Drugs to

Watch
2021
A Clarivate Report
A medical Despite the many
challenges of 2020, drug
• B
 iogen and Eisai’s aducanumab,
a potential game changer in the costly
This year’s list is a conservative one,
reflecting, in part, a trend towards
In addition to rewarding shareholders
and funding future innovation, these

moonshot in
and so-far fruitless fight to build a specialty drugs launching with very treatments hold enormous potential
development triumphed. pharmacopeia against Alzheimer's narrow initial indications and expanding to advance human health, redefining
disease, which affects an estimated gradually into others, over many years. standards of care in their categories

vaccines and
Through all the disruption, biopharmas 50  million patients worldwide (not to This trend is particularly true for oncology and saving or improving patient lives.
managed to produce a crop of highly- mention their families and caregivers);​ therapeutics, where a still-relatively- This report offers an overview of each
effective vaccines and treatments young field of immuno-oncology of these four Drugs to Watch in 2021,

strides against
that, scarcely a year into the pandemic, • UCB’s  bimekizumab, which promises agents (e.g., Keytruda, Opdivo, Yervoy) along with a snapshot of the fast-
promise to downgrade a deadly disease significantly fewer side effects to continues to expand its applications.  emerging field of COVID-19 vaccines. 
to something more like a seasonal flu. patients with psoriasis, a condition

serious diseases
It’s the medical equivalent of many affecting an estimated 2–3% of the Other experimental treatments on our
simultaneous moonshots, with global population, and potentially a radar this year, ones which didn't quite
dozens of SARS-CoV-2 vaccines in host of  other autoimmune diseases;​ fit our criteria for inclusion in this list, but
the pipeline yet. which have notable potential, include:
• T
 akeda’s  relugolix, one of the first of CAR T-cell immunotherapies from Bristol
Beyond the unprecedented achievements a new class of treatments, with an oral Myers Squibb (idecabtagene vicleucel)
of the industry’s response to COVID-19, formulation to address prostate cancer, and Janssen  (ciltacabtagene autoleucel),
drug developers have advanced the second-most-common malignancy currently in FDA review for use in
milestone treatments for conditions afflicting men, as well as endometriosis treating various multiple myeloma
affecting tens of millions of patients and uterine fibroids, painful conditions indications;  Reata’s bardoxolone methyl,
worldwide, including Alzheimer’s and affecting millions of women;​ an anti-inflammatory granted FDA
congestive heart failure. Among the Orphan Drug designation for treatment
new drugs and biologics that have • B
 ayer and Merck’s  vericiguat, of connective tissue disease-associated
either won approval or are on the an innovative heart failure treatment pulmonary arterial hypertension and
cusp of doing so, we have identified and the first indicated specifically for chronic kidney disease in patients
four treatments that are likely to reach high-risk, chronic heart failure with with Alport syndrome; Pfizer and Lilly’s
blockbuster status, delivering annual reduced ejection fraction (HFrEF), tanezumab, an NGF inhibitor filed
sales of more than $1 billion within five a  particularly at-risk population. with FDA for treatment of chronic pain
years. These Drugs to Watch™ include:  in moderate-to-severe osteoarthritis
patients; LEO Pharma’s tralokinumab and
Galderma’s nemolizumab, monoclonal
antibodies for treatment of atopic
dermatitis; and Pfizer’s PF-06482077
experimental pneumonia vaccine.  

2
 Contents

04 Methodology

Data sources
05 
and contributors

06 Drugs to Watch

06 — Aducanumab 

09 — Bimekizumab 

12 — Relugolix 

16 — Vericiguat 

19 C
 OVID-19 vaccine
landscape

24 Looking ahead

3
Methodology

Drugs to Watch showcases drugs entering the market

that year with the potential to become blockbusters
within five years. Blockbuster is defined by the common
$1 billion annual sales milestone. 

