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Pharmaceutical Contract Manufacturing Market by business segment, type of API, type of FDF, type of packaging form, scale of operation, end-users and key geographical regions : Industry Trends and Global Forecasts, 2021-2030

Pharmaceutical Contract Manufacturing Market by business segment, type of API, type of FDF, type of packaging form, scale of operation, end-users and key geographical regions : Industry Trends and Global Forecasts, 2021-2030

  • July 2021
  • 545 pages
  • ID: 6130489
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
At present, the pharmaceutical industry is dominated by the presence of small molecule products, which represent close to 80% of the overall pipeline. Even though biologics have shown significant promise in the treatment of a wide range of disorders, in recent years, approval of novel small molecules has been on the rise. In fact, in 2020, over 50 small molecule drugs were approved by the US FDA, while around 8,000 such candidates are being evaluated across different stages of development. It is worth mentioning that the pipeline features increasingly complex candidates, which require specialized facilities, advanced equipment and operational expertise. As setting-up / acquiring manufacturing capabilities is both time and cost intensive process, it is extremely challenging for pharmaceutical companies to perform development and manufacturing operations independently. The aforementioned constraints, coupled to the rising demand for safer and effective drugs (currently driven by the COVID-19 pandemic), have prompted players to outsource a significant portion of their business segments to contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs).

The current landscape of pharmaceutical contract service providers is highly fragmented, featuring a mix of start-ups, mid-sized firms and established players. The inherent expertise of CMOs and CDMOs is believed to be capable of enabling reduction in the time-to-market a product, significant cost-benefits, as well as access to larger production capacities and novel technologies. It is worth mentioning that there has been substantial merger and acquisition activity in the pharmaceutical contract manufacturing market in the past few years, as players strive to become one stop shops, in order to cater to the diverse needs of pharmaceutical developers (ranging from early-stage development to commercial production). Considering the ongoing innovation in production technologies, evolving pipeline of small molecule products and the increasing demand for such drug candidates, we believe that the pharmaceutical contract manufacturing market is likely to witness positive growth in the coming years.

SCOPE OF THE REPORT
The “Pharmaceutical Contract Manufacturing Market (3rd Edition) Distribution by [A] key business segments (API(s) and FDF(s)), [B] type of API(s) manufactured (branded and generic), [C] type of FDF(s) offered (oral solids, parenteral and others), [D] type of primary packaging form (blisters, bottles, injectables and others), [E] scale of operation (clinical and commercial), [F] type of end-users (small pharmaceutical companies, mid-sized pharmaceutical companies and large pharmaceutical companies) and [G] key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa.: Industry Trends and Global Forecasts, 2021-2030” report features an extensive study of the current market landscape and future opportunities associated with the pharmaceutical contract manufacturing industry. Amongst the other elements, the report features:
A detailed overview of the overall market landscape, featuring an elaborate list of over 450 active CMOs engaged in this domain, along with information on several relevant parameters, such as year of establishment, company size, geographical location of CMOs, type of business segment (active pharmaceutical ingredients (APIs), intermediates and finished dosage formulations (FDFs)), type of API(s) manufactured (complex, generic and sterile), type of FDF(s) offered (oral solids, liquids / semi-solids, injectables, inhalation and others), type of service(s) offered, type of primary packaging form (blister, tubes, vial / cartridge, ampoule, sachets / pouches / bags, inhalers / nasal sprays, glass / plastic / dropper bottles, pre-filled syringes / autoinjectors), scale of operation (preclinical, clinical and commercial) and specific location of manufacturing facilities (country-wise).
A detailed analysis of various mergers and acquisitions that have taken place in this domain, highlighting the trend in number of companies acquired and geographical distribution of the activity, during the period 2017-2021. Further, it highlights the relationship between deal multiples (based on revenues), number of employees and experience of the acquired firm.
A detailed analysis of the recent expansions (since 2017) undertaken by various service providers in order to augment their respective pharmaceutical contract manufacturing service portfolios, based on a several relevant parameters, such as year of expansion, purpose of expansion (capability expansion, capacity expansion, facility expansion, new facility), type of business segment (API(s), FDF(s)), capital invested, scale of operation (clinical, commercial), type of service(s) offered (formulation, manufacturing, packaging), geographical location of facility, and most active players (in terms of number of instances).
An estimate of the global, installed capacity for the manufacturing of small-molecule drugs, based on information provided by various industry stakeholders in the public domain. It also features distribution of the available capacity on the basis of scale of operation (clinical and commercial), company size (small, mid-sized and large firms) and key geographical regions (North America, Europe and Asia Pacific).
Informed estimates of the annual clinical and commercial demand for small molecule drugs, across key geographical regions.
A detailed analysis of pharmaceutical contract manufacturing service providers’ capabilities in different regions, based on several relevant parameters, such as type of business segment, type of service(s) offered and type of packaging form.
A detailed analysis of various pharmaceutical contract manufacturing service providers featuring schematic representations, including [A] a heat map analysis, highlighting the distribution of integrated contract service providers (companies offering manufacturing services for both small and large molecules), on the basis of location of their headquarters, year of establishment and number of employees, [B] a geographical landscape analysis, highlighting CMOs that have a wide geographical reach, on the basis of their presence (manufacturing facilities) across various regions, and [C] a grid representation, highlighting the global and regional trend of API and FDF outsourcing services, based on the location of headquarters of the company, number of employees, type of business segment, type of service(s) offered and scale of operation.
A detailed discussion on various guidelines laid down by major regulatory bodies, across different countries, featuring an elaborative assessment of over 450 CMOs engaged in this domain, along with information on their operational approvals, certifications received, and relative popularity of the key regulatory body. Additionally, the chapter features an insightful multi-dimensional bubble analysis, presenting a comparison of the current regulatory scenario in key geographies.
Elaborate profiles of key players engaged in offering pharmaceutical contract manufacturing services. Each profile features a brief overview of the company, along with information on its financial performance (if available), service(s) portfolio, manufacturing facilities and capabilities, recent developments and an informed future outlook.
A case study highlighting a comparison of the key characteristics of large and small molecule drugs, along with information on the steps involved in their respective manufacturing processes.
A qualitative analysis highlighting the various factors that need to be taken into consideration by pharmaceutical drug developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
A detailed analysis capturing the key parameters and trends that are likely to influence the future of the pharmaceutical contract manufacturing market, under an elaborate SWOT framework. Further, it presents a schematic Harvey ball analysis highlighting the relative impact of each SWOT parameter on the overall pharmaceutical industry.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future opportunity within the market based on several parameters, such as growth of the overall pharmaceutical market, cost of goods sold, direct manufacturing costs. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2021-2030. The report also features the likely distribution of the opportunity across [A] key business segments (API(s) and FDF(s)), [B] type of API(s) manufactured (branded and generic), [C] type of FDF(s) offered (oral solids, parenteral and others), [D] type of primary packaging form (blisters, bottles, injectables and others), [E] scale of operation (clinical and commercial), [F] type of end-users (small pharmaceutical companies, mid-sized pharmaceutical companies and large pharmaceutical companies) and [G] key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa. In order to account for future uncertainties and add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

