The lupus nephritis biologics market, as of the current year (2019), stands at USD $243.07 million, with an anticipated growth rate of 9.0% for the period 2020 to 2026. In parallel, the market for the targeted biologic molecule X was valued at USD $24.31 million in 2019, and it is projected to experience a significant growth rate of 20.0% from 2020 to 2026. Within the population of lupus nephritis patients, approximately 0.39 million individuals are affected, with 0.08 million of them opting for biologic treatments. In the case of the targeted biologic molecule X, it is chosen by 0.01 million patients suffering from lupus nephritis. Notably, there are 152 ongoing clinical studies dedicated to the condition of lupus nephritis. Leading players in these clinical studies include F. Hoffmann-La Roche Ltd, Astellas Pharma Inc, Novartis, Bristol-Myers Squibb, and Aurinia Pharmaceuticals Inc. Introduction: Lupus nephritis is a chronic complication arising from systemic lupus erythematosus (SLE) and primarily affects the kidneys. SLE, an autoimmune disease where the body's immune system targets healthy cells and organs, is the underlying cause. Lupus nephritis is more prevalent in women, often occurring during their childbearing years. Symptoms of lupus nephritis include foamy urine, edema (swelling, especially in areas with excess fluid, like legs, ankles, and feet), and the presence of blood in the urine. Diagnosis: Diagnosing lupus nephritis involves urine tests, blood tests, kidney biopsies, and ultrasound examinations. Lupus Nephritis Patient Pool: In the United States, there are approximately 0.58 million patients afflicted with Systemic Lupus Erythematosus, with 0.39 million of them experiencing lupus nephritis. Systemic Lupus Erythematosus has a prevalence rate of 150 cases per 100,000 and an incidence rate of 25 cases per 100,000. The prevalence rate for lupus nephritis is 20 cases per 100,000 persons.

1. U.S. LUPUS NEPHRITIS MARKET
By Pranay Kumar
:- pranayraju66@gmail.com

2. ❑ Lupus Nephritis - Overview
❑ Epidemiology In U.S.
❑ Companies Prevalent Number
❑ Targeted Population – Molecule X
❑ Biologics - Overview
❑ Clinical Studies - Lupus Nephritis
❑ Competitive landscape - Lupus Nephritis
❑ Biologics - Lupus Nephritis
❑ Target Market - Maximum Commercial Potential For Biologic Molecule X
❑ Lupus Nephritis – Industry Recent Activities
❑ Value Analysis Of Biologics And Molecule X
2
TableOfContent

3. Executive Summary
3
Lupus Nephritis -Overview
Introduction
❑ Lupus nephritis is a chronic complication of systemic lupus
erythematosus (SLE) caused in kidney, Lupus is an autoimmune disease
where a person’s own immune system attacks healthy cells and organs.
❑ Lupus nephritis is more common in women then men and most
frequently occur during child bearing year.
❑ Symptoms for lupus nephritis:
• Foamy urine and edema
• Swelling in body specially when body has too much of fluid (legs,
ankles, feet)
• Blood in urine
❑ Diagnosis:
• Urine test
• Blood test
• Kidney Biopsy
• Ultrasound
Source: https://www.niddk.nih.gov/health-information/kidney-disease/lupus-nephritis, https://www.mayoclinic.org/diseases-conditions/lupus-nephritis/diagnosis-treatment/drc-20446438
❖ The lupus nephritis biologics market is USD $ 243.07 Mn
(2019/current year) and expected to grow with a CAGR of 9.0%
(2020 – 2026).
❖ The market of target biologics molecule X is USD $ 24.31 Mn
(2019/current year) and expected to grow with a CAGR of 20.0%
(2020-2026).
❖ The patient suffering from lupus nephritis is 0.39 Mn and 0.08 Mn
lupus nephritis patient opt for biologics.
❖ Targeted biologic molecule X is opt by 0.01 Mn patient suffering
from lupus nephritis.
❖ 152 clinical studies has been found which are working for lupus
nephritis condition.
❖ F. Hoffmann-La Roche Ltd, Astellas Pharma Inc, Novartis , Bristol-
Myers Squibb , Aurinia Pharmaceuticals Inc. are the leading
players in lupus nephritis clinical studies.

