The global biopharmaceuticals market was valued at $162 billion in 2014 and pre¬dicted by Persistence Market Research to grow at a compound annual growth rate of 9.4% from 2014 to 2020 to reach $278 billion.1 According the Nice Insight, this healthy growth rate is attributed to the increasing prevalence of chronic diseases, for which biologic drugs are more effective than traditional small-molecule treatments, the aging of the global population, and increased invest¬ment in R&D technological advances, particularly in the area of targeted and personalized therapies.
Yet, there is increasing pressure on the industry to reduce the price of these drugs. One possibility is in the development of biosimilar products. President Trump has promised to repeal and replace the Affordable Care Act (ACA), but what impact might this have on biosimilar development? As part of the ACA, the Biologics Price Competition and Innovation (BPCI) Act created an abbreviated licensure pathway for biosimilar products. In contrast, Zarxio has been available in Europe since 2006. There are more than 700 biosimilars approved or in the pipeline globally. Analysts expect the worldwide biosimilars market to reach $25 billion to $35 billion by 2020.2 Many experts recall Trump’s criticism of high drug prices and expect that he will try to control pricing by holding onto the BPCI portion of the Act. Ultimately, biosimilars will continue to grow over the course of the next four years.2
Also growing is industry’s investment in continuous processing technologies. Despite the advent of regulations and technical capabilities, market leaders at Interphex 2016 expressed their confidence to Process Development Forum that continuous processing, ripe with innovation, will result in better quality products, fewer scale-up risks, and long-term economic advantages.
Last year also marked a significant step towards integrating continuous manufacturing into pharmaceutical production for a small-molecule drug when FDA approved, for the first time, a manufacturer’s change in their production method from “batch” to continuous manufacturing. This new approval was for manufacturing Janssen Products, LP’s, medication for the treatment of HIV-1 infection, Prezista (darunavir). The company’s efforts in manufacturing advancement were facilitated by the use of FDA’s recently-released draft guidance to industry titled, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base, a product of the agency’s Emerging Technology Team (ETT) designed to help manufacturers implement a variety of technological advancements.3 This draft guidance document also applies to biologic-based drug development and manufacturing.
In addition to continuous processing, other flexible solutions remain prevalent in biopharma manufacturing. This includes single-use technology, which has been shown to reduce capital and operating costs by 40%-50%,1 and modular and flexible manufacturing systems, which are seen by many as a way for biopharma manu¬facturers to standardize manufacturing across multiple sites, achieve in-country manufacturing more rapidly, and ensure efficient operation of multi-product facili¬ties at lower costs.1 Process Development Forum reported on a pre-fabricated KUBio plant manufactured by Cytiva for JHL Biotech was assembled from 62 containers in Wuhan, China, in 11 days. According to Cytiva, the cost of a KUBio plant can be as much as 45% lower than a comparable, traditional facility
This year, Process Development Forum will continue to report on drug approvals, innovations, and industry trends that interest our readers. In the meantime, if you didn’t catch these stories the first time around, be sure to check out some of the some of the top Process Development Forum articles of 2016:
mAbs to Watch in 2016
FDA Releases Draft Guidance on Emerging Manufacturing Technology
Continuous Processing for the Production of Biopharmaceuticals
Antibody Production in Microbial Hosts
Single-use Technologies in Downstream Process Intensification
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
A Second Modular Biopharma Facility Opens: KUBio in Hangzhou
Lessons Learned Accelerate Vaccine Development
Overcoming Buffer Challenges With In-Line Conditioning
A Platform Approach to Purification of Antibody Fragments
1. Walker, Nigel, Innovation at the Heart of Biopharmaceutical Industry Growth: Nice Insight Highlights Key Trends Driving Growth in the Biopharmaceutical Market, Nice Insight, 2016.
2. 2016 Global Life Sciences Outlook, Moving Forward With Cautious Optimism, Deloitte, https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-2016-life-sciences-outlook.pdf.
3. Yu, Lawrence, PhD, Continuous Manufacturing Has a Strong Impact on Drug Quality, FDA Voice, April 12, 2016.