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세계의 암 면역치료제 시장 : 분석과 예측(-2025년)

Global Cancer Immunotherapy Market Analysis & Forecast to 2025

리서치사 Kelly Scientific Publications
발행일 2020년 11월 상품 코드 968537
페이지 정보 영문 417 Pages
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세계의 암 면역치료제 시장 : 분석과 예측(-2025년) Global Cancer Immunotherapy Market Analysis & Forecast to 2025
발행일 : 2020년 11월 페이지 정보 : 영문 417 Pages

본 상품은 영문 자료로 한글과 영문목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

세계의 암 치료제 시장 규모는 1,600억 달러를 넘고 있으며, 이 중 거의 절반을 차지하는 암 면역치료제 시장은 2019년 750억 달러에서 2024년에는 1,430억 달러로 확대할 것으로 예측됩니다. 시장 확대의 원동력이 되는 것은 암의 신규 증례 수와 환자 수 증가, 암 면역치료를 선택하는 환자의 증가, 적응증의 확대, 승인되는 제품의 증가 등의 요인입니다.

세계의 암 면역치료제 시장을 조사했으며, 암 면역치료의 개요와 현황, 암 치료제 연구의 과제, 주요 제품, 질환 유형별 치료제, 신규 증례 수와 치사율, 시장 분석과 예측, 기업 개요, 각국의 규제, 제품 제조, 공급망과 물류, 가격과 비용 분석, 사례 연구 등의 정보를 정리하여 전해드립니다.

목차

제1장 개요

제2장 암 면역치료 : 개요

  • 인간 면역 시스템
  • 암 면역치료의 유형
  • 암을 치료하기 위한 모노클로널 항체(MAb)
  • 모노클로널 항체(MAb)의 유형
  • 암백신
  • 비특이적 암 면역치료와 항원보강제
  • 암 면역치료 연구의 미개척 영역
    • 면역관문을 표적으로 하는 약
    • 키메라 항원 수용체(CAR) T세포치료
    • 종양 침윤 림프구(TIL)와 인터류킨-2(IL-2)
  • 암 면역치료 : 진보의 타임라인

제3장 암 면역치료의 현황 : 개요

  • Programmed Death(PD-1) 저해제
    • 흑색종의 적응증에서 Nivolumab의 중요한 이벤트와 이점
    • 비소세포폐암에서 Nivolumab의 중요한 이벤트와 이점
    • 신세포암에서 Nivolumab의 중요한 이벤트와 이점
    • 흑색종에 대한 Nivolumab 연구
    • 비소세포폐암(NSCLC)에 대한 Nivolumab 연구
    • 신세포암(RCC)에 대한 Nivolumab 연구
  • Keytruda(Pembrolizumab, MK-3475)
    • 흑색종에서 Keytruda의 중요한 이벤트와 이점
    • NSCLC에서 Keytruda의 중요한 이벤트와 이점
    • RCC에서 Keytruda 중요한 이벤트
  • Roche Tecentriq
    • 흑색종에서 Tecentriq 중요한 이벤트
    • NSCLC에서 Tecentriq의 중요한 이벤트와 이점
    • RCC에서 Tecentriq 중요한 이벤트
    • NSCLC에서 Tecentriq 연구
    • RCC에서 Tecentriq 연구
    • RCC에서의 Tecentriq 연구
  • CureTech Pidilizumab
  • 항PD-1 임상 개발의 개요
  • Yervoy(Ipilimumab) 연구
  • Tremelimumab 연구
  • KAHR-102
  • TIM3 항체
  • BMS-989016
  • ImmuTuneIMP701 및 ImmuFactIMP321
  • 수지상세포 요법
    • Provenge(Sipuleucel-T)
    • ArgosTherapeutics AGS-003
    • DCPrime DCP-001
    • NorthwestBiotherapeutics DC-Vax
  • 키메라 항원 수용체 T세포(CAR-T) 요법
    • CLT109
    • Juno의 키메라 항원 수용체(CAR) 프로그램
    • Bluebird Bio의 CAR-T프로그램
    • Cellectis의 UCART19
    • Abramson Cancer Center의 CAR-T 요법
    • KitePharma의 CD19 eACT CAR-T 요법
    • Adaptimmune의 유방암을 위한 자가 CAR-T 프로그램
  • 암백신
    • HyperAcute
    • MAGE-A3 항원 특이적 암 면역치료
    • ADXS-HPV
    • IDO 저해제
    • Indoximod와 NLG-919(INCY)
    • INCB24360(INCY)
    • deCellVax(BMSN)
  • 기타 면역치료
    • Contego(Lion Biotechnologies)
    • TG4010(Transgene)
  • 암 면역치료의 중요한 연구개발 프로젝트
    • Nivolumab(Opdivo)
    • Keytruda
    • Tecentriq
    • Palbociclib
    • DCVax-L
    • Imfinzi

제4장 암 의약 연구의 과제 : 개요

  • 흑색종 의약 연구에서 수년간의 실패와 새로운 성공
    • 흑색종 약의 미래 전망
  • 폐암 치료제의 신시대
    • 폐암 의약 연구의 진보
    • 폐암 치료제 개발의 성공과 실패
    • 폐암 치료제의 미래 전망
  • 뇌종양 환자에게 희망의 빛
    • 최근 뇌종양 치료의 진보
    • 뇌종양 치료제 개발의 성공과 실패

제5장 암 면역치료 제품 : 개요

  • I-Labelled Tositumomab(Bexxar)
  • Y-Labelled Ibritumomab(Zevalin)
  • Alemtuzumab(Campath)
  • Adotrastuzumab Emtansine(Kadcyla)
  • Bacillus Calmette-Guerin(BCG)
  • Bevacizumab(Avastin)
  • Brentuximab Vedotin(Adcetris)
  • Cetuximab(Erbitux)
  • Cervarix
  • Denileukin Diftitox(Ontak)
  • Gardasil
  • Gemtuzumab(Mylotarg)
  • Hepatitis B Vaccine
  • Interferon Alfa(IFN-alfa)
  • Interleukin-2(IL-2)
  • Ipilimumab(Yervoy)
  • Ofatumumab(Arzerra)
  • Panitumumab(Vectibix)
  • Pembrolizumab(Keytruda)
  • Rituximab(Mabthera)
  • Sargramostim(Leukine)
  • Sipuleucel-T(Provenge)
  • Trastuzumab(Herceptin)

제6장 질환 유형별 암 면역치료제 : 개요

  • 흑색종 피부암
  • 유방암
  • 전립선암
  • 폐암
  • 결장직장암
  • 림프종
  • 신장암
  • 암 임상 조사에서 MAb와 백신의 우위성
  • 특허 유효기간이 종료하는 생물제제

제7장 암의 신규 증례 수와 치사율 : 개요

  • 암의 경제적 부담
  • 암의 부담
  • 세계에서 가장 빈도간 높은 암 상위 5종
  • 여성의 암치사율
  • 면역치료에 의해 대처 가능한 암의 유형별 유병률과 치사율
    • 유방암
    • 위암
    • 결장직장암
    • 폐암
    • 교아종
    • 신장암
    • 혈액암
    • 자궁경부암
    • 전립선암
    • 흑색종

제8장 세계 시장의 분석과 2025년까지의 예측

  • 지역별 분석과 2025년까지의 예측
  • 종양 치료제 판매의 상위 기업
    • Roche
    • Novartis
    • Pfizer
    • Bristol-Myers Squibb
    • Merck
    • Celgene
    • AstraZeneca
    • Eli Lilly
    • Takeda
  • FDA 승인 종양 치료제
  • 2025년까지의 주요 종양 치료제 시장 예측
  • 암 유형별 종양 치료제 시장

제9장 암 면역치료의 시장

  • 주요 성장 촉진요인
  • 지역별 시장
  • 제품 클래스별 시장
  • 암 유형별 시장
  • 유형별 모노클로널 항체 시장
  • 암백신의 시장과 예측
  • 비특이적 암 면역치료의 시장

