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PD-1 & PD-L1 Inhibitors Pipeline Analysis

P&S Market Research-PD1 and PDL1 Inhibitors Market report

Global Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PD-L1) Inhibitors Pipeline Analysis, Market Size, Share, Development, Growth and Demand Forecast to 2025 – Industry Insights by Drug (Opdivo, Keytruda, Tecentriq, Durvalumab, Avelumab), by Mechanism of Action (PD-1 Inhibitor, PD-L1 Inhibitor)

Published: January 2017
Report Code: LS10752
Available Format: pdf
Pages: 168

Programmed Death-1 (PD-1) and Programmed Death Ligand-1 (PD-L1) inhibitors are the therapeutic candidates or drugs, popularly known as checkpoint inhibitors, used most commonly for the treatment of cancer and other malignancies. Programmed death 1 (PD-1) is found on the surface of cancer cells and it is used by tumor cells to evade the immune system. PD-1 inhibitors block the action of PD-1 receptor, enable the body to attack and kill cancer cells. It can constantly monitor body for abnormal cells, and eliminate them before they can turn into cancer. The tumor development process tries to find its way in shutting down the activation of immune system. After the activation of T cells, a stop signal is needed to make sure it does not get over-activated. This can be done through inhibitory receptors, such as PD-1.

PD1 and PDL1 Inhibitors Pipeline Analysis

PD-1 proteins bind with two ligands, programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). PD-L1 in humans is encoded by the CD274 gene. PD-L1 is a 40kDa type 1 transmembrane protein that contains CD274 gene. PD-L1 inhibitors plays a key role in suppressing the immune system during tissue allograft, pregnancy, autoimmune disease, hepatitis and other diseases.

The PD-1 and PD-L1 inhibitors market is estimated at $4,926.4 million in 2016, and it is expected to grow at a CAGR of 23.4% during 2017 - 2025. The increased investment and funding, strong pipeline, technological advancements and innovations, high prevalence of cancer, and improved safety and efficacy are the key factors driving the growth of global market. Different companies are developing PD-1 and PD-L1 inhibitor drugs by using innovative techniques such as combination therapy and biomarkers. In combination therapy approach, PD-1 and PD-L1 inhibitors combine with all types of molecules such as monoclonal antibodies, vaccines, small molecule and cell therapies. The two therapies given together are more effective and powerful as compared to single immunotherapy. This will significantly drive the growth of the global PD-1 and PD-L1 inhibitors market.

Globally, Opdivo was the largest selling drug among the different PD-1 and PD-L1 inhibitor drugs in 2016. The global Tecentriq sale is expected to grow at a good rate during the forecast period to become the second largest selling drug in the global market by the end of 2024, overtaking Keytruda.

The pipeline of PD-1 and PD-L1 inhibitors is enriched with 47 drugs and there are approximately 245 active clinical studies. The pipeline of PD-1 and PD-L1 inhibitors has been analyzed based on their mechanism of action (MOA). It was found that around 74% of pipeline molecules acts as PD-1 inhibitors and 26% of pipeline molecules as PD-L1 inhibitors. The pipeline is also analyzed on the basis of monotherapy and combination therapy, and different clinical phases including phase III, phase II, phase I and preclinical stage.

The increased use of combination therapy of PD-1 and PD-L1 inhibitors represent a new signal of immunotherapeutic, which is expected to alter the standard of care for cancer across the globe. In November 2016, Bristol-Myers Squibb Company and Infinity Pharmaceuticals collaborated to check the efficacy of combination of Opdivo (a PD-1 inhibitor monoclonal antibody) and IPI-549 (a phosphoinositide-3-kinase gamma inhibitor) in patients with advanced solid tumors.

Some of the key players operating in the global market include Merck & Co., Inc., Bristol-Myers Squibb Company, AstraZeneca plc, Pfizer Inc., F. Hoffmann-La Roche AG, Novartis AG, Regeneron Pharmaceuticals, Inc., Ono Pharmaceutical Co., Ltd., and Merck KGaA.

