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Pharma Outsourcing: The Numbers, Trends, and Partnership Strategies

DCAT Week 2017: PharmSource’s Jim Miller provided an in-depth analysis of the market for contract development and manufacturing for drug substances and drug products, including levels of outsourcing, capacity utilization, trends in capital expenditures impacting outsourcing, and strategies for supplier differentiation.

CMO Industry Update

Contract Pharma/CPhI 2016: The dose contract manufacturing organization (CMO) industry had modest growth in 2015. The strong US dollar hurt revenue translation of global CMOs. And the total number of NDA approvals is up, but outsourced NDAs fell flat.

CDMO Industry Update

AAPS 2015: PharmSource’s Jim Miller presented a CDMO industry update at an AAPS 2015 breakfast co-sponsored by Pharmaceutical Technology magazine. Strong financing is fueling pipeline growth and will continue to drive R&D. How long will it last?

CMO Industry Update

Contract Pharma/CPhI 2015: The outlook for the contract manufacturing industry is generally positive but the industry must buck stiff headwinds. The well-financed pipeline makes the near term outlook favorable, but record investment in captive capacity means the propensity to outsource isn’t likely to increase. Smaller products and payer resistance are also factors.

Contract Manufacturing Update

In his keynote presentation at INTERPHEX 2015, Jim Miller, President of PharmSource, provided a detailed review of the contract services landscape. He stated that 2015 should be a good year for contract dose manufacturers. While revenue growth was slow in 2014, the large number of approvals in 2014 and expectations for an equally-strong 2015 presage a revenue rebound in 2014. Challenges remain, notably the slow growth In Europe and continued high level of investment in new capacity by global and mid-size bio/pharma companies. Consolidation remains a major theme thanks to acquisitions, companies leaving the industry and the success of a few companies that are winning a predominant share of new approvals.

The Outlook for the CMO Industry

Contract Pharma 2014: The outlook for the contract manufacturing industry is being shaped by several significant trends. The well-financed pipeline makes the near term outlook favorable, but much depends on the number of new approvals for small and mid-size companies. Injectables CMOs should get better pricing thanks to tight capacity. Mergers and acquisitions will consolidate the industry and the hunger for acquisitions will benefit CMOs with specialty capabilities. CMOs will pursue new business models, including proprietary products, to fuel profit growth.

The Changing Contract Services Landscape

INTERPHEX 2014: The contract services industry finds itself in a different place than it did one year ago. The favorable financial environment is creating opportunities for CMOs and CDMOs to raise capital to fund investments and acquisitions, and in some cases launch themselves as public companies. At the same time, a growing number of CMOs and CDMOs are diversifying their business models by venturing into proprietary products. The robust financial markets have also been good news for the demand side of the contract services equation. The in-flow of capital has meant that bio/pharma companies have substantial resources for R&D spending, and there are strong signs that companies are refilling the pipeline with more early development candidates.

Recalibrating the Pharmaceutical Services Opportunity

INTERPHEX 2013: Global bio/pharmaceutical companies are replacing their low-percentage strategy of “maximizing shots on goal” with more rigorous criteria for graduating candidates into the development pipeline. While they’ve become more selective, early stage companies have faced more challenges gaining financing. The combined effect of these two trends has been to reduce the number of candidates coming through the pipeline and tilt the game more in favor of larger bio/pharma companies. These new dynamics have serious implications for contract service providers. Only a relative handful will qualify to work with the largest bio/pharma companies, and those that don’t win preferred provider status will be fighting over a smaller market.

Industry Update and A Look Ahead to 2013

Miller Interphex 2011

PharmSource’s Jim Miller presented an industry update at an AAPS 2012 breakfast co-sponsored by Pharmaceutical Technology magazine. Based on several trends measured since H1 2011, he noted that overall contract service industry performance is robust, though less so in early stage revenue growth. Citing higher R&D and service spends, as well as cash fund growth fueled by partnering, a positive path to bio/pharma’s future seems evident.

Are CMOs Winning the War Against In-House Capacity?

Miller Interphex 2011

At Contract Pharma’s 2012 Contracting and Outsourcing Conference, PharmSource’s Jim Miller addressed the direct impacts of manufacturing on the bio/pharma business model. His analysis focused on the key issues CMOs must face to gain a compelling foothold against captive capacity. His presentation provided important insights in understanding the supply chain context; the likely negative consequences of failing to differentiate operating skills; how CMOs can reduce risk and add value; and much more.

What the New Bio/Pharma Business Model Means for CMOs and CROs

Miller Interphex 2011

In his keynote presentation at INTERPHEX 2012, Jim Miller, President of PharmSource, addressed the transformation of today’s bio/pharma business model, and the opportunities and challenges it presents to providers of development and manufacturing services. The presentation was sponsored by Pharmaceutical Technology magazine.

How Real is the Recovery in Contract Services?

Miller Interphex 2011

At INTERPHEX 2011, PharmSource’s President, Jim Miller, made an incisive presentation addressing the issue of how real the recovery in contract services is. In this session, which was co-sponsored by PharmSource and Pharmaceutical Technology magazine, Jim talked about the impact of recent events on the supply chain, diverging paths in India and China, integrated models for early development, and much more.

Contract Services Make a Comeback?

Contract Services Presentation

Jim Miller, President of PharmSource, made a noteworthy presentation at the 2010 annual AAPS breakfast, which was co-hosted by PharmSource and Pharmaceutical Technology on November 15, 2010 in New Orleans, LA, USA.

How Outsourcing Can Accelerate Early CMC Development

At BIO 2010, Jim Miller, president of PharmSource, interviewed Susan Dana Jones, PhD, vice president and senior consultant of BioProcess Technology Consultants, a provider of strategic and regulatory consulting services to the biopharmaceutical industry. The two industry experts discussed pharmaceutical outsourcing practices. The interview was sponsored by BioPharm International magazine.


State of the Pharmaceutical Outsourcing Industry 2010

At INTERPHEX 2010, in a session co-sponsored by PharmSource and Pharmaceutical Technology magazine, PharmSource president Jim Miller gave a much anticipated “State of the Contract Services Industry” presentation, where he reviewed the state of the market for contract services and issues facing service providers.


The Outlook for Contract Services: Is That Light at the End of the Tunnel?

On November 9, 2009, Jim Miller made a presentation entitled “The Outlook for Contract Services:Is That Light at the End of the Tunnel?” at a breakfast meeting sponsored by Pharmaceutical Technology magazine, where he discussed current market conditions and prospects for 2010.