From tracking pharmaceutical industry growth to evaluating sourcing and supply strategies for small molecules, biologics, and drug products, the DCAT Week '17 education programs addressed a range of issues of paramount importance to the pharmaceutical manufacturing value chain.
Leading industry experts provided insight on what is in store for global pharma industry growth, pharmaceutical outsourcing, the performance of the emerging pharma sector, best practices in sources and procurement, the near- and long-term outlook for biomanufacturing, and next-generation formulation and drug-delivery technologies.
Global Pharma Strategy
Pharma industry outlook
Central to the business strategy of pharmaceutical companies and their suppliers is the performance of the global pharmaceutical industry. Graham Lewis, Vice President, Global Pharma Strategy, QuintilesIMS, provided a global market overview at the education program, Pharma Industry Outlook: Market Overview and Executive Insights, at DCAT Week ’17. Overall, the global pharmaceutical market is expected to grow at a compound annual growth rate (CAGR) of 4% to 7%, at ex-manufacturers’ levels, through the forecast period (2016 to 2020), when the market is projected to reach $1.4 trillion, according to data from QuintilesIMS. Growth in developed markets will be in the 4% to 7% range with growth in the US expected to be between 6% and 9%. Growth in pharmerging markets, a term used by QuinitlesIMS to define the most promising emerging markets based on macroeconomic metrics and pharmaceutical market forecasts, is expected to be 6% to 9% in the forecast period (2016 to 2020) overall, with India projected for the most positive growth among the larger emerging markets at 10% to 13%. Growth in China, the largest pharmerging market has moderated with projected growth at 6% to 9% in the forecast period. Slowing macroeconomic growth and currency devaluations have impacted growth in pharmerging markets. Since 2012-15, 77% ($46 billion) of pharmerging growth was wiped out due to currency devaluation, according to data from QuintilesIMS.
On a therapeutic-sector basis, five areas (oncology, diabetes, autoimmune, anticoagulants, and HIV) account for more than 60% of global pharmaceutical growth, according to QuintileIMS. Christina Vasilou, Senior Immunology & Inflammation Analyst, Datamonitor Healthcare, who also presented at the Pharma Industry Outlook program, provided an overview of the autoimmune market, looking at the market for two leading indications: rheumatoid arthritis (RA) and psoriasis by examining the performance of leading innovator drugs, both commercial products and pipeline contenders, and increasing competition in the biosimilars market. The RA market across the US, Japan, and the five leading European Union (EU) countries (France, Germany, Italy, Spain, and the UK) is forecast to peak in 2020 with sales of $19.2 billion, before declining to $18.3 billion in 2025, according to data from Datamonitor Healthcare.
To gain a further perspective on the macro issues impacting drug development and commercialization, John LaMattina, PhD, Former Senior Vice President, Pfizer Inc., and Former President, Pfizer Global Research and Development, participated in on Executive Forum, moderated by Kenneth I. Kaitin, PhD, Professor of Medicine and Director of the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. In a thought-provoking dialogue, the two industry experts discussed the impact on drug pricing , the move to value-based healthcare systems, and the related impact on drug development and commercialization strategies.
The outlook for pharmaceutical outsourcing is important for pharma companies using the services of contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) as well as for the CMDOs and CMOs themselves. Jim Miller, President of PharmaSource, a GlobalData company, provided an overview of the market for pharmaceutical outsourcing in the program: Pharma Outsourcing: The Numbers, Trends and Partnership Strategies . Some key overall issues noted by Miller: the CMO industry is growing, but some segments and CMOs are healthier than others; mergers and acquisitions will remain a growth strategy but performance is still the most significant consolidating factor; strategic vision, operating excellence, and senior executive leadership are keys to continued success; and the entire bio/pharma industry is facing an uncertain period and that can create opportunities for CMOs.
To examine those opportunities in more depth, the program focused on geographic-market-based and technology-based partnerships and innovation in these partnership models. Bin Wang, PhD, Director, Strategic Marketing, Boehringer Ingelheim Biopharmaceuticals GmbH, provided a perspective on the so-called “In China, For China” business model in which pharmaceutical companies are leveraging domestic production, including external manufacturing, to position themselves in this geographic end market. Dr. Wang discussed the key issues in doing business in China and the potential advantages that domestic production plays in the strategies of sponsor companies for external development and manufacturing.
To gain a perspective on technology-based outsourcing, three industry experts examined the use of continuous manufacturing for solid-dosage products. In a co-presentation, Jim Bonner, PhD, Senior Principal Engineer, Shire, and Eric Jayjock, Director, Continuous Manufacturing, Patheon, examined the technology benefits and business case for continuous manufacturing, and Douglas B. Hausner, PhD, Associate Director, ERC for Structured Organic Particulate Systems, Rutgers University, provided an overview of the adoption of continuous manufacturing in the pharmaceutical industry and the factors that are facilitating and limiting adoption. And Livius Cotarca, PhD, Chief Scientific Officer, Synchro Morph Solutions SA, provided the decision criteria that his company took in launching as a specialist outsourcing firm for solid-state chemistry services that uses specialized technology, a synchrotron for improved detection in advanced polymorph screening.
Other education programs at DCAT Week
In 2017, DCAT launched a new education program, Emerging Pharma: Market Overview, Innovation in Project Management and CMC Readiness to examine the specialized outsourcing needs of emerging pharma companies, including innovation in project management and the role that CMC (chemistry manufacturing, and controls) readiness plays in investor valuations and partnering decisions.
The program, The Future of Sourcing and Procurement, featured perspectives from Bristol-Myers Squibb relating to talent development and management in sourcing and procurement and how evolving manufacturing and supply chain needs are impacting the capabilities required of the category/sourcing manager of the future. Other topics covered in the program were a co-presentation by Johnson & Johnson’s Janssen Pharmaceuticals and GE Healthcare on supplier-led innovation, and materials management for complex supply chains with a focus on antibody-drug conjugates by Pfizer. The program also featured a panel discussion on value-based metrics, metrics used to evaluate suppliers’ performance in value-creation activities with perspectives from three pharmaceutical companies on value-based metrics that they use: Bristol-Myers Squibb, Janssen Pharmaceuticals, and Pfizer.
The program, Biomanufacturing 2027: Capacity, Investment, and Technology, provided a market overview of the market for biologic drug substances and insight on the current and future direction of biomanufacturing from executives from Pfizer, AstraZeneca, and Kite Pharma.
The program, Market Opportunities: Advanced Formulation and Next-Generation Drug Delivery Technologies, featured next-generation formulation and drug-delivery technologies, including strategic perspectives in evaluating advanced drug-delivery technologies from Merck & Co., and Boehringer Ingehelheim and well as the technologies themselves: digital medicines (Proteus Digital Health) and advances in small-molecule drug delivery (Bill & Melinda Gates Foundation). Also, a market overview of the drug-delivery market, including trends in partnership activity, was provided by PharmaCircle, and insight on the 505 (b) (2) pathway was provided by Camargo Pharmaceutical Services and Medichem SA.
More detailed analysis and summaries of the DCAT Week ’17 education programs will be provided in upcoming issues of DCAT Value Chain Insights.