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Antibody Drug Conjugates Market by Indication, Linker, Payload, Target Antigens and Geography : Industry Trends and Global Forecasts, 2021-2030

Antibody Drug Conjugates Market by Indication, Linker, Payload, Target Antigens and Geography : Industry Trends and Global Forecasts, 2021-2030

  • August 2021
  • 630 pages
  • ID: 6154589
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
Over the years, various technological advancements, such as antibody engineering for site-specific conjugation and enhanced pharmacokinetic and pharmacodynamic properties, have paved the way for antibody drug conjugates (ADCs) to be recognized as potent therapies targeting a wide range of indications, including solid tumors and hematological malignancies. ADCs are engineered therapeutics comprised of monoclonal antibodies attached to potent cytotoxic payloads through chemical linkers. In fact, the FDA has approved 11 ADCs, namely ado-trastuzumab emtansine (Kadcyla®), brentuximab vedotin (Adcetris®), inotuzumab ozogamicin (Besponsa®), gemtuzumab ozogamicin (Mylotarg®), moxetumomab pasudotox (Lumoxiti®), polatuzumab vedotin-piiq (Polivy®), enfortumab vedotin (Padcev®), sacituzumab govitecan (Trodelvy®), trastuzumab deruxtecan (Enhertu®), belantamab mafodotin-blmf (Blenrep®), and loncastuximab tesirine-lpyl (Zynlonta™) till date. , , The success of these therapeutics can be attributed to their high tumor selectivity and cell-killing potential of monoclonal antibodies, while limiting off target toxicities. These advantages have made ADCs a new frontier of chemotherapy, thus, bringing about a paradigm shift in the treatment protocol of different types of cancer.

The growing popularity of ADCs is evident from the number of patents filed / granted for ADCs, which has increased from 1,992 in 2011 to over 22,700 in the first quarter of 2021. With approximately 80 ADCs being investigated in more than 250 clinical trials, the pharmaceutical industry is witnessing a dynamic shift from conventional technologies to newer and more robust approaches for the development of such complex biomolecules. In the past few years, several well-funded start-ups / small companies, offering advanced linker technologies, more potent warheads, and novel conjugation technologies, were established. Moreover, multiple licensing deals were inked in the past few years between various stakeholders, to advance the development of ADCs product pipeline. It is worth noting that companies are also evaluating their proprietary ADCs in combination with other effective therapeutic modalities, such as epigenetic modulator, immune checkpoint inhibitors, and monoclonal antibodies. ADC-based combination therapies offer multifaceted advantages, such as reduced drug resistance, improved drug efficacy, shrinking tumor metastasis, and increased cancer survival rates. In addition, novel conjugated drug molecules, such as bicycle drug conjugate (Bicycle Therapeutics), extracellular drug conjugate (Centrose), peptide conjugate (Esperance Pharmaceuticals), phospholipid drug conjugate (Cellectar Biosciences), radionucleotide conjugate (Nordic Nanovector), and tunable drug conjugate (BlinkBio) have also been introduced. Driven by the substantial progress in the use of novel ADC-based combination therapies, the associated clinical results, and ongoing technological advancement, coupled to the marketing authorization of multiple ADCs, the ADC therapeutics market is anticipated to grow at a commendable rate in the mid to long-term.