Chapter 1. Research Scope and Methodology

1.1 Market Definition

1.2 Research Scope

1.2.1 Market segmentation by drug

1.2.2 Market segmentation by mechanism of action (MoA)

1.3 Research Methodology and Sources

Chapter 2. Executive Summary

2.1 Key Findings

2.2 Research Summary

Chapter 3. Market Outlook

3.1 Introduction

3.2 Trends in the Global PD-1 & PD-L1 Inhibitors Market

3.2.1 Increasing number of collaboration for combination therapy

3.2.2 Designation for the development of the PD-1 and PD-L1 inhibitors

3.3 Oppurtunities in the Global PD-1 & PD-L1 inhibitor market

3.3.1 Less number of competitors

3.3.2 Expected launch of Phase III drug candidate

3.4 Factors Driving Growth of the Market and its Impact on Market Forecast

3.4.1 Strong pipeline

3.4.2 Increased investment and funding

3.4.3 Improved safety and efficacy

3.4.4 Technological advancements and innovations

3.4.5 High prevalence of cancer

3.4.6 Impact analysis of drivers on market forecast

3.5 Factors Hindering the Growth of the Market and its Impact on Market Forecast

3.5.1 High cost of research and therapy

3.5.2 Side effects and toxicity

3.5.3 Stringent and time consuming regulatory process

3.5.4 Impact analysis of restraints on market forecast

Chapter 4. Global PD-1 & PD-L1 Inhibitors Pipeline Analysis

4.1 Overview

4.1.1 Pipeline analysis by MOA

4.1.2 Pipeline analysis by molecule type

4.1.3 Pipeline analysis by route of administration

4.1.4 Pipeline analysis by company

4.1.5 Pipeline analysis by phase

4.1.5.1 Filed stage

4.1.5.1.1 Opdivo (Nivolumab)

4.1.5.1.1.1 Clinical trials

4.1.5.1.1.2 Interim results

4.1.5.1.1.3 Results

4.1.5.1.2 Keytruda (Pembrolizumab)

4.1.5.1.2.1 Clinical trials

4.1.5.1.2.2 Interim results

4.1.5.2 Phase III

4.1.5.2.1 Atezolizumab

4.1.5.2.1.1 Clinical trials

4.1.5.2.2 Durvalumab

4.1.5.2.2.1 Clinical trials

4.1.5.2.3 Avelumab

4.1.5.2.3.1 Clinical trials

4.1.5.3 Phase II

4.1.5.3.1 PDR001

4.1.5.3.1.1 Clinical trials

4.1.5.3.2 REGN2810

4.1.5.3.2.1 Clinical trials

4.1.5.4 Phase I

4.1.5.4.1 SHR-1210

4.1.5.4.1.1 Clinical trials

4.1.5.4.2 TSR-042

4.1.5.4.2.1 Clinical trials

4.1.5.4.2.2 Technology

4.1.5.4.3 BMS-936559

4.1.5.4.3.1 Clinical trials

4.1.5.4.3.2 Technology

4.1.5.4.4 MEDI-0680

4.1.5.4.4.1 Clinical trials

4.1.5.4.4.2 Technology

4.1.5.4.5 TG4010

4.1.5.4.6 Pexa-Vec

4.1.5.4.7 Tipapkinogene sovacivec

4.1.5.4.8 GSK-2661380

4.1.5.4.8.1 Clinical trials

4.1.5.4.9 BGB -A317

4.1.5.4.9.1 Clinical trials

4.1.5.4.9.2 Product development activities

4.1.5.5 Pre-clinical drugs

4.1.5.5.1 PDL1.taNK

4.1.5.5.1.1 Product development activities

4.1.5.5.1.2 Technology

4.1.5.5.2 MGD013

4.1.5.5.2.1 Technology

4.1.5.5.3 PD-1 Antibodies

4.1.5.5.3.1 Product development activities

4.1.5.5.3.2 Technology

4.1.5.5.4 PD-1 Monoclonal Antibody

4.1.5.5.4.1 Product development activities

4.1.5.5.4.2 Technology

4.1.5.5.5 KD 033

4.1.5.5.6 STI-1110

4.1.5.5.6.1 Product development activities

4.1.5.5.6.2 Technology

4.1.5.5.7 STI-A1014

4.1.5.5.7.1 Product development activities

4.1.5.5.7.2 Technology

4.1.5.5.8 PD-L1 Inhibitor

4.1.5.5.9 PD-1 Inhibitor

4.1.5.5.10 Anti-PD-L1

4.1.5.5.11 INDUS903