4. Lupus Nephritis Patient Pool
4
Epidemiology InU.S.
Source: https://www.uptodate.com/contents/epidemiology-and-pathogenesis-of-systemic-lupus-erythematosus, http://www.ahdbonline.com/articles/1613-the-epidemiology-of-systemic-lupus-
erythematosus-disease-prevalence-and-impact-on-employment-and-work-productivity
❑ Approx. 0.58 Mn patient suffering from Systemic Lupus Erythematosus and
0.39 Mn patient suffering from lupus nephritis in the U.S.
❑ Systemic Lupus Erythematosus has prevalence rate of (150 cases per
100,000) and incidence rate of (25 cases per 100,000).
❑ The prevalence rate of lupus nephritis is (20 per 100,000 persons).
U.S. Population -
2019 (Mn) 329.06 Mn
Population
suffering -
Systemic Lupus
Erythematosus
Population
suffering -Lupus
Nephritis
0.58 Mn
0.39 Mn

5. 5
Companies PrevalentNumber
Source: https://www.roche.com/dam/jcr:d3202429-f38c-4dd3-9295-8c2ad0ef4d7a/en/18092019-ir-gazyva-lupus-nephritis-btd-en.pdf, https://www.gsk.com/media/5824/fy-2019-results-slides-
vfinal-slides-only.pdf, https://www.astrazeneca.com/content/dam/az/Investor_Relations/events/AZN%20Investor%20science%20conference%20call%20ACR%202019%20Presentation.pdf
❑ F. Hoffmann-La Roche Ltd, (Headquarters: Basel,
Switzerland)
❑ It is estimated that SLE affects 24 per 100,000 in
the population globally. Up to 60% of people with
SLE will develop lupus nephritis, and up to 25% of
people with the condition develop end-stage
renal disease.
❑ Lupus overwhelmingly impacts women, making
up 90% of the patient population. Women from
African, Hispanic and Asian ethnic groups are two
to three times more likely than Caucasian women
to be diagnosed with lupus. Currently, there is no
cure for lupus or lupus nephritis.
❑ GlaxoSmithKline, (Headquarters:
Brentford, United Kingdom)
❑ Lupus nephritis (LN) is a common and
serious complication of systemic
lupus erythematosus (SLE).
❑ Active LN can occur in up to 60% of
adults with SLE and remains an
indicator of poor prognosis
❑ AstraZeneca, (Headquarters: Cambridge, United
Kingdom)

6. 6
Targeted Population –Molecule X
Source: https://www.uptodate.com/contents/epidemiology-and-pathogenesis-of-systemic-lupus-erythematosus, http://www.ahdbonline.com/articles/1613-the-epidemiology-of-systemic-lupus-
erythematosus-disease-prevalence-and-impact-on-employment-and-work-productivity
Lupus Nephritis Patient Pool – Molecule X
U.S. Population -
2019 (Mn)
329.06 Mn
Population
suffering -
Systemic Lupus
Erythematosus
Population suffering -Lupus
Nephritis
0.58 Mn
0.39 Mn
Population suffering -Lupus
Nephritis – Opting for Biologics
0.08 Mn
Population suffering -Lupus Nephritis –
Opting for Biologics Molecule X
0.01 Mn
❑ The total number of patient opting for Biologics are
0.08 Mn from which only for 10% of the patients
molecule X is prescribed, so the patient pool for opting
biologics molecule X is 0.01 Mn.
❑ As molecule X is prescribed to critical patient suffering
from lupus nephritis.

