Pharmaceutical Contract Manufacturing Market (2nd Edition), 2018-2028

Thursday, May 31, 2018 Drug News
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LONDON, May 31, 2018 /PRNewswire/ --

INTRODUCTIONIn 2017, the Food and Drug Administration's (FDA) Center

for Drug Evaluation and Research approved 46 novel drugs, out of which 34 were small molecules. Moreover, it is important to acknowledge that the present pipeline of pharmaceutical products is increasingly complex and requires specialized facilities,
equipment and operational expertise. In addition, the costs associated with acquiring manufacturing capabilities are exorbitant and, therefore, it is difficult for companies with limited finances and capacity constraints to succeed by themselves. The aforementioned constraints have led many of the smaller players in the industry and, at times, certain pharma giants as well, to outsource a significant part of their business operations to contract service providers. Such third-party service providers are known to offer significant cost-benefits, access to larger production capacities and reductions in time-to-market. Over the years, the contract manufacturing market has grown into a prominent and promising segment of the overall pharmaceutical industry. In fact, post 2000, more than 138 new CMOs have been established, offering cost-efficient solutions to several stakeholders in the industry.

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It is worth mentioning that the current global CMO market is highly fragmented but characterized by multiple acquisitions and mergers as stakeholders strive to broaden their respective service portfolios. In fact, this has enabled several CMOs to start offering end-to-end services across the entire value chain, from drug development, including preliminary R&D, preclinical and clinical trials, to commercial scale production and regulatory filings. However, given the ongoing innovation in production technologies and the steadily evolving pipeline of small molecules, the pressure on the contract manufacturing industry is expected to increase in the coming years. This is likely to require CMOs to devise and implement different business strategies and models in order to cope with the evolving demand.

The 'Pharmaceutical Contract Manufacturing Market (2nd Edition), 2018-2028' report provides a comprehensive study on the current scenario of contract manufacturing services related to pharmaceutical products. The study features an in-depth analysis, highlighting the capabilities of a diverse set of pharmaceutical CMOs.

