NEW YORK, Jan. 28, 2016 /PRNewswire/ -- INTRODUCTION
Antibody Drug Conjugates (ADCs) are a new class of therapeutic drugs consisting of a cytotoxic drug linked to a monoclonal antibody. These novel conjugates are believed to be very effective and efficient in treatment of a disease. However, manufacturing such highly potent toxic molecules is accompanied with several known and unknown challenges.
In-house manufacturing of ADCs is rare primarily because of the complex nature of these molecules. Their manufacturing requires both clean room biologic and high containment cytotoxic facilities. This combination is rare and difficult to achieve, requiring significant capital investment.Considering the utilisation rates are likely to be low in the near future, the investment required for setting up such high-containment biologic facilities is a huge financial risk.Even the leading technology providers, including Seattle Genetics and ImmunoGen, are dependent on contract manufacturers to supply the components. Despite the fact that some developers (e.g. Roche) have recently announced their plans to build in-house facilities, the trend of outsourcing is likely to continue for at least the coming decade.
It is worth highlighting there has been a surge in investment activity for facility expansions by a number of CMOs. The concept of one-stop-shop is also gaining traction as CMOs have collaborated with one another in an effort to cater to the increasing demand and to streamline the manufacturing process under one umbrella. Althoughthere are two marketed ADCs till date, a rich and extensive pipeline presents a very big opportunity for the contract manufacturers.
SCOPE OF THE REPORT
The "ADC Contract Manufacturing Market, 2015-2025" report provides an extensive study of the contract manufacturing opportunity for the emerging class of ADCs. The report covers various aspects, such as, identifying CMOs active in this space, their capabilities with respect to ADCs, available capacity (clinical / commercial) for bio-conjugation and geographic location / spread of the facilities.
With several drugs in pipeline, the opportunity for contract manufacturers is likely to increase significantly in the coming years. One of the key objectives of this report is to understand the future potential for CMOs in the ADC market. Amongst other things, the report elaborates on the following key areas:
- The current state of the market with respect to developmental stage of pipeline products (both clinical / pre-clinical) and indications targeted.
- Recent partnerships which have taken place over the last five years including product manufacturing agreements, technology collaborations and mergers / acquisitions.
- CMO investments to develop new / expand existing plants and supporting facilities in order to ensure sufficient production capacity and safe handling of these compounds.
- Upcoming growth areas and inherent threats to development in the short and long term.
- Development and sales potential of ADCs in advanced clinical stages; likely outsourcing profile across various steps involved in ADC manufacturing.
The base year for the report is 2015. The report provides short-mid term and long term market forecasts for the period 2015 - 2020 and 2020 - 2025, respectively. We have discussed, in detail, the key drivers behind the growth of the ADC contract manufacturing market. The research, analysis and insights presented in this report are backed by a comprehensive survey on ADC manufacturing capabilities of several CMOs. In addition, we interviewed important stakeholders to solicit their opinions around the future opportunities and challenges which must be considered for a more inclusive growth. Examples of companies we interviewed include Piramal Healthcare, Pierre Fabre, Catalent, Lonza and BSP Pharmaceuticals.
To add robustness to our forecast model, we have provided three market scenarios which vary in terms of the overall ADC commercial sales and the likely cost of manufacturing. The conservative, base and optimistic scenarios represent three different tracks of market evolution.
All actual figures have been sourced and analysed from publicly available information. The figures mentioned in this report are in USD, unless otherwise specified.
Most of the data presented in this report has been gathered by secondary research. As mentioned above, we have also conducted 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 shape up across different regions and drug 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
- Other analysts' opinion reports
While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and 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.
Chapter 2 provides the executive summary of the insights captured during our research. The summary offers a high level view on the present scenario of ADC contract manufacturing market and where it is headed in the mid-long term.
Chapter 3 provides a general introduction to antibody drug conjugates. We have discussed in detail the components of an ADC. In addition, we have highlighted the advantages of ADC as a therapeutic drug over traditional treatments.
Chapter 4 provides details about the existing ADC therapeutics, both commercial and under clinical/preclinical development. It lists all the companies along with their respective molecules, highlighting their current phase of development and targeted indications. Furthermore, we have analysed the ADC market from the point of view of the commonly used linkers and cytotoxins.
