Continuous Manufacturing (Small Molecules and Biologics) Market (2nd Edition), 2022-2035

Continuous Manufacturing (Small Molecules and Biologics) Market (2nd Edition), 2022-2035

Over time, advances in manufacturing technologies have prompted pharmaceutical companies to shift from the traditional multi-step, batch manufacturing processes to faster and relatively efficient continuous manufacturing. Continuous manufacturing, also known as continuous flow chemistry, is an advanced manufacturing technology, which drives operations in a continuous manner (24×7) in one facility, without hold times. The concept was first described in the 1700s, for the production of pig iron in blast furnaces. Since then, the technique has been adopted by various industries, including automotive, food and beverage, oil refining, chemicals, pulp and paper, electronics, metal smelting, steel making, and waste-water treatment industries. , In recent years, continuous manufacturing has gained traction in the biopharmaceutical industry as well, having captured the attention of big pharma players, as well as leading contract manufacturing organizations (CMOs). Moreover, the ongoing COVID-19 pandemic has prompted the pharmaceutical industry to shift to continuous manufacturing to scale up processing. The continuous manufacturing technology offers several benefits, including reduction in manufacturing cost (by 15-30%), manpower (by 50-70%) and power consumption (by 40%), lesser product deviation (by 50%), smaller footprint (by 50-70%) and faster scale up. Specifically, for biologics, continuous manufacturing, through upstream perfusion, is already a well-established method. In fact, more than 20 biologics manufactured using this approach have been approved by the FDA. Moreover, continuous processing technology presents a versatile and beneficial manufacturing approach for oral solid dosage (OSD) forms and small molecules as well. In the last few years, many orally administrable drugs, including TRIKAFTA® (Vertex Pharmaceuticals, 2019), DAURISMO™ (Pfizer, 2018), SYMDEKO® (Vertex Pharmaceuticals, 2018), VERZENIO® (Eli Lilly, 2017), PREZISTA® (Johnson & Johnson, 2016) and ORKAMBI® (Vertex Pharmaceuticals, 2015) manufactured using the continuous technique, have been approved by the FDA. , , ,

Presently, several technology providers / equipment suppliers are engaged in offering the necessary technologies and equipment for continuous manufacturing; these include continuous flow reactors (plug flow reactors, continuous stirred tank reactors (CSTR) and microreactors), continuous granulators, continuous coaters, continuous mixers / blenders, continuous chromatography equipment, continuous dryers and process analytical technologies (PAT). Additionally, many companies have made heavy investments in order to install this technology and expand their facilities and capabilities. Innovators in this field have received significant support in the form of grants from various administering institutes and incentives from key regulatory agencies as well. It is also important to highlight that, despite the ongoing efforts, the adoption of this technology is fraught with some challenges, including cost of equipment, process development restrictions, manufacturing of a new facility and maintenance of the equipment. However, owing to the rising interest of investors and technological advancements, we are led to believe that the opportunity for technology developers and manufacturers / users engaged in this domain is likely to grow in the foreseen future. ,

The “Continuous Manufacturing (Small Molecules and Biologics) Market (2nd Edition), 2022 – 2035, Distribution by Purpose of Manufacturing (In-House and Contract Services), Scale of Operation (Preclinical, Clinical and Commercial), Type of Drug Molecule (Biologic and Small Molecule), Type of Continuous Manufacturing Related Service Offered (Process Development, API Manufacturing, Intermediate Manufacturing, Drug Product Manufacturing, and Packaging and Fill / Finish), Type of Dosage Form Offered (Solid and Liquid), Installed Capacity and Geographical Regions (North America, Europe and Asia-Pacific)” report features an extensive study of the current market landscape and future opportunities for companies with capabilities in continuous manufacturing (both innovator companies with in-house expertise and contract manufacturers). It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. In addition to other elements, the study includes:

A detailed assessment of the overall landscape of companies with capabilities for continuous manufacturing, along with information on a number of relevant parameters, such as year of establishment, company size, purpose of manufacturing (in-house and contract services), scale of operation (preclinical, clinical and commercial), location of headquarters, location of manufacturing facilities, type of drug molecule (biologic and small molecule), type of continuous manufacturing related service(s) offered (process development, API manufacturing, intermediate manufacturing, drug product manufacturing, and packaging and fill / finish), type of dosage form (solid and liquid), and installed capacity and batch size (if available).

