Clinical Trials Roundup Whitepaper

2019 Clinical Trials Roundup

WHITEPAPER

2 / October 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)

2020 has unfolded into a year unlike any other, and trial activity was not immune to the widespread impacts of the COVID-19 pandemic. Despite disruptions to the clinical and pharma ecosystems, the industry has, and continues to, persevere. As of 2 October 2020, Trialtrove captured 5,293 trials that initiated within 2020, 1,583 of which evaluated drugs and vaccines to treat and/or prevent COVID-19 diseases and its complications – nearly 30% of the total.

Here, we revisit 2019 through our annual review of new clinical trial activity to assess the competitive trial landscape and the stage that was set before strategies were forced to shift with the backdrop of COVID-19. This analysis includes an overview of the Phase I–III clinical trials that initiated in the previous year across all therapeutic areas (TAs) comprehensively covered by Trialtrove, including all drugs in active development, as well as a dive into the key diseases, players, and geographies that played a role in driving the industry’s plot forward.

Introduction

Doro ShinDirector, Content Performance Marketing, Pharma Intelligence

1. The data snapshot dates for the prior Clinical Trial Roundup analyses were 5 June 2019, 6 June 2018, and 6 July 2017. The 2016 Clinical Trials Roundup was the first year the analysis was expanded to include all therapeutic areas and all drug types. Prior versions of the roundup either focused on key therapeutic areas and/or unapproved drug activity only.

October 2020 / 3© Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)

Oncology continued to be the most active TA2 and comprised 40% of new trial activity in 2019, maintaining its share of total trial activity from 2018. The rankings across all TAs were also consistent with last year’s rankings, with CNS and Autoimmune/Inflammation (A/I) following Oncology as the most active areas (see Figure 1: Therapeutic areas by rank order). However, multiple TAs saw a notable slowing in new trial activity. Prior observed growth for between 2017 and 2018 was 17.8% for CNS, 15.7% for Metabolic/Endocrinology, 15.7% for Infectious Disease (ID)3, and 22% for Cardiovascular (CV). Between 2018 and 2019, CNS and Metabolic/Endocrinology experienced 2.9% and 3.5% growth while ID and CV activity both shrank, by 5.2% and 13.8%, all of which could have contributed in part to the slowed growth in overall trial activity (data not shown).

The proportion of trials evaluating at least one unapproved4 primary drug continued to hold at 60% (see Figure 1: Drug approval status), after last year’s increase from 57% to 60%. However, unlike last year where all TAs skewed activity toward unapproved drugs, 53% of new Genitourinary (GU) trials evaluated approved drugs alone.

The smallest TA of Ophthalmology demonstrated the largest proportion of unapproved drug trials, with 70%, along with ID (70%) and CV (66%). Although the number of trial initiations has decreased for ID and CV, both areas continue to focus the majority of new activity on evaluating innovation (see Figure 1: Distribution of trials by drug approval status).

As of 12 June 2020, Trialtrove captured 7,765 Phase I to III clinical trials investigating at least one drug and with a start date within the calendar year of 2019. While new clinical trial activity

has continued to grow, the rate of growth has decreased markedly from 12% in prior years to just 2% for 2019 trial starts (Table 1).

An Overview of the Clinical Trials Initiated in 2019

Table 1. Phase I–III clinical trial activity by volume and growth, 2016–191

2. Trials that include multiple indications across different therapeutic areas (TAs) will be counted for each targeted TA. As such, the sum of trial counts for the eight TAs will be higher than the total number of Phase I–III trials started in 2019.3. Trial counts for Infectious Disease (ID) include activity from Vaccines (Infectious Diseases), which is a separate TA module within Trialtrove. For the purposes of this analysis, all ID activity has been combined into a singular TA.4. Unapproved drugs have not received regulatory approval for any indication. This excludes drugs that were approved for an initial indication, but are unapproved for additional indications or other patient populations. Trials evaluating multiple drugs are classified as an unapproved drug trial if at least one primary drug is unapproved.