Data and analysis to identify this Our experts then manually evaluated The drug snapshots within the report
year's Drugs to Watch drew from each drug in its individual context, draw from: interviews with therapy
Clarivate life sciences solutions and based on factors such as expected experts for the respective drug markets;
integrated data sets that span the approval or launch dates, competitive Clarivate drug, disease landscape
R&D and commercialization lifecycle. landscape, regulatory status, trial results, and forecast reports; Cortellis™ sales
market dynamics and other factors.   data (sourced from Refinitiv I/B/E/S);
Drug selection criteria: and other industry sources including
From there, we determined four biopharma company press releases
• D
 rugs in phase 2 or phase 3 trials, at Drugs to Watch in 2021: and peer-reviewed publications.
pre-registration or registration stage,
or already launched early in 2021 • Aducanumab  This year's Drugs to Watch also includes
were selected for analysis, including a special section on the COVID-19
drugs launched for a new indication • Bimekizumab  vaccine landscape, which summarizes
that could be particularly impactful the vaccines that were granted
on the industry; drugs launched • Relugolix  (Orgovyx) emergency use authorizations/conditional
prior to 2021 were excluded approvals as of February 10, 2021.
• Vericiguat  (Verquvo)
• D
 ataset was then filtered for Please note that Clarivate analysts
drugs that had total forecast sales generated the data shown in this
of $1 billion or more in 2025 report on January 21, 2021 and the
data were correct as of that time. 

4
Data sources
and contributors
Since 2013, Clarivate has applied the proprietary
technologies, tools and techniques trusted by
its global life sciences customers to produce the
Drugs to Watch report.

 ortellis Competitive Intelligence™

C Expert contributors 
provides access to data such as
drug pipeline, deals, patents, Michael Ward T.J. Arndt
global conferences and company Global Head of Thought Leadership, Epidemiology
content, along with the latest Life Sciences and Healthcare
industry news and press releases. Oliver Blandy
Karen Walker Epidemiology
 isease Landscape & Forecast
D Managing Editor,
provides comprehensive market Cortellis Alison Isherwood
intelligence and actionable insights Epidemiology
across 180+ indications to help Joan Tur
optimize long-term disease strategies. Life Sciences Editor  lexandre Vo Dupuy
A
Epidemiology
 rug Timeline & Success Rates is
D  lsa Arias Barrau
E
an analytic tool that applies statistical Senior Manager, Mohit Nasa
modeling and machine learning to Cortellis Immune & Inflammatory Disorders
reliably and accurately forecast drug
development milestones, timelines Anne Lecocq Colleen Albacker
and probability of success. Business of Science Director, Immune & Inflammatory Disorders
Content
John Crowley
Matthew Arnold Infectious, Niche and Rare Diseases
Principal Analyst,
Life Sciences and Healthcare Anamika Ghosh
Oncology
Dominika Rudnicka-Noulin
Cardiovascular  arolina do Pazo
C
Prostate Cancer
 eher Baba Kumar Nakka
M
Central Nervous System Alice Zeng
Vaccines
Jonathan Searles
Central Nervous System Gang Wang
Chief Scientist,
Ruchita Kumar Life Sciences, China
Central Nervous System

5
All eyes are on aducanumab, which could
become the first disease-modifying
therapy (DMT) for Alzheimer's disease
(AD), a landmark achievement following
decades of failure in this perennially
underserved market.

About aducanumab

• D
 eveloped by Biogen Inc
and Eisai Co Ltd

• R
 ecombinant chimeric human
IgG1 mAb targeting beta-amyloid

• I n November 2020, FDA Advisory

Committee issued a negative review,
finding that available clinical trial
evidence did not prove effectiveness

• A
 fter submission of additional
data and analysis, PDUFA date
was extended by three months to
June 7, 2021 (as of Jan 29, 2021)

• U
 ndergoing standard MAA/NDA
review by the EMA and PMDA

Aducanumab
6
Aducanumab (BIIB037)
Neurology/psychiatric –
Alzheimer’s disease

Market overview

~50m
About the Alzheimer's disease market Unmet patient needs

• C
 urrently only symptomatic therapy: The most critical need for patients has
AChEIs and memantine, now generic, been a safe, effective DMT that slows
people with Alzheimer's are the standard of care across mild, cognitive decline. Tools that enable
disease globally moderate and severe disease earliest possible diagnosis are also critical.