7. Introduction:
7
Biologics -Overview
Source: https://pubmed.ncbi.nlm.nih.gov/20647994/, https://www.lupus.org/resources/treatments-being-studied-for-lupus, https://www.niddk.nih.gov/health-information/kidney-disease/lupus-
nephritis, https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
❑ Biologics has provided a new hope to treating lupus nephritis.
❑ Biologic agents stimulate opportunities to T cells, B cells, cytokines as
a potential target for these therapies.
❑ B cells therapies:
❑ Biologics targeting B cells directed at both the ends for deleting B-cells
or blocking surface ligand- receptors interactions.
❑ 3 deletional agents are : (monoclonal (humanized) directed counter-B-
cell surface marker CD20)
▪ Rituximab (RTX)
▪ Ocrelizumab
▪ Obinutuzumab
Timeline for approval:
❑ A strick process has been followed to get approval for any drug to treat
medical condition.
❑ Various phase has been involved in approach process to check
effectiveness and side effects of drugs.
❑ Clinical Phase: Preclinical –Phase 1- Phase 2- Phase 3- Phase 4 (Post-
Marketing Surveillance Trials)
❑ For conducting various clinical phases this can take as much as 15
years.

8. 8
Clinical Studies -Lupus Nephritis
Source: https://clinicaltrials.gov/ct2/results?term=Lupus+Nephritis&cond=Lupus+Nephritis+AND+%22Lupus+Nephritis%22
Clinical Trails Insight
❑ 152 studies has been found for lupus nephritis.
20
9
6
33
5
30
18
31
Phase Analysis
Not Applicable Phase 1 Phase 1|Phase 2
Phase 2 Phase 2|Phase 3 Phase 3
Phase 4 Blanks
152 studies
60
5
14
30
17
18
8
Status Analysis
Completed Active, not recruiting
Not yet recruiting Recruiting
Terminated Unknown status
Withdrawn
152 studies
19
133
Study Results Analysis
Has Results No Results Available
152 studies
Key Takeaways
• Phase 3 and phase 4 are the prominent stage which assist in deriving the potential of the market.
• Major companies and academics institute have completed status for the phase 2, phase 3 and phase 4, as to promote the drugs for lupus nephritis.
1/4

9. 9
Clinical Studies -Lupus Nephritis
Source: https://clinicaltrials.gov/ct2/results?term=Lupus+Nephritis&cond=Lupus+Nephritis+AND+%22Lupus+Nephritis%22
Clinical Trails Insight
❑ 152 studies has been found for lupus nephritis.
11
5
2
12
1
15
6 8
4
1
2
3
2
3
4
2
1
1
7
1
5
13
3
3
3
7
1
4
3
4
1
1
5
1
4
3
0
5
10
15
20
25
30
35
Not Applicable Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Blanks
Phase Vs Status Analysis
Completed Active, not recruiting Not yet recruiting Recruiting Terminated Unknown status Withdrawn
Key Takeaways
• Major clinical studies for lupus nephritis are in phase 2 and phase 3 which help in identifying the potential market of lupus nephritis.
• Players such as F. Hoffmann-La Roche Ltd, Astellas Pharma Inc are working on 3 to 4 studies at a time which are focusing on lupus nephritis.
2/4

10. 10
Clinical Studies -Lupus Nephritis
Source: https://clinicaltrials.gov/ct2/results?term=Lupus+Nephritis&cond=Lupus+Nephritis+AND+%22Lupus+Nephritis%22
Clinical Trails Insight
❑ 152 studies has been found for lupus nephritis.
7
23 30
4 1
6 8
2
9
19
1
12
4
1
1
17
2
6
0
10
20
30
40
50
60
70
80
90
NIH Other U.S. Federal
agency
Industry All others (individuals,
universities,
organizations)
Phase Vs Status Analysis
Completed Active, not recruiting Not yet recruiting Recruiting
Terminated Unknown status Withdrawn
10
1
57
84
Funder Type Analysis
NIH
Other U.S. Federal agency
Industry
All others (individuals, universities, organizations)
152 studies
Key Takeaways
• Industry has the second largest share in the clinical phase and most of the stages are completed.
• Some industry are also collaborated with universities to conduct the studies. For instance,
“Corestem, Inc. | Hanyang University” have a combined study to “Evaluate the Safety of
CS20AT04 Inj. in Subjects With Lupus Nephritis” which is in phase 1.
3/4