SCOPE OF THE REPORT
The “Antibody Drug Conjugates Market (6th Edition) by Target Indication (Breast cancer, Blood cancer, Colorectal cancer, Gastric cancer, Gynecological cancer, Head and neck cancer, Lung cancer, and Others), Type of Linker Used (VC, Sulfo-SPDB, VA, Hydrazone linker, and Others), Type of Payload (MMAE, DM4, Camptothecin, DM1, MMAF, and Others), Target Antigens (CD30, HER2, CD22, CD33, and Others), and Geography (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World): Industry Trends and Global Forecasts” report features an extensive study of the current and future potential of ADCs being developed for the treatment of various indications. In addition, it features an elaborate discussion on the likely opportunity for the players engaged in this domain, over the next decade. Amongst other elements, the report includes:
A detailed review of the current market landscape of ADCs, providing information on drug developer(s) and technology provider(s), phase of development (marketed, phase III, phase II/III, phase II, phase I/II, phase I, preclinical / discovery stage) of lead candidates, target antigen (CD30, HER2, CD22, CD33, and Others), type of linker used (VC, Sulfo-SPDB, VA, Hydrazone linker, and Others), type of payload / warhead / cytotoxin (MMAE, DM4, Camptothecin, DM1, MMAF, and Others), type of antibody (Anti-HER2, Anti-TROP2, Anti-CD30, Anti-mesothelin, Anti-CD22, and Others), antibody isotype (IgG, IgG1, IgG2, and IgG4), type of therapy (monotherapy and combination therapy), combination drug(s) (if being evaluated as combination therapy), target indication(s) (breast cancer, blood cancer, colorectal cancer, gastric cancer, gynecological cancer, head and neck cancer, lung cancer, and others), line of treatment (1st line, 2nd line, 3rd line, and Others), route of administration (intravenous and subcutaneous), and dosing frequency (Q1 weeks, Q2 weeks, Q3 weeks, Q4 weeks, and Others).
Elaborate profiles of companies (shortlisted based on phase of development of the lead drug) and their respective product portfolios. Each profile features a brief overview of the company, its financial information (if available), product portfolio, recent developments, and an informed future outlook.
An analysis of the most commonly targeted therapeutic indications and details of ADC candidates being developed against them, highlighting key epidemiological facts about the diseases and currently available treatment options, other than ADCs.
A list of key opinion leaders (KOLs) within this domain, featuring detailed 2×2 matrices to assess the relative experience of the individuals, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field. It also includes a schematic world map representation, highlighting the geographical locations of eminent scientists / researchers engaged in this domain. In addition, it presents an analysis assessing the credibility and (relative) level of expertise of different KOLs, based on number of publications, number of citations, number of clinical trials, number of affiliations, and strength of professional network (based on information available on LinkedIn).
An insightful competitiveness analysis of biological targets, featuring a [A] three-dimensional bubble representation that highlights the targets that are being evaluated for ADC development, taking into consideration the number of lead molecules based on a particular target, phase of development of candidate therapies, number of clinical trials and number of target disease indications, and [B] a five-dimensional spider-web analysis, highlighting the most popular biological targets based on a number of relevant parameters, including affiliated publications, grants received to support research on a particular target, number of industry players involved in drug development efforts based on a singular target and geographical distribution of associated clinical trials.
An analysis of the recent collaborations (since 2014) focused on the development of ADCs. It includes partnerships inked by various stakeholders in this domain, covering R&D collaborations, licensing agreements (specific to technology platforms and product candidates), product development and commercialization agreements, clinical trial agreements, mergers and acquisitions, and other relevant agreements.
An analysis of the investments made, including seed funding, venture capital financing, debt funding, grants, capital raised from IPOs and subsequent offerings, at various stages of development, in companies that are focused on developing ADCs.
An in-depth analysis of the various patents that have been filed / granted related to ADCs. It includes information on key parameters, such as patent type, publication year, geographical location, issuing authority, assigned CPC symbol, emerging focus areas, and leading industry / academic players (in terms of size of intellectual property portfolio). It also includes a patent benchmarking analysis and a detailed valuation analysis.
A study of the various grants that have been awarded to research institutes engaged in projects related to ADCs, between 2016 and 2021, highlighting various important parameters, such as year of award, support period, amount awarded, funding institute, grant type, focus area, type of recipient organization, key project leaders, key regions, and leading recipient organizations.
An in-depth analysis of completed, ongoing, and planned clinical studies of various ADCs, based on several relevant parameters, such as trial registration year, phase of development, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), study focus, target disease indication, and key geographical regions.
An elaborate discussion on the various strategies that can be adopted by the drug developers across key commercialization stages, namely prior to product launch, during / post launch, including a timeline representation of the key strategies adopted by drug developers for the commercialization of their proprietary products.
An analysis of the key promotional strategies that have been adopted by the developers of marketed products, namely POLIVY™, LUMOXITI™, BESPONSA®, MYLOTARG™, KADCYLA® and ADCETRIS®.
An assessment of various therapeutics that are being evaluated in combination with ADCs. The study also presents the likely evolution of these therapeutics across different indications.
A review of the evolution of ADC conjugation technologies, highlighting the various approaches that have been adopted across different generations; in addition, it presents a review of the existing competition between various conjugation approaches that are available / under development.
An overview of the studies conducted to better analyze non-clinical data and support first-in-human (FIH) dose selection in ADCs. The study presents findings from various ADC studies in different animal models. It also includes an analysis of different methods used in estimating FIH doses. In addition, it highlights the possible FIH starting doses and estimated dose escalations required to reach human maximum tolerated dose (MTD).
An elaborate discussion on various factors that form the basis for the pricing of ADC products, featuring different models / approaches that pharmaceutical companies may choose to adopt while deciding the price of their respective lead therapy candidates that are likely to be marketed in the coming years.
A case study on manufacturing of ADCs, highlighting the key challenges, and a list of contract service providers that are involved in this domain.
A case study on companies offering companion diagnostics that can potentially be used to make treatment related decisions involving ADCs, providing information on the geographical location of key diagnostic developers, affiliated disease biomarkers, assay technique involved, target indication(s), the type of sample required (tumor tissue, blood, bone marrow and others) and the drug candidates for which a particular test was developed.
A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.