제10장 기업 개요

  • Ablynx NV
  • Activartis Biotech GmbH
  • Advaxis Inc
  • Aduro BioTech Inc
  • Agenus Inc
  • AlphaVax Inc
  • A. Menarini Industrie Farmaceutiche Riunite Srl
  • Amgen Inc
  • Antigen Express Inc
  • Argos Therapeutics Inc
  • Bavarian Nordic A/S
  • Bellicum Pharmaceuticals Inc
  • Biogen Idec Inc
  • Biovest International Inc
  • Bristol-Myers Squibb Company
  • Cellectis
  • Cellerant Therapeutics Inc
  • Celldex Therapeutics
  • CEL-SCI Corp.
  • CureTech Ltd.
  • Delta-Vir GmbH
  • Dendreon Corp.
  • DenDrit Biotech USA
  • DNAtrix Inc
  • Eli Lilly and Co.
  • EMD Serono Inc
  • Etubics Corp.
  • Galena Biopharma Inc
  • Genentech Inc
  • Genmab AS
  • GlaxoSmithKline
  • Gliknik Inc
  • GlobeImmune Inc
  • Heat Biologics Inc
  • Immatics Biotechnologies GmbH
  • ImmunoCellular Therapeutics Ltd.
  • Immunocore Ltd.
  • ImmunoFrontier Inc
  • ImmunoGen Inc
  • Immunomedics Inc
  • Immunotope Inc
  • Immunovaccine Inc
  • Inovio Pharmaceuticals Inc
  • Janssen Biotech Inc
  • Juno Therapeutics Inc
  • Kite Pharma Inc
  • MabVax Therapeutics Holdings Inc
  • MedImmune LLC
  • Merck & Co., Inc
  • Merrimack Pharmaceuticals Inc
  • Morphotek Inc
  • NewLink Genetics Corp.
  • Northwest Biotherapeutics Inc
  • NovaRx Corp.
  • OncoPep Inc
  • Oncothyreon Inc
  • OSE Pharma SA
  • Oxford BioTherapeutics Ltd.
  • Pique Therapeutics
  • Polynoma LLC
  • PrimaBioMedLtd.
  • Progenics Pharmaceuticals Inc
  • Regen Biopharma Inc
  • Roche Holdings Inc
  • Seattle Genetics Inc
  • Sorrento Therapeutics Inc
  • Spectrum Pharmaceuticals Inc
  • Synthon Pharmaceuticals Inc
  • TapImmune Inc
  • ThioLogicsLtd.
  • Transgene SA
  • TVAX Biomedical Inc
  • Vaccinogen Inc
  • Viventia Biotechnologies Inc
  • Wilex AG
  • Ziopharm Oncology Inc

제11장 제품 부문별 참여 기업

제12장 CAR-T 요법

  • 면역치료에서 키메라 항원 수용체 T세포에 관련된 과제
    • CD19 CAR-T세포 임상 연구의 현재까지 상황
    • CAR-T세포 개발에 관한 임상면과 규제면의 과제
    • CAR-T 개발에 관련된 주요 규제면의 과제
    • Juno, Novartis, Kite에 의한 주요 CAR-T 제품의 개요
    • CD19를 대상으로 한 모든 임상시험에서 임상적 이점과 독성
    • CAR-T 요법의 독성을 관리하는 방법

제13장 미국에서의 면역치료에 관련된 규제

제14장 일본에서의 면역치료에 관련된 규제

제15장 유럽에서의 규제와 면역치료

제16장 면역치료제의 제조

  • 서론
  • CAR 수식 T세포의 생성
  • 면역치료의 생산에 필요한 제조 기기와 기구
  • 면역치료를 위한 적정 제조 기준(GMP)
  • GMP 조건하에서 렌티바이러스 유발 수지상세포의 사례 연구 생산
  • 품질관리
  • 규제 관련
  • 제조면의 주요 과제

제17장 공급망과 물류

제18장 가격과 비용 분석

제19장 CAR-T 요법 시장에서의 현재 거래

제20장 CAR-T 요법 관련 기업의 사례 연구

  • Juno Therapeutics
  • Kite Pharma
  • Cellectis

부록

도표 색인

KSA 20.11.19

Within the cancer therapeutics space, which today is worth over $160 billion globally, immunotherapeutic drugs have gained worldwide acceptance. This is because they are targeted therapeutics that have high specificity for cancer cells. Today, cancer immunotherapy drugs have captured nearly 50% of the overall oncology drugs market, generating about $75 billion in 2019 alone and are forecast to surpass $143 billion in 2025. This report describes the evolution of such a huge market in 20 chapters supported by over 180 tables and figures in 450 pages.

  • An overview of cancer immunotherapy that includes: monoclonal antibodies, ADC's, cancer vaccines and non-specific cancer immunotherapies and CAR T therapies.
  • Focus on current trends in cancer immunotherapies that include: anti-PD-1 and anti-PDL1 drugs, Dendritic cell vaccines, T-cell therapies and cancer vaccines.
  • Insight into the challenges faced by drug developers, particularly about the success vs. failure ratios in developing cancer immunotherapy drugs.
  • Descriptions of more than 23 cancer immunotherapeutics approved and used as targeted drugs
  • Insight into the various immunotherapeutics available for specific cancer types.
  • Description and data for the prevalence of cancer types that are addressed by cancer immunotherapeutics.
  • Overall global cancer therapeutics market, leading market players and the best selling cancer drugs.
  • Detailed account of the market for cancer immunotherapeutics by geography, indication, company and individual drugs.
  • Profiles, marketed products and products in the pipeline of 79 companies that are located globally
  • Summary table to identify the category of immunotherapy drug offered by the 79 companies.
  • Specific chapter on the CAR-T industry detailing manufacturing, regulations and pricing

Executive Summary

Immunotherapy is forecast to become the oncology treatment of choice by 2026 with an estimated 60% of previously treated cancer patients likely to adopt immunotherapy in this timeframe. Multiple treatment lines, combination therapy and the opportunity for repeat treatment are likely to accelerate fast growth. Cancer immunotherapy also expands into multiple indications and our analysis indicates that key immunotherapies including anti-PD-1 drugs, dendritic cell vaccines, T-cell therapies and cancer vaccines are all driving the market. The rising incidence and prevalence of numerous cancers globally is a significant accelerator of growth. This is due to more sensitive early detection techniques, higher patient awareness and a growing aging population. Furthermore, the FDA's pro-science attitude will accelerate development and regulatory approval for these drugs. To that end, the cancer immunotherapy market is forecast to hit $143 billion by 2025. Overall strong growth rates are expected due to a significant unmet need and increasing trends of hematological cancers.

Prior to the launching of Yervoy, the five-year survival rate for patients with early stage melanoma was 98%; but the five-year survival rate for late-stage melanoma was just 16%. Yervoy has been reported to have a survival rate of 25% when tested alone. When tested as part of a combination therapy treatment with Bristol's nivolumab, the two-year survival rates rose to 88% for patients with late-stage cancer. Increase in patient survival rates brought about by cancer immunotherapy treatment is similar to that seen when bone marrow transplantation changed our conception on how blood cancer was treated. Other key therapeutic players in this market include Opdivo (nivolumab), Keytruda (pembrolizumab), Tecentriq (atezolizumab), Ibrance (palbociclib) the newly approved Bavencio (avelumab) and Imfinzi (durvalumab) and of course the first CAR-T therapies Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel).

Opdivo (nivolumab) from BMS is one of the most exciting agents in the immunotherapy space, and is indicated for melanoma, lung cancer, kidney cancer, blood cancer, head and neck cancer, and bladder cancer. It was given a fast-track approval on December 22, 2014. The majority of immune-oncology agents are anti-programmed death-1 (PD-1) monoclonal antibodies, which will certainly guide the market over the coming years. Projects that currently are valuable include combined immunotherapies on our knowledge of CD137 and PD-1/PDL1 mechanisms. A study on a novel effector activating monoclonal antibody known as IMAB362 for the treatment of solid cancers is also exciting. Other projects comparing CAR-T cell effectiveness against T-cells that target CD19 or mesothelin are interesting in a preclinical setting. Of course, Novartis gained the first CAR-T FDA approval for Kymriah (tisagenlecleucel, CTL019) for children and young adults with B-cell ALL. FDA approved Yescarta (axicabtagene ciloleucel) from Kite Pharma for adult patients large B-cell lymphoma is a major boost for the global and US immunotherapy, and gene therapy markets.

What Are CAR-T Therapies? How Will They Impact the Market?

CAR T (chimeric antigen receptor T) cells are engineered specificity using antibody fragments directed to the tumor cell, and also T-cell CD8/CD3 plasma membrane proteins that elicit specific activity towards the tumor cell, via intracellular signaling pathways. To date publications have revealed a number of effective intracellular molecules in the engineered T cell including CD28, 4-1BB (CD137) and CD3 zeta. These engineered T cells have numerous advantages including:

  • Intracellular domain can be modified to increase efficacy and durability of CAR-T
  • CAR-T are still subject to the same regulatory and tolerogenic constraints of natural T cells, including checkpoints, Treg, MDSC
  • CAR-T can be engineered to express cytokines and chemokines that further enhance function and migration
  • Can be modified to express suicide genes that limit CAR-T population if toxicity occurs

To date, the main challenges associated with CAR T therapy include manufacturing, regulations, pricing and toxicity in patients. Currently there are over 100 recruiting CAR-T clinical trials globally, mainly in the US, China and Europe. To date a number of CAR T Cells (autologous/allogeneic) trials are demonstrating clinical benefit to patients, but others have demonstrated toxicity such as cytokine release syndrome. In July 2017, an FDA advisory panel determined that the benefits of CAR T outperform the risks. Kymriah (tisagenlecleucel) by Novartis is indicated to treat children and young adults with acute leukemia and performed well in the ELIANA trial. The FDA's Oncologic Drugs Advisory Committee (ODAC) recommended this agent for approval and became the first CAR-T cell therapy on the US market. In October 2017, Yescarta (axicabtagene ciloleucel) from Kite Pharma for adult patients large B-cell lymphoma was also given FDA approval.