Source: Trialtrove®, June 2020

Year of trial initiation 2019 2018 2017 2016Trial count 7,765 7,606 6,794 6,067Year-on-year growth (%) 2% 12% 12% N/A


Figure 1. Phase I–III clinical trials status in 2019, by drug status

Powered by Informa’s Trial API Source: Trialtrove®, June 2020


Phase I trials continue to comprise the largest proportion of new activity, slowly growing from 35% in 2017 to 38% in 2018, and to 39% in 2019. Phase II and III held steady at 32% and 18%, maintaining the same proportion as the prior year (see Figure 2: Overall).

In line with overall activity, Phase I comprised the highest percentage of activity for most TAs.

The exceptions were Oncology, which continues to have the bulk of its activity in Phase II where proof-of-concept efficacy for a single drug is typically explored in multiple treatment settings, as well as GU and Ophthalmology. GU had the largest proportion of its 2019 activity squarely in Phase III, whereas the TA previously had a near even distribution between the major phases in 2018 (Figure 2).

Figure 2. Distribution of Phase I–III clinical trials started in 2019, by phase

Note: Due to rounding, % may not add up to 100%.Powered by Informa’s Trial API Source: Trialtrove®, June 2020


Oncology continues to dominate, with 15 various cancers included in the Top 20 diseases across newly initiated trials in 2019, once again led by non-small cell lung cancer (NSCLC) and followed by unspecified solid tumor, breast cancer, and non-Hodgkin’s lymphoma. Last year’s runner up, respiratory infections, fell to fifth place, while type 2 diabetes (T2D) slipped to sixth. Other non-oncology indications within the Top 20 most active diseases were pain (nociceptive) at ninth place, hypertension at 12th, and a new entrant, psoriasis, at 20th. In addition to psoriasis, the tail end included other new entrants, specifically unspecified cancer and multiple myeloma, replacing melanoma, bladder cancer, and

thrombotic disorders from last year’s Top 20 (Figure 3).

In terms of the trial phase breakdown for each disease, new trial activity was split between Phase I and II, which were the most common for 10 diseases each. The overall top disease, NSCLC, also led as the top disease for Phase II trials, while unspecified solid tumor led for Phase I trials, often denoting a basket-style design with multiple tumor locations. Among Phase III trials, non-oncology indications had the most activity, with T2D starting the largest volume of late-stage research, followed by respiratory infections, primarily for pneumococcal and seasonal influenza vaccines (Figure 3).

Figure 3. Top 20 diseases for Phase I–III clinical trials started in 2019, by trial count



In 2019, the Top 20 industry sponsors/collaborators5 initiated 1,520 of the 7,765 trials, or 20%, which is consistent with the proportion of trials initiated by the Top 20 companies in 2018. Bristol Myers Squibb (BMS) returns as the leading company, while last year’s leader, AstraZeneca, falls back to second place. BMS, previously the leader of the 2017 Clinical Trials Roundup, returned to the top in part due to its acquisition of Celgene, which previously held 14th place in last year’s analysis and contributed 23% of the wider company’s total trials initiated in 2019. Roche, Merck & Co, and Pfizer continued to hold the remaining positions within the top five, with Roche and Merck switching places in their rankings (Figure 4).

Many of the Top 20 companies have made appearances in prior versions of the roundup, including a few of the new entrants to this year’s analysis. At the tail end of the Top 20, CSPC

Pharmaceutical, Chia Tai Tianqing Pharmaceutical, Novo Nordisk, Eisai, and Astellas Pharma replaced Bayer, Merck KGaA, Incyte, Regeneron, and Celgene. With the entry of CSPC Pharmaceutical and Chia Tai Tianqing Pharmaceutical and return of Astellas Pharma into the Top 20, East Asia is further positioning itself as a key region driving new trial activity (Figure 4).

Phase I was the most common for 10 of the Top 20 most active companies, ranging from 36–69% of overall activity, while seven devoted 35–43% of their new trials to Phase II research. The remaining three – AbbVie, Sanofi, and Amgen – prioritized Phase III activity, which comprised 34–43% of their total trial volumes (Figure 4). The fact that these companies were able to concentrate on expensive, late-stage trials is facilitated by their relatively low positions in the ranking, with Sanofi falling out of the top 10 for new trial starts.