11. 11
Clinical Studies -Lupus Nephritis
Source: https://clinicaltrials.gov/ct2/results?term=Lupus+Nephritis&cond=Lupus+Nephritis+AND+%22Lupus+Nephritis%22
Clinical Trails Insight
❑ 152 studies has been found for lupus nephritis.
Key Takeaways
• Hoffmann-La Roche and Astellas Pharma Inc are the leading
players with maximum number of clinical studies.
• Most of the clinical studies are in phase 3 targeting lupus
nephritis.
9
8
6
4 4
0
1
2
3
4
5
6
7
8
9
10
Hoffmann-La
Roche
Astellas Pharma Inc Novartis Bristol-Myers
Squibb
Aurinia
Pharmaceuticals
Inc.
Top Players Analysis
2 3
1 2 3
1
1
1
1 1
1
2
2
1
0
2
4
6
8
Hoffmann-La
Roche
Astellas Pharma
Inc
Novartis Bristol-Myers
Squibb
Aurinia
Pharmaceuticals
Inc.
Players Vs Status Analysis
Completed Active, not recruiting Not yet recruiting Recruiting
Terminated Unknown status Withdrawn
1
1 2 1 2
1
6
3
3
1
2
1
1
0
2
4
6
8
Hoffmann-La
Roche
Astellas Pharma
Inc
Novartis Bristol-Myers
Squibb
Aurinia
Pharmaceuticals
Inc.
Players Vs Phase Analysis
Not Applicable Phase 1 Phase 1|Phase 2 Phase 2
Phase 2|Phase 3 Phase 3 Phase 4 Blanks
4/4

12. 12
Competitive Landscape -Lupus Nephritis
Source: https://clinicaltrials.gov/ct2/results?term=Lupus+Nephritis&cond=Lupus+Nephritis+AND+%22Lupus+Nephritis%22
Company NCT Number Title Status Study Results Interventions Phases Study Type
Hoffmann-La Roche
NCT00377637
A Study of Mycophenolate
Mofetil (CellCept) in Management
of Patients With Lupus Nephritis.
Completed Has Results
Drug: Mycophenolate mofetil (MMF)|Drug:
Cyclophosphamide|Drug: Azathioprine|Drug: Placebo to
Azathioprine|Drug: Placebo to Mycophenolate
mofetil|Drug: Corticosteroid
3 Interventional
NCT04221477
A Study To Evaluate The Efficacy And
Safety Of Obinutuzumab In Patients
With ISN/RPS 2003 Class III Or IV
Lupus Nephritis
Not yet
recruiting
No Results Available
Drug: Obinutuzumab|Drug: MMF|Drug: Prednisone|Drug:
Placebo|Drug: Methylprednisolone|Drug:
Acetaminophen|Drug: Diphenhydramine
3
Interventional
Astellas Pharma Inc
NCT00429377
Phase 3 Study of Tacrolimus (FK506)
for Lupus Nephritis: A Placebo
Controlled, Double-Blind
Multicenter, Comparative Study
Completed No Results Available Drug: tacrolimus 3 Interventional
NCT01316133
A Study to Evaluate the Efficacy and
Safety of Tacrolimus With Steroid in
Korean Lupus Nephritis Patients
Terminated No Results Available Drug: tacrolimus 4 Interventional
Novartis NCT03610516
Safety, Pharmacokinetics and
Preliminary Efficacy Study of CFZ533
in Patients With Lupus Nephritis.
Recruiting No Results Available Drug: CFZ533|Drug: Placebo 2 Interventional
Bristol-Myers Squibb NCT00423098
Efficacy and Safety Study of
Abatacept to Treat Lupus Nephritis
Completed Has Results
Biological: BMS-188667|Drug: Mycophenolate
mofetil|Drug: Prednisone|Biological: Placebo matching with
BMS-188667
3 Interventional
Aurinia
Pharmaceuticals Inc.
NCT02141672
AURA-LV: Aurinia Urinary Protein
Reduction Active - Lupus With
Voclosporin (AURA-LV)
Completed No Results Available
Drug: Voclosporin High Dose|Drug: Voclosporin Low
Dose|Drug: Placebo
2 Interventional

