Dig­i­tal ther­a­peu­tics: The key to max­i­miz­ing the po­ten­tial of med­i­c­i­nal as­sets

Key take­aways:

• Dig­i­tal ther­a­peu­tics sup­port in­creased ac­cess to safe and ef­fec­tive ther­a­pies, pro­vid­ing an un­tapped op­por­tu­ni­ty for bio­phar­ma­ceu­ti­cal com­pa­nies to max­i­mize the val­ue of med­i­c­i­nal as­sets and dri­ve dif­fer­en­ti­a­tion
• When de­vel­oped in com­bi­na­tion with a med­i­c­i­nal as­set, dig­i­tal ther­a­peu­tics en­able sig­nif­i­cant mar­ket dif­fer­en­ti­a­tion and sig­nif­i­cant ben­e­fits for stake­hold­ers—from op­ti­miz­ing pa­tient out­comes to sup­port­ing more ef­fi­cient gen­er­a­tion of com­pelling re­al-world da­ta
• In­te­grat­ing dig­i­tal ther­a­peu­tics ear­ly in the as­set de­vel­op­ment process will al­low for gath­er­ing of clin­i­cal da­ta to dri­ve a clear­er val­ue propo­si­tion that max­i­mizes the po­ten­tial of both prod­ucts
• Ear­ly mar­ket en­try is fun­da­men­tal, and man­u­fac­tur­ers must plan strate­gi­cal­ly to con­sid­er how dig­i­tal ther­a­peu­tics (DTx) are best in­cor­po­rat­ed in­to the launch and go-to-mar­ket strat­e­gy. In­ter­nal dig­i­tal and da­ta sci­ence ex­per­tise is crit­i­cal to de­vel­op­ing a unit­ed val­ue propo­si­tion that aligns the ben­e­fits of the dig­i­tal and med­i­c­i­nal prod­uct

This is a sum­ma­ry, tak­en from Fishawack Health’s new pub­li­ca­tion “Dig­i­tal ther­a­peu­tics: The key to max­i­miz­ing the po­ten­tial of med­i­c­i­nal as­sets.” Down­load it here.

It is es­ti­mat­ed that the num­ber of peo­ple us­ing dig­i­tal ther­a­peu­tics will in­crease by 381% over the next four years.¹

Dig­i­tal ther­a­peu­tics are a sub­cat­e­go­ry of dig­i­tal med­i­cine. They can be cat­e­go­rized in­to three sub­types de­pend­ing on whether they are de­signed to pre­vent, man­age, and/or treat a dis­ease or con­di­tion.

The key dif­fer­ence be­tween dig­i­tal med­i­cine and dig­i­tal ther­a­peu­tics is that dig­i­tal med­i­cines re­quire clin­i­cal ev­i­dence alone, where­as dig­i­tal ther­a­peu­tics re­quire both clin­i­cal ev­i­dence and re­al-world out­comes da­ta. This means dig­i­tal ther­a­peu­tics are held to the same stan­dards of ev­i­dence and reg­u­la­to­ry re­quire­ments as con­ven­tion­al phar­ma­co­log­i­cal treat­ments, re­quir­ing ap­proval from reg­u­la­to­ry bod­ies to sup­port prod­uct claims of risk, ef­fi­ca­cy, and in­tend­ed use.²

Fig­ure 1: The key dif­fer­ences be­tween dig­i­tal health, dig­i­tal med­i­cine, and dig­i­tal ther­a­peu­tics²

Proac­tive­ly in­te­grat­ing dig­i­tal ther­a­peu­tics in­to your ear­ly glob­al com­mer­cial as­set strat­e­gy can in­crease the chances of a suc­cess­ful launch and com­mer­cial­iza­tion, en­sur­ing as­sets are pos­i­tive­ly dif­fer­en­ti­at­ed from the com­pe­ti­tion and of­fer ben­e­fits be­yond the drug for all stake­hold­ers, in­clud­ing:

• Im­proved out­comes, ac­cess, and ex­pe­ri­ence for pa­tients
• Health­care pro­fes­sion­als can im­prove care for pa­tients through ad­di­tion­al mon­i­tor­ing, along­side lever­ag­ing ap­pli­ca­tions that sup­port pa­tient ad­her­ence
• Scal­able and cost-ef­fec­tive in­ter­ven­tions for pay­ers, in­clud­ing im­proved clin­i­cal and health eco­nom­ic out­comes, re­duced cost of med­ical in­ter­ven­tions, and the abil­i­ty to col­lect re­al-world da­ta

For bio­phar­ma­ceu­ti­cal man­u­fac­tur­ers, the ben­e­fits are far reach­ing and in­clude the abil­i­ty to dif­fer­en­ti­ate as­sets pos­i­tive­ly in crowd­ed mar­kets with mul­ti­ple com­pet­ing modes of ac­tion and where sev­er­al gen­er­a­tions of a prod­uct are on the mar­ket si­mul­ta­ne­ous­ly.