Drivers of New Clinical Trial Activity

5. Similar to disease counts, the trial counts by sponsor/collaborator represent each study that the company was involved in, including collaborative research. Trials that include multiple sponsors will be counted for each company.


Figure 4. Top 20 industry sponsors/collaborators by number of Phase I–III trials started in 2019


Bristol Myers Squibb

AstraZeneca

Roche

Merck & Co.

Pfizer

Novartis

Johnson & Johnson

Eli Lilly

GlaxoSmithKline

Jiangsu Hengrui Medicine

Boehringer Ingelheim

AbbVie

Takeda

Sanofi

Amgen

CSPC Pharmaceutical

Chia Tai Tianqing Pharmaceutical Group Co.

Novo Nordisk

Eisai

Astellas Pharma

60

42

45

24

46

27

33

43

17

37

45

20

25

18

12

30

20

18

9

11

21

9

10

14

12

5

6

8

9

5

1

1

10

4

5

2

2

8

3

5

73

57

44

43

34

36

39

17

30

18

12

21

16

11

17

11

15

14

12

7

26

28

25

38

12

32

18

24

13

9

7

22

10

25

18

8

6

1

1

3

2

1

1

3

3

0

Trial count

20 40 60 80 100 120 140 160 180 200

I I/II II/III IIIII


Most companies diversified efforts across five to six different TAs, but half of the Top 20 initiated the majority of their new trials in a single TA. Oncology was the largest priority for 15 of the Top 20 companies, with companies devoting between 35% (Novartis) to 73% (BMS) of their trials to anti-cancer efforts. Novo Nordisk was the sole company without any Oncology trials, instead continuing its keen focus on Metabolic/

Endocrinology (84%) in addition to smaller efforts in CV (12%), A/I (2%), and Ophthalmology (2%). Among the remaining companies, Boehringer Ingelheim and AbbVie prioritized A/I, while Sanofi focused a larger effort on ID and CSPC Pharmaceutical distributed most of its new activity between A/I, CNS, Metabolic/Endocrinology, and Oncology, at 20% each (Figure 5).

Figure 5. Distribution of therapeutic areas for Top 20 sponsors/collaborators starting trials in 2019



For an alternative view of leading companies, Table 2 reviews the top sponsors/collaborators within individual TAs rather than across all new trial activity. The Top 20 cohort appeared across the individual TAs and were the sole top sponsors for A/I, Metabolic/Endocrinology, and Oncology. GU had the largest number of non-Top 20

companies leading trial activity; in fact, Astellas Pharma was the only Top 20 company that made it as a leading sponsor specifically for the TA. Other non-Top 20 companies include Chong Kun Dang Pharmaceutical and Bayer for CV, UCB and Lundbeck for CNS, ViiV Healthcare for ID, and Santen for Ophthalmology.

Table 2. Top sponsors per therapeutic area for Phase I–III clinical trials starting in 2019


Oncology (n = 3,112)

Sponsor Trials

Bristol Myers Squibb 135

Merck & Co. 83

AstraZeneca 82

Roche 82

Pfi zer 56

Metabolic/Endocrinology (n = 893)

Sponsor Trials

Novo Nordisk 36

Eli Lilly 26

Novartis 16

AstraZeneca 13

Sanofi 13

Autoimmune/Infl ammation (n = 1,104)

Sponsor Trials


Boehringer Ingelheim 31

Pfi zer 30

AstraZeneca 26

AbbVie 24

Infectious Disease (n = 754)

Sponsor Trials

Merck & Co. 31

Johnson & Johnson 28

GlaxoSmithKline 18

Sanofi 15

ViiV Healthcare 13

Genitourinary (n = 149)

Sponsor Trials

Grunenthal 5

ObsEva 5

Astellas Pharma 4

Ferring 4

Mithra Pharmaceuticals 3

Sumitomo Dainippon Pharma

3

Ophthalmology (n = 128)

Sponsor Trials

Novartis 9

Roche 5


Santen 4

Cardiovascular (n = 631)

Sponsor Trials

AstraZeneca 14

Novartis 12

Chong Kun Dang Pharmaceutical 10

Amgen 7

Bayer 7


CSPC Pharmaceutical 7

Johnson & Johnson 7

CNS (n = 1,205)