Elaborate profiles of some of the companies active in the pharmaceutical and biopharmaceutical continuous manufacturing market in North America, Europe and Asia-Pacific. Each profile features an overview of the company, along with information related to its service portfolio, continuous manufacturing capabilities and facilities, recent developments and an informed future outlook.

An analysis of the various partnerships related to continuous manufacturing, which have been established since 2013, based on several parameters, such as year of an agreement, the type of partnership (research agreements, facility development / establishment agreements, technology enhancement agreements, service alliances, process development agreements, manufacturing agreements and other relevant agreements), scale of operation (preclinical, clinical and commercial), type of drug molecule (biologic and small molecule), type of continuous manufacturing related service (API manufacturing, intermediate manufacturing and end product manufacturing) and type of dosage form (solid and liquid). It also highlights the regional distribution of the collaborations.

An analysis of the expansions undertaken by companies engaged in continuous manufacturing, based on several parameters, such as year of expansion and the type of expansion (facility / plant expansion, technology installation, technology enhancement and service expansion), geographical location of the facility, scale of operation (preclinical, clinical and commercial), type of drug molecule (biologic and small molecule), type of continuous manufacturing related service (API manufacturing, intermediate manufacturing and end product manufacturing) and type of dosage form (solid and liquid).

A detailed competitiveness analysis of companies having expertise in continuous manufacturing, based on various relevant parameters, such as years of experience (YoE- the current year), company size, scale of production (pre-clinical, clinical and commercial), type of services (process development, drug substance manufacturing, intermediate manufacturing, final dosage form, packaging and labelling) and geographical location.

An estimate of the global, continuous manufacturing capacity, based on the capacities of various industry stakeholders (as available on their respective company websites). The study includes analysis of capacity, based on the type of drug molecule (biologic and small molecule), company size (small-sized, mid-sized and large), scale of operation (preclinical, clinical and commercial), location of headquarters (North America, Europe and Asia-Pacific) and location of manufacturing facilities (North America, Europe and Asia-Pacific).

A study of the various grants that have been awarded to research institutes engaged in projects related to continuous manufacturing, between 2016 and 2021, highlighting multiple parameters, such as year of award, type of grant, grant amount, focus area, support period, popular recipient organizations, type of recipient organization, funding institute center, funding mechanism and prominent program officers.

An in-depth analysis of the various patents that have been filed / granted related to continuous manufacturing till 2021, based on the parameters, such as patent type, publication year, geographical location, CPC symbol, emerging focus areas, type of applicant and leading industry / non-industry players (in terms of the size of intellectual property portfolio). It also features a three-dimensional bubble analysis (based on patent citation count, publication year, extended geographical reach), patent benchmarking and a detailed patent valuation analysis.

Initiatives taken by the leading pharmaceutical companies (in terms of revenues), covering both partnered as well as in-house projects.

An overview of the companies offering modular facilities / modular cleanrooms, including information on their geographical location (North America, Europe, Asia-Pacific and rest of the world), year of establishment, company size (small-sized, mid-sized or large) and type of industries served (pharmaceutical, biotechnology or others). It also provides details on the recent projects undertaken / executed by the companies providing modular facilities.

A case study of the companies offering technologies / equipment (continuous blenders and mixers, continuous granulators, continuous dryers, continuous compressors, continuous coaters, flow reactors, continuous filtration, distillation and centrifugation equipment, continuous chromatography, PAT technology and other technologies) that can potentially be used in a continuous manufacturing process, providing information on the geographical location of potential stakeholders and the type of technology / equipment provided.

A case study on the roadmap for the adoption of continuous manufacturing technique, discussing different strategies that can be followed by the company in order to adopt this technology or transition from batch manufacturing to continuous manufacturing.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as overall market of the currently approved drugs based on continuous manufacturing, cost of goods sold and direct manufacturing cost, we have provided an informed estimate of the likely evolution of the market in the mid to long term, for the time period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] purpose of manufacturing (in-house and contract services) [B] scale of operation (preclinical, clinical and commercial), [C] type of drug molecule (small molecule and biologic), [D] type of continuous manufacturing related service (API manufacturing and end product manufacturing), [E] type of dosage form (solid and liquid) and [F] key geographical regions (North America, Europe, Asia-Pacific and rest of the world). To account for the uncertainties associated with the continuous manufacturing of pharmaceuticals and biopharmaceuticals and to 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 also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:

Andrea Adamo (Founder and Chief Executive Officer, Zaiput Flow Technologies)

Bayan Takizawa (Co-Founder and Chief Business Officer, CONTINUUS Pharmaceuticals)

Eric Fang (Chief Scientific Officer, Snapdragon Chemistry)

Himanshu Gadgil (Director and Chief Scientific Officer, Enzene Biosciences)

Nick Thomson (Senior Director Chemical Research and Development, Pfizer)

Ian Houson (Technical Project Manager, Continuous Manufacturing and Crystallization, University of Strathclyde)

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 gathered via secondary and primary 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 2035, 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.

KEY QUESTIONS ANSWERED

Who are the leading players providing in the continuous manufacturing services?

In which regions are the majority of continuous manufacturers located?

What is the installed, global capacity for continuous manufacturing?

Which partnership models are commonly adopted by stakeholders engaged in providing continuous manufacturing services?

Who are the other key stakeholders (modular facility providers and technology / equipment developers) in this domain?

Which factors are likely to influence the evolution of this market?

How has the patent landscape evolved over the last several years?

Which research institutes have received relatively more grants for projects related to continuous manufacturing?

Which organizations have taken significant in-house initiatives in the field of continuous manufacturing?

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 key insights captured during our research. It offers a high-level view on the likely evolution of the pharmaceutical and biopharmaceutical continuous manufacturing market in the short to mid-term and long term.

Chapter 3 provides a general introduction to continuous flow chemistry. The chapter also includes the historical evolution of continuous manufacturing in the pharmaceutical industry. It features a brief overview of the regulatory landscape, the early adopters of this technology, advantages and key challenges associated with this technique. The chapter also discusses the future perspective of the pharmaceutical and biopharmaceutical continuous manufacturing market in this domain.

Chapter 4 provides an overview of the market landscape of companies engaged in continuous manufacturing. The chapter features information on year of establishment, company size, purpose of manufacturing (in-house and contract services), scale of operation (preclinical, clinical and commercial), location of headquarters, location of manufacturing facilities, type of drug molecule (biologic and small molecule), type of continuous manufacturing related service offered (process development, API manufacturing, intermediate manufacturing, drug product manufacturing, and packaging and fill / finish), type of dosage form offered (solid and liquid), and installed capacity and batch size (if available).

Chapter 5 features detailed profiles of key North American players engaged in pharmaceutical and biopharmaceutical continuous manufacturing. Each profile presents a brief overview of the company, its overall contract service offerings, continuous manufacturing capabilities and facilities, recent developments and future outlook.

Chapter 6 features detailed profiles of key European players engaged in pharmaceutical and biopharmaceutical continuous manufacturing. Each profile presents a brief overview of the company, its overall contract service offerings, continuous manufacturing capabilities and facilities, recent developments and future outlook.

Chapter 7 features detailed profiles of some of key Asia-Pacific players in pharmaceutical and biopharmaceutical continuous manufacturing. Each profile presents a brief overview of the company, its overall contract service offerings, continuous manufacturing capabilities and facilities, recent developments and future outlook.

Chapter 8 features an elaborate discussion and analysis of the various collaborations established in this market, since 2013. Further, the partnership activities in this domain have been analyzed on the basis of year of agreement, the type of partnership (research agreements, facility development / establishment agreements, technology enhancement agreements, service alliances, process development agreements, manufacturing agreements and other relevant agreements) and geographical location of the players involved in the collaborations. The instances that we came across were analyzed based on various parameters including scale of operation (preclinical, clinical and commercial), type of drug molecule (biologic and small molecule), type of continuous manufacturing related service (API manufacturing, intermediate manufacturing and end product manufacturing) and type of dosage form (solid and liquid).

Chapter 9 features an elaborate discussion on the various expansions that have taken place in this market, since 2013. Further, the expansion initiatives have been analyzed on the basis of year of expansion and the type of expansion (facility / plant expansion, technology installation, technology enhancement and service expansion), geographical location of the facility, scale of operation (preclinical, clinical and commercial), type of drug molecule (biologic and small molecule), type of continuous manufacturing related service (API manufacturing, intermediate manufacturing and end product manufacturing) and type of dosage form (solid and liquid).