Chapter 5 presents our analysis of the in-house and contract manufacturing of ADCs. There is special focus on CMOs which have capabilities to carry out the different steps in ADC manufacturing. It also includes details about full service providers for ADC manufacturing along with their respective manufacturing sites.
Chapter 6 highlights the regional landscape of CMOs manufacturing different components of ADC, conducting conjugation and / or fill/finish. The analysis has been done for over 40 CMOs by looking at the location of CMOs facilities where these activities are handled.
Chapter 7 includes profiles of 12 leading CMOs in the ADC market. Each company profile includes information such as company overview, financial performance, geographical presence, ADC manufacturing capabilities, ADC manufacturing experience, recent investments for ADC manufacturing and future plans.
Chapter 8 highlights the recent advances in terms of investments made by the CMOs to expand or set up new facilities to support ADC manufacturing. It also provides details about the various partnership models through which the CMOs have collaborated recently. We have analysed the investments to highlight the growing number of investments and the most active players which are leading the capacity expansions.
Chapter 9 presents our detailed analysis of the current and potential future market (in terms of value) for contract manufacturing of ADCs. We have presented the market data for base year 2015 and our forecasts for the period 2015 - 2025. The chapter includes, in detail, our revenue forecast for manufacturing antibody, drug-linker, conjugation, fill/finish and other components involved in ADC production. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as conservative, base and optimistic scenarios.
Chapter 10 provides our analysis of the strengths, weaknesses, opportunities and threats in the ADC contract manufacturing market. This section captures the key elements likely to influence future growth.
Chapter 11 summarises the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.
Chapter 12 includes seven interview transcripts based on our discussion with some of the leading CMOs in the ADC manufacturing market. The CMOs interviewed include Piramal Healthcare, Catalent, BSP Pharmaceuticals, Lonza and Pierre Fabre. Two additional CMOs which were interviewed requested the details to be published as anonymous.
Chapters 13 and 14 are appendices and provide the list of companies and tabulated data for all the figures presented in the report.
1. We expect Adcetris and Kadcyla,the two commercially available ADCs,to start generating annual sales of close to USD 1 billion in the near future. In addition to the marketed molecules, there are over 40 candidates in clinical development; of these, 25% are in Phase II & III.
2. Seattle Genetics and Roche, with 7 and 6 molecules in clinical development respectively, currently have the most developed portfolio of ADC molecules.Relatively new entrants include (indicative list, in alphabetical order) AbGenomics, Abzena, Affinicon, Allozyne, Endo Pharmaceuticals, Formation Biologics, Intellect Neurosciences, Kairos Therapeutics, Menarini Biotech, Mersana Therapeutics, Oxford BioTherapeutics, Philochem, Synthon and Zymeworks; emergence of these firms is likely to provide the necessary push, both in terms of technology and innovation.
3. Majority of ADC developers are dependent on contract manufacturers to supply the components.Discussions with senior experts in the industry reveal that around 70% of ADC manufacturing is currently outsourced.
4. In less than two years, there has been a healthy increase in the number of CMOs providing services specific to ADC development; we have identified over 40 such CMOs.There are more than 20 CMOs with capabilities of manufacturing cytotoxics and providing conjugation services. Over 15 CMOs extend their fill/finish capabilities specific to ADC manufacturing.
5. CMOs have been investing heavily to expand their manufacturing capabilities. In the last few years, there have been at least 15 published instances of investments from several CMOs to either expand their respective facilities or acquire new ones. Notably, CARBOGEN AMCIS has been one of the most active players.
6. Collaborations have helped the market reach its current growth trajectory.For example, SAFC and Baxter BioPharma Solutions partnered to manufacture and conduct all the steps of ADC manufacturing to cater to the customer needs. Earlier, Goodwin and Coldstream had collaborated to act as full service providers of ADCs.
7. In the base scenario, we anticipate the overall CMO market for ADC manufacturing to breach the USD 1 billion mark in the coming decade.Infact, there is a strong belief in the market that existing CMO facilities for ADC manufacturing will require expansion to cater to the growing population of pipeline molecules.
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