Sponsor Trials

Roche 22

UCB 15

AbbVie 12


Lundbeck 11


While the most common diseases targeted by the Top 20 companies were largely the same as the overall top diseases across all trials, when comparing Figure 6 with Figure 3, a few emerged as a larger priority for this cohort, namely melanoma, bladder cancer, ulcerative colitis, renal cancer, and asthma. These indications replaced pain (nociceptive), hypertension, as well as esophageal, pancreatic, and unspecified cancer. Clinical research in CNS has seen a steady retreat from large industry players over many years, while Sanofi was one such company exiting the diabetes

and cardiovascular space last year.

NCSLC continued to be the leading indication, with the Top 20 companies initiating 30% of all NCSCLC trials in 2019. Among the 15 diseases with the most activity both overall and for these active companies, the Top 20 cohort drove between 18–40% of new trial activity. Psoriasis had the most activity initiated by the Top 20 cohort (40%; 54/134 trials), followed by multiple myeloma (37%; 52/142), breast cancer (32%; 109/341 trials), and prostate cancer (31%; 48/156 trials).

Figure 6. Top 20 diseases for trials started in 2019 by the most active industry sponsors/collaborators



Table 3 provides a view of the leading diseases by trial volume for each of the Top 20 companies, in order to give a more detailed picture of company-specific priorities, which totaled 41 different diseases. 25 of these diseases were unique to a single company, nine of which pursued two or three unique diseases while three prioritized a single unique disease.

Unsurprisingly, the most common disease was NSCLC, which was the leading indication for AstraZeneca, Roche, and Merck & Co, and a top indication for nine additional companies. Other

cancers were also commonly shared priorities, namely breast cancer (nine companies) and unspecified solid tumor (eight companies).

Despite BMS’s prolific Oncology activity, the company’s largest volumes of trials in 2019 were for psoriasis (18 trials) and lupus (15 trials). This indicates considerable diversity in BMS’s current approach to Oncology, as BMS was one of the eight companies that prioritized research for unspecified solid tumors and also initiated an equal number of colorectal cancer trials (Table 3).

Table 3. Top diseases by sponsor/collaborator for clinical trials starting in 2019

Top Diseases by Trial VolumeCompany #1 #2 #3

Bristol Myers Squibb Psoriasis (18) Lupus (15) Colorectal (13)Unspecified Solid Tumor (13)

AstraZeneca Lung, Non-Small Cell (17) Asthma (16) Unspecified Solid Tumor (13)Roche Lung, Non-Small Cell (15) Breast (14) Unspecified Solid Tumor (12)

Merck & Co. Lung, Non-Small Cell (16) Respiratory Infections (12) Breast (10)Respiratory Vaccines (10)

Pfizer Breast (22) Ulcerative Colitis (13) Crohn’s Disease (12)

Novartis Asthma (8) Congestive Heart Failure (7)Breast (6)Lung, Non-Small Cell (6)Lymphoma, Non-Hodgkin’s (6)

Johnson & Johnson Multiple Myeloma (16) Respiratory Infections (11) Prostate (8)

Eli Lilly Type 2 Diabetes (18) Lung, Non-Small Cell (9)Atopic Dermatitis (7)Breast (7)Type 1 Diabetes (7)

GlaxoSmithKlineOther Viral Vaccines (6)Respiratory Infections (6)Respiratory Vaccines (6)

Multiple Myeloma (5) Endometrial (4)Ovarian (4)

Chia Tai Tianqing Pharmaceutical Group Co. Lung, Non-Small Cell (13) Liver (7)

HBV (5)Rheumatoid Arthritis (5)Type 2 Diabetes (5)

Jiangsu Hengrui Medicine Breast (11) Unspecified Solid Tumor (7)Lung, Non-Small Cell (5)Type 2 Diabetes (5)Unspecified Cancer (5)

Boehringer Ingelheim Psoriasis (10)Chronic Obstructive Pulmonary Disorder (7)Unspecified Solid Tumor (7)

Lung, Non-Small Cell (6)Renal Disease (6)Schizophernia (6)