In­te­grat­ing a dig­i­tal ther­a­peu­tic in­to the as­set strat­e­gy can al­so help dri­ve ef­fi­cient clin­i­cal tri­als and sup­port ef­fec­tive ev­i­dence gen­er­a­tion, pro­vid­ing more com­pelling da­ta to reg­u­la­tors and pay­ers to achieve fa­vor­able ac­cess.

How­ev­er, the win­dow of op­por­tu­ni­ty for bio­phar­ma­ceu­ti­cal com­pa­nies to de­vel­op dig­i­tal plat­forms that can be op­ti­mal­ly com­bined with as­sets to fill un­met needs is clos­ing. Man­u­fac­tur­ers need to act quick­ly, be­fore the tech gi­ants shape this are­na, to de­vel­op dig­i­tal ther­a­peu­tics that tru­ly in­crease the val­ue of prod­ucts for all stake­hold­ers.

Key con­sid­er­a­tions for bio­phar­ma­ceu­ti­cal com­pa­nies to align on be­fore en­ter­ing the DTx mar­ket

Be­fore en­ter­ing the mar­ket, man­u­fac­tur­ers must plan strate­gi­cal­ly with a fu­ture-fo­cused lens to max­i­mize the val­ue of the as­set and port­fo­lio, en­sur­ing a clear vi­sion and busi­ness case to sup­port the com­mer­cial­iza­tion of the dig­i­tal ther­a­peu­tic, which in­cludes the fol­low­ing con­sid­er­a­tions:

1. A unit­ed val­ue propo­si­tion

Dig­i­tal ther­a­peu­tics and as­set de­vel­op­ment should not be seen as sep­a­rate but of the same over­all val­ue propo­si­tion and to­tal prod­uct pro­file (ToPP). This mind­set en­sures tru­ly syn­er­gis­tic de­vel­op­ment, over­com­ing bar­ri­ers, and max­i­miz­ing po­ten­tial.

Em­bed­ding dig­i­tal ther­a­peu­tics in­to the over­all down­stream de­vel­op­ment process must com­ple­ment ex­ist­ing process­es with­out caus­ing ad­di­tion­al con­straints. To achieve this, bio­phar­ma­ceu­ti­cal com­pa­nies will need deep knowl­edge of the ex­ist­ing process­es and sys­tems, us­ing de­sign think­ing and deep­er in­sight method­olo­gies to dri­ve in­te­gra­tion.

2. Ear­ly in­te­gra­tion in­to re­search and de­vel­op­ment

Dig­i­tal ther­a­peu­tic de­vel­op­ment is not a quick process. To en­sure max­i­mum val­ue for both pa­tients and com­pa­nies, it must be in­te­grat­ed ear­ly in the as­set re­search and de­vel­op­ment process. This en­ables the gath­er­ing of ev­i­dence of clin­i­cal­ly sig­nif­i­cant out­comes, which are in­te­gral to the dig­i­tal ther­a­py ap­proval process­es.

With the pre­dic­tion that dig­i­tal ther­a­peu­tics mar­kets will in­ten­si­fy due to both bio­phar­ma­ceu­ti­cal and tech com­pa­nies en­ter­ing this space, it is crit­i­cal the nar­ra­tive is shaped proac­tive­ly, high­light­ing the im­por­tance of ear­ly mar­ket en­try. Teams must con­sid­er how they it­er­a­tive­ly test hu­man-cen­tric dig­i­tal ther­a­peu­tic so­lu­tions and scale promis­ing as­pects in the same way they would with a non-dig­i­tal ther­a­py.

3. Dig­i­tal and da­ta sci­ence ex­per­tise and mind­set

Build­ing the re­quired ca­pa­bil­i­ties and ex­per­tise with­in tech­nol­o­gy, da­ta sci­ence, and an­a­lyt­ics is crit­i­cal and takes plan­ning and tim­ing. Bring­ing teams on this trans­for­ma­tion jour­ney will re­quire new process­es and struc­tures. Un­der­stand­ing the needs of and con­nect­ing with a wide range of stake­hold­ers (KOLs, PCPs, pa­tients, care­givers, reg­u­la­tors, pay­ers—and spe­cif­ic seg­ments of each) is es­sen­tial for en­sur­ing a suc­cess­ful mar­ket up­take. It is im­per­a­tive that your tar­get stake­hold­ers can see the sig­nif­i­cant val­ue that your dig­i­tal ther­a­py can pro­vide.