• N
 o novel therapies
approved in >15 years

• O
 ther key anti-beta-amyloid
DMTs in late-phase development:
lecanemab (BAN2401; Eisai/Biogen)

>30%
and gantenerumab (Roche)

• M
 any more drugs from a range of
MOAs (e.g., tau-based therapies,
expected increase in total sigma-1 receptor inhibitors and
prevalent cases of early SIGLEC3 and Trem2 antibodies)
Alzheimer's disease by 2029 are in mid- and late-phase trials
due to aging population

7
Aducanumab (BIIB037) "I have to say that the data are convincing…there is clear clinical effect. I don’t
Neurology/psychiatric – think it’s a false positive. …aducanumab is, biomarker-wise, the strongest thing
Alzheimer’s disease
possible… from the point of MOA, biomarkers and the effect on the brain
amyloid and tau... for how long would you treat patients and what their dosage
would be to achieve the clinical effects? If you look closely, the limited data
Analysis
they have sort of parallels the observations they made during phase 1."
Neurologist,
United States

 Why is it a drug to watch? What you need to know Based on Cortellis data, there is a 49% probability
of success for aducanumab in the U.S.
Aducanumab is the first putative DMT Aducanumab could unlock a monumental
to demonstrate a clinical effect in opportunity to radically change AD
early Alzheimer's disease patients in a patient care and transform the market. If
phase 3  study and the first to undergo approved, demand for treatment will be
regulatory review. Results from the enormous, potentially even  decreasing
terminated ENGAGE/EMERGE and willingness to forgo this treatment for
completed PRIME trials indicate that an investigational drug in future clinical
aducanumab is biologically active trials. It could have a similar effect on
and suggest the potential for efficacy companies' decisions about which
with sufficient exposure to the 10 drugs to develop, bypassing other
mg/kg dose. If approved, it would sorely needed MOAs to develop next-
mark a  major clinical, commercial gen anti-amyloid drugs. Nevertheless,
and  regulatory milestone. However, many questions remain about the drug’s
the overall data package is complex prospects, including, first and foremost,
and contentious given the limitations the probability of approval given the
associated with the data and its analysis. questions about its true efficacy, followed
by future competition from other DMTs
and overall health system preparedness—
What to watch availability, cost and reimbursement of
the drug and requisite diagnostic testing;
The uncertainty around approval is patient/physician awareness to drive
the key factor. If approved, market early presentation, specialist referral and
access hurdles (cost/reimbursement diagnosis; and  infusion infrastructure. 
and practical/logistical) will be
the key rate-limiting factors.

$3.74B
expected sales in 2025
Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rates
Prediction current as of January 26, 2021

8
Bimekizumab
This innovative psoriasis treatment
promises substantially fewer side effects,
along with modest gains in efficacy.

About bimekizumab

• H
 umanized monoclonal IgG1
antibody developed by UCB

• F
 irst biologic agent to enter
phase 3 studies that simultaneously
targets  both  IL-17A and IL-17F

• U
 ndergoing review by the FDA and
EMA as of September 2020 to treat
moderate to severe, chronic plaque
psoriasis based on data from three
phase 3 trials showing superiority
to placebo, ustekinumab (Stelara)
and adalimumab (Humira)

9
Bimekizumab
UCB-4940; BKZ
Excessive immune response/
autoimmunity – psoriasis

Market overview

2–3%
About the psoriasis market Unmet patient needs

• C
 urrently very crowded, Current biologic treatments offer
with both biologic and non- many patients relief, but often do not
estimated global biologic treatment options induce long-term remission. For a
prevalence of psoriasis more comprehensive set of treatment
• B
 iologic classes for psoriasis options, patients would benefit from 
with the largest market share:   novel, efficacious, topical therapies
TNF-inhibitors (typically first-line without steroidal side effects and oral
treatment; Humira, Embrel), therapies that are safe and have an
IL-12/IL-23 (Stelara),  IL-17 (Cosentyx, efficacy similar to that of biologics.
Taltz) and IL-23 (Tremfya, Skyrizi)

• C
 urrent mainstay: methotexate
(non-biologic)

• F
 uture market share likely to grow
due to increasing evidence for
IL-23 and IL-17 efficacy and physician
familiarity with these drugs