AbbVie Leukemia, Acute Myelogenous (7) Lymphoma, Non-Hodgkin’s (6) Multiple Myeloma (5)

Psoriasis (5)Takeda Lung, Non-Small Cell (11) Multiple Myeloma (9) Lymphoma, Non-Hodgkin’s (6)

Sanofi Type 2 Diabetes (9)Influenza Vaccines (5)Other Bacterial Vaccines (5)Respiratory Infections (5)

Breast (4)Multiple Sclerosis (4)Type 1 Diabetes (4)


Amgen Multiple Myeloma (11)Asthma (4)Congestive Heart Failure (4)Migraine (4)

Colorectal (3)Coronary Artery Disease (3)Lung, Non-Small Cell (3)Psoriasis (3)Unspecified Solid Tumor (3)

CSPC Pharmaceutical Breast (6) Respiratory Infections (5) Bacterial Skin Infection (4)Urinary Tract Infection (4)

Novo Nordisk Type 2 Diabetes (16) Obesity (11) Growth Disorders (4)

Eisai Liver (6) Alzheimer’s Disease (4)Breast (3)Lung, Non-Small Cell (3)Unspecified Solid Tumor (3)

Astellas Pharma Prostate (7)

Leukemia, Acute Myelogenous (4)Menopausal Symptoms (4)Unspecified Solid Tumor (4)

Lung, Non-Small Cell (3)Myelodysplastic Syndrome (3)

*Top diseases limited to indications with 3 or more trialsPowered by Informa’s Trial API Source: Trialtrove®, June 2020

All countries in the overall Top 10 locations listed in Table 4 are consistent with the prior year’s most popular destinations, although the rankings have changed slightly, and decreased trial counts are observed for most countries. This includes the US, which remained the most disclosed location despite decreasing slightly from 2,945 trials in 2018 to 2,859 trials in 2019. China maintained its position as the second most common location overall, with the number of trials continuing to grow, albeit at a slower rate. After increasing by 48% in 2017 and 57% in 2018, the number of trials listing China as a location only grew by 10% in 2019.

Outside of China, most countries saw decreased or flat trial activity, particularly Germany, Japan, and Australia, which all contracted by 5%. The only other countries with increased trial volume were France and Italy, although both countries only demonstrated a growth rate of 2% each (Table 4).

When reviewing the top locations by TA, the US

and China consistently held the top two rankings, except for GU where Iran was the most active location, followed by the US, and then China in third. Oncology’s top destinations are consistent with the overall Top 10 countries, with the TA driving between 33–49% of overall trial activity per country. France had the largest proportion, followed by China and Japan with 47% each. CNS was the only other TA with the same locations as the overall Top 10, contributing between 9–18% of trial activity for each country. In contrast, GU had the largest number of emerging markets, in addition to being the only TA with a country besides the US and China as its most active location.

In terms of emerging markets, the most common trial locations include Eastern European countries, such as Russia (CV, GU, ID, Ophthalmology) and Poland (A/I, GU, Ophthalmology), as well as Asian countries, such as South Korea (CV, GU, Ophthalmology) and India (ID, Metabolic/Endocrinology).

Geographic Survey of 2019 Trial Activity


Table 4. Top locations for Phase I–III trials starting in 2019, by therapeutic area


