This report, the third edition of its series, features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of HPAPIs and cytotoxic drugs. The study also features a detailed analysis of the key drivers and trends related to this evolving domain.
One of the key objectives of the report was to estimate the existing market size and the future growth potential within the HPAPI and cytotoxic drugs contract manufacturing market. Based on multiple parameters, such as projected growth of the overall highly potent drug products market, cost of goods sold and direct manufacturing costs, we have developed informed estimates on the financial evolution of the market, over the period 2020-2030.
The report also provides details on the likely distribution of the current and forecasted opportunity across:
[A] type of product (HPAPIs and highly potent finished dosage forms)
[B] company size (small-sized, mid-sized and large / very large)
[C] scale of operation (preclinical, clinical and commercial)
[D] type of pharmacological molecule (small molecules and biologics)
[E] type of highly potent finished dosage form (injectables, oral solids, creams and others)
[F] key geographical regions, covering North America (the US, Canada and Mexico), Europe (the UK, Germany, France, Spain, Italy and rest of Europe), Asia Pacific (India, China, and rest of Asia-Pacific), and rest of the world
The increasing focus on HPAPIs in development pipelines and the rising demand for cytotoxic drugs has led to a growing need for safe manufacturing and containment technologies. Though some pharmaceutical companies have invested in building in-house capabilities, the capital-intensive nature and specialized containment requirements make the role of contract manufacturers crucial. In fact, since 2000, several contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), offering HPAPI and cytotoxic drug manufacturing services have been established.
Amidst growing competition, the availability of cutting-edge tools and technologies has emerged as a differentiating factor. This has caused many service providers to actively expand their service portfolios, either through strategic acquisitions or facility/capability expansions. Over time, many CMOs / CDMOs claim to have developed end-to-end service capabilities, ranging from drug development (including preliminary R&D, preclinical studies and clinical trials), to regulatory filings, and commercial scale production.
Amongst other elements, the report includes:
A detailed review of the overall landscape of companies offering contract services for the manufacturing of HPAPIs and cytotoxic drugs, along with information on year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number and location of manufacturing facilities, facility size, type of service(s) offered (clinical manufacturing, commercial manufacturing, analytical testing, scale-up, process development / pre-formulation, formulation development, stability studies, regulatory support and fill/finish and packaging), type of product manufactured (HPAPIs and highly potent finished dosage forms), type of pharmacological molecule (biologics and small molecules), type of highly potent finished dosage form manufactured (capsules, granules, injectables, liquids and tablets), and type of primary packaging used (ampoules, blisters, prefilled syringes, conventional syringes, vials and others).
A competitiveness analysis of HPAPI and cytotoxic drugs contract manufacturers, taking into consideration supplier strength (based on company size and its experience in this field) and service strength (based on scale of operation, type of service(s) offered, type of product(s) manufactured, number and location of manufacturing facilities, type of highly potent finished dosage forms manufactured and type of primary packaging used).
Elaborate profiles of the key players (shortlisted based on a proprietary criterion) that offer a diverse range of capabilities for the development, manufacturing and packaging of HPAPIs and cytotoxic drugs, across North America, Europe and Asia Pacific. Each profile includes a brief overview of the company, its year of establishment, location of headquarters, number of employees and financial information (if available). In addition to this, the profile includes information on the various HPAPIs / cytotoxic dugs manufacturing services offered by the company, along with the location of their manufacturing facilities. Further, we have provided the recent developments of the company and an informed future outlook.
An analysis of the various partnerships pertaining to the contract manufacturing of HPAPIs and cytotoxic drugs, which have been established since 2014, based on several parameters, such as the year of partnership, type of partnership, type of product, scale of operation, company size, amount invested in acquisitions, most active player and geographical analysis.
An analysis of the various expansion initiatives undertaken by service providers, in order to augment their respective HPAPI and cytotoxic drug manufacturing capabilities, over the period 2014-2019, taking into consideration several relevant parameters, such as year of expansion, type of expansion (capacity expansion, facility expansion and new facility), scale of operation (preclinical, clinical and commercial), type of product manufactured (HPAPIs and highly potent finished dosage forms), and location of manufacturing facility.
An estimate of the overall, installed capacity for manufacturing HPAPIs and cytotoxic drugs based on data reported by industry stakeholders in the public domain; it highlights the distribution of available HPAPIs and cytotoxic drugs production capacity on the basis of company size (small-sized, mid-sized, large and very large companies), scale of operation (preclinical, clinical and commercial), and across key geographical regions (North America, Europe, Asia Pacific and rest of the world).
A qualitative analysis, highlighting the various factors that need to be taken into consideration by highly potent drug developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
A discussion on affiliated trends, key drivers and challenges which are likely to impact the industry's evolution, under a comprehensive SWOT framework; it includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.
A case study on the antibody drug conjugates (ADCs) manufacturing market, highlighting a list of contract service providers and in-house manufacturers that are currently active in this space. Additionally, it includes a detailed set of analyses of these companies based on several parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number and location of manufacturing facilities, and type of service(s) offered.
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 this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:
Antonella Mancuso and Maria Elena Guadagno, Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals
Stacy McDonald and Jennifer L Mitcham, Group Product Manager and Director-Business Development, Catalent Pharma Solutions
Roberto Margarita, Business Development Director, CordenPharma
Allison Vavala, Senior Manager, Business Development, Helsinn
Javier E. Aznrez Araiz, Business Development, Idifarma
Dr. Mark Wright, Site Head, Grangemouth, Piramal Healthcare
Klaus Hellerbrand, Managing Director, ProJect Pharmaceutics
Kevin Rosenthal, Business Head, Formulations and Finished Products, Alphora research
1. Preface 2. Executive Summary 3. Introduction 4. Market Landscape 5. Company Competitive Analysis 6. HPAPI and Cytotoxic Drugs Contract Manufacturers Based in North America: Company Profiles 7. HPAPI and Cytotoxic Drugs Contract Manufacturers Based in Europe: Company Profiles 8. HPAPI and Cytotoxic Drugs Contract Manufacturers Based in Asia-Pacific: Company Profiles 9. Partnerships and Collaborations 10. Recent Expansions 11. Capacity Analysis 12. Make Versus Buy Decision Making Framework 13. Market Sizing and Opportunity Analysis 14. SWOT Analysis 15. Case-In-Point: Contract Manufacturing of Antibody Drug Conjugates 16. Concluding Remarks 17. Executive Insights