10
Bimekizumab
UCB-4940; BKZ
Excessive immune response/
autoimmunity – psoriasis

Analysis "It is highly likely to get approval. It is probably going

to prove to be one of the fastest biologics we have
and one of the most effective, but also it seems
to be particularly effective for joint disease."
Dermatologist,
France

Why is it a drug to watch? Development also underway for: Based on Cortellis data, bimekizumab is predicted to reach first approval in the U.S.
While bimekizumab is a late-class entrant • Psoriatic arthritis (PsA)
providing incremental improvement over
existing treatment options, it is expected • Ankylosing spondylitis (AS)
to have best-in-class efficacy and fewer
serious side effects. Its dual inhibition of • Non-radiographic axial
IL-17A and IL-17F differentiates its MOA spondyloarthritis (nr-axSpA)
from other biologics,  and clinical trials
results are promising. It also has the • Ulcerative colitis 
potential to benefit the ~30% of patients
with concomitant psoriatic arthritis. • Hidradenitis suppurativa
 

What you need to know What to watch

• B
 imekizumab will likely be used as Bimekizumab's blockbuster status could
a third- or fourth-line treatment for be impacted by uptake of the IL-23
patients with primary non-response, inhibitor SKYRIZI (risankizumab) and its
loss of response or unacceptable anticipated approval for extension to
side effects with other treatments PsA treatment in the U.S. and E.U. Also
facing stiff competition within the IL-17
• L ong-term efficacy and safety class, bimekizumab will need to achieve
profile will be crucial to the preferred inhibitor status on at least
use of bimekizumab some of the three in-class competitors
(brodalumab [Siliq], ixekizumab [Taltz]
and secukinumab [Cosentyx]). 

$1.86B
expected sales in 2025
Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rates
Prediction current as of January 26, 2021

11
Relugolix
For these patients who have few effective
treatment options, there is great opportunity for
novel drugs to have a big impact on outcomes and
quality of life. With relugolix, patients have an
effective, oral choice, although with long-term
hypoestrogeneic side effects that will need to be
taken into consideration and potentially managed.

About relugolix Relugolix for endometriosis

• D
 eveloped by Takeda Pharmaceutical • P
 hase 3 trials ongoing in Australia,
Co Ltd and licensees Myovant Sciences Canada, Japan, New Zealand,
Ltd, Pfizer Inc, ASKA  Pharmaceutical South Africa, South America and
Co Ltd and  Gedeon Richter the United States

• GnRH receptor antagonist

Relugolix for uterine fibroids

Relugolix for prostate cancer • A

 pproved for treatment of uterine
fibroids in Japan (February 2019)
• A
 pproved for treatment of prostate
cancer in the U.S. (December 2020)  • U
 ndergoing MAA/NDA review
by the EMA  and U.S. FDA
• M
 ulticountry phase 3 (HERO)
trial ongoing in Australia, Brazil, • P
 hase 3 trials ongoing in Brazil,
Canada, Europe, Japan, Mainland Chile and South Africa
China, New Zealand, South Korea
and Taiwan

12
Relugolix
TAK-385; Orgovyx; Relumina
Oncology – prostate cancer
Reproductive health  –
endometriosis & uterine fibroids

Market overview

Oncology –
1.5% prostate cancer

CAGR  About the prostate cancer market

• M
 ainstay frontline treatment:
Unmet patient needs

Patients with prostate cancer would

of diagnosed incident androgen deprivation therapy, i  ncluding benefit from therapies with greater
cases  from 2019 to 2029, orchidectomy,  GnRH agonists and effectiveness, targeting predictive
driving an increase in GnRH antagonists (administered alone biomarkers with new MOAs and that
or in combination  with chemotherapy, prevent or delay progression to CRPC.
drug-treatable cases
radiotherapy or androgen antagonists)

• P
 rimary competitors: Lupron
depot (GnRH agonist), Firmagon
(GnRH antagonist)

2nd
• O
 ther drug classes used for treatment:
chemotherapy, immunotherapy,
bone metastases-targeted
agents and PARP inhibitors
most frequent malignancy
in men worldwide • D
 ynamic late-phase development
pipeline that spans a wide range of
drug classes, including novel classes,
with significant potential for drug
developers to target large number
of drug-treatable cases of hormone-
sensitive and castration-resistant
prostate cancer (CRPC)

