The pharmaceutical contract manufacturing industry
Here is an overview on the pharmaceutical contract manufacturing industry:
Types of pharmaceutical services: There is a wide range of pharmaceutical contract manufacturers that are offering an array of services throughout the world to its customers. The services offered include formulation, stability testing and research, research method and analytical processes development, clinical trials, scaling up, commercial production, packaging and labelling.
Manufacturing market mix: Currently, the pharmaceutical contract manufacturing industry is segmented into large, medium and small-sized companies. The pharmaceutical manufacturing companies in Europe, the USA and other parts of the world are offering their services at several different scales of operations. Around 50% of these companies are providing FDF manufacturing services whereas around 25% are specific to API manufacturing. The rest of the 25% of companies are engaged in both API and FDF services.
Regulatory competencies: The regulatory bodies play their vital role in developing pharmaceutical contract manufacturing into the most regulated industries throughout the world. As per statistics from Research and Markets around 80% of these industries follow the operational and certification regime from FDA. Around 33% of companies get their operational approvals from EMA (European Medicines Agency), 30% from WHO (World Health Organisation) and 20% get their approvals from the UK Medicines and Healthcare Regulatory Agency.
Global manufacturing capacity: At this time the pharmaceutical contract manufacturing industry has the installed capacity worldwide of approximately more than 115 million litres, out of which 75% is being utilized for commercial as well as clinical productions.
Productivity trends: The strong competition in the pharmaceutical manufacturing outsourcing industry has forced the CMOs to adopt such innovative and strategic tools that may help them in advancing drug manufacturing with enhanced productivity and success rates. These tools include data analytics, continuous process manufacturing systems, green chemistry for optimizing API synthesis, digital medicines, 3D-printing technologies for pills, automation and robotics. Automation of pharmaceutical manufacturing machines for packaging and waste management. These companies have also adopted environmentally friendly strategies integrating all processes with cybersecurity solutions to make the whole manufacturing process foolproof.
API manufacturing market: Regarding the API (Active Pharmaceutical Ingredients) product category such as branded and generic, the generic APIs currently has a market share of around 84%, the rest as of 16% of the outsourced API market is utilized by different brands.
FDF manufacturing market: Within the FDF (Finished Dosage Form) contract manufacturing market the solid dose compounds dominates the sector with a share of around 50%, followed by injectables with a share of 33% and semi-solid and or liquid compounds by 17%. Furthermore, in terms of FDF packaging type: The primary packaging of blisters, tablets and capsules holds the major share of almost 26% of the total FDF market. It is followed by bottling sector (droppers, plastic and glass) with 21% share whereas vials and cartridges hold 15% share. There is however another segment of packaging forms including ampoules, gels, tubes, ointments, pouches, sachets and infusion bags. This segment also holds a reasonable size of FDF contract manufacturing market.
Regional market share: North America is the largest shareholder of the overall contract manufacturing market with an estimation of around 3% annual growth. North America is followed by Asia-Pacific and Europe with a market share of around 34% and 30% respectively.
Find the Top pharmaceutical