The worldwide bioreactors market is projected over USD 550 million by 2024, growing at a CAGR above 18% during the forecast period (2016-2024). It is driven by the adoption of single-use bioreactors (SUBs) & hybrid bioreactors and demand for biologics. Rising popularity of SUBs in pharmaceutical manufacturing companies is yet another key market propeller.
Current industry trends include the production of SUBs with high titer quality & improved cell cultivation. SUBs for microbial fermentation and high-end sensors face huge demand. Systems capable of perfusion or run processes for adherent and suspended cells are also required within industry premises.
Low operational costs of SUBs can drive market demand in the coming eight years. Additionally, the simplicity of ‘marine-microbial’ culturing and low energy consumption by SUBs will favor these systems. But low ‘SUB’ volume capacities can hinder market flow. Also, few companies refusing to switch from stainless steel bioreactor systems to SUBs could deter industry growth.
The global bioreactors market is divided according to products, cells, molecules, technologies, end-users, and regions. Products comprise monoclonal antibodies and recombinant proteins. Monoclonal antibodies are likely to dominate owing to their therapeutic efficiency. Yeasts, bacteria, and mammalian are the different cells.
Mammalian would to be the fastest growing segment. This should be attributed to their biomolecule-effectiveness. Mammalian cells are also used to grow mesenchymal stem cells, a vital component for treating infected tissues. Mesenchymal stem cells can be grown in cell culture plates & flasks.
Stirred tank bioreactors are ideal for supervising their growth. The only factors hindering this segment are sluggish segment expansion, low productivity of non-optimized cell lines, and sensitivity to shear stress. But the invention of microcarriers has allowed adherent cells to grow on surfaces.
Recombinant proteins, stem cells, monoclonal antibodies (MAbs), gene therapy, and vaccines are grouped under molecules. MAbs are used by the biologics industry to create vaccines. This can increase the demand for bioreactors. Low investment costs of SUBs in the manufacture of MAbs on a small scale will contribute to global demand for bioreactors.
Single use bubble column bioreactors, stirred SUBs, and wave-induced motion SUBs are the market technologies. Wave-induced motion is expected to exhibit the highest growth till 2024. This growth would be credited to its short lead time and high flexibility.
Disposable bioreactors or SUBs contain disposable bags instead of cultural vessels. They witness high demand from the medical sector. These systems are used by pharmaceutical companies to manufacture drugs without compromising on their quality within the same facility. They vary on the basis of flexibility and cultural medium. Commercial bioreactors include HyClone SUB (by Thermo Fisher Scientific) and CellMarket Regular (by Cellexus).
End-users of the bioreactors market encompass biopharmaceutical manufacturers and R&D departments. R&D departments are further sub-divided into biopharmaceutical companies, contract research organizations (CROs), and research institutes. Orphan drugs and customized medicines which require smaller production batches have created huge demand from biopharmaceutical manufacturers.
Nearly 80% of the production requirements of these companies are met by systems with 5, 000 liters of capacity or less. The same would usher in massive demand for the worldwide industry in the long run. But the lack of standardization may deter market progress in the near future.
Industry regions comprise Asia Pacific, North America, Europe, and RoW (Rest of the World). North America and Europe are estimated to occupy major shares over the forecast period. This should be ascribed to their multiple biopharmaceutical companies.
Europe can capture large shares owing to biologic drug patents reaching expiry. Plus, regional support for biologic manufacturers to make highly-effective drugs will benefit Europe. For instance, the European Union (EU) has partnered with Eppendorf to produce cardiac microtissues on a large scale.
Asia Pacific will exhibit considerable growth due to major biologic manufacturers that have several investment opportunities. Key firms opening their production units across Latin America are predicted to benefit this region.
Major players operating in the global bioreactors market are GE Healthcare, Thermo Fisher Scientific Inc., Merck KGaA, and Sartorius Stedim Biotech S.A. Other companies include Pall Biopharmaceuticals, Eppendorf, and Applikon Biotechnology B.V. They are expected to expand their product portfolio and provide system flexibility. These steps will make end-users familiar with various combinations of ‘bioprocessing components’ and help them take right buying decisions.
Product promotions via commercial production to derive superior application solutions could bode well for the market. For e.g., micro-bioreactors are needed to develop new drugs within a short time. These systems from ‘Applikon Biotechnology’ can overcome the challenges faced by ‘large-scale’ bioreactors. They make smaller drug doses through the precise measurement of pH & temperature. These bioreactors successfully cultivate Pichia pastoris, a species of yeast widely adopted for protein production.
‘Sartorius Stedim’ recently introduced the ambr 250 modular (in 2016), a mini bioreactor system for cultivating cells. It can work with 2-8 bioreactors at a time to generate drug volumes between 100 to 250 ml. The modular is based on stirred tank bioreactor systems of the same company.
Portability associated with this design enables bioreactor systems to be setup anywhere. The novel system has been adopted by FUJIFILM Diosynth Biotechnologies to boost the production of protein-based therapeutics. Scientists at FUJIFILM have successfully used the system to experiment with microbial fermentation.
Pall Biopharmaceuticals bought the rights for ‘Acoustic Wave Separation’ (AWS) from FloDesignSonics in 2015. AWS allows cells to assemble & form clusters and disperse the remaining liquid in air. This should permit continuous cell-cultivation, bypassing the bottleneck of 90 days usually associated with perfusion systems.
Pall also introduced a 2, 000 liter bioreactor; the Allegro STR Single-Use Bioreactor, with 3 stirred tank bioreactors. It has the ability to generate400 – 2, 000 liters of volumes, enabling it to produce cells on a large scale.
Expansions are another key strategy adopted by market players to occupy greater shares and extend their geographical reach. In 2016, Novartis International AG decided to open a manufacturing facility in France to cater to the demands of Novartis biologic drugs. This would allow the company to make medicines for asthma, psoriasis, and kidney transplants, boosting its MAbs production by nearly 70%.
Research Support Specialist, USA