13
Relugolix
TAK-385; Orgovyx; Relumina
Oncology – prostate cancer
Reproductive health  –
endometriosis & uterine fibroids

Market overview

Reproductive health – Reproductive health –

>60% endometriosis uterine fibroids

of women with a confirmed About the endometriosis market About the uterine fibroid market
endometriosis diagnosis are
drug-treated • E
 lagolix (Orilissa), an oral GnRH • E
 lagolix (Oriahnn): first and only GnRH
antagonist, first and only drug antagonist approved by the U.S. FDA
to be approved by the U.S. (June 2020) to treat uterine fibroids
FDA (August 2018) to treat
endometriosis-related pain • C  ornerstones of medical management
for u  terine f  ibroids: hormonal

13M+ 
• S urgical options: excision or contraceptives, GnRH agonists,
ablation, hysterectomy with tranexamic acid, NSAIDs, l  euprolide
concurrent oophorectomy a  nd ulipristal (Europe only)

women aged 15–54 years • F

 irst-line therapies for endometriosis- • S urgical options: hysterectomy, 
worldwide have confirmed related pain:  hormonal myomectomy and minimally
or suspected endometriosis contraceptives and NSAIDs invasive procedures such as uterine
artery embolization, myolysis
• S econd-line therapies for and endometrial ablation 
endometriosis-related pain:
GnRH agonists (e.g., Lupron)  Unmet patient needs

50M+ 
• L arge drug-treated population There are few safe, long-term
as a sizable target for medical treatments for uterine fibroid 
developers of novel therapies management, and rebound fibroid
growth can occur once treatment ends.
women aged  20–54 years Unmet patient needs Patients are reliant on therapies that
worldwide have uterine fibroids are safe but less effective, are effective
There are few safe, long-term medical but with a suboptimal safety profile, or
treatments, particularly non-hormonal have menopause-like side effects (hot
or non-invasive options, for the flashes, headache, nausea). Due to an
management of endometriosis-related increasing proportion of women delaying
pain. Many treatments have undesirable childbearing until later in life, there is also
Hysterectomy is currently menopause-like side effects (hot demand for uterus-sparing treatments.
the only definitive cure for flashes, headache, nausea). Due to an
uterine fibroids, but it also increasing proportion of women delaying
childbearing until later in life, there is also
results in permanent loss
demand for uterus-sparing treatments.
of childbearing capability. 

14
Relugolix
TAK-385; Orgovyx; Relumina
Oncology – prostate cancer
Reproductive health  –
endometriosis & uterine fibroids

"Using birth control pills continuously can help the majority

Analysis of the endometriosis-related pain. GnRH antagonists are
likely to be used in the second line following birth control
pills, and they have the potential for long-term use."

Gynecologist,
United States

Why is it a drug to watch? • A

 lthough it will be  first to Based on Cortellis data,  relugolix  is predicted to reach next approval in the E.U.
market in the  E.U., it is a smaller
Its potential use for three indications commercial opportunity
increases its chances of success.
The oral formulation (daily • I ts uptake for prostate cancer will likely
administration) provides advantages be modest, despite its entry as the first
over the injectable (administered and only GnRH antagonist approved
every 3 months) GnRH agonist for prostate cancer, owing to fierce
competitors, including convenience competition from the well-established
and better management of side effects. GnRH agonists and Firmagon
Demonstrated to be efficacious (injectable GnRH antagonist), and
and comparatively safe, relugolix sales will be further constrained by the
provides another option for  medical expected entry of generic alternatives
management and might prevent or
delay the need for  surgical treatment.
What to watch

What you need to know Uptake across all three indications

might be slow due to the entrenched
• F
 or women with few effective first-line drug therapies and physician
medical management options for reluctance to prescribe because of
uterine fibroids and endometriosis, the potential long-term side effects.
relugolix is promising for its efficacy
and ease of use. However,  long-
term use of  GnRH antagonists is 
hampered by hypoestrogenic
side effects, including bone loss 

• A
 s the second-to-market GnRH

$1.48B
antagonist for both endometriosis
and uterine fibroids in the U.S.,  
it will compete with AbbVie's 
Orilissa/Oriahnn, which had
combined  sales of  $125M in 2020
Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rates
expected sales in 2025 Prediction current as of January 26, 2021

15
This key emerging therapy is the first in
the market to specifically address high-
risk cases of chronic heart failure with
reduced ejection fraction (HFrEF), who
were often excluded from clinical trials
of other HFrEF treatments.

