Indication name: PD-1
and PD-L1
"Market Outlook - Evolutions of PD-1
and PD-L1, Navigating through Lines of Therapy; Competitive Landscape, Drug
Utilization, and Market Forecast by cancer Types; Non-Small Cell Lung Cancer
(NSCLC), Squamous cell carcinoma of the head and neck (SCCHN), Renal Cell
Carcinoma (RCC), Bladder Cancer (BC), Melanoma, Hepatocellular carcinoma (HCC),
Small Cell Lung Cancer (SCLC), Gastric Cancer, Breast cancer, Colorectal
cancer, and Other Cancer types – 2021 to 2030
Background: PD-1 is a receptor expressed on
mature T cells in peripheral tissues and the TIME, as well as on non-T cell
immune cells such as B cells, DCs, and NK cells. PD-L1 is found on the surface
of tumor cells, DCs and macrophages. PD-1 on T cells interact with its ligand
PD-L1 (B7-H1/CD274) and PD-L2 (B7-DC/CD273), it leads to an immunosuppressive
response such as decreased production of inflammatory cytokines and cell
survival proteins in the T cells. Also, PD-L1 is able to interact with CD80 to
provide a secondary mechanism of T cell suppression. In this instance, CD80
acts as the receptor and provides additional inhibitory signals. Clinically,
this interaction has become one of the most successful targets in the current
I/O therapies.
Key segments: T-Cell Targeted Immunotherapy,
Cell Therapy, Cancer Vaccines, Oncolytic Virus, CD3-targeted antibody, and
Other Immunomodulators.
PD-1/ PD-L1 achieved approximately 22% to
45% of overall response rates (ORR) in melanoma, 25% to 62% in NSCLC, ~19% in
SCLC, 43% to 71% in lymphoma, 21% to 50% in urothelial carcinoma, ~20% in
hepatocellular carcinoma, 32% to 50% in high microsatellite instability (MSI-H)
tumors, and over 50% in Merkel cell or renal cell carcinomas. Solid commercial
success has also been attained with the clinical achievements, as Keytruda
alone has generated over $11BN and Opdivo generated another $8.5BN in sales
worldwide in 2020.
Potential patient pool and Utilization of
Immunotherapy
Cancer segment: Non-Small Cell Lu nm,,mkmmng Cancer (NSCLC), Squamous cell
carcinoma of the head and neck (SCCHN), Bladder Cancer (BC), Hepatocellular
carcinoma (HCC), Gastric Cancer, Colorectal cancer, and Other cancer types,
Melanoma, PMBCL, urothelial carcinoma, microsatellite instability-high cancer,
and endometrial carcinoma
Patient Segmentation: Incidence, Prevalence
(Survival adjusted), Stage wise segmentation (Localized, Regional, Distant, and
Unknown), Treated population-based o Lines of Therapy (LoT1, LoT2, LoT3).
Endpoints: I/ O Treated pool LoT 1L+,
Responder, Non- responder, Overall Response Rate
Investment risk analysis:
Novel biologic development is inherent with
a risk of non-standardized nature. Clinical trials always carry a risk of
failure in demonstrate significantly enough levels of efficacy or safety in
current or future clinical trials. Risk analysis; Clinical development risk,
Regulatory and approval risk, Commercialization risks, Competitive risk,
financial risk (NPV, eNPV and IRR)
Competitive Landscape:
Competitive landscape includes country
specific approved (Indications and Key Efficacy (ORR, CR, mDOR (months), mPFS
(months), mOS (months)) as well as pipeline therapies; PD-1 & PD-L1 Agents
in the Current Global Drug Development Pipeline. Any asset/ product specific
designation or review such as Orphan drug designation, Fast track, Priority
review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation
and Accelerated Approval are being tracked and supplemented with analyst
commentary.
Clinical Trial Assessment-
Detailed clinical trial data analysis and
key product positioning includes trial design, primary outcomes, secondary
outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment
status and essentially covers the reported adverse events. Majorly the trial
analysis helps in determining the potential of the key assets as well as their
probable filing and launch date.
Market Access and Payers perspective:
From the payer’s perspective majorly focused
on wide range of treatment options off course cost savings is the major
concern. In coming year, the PD-1 and PD-L1 could change dramatically treatment
landscape dramatically based on strong clinical outcomes data which have great
evidence on managing the clinical outcomes
Geography Covered
North America- United States and Canada
Europe- EU5 (Germany, France, Italy, Spain,
and the United Kingdom)
Other countries- Japan & China
Study Period: 2020-2030
Current Clinical Practice and Treatment
Algorithm
Country-specific current clinical practice,
the standard of care, and significant limitations around addressing the unmet
needs are being covered under this section of the study. Retrospective analysis
and bench-marking of clinical study outcomes are being presented in terms of
Pr-treatment & post-treatment clinical and demographic patient
characteristics. Essentially the evolution of the current competitive landscape
and its impact on the future treatment paradigm is being well covered under
this section.
KOL Insights:
KOLs across 8 MM market from center of
Excellence/ Public/ Private hospitals participated in the study. Insights
around current treatment landscape, epidemiology, clinical characteristics,
future treatment paradigm and Unmet needs.
Market Forecast: Patient Based Forecast
Model (MS. Excel Based Automated Dashboard)
- Data Inputs with sourcing
- Market Event and Product Event
- Country specific Forecast Model
- Market uptake and patient share uptake
- Attribute Analysis
- Analog Analysis
- Disease burden and pricing scenario
- Summary and Insights
Competitive Landscape: Competitive landscape
includes country specific approved as well as pipeline therapies. Any asset/
product specific designation or review such as Orphan drug designation, Fast track,
Priority review, Breakthrough Therapy Designation, Rare Pediatric Disease
Designation and Accelerated Approval are being tracked and supplemented with
analyst commentary.
Clinical Trial Assessment-
Detailed clinical trial data analysis and
key product positioning includes trial design, primary outcomes, secondary
outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment
status and essentially covers the reported adverse events. Majorly the trial
analysis helps in determining the potential of the key assets as well as their
probable filing and launch date.
Unmet Medical Needs Overview-
This report presents the most important
clinical unmet needs in the treatment, according to Thelansis research and
analysis. Other important unmet needs identified through our research, include
decreased cost burden on patients, improved administration convenience, and
improved patient compliance."
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