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Pharmaceutical API Contract Manufacturing: Reading Room

I’ve been trying to get caught up on some reading this month, and thought I’d put together a roundup of interesting articles I’ve run across recently.

Grading GDUFA, at Contract Pharma:

GDUFA, the FDA’s Generic Drug User Fee Amendments released in 2012, have come under a lot of fire over the last few years. This assessment at points out some of the positives and negatives:

“If we did a report card on the Generic Drug User Fee Amendments (GDUFA) of 2012, at best, it might get a C. In the three years since Congress voted for GDUFA, naysayers and supporters can both claim to have been right—on some aspects of the law. For example, GDUFA was intended to speed approvals to provide access to safe and effective generic drugs to the public, and we’re starting to see speedier approvals. GDUFA was also supposed to reduce costs to the industry, but we’ve seen just the opposite happen. And while the law has increased inspections, both of domestic and international manufacturers, to ensure foreign facilities meet U.S. standards, and to maintain public trust—the number of enforcement recommendations has not increased.”

Four Pillars to Guide Your CRO Search, also at Contract Pharma:

As an API contract manufacturer, contract research services fall outside of Neuland’s purview. Nonetheless, this paragraph caught my eye:

“Companies look to a CRO for their specialization. But the meaning of that goes far beyond types of studies or molecules. Many large CROs have evolved to deal with high volumes of repetitive, clearly prescribed work from large pharmaceutical companies. That’s great if you have a defined project. If you’re a smaller company however, that service may have specialized away from your core needs.”

I smiled when I read this, since it’s a question that has come up recently in discussions I’ve had with others in the industry: “How are you guys handling the considerable merger activity that’s happening in the contract pharma manufacturing space?”

The paragraph’s lede really sums up our approach: Bigger isn’t Always Better. We have highly-specific advanced chemistry competencies that even firms that are orders of magnitude larger lack. It really is as simple as that.

Outlook Bright for Branded and Generic Active Ingredients, at PharmTech:

“Global demand for APIs is expected to increase at a compound annual growth rate (CAGR) of 6.5% from nearly $120 billion in 2013 to just under $186 billion in 2020, according to Transparency Market Research (1). APIs for drugs that treat cancer and central nervous system diseases will grow at the fastest rate, while those intended for the formulation of therapeutics for cardiovascular disease will account for the largest percentage of revenues.”

This dovetails with a great deal of what I’ve heard from others, and (by good fortune or amazing planning skills) also aligns with many of our API focal areas – Alzheimer’s, hypertension and Parkinson’s among them.

The same article, by the way, also featured one of the slickest advances I’ve read about this year – the FDA’s approval of Aprecia’s Spritam, the world’s first 3D-printed drug with a rapid dissolution profile. Neat stuff.

2016 Pharma Predictions, at PharmaManufacturing:

Prediction articles are all the rage at year-end, and 2015 was no exception. Every single one I read referenced the merger mania I alluded to above, which isn’t confined just to the contract pharma space, but has become a hallmark of the larger life science industry.

The continued growth of CRO/CMO outsourcing in 2016 has been almost universally predicted, as industry continues to lean towards cost-savings and a tightening of core competencies & in-house capabilities.

“Expect more shedding of non-core business units to reduce expenses and drive profitability. Sanofi, for example, hasn’t been secretive about its desire to sell its profitable animal health outfit, and others will follow suit. Branded companies will extend their generic portfolios; generics manufacturers will buy branded products. Like the Allergan/Teva deal, the lines that once defined “who offers what” will be blurred and reshaped.”

Consolidation was also a topic of discussion in an article at PharmTech, the 2016 Outsourcing Outlook (I was one of the people interviewed). In addition to mergers, I  mentioned some of the challenges and opportunities for peptide therapeutics (a topic we wrote about in our last post).

Have you read any interesting articles lately? Feel free to share in the comments, below.


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