13. 13
Biologics -Lupus Nephritis
Source: https://www.ackdjournal.org/article/S1548-5595(19)30148-X/fulltext
Drug Name Trail Trial ID Mechanism Phase Results/Status Active Comparator
B-cell targets
Rituximab Lunar Anti-CD20 3 Published/failure MMF
Ocrelizumab Belong NCT00626197 Anti-CD20 3 Published/failure
CYC (Euro-Lupus)/AZA or
MMF
Obinutuzumab Nobility NCT02550652 Anti-CD20 2 Recruiting MMF
Belimumab Bliss-LN NCT01639339 Anti-BLyS 3 Active, no longer recruiting SOC
Rituximab and belimumab CALIBRATE NCT02260934 Anti-CD20 1 Anti-BLyS 2 Active, no longer recruiting RTX 1 CYC
Atacicept NCT00573157
TACI-Fc fusion protein binds
BAFF and APRIL
2/3 Terminated, safety issue
T-cell targets
Abatacept ACCESS NCT00774852 CTLA4 Ig 3 Published/failure CYC Euro-Lupus
Abatacept IM101075 NCT00430677 CTLA4 Ig 2/3 Published/failure MMF
Abatacept IM101075 NCT01714817 CTLA4 Ig 3 Completed/failure MMF
RG2077 NCT00094380 CTLA4 IgG4m 2/3
Open label dose escalation,
completed
BI 655064 NCT02770170 Anti-CD40 2 Dose efficacy, recruiting SOC
BI 655064 NCT03385564 Anti-CD40 2
Exploratory, as maintenance
in CR and PR
SOC, CNI allowed

14. 14
TargetMarket-Maximum CommercialPotential ForBiologic
Molecule X
Identify the gaps in existing product, so that your company can come up with innovative
product.
Collaborate with academics institutes, companies which can provide a quality work to study
the drug efficacy at low investment.
Understand the challenges of market before working on any product/drugs/molecules.
Use of AI (artificial intelligence) based platform to conduct initial studies of drug molecules is
an effective tool and the cost of study is lower then studies conducted in laboratories.
Study the clinical output, drug efficacy of similar molecules which analyze the relative research
to interpret the out come of targeted molecule.
Prepare an effective product pricing strategy to gain maximumn market share.

15. 15
Lupus Nephritis –Industry Recent Activities
Source: https://www.lupusresearch.org/new-phase-3-study-shows-positive-results-for-benlysta-in-lupus-nephritis/, https://www.lupusresearch.org/lupus-therapeutics-partners-with-takeda-to-test-
potential-treatment-for-lupus/, https://lupusnewstoday.com/2020/03/18/aurinia-begins-rolling-nda-seeking-fda-approval-voclosporin-lupus-nephritis/, https://www.roche.com/media/releases/med-cor-
2019-09-18.htm
In December 2019, GlaxoSmithKline's Benlysta
(belimumab) is a biologics approved for treating
lupus. As Benlysta show positive response in phase
3 trails.
In March 2020, Aurinia Pharmaceuticals announced
the rolling submission of its application for
Voclosporin to be approved by U.S FDA for treating
lupus nephritis, the application process may be
finished by mid year and allowing the regulatory
decision by 2021.
In March 2019, Lupus therapeutics partnership with
Takeda to investigation potential treatment for lupus,
using biologic TAK-079 as a prospective in Phase 1 trails
(NCT03724916)
In September 2019, Roche announced that the U.S FDA,
granted the “Breakthrough Therapy Designation (BTD) to
Gazyva (obinutuzumab) for treating the adult suffering
from lupus nephritis.

16. 16
Value Analysis OfBiologics AndMolecule X
Market (Mn) 2019 2020 2021 2022 2023 2024 2025 2026 CAGR
Value (Mn) for
Biologics Market
243.07 262.66 284.53 309.00 336.46 367.35 402.20 441.62 9.0%
Value (Mn) for
Biologics Molecule X
Market
24.31 28.89 34.43 41.13 49.26 59.16 71.25 86.06 20.0%
Value (Mn) for
Biologics Market
Others
218.76 233.77 250.10 267.87 287.20 308.19 330.95 355.56 7.2%
▪ 10% contribution for molecule X from total revenue of biologics market.

17. THANK YOU