One of the key objectives of the report was to estimate the existing market size and potential growth opportunities, over the coming decade. Based on various parameters, such as target consumer segments, region specific adoption rates, and the likely selling price of such therapeutic products, we have provided informed estimates on the evolution of the market for the period 2021-2030. The report includes potential sales forecast of ADCs that are currently marketed or are in late stages of development. Additionally, it features the likely distribution of the current and forecasted opportunity across [A] target indication (Breast cancer, Blood cancer, Colorectal cancer, Gastric cancer, Gynecological cancer, Head and neck cancer, Lung cancer, and Others), [B] type of linker used (VC, Sulfo-SPDB, VA, Hydrazone linker, and Others), [C] type of payload (MMAE, DM4, Camptothecin, DM1, MMAF, and Others), [D] target antigens (CD30, HER2, CD22, CE33, and Others), and [E] key geographies (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:
• Christian Rohlff, (Founder and Chief Executive Officer, Oxford BioTherapeutics)
Paul Jaminet (Founder and Chief Executive Officer, Angiex)
Sasha Koniev (Co-Founder and Chief Executive Officer, Syndivia)
Aldo Braca (President and Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciarini (Technical Business Development Senior Manager, BSP Pharmaceuticals)
John Burt (Chief Executive Officer, Abzena)
Michael Schopperle (Chief Executive Officer, CureMeta)
Jeff Landau (Chief Business Officer and Head of Strategy, CytomX)
Wouter Verhoeven (Chief Business Officer, NBE-Therapeutics)
Denis Angioletti (Chief Commercial Officer, Cerbios-Pharma)
Toshimitsu Uenaka (Executive Director, Eisai) and Takashi Owa (Chief Innovation Officer, Eisai)
Justin Oh (Executive Director, AbTis)
Sukumar Sakamuri (Vice President and Head of Chemistry, AmbrX)
Anthony DeBoer (Director, Business Development, Synaffix)
Christian Bailly (Director of CDMO, Pierre Fabre)
Jennifer L. Mitcham (Director, SMARTag ADCs and Bioconjugates, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions)
Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza)
Mark Wright (Site Head, Piramal Healthcare)
Tatsuya Okuzumi (Associate General Manager, Ajinomoto Bio-Pharma Services)
Alan Burnett (Professor, School of Medicine, Cardiff University)
Anonymous (Chief Executive Officer, Leading CMO)
Anonymous (Director, Business Development, Leading CMO)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been primarily gathered via primary and secondary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views
While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED
Who are the leading players engaged in the development of ADCs?
Which indications can be treated with ADCs?
Which partnership models are commonly adopted by stakeholders in this domain?
What are the investment trends in this industry?
Which are the most active clinical trial centers?
Who are the key opinion leaders that can help you drive your development efforts?
How is the current and future market opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the current state of the market for ADCs and its likely evolution in the short-mid-term and long term.

Chapter 3 provides an introduction to ADCs, featuring brief description of ADCs, its components, mechanisms of action, and advantages over traditional targeted therapies. It also features a brief description of the absorption, distribution, metabolism and excretion (ADME) properties of various ADCs that are under development.