Chapter 10 provides a detailed competitiveness analysis of companies having expertise in continuous manufacturing, considering various relevant parameters, such as year of experience (year of establishment - the current year), company size which comes under supplier strength, scale of production (pre-clinical, clinical and commercial) which comes under portfolio strength, type of service(s) (process development, drug substance manufacturing, intermediate manufacturing, final dosage form, packaging and labelling) and regions which comes under service applicability.

Chapter 11 features an estimate of the overall, installed capacity for manufacturing drug substances and drug products based on information reported by industry stakeholders in the public domain, highlighting the distribution of the available capacity on the basis of type of drug molecule (biologic and small molecule), company size (small-sized, mid-sized and large), scale of operation (preclinical, clinical and commercial), location of headquarters (North America, Europe and Asia-Pacific), location of manufacturing facilities (North America, Europe and Asia-Pacific).

Chapter 12 provides information on the various grants that were awarded to research institutes conducting projects related to continuous manufacturing, between 2016 and 2021. The analysis also highlights important parameters associated with grants, such as year of award, type of grant, grant amount, focus area, support period, popular recipient organizations, type of recipient organization, funding institute center, funding mechanism and prominent program officers.

Chapter 13 provides an in-depth patent analysis, presenting an overview on the filed / granted patents related to continuous manufacturing. For this analysis, we looked at the patents that have been published by various players, till 2021. The analysis highlights key details and trends associated with these patents, including patent type, publication year, geographical location, assigned CPC symbol, emerging focus area, type of applicant and leading industry / academic players (in terms of size of intellectual property portfolio). It features a three-dimensional bubble analysis (based on patent citation count, publication year, extended geographical reach). It also includes a patent benchmarking analysis and a detailed valuation analysis.

Chapter 14 highlights initiatives taken by the leading pharmaceutical companies (in terms of revenues), covering both partnered as well as in-house projects.

Chapter 15 features a review of the companies offering modular facility / modular cleanroom with information on their geographical location (North America, Europe, Asia-Pacific and rest of the world), establishment year, size (small-sized, mid-sized or large) and type of industries served (pharmaceutical, biotechnology or others). It also includes information on the recent projects undertaken by these companies.

Chapter 16 presents a case study on the companies offering technologies / equipment (flow reactors, continuous blenders and mixers, continuous granulators, continuous compressors, continuous coaters, continuous dryers, continuous filtration, distillation and centrifugation equipment, continuous chromatography, PAT technology and other technologies) that can potentially be used in a continuous manner, providing information on the geographical location of potential stakeholders and the type of technology / equipment provided.

Chapter 17 a case study on the roadmap for the adoption of continuous manufacturing technique, discussing different strategies that can be followed by the company in order to adopt this technology or transition from batch manufacturing to continuous manufacturing.

Chapter 18 presents a comprehensive market forecast analysis, highlighting the likely growth of the pharmaceutical and biopharmaceutical continuous manufacturing market, for the time period 2022-2035. In order to provide an informed future outlook, our projections have been segmented on the basis of [A] purpose of manufacturing (in-house and contract services) [B] scale of operation (preclinical, clinical and commercial), [C] type of drug molecule (small molecule and biologic), [D] type of continuous manufacturing related service (API manufacturing and end product manufacturing) and [E] type of dosage form (solid and liquid) and [F] key geographical regions (North America, Europe, Asia-Pacific and rest of the world).

Chapter 19 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 20 is a collection of transcripts of interviews conducted with key stakeholders in the market. In this chapter, we have presented the details of our conversations with Andrea Adamo (Founder and Chief Executive Officer, Zaiput Flow Technologies), Bayan Takizawa (Co-Founder and Chief Business Officer, CONTINUUS Pharmaceuticals), Eric Fang (Chief Scientific Officer, Snapdragon Chemistry), Himanshu Gadgil (Director and Chief Scientific Officer, Enzene Biosciences), Nick Thomson (Senior Director Chemical Research and Development, Pfizer) and Ian Houson (Technical Project Manager, Continuous Manufacturing and Crystallization, University of Strathclyde).

Chapter 21 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 22 is an appendix, which contains the list of companies and organizations mentioned in the report.