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:
Scott Goldstein (Ex - Director, Business Development, Ajinomoto Bio-Pharma Services)
Thomas Früh (Ex - CEO, Bachem)
Bhaskar Venepalli (President and CEO, CiVentiChem)
Roberto Margarita (Director, Business Development, CordenPharma)
Allison Vavala (Director, Commercial Development, Helsinn Group)
Kevin Daley (Director, Pharmaceuticals Marketing, Novasep)
Piyush Desai (Director, Operations, Sovereign Pharma)
Ilan Avni (Vice President Business Development, Marketing, and IP, Wavelength Pharmaceuticals)

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

RESEARCH METHODOLOGY
The research, analysis and insights presented in this report are backed by a deep understanding of insights gathered from both secondary and primary sources. For all our projects, we conduct interviews with experts in the area (academia, industry 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 key players engaged in offering contract manufacturing services for small molecules?
What are the key value drivers of the merger and acquisition activity observed within the pharmaceutical contract manufacturing industry?
What are the different expansion initiatives undertaken by pharmaceutical contract manufacturers in the recent past?
Which regions represent the current key contract manufacturing hubs for small molecules?
What is the current, installed capacity for contract manufacturing of small molecules?
What is the current, global demand for small molecules? How is the demand for such candidates likely to evolve in the foreseen future?
What percentage of the pharmaceutical manufacturing operations are presently outsourced?
What factors should be taken into consideration while deciding whether the manufacturing operations for small molecules should be kept in-house or outsourced?
How is the current and future opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES
Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the pharmaceutical contract manufacturing market in the mid-long term.

Chapter 3 provides a general introduction to various type of manufacturers engaged in the pharmaceutical market. It further includes a brief overview of the concept of contract manufacturing, featuring a discussion on the evolution of contract services in this industry. Additionally, it highlights details related to the need for outsourcing in this domain. Further, the chapter includes a brief overview of contract manufacturing models that have been adopted in the pharmaceutical industry and an exhaustive list of services offered by CMOs; the chapter concludes with a discussion on the challenges associated with the outsourcing of pharmaceutical manufacturing operations.

Chapter 4 features a detailed discussion on various guidelines laid down by major regulatory bodies, across different countries, featuring an elaborative assessment of over 450 CMOs engaged in this domain, along with information on their operational approvals, certifications received, and relative popularity of the key regulatory body. Additionally, the chapter features an insightful multi-dimensional bubble analysis, presenting a comparison of the current regulatory scenario in key geographies

Chapter 5 provides a detailed overview of the overall market landscape, featuring an elaborate list of over 450 active CMOs engaged in this domain, along with information on several relevant parameters, such as year of establishment, company size, geographical location of CMOs, type of business segment (active pharmaceutical ingredients (APIs), intermediates and finished dosage formulations (FDFs)), type of API(s) manufactured (complex, generic and sterile), type of FDF(s) offered (oral solids, liquids / semi-solids, injectables, inhalation and others), type of service(s) offered, type of primary packaging form (blister, tubes, vial / cartridge, ampoule, sachets / pouches / bags, inhalers / nasal sprays, glass / plastic / dropper bottles, pre-filled syringes / autoinjectors), scale of operation (preclinical, clinical and commercial) and specific location of manufacturing facilities (country-wise).