The CAR-T industry is addressing unmet needs in specific relapsed cancers, and trials have indicated that some patients show long term activity and high remission rates, but there is a large proportion of patients with toxicities such as cytokine release syndrome and neurotoxicity. The main players within the CAR-T market are Novartis, Juno Therapeutics, Kite Pharma and Cellectis. The market is moving ahead, backed by years of R&D, from both academia and industry, investors capitol and small clinical studies. From now on Kelly Scientific forecasts that CAR T therapy will become more streamlined, with faster manufacturing times as advances in technologies take hold and clinical trials provide more robust evidence that this immunotherapy is robust. These factors, plus strategies to reduce adverse reactions and toxicities and larger players like Novartis taking stage will push CAR-T therapy ahead. However, recent deaths in the Juno ROCKET trial are creating questions amongst investors. How will the CAR T space influence the total immunotherapy industry going forward? This comprehensive report scrutinizes the total market and provides cutting-edge insights and analysis.

Key Questions Answered in this Report

  • What is the global market for cancer immunotherapeutics by product class such as MAbs, vaccines and non-specific immunotherapies, through 2025?
  • What is the global market for cancer immunotherapeutics by geography, through 2025?
  • What is the global market for cancer immunotherapeutics by indication, through 2025?
  • What is the global market for MAbs by type such as naked MAbs and ADCs, through 2025?
  • What are the market values for Herceptin, Avastin, Erbitux, Yervoy, Mabthera, Adectris, and Keytruda?
  • What is the global market for cancer vaccines?
  • What is the global market for cytokines in cancer immunotherapy?
  • The projected market values for Nivolumab, Tecentriq, DCVax-L, Imfinzi?
  • What immunotherapies have been approved to date?
  • What monoclonal antibodies (MAbs) were approved by the FDA to treat different types of cancers?
  • What are naked MAbs and how many of them have been approved by the FDA?
  • What are antibody-drug conjugates (ADCs) and how many of them are available in the market?
  • What are the common cytotoxic "wareheads" used in ADCs?
  • What are the important clinical assets in ADCs?
  • How many bispecific MAbs are in late-stage development?
  • What are the common side effects of MAbs in cancer immunotherapy?
  • What are cancer vaccines and how many of them have been licensed to be marketed?
  • How many cytokines have been approved for being used in cancer immunotherapy?
  • What are the major checkpoint inhibitors in clinical development?
  • What is the current status of anti-PD-1 drugs, dentritic cell therapies, T-cell therapies and cancer vaccines?
  • What are the most valuable R&D projects in cancer immunotherapy and what would be their approximate sales revenues in 2025?
  • Number of melanoma drugs approved to date?
  • Number of lung cancer drugs approved to date?
  • Number of brain cancer drugs approved to date?
  • What is CAR T Therapy?
  • What are the main challenges associated with CAR T therapy?
  • What is the status of CAR T therapeutic approval?
  • What are the current regulations for immunotherapies in USA, Europe & Japan?
  • What are the main manufacturing steps in CAR T therapy?
  • What challenges lie ahead for CAR T production?

Table of Contents

1.0 Executive Summary

  • 1.1 Objectives of Report
  • 1.2 Key Questions Answered in this Report
  • 1.3 Data Sources and Methodology

2.0 Cancer Immunotherapy: An Overview

  • 2.1 Human Immune System
    • 2.1.1 Components of Human Immune System
  • 2.2 Types of Cancer Immunotherapy
  • 2.3 Monoclonal Antibodies (Mabs) to Treat Cancer
    • 2.3.1 Most Frequently Targeted Antigens by MAbs
  • 2.4 Types of Monoclonal Antibodies (MAbs)
    • 2.4.1 Naked MAbs
    • 2.4.2 Conjugated Monoclonal Antibodies
      • 2.4.2.1 Components of an Antibody Drug Conjugate (ADC)
      • 2.4.2.2 Mechanism of Action of Antibody Drug Conjugate (ADC)
      • 2.4.2.3 The Cytotoxic Wareheads used in ADCs
      • 2.4.2.4 Successful Cytotoxin Wareheads
      • 2.4.2.5 Developmental Timeline of ADCs
      • 2.4.2.6 Target Antigens for ADCs in Preclinical and Clinical Development
      • 2.4.2.7 Important Clinical Assets in ADCs
    • 2.4.3 Bispecific Monoclonal Antibodies
      • 2.4.3.1 Technology Platforms for the Production of Bispecific MAbs
    • 2.4.4 Safety and Side Effects of MAbs in Cancer Immunotherapy
  • 2.5 Cancer Vaccines
    • 2.5.1 Cancer Vaccines in Development
  • 2.6 Non-Specific Cancer Immunotherapies and Adjuvants
    • 2.6.1 Cytokines
    • 2.6.2 Interferon (IFN)
  • 2.7 New Frontiers in Cancer Immunotherapy Research
    • 2.7.1 Drugs for Targeting Immune Checkpoints
      • 2.7.1.1 Cytotoxic T-Lymphocyte-Associated Protein-4 (CTLA-4)
      • 2.7.1.2 Programmed Death 1 (PD-1) and Programmed Death Ligand 1 (PD-L1)
      • 2.7.1.3 Major Checkpoint Inhibitors in Clinical Development
    • 2.7.2 Chimeric Antigen Receptor (CAR) T Cell Therapy
    • 2.7.3 Tumor-Infiltrating Lymphocytes (TILs) and Interleukin-2 (IL-2)
  • 2.8 Cancer Immunotherapy: Timeline of Progress

3.0 Current Status of Cancer Immunotherapy: An Overview

  • 3.1 Programmed Death (PD-1) Inhibitors
    • 3.1.1 Important Events and Advantages for Nivolumab in Melanoma Indication
    • 3.1.2 Important Events and Advantages for Nivolumab in Non-Small Cell Lung Cancer
    • 3.1.3 Important Events and Advantages for Nivolumab in Renal Cell Cancer
    • 3.1.4 Nivolumab Studies for Melanoma
    • 3.1.5 Nivolumab Studies for Non-Small Cell Lung Cancer (NSCLC)
    • 3.1.6 Nivolumab Studies for Renal Cell Cancer (RCC)
  • 3.2 Keytruda (Pembrolizumab, MK-3475)
    • 3.2.1 Important Events and Advantages for Keytruda in Melanoma
    • 3.2.2 Important Events and Advantages for Keytruda in NSCLC
    • 3.2.3 Important Events for Keytruda in RCC
  • 3.3 Tecentriq from Roche
    • 3.3.1 Important Events for Tecentriq in Melanoma
    • 3.3.2 Important Events and Advantages for Tecentriq in NSCLC
    • 3.3.3 Important Event for Tecentriq in RCC
    • 3.3.4 Tecentriq Studies in NSCLC
    • 3.3.5 Tecentriq Studies in RCC
    • 3.3.6 Tecentriq Study in RCC
  • 3.4 Pidilizumab from CureTech
  • 3.5 An Overview of Anti-PD-1 Clinical Development
    • 3.5.1 Other Checkpoint Inhibitors in Development
  • 3.6 Studies with Yervoy (Ipilimumab)
  • 3.7 Studies with Tremelimumab
  • 3.8 KAHR-102
  • 3.9 TIM3 Antibody
  • 3.10 BMS-989016
  • 3.11 ImmuTune IMP701 and ImmuFact IMP321
  • 3.12 Dendritic Cell Therapies
    • 3.12.1 Provenge (Sipuleucel-T)
    • 3.12.2 AGS-003 from Argos Therapeutics
    • 3.12.3 DCP-001 from DCPrime
    • 3.12.4 DC-Vax from Northwest Biotherapeutics
  • 3.13 Chimeric Antigen Receptor T-Cells (CAR-T) Therapies
    • 3.13.1 CLT109
    • 3.13.2 Chimeric Antigen Receptors (CAR) Program by Juno
    • 3.13.3 Chimeric Antigen Receptor (CAR) T-Cell Program by Bluebird Bio
    • 3.13.4 UCART19 from Cellectis
    • 3.13.5 Chimeric Immune Receptor (CIR) T-Cells from Abramson Cancer Center
    • 3.13.6 CD19 eACT CAR-T Therapy from Kite Pharma
    • 3.13.7 Autologous CAR-T Program for Breast Cancer from Adaptimmune
  • 3.14 Cancer Vaccines
    • 3.14.1 HyperAcute
    • 3.14.2 MAGE-A3 Antigen-Specific Cancer Immunotherapeutic
    • 3.14.3 ADXS-HPV
    • 3.14.4 IDO Inhibitors
    • 3.14.5 Indoximod and NLG-919 (INCY)
    • 3.14.6 INCB24360 (INCY)
    • 3.14.7 deCellVax (BMSN)
  • 3.15 Miscellaneous Immunotherapies
    • 3.15.1 Contego (Lion Biotechnologies)
    • 3.15.2 TG4010 (Transgene)
  • 3.16 Most Valuable R&D Projects in Cancer Immunotherapy
    • 3.16.1 Nivolumab (Opdivo)
    • 3.16.2 Keytruda
    • 3.16.3 Tecentriq
    • 3.16.4 Palbociclib
    • 3.16.5 DCVax-L
    • 3.16.6 Imfinzi

4.0 Challenges in Cancer Medicine Research: An Overview

  • 4.1 Years of Failures and Emerging Successes in Melanoma Medicine Research
    • 4.1.1 Future Outlook for Melanoma Drugs
  • 4.2 A New Era for Lung Cancer Medicines
    • 4.2.1 Progresses Made in Lung Cancer Medicine Research
    • 4.2.2 Successes and Failures in Lung Cancer Medicine Development
    • 4.2.3 Future Outlook for Lung Cancer Medicines
  • 4.3 Ray of Hope for Brain Cancer Patients
    • 4.3.1 Progress made for Brain Cancer Treatment in Recent Years
    • 4.3.2 Successes and Failures in Brain Cancer Drug Development

5.0 Cancer Immunotherapeutic Products: An Overview

  • 5.1 I-Labelled Tositumomab (Bexxar)
  • 5.2 Y-Labelled Ibritumomab (Zevalin)
  • 5.3 Alemtuzumab (Campath)
  • 5.4 Adotrastuzumab Emtansine (Kadcyla)
  • 5.5 Bacillus Calmette-Guerin (BCG)
  • 5.6 Bevacizumab (Avastin)
  • 5.7 Brentuximab Vedotin (Adcetris)
  • 5.8 Cetuximab (Erbitux)
  • 5.9 Cervarix
  • 5.10 Denileukin Diftitox (Ontak)
  • 5.11 Gardasil
  • 5.12 Gemtuzumab (Mylotarg)
  • 5.13 Hepatitis B Vaccine
  • 5.14 Interferon Alfa (IFN-alfa)
  • 5.15 Interleukin-2 (IL-2)
  • 5.16 Ipilimumab (Yervoy)
  • 5.17 Ofatumumab (Arzerra)
  • 5.18 Panitumumab (Vectibix)
  • 5.19 Pembrolizumab (Keytruda)
  • 5.20 Rituximab (Mabthera)
  • 5.21 Sargramostim (Leukine)
  • 5.22 Sipuleucel-T (Provenge)
  • 5.23 Trastuzumab (Herceptin)

6.0 Available Immunotherapies for Cancer by Disease Type: An Overview

  • 6.1 Melanoma Skin Cancer and Immunotherapy
    • 6.1.1 Ipilimumab (Yervoy) for Advanced Melanoma
    • 6.1.2 PD-1 Inhibitors (Keytruda and Opdivo) for Advanced Melanoma
    • 6.1.3 Cytokines for Advanced Melanoma
    • 6.1.4 Interferon Alfa as Adjuvant Therapy for Melanoma
    • 6.1.5 Bacille Calmette-Guerin (BCG) Vaccine for Melanoma
    • 6.1.6 Imiquimod (zyclara) Cream for Melanoma
  • 6.2 Breast Cancer and Immunotherapy
    • 6.2.1 Promising Therapeutic Vaccine Product Candidates for Breast Cancer
    • 6.2.2 Promising Checkpoint Inhibiting Product Candidates for Breast Cancer
    • 6.2.3 Promising Adoptive T Cell Therapy Product Candidates for Breast Cancer
    • 6.2.4 Promising Antibody Product Candidates for Breast Cancer
  • 6.3 Immunotherapy for Prostate Cancer
    • 6.3.1 Therapeutic Vaccines for Prostate Cancer
    • 6.3.2 Checkpoint Inhibitors for Prostate Cancer
    • 6.3.3 Adoptive Cell Therapy for Prostate Cancer
  • 6.4 Immunotherapy for Lung Cancer
    • 6.4.1 Monoclonal Antibodies for Lung Cancer
      • 6.4.1.1 Promising MAb Product Candidates for Lung Cancer
      • 6.4.1.2 Checkpoint Inhibitors for Lung Cancer
      • 6.4.1.3 Therapeutic Vaccines for Lung Cancer
      • 6.4.1.4 Promising Adoptive T Cell Transfer Product Candidates for Lung Cancer
  • 6.5 Immunotherapy for Colorectal Cancer
    • 6.5.1 Promising Monoclonal Antibody Product Candidates for Colorectal Cancer
    • 6.5.2 Trials Using Checkpoint Inhibitors and Immune Modulators for Colorectal Cancer
    • 6.5.3 Clinical Trials for Vaccines Indicated for Colorectal Cancer
    • 6.5.4 Adoptive Cell Therapy for Colorectal Cancer
    • 6.5.5 Oncolytic Virus Therapy for Colorectal Cancer
    • 6.5.6 Adjuvant Immunotherapy for Colorectal Cancer
    • 6.5.7 Cytokines for Colorectal Cancer
  • 6.6 Immunotherapies in Development for Lymphoma
    • 6.6.1 Therapeutic Vaccines in Development for Lymphoma
    • 6.6.2 Checkpoint Inhibitors for Lymphoma
    • 6.6.3 Adoptive T Cell Transfer for Lymphoma
    • 6.6.4 Monoclonal Antibodies for Lymphoma
  • 6.7 Immunotherapy for Kidney Cancer
    • 6.7.1 Checkpoint Inhibitors for Kidney Cancer
    • 6.7.2 Vaccines for Kidney Cancer
    • 6.7.3 Adoptive Cell Therapy for Kidney Cancer
  • 6.8 Dominance of MAbs and Vaccines in Cancer Clinical Research
  • 6.9 Oncology Biologics Losing Patent Protection

7.0 Cancer Incidence and Mortality: An Overview

  • 7.1 Global Economic Burden of Cancer
  • 7.2 Global Burden of Cancer
  • 7.3 Top Five Most Frequent Cancers, Globally
    • 7.3.1 Global Prevalence of Colorectal, Breast and Lung Cancers
    • 7.3.2 Percentage of Top Three Cancers Diagnosed Globally
      • 7.3.2.1 Mortality due to Lung, Liver and Stomach Cancers
      • 7.3.2.2 Percentage of Death due to Lung, Liver and Stomach Cancers
  • 7.4 Cancer Deaths in Women
  • 7.5 Prevalence and Mortality for Cancer Types Addressed by Immunotherapy
    • 7.5.1 Breast Cancer
      • 7.5.1.1 Worldwide Incidence of Breast Cancer and Mortality Rate by Geography
      • 7.5.1.2 Female Breast Cancer Incidence in the U.S
      • 7.5.1.3 Five Year Breast Cancer Survival Rates by Stage at Diagnosis and Age in the U.S
      • 7.5.1.4 Breast Cancer Incidence in Canada
      • 7.5.1.5 Breast Cancer Incidence and Mortality in Latin America
      • 7.5.1.6 Breast Cancer Incidence and Mortality in Europe
      • 7.5.1.7 Breast Cancer Incidence in Asia/Pacific
      • 7.5.1.8 Breast Cancer Incidence by Country
    • 7.5.2 Gastric Cancer (Stomach Cancer)
      • 7.5.2.1 Incidence of Gastric Cancer in Top 15 Countries
    • 7.5.3 Colorectal Cancer
      • 7.5.3.1 Global Incidence of Colorectal Cancer
      • 7.5.3.2 Worldwide Variations in the Incidence of Colorectal Cancer
      • 7.5.3.3 Risk Factors for Colorectal Cancer
      • 7.5.3.4 Colorectal Cancer Screening in the U.S
      • 7.5.3.5 Colorectal Cancer Incidence Rates in the U.S. by State
      • 7.5.3.6 Colorectal Cancer Mortality Rates (per 100,000) in the U.S. by States
    • 7.5.4 Lung Cancer
      • 7.5.4.1 Non-Small Cell Lung Cancer (NSCLC)
      • 7.5.4.2 Global NSCLC Incidence
      • 7.5.4.3 Lung Cancer in Americas by Gender
      • 7.5.4.4 Tobacco Use and Lung Cancer
      • 7.5.4.5 Current Therapeutic Options for Lung Cancer
    • 7.5.5 Glioblastoma
      • 7.5.5.1 Global Incidence of Glioblastoma
    • 7.5.6 Kidney Cancer
      • 7.5.6.1 Global Incidence of Kidney Cancer
    • 7.5.7 Blood Cancer
      • 7.5.7.1 Leukemia
      • 7.5.7.2 Blood Cancer in the U.S
    • 7.5.8 Cervical Cancer
      • 7.5.8.1 Global Incidence of Cervical Cancer
    • 7.5.9 Prostate Cancer
      • 7.5.9.1 Global Incidence of Prostate Cancer
      • 7.5.9.2 Prostate Cancer Incidence and Mortality by Geography
      • 7.5.9.3 Prostrate Cancer in the U. S
    • 7.5.10 Melanoma
      • 7.5.10.1 Skin Cancer in the U. S

8.0 Global Oncology Market Analysis and Forecast to 2025

  • 8.1 Global Oncology Market Geographical Analysis and Forecast to 2025
  • 8.2 Top Companies in Oncology Drug Sales
    • 8.2.1 Roche
    • 8.2.2 Novartis
    • 8.2.3 Pfizer
    • 8.2.4 Bristol-Myers Squibb
    • 8.2.5 Merck
    • 8.2.6 Celgene
    • 8.2.7 AstraZeneca
    • 8.2.8 Eli Lilly
    • 8.2.9 Takeda
  • 8.3 FDA approved oncology drugs
  • 8.4 Top Oncology Drug Market Forecast to 2025
  • 8.5 Global Oncology Therapeutics Market by Cancer Type

9.0 Market for Cancer Immunotherapy

  • 9.1 Key Drivers
  • 9.2 Global Market for Cancer Immunotherapeutics by Geography
  • 9.3 Global Market for Cancer Immunotherapy by Product Class
  • 9.4 Global Market for Immunotherapy Drugs by Cancer Type
  • 9.5 Global Market for Monoclonal Antibodies for Cancer by Type
    • 9.5.1 Best Selling MAbs
      • 9.5.1.1 Market Forecast for Herceptin
      • 9.5.1.2 Market Value and Forecast for Avastin
      • 9.5.1.3 Global Market and forecast for Erbitux
      • 9.5.1.4 Global Market and Forecast for Yervoy
      • 9.5.1.5 Global Market and Forecast for Mabthera
      • 9.5.1.6 Global Market and Forecast For Opdivo (Nivolumab)
    • 9.5.2 Global Market and Forecast for Antibody Drug Conjugates (ADCs)
      • 9.5.2.1 Global Market and Forecast for Adcetris
      • 9.5.2.2 Global Market and Forecast for Keytruda
  • 9.6 Global Market and Forecast for Cancer Vaccines
    • 9.6.1 Global Market for Cancer Vaccines by Type
  • 9.7 Global Market for Non-Specific Cancer Immunotherapeutics
    • 9.7.1 High Cost of MAbs

10.0 Company Profiles

  • 10.1 Ablynx NV
  • 10.2 Activartis Biotech GmbH
    • 10.2.1 GBM Vax Study
  • 10.3 Advaxis Inc
    • 10.3.1 Advaxis' Technology
    • 10.3.2 Advaxis' Product Pipeline
      • 10.3.2.1 ADXS-HPV
      • 10.3.2.2 ADXS-PSA
      • 10.3.2.3 ADXS-cHER2
  • 10.4 Aduro BioTech Inc
    • 10.4.1 Aduro's Technology
      • 10.4.1.1 CRS-207
      • 10.4.1.2 AUD-623
      • 10.4.1.3 ADU-741
      • 10.4.1.4 ADU-S100
  • 10.5 Agenus Inc
    • 10.5.1 QS-21 Stimulon
  • 10.6 AlphaVax Inc
    • 10.6.1 Alpha Vax's Technology
  • 10.7 A. Menarini Industrie Farmaceutiche Riunite Srl
    • 10.7.1 MEN1112
  • 10.8 Amgen Inc
    • 10.8.1 Vectibix (panitumumab)
    • 10.8.2 Blinatumomab (Blincyto)
    • 10.8.3 Rilotumumab
  • 10.9 Antigen Express Inc
    • 10.9.1 Li-Key Hybrid Vaccines (AE37)
  • 10.10 Argos Therapeutics Inc
    • 10.10.1 AGS-003
  • 10.11 Bavarian Nordic A/S
    • 10.11.1 Prostvac
    • 10.11.2 CV-301
    • 10.11.3 MVA-BN PRP
    • 10.11.4 MVA-BN HER2
      • 10.11.4.1 MVA-BN Brachyury
  • 10.12 Bellicum Pharmaceuticals Inc
    • 10.12.1 BPX-501
    • 10.12.2 BPX-201
    • 10.12.3 BPX-401
    • 10.12.4 BPX-601
    • 10.12.5 BPX-701
  • 10.13 Biogen Idec Inc
    • 10.13.1 Rituxan (Rituximab)
    • 10.13.2 Gazyva (Obinutuzumab)
  • 10.14 Biovest International Inc
    • 10.14.1 BiovaxID
  • 10.15 Bristol-Myers Squibb Company
    • 10.15.1 Erbitux (cetuximab)
    • 10.15.2 OPDIVO (nivolumab)
    • 10.15.3 Yervoy (ipilimumab)
  • 10.16 Cellectis
  • 10.17 Cellerant Therapeutics Inc
    • 10.17.1 CLT-008
    • 10.17.2 CLT-009
  • 10.18 Celldex Therapeutics
    • 10.18.1 Rindopepimut
    • 10.18.2 Glembatumumab vedotin (CDX-011)
    • 10.18.3 Varlilumab (CDX-1127)
    • 10.18.4 CDX-1401
    • 10.18.5 CDX-301
  • 10.19 CEL-SCI Corp.
    • 10.19.1 Multikine
  • 10.20 CureTech Ltd.
    • 10.20.1 Pidilizumab (CT-011)
  • 10.21 Delta-Vir GmbH
    • 10.21.1 Treatment
  • 10.22 Dendreon Corp.
    • 10.22.1 Provenge (Sipuleucel-T)
  • 10.23 DenDrit Biotech USA
    • 10.23.1 MelCancerVac
  • 10.24 DNAtrix Inc
    • 10.24.1 DNX-2401
  • 10.25 Eli Lilly and Co.
    • 10.25.1 Erbitux (Cetuximab)
  • 10.26 EMD Serono Inc
  • 10.27 Etubics Corp.
  • 10.28 Galena Biopharma Inc
  • 10.29 Genentech Inc
    • 10.29.1 Avastin (bevacizumab) for Metastatic Colorectal Cancer
      • 10.29.1.1 Avastin and Interferon Alfa for Metastatic Kidney Cancer
      • 10.29.1.2 Avastin for Metastatic NLCLC
    • 10.29.2 Gazyva (obinutuzumab) for Chronic Lymphocytic Leukemia
    • 10.29.3 Herceptin (trastuzumab) for Breast Cancer
      • 10.29.3.1 Herceptin and Chemotherapy for Gastric Cancer
    • 10.29.4 Kadcyla (ado-trastuzumab emtansine)
    • 10.29.5 Perjeta (pertuzumab)
    • 10.29.6 Rituxan (rituximab)
    • 10.29.7 Genentech's Cancer Immunotherapy Pipeline Products
  • 10.30 Genmab AS
    • 10.30.1 Ofatumumab
  • 10.31 GlaxoSmithKline
    • 10.31.1 Arzerra (Ofatumumab)
    • 10.31.2 Cervarix
  • 10.32 Gliknik Inc
  • 10.33 GlobeImmune Inc
  • 10.34 Heat Biologics Inc
  • 10.35 Immatics Biotechnologies GmbH
  • 10.36 ImmunoCellular Therapeutics Ltd.
  • 10.37 Immunocore Ltd.
    • 10.37.1 Product Pipeline
  • 10.38 ImmunoFrontier Inc
  • 10.39 ImmunoGen Inc
    • 10.39.1 IMGN853
    • 10.39.2 IMGN529
    • 10.39.3 IMGN289
    • 10.39.4 IMGN779
  • 10.40 Immunomedics Inc
  • 10.41 Immunotope Inc
    • 10.41.1 IMT-1012 Immunotherapeutic Vaccine
  • 10.42 Immunovaccine Inc
  • 10.43 Inovio Pharmaceuticals Inc
  • 10.44 Janssen Biotech Inc
    • 10.44.1 Doxil
    • 10.44.2 Procrit
    • 10.44.3 Zytiga
    • 10.44.4 Imbruvicia
  • 10.45 Juno Therapeutics Inc
  • 10.46 Kite Pharma Inc
    • 10.46.1 Kite Pharma's Technology
      • 10.46.1.1 eACT (engineered Autologous Cell Therapy)
      • 10.46.1.2 DC-Ad GM-CAIX
  • 10.47 MabVax Therapeutics Holdings Inc
  • 10.48 MedImmune LLC
  • 10.49 Merck & Co., Inc
    • 10.49.1 Gardasil (Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine
    • 10.49.2 Keytruda (Pembrolizumab)
  • 10.50 Merrimack Pharmaceuticals Inc
  • 10.51 Morphotek Inc
    • 10.51.1 Farletuzumab (MORAb-003)
    • 10.51.2 Amatuximab (MORAb-009)
    • 10.51.3 Ontuxizumab (MORAb-004)
    • 10.51.4 MORAb-066
  • 10.52 NewLink Genetics Corp.
  • 10.53 Northwest Biotherapeutics Inc
  • 10.54 NovaRx Corp.
  • 10.55 OncoPep Inc
    • 10.55.1 PVX-410
  • 10.56 Oncothyreon Inc
  • 10.57 OSE Pharma SA
  • 10.58 Oxford BioTherapeutics Ltd.
    • 10.58.1 Technologies
      • 10.58.1.1 OGAP - Cancer Targeting
      • 10.58.1.2 Antibody Development
      • 10.58.1.3 Antibody "arming"
    • 10.58.2 Lead Programs
      • 10.58.2.1 OX001/MEN1112
      • 10.58.2.2 OX002
      • 10.58.2.3 OX003
      • 10.58.2.4 OX004
  • 10.59 Pique Therapeutics
  • 10.60 Polynoma LLC
    • 10.60.1 MAVIS Trial
  • 10.61 Prima BioMed Ltd.
  • 10.62 Progenics Pharmaceuticals Inc
    • 10.62.1 PSMA Targeted Imaging Compound (1404)
    • 10.62.2 PSMA ADC Therapeutic
    • 10.62.3 Small Molecule Therapeutic (1095)
    • 10.62.4 Azedra
  • 10.63 Regen Biopharma Inc
    • 10.63.1 HemaXellerate
    • 10.63.2 dCellVax
    • 10.63.3 Diffron C
  • 10.64 Roche Holdings Inc
    • 10.64.1 Avastin (Bevacizumab)
    • 10.64.2 Gazyva/Gazyvaro (Obinutuzumab; GA101)
    • 10.64.3 Herceptin (Trastuzumab)
    • 10.64.4 Kadcyla (Trastuzumabum emtansinum)
    • 10.64.5 Mabthera (Rituximab)
    • 10.64.6 Perjeta (Pertuzumab)
  • 10.65 Seattle Genetics Inc
    • 10.65.1 Adcetris (Brentuximab vedotin)
    • 10.65.2 Seattle Genetics' Collaborarator Pipeline
  • 10.66 Sorrento Therapeutics Inc
    • 10.66.1 Sorrento's Antibody Technologies
      • 10.66.1.1 G-MAB
      • 10.66.1.2 Antibody Drug Conjugates (ADCs)
  • 10.67 Spectrum Pharmaceuticals Inc
    • 10.67.1 Zevalin
  • 10.68 Synthon Pharmaceuticals Inc
  • 10.69 TapImmune Inc
  • 10.70 ThioLogics Ltd.
  • 10.71 Transgene SA
  • 10.72 TVAX Biomedical Inc
    • 10.72.1 TVI-Brain-1
    • 10.72.2 TVI-Kidney-1
  • 10.73 Vaccinogen Inc
  • 10.74 Viventia Biotechnologies Inc
  • 10.75 Wilex AG
  • 10.76 Ziopharm Oncology Inc

11.0 Cancer Immunotherapy Market Participants by Product Segment

12.0 CAR T Therapy

  • 12.1 Challenges Relating to Chimeric Antigen Receptor T Cells in Immunotherapy
    • 12.1.1 Clinical Status of CD19 CAR-T Cells To Date
    • 12.1.2 Clinical and Regulatory Challenges for Development of CAR T Cells
    • 12.1.3 Key Regulatory Challenges Associated with CAR-T Development
    • 12.1.4 Summary of Select CAR-T Products by Juno, Novartis and Kite
    • 12.1.5 Clinical Benefit Versus Toxicity in CD19-Directed ALL Clinical Trials
    • 12.1.6 How to Manage Toxicity of CAR-T Therapy

13.0 Regulations Pertaining to Immunotherapy Regulation in the USA

  • 13.1 Center for Biologics Evaluation and Research (CBER)
    • 13.1.1 Compliance and Surveillance
    • 13.1.2 Extra Resources on Immunotherapeutics from the FDA
    • 13.1.3 Cellular, Tissue and Gene Therapies Advisory Committee
    • 13.1.4 Consumer Affairs Branch (CBER) Contact in FDA
    • 13.1.5 FDA Regulations Pertaining to Immunotherapies
    • 13.1.6 Case Study Ovarian Cancer Immunotherapy Regulations
      • 13.1.6.1 Efficacy
      • 13.1.6.2 Adverse Effects
    • 13.1.7 Trial Design Considerations for Immunotherapy
    • 13.1.8 Development of Immune-Related Response Criteria (irRC) & Clinical Endpoints Specific to Immunotherapies

14.0 Regulations for Immunotherapy in Japan

  • 14.1 PMDA and Immunotherapy
    • 14.1.1 Increasing the Efficiency in Immunotherapy Regulatory Review
    • 14.1.2 Forerunner Review Assignment System
    • 14.1.3 Revised Guidelines for Clinical Evaluation of Anti-Malignant Tumor Agents
    • 14.1.4 Key Contacts Within the PMDA for Immunotherapeutics

15.0 European Regulation and Immunotherapeutics

  • 15.1 Introduction
  • 15.2 Challenges for Immunotherapy in EMEA
    • 15.2.1 EMA Status on Potency Testing
      • 15.2.1.1 In Vivo Potency Testing
      • 15.2.1.2 In Vitro Potency Testing
      • 15.2.1.3 Viable Cell Count
      • 15.2.1.4 Autologous Cell Based Products
      • 15.2.1.5 Reference Preparation
      • 15.2.1.6 Adjuvant Containing Immunotherapy Products
    • 15.2.2 EMA Status on Identifying hyper, Hypo or non-Responders
  • 15.3 Challenges Relating to Biomarkers in Immunotherapy
  • 15.4 Challenges Relating to Chimeric Antigen Receptor T Cells in Immunotherapy
  • 15.5 Estimating Optimal Cut-Off Parameters
  • 15.6 EU-Approved Immunotherapies in Melanoma
  • 15.7 Key Contacts Within EMA for Immunotherapeutics

16.0 Manufacturing of Immunotherapies

  • 16.1 Introduction
  • 16.2 Generation of CAR-Modified T Cells
    • 16.2.1 What Co-Stimulation and Activity Domain is Optimal to Use?
    • 16.2.2 Optimizing Cell Culture Media
    • 16.2.3 Manufacturing Lentiviral Vectors
    • 16.2.4 Detection of Integrated CAR-Expressing Vectors
    • 16.2.5 Donor Lymphocyte Infusion Procedure
    • 16.2.6 Ex Vivo Costimulation & Expansion of Donor T Cells
    • 16.2.7 Infusion to the Patient
  • 16.3 Manufacturing Devices and Instruments Required for Immunotherapy Production
    • 16.3.1 Leukapheresis
    • 16.3.2 Cell Counters and Analyzer
    • 16.3.3 Cell Seeding, Growth and Propagation
  • 16.4 Good Manufacturing Procedure (GMP) for Immunotherapy
  • 16.5 Case Study Production of Lentivirus Induced Dendritic Cells under GMP Conditions
  • 16.6 Quality Control
  • 16.7 Regulatory Affairs
  • 16.8 Key Challenges in Manufacturing
    • 16.8.1 Electroporation of T-cells
    • 16.8.2 Allogenic CAR T cells
    • 16.8.3 Relapse Rates are Critical
    • 16.8.4 Antigen Negative Relapse
    • 16.8.5 Incorporating Suicide Genes
    • 16.8.16 Automation in Cell Therapy Manufacturing
    • 16.8.17 Autologous Cell Therapy Manufacture Scale Up

17.0 Supply Chain & Logistics

  • 17.1 Introduction
  • 17.2 Case Study: Juno Therapeutics

18.0 Pricing & Cost Analysis

  • 18.1 Introduction
  • 18.2 CAR T Therapy Market Evaluation

19.0 Current Deals Within the CAR T Market

20.0 CAR T Therapy Company Case Studies

  • 20.1 Juno Therapeutics
  • 20.2 Kite Pharma
  • 20.3 Cellectis

Appendix

  • Immuno-Oncology Highlights and Approvals over the last number of years
  • Future Directions of Immuno-Oncology

INDEX OF FIGURES

  • Figure 2.1: Components of an Antibody Drug Conjugate (ADC)
  • Figure 2.2: Mechanism of Action of Antibody Drug Conjugates
  • Figure 2.3: Ranking of Commonly Used Cytotoxin Warheads
  • Figure 4.1: Number of Successful and Unsuccessful Melanoma Drugs
  • Figure 4.2: Successes and Failures in Lung Cancer Medicine Development
  • Figure 4.3: Successes and Failures in Brain Cancer Drug Development
  • Figure 5.1: Ibritumomab Linked to Yttrium Radfionucleotide
  • Figure 5.2: Kadcyla (Trastuzumab + DMI)
  • Figure 6.1: Dominance of MAbs and Vaccines in Cancer Clinical Research
  • Figure 7.1: Global Economic Burden of Cancer
  • Figure 7.2: Number of Colorectal, Breast and Lung Cancer Cases Diagnosed Globally
  • Figure 7.3 Percentage of Top Three Cancers Diagnosed Globally
  • Figure 7.4: Number of Deaths due to Lung, Liver and Stomach Cancers Globally
  • Figure 7.5: Percentage of Deaths due to Lung, Liver and Stomach Cancers
  • Figure 7.6: Global Cancer Deaths in Women by Type of Cancer
  • Figure 7.7: Worldwide Incidence of Female Breast Cancer and Mortality Rate by Geography
  • Figure 7.8: Five Year Relative US Breast Cancer Survival Rates by Stage at Diagnosis & Age
  • Figure 7.9: Breast Cancer Incidence and Mortality in Latin America
  • Figure 7.10: Breast Cancer Incidence and Mortality in Europe
  • Figure 7.11: Breast Cancer Incidence Rates in Asia/Pacific Region
  • Figure 7.12: Top 15 Countries in Gastric Cancer Incidence
  • Figure 7.13: Top 15 Countries in Colorectal Cancer Incidence
  • Figure 7.14: Adults Aged 50-75 Years (%) That are Up-to-Date with Colorectal Screening Tests by State in the U.S
  • Figure 7.15 Colorectal Cancer Incidence Rates (per 100,000) by State in the U.S
  • Figure 7.16: Colorectal Cancer Mortality Rates (per 100,000) in the U.S. by States
  • Figure 7.17: Top 15 Countries with Lung Cancer
  • Figure 7.18: Global NSCLC Incidence
  • Figure 7.19: Number of Smokers in China, India, Russia, the U.K. and U.S
  • Figure 7.20: Global Incidence of Glioblastoma
  • Figure 7.21: Global Incidence of Kidney Cancer
  • Figure 7.22: Top 15 Countries in Leukemia Mortality
  • Figure 7.23: Five Year Survival Rates in the U.S. for Blood Cancer Patients
  • Figure 7.24 Top 15 Countries in Cervical Cancer
  • Figure 7.25: Top 15 Countries with Prostate Cancer
  • Figure 7.26: Skin Cancer Death Rates for Top 15 Countries
  • Figure 8.1: Global Market for Oncology Drugs to 2025
  • Figure 8.2: Global Oncology Drug Sales by Top Companies, Through 2025
  • Figure 8.3: Top Oncology Drugs, Through 2025
  • Figure 8.4: Global Oncology Therapeutics Market by Cancer Type
  • Figure 9.1: Global Cancer Immunotherapy Market, Through 2025
  • Figure 9.2: Global Market for Immunotherapy by Product Class, Through 2025
  • Figure 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2025
  • Figure 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2025
  • Figure 9.5: Global and U.S. Market for Herceptin, Through 2025
  • Figure 9.6: Global and U.S. Market for Avastin, Through 2025
  • Figure 9.7: Global Market for Erbitux, Through 2025
  • Figure 9.8: Global Market for Yervoy, Through 2025
  • Figure 9.9: Global Market for Mabthera, Through 2025
  • Figure 9.10: Global Market for Adcetris, Through 2025
  • Figure 9.11: Global Market for Keytruda, Through 2025
  • Figure 9.12: Global Market for Cancer Vaccines, Through 2025
  • Figure 9.13: Global Market for Cancer Vaccines by Type, Through 2025
  • Figure 9.14: Global Market for Cytokine Drugs for Cancer, Through 2025
  • Figure 13.1: Clinical Regulatory Pathway - Conventional Route
  • Figure 13.2: Clinical Regulatory Pathway - Option for Rapid Translation
  • Figure 14.1: PMDA Total Review Period of Standard Drugs
  • Figure 14.2: PMDA Total Review Period of Priority Drugs
  • Figure 14.3: Number of Approved Recombinant Protein Products by PMDA
  • Figure 14.4: Forerunner Review Assignment System Timeframe
  • Figure 14.5: Adaptive Licensing and Accelerated Approval in Japan-US-EU
  • Figure 15.1: CheckMate 066 Clinical Trial
  • Figure 15.2: CheckMate 037 Clinical Trial
  • Figure 16.1: Method of Generating CAR-Modified T Cells
  • Figure 16.2: Clinical Activity, Cost Structure Patient Flow Chart of CAR-T Therapy
  • Figure 16.3: Allogenic Versus Autologous Cell Manufacturing
  • Figure 17.1: Streptamer® -Based Magnetic Bead Cell Isolation
  • Figure 18.1: Annual Cost of Patented Cancer Therapeutics from 2000 to Today
  • Figure 18.2: Cost of Nivolumab, Pembrolizumab & Ipilimumab per mg
  • Figure 20.1 Juno Therapeutics CAR T Therapeutic Molecular Design
  • Figure 20.2 Juno Therapeutics CAR T Therapeutic Mechanism of Action
  • Figure 20.3 Juno Therapeutics T Cell Receptor (TCR) Technology Mechanism of Action
  • Figure 20.4: Streptamer® -Based Magnetic Bead Cell Isolation
  • Figure 20.5 Kite Pharma CAR Technology
  • Figure 20.6 Kite Pharma TCR Technology

INDEX OF TABLES

  • Table 2.1: Types of Immune Cells and their Functions
  • Table 2.2: FDA-Approved Cancer Immunotherapies
  • Table 2.3: FDA-Approved Monoclonal Antibodies (MAbs) to Treat Cancer
  • Table 2.4: Most Frequently Targeted Antigens by MAbs
  • Table 2.5: FDA-Approved Monoclonal Antibodies
  • Table 2.6: Cytotoxic Warheads Used in ADCs
  • Table 2.7: Targeted Indications for ADCs
  • Table 2.8: Antibody Drug Conjugates: Developmental Timeline
  • Table 2.9: Target Antigens for ADCs in Preclinical and Clinical Development
  • Table 2.10: Current ADCs Launched, Withdrawn and in Phase I/II/III Trials by Sponsor, Indication, Antigen, Cytotoxin and Linker
  • Table 2.11: MAb Products and Candidates that Recruit T Cells
  • Table 2.12: Bispecific MAbs in Clinical Trials Targeting Cancer by Indication and Company
  • Table 2.13: Bispecific Antibody Technology Platforms
  • Table 2.14: Side Effects of Some of the Approved Cancer Immunotherapy MAbs
  • Table 2.15: FDA-Approved Cancer Vaccines
  • Table 2.16: Cancer Vaccines in Development
  • Table 2.17: FDA-Approved Cytokines for Cancer Immunotherapy
  • Table 2.18: Cancer Indications Approved for IFN-alfa
  • Table 2.19: FDA-Approved Immune Checkpoint Modulators
  • Table 2.20: Immune Checkpoint Inhibitors in Clinical Development
  • Table 2.21: Cancer Immunotherapy: Timeline of Progress
  • Table 3.1: PD-1 Therapies Targeting either the PD-L1/L2 or PD-1 Receptor
  • Table 3.2: Overview of Clinical Trial Landscape for Top Five Anti-PD-1 and Anti-PD-L1 Drugs
  • Table 3.3: Nivolumab Efficacy from Expansion Cohorts of Study 003
  • Table 3.4: Key Clinical Trial Data of Pembrolizumab in Melanoma
  • Table 3.5: IMpower132 Phase III Data of Tecentriq, (atezolizumab RG7446) in NSCLC Patients
  • Table 3.6: Phase III IMmotion151 study results of Roche's Tecentriq (atezolizumab) and Avastin (bevacizumab) in Renal Cell Carcinoma
  • Table 3.7: Phase I Melanoma Data for Tecentriq
  • Table 3.8: Phase II Data for Pidilizumab in Diffuse Large B Cell Lymphoma (DLBCL)
  • Table 3.9: Phase II Melanoma Data for Pidilizumab
  • Table 3.10: An Overview of Anti-PD-1 Development by Company, Drug Candidate, Indication and Clinical Phase
  • Table 3.11: Clinical Development of CTLA-4, TIM3, and LAG3 Checkpoint Inhibitors by Company, Drug Candidate, Indication and Clinical Trial Stage
  • Table 3.12: Pivotal Phase III Results for Yervoy in Second-Line Patients with Metastatic Melanoma
  • Table 3.13: Updated Data from Phase III Clinical Study 024 for Yervoy
  • Table 3.14: Data from the Failed Phase III Study of Tremelimumab for Melanoma
  • Table 3.15: An Overview of Clinical Development of Dendritic Cell Therapies by Company, Drug Candidate, Indication and Clinical Phase
  • Table 3.16: Pivotal Phase III Results for Yervoy in Second-Line Patients with Metastatic Melanoma
  • Table 3.17: Phase I/Iia Results from Kite Pharma's CAR-T Therapy
  • Table 3.18: Cancer Vaccines in Development by Company, Drug Candidate, Indication & Clinical Phase
  • Table 3.19: Advaxis Phase II Results for Cervical Cancer Patients in India
  • Table 3.20: Phase II Data for Contego
  • Table 3.21: Valuable R&D Projects in Cancer Immunotherapy
  • Table 6.1: Cancer Types Addressed by Immunotherapies by Drug, Trade Name and Company
  • Table 6.2: Oncology Drugs Losing Patent Protection by 2020 by Product, U.S. Expiry Date and E.U. Expiry Date
  • Table 7.1: Global Cancer Statistics - Key Facts
  • Table 7.2: Top Five Most Frequent Cancers, Globally
  • Table 7.3: Estimated Breast Cancer Cases and Deaths in the U.S. by Age
  • Table 7.4: Estimated Canadian Breast Cancer Statistics
  • Table 7.5: Age-Standardized Breast Cancer Incidence Rate per 100,000 Women by Country
  • Table 7.6: Global Colorectal Cancer Incidence and Mortality Rates by Gender per 100,000 people
  • Table 7.7: Risk Factors for Colorectal Cancer
  • Table 7.8: Lung Cancer Incidence and Mortality Rate in Americas by Gender
  • Table 7.9: Current Therapeutic Options for Lung Cancer
  • Table 7.10: Estimated Number of New Leukemia Cases in the U.S.
  • Table 7.11: Estimated Deaths in the U.S. from Leukemia
  • Table 7.12: Estimated Deaths from HL and NHL in the U.S.
  • Table 7.13: Estimated Incidence and Deaths for Myeloma in the U.S.
  • Table 7.14 Global Prostate Cancer Incidence and Mortality Rates by Geography
  • Table 7.15: Incidence and Mortality Rates of Prostate Cancer in Americas
  • Table 7.16: Incidence and Mortality Rates for Melanoma in Americas
  • Table 8.1: Global Market for Oncology Drugs Through 2025
  • Table 8.2: Top Ten Companies in Oncology Sales, Through 2025
  • Table 8.3: Top Five Oncology Drugs, Through 2025
  • Table 9.1: Global Cancer Immunotherapy Market, Through 2025
  • Table 9.2: Global Market for Immunotherapy by Product Class, Through 2025
  • Table 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2025
  • Table 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2025
  • Table 9.5: Global and U.S. Market for Herceptin, Through 2025
  • Table 9.6: Global and U.S. Market for Avastin, Through 2025
  • Table 9.7: Global Market for Cancer Vaccines, Through 2025
  • Table 9.8: Global Market for Cancer Vaccines by Type, Through 2025
  • Table 9.9: Projected Market for the Forthcoming DCVax-L and Imfinzi
  • Table 9.10: Annual Cost of MAbs in the U.S. by Product, Indication and Biomarker
  • Table 10.1: Ablynx's Product Pipeline
  • Table 10.2: Aduro's Product Pipeline
  • Table 10.3: Agenus' Product Pipeline
  • Table 10.4: AlphaVax Cancer Immunology Product Pipeline
  • Table 10.5: Amgen's Product Pipeline
  • Table 10.6: Antigen Express' Cancer Therapeutic Pipeline
  • Table 10.7: Argos' Cancer Product Pipeline
  • Table 10.8: Bavarian Nordic's Product Pipenine
  • Table 10.9: Bellicum's Pipeline Product Candidatea
  • Table 10.10: Biogen's Oncology Pipeline
  • Table 10.11: Bristol-Myers Squibb's Pipeline Products in Cancer Immunotherapy
  • Table 10.12: Cellectis' Products in Development
  • Table 10.13: Cellerant's Product Pipeline
  • Table 10.14: Celldex's Therapeutic Pipeline
  • Table 10.15: CEL-SCI's Immunotherapy Products in Development
  • Table 10.16: EMD Serono's Product Pipeline
  • Table 10.17: Etubic's Product Pipeline
  • Table 10.18: Galena's Product Pipeline
  • Table 10.19: Genentech's Cancer Immunotherapy Pipeline Products
  • Table 10.20: Genmab's Products in Development
  • Table 10.21: Gliknik's Product Pipeline
  • Table 10.22: GlobeImmune's Product Pipeline
  • Table 10.23: Heat Biologic's Product Pipeline
  • Table 10.24: Immatics Biotechnology's Product Pipeline
  • Table 10.25: ImmunoCellular's Product Pipeline
  • Table 10.26: Immunomedics' Late-Stage Antibody-Based Therapies
  • Table 10.27: Immunovaccine's Product Pipeline
  • Table 10.28: Inovio Pharmaceuticals Product Pipeline
  • Table 10.29: Juno Therapeutics' Current Pipeline
  • Table 10.30: Kite Pharma's Product Pipeline
  • Table 10.31: MabVax's Product Pipeline
  • Table 10.32: MedImmune's Products in Development
  • Table 10.33: Merck's Pipeline of Cancer Immunotherapy Products
  • Table 10.34: Merrimack's Product Pipeline
  • Table 10.35: NewLink Genetics' Product Pipeline
  • Table 10.36: Northwest's Product Pipeline
  • Table 10.37: NovaRx Clinical Development Pipeline
  • Table 10.38: Oncothyreon's Immunotherapy Product Pipeline
  • Table 10.39: OSE Pharma's Product Pipeline
  • Table 10.40: Pique Therapeutics' Product Pipeline
  • Table 10.41: Prima BioMed's Pipeline
  • Table 10.42: Progenics Pharmaceutical's Pipeline
  • Table 10.43: Roche Holding's Cancer Immunotherapy Product Pipeline
  • Table 10.44: Seattle Genetics' Pipeline Products
  • Table 10.45: Seattle Genetics' Collaborarator Pipeline
  • Table 10.46: Synthon Biopharmaceuticals' Pipeline
  • Table 10.47: TapImmune's Product Pipeline
  • Table 10.48: ThioLogic's Product Pipeline
  • Table 10.49: Transgene's Product Pipeline
  • Table 10.50: Vaccinogen's Product Pipeline
  • Table 10.51: Viventia's Product Pipeline
  • Table 10.52: Wilex's Product Pipeline
  • Table 10.53: Ziopharm's Products in Development
  • Table 11.1: Cancer Immunotherapy Market Participants by Product Segment
  • Table 12.1: Selected CD19-directed Product Candidates in Clinical Trials by Costimulatory & Binding Domains, Starting Cell Population, Vector and Ablation Technology
  • Table 12.2: Select CD19-Directed ALL Clinical Trials
  • Table 12.3: Select Anti-CD22 CAR-T Clinical Projects
  • Table 13.1: CBER Compliance and Surveillance Activities
  • Table 13.2: Contacts for the Cellular, Tissue and Gene Therapies Advisory Committee, FDA
  • Table 14.1: Key Contacts Within PMDA, Japan
  • Table 15.1: Contact Details for EMA Immunotherapy Experts
  • Table 16.1: General Technical and Personnel Requirements of a GMP, QC, QA, FDA Regulated Cell Therapy Manufacturing Facility
  • Table 16.2: Technician/Scientific Requirements for CAR T Manufacturing
  • Table 16.3: Selection of Apheresis Instruments Currently on the Market
  • Table 16.4: Selection of Cell Counters and Analyzer Instruments Currently on the Market
  • Table 16.5: Main Objectives of GMP Manufacturing Immunotherapeutics
  • Table 16.6: Main Objectives of Quality Control While Manufacturing Immunotherapeutics
  • Table 16.7: Main Objectives of Regulatory Affairs During Manufacturing Immunotherapeutics
  • Table 16.8: CAR-T Studies Using mRNA Transfection Electroporation
  • Table 16.9: Challenges for Autologous Cell Therapy Manufacture
  • Table 16.10: Current Company/Institutions with Suicide Gene CAR T Projects
  • Table 16.11: Advantages of Using Automated Cell Therapy Manufacturing
  • Table 16.12: Main Drivers to Implement Automated Cell Therapy Manufacturing
  • Table 16.13: Main Benefits of Automated Cell Therapy Manufacturing
  • Table 16.14: Advantages & Disadvantages of Autologous Cell Therapy Manufacture Scale Up
  • Table 17.1: Juno Therapeutics Manufacturing Facility Objectives
  • Table 18.1: Current Juno Therapeutics Trials and CAR T Products
  • Table 19.1: Current CAR T Business Deals
  • Table 20.1: Juno Therapeutics Target Biomarker Portfolio
  • Table 20.2 Juno Therapeutics CAR Technology
  • Table 20.3 Juno Therapeutics T Cell Receptor (TCR) Technology
  • Table 20.4 Juno Therapeutics Clinical Pipeline by Target, Product and Trial
  • Table 20.5: Select CD19-Directed ALL Clinical Trials
  • Table 20.6: Select Anti-CD22 CAR-T Clinical Projects
  • Table 20.7 Juno Therapeutics Manufacturing Facility Objectives
  • Table 20.8 Current Kite Pharma CAR T Clinical Studies and Trials
  • Table 20.9 Current Kite Pharma TCR Clinical Studies and Trials
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