About vericiguat

• D
 eveloped by Bayer AG
and  Merck & Co

• Soluble guanylate cyclase stimulator

• I n the U.S., indicated for treatment

of adults with chronic  HFrEF
(approved Jan 2021) following
hospitalization for HF or receiving
outpatient intravenous diuretics

• U
 ndergoing MAA/NDA review
by the EMA, PMDA and Chinese
National Medical Products
Administration (NMPA) 

Vericiguat
16
Vericiguat 
BAY-1021189;
MK-1242; Verquvo
Cardiovascular – heart failure

Market overview

30%
About the HFrEF market Unmet patient needs

• C
 rowded, competitive market that HF (heart failure) remains associated
has been highly genericized for with high mortality, morbidity and
of HFrEF patients are decades and consists of multiple hospitalization rates. Patients  with
rehospitalized within effective treatment options worsening HFrEF are at the highest risk
three months of re-hospitalization and mortality, and
• R
 ecent approvals of major new treatments evaluated specifically for
drugs for HFrEF include Entresto this subpopulation have been lacking. 
(sacubitril/valsartan)  in 2015 and
Farxiga (dapagliflozin)  in 2020

25%
• D
 ifferentiation necessary for
new entrants to be successful

expected  increase in 

prevalence of heart failure 
in the U.S. by  2030

17
Vericiguat  "The target population for vericiguat is a pretty high-risk group
BAY-1021189; of patients. I don't think we have the data to suggest that we
MK-1242; Verquvo should use it widely in all heart failure patients, but I think this
Cardiovascular – heart failure
drug holds promise for people who are failing the standard of
care and are coming to the hospital with worsening heart failure."  
Analysis Cardiologist,
United States 

Why is it a drug to watch? What you need to know Based on Cortellis data, vericiguat is predicted to reach
its next approvals simultaneously in Japan and the E.U.
The phase 3 VICTORIA trial • V
 ericiguat's novel mechanism
demonstrated a clear reduction in of action should result in its
hospitalization rates and a  trend toward acceptance as an add-on therapy
reduction in cardiovascular (CV) mortality to existing treatments and will be
in patients with severe, deteriorating less exposed to direct competition
HFrEF, leading to its approval to treat from typical low-cost HF therapies
HFrEF in the U.S. For these patients,
treatments that  reduce hospitalizations • I t will likely find its niche among
and CV deaths remains an unmet need.   high-risk HFrEF patients,  become
a welcome addition to the
Because vericiguat's mechanism treatment armamentarium and
of action is distinct from current HF expand their treatment options
therapies, it can be prescribed as 
add-on therapy with little risk of severe
side effects.  Drug switching or new What to watch
drug  initiation for chronic HF patients  is
most common post-hospitalization, which Competition from established first-line
is expected to accelerate vericiguat’s  agents, a limited target patient population
uptake  compared with drugs that  should and payer hesitance for reimbursement
be initiated in stable  patients, especially could result in slow uptake and impact
given its ease of use, once-daily oral vericiguat's blockbuster status.
dosing  and simple titration.

$1.21B
expected sales in 2025
Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rates
Prediction current as of January 26, 2021