Chapter 6 presents a detailed analysis of pharmaceutical contract manufacturing service providers’ capabilities in different regions, based on several relevant parameters, such as type of business segment, type of service(s) offered and type of packaging form.

Chapter 7 features elaborate profiles of key players engaged in offering pharmaceutical contract manufacturing services. Each profile features a brief overview of the company, along with information on its financial performance (if available), service(s) portfolio, manufacturing facilities and capabilities, recent developments and an informed future outlook.

Chapter 8 presents a qualitative analysis highlighting the various factors that need to be taken into consideration by pharmaceutical drug developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO.

Chapter 9 presents a detailed analysis of various mergers and acquisitions that have taken place in this domain, highlighting the trend in number of companies acquired and geographical distribution of the activity, during the period 2017-2021. Further, it highlights the relationship between deal multiples (based on revenues), number of employees and experience of the acquired firm.

Chapter 10 features A detailed analysis of the recent expansions (since 2017) undertaken by various service providers in order to augment their respective pharmaceutical contract manufacturing service portfolios, based on a several relevant parameters, such as year of expansion, purpose of expansion (capability expansion, capacity expansion, facility expansion, new facility), type of business segment (API(s), FDF(s)), capital invested, scale of operation (clinical, commercial), type of service(s) offered (formulation, manufacturing, packaging), geographical location of facility, and most active players (in terms of number of instances).

Chapter 11 features an estimate of the global, installed capacity for the manufacturing of small-molecule drugs, based on information provided by various industry stakeholders in the public domain. It also features distribution of the available capacity on the basis of scale of operation (clinical and commercial), company size (small, mid-sized and large firms) and key geographical regions (North America, Europe and Asia Pacific). Overall, the analysis represents a holistic view of the supply-side of the market, allowing us to present an informed opinion on whether the present capacity will be able to meet the likely future demand.

Chapter 12 provides informed estimates of the annual clinical and commercial demand for small molecule drugs, across key geographical regions, based on relevant parameters, such as number of patient population, dosage and dose frequency.

Chapter 13 represents a detailed market forecast, highlighting the future potential of the pharmaceutical contract manufacturing market, till 2030. Additionally it features the likely distribution of the opportunity across different [A] key business segments (API(s) and FDF(s)), [B] type of API(s) manufactured (branded and generic), [C] type of FDF(s) offered (oral solids, parenteral and others), [D] type of primary packaging form (blisters, bottles, injectables and others), [E] scale of operation (clinical and commercial), [F] type of end-users (large pharmaceutical companies, mid-sized pharmaceutical companies and small pharmaceutical companies) and [G] key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa.

Chapter 14 presents a detailed analysis of various pharmaceutical contract manufacturing service providers featuring schematic representations, including [A] a heat map analysis, highlighting the distribution of integrated contract service providers (companies offering manufacturing services for both small and large molecules), on the basis of location of their headquarters, year of establishment and number of employees, [B] a geographical landscape analysis, highlighting CMOs that have a wide geographical reach, on the basis of their presence (manufacturing facilities) across various regions, and [C] a grid representation, highlighting the global and regional trend of API and FDF outsourcing services, based on the location of headquarters of the company, number of employees, type of business segment, type of service(s) offered and scale of operation.

Chapter 15 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of the pharmaceutical contract manufacturing market, under an elaborate SWOT framework. Further, it presents a schematic Harvey ball analysis highlighting the relative impact of each SWOT parameter on the overall pharmaceutical industry.

Chapter 16 is a case study highlighting a comparison of the key characteristics of large and small molecule drugs, along with information on the steps involved in their respective manufacturing processes.

Chapter 17 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it summarizes the various evolutionary trends that are likely to influence the future of this market.

Chapter 18 is a collection of executive insight(s) of the discussion(s) that were held with key stakeholder(s) in this market. We have presented details of interviews held with Scott Goldstein (Ex - Director, Business Development, Ajinomoto Bio-Pharma Services), Thomas Früh (Ex - CEO, Bachem), Bhaskar Venepalli (President and CEO, CiVentiChem), Roberto Margarita (Director, Business Development, CordenPharma), Allison Vavala (Director, Commercial Development, Helsinn Group), Kevin Daley (Director, Pharmaceuticals Marketing, Novasep), Piyush Desai (Director, Operations, Sovereign Pharma), Ilan Avni (Vice President Business Development, Marketing, and IP, Wavelength Pharmaceuticals).

Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 20 is an appendix, which provides the list of companies and organizations included in the report.

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