4.1.5.5.12 Ropeginterferon alfa-2b + PD-1 inhibitor

4.1.5.5.12.1 Technology

4.1.5.5.13 PD-1 Inhibitor

4.1.5.5.14 PD-1 Inhibitor

4.1.5.5.15 Anti–CTLA-4 + Anti–PD-1

4.1.5.5.15.1 Product development activities

4.1.5.5.15.2 Licensing

4.1.5.5.15.3 Technology

4.1.5.5.16 AUNP-12

4.1.5.5.17 CA-170

4.1.5.5.17.1 Product development activities

4.1.5.5.18 ALN-PDL

4.1.5.5.19 CX-072

4.1.5.5.19.1 Product development activities

4.2 SWOT Analysis of PD-1 and PD-L1 Inhibitors

Chapter 5. Global PD-1 & PD-L1 Inhibitors Market Size and Forecast (2015 - 2025)

5.1 Global PD-1 & PD-L1 inhibitors Market, by Drug

5.2 Global PD-1 & PD-L1 Inhibitors Market, by Mechanism of Action (MoA)

Chapter 6. Global PD-1 & PD-L1 Inhibitors Market, by Drug

6.1 Opdivo (Nivolumab) Market

6.2 Keytruda (Pembrolizumab) Market

6.3 Tecentriq (Atezolizumab) Market

6.4 Durvalumab Market

6.5 Avelumab Market

Chapter 7. Global PD-1 & PD-L1 Inhibitors Market, by Mechanism of Action (MoA)

7.1 PD-1 Inhibitor Market

7.2 PD-L1 Inhibitor Market

Chapter 8. Competitive Analysis

8.1 Porter’s Five Forces of Competitive Position Analysis

8.1.1 Bargaining power of buyers

8.1.2 Bargaining power of suppliers

8.1.3 Threat of new entrants

8.1.4 Intensity of rivalry

8.1.5 Threat of substitutes

8.2 Market Share Analysis of Key Players

Chapter 9. Company Profiles and Strategic Developments

9.1 Key Company Profiles

9.1.1 Ono Pharmaceutical Co., Ltd.

9.1.1.1 Business overview

9.1.1.2 Product and service offerings

9.1.2 Pfizer Inc.

9.1.2.1 Business overview

9.1.2.2 Product and service offerings

9.1.3 Novartis AG

9.1.3.1 Business overview

9.1.3.2 Product and service offerings

9.1.4 Bristol-Myers Squibb Company

9.1.4.1 Business overview

9.1.4.2 Product and service offerings

9.1.5 AstraZeneca plc

9.1.5.1 Business overview

9.1.5.2 Product and service offerings

9.1.6 F. Hoffmann-La Roche Ltd.

9.1.6.1 Business overview

9.1.6.2 Product and service offerings

9.1.7 Regeneron Pharmaceutical, Inc.

9.1.7.1 Business overview

9.1.7.2 Product and service offerings

9.1.8 Merck KGaA

9.1.8.1 Business overview

9.1.8.2 Product and service offerings

9.1.9 Merck & Co., Inc.

9.1.9.1 Business overview

9.1.9.2 Product and service offerings

9.2 Strategic Developments in the PD-1 & PD-L1 Inhibitors Market

9.2.1 Product launch and approval

9.2.2 Designation

9.2.3 Partnership & collaboration

9.2.4 Clinical trial

9.2.5 Others

Chapter 10. Appendix

10.1 List of Abbreviations

  

LIST OF TABLES   

TABLE 1: SPECIFIC PRIMARY AND SECONDARY SOURCES USED FOR THIS PUBLICATION

TABLE 2: GLOBAL PD-1 & PD-L1 INHIBITORS MARKET SNAPSHOT

TABLE 3: ANTI-PD-1 COMBINATIONS WITH MONOCLONAL ANTIBODIES OR OTHER IMMUNO-ONCOLOGY AGENTS

TABLE 4: ANTI-PD-L1 COMBINATIONS WITH MONOCLONAL ANTIBODIES OR OTHER IMMUNO-ONCOLOGY AGENTS

TABLE 5: ANTI PD-1 & PD-L1 MAB COMBINATIONS WITH VACCINES

TABLE 6: ANTI PD-1 & PD-L1 MAB COMBINED WITH GENE AND CELL THERAPIES AND OTHER NOVEL APPROACHES

TABLE 7: DIFFERENT DRUG DESIGNATION FOR PD-1 & PD-L1 INHIBITORS

TABLE 8: DRIVERS FOR THE MARKET: IMPACT ANALYSIS

TABLE 9: RESTRAINTS FOR THE MARKET: IMPACT ANALYSIS

TABLE 10: NUMBER OF PRODUCTS UNDER DEVELOPMENT FOR PD-1 AND PD-L1 INHIBITORS, (2016)