Genitourinary

Country Trials

Iran 39

United States 31

China 22

Spain 10

Germany 8

South Korea 8

Poland 7

United Kingdom 7

Canada 6

Czech Republic 6

Hungary 6

Russia 6

CNS

Country Trials

United States 510

China 187

United Kingdom 92

Canada 87

Germany 76

Australia 74

France 73

Spain 72

Italy 63

Japan 60

Autoimmune/Infl ammation

Country Trials

United States 398

China 249

Germany 155

United Kingdom 149

Canada 127

Poland 113

Japan 111

France 106

Spain 105

Australia 104

Infectious Disease

Country Trials

China 238

United States 212

United Kingdom 53

Spain 49

Russia 38

Canada 37

Germany 37

Australia 33

Belgium 33

France 33

India 33

Metabolic/Endocrinology

Country Trials

United States 282

China 227

Germany 81

United Kingdom 79

South Korea 63

Iran 56

Canada 54

India 50

Japan 50

Spain 49

Oncology

Country Trials

United States 1,321

China 1,026

France 275

Spain 263

Japan 248

Germany 221

United Kingdom 205

Italy 203

Australia 202

Canada 202

Ophthalmology

Country Trials

United States 72

China 21

United Kingdom 15

Germany 13

Japan 13

Spain 12

France 11

Russia 10

Canada 9

Israel 9

Italy 9

Poland 9

Cardiovascular

Country Trials

China 247

United States 138

Canada 52

United Kingdom 48

Germany 43

South Korea 40

France 38

Spain 36

Japan 35

Russia 30

Overall

Country 2019 2018

United States 2,859 2,945

China 2,161 1,969

United Kingdom 622 642

Germany 615 644

Spain 579 579

France 561 552

Canada 558 568

Japan 532 562

Australia 466 493

Italy 459 449


For the Top 20 most active sponsors/collaborators, the US was the most frequently disclosed country for new trial activity for all except Jiangsu Hengrui Medicine, which focused efforts in China. Jiangsu Hengrui’s previously narrow geographic focus has continued to expand outside China, primarily through a single Phase III trial, involving a US collaborator, taking place in a total of 14 countries. Most companies included two to three countries outside of the overall Top 10 trial locations, most frequently Belgium,

Poland, and South Korea (Table 5).

While China has continued to grow as a trial destination, this primarily seems to be driven by China-based companies. Among the most active companies, Eli Lilly was the only sponsor besides Jiangsu Hengrui to include China as a top location. In fact, a total of 320 trials were initiated in China by the Top 20 companies, 154 of which were started by the three China-based companies.

Table 5. Top locations for trials starting in 2019 by the most active industry sponsors/collaborators*

*Sponsors/collaborators limited to top 10 companies initiated the largest number of trials in 2019Powered by Informa’s Trial API Source: Trialtrove®, June 2020

Pfi zerCountry TrialsUnited States 72Belgium 21Australia 14Spain 14Canada 13Italy 13Japan 13France 11Poland 10United Kingdom 10

United Kingdom 15

Bristol Myers Squibb

Country TrialsUnited States 133France 37Spain 37Germany 35Canada 33United Kingdom 30

Australia 29Italy 29Poland 25Belgium 24

NovartisCountry TrialsUnited States 57Germany 43Spain 38Italy 33United Kingdom 30

France 29Belgium 28Canada 26Japan 25Netherlands 23Russia 23

AstraZenecaCountry TrialsUnited States 75United Kingdom 33

Canada 28Germany 26Japan 26Spain 24France 23South Korea 22Italy 18Poland 15

Johnson & JohnsonCountry TrialsUnited States 49Germany 28Belgium 26Spain 26Italy 22France 21Poland 19United Kingdom 19

Australia 16Russia 15

RocheCountry TrialsUnited States 67Spain 34Japan 26France 24United Kingdom 23

Italy 21Australia 18Germany 18Poland 17South Korea 15

Eli LillyCountry TrialsUnited States 63Japan 28Spain 23Germany 20France 19China 18Italy 17Australia 16Mexico 15United Kingdom 15

Mexico 9Poland 9Singapore 9

Merck & Co.Country TrialsUnited States 78United Kingdom 37

Spain 31Australia 29Canada 29Germany 29France 26Japan 25Israel 23Italy 22South Korea 22

GlaxoSmithKlineCountry TrialsUnited States 47Spain 24United Kingdom 23

Canada 19France 16Germany 14Italy 13Netherlands 13Mexico 12Australia 11Belgium 11Japan 7

Jiangsu Hengrui Medicine

Country TrialsChina 68Poland 2Ukraine 2United States 2Australia 1Belgium 1France 1Germany 1Hong Kong 1Italy 1Russia 1South Korea 1Spain 1Taiwan 1Turkey 1