18
COVID-19
Vaccines for SARS-
CoV-2 infection
(COVID-19)

Prevention and treatment One thing is for certain: Success will

of SARS-CoV-2 infection depend on continued responsiveness
and collaboration. The solution might
remain paramount not be a single vaccine, but a vaccination
to ending the COVID-19 strategy that accounts for the need to
pandemic. quickly pivot for new strains (as mRNA
and viral vector vaccines could do) and
Yet, more than a year after we first the differing geographic situations. The
heard of the virus, it seems as if we Johnson & Johnson vaccine provides
are faced with more questions opportunities for developing countries,
than answers: What is the optimal where a single-dose vaccine without
vaccination strategy? How does extensive cold-chain requirements is
changing political environments affect suited to areas with limited infrastructure.
distribution and uptake of vaccines? In addition, effective treatment
Do we have the manufacturing capacity options are of the utmost importance
to supply enough vaccine for the for patients in urgent need of care.
global population? How long will
post-vaccination immunity last? Partnerships, such as Sanofi announcing
Will vaccines be effective against its intent to manufacture the BioNTech/
new strains? Will we have to adjust Pfizer vaccine, will be critical to ensuring
vaccines annually, as we do for the flu? capacity. And approval of the mRNA
The list goes on.  vaccines from Pfizer and Moderna,
and the associated investment in
Answering these questions is challenging facilities, will enable the technology
for many reasons. New information use in other areas, like the recently
and data become available nearly announced mRNA influenza vaccine.
daily. Responses and strategies differ
by country, public opinions of vaccine In this section, we review vaccines
roll-out can affect government strategies granted emergency use authorizations/
in the "race to vaccinate" and the conditional approvals as of February
effectiveness of non-pharmaceutical 10, 2021. We'll be monitoring the
intervention strategies (e.g., social progress of near-term candidates like
distancing, testing, contact tracing) those from J&J and AstraZeneca.
depends on governmental policy For complete coverage of the race to
and human behavior.  develop SARS-CoV-2 vaccines and
treatments, please visit BioWorld™
AZD-1222 BBIBP-CorV
AstraZeneca/ Beijing Institute of Biological
University of Oxford Products Co. Ltd/Sinopharm
Two-dose recombinant viral vector vaccine Two-dose, inactivated vaccine
Development status Distribution Deals Development status Distribution Deals

34 10+
• Emergency use/conditional The vaccine is well-tolerated, easily • Emergency use/conditional The vaccine is easily distributed and
marketing authorizations granted distributed, storable at refrigerator  marketing authorizations stored. While it has a reported 79%
in multiple countries temperatures  and easily administered granted in multiple countries efficacy when administered per protocol,
but there is some concern about its active deals it is associated with a lower cost that could procurement contracts with countries
• P
 hase 3 clinical trials underway in Brazil, efficacy, which is as low as 59.5% as • P
 hase 3 clinical trials underway in be attractive to low-income countries. including Algeria, Argentina, Brazil,
Chile, Colombia, Japan, Mainland per  protocol and as high as  90% with a Argentina, Egypt, Jordan and Peru Egypt, Indonesia, Malaysia, Mexico,
China (sublicensed to Shenzhen prime-boost regimen that is not included Morocco, Pakistan, Peru, Senegal,
Kangtai Biological Products), Peru, in the  planned protocol. Data are Thailand, Turkey and Ukraine
Russia, South Africa and the U.S.  lacking for older patients (>55 years).

• K
 orea Disease Control and
Prevention Agency (KDCA) reviewing
application for emergency use

Emergency use authorizations granted in: Emergency use authorizations granted in:

20
 CoronaVac
Sinovac Biotech Ltd.

Two-dose, inactivated vaccine

Development status Distribution Deals

11+
• Emergency use/conditional The vaccine is easily distributed and
marketing authorizations stored. The efficacy remains to be
granted in multiple countries determined, with rates as low as 50%
reported by Brazil, but the vaccine procurement contracts
• P
 hase 3 clinical trials underway can reportedly reduce the need for with 11+ countries
in multiple countries hospitalization and the most severe
forms of COVID-19 by 100%.

Emergency use authorizations granted in:

21
Gam-COVID-Vac mRNA-1273
Sputnik V; Gamaleya Moderna
Research Institute Therapeutics/NIAID
Two-dose, heterologous recombinant Two-dose, lipid nanoparticle RNA vaccine
adenovirus vaccine
Development status Distribution Deals

26
Development status Distribution Deals • Emergency use/conditional The vaccine is well-tolerated, easily
marketing authorizations distributed,  storable at  refrigerator 
• Emergency use/conditional
marketing authorizations
granted in multiple countries
The vaccine is well-tolerated and
easily administered, with  a  reported 
91.6% efficacy when administered
15 granted in multiple countries