TABLE 11: PIPELINE ANALYSIS OF PD-1 AND PD-L1 INHIBITORS BY COMPANY, 2016

TABLE 12: CLINICAL TRIALS OF NIVOLUMAB

TABLE 13: DESCRIPTION OF NIVOLUMAB

TABLE 14: CLINICAL TRIALS OF PEMBROLIZUMAB

TABLE 15: DESCRIPTION OF PEMBROLIZUMAB

TABLE 16: CLINICAL TRIALS OF ATEZOLIZUMAB

TABLE 17: DESCRIPTION OF ATEZOLIZUMAB

TABLE 18: CLINICAL TRIALS OF DURVALUMAB

TABLE 19: DESCRIPTION OF DURVALUMAB

TABLE 20: CLINICAL TRIALS OF AVELUMAB

TABLE 21: DESCRIPTION OF AVELUMAB

TABLE 22: CLINICAL TRIALS OF PDR001

TABLE 23: DESCRIPTION OF PDR001

TABLE 24: CLINICAL TRIALS OF REGN2810

TABLE 25: DESCRIPTION OF REGN2810

TABLE 26: CLINICAL TRIALS OF SHR-1210

TABLE 27: DESCRIPTION OF SHR-1210

TABLE 28: CLINICAL TRIALS OF TSR-042

TABLE 29: DESCRIPTION OF TSR-042

TABLE 30: CLINICAL TRIALS OF BMS-936559

TABLE 31: DESCRIPTION OF BMS-936559

TABLE 32: CLINICAL TRIALS OF MEDI-0680

TABLE 33: DESCRIPTION OF MEDI-0680

TABLE 34: DESCRIPTION OF TG4010

TABLE 35: DESCRIPTION OF PEXA-VEC

TABLE 36: DESCRIPTION OF TIPAPKINOGENE SOVACIVEC

TABLE 37: CLINICAL TRIALS OF GSK-2661380

TABLE 38: DESCRIPTION OF GSK-2661380

TABLE 39: CLINICAL TRIALS OF BGB -A317

TABLE 40: DESCRIPTION OF BGB -A317

TABLE 41: DESCRIPTION OF PDL1.TANK

TABLE 42: DESCRIPTION OF MGD013

TABLE 43: DESCRIPTION PD-1 ANTIBODIES

TABLE 44: DESCRIPTION PD-L1 MONOCLONAL ANTIBODY

TABLE 45: DESCRIPTION OF KD 033

TABLE 46: DESCRIPTION OF STI-1110

TABLE 47: DESCRIPTION OF STI- A1014

TABLE 48: DESCRIPTION OF PD-L1 INHIBITOR

TABLE 49: DESCRIPTION OF PD-L1 INHIBITOR

TABLE 50: DESCRIPTION OF ANTI-PD-L1

TABLE 51: DESCRIPTION OF INDUS903

TABLE 52: DESCRIPTION OF ROPEGINTERFERON ALFA-2B + PD-1 INHIBITOR

TABLE 53: DESCRIPTION OF PD-1 INHIBITOR

TABLE 54: DESCRIPTION OF PD-1 INHIBITOR

TABLE 55: DESCRIPTION OF ANTI–CTLA-4 + ANTI–PD-1

TABLE 56: DESCRIPTION OF AUNP-12

TABLE 57: DESCRIPTION OF CA-170

TABLE 58: DESCRIPTION OF ALN-PDL

TABLE 59: DESCRIPTION OF CX-072

TABLE 60: GLOBAL PD-1 & PD-L1 INHIBITORS MARKET, BY DRUG, $M (2014 – 2016)

TABLE 61: GLOBAL PD-1 & PD-L1 INHIBITORS MARKET, BY DRUG, $M (2017 – 2025)

TABLE 62: GLOBAL PD-1 & PD-L1 INHIBITORS MARKET, BY MOA, $M (2014 – 2016)

TABLE 63: GLOBAL PD-1 & PD-L1 INHIBITORS MARKET, BY MOA, $M (2017 – 2025)

TABLE 64: GLOBAL OPDIVO MARKET, BY COUNTRY, $M (2014 – 2016)