Amongst other elements, the report features:• An overview of the current market landscape, featuring a comprehensive list of over 500 active CMOs, and detailed analysis of manufacturing service providers based on a number of parameters, such as geographical location of CMOs, type of business segments (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs)), type of FDFs manufactured (solids, liquids / semi-solids and injectables), scale of operation (pilot, clinical, and commercial), type of service(s) offered, specific location of manufacturing facilities (country-wise) and types of primary packaging forms being manufactured (tablet / capsule / blister packing, ointment / gel / tube, vial, ampoule, sachet / pouch / bag, glass / plastic bottle and pre-filled syringe). In addition, the report features a year-wise analysis of the number of CMOs that have been established over the past five decades, based on the year in which they were founded.• An analysis of the most active regions, based on the presence of contract manufacturers; the report contains schematic world map representations indicating the geographical location of key hubs with respect to contract manufacturing activity across the globe.• A detailed discussion of various guidelines laid down by major regulatory bodies in different countries. The report also includes a comprehensive assessment of over 500 CMOs, including details of operational approvals and certifications received by each firm. In addition, the report highlights the relative popularity of the key regulatory bodies across the globe based on the number of companies which comply to the guidelines laid down by each of these authorities. The report also features an insightful multi-dimensional bubble analysis, featuring a comparison of the current regulatory scenario in key geographies across the globe.• Elaborate profiles of key players that offer end-to-end services ranging from product design and discovery to final packaging. Each profile provides an overview of the company, its financial performance (if available), information on its service(s) portfolio, manufacturing facilities and capabilities, recent developments (acquisitions / mergers, collaborations and expansions) and a comprehensive future outlook.• A case study comparing the key characteristics of large molecule and small molecule drugs, along with the steps involved in their respective manufacturing processes. In addition, it provides an overview of the current biopharmaceutical contract manufacturing landscape, featuring a list of over 200 CMOs that are currently offering contract manufacturing services for large molecules.• A comprehensive set of analyses on pharmaceutical contract manufacturing service providers featuring three schematic representations, which include [A] a heat map analysis featuring the distribution of integrated contract service providers (companies offering manufacturing services for both small and large molecules), on the basis of location of headquarters, year of establishment and number of employees, [B] a geographical landscape analysis, highlighting those CMOs that have a significantly 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 and the type of business operation.• A detailed capacity analysis, based on global, market wide research on the individual development and manufacturing capacities of various stakeholders in the industry. The analysis takes into consideration the actual capacities of small-sized, mid-sized, large and very large CMOs, and is based on robust data collection done via both secondary and primary research. The study highlights the distribution of global capacity by scale of operation (clinical, commercial, both), regions (North America, Europe, Asia-Pacific, rest of the world) and specific countries within North America (the US, Canada and Mexico), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia-Pacific (China, India, Japan, Australia and rest of Asia) and rest of the world.• A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry's evolution. It also offers a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall pharmaceutical industry.• A review of emerging trends, including the increase in outsourcing activity in emerging markets, shift towards an integrated business model through expansions and consolidation, introduction of innovative technologies / continuous processing systems, use of big data and advanced analytics to improve the manufacturing process and adoption of cybersecurity solutions to protect confidential customer data. It also includes a detailed discussion on the various growth drivers, such as increasing demand for biologics, biosimilars, and highly potent and cytotoxic drugs.One of the key objectives of this report was to evaluate the current opportunity and the future potential of the pharmaceutical contract manufacturing market over the coming decade. Based on various parameters, 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 2018-2028. In addition, we have provided the likely distribution of the market based on [A] type of business segment (API and FDF), [B] regional evolution of the market covering North America (the US, Canada and Mexico), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia-Pacific (China, India, Japan, Australia and rest of Asia) and rest of the world, [C] type of API product (branded and generic) within the aforementioned regions, [D] type of FDFs manufactured (solids, liquids / semi-solids and injectables), [E] type of packaging forms (tablet / capsule / blister packing, ointment / gel / tube, vial, ampoule, sachet / pouch / bag, glass / plastic bottle and pre-filled syringe), [F] scale of API manufacturing (clinical, commercial, and both) and [G] size of manufacturers (small sized, mid-sized, large and very large companies). To account for the uncertainties associated with the growth of pharmaceutical contract manufacturing market 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 research, analysis and insights presented in this report is backed by a deep understanding of insights gathered both from secondary and primary sources. This enabled us to solicit inputs on upcoming opportunities and challenges that were considered to develop estimates for a more inclusive growth. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following stakeholders:• Scott Goldstein (Associate Director, Drug Product Manufacturing, Ajinomoto Althea)• Thomas Früh (Chief Executive Officer, Bachem)• Piyush Desai (Director-Operations, Sovereign Pharma)• Claire Otjes (Assistant Marketing Manager, Batavia Biosciences)• Dietmar Katinger (CEO, Polymun Scientific)• Birgit Schwab (Senior Manager Strategic Marketing, Rentschler Biotechnologie)• Sebastian Schuck (Head of Business Development, Wacker Biotech)• Bhaskar Venepalli (President and Chief Executive Officer, CiVentiChem)• Roberto Margarita (Business Development Director, CordenPharma)• Allison Vavala (Senior Manager, Business Development, Helsinn)• Kevin Daley (Market Director Pharmaceuticals, Novasep)

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.

1.1. RESEARCH METHODOLOGYThe 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' viewsWhile the focus has been on forecasting the market till 2030, the report also provides our independent view on various 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.1.1. CHAPTER OUTLINESChapter 2 provides an executive summary of the key insights captured in our research. The summary offers a high-level view on the likely evolution of pharmaceutical contract manufacturing market, in the short-mid and long term.Chapter 3 is a general introduction to various type of manufacturers in the pharmaceutical market. It features a brief overview of the concept of contract manufacturing and a general discussion on the evolution of the contract services in the pharmaceutical industry. It also includes a detailed discussion on the need for outsourcing in this domain. Further, we have provided a brief overview of contract manufacturing models that have been adopted in the pharmaceutical industry, till date. We have also presented an exhaustive list of services offered by CMOs; the chapter concludes with a discussion on the challenges associated with the market.Chapter 4 provides a comprehensive view on the global landscape of pharmaceutical CMOs. It includes information related to over 500 CMOs that are currently active in the pharmaceutical industry. It features an in-depth market review, including regional distribution, analysis by company size and year of establishment, type of business segments, type of FDFs manufactured, scale of operation, type of service(s) offered, location of manufacturing facilities and different types of primary packaging forms being manufactured.Chapter 5 features a detailed discussion on the guidelines laid down by major regulatory bodies across different countries. The report also includes an assessment of over 500 CMOs related to the operational approvals and certifications received from various regulatory bodies, along with a schematic world map representation, highlighting the relative popularity (in terms of the number of companies that are operating in compliance to the guidelines laid down by each regulatory authority) of the key regulatory bodies across the globe. In addition, the chapter features an insightful multi-dimensional bubble analysis, presenting a comparison of the current regulatory scenario in key geographies across the globe.Chapter 6 features detailed profiles of some of the key players that are active in the pharmaceutical contract manufacturing market and are acting as one-stop-shops. Each profile presents a brief overview of the company, its financial information (if available), details related to its service(s) portfolio, manufacturing facilities and capabilities, recent developments (acquisitions / mergers, collaborations and expansions) and a comprehensive future outlook.Chapter 7 is a case study comparing the key characteristics of large and small molecule drugs, along with information on the steps involved in their respective manufacturing processes. In addition, it provides an overview of the current biopharmaceutical contract manufacturing landscape, featuring a list of over 200 CMOs that are offering contract manufacturing services for large molecules / biologics.Chapter 8 presents a collection of key insights derived from the study. It includes a heat map analysis, highlighting the number of integrated players based on the location of their headquarters, year of establishment and number of employees. The chapter also features a geographical landscape analysis, wherein pharmaceutical CMOs having a relatively wide geographical reach, are highlighted. For this analysis, we have also highlighted the geographical locations of the aforementioned companies on a world map. In addition, the chapter includes a schematic grid analysis, featuring the distribution of pharmaceutical CMOs based on location of their headquarters, number of employees and the type of business operations (API / FDF / both).Chapter 9 features a comprehensive analysis of the global / regional capacity of contract manufacturers that are engaged in the manufacturing of pharmaceutical products. The analysis is based on meticulous data collection of reported capacities, via both secondary and primary research, of various small-sized, mid-sized, large and very large CMOs, distributed across their respective facilities. The results of this analysis were used to establish an accurate opinion on outsourcing capabilities of the CMOs across different geographies / regions and scales of operation (clinical, commercial and both). 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 10 provides a comprehensive market forecast analysis, highlighting the future potential of pharmaceutical contract manufacturing till the year 2028. It features the likely distribution of the market based on [A] type of business segment (API and FDF), [B] region (North America, Europe, Asia-Pacific and rest of the world) and further distribution by major countries within the aforementioned regions, [C] type of API product (branded and generic) within the aforementioned regions, [D] type of FDFs manufactured (solids, liquids / semi-solids and injectables), [E] type of packaging forms (tablet / capsule / blister packing, ointment / gel / tube, vial, ampoule, sachet / pouch / bag, glass / plastic bottle and pre-filled syringe), [F] scale of API manufacturing (clinical, commercial, and both) and [G] size of manufacturers (small sized, mid-sized, large and very large-companies).Chapter 11 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of the pharmaceutical contract manufacturing market, under a comprehensive SWOT framework. The chapter also highlights a schematic Harvey ball analysis to highlight the relative impact of each SWOT parameter on the overall pharmaceutical industry.Chapter 12 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. It also provides a brief overview of some of the upcoming future trends, which, we believe, are likely to influence the growth of pharmaceutical CMOs in the foreseen future.Chapter 13 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with Scott Goldstein (Associate Director, Drug Product Manufacturing, Ajinomoto Althea), Thomas Früh (Chief Executive Officer, Bachem), Piyush Desai (Director-Operations, Sovereign Pharma), Claire Otjes (Assistant Marketing Manager, Batavia Biosciences), Dietmar Katinger (CEO, Polymun Scientific), Birgit Schwab (Senior Manager Strategic Marketing, Rentschler Biotechnologie), Sebastian Schuck (Head of Business Development, Wacker Biotech), Bhaskar Venepalli (President and Chief Executive Officer, CiVentiChem), Roberto Margarita (Business Development Director, CordenPharma), Allison Vavala (Senior Manager, Business Development, Helsinn), Kevin Daley (Market Director Pharmaceuticals, Novasep).Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.Chapter 15 is an appendix, which provides the list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS1. Over 500 companies across the world are currently offering pharmaceutical contract manufacturing services. Service providers offer a variety of pharmaceutical services; these range from formulation services, stability studies / stability testing, method development / analytical development / process development, clinical trial material manufacturing, scale-up, registration batch manufacturing, commercial production and packaging and labelling service. It is worth highlighting that several CMOs offer end-to-end services across all scales of operations; examples of such players include (in alphabetical order) Aenova, Alcami® Pharma, AMRI, Catalent®, CMIC Group, CordenPharma, Dalton Pharma Services, Fresenius Kabi, Hovione, Recipharm, Siegfried Group and WuXi AppTec.2. At present, the market is highly fragmented and is a mix of established companies (>200 employees, 52%), mid-sized companies (>50 employees, 26%) and small-sized companies (<50 employees, 21%) offering contract manufacturing services at various scales of operations. 46% of the companies are specifically providing FDF manufacturing services while 23% are specifically providing API manufacturing services. The remaining 31% of the companies offer both API and FDF contract manufacturing services.>3. Regulatory authorities play an active role in making pharmaceutical industry one of the most highly regulated industries across the world. We observed that 79% of the CMOs have received operational approval and certification from the USFDA. This is followed by the companies that have received operational approval from the European Medicines Agency (33%), World Health Organization (30%) and UK Medicines and Healthcare products Regulatory Agency (20%). In addition, several CMOs have sought / received operational approval and certification from the regulatory bodies in other regions such as Australia, Brazil, China, Canada, India and South Africa.4. The current global contract pharmaceutical installed manufacturing capacity is estimated to be over 115 million liters. It is also worth mentioning that, amongst all the CMOs we evaluated, established CMOs contribute a significant proportion (78%) to the overall supply. Having said that, relatively small-sized or mid-sized companies are one of the key driving forces behind the heightened pace of pharmaceutical research and development. In addition, of the total installed capacity, over 75% of the total installed capacity is being used for both clinical and commercial production.5. Amidst increasing competition in the outsourcing domain, CMOs are actively investigating and adopting several innovative tools and strategies in order to advance the development of drugs with higher success rates and improve the overall productivity. Examples of such strategies (in no specific order) include usage of big data analytics, green chemistry (such as solvent reduction and replacement, refining a chemical route and biocatalysis to optimize API synthesis), continuous process manufacturing system, digital medicines, 3D printed pill technologies, robotics and automation instruments for packaging, adoption of improved waste management and environment friendly strategies along with the integration of cybersecurity solutions.6. Driven by increasing global demand and rapid approval of small molecule drugs by the USFDA, we expect the overall contract manufacturing market in the pharmaceutical domain to grow at an annualized rate of 4.8% between 2018 and 2028. The growth is likely to be higher in emerging markets of Asia-Pacific and rest of the world.7. In terms of type of API product (branded and generic), generic APIs hold the current major share of the market (84%) while the remaining share (16%) of the total outsourced API market is occupied by branded APIs. Within the contract FDF market, solid dose compounds (~50%) currently dominate the market followed by injectables (33%) and semi-solid / liquid compounds (17%). The future growth is likely to be driven by injectables dose manufacturing primarily due to increased focus on complex disease areas and the growing trend of self-administration.8. In terms of type of FDF, the most popular type is primary packaging of tablets / capsules / blisters, which currently hold 26% of the total FDF contract manufacturing market. This is further followed by glass / plastic / dropper bottles (21%) and vials / cartridge (15%). Other packaging forms such as ampoules, ointments / gels / tubes and sachets / pouches / infusion bags also hold a considerable share of the current FDF contract manufacturing market.9. North America currently holds the largest share (34.3%) in the overall contract manufacturing market and is anticipated to continue to grow at an annualized growth rate of 2.9%. This is followed by Asia-Pacific and Europe that account for 34.1% and 30.3% share of the overall contract manufacturing market, respectively. However, markets in Asia-Pacific are expected to grow at a significantly higher CAGR of 7.1%, owing to inherent advantages such as relatively low labor costs and less stringent regulatory constraints.

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