The needs of your stake­hold­ers are key to cre­at­ing a prod­uct that pro­vides val­ue to an area of un­met need for all stake­hold­er groups. Strong col­lab­o­ra­tions and part­ner­ships will en­sure that the over­all ToPP pro­vides a com­pelling of­fer­ing.

4. Launch and mar­ket strat­e­gy

An al­tered launch strat­e­gy is re­quired to en­sure the launch of both the as­set and dig­i­tal ther­a­peu­tic are firm­ly es­tab­lished and the tar­get­ed val­ue is achieved with­in the re­al world, par­tic­u­lar­ly as the mar­ket be­comes more com­pet­i­tive and am­bigu­ous.

Get the full analy­sis

This is a sum­ma­ry tak­en from Fishawack Health’s new pub­li­ca­tion “Dig­i­tal ther­a­peu­tics: The key to max­i­miz­ing the po­ten­tial of med­i­c­i­nal as­sets.”

Down­load the whitepa­per to gain in­sights on:

• Dig­i­tal ther­a­peu­tics mar­ket growth
• Key ther­a­py ar­eas and ap­pli­ca­tions
• De­tailed ben­e­fits for stake­hold­ers and ad­vice on over­com­ing adop­tion hur­dles
• Strate­gic rec­om­men­da­tions for bio­phar­ma­ceu­ti­cal com­pa­nies for de­vel­op­ing a dig­i­tal ther­a­peu­tics strat­e­gy in com­bi­na­tion with as­set com­mer­cial­iza­tion

Ref­er­ences:

1. Ju­niper Re­search. https://www.ju­niper­re­search.com/re­search­store/health­care-gov­ern­ment/dig­i­tal-ther­a­peu­tics-mar­ket-re­search-re­port; 2022 [ac­cessed Jan­u­ary 13, 2023].
2. Dig­i­tal Ther­a­peu­tics Al­liance. https://dtx­al­liance.org; [ac­cessed Jan­u­ary 12, 2023]

About the Au­thors

Kirsten Ren­nie, Se­nior As­so­ciate Con­sul­tant, Fishawack Health
Kirsten has ex­pe­ri­ence in go-to-mar­ket strat­e­gy, ear­ly as­set brand strat­e­gy, dig­i­tal trans­for­ma­tion, om­nichan­nel en­gage­ment strate­gies, and tac­ti­cal roll-out for glob­al brands.  She is pas­sion­ate about im­prov­ing pa­tient out­comes glob­al­ly through the adop­tion of in­no­va­tions such as dig­i­tal health and how these can be har­nessed to in­crease pa­tient ac­cess to life-sav­ing ther­a­peu­tics.

Has­san Choud­hury, PhD, Ear­ly-Stage Strat­e­gy Lead, Fishawack Health
Has­san fo­cus­es on max­i­miz­ing the po­ten­tial of as­sets dur­ing ear­ly‑stage de­vel­op­ment through to launch and the im­ple­men­ta­tion of go-to-mar­ket mod­els. He is pas­sion­ate about de­liv­er­ing im­proved out­comes to pa­tients through the in­te­gra­tion of deep­er in­sights ear­li­er and chal­leng­ing norms in the pur­suit of ad­vance­ment for pa­tients and health­care sys­tems.

About Fishawack Health

Es­tab­lished in 2001, Fishawack Health (FH) is a pur­pose­ful­ly built com­mer­cial­iza­tion part­ner for the bio­phar­ma­ceu­ti­cal, med­ical tech­nol­o­gy, and well­ness in­dus­tries. Our 1,400+ ex­perts com­bine their knowl­edge and ex­per­tise across our core dis­ci­plines—Med­ical; Mar­ket­ing; Pol­i­cy; Val­ue, Ev­i­dence, and Ac­cess; and Con­sult­ing—to cre­ate the con­nec­tions that make bet­ter health hap­pen. We part­ner with our clients to nav­i­gate the com­plex and rapid­ly chang­ing health­care ecosys­tem. To­geth­er, we re­al­ize the po­ten­tial of strate­gies and so­lu­tions to bring in­no­va­tion to the hands of those who can ben­e­fit from it.