is in need of op­er­a­tional staff who are able to ad­dress the dif­fer­ences in var­i­ous cul­tures and dif­fer­ent clin­i­cal trial land­scapes.

Chang Lee: The big­gest chal­lenge CROs in the APAC re­gion, es­pe­cially in China, face to­day is the lack of ad­e­quate clin­i­cal re­search in­fras­truc­ture specif­i­cally lim­ited clin­i­cal re­search sites, lack of qual­i­fied Prin­ci­pal In­ves­ti­ga­tor (PI) and re­search staff, and in­ef­fi­cient IRB/EC pro­cesses, among other chal­lenges.

What ac­cord­ing to you are some of the key driv­ers and res­traints of APAC CRO in­dus­try?

Karen Chu: Key driv­ers of the APAC CRO in­dus­try con­tinue to be the phar­ma­ceu­ti­cal mar­ket in the re­gion. China is an­tic­i­pated to be­come the largest phar­ma­ceu­ti­cal mar­ket by 2020, and Ja­pan still re­mains in the top five. In ad­di­tion, both have large pa­tient pop­u­la­tions which al­low clin­i­cal tri­als to en­roll much faster than other mar­kets, and both coun­tries con­tinue to be an at­trac­tive re­gion for bio­phar­ma­ceu­ti­cal com­pa­nies to con­duct clin­i­cal re­search.

An­other key driver for CROs are the cap­i­tal in­vest­ments pour­ing into Chi­nese bio­phar­ma­ceu­ti­cal com­pa­nies, as well as the tra­di­tional lo­cal phar­ma­ceu­ti­cal com­pa­nies in­vest­ing in trans­form­ing them­selves into more in­no­va­tive com­pa­nies. Many of these com­pa­nies lack the man­power to de­sign drug de­vel­op­ment strate­gies and ef­fi­ciently ex­e­cute tri­als, which is an­other driver of op­por­tu­nity for CROs in the in­dus­try. It is wor­thy to note that in pre­vi­ous years, China seemed to also of­fer an­other ben­e­fit of low costs, how­ever re­cently as com­pe­ti­tion has

in­creased, this ben­e­fit has di­min­ished. This presents a po­ten­tial re­straint for CROs, as clients in this re­gion of­ten ex­pect a more cost-ef­fec­tive so­lu­tion. One of the ways to curb the cost and also to en­sure a steady in-flow of tal­ent, PAREXEL has been in­vest­ing in mul­ti­ple fronts to de­vel­op­ment its own pipeline of tal­ent, un­der strate­gic work force plan­ning. In the past two years, there has been sig­nif­i­cant in­vest­ment place into lo­cal tal­ent de­vel­op­ment pro­grams, ex­change pro­grams, etc.

Chang Lee: In my opin­ion, the ma­jor driv­ers of the APAC CRO in­dus­try in­clude the grow­ing of phar­ma­ceu­ti­cal mar­ket size, reg­u­la­tory re­form in China, in­creased in­vest­ment and in­no­va­tion in drug de­vel­op­ments and more global pharma com­pa­nies com­ing to APAC. Res­traints in­clude the short­age of ad­e­quate ex­per­tise, high turn-over rate in staff, in­creased study cost and selec­tion of right tech­nol­ogy for the re­gion.

What are the coun­tries in Asia ex­hibit­ing promis­ing growth in CRO space and why?

Karen Chu: China ex­hibits some of the most promis­ing growth in the pre-clin­i­cal, clin­i­cal, and big data space. There may even be a po­ten­tial uptick in med­i­cal de­vice de­vel­op­ment and tri­als. The se­cond is Ja­pan, where the most growth might con­cen­trate in big data, new tech­nol­ogy plat­forms and in­no­va­tion.

Chang Lee: Yes, China has the largest op­por­tu­nity for growth, due to the re­cent reg­u­la­tory re­forms and in­creased in­vest­ment in in­no­va­tion. An­other growth area is Korea. The suc­cess of Sam­sung’s bio-tech ven­ture has stim­u­lated flows of in­vest­ments from en­ter­prises and gov­ern­ment. These in­vest­ments have re­sulted in am­ple lab spa­ces at many bio­phar­ma­ceu­ti­cal re­search com­plexes — a hall­mark of in­dus­trial-re­search fa­cil­i­ties — and so­phis­ti­cated, state-of-the-art equip­ment.

What do you en­vi­sion as the fu­ture for the CRO in­dus­try – 10 years from now?

Karen Chu: In China, I en­vi­sion that the CRO in­dus­try will mimic that of the west­ern coun­tries – con­sol­i­da­tion of lo­cal CROs and ven­dors. The ser­vice provider will be­come more of one-stop­shop with global ex­per­tise sit­ting lo­cally for the bio­phar­ma­ceu­ti­cal com­pa­nies to tap into. In ad­di­tion, we can ex­pect very in­no­va­tive ways to con­duct tri­als with tech­nol­ogy and tap into the large pop­u­la­tion in China. In 10 years, big data be­comes even more pow­er­ful. We can also ex­pect much more rigor in post-mar­ket­ing sur­veil­lance – if that term still means the same thing in 10 years. Ba­si­cally, there will be much more “man­age­ment” from the gov­ern­ment on prod­ucts that are mar­keted.

Chang Lee: In the fu­ture, I en­vi­sion that the tra­di­tional CRO model (i.e., clin­i­cal trial fo­cused) is go­ing to be changed to CRO plus (some­thing else) model. For ex­am­ple, this might in­clude CRO + Mar­ket­ing Data; CRO + Clin­i­cal Lab; CRO + CMO; CRO + tech­nol­ogy (e.g., AI, big data).

Could you please high­light some of the key mile­stones PAREXEL has crossed in the last 2-3 years? And how do these pro­vide the com­pany lever­age in the APAC re­gion?

Karen Chu: In the last 2-3 years, PAREXEL has suc­cess­fully brought all its busi­ness ser­vices into Asia. Now, not only are the tra­di­tional clin­i­cal re­search ser­vices PAREXEL has de­liv­ered in the re­gion for 20+ years, but also PAREXEL’s reg­u­la­tory and mar­ket ac­cess ser­vices are able to sup­port our clients in Asia. This is very mean­ing­ful as PAREXEL de­liv­ers an in­te­grated ser­vice of­fer­ing and one-stop­shop for our clients based in Asia. PAREXEL’s long­time pres­ence and depth of ex­per­tise in the re­gion has en­abled trust amongst our clients in APAC, and we look for­ward to con­tin­u­ing to ad­vance these part­ner­ships.

Does PAREXEL have any plans for fur­ther ex­pan­sion in Asia?

Karen Chu: The APAC re­gion is a top pri­or­ity for PAREXEL and will con­tinue to be as the in­dus­try grows. The re­gion shows great prom­ise and we are pre­pared to meet the needs of our clients as they work to de­liver im­por­tant new ther­a­pies across the globe.

Karen Chu, Cor­po­rate Vice Pres­i­dent, Global Clin­i­cal Op­er­a­tions, PAREXEL

Chang Lee, Vice Pres­i­dent,PAREXEL Con­sult­ing APAC

Karen Chu, Cor­po­rate Vice Pres­i­dent, Global Clin­i­cal Op­er­a­tions, PAREXEL

Chang Lee, Vice Pres­i­dent, PAREXEL Con­sult­ing APAC

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