Overview

The present pipeline of pharmaceutical products is increasingly complex and requires specialized facilities, equipment and operational expertise. Small molecule drugs account for nearly 90% of the therapeutics in the pharmaceutical market. In fact, in 2017, FDA’s Center for Drug Evaluation and Research approved 34 small molecule drugs; this represents an annual growth of nearly 56%, signifying the growing importance of contract manufacturing in the overall pharmaceutical industry. 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. 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. Since 2000, close to 150 new CMOs have been established, offering cost-efficient solutions to several stakeholders in the industry.

The current global CMO market is highly fragmented but characterized by multiple acquisitions and mergers as stakeholders strive to broaden their respective service portfolios. This has enabled several CMOs to start offering end-to-end services, ranging from drug development, including preliminary R&D, preclinical and clinical trials, to commercial scale production and regulatory filings.

Despite the fact that the pharmaceutical sector is amongst the most highly regulated industries, we expect the demand for core competencies to continue to drive sponsor companies to outsource various parts of their manufacturing operations. Amidst tough competition, the availability of advanced tools and technologies is an important differentiating factor and will grant a competitive edge to certain CMOs over other stakeholders in the industry. 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.

Scope of Report

The ‘Pharmaceutical Contract Manufacturing Market (2^nd 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 (CEO, Bachem)
• Piyush Desai (Director, Operations, Sovereign Pharma)
• Claire Otjes (Assistant Manager, Marketing, Batavia Biosciences)
• Dietmar Katinger (CEO, Polymun Scientific)
• Birgit Schwab (Senior Manager, Strategic Marketing, Rentschler Biopharma)
• Sebastian Schuck (Head, Business Development, WACKER Biotech)
• Bhaskar Venepalli (President and CEO, CiVentiChem)
• Roberto Margarita (Director, Business Development, CordenPharma)
• Allison Vavala (Senior Manager, Business Development, Helsinn Group)
• Kevin Daley (Director, Pharmaceuticals Marketing, 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.