In addition to reduced growth, trial sizes contracted slightly in 2019 in terms of the average number of countries disclosed per trial. The overall median across the Top 20 cohort was 4.2, a slightly smaller geographic breadth in comparison to last year’s median of 4.5 countries per trial. The reduced size was also observed for Phase I (1.6 in 2018 vs 1.3 in 2019) and Phase III (12.0 in 2018 vs 11.2 in 2019), but the median remained at 3.0 for Phase II. While Jiangsu Hengrui has expanded the

size of its trials slightly, the other two China-based companies solely focused their activity within China, reducing the overall trial size for the cohort. On the other hand, Novartis initiated the largest trials, disclosing an average of 8.1 countries overall. Novartis also held the largest averages for Phase I and II trials, using 2.9 and 9.4 countries, respectively, but Novo Nordisk had the largest average for Phase III (Table 6).

Table 6. Average number of countries disclosed per trial across the most active industry sponsors/collaborators*

*Excludes trials with no disclosed locations. Trial hybrids rolled into calculations for higher phase of development (ie Phase I/II included in Phase II calculations).Powered by Informa’s Trial API Source: Trialtrove®, June 2020

Average Number of Countries/Trial

Sponsor Overall I II IIIBristol Myers Squibb 4.3 1.3 3.3 14.4AstraZeneca 4.0 1.1 2.6 11.4Roche 4.1 1.8 2.6 11.5Merck & Co. 5.7 1.7 2.2 12.8Pfi zer 2.9 1.2 3.9 5.5Novartis 8.1 2.9 9.4 10.8Johnson & Johnson 5.2 1.6 4.7 12.2Eli Lilly 4.9 1.7 3.1 11.9GlaxoSmithKline 5.0 1.4 3.6 13.6Chia Tai Tianqing Pharmaceutical Group Co. 1.0 1.0 1.0 1.0Jiangsu Hengrui Medicine 1.2 1.0 1.2 2.4Boehringer Ingelheim 3.2 1.1 5.0 14.3AbbVie 6.3 2.1 4.8 11.0Takeda 3.8 1.3 2.8 11.5Sanofi 4.6 1.4 5.7 6.3Amgen 5.3 2.2 2.9 10.8CSPC Pharmaceutical 1.0 1.0 1.0 1.0Novo Nordisk 7.2 1.1 6.8 15.4Eisai 2.0 1.1 1.8 7.5Astellas Pharma 3.2 1.0 2.3 8.3


As with prior versions of this roundup, some trends in new trial activity remained largely the same, while shifts were observed in others. Innovation and Phase I research continue to fuel the research pipeline as the US reigns as the most popular destination for clinical trials. However, East Asia appears to be gaining a stronger foothold in clinical research, with six of the Top 20 companies based in Japan and China, while China sees further growth in its new trial volume.

Growth for the volume of new clinical research did slow noticeably in 2019 as the average size of clinical trials also reduced slightly, perhaps a precursor of the delays and disruptions to come.

Although Oncology has consistently held the largest proportion of the industry’s attention, also reflected by the most active companies behind the new clinical research, 2019 may be the last year this TA dominates the trial landscape to its current extent. Despite the decreased trial volume observed for ID in 2019, activity for the TA rapidly ramped up in 2020 with the industry’s rapid response to the novel coronavirus pandemic, reshaping the trial landscape on multiple fronts. COVID-19 has certainly caused a seismic shift in the distribution of clinical trial activity, and it will be fascinating to see this evolve through the acute and “new normal” post-pandemic stages.

Concluding Thoughts

Doro Shin, MPHDirector, Content Performance Marketing

As a recognized thought leader, Doro heads the content marketing st rategy and development for the Pharma Intelligence business at Informa. Drawing on nearly 15 years of experience supporting drug development, primarily as an Infectious and Genitourinary Disease analyst, for Citeline, Doro is acutely aware of the trends in the ever-changing pharmaceutical research

landscape. As an analyst, Doro supported the editorial content of Citeline’s pharmaceutical clinical trial products and assisted clients with competitive intelligence needs. Prior to Informa, Doro coordinated biomedical HIV prevention trials in Zimbabwe with the Women’s Global Health Imperative at University of California, San Francisco (UCSF), and received her Master’s degree in Public Health, with a specialty in Infectious Diseases, from the University of California, Berkeley.

About The Author

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