• Phase 1/2 trial underway in Japan

temperatures  and easily administered,
with a  reported 94% efficacy when
administered per protocol.
active deals

per protocol but it does require active deals

• P
 hase 3 clinical trials underway storage at freezer temperatures.
in Belarus, the United Arab
Emirates, Venezuela and India

Emergency use authorizations granted in: Emergency use authorizations granted in:

22
Tozinameran
Comirnaty; BioNTech
SE/Pfizer Inc
Two-dose, lipid nanoparticle RNA vaccine
Development status Deals

18
• F
 irst COVID-19 vaccine • P
 hase 3 clinical trials
approved worldwide underway in Argentina, Brazil,
South Africa and Turkey
• First-in-class lipid nanoparticle vaccine active deals
• J
 apan PMDA reviewing an
• Emergency use/conditional application for emergency use
marketing authorizations
granted in multiple countries Distribution

• P
 hase 1 clinical trial (sublicensed  he vaccine is well-tolerated, is easily
T
to Shanghai Fosun Pharmaceutical administered and has a reported 95%
[Group] Co Ltd) underway in efficacy when administered per protocol,
Mainland China but it requires ultra-cold chain storage.

Emergency use authorizations granted in:

23
Looking
COVID-19 is set to impact • A
 surge in investment: Even as
drug development going the world economy shuddered,
investment in biotechs soared last
forward, both for better year to nearly $134 billion1, while
and for worse.   biopharmas raised nearly $7 billion
in seed and series A rounds, with
Little more than a year into the much of that activity focused on
COVID-19 pandemic, encouraging oncology and infectious diseases. 
developments on the vaccine front
are coming so fast it’s hard to keep up, • A
 more collaborative approach:
with a handful of vaccines already in One early ray of hope amid the
distribution and candidates from like gloom of the pandemic’s onset
Novavax and Johnson & Johnson came as biopharma competitors
posting solid efficacy numbers. formed consortia and joint ventures
This remarkable turnaround reflects, to pool data, share information, and
in part, huge adjustments made on the speed the development of vaccines
fly by industry and regulators alike to and treatments for the disease.
accelerate development. Learnings
from some of these adjustments are • M
 ore remote care and consultation:
likely to shape biopharma R&D and Much of life has gone virtual, from
commercialization well beyond the patient care to clinical trial check-ins
immediate crisis of the COVID-19 to biopharma financing roadshows
pandemic, including:  and payer negotiations. Some of this
shift from in-person to digital will stick
• F
 aster clinical trials: Meeting the and could help to accelerate timelines
urgency of the moment required that going forward. 
regulators and drug developers rethink
the traditional sequential model of
conducting clinical trials, operating On the downside, however, social and
instead with multiple overlapping travel restrictions have resulted in the
trials and phases running in tandem. disruption of at least 427 ongoing clinical
Some of the factors that enabled trials1, from delays and suspensions to
companies to collapse vaccine terminations. And while FDA approvals for
development from years to months 2020 came in at a robust 46 new molecular
safely are specific to vaccines – for entities, tracking with the previous
example, the development of mRNA year’s, there was a substantial decline in
and other vectors, for example, and new drug and biologic applications and
recent leaps in our understanding efficacy supplements for the first half of
of viruses and immunology, for the year, suggesting that a corresponding
example. Others may well bleed dip in approvals is likely for 2021. 
over into the development of small
and large molecule therapeutics.

24
ahead 1. Ward, M. (2021) Biotech set for good start to 2021, Clarivate
About Clarivate
Clarivate™ is a global leader in We help customers discover, protect
providing solutions to accelerate and commercialize their inventions
the lifecycle of innovation. Our bold using our trusted subscription and
mission is to help customers solve technology-based solutions coupled
some of the world’s most complex with deep domain expertise. For more
problems by providing actionable information, please visit clarivate.com.
information and insights that reduce
the time from new ideas to life-
changing inventions in the areas of
science and intellectual property.

Contact our experts today:

+1 215 386 0100 (U.S.)

+44 (0) 20 7433 4000 (Europe)
clarivate.com

© 2021 Clarivate. Clarivate and its logo, as well as all other trademarks used herein are trademarks
of their respective owners and used under license.