TABLE 65: GLOBAL OPDIVO MARKET, BY COUNTRY, $M (2017 – 2025)

TABLE 66: ONO PHARMACEUTICAL CO., LTD.– KEY FACTS

TABLE 67: PFIZER INC.– KEY FACTS

TABLE 68: NOVARTIS AG– KEY FACTS

TABLE 69: BRISTOL-MYERS SQUIBB COMPANY– KEY FACTS

TABLE 70: ASTRAZENECA PLC– KEY FACTS

TABLE 71: F. HOFFMANN-LA ROCHE LTD. – KEY FACTS

TABLE 72: REGENERON PHARMECEUTICALS, INC. – KEY FACTS

TABLE 73: MERCK KGAA – KEY FACTS

TABLE 74: MERCK & CO., INC. – KEY FACTS

   

LIST OF FIGURES   

FIG 1: RESEARCH SCOPE FOR GLOBAL PD-1 & PD-L1 INHIBITORS MARKET

FIG 2: RESEARCH METHODOLOGY FOR GLOBAL PD-1 & PD-L1 INHIBITORS MARKET

FIG 3: DEACTIVATED T CELL IN PD-1 AND PD-L1

FIG 4: ACTIVATED T CELL IN PD-1 AND PD-L1 INHIBITORS

FIG 5: GLOBAL DEATHS CAUSED BY CANCER (2012)

FIG 6: NUMBER OF PRODUCTS UNDER DEVELOPMENT FOR PD-1 AND PD-L1 INHIBITORS (2016)

FIG 7: GLOBAL PD-1 AND PD-L1 INHIBITORS PIPELINE SPLIT, BY MECHANISM OF ACTION (2016)

FIG 8: GLOBAL PD-1 AND PD-L1 INHIBITORS PIPELINE SPLIT, BY MOLECULE TYPE (2016)

FIG 9: GLOBAL PD-1 AND PD-L1 INHIBITORS PIPELINE SPLIT, BY ROUTE OF ADMINISTRATION (2016)

FIG 10: GLOBAL PD-1 & PD-L1 INHIBITORS MARKET, $M (2014 – 2025)

FIG 11: GLOBAL PD-1 & PD-L1 INHIBITORS MARKET, BY DRUG, $M (2014 – 2025)

FIG 12: GLOBAL PD-1 & PD-L1 INHIBITORS MARKET SPLIT, BY DRUG (2016)

FIG 13: GLOBAL PD-1 & PD-L1 INHIBITORS MARKET, BY MOA, $M (2014 – 2025)

FIG 14: GLOBAL PD-1 & PD-L1 INHIBITORS MARKET SPLIT, BY MOA (2016)

FIG 15: GLOBAL OPDIVO MARKET, $M (2014 – 2025)

FIG 16: GLOBAL OPDIVO MARKET, BY COUNTRY, $M (2014 – 2025)

FIG 17: GLOBAL OPDIVO MARKET SPLIT, BY COUNTRY (2016)

FIG 18: GLOBAL KEYTRUDA MARKET, $M (2014 – 2025)

FIG 19: GLOBAL TECENTRIQ MARKET, $M (2014 – 2025)

FIG 20: GLOBAL DURVALUMAB MARKET, $M (2014 – 2025)

FIG 21: GLOBAL AVELUMAB MARKET, $M (2014 – 2025)

FIG 22: GLOBAL PD-1 INHIBITOR MARKET, $M (2014 – 2025)

FIG 23: GLOBAL PD-L1 INHIBITOR MARKET, $M (2014 – 2025)

FIG 24: PORTER’S FIVE FORCES OF COMPETITIVE POSITION ANALYSIS

FIG 25: MARKET SHARE ANALYSIS OF KEY PLAYERS (2016)

FIG 26: MARKET SHARE ANALYSIS OF KEY PLAYERS (2025)

The research offers pipeline analysis as of the year 2016, historical market size for the year 2014 and 2015, estimate for the year 2016 and forecast for the period 2017 – 2025 in terms of U.S. dollars.

GLOBAL PD-1 & PD-L1 INHIBITORS PIPELINE ANALYSIS

  • By mechanism of action (MoA)
  • By molecule type
  • By route of administration
  • By company
  • By phase

GLOBAL PD-1 & PD-L1 INHIBITORS MARKET

  • By drug
  • By MoA

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