Weekly Pharmaceutical Manufacturing News Roundup— October 17, 2014

In the news this week, CPhl released part 2 and 3 of its 2014 annual report discussing the need for new technologies and Quality by Design, while also addressing the challenges facing API manufacturers. The biosimilar market is set to see increases a steep increase in value by 2018, and a new survey highlights the Life Sciences industry’s concerns about and goals for the pharma supply chain.

Ultra-Rapid Type 1 Diabetes Treatments To Dominate Market

GlobalData reports that ultra-rapid formulations of insulin analogs are poised to alter the face of the insulin market by 2019. Rapid- and ultra-rapid insulin analogs are steadily emerging as a prime form of treatment for type 1 diabetes and are threatening the use of long-acting insulin analogs. This shift is a result of more reliance on insulin pumps and the development of closed-loop systems and the artificial pancreas.

CPhl Releases Part 2 And 3 Of 2014 Annual Report

In part 2 of its annual report, a panel of CPhl experts argues in favor of the need for a Pharmaceutical Technology Commons in order to promote knowledge/technology sharing and collaboration with outside parties and to enable companies to embrace Quality by Design. 3D printing as well as continuous processing are expected to become more widespread, which could lead to the ability to distribute personalized dosage forms. Overall, experts argue that QbD should be implemented rather than relying on the quality by inspection approach.

In part 3, one expert identifies “commitment diversion” as a problem plaguing the industry and hampering innovation—a problem formed by various parties’ interest in abandoning the development process or only choosing to develop products that are proven. Rising prices have also been pinpointed as a problem for API manufacturers, resulting in a split that will send flexible delivery across multipurpose plants to Europe and single use to Asian Facilities. The changing industry will lead more pharma and big CDMOs into partnerships, granting certain CDMOs more clout in the market. 

Global Biosimilars Market To Reach $6B By 2018

According to RNCOS, the global biosimilars market will be worth $5.6 billion by 2018 (up from $1 billion in 2013), especially as 40 percent of biologics will be off-patent in 2015. Increased clarity in the regulatory frameworks in the U.S., India, China, and South Korea, as well as the demand for affordable healthcare are all expected to play a role in this surge in the biosimilar market.

DNA Vaccines Forecasted To Transform Healthcare Landscape

An article on Bio IT World argues that DNA and RNA vaccines are poised to change the landscape of the vaccination market because of their cost-effectiveness and their scalability. Recently, DNA and RNA vaccines have shown some promise as cancer immunotherapies. The emergence of electroporation and needle-free jet injectors, as well as the advances in plasmid backbone and antigen design, have all contributed to the efficacy of DNA vaccines. There are still several barriers that need to be overcome—including misconceptions about poor human immunogenicity and safety concerns amongst European and Asian regulators.

Current Manufacturing Outsourcing Challenges

An article in Chemistry Today highlights some of the industry’s new and changing outsourcing needs as generics and niche players become more prominent in the industry. Several of the factors playing a role in these changing needs include: more regulations and control over API manufacturing; the complexity of drug molecules which now requires specialist scientists and technology; the demand for tighter deadlines and flexibility; and increased interest in sustainability.

Pharma Focused On Visible, Flexible Supply Chains, Survey Shows

A new survey conducted by DHL has identified several of the primary concerns of the Life Sciences and Healthcare industry. According to the results of the survey, members in the industry have grown increasingly concerned with supply chain visibility and increased flexibility. Logistics process management and outsourcing are also key areas of concern and focus. Indeed, 58 percent of those surveyed consider differentiated supply chains by product categories to be a current trend. Thirty-one percent surveyed expressed an interest in expanding logistics capabilities to tier 2 and tier 3 cities and rural areas. Other areas of importance highlighted included temperature/cold chain, cost-efficiency, growth in and exposure to emerging markets, and regulatory compliance.