Pharmaceutical Procedure for Analytical Process Development and Validation

The biopharmaceutical industry is complex and dynamic and each year it continues to grow at the rate of 14% to 15%. This year the industry is demanding new and enhanced technologies to lower costs, boost efficiencies, especially in developing economies. Enabling this upward trend is the gradual introduction of innovations in manufacturing productivity.

Growth in products in the area of cellular/gene therapies will be so rapid that the industry is expecting a falling bioprocessing capacity crunch. One exception to the growth is in the biopharmaceutical sector as very few small CMOs are being founded or coming online recently.

Here are some of the key drivers in the field of biopharmaceutical process development: 

Biopharma industry and supplier growth continue to remain healthy:

The biopharma sector and its suppliers, both services and equipment have grown steadily at close to 12–14% annually in terms of revenue over the past two decades. This year, suppliers reported an average of 13.7% revenue growth, with “equipment and instrumentation” having the highest growth at 16.8%.

Manufacturing productivity remains a key concern:

Manufacturing productivity/efficiency remains the most important trend and output associated with cost-savings continues to be a key concern. Several trends in the bioprocessing industry are driven by perceived needs for cost reductions, improved quality, and efficiencies in manufacturing processes.

Facility constraints are creating bottlenecks leading to calls for continuous downstream processing:

 Downstream purification processes such as chromatography continues to be an area that requires technological improvements. Yet, other recent studies reiterate that downstream yield improvements remain more resistant to change. Facility constraints remain the most quoted factor that is expected to cause capacity limitations at facilities.

China is all set to become an industry leader:

Major growth in the biopharma industry is taking place in China, and it has overtaken India in terms of bioprocessing capacity even as both nations are raising their internal manufacturing abilities. In 2019, China has been the most sought-after destination for outsourcing.

Single-use systems growing steadily:

Nearly 90% of respondents use single use bioprocessing equipment currently. The rates of usage of diverse disposables in biopharma manufacturing have relatively remained steady recently, as the market nears saturation, for smaller, clinical-scale operations.

Hiring in bioprocessing continues to be a problem:

Recruiting talented bioprocessing professionals is an inherent challenge for the industry. The process development staff has been reported as the toughest area to fill, followed by process development staff at 40%.

Continuous bioprocessing innovation:

Continuous bioprocessing is an area that needs improvements urgently. Continuous bioprocessing downstream is one area where suppliers should focus their development efforts.

Biosimilars are introducing various biopharma products and players:

A widespread biosimilar product development is resulting in several new players entering the industry. Established drug companies, virtual companies, startups, generic-drug companies, and foreign companies are working to build portfolios of biosimilars.

Bioprocessing will grow:

Respondents have recorded an 8.2% growth in their bioprocessing budgets in 2018. In 2019, there has been no budget cut reported in the areas surveyed.

The industry is seeking to lower manufacturing costs:

Most respondents have implemented programs to lower bioprocessing costs. The other most-cited cost-reduction activity being actively negotiating with vendors to lower costs.

The trends in the bioprocessing and biotech CMO contract manufacturing industry will speed up discovery and drive down costs and enhance productivity. The current situation in the industry is terrific, with biosimilars, new technologies, gene and cell therapies, and immense opportunities in the emerging markets. With the industry growing at 14% based on sales of biologics over the past two decades, the revenue is expected to grow further.