Chapter 4 provides information on 300 ADCs that are either approved or under development for the treatment of various indications. It features a detailed analysis of marketed / under development molecules, based on phase of development (marketed, phase III, Phase II/III, phase II, phase I/II, phase I, preclinical / discovery stage) of lead candidates, target antigen (CD30, HER2, CD22, CD33, and Others), type of linker used (VC, Sulfo-SPDB, VA, Hydrazone linker, and Others), type of payload / warhead / cytotoxin (MMAE, DM4, Camptothecin, DM1, MMAF, and Others), type of antibody (Anti-HER2, Anti-TROP2, Anti-CD30, Anti-mesothelin, Anti-CD22, and Others), antibody isotype (IgG, IgG1, IgG2, and IgG4), type of therapy (monotherapy and combination therapy), combination drug(s) (if being evaluated as combination therapy), target indication(s) (breast cancer, blood cancer, colorectal cancer, gastric cancer, gynecological cancer, head and neck cancer, lung cancer, and others), line of treatment (1st line, 2nd line, 3rd line, and Others), route of administration (intravenous and subcutaneous), and dosing frequency (Q1 weeks, Q2 weeks, Q3 weeks, Q4 weeks, and Others).

Chapter 5 presents elaborate profiles of companies (shortlisted based on phase of development of the lead drug) and their respective product portfolios. Each profile features an overview of the company, its financial information (if available), product portfolio, recent developments, and an informed future outlook.

Chapter 6 provides information on the most commonly targeted therapeutic indications and features brief description of the ADC candidates being developed against them. It highlights the key epidemiological facts about the diseases and currently available treatment options, other than ADCs.

Chapter 7 provides an analysis of KOLs in the field of ADCs. It features a comprehensive list of principal investigators / study directors of different clinical trials, along with the information related to the affiliated research institutes. The chapter features a schematic representation on a world map, highlighting the geographical locations of eminent scientists / researchers who are engaged in clinical research in this domain. It also presents a comparative analysis, highlighting those KOLs who have relatively more experience in this domain. The credibility and (relative) level of expertise of different KOLs defined by other analysts / industry experts were compared to the results obtained using a proprietary scoring criteria, which was based on number of publications, number of citations, number of clinical trials, number of affiliations, and extent of professional network.

Chapter 8 presents an insightful competitiveness analysis of biological targets, featuring a [A] three-dimensional bubble representation that highlights the targets that are being evaluated for ADC development, taking into consideration the number of lead molecules based on a particular target, phase of development of candidate therapies, number of clinical trials and number of target disease indications, and [B] a five-dimensional spider-web analysis, highlighting the most popular biological targets based on a number of relevant parameters, including affiliated publications, grants received to support research on a particular target, number of industry players involved drug development efforts based on a singular target and geographical distribution of associated clinical trials.

Chapter 9 features an elaborate discussion and analysis of the various partnerships and collaborations that have been inked between various stakeholder in the industry, since 2014. Further, the partnership activity in this domain has been analyzed on the basis of year of agreement / partnership, the type of partnership model (R&D collaborations, licensing agreements (specific to technology platforms and product candidates), product development and commercialization agreements, clinical trial agreements, mergers and acquisitions, and others), companies involved, and regional distribution of the collaborations.

Chapter 10 presents details on various investments received by various players engaged in the development of ADCs. It also includes an analysis of the funding instances that have taken place in the market, till July 2021, highlighting the growing interest of the venture capital community and other strategic investors within this market.

Chapter 11 provides an in-depth patent analysis, presenting an overview on the filed / granted patents related to ADCs. The analysis highlights key details and trends associated with these patents, including patent type, publication year, geographical location, issuing authority, assigned CPC symbol, emerging focus areas, and leading industry / academic players (in terms of size of intellectual property portfolio). It also includes a patent benchmarking analysis and a detailed valuation analysis.

Chapter 12 provides information on the various grants that were awarded to research institutes conducting projects related to ADCs, between 2016 and 2021. The analysis also highlights important parameters associated with grants, such as year of award, support period, amount awarded, funding institute, grant type, focus area, type of recipient organization, key project leaders, key regions and leading recipient organizations.

Chapter 13 provides a detailed analysis of completed, ongoing, and planned clinical studies of various ADCs, highlighting prevalent trends across various relevant parameters, such as trial registration year, phase of development, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), study focus, target therapeutic area, and key geographical regions.

Chapter 14 presents an elaborate discussion on the various strategies that can be adopted by the drug developers across key commercialization stages, namely prior to product launch and during / post launch. It also features an in-depth analysis and timeline representation of the key strategies adopted by drug developers for the commercialization of their proprietary products. In addition, it provides a general overview of the drugs considered for studying the strategies in detail.

Chapter 15 highlights the key promotional strategies that are being implemented by the developers of marketed products, including POLIVY™, LUMOXITI™, BESPONSA®, MYLOTARG™, KADCYLA®, and ADCETRIS®. The promotional aspects covered in the chapter include details provided on the product website (including key messages for patients and healthcare professionals), patient support offerings and informative downloadable content.

Chapter 16 features an overview of the various therapeutics being evaluated in combination with ADCs. It also features a study of the likely evolution of these therapeutics across different therapeutic indications.

Chapter 17 provides a review of the evolution of ADC conjugation technologies, highlighting the various approaches that have been adopted across different generations. In addition, it presents a review of the existing competition between various conjugation approaches that are available / under development.

Chapter 18 provides an overview of the studies conducted to better analyze non-clinical data and support first-in-human (FIH) dose selection. The chapter presents insights from recently conducted studies in different animal models, analyzing the different methods used in estimating FIH doses. In addition, it highlights possible FIH starting doses and estimated dose escalations required to reach human maximum tolerated dose (MTD). The chapter highlights different types of ADC-related toxicities observed in animal models, highlighting the doses at which these toxicities were observed.

Chapter 19 highlights our views on the various factors that must be taken into consideration while deciding the prices of ADC products. It features discussions on different models / approaches that pharmaceutical companies may choose to adopt while deciding the prices at which their ADC products can be marketed.

Chapter 20 provides details of the players that offer contract manufacturing services for ADCs, or possess the necessary capabilities and infrastructure to manufacture such products in-house. The chapter illustrates the manufacturing capabilities of different contract manufacturers highlighting their expansion plans and other agreements inked between companies.

Chapter 21 is a case study focused on the use of companion diagnostics in the field of ADCs. It provides a list of companies offering companion diagnostics for targets being targeted by ADCs, including information on their geographical location, affiliated biomarker, assay technique involved, target indication(s), the type of sample required (tumor tissue, blood, bone marrow and others) and the drug candidate(s) for which it is already available.

Chapter 22 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of the ADCs market within the biopharmaceutical industry, under a comprehensive SWOT framework.

Chapter 23 features an elaborate market forecast analysis, highlighting the likely growth of ADC market, till the year 2030. In order to provide details on future opportunity, our projections have been segmented on the basis of [A] target indication (Breast cancer, Blood cancer, Colorectal cancer, Gastric cancer, Gynecological cancer, Head and neck cancer, Lung cancer, and Others), [B] type of linker used (VC, Sulfo-SPDB, VA, Hydrazone linker, and Others), [C] type of payload (MMAE, DM4, Camptothecin, DM1, MMAF, and Others), [D] target antigens (CD30, HER2, CD22, CE33, and Others), and [E] key geographies (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s growth.

Chapter 24 is a collection of interview transcripts of discussions held with key stakeholders in this market. In this chapter, we have presented a brief overview of the companies and details of our conversations with Christian Rohlff, (Founder and Chief Executive Officer, Oxford BioTherapeutics), Paul Jaminet (Founder and Chief Executive Officer, Angiex), Sasha Koniev (Co-Founder and Chief Executive Officer, Syndivia), Aldo Braca (President and Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciarini (Technical Business Development Senior Manager, BSP Pharmaceuticals), John Burt (Chief Executive Officer, Abzena), Michael Schopperle (Chief Executive Officer, CureMeta), Anonymous (Chief Executive Officer, Leading CMO), Jeff Landau (Chief Business Officer and Head of Strategy, CytomX), Wouter Verhoeven (Chief Business Officer, NBE-Therapeutics), Denis Angioletti (Chief Commercial Officer, Cerbios-Pharma), Toshimitsu Uenaka (Executive Director, Eisai) and Takashi Owa (Chief Innovation Officer, Eisai), Justin Oh (Executive Director, AbTis), Sukumar Sakamuri (Vice President and Head of Chemistry, AmbrX), Anonymous (Director, Business Development, Leading CMO), Anthony DeBoer (Director, Business Development, Synaffix), Christian Bailly (Director of CDMO, Pierre Fabre), Jennifer L. Mitcham (Director, SMARTag ADCs and Bioconjugates, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions), Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza), Mark Wright (Site Head, Piramal Healthcare), Tatsuya Okuzumi (Associate General Manager, Ajinomoto Bio-Pharma Services), and Alan Burnett (Professor, School of Medicine, Cardiff University).

Chapter 25 is the summary of the overall report, which presents the insights on the contemporary market trends and the likely evolution of the ADC therapeutics market.

Chapter 26 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 27 is an appendix, which contains a list of companies and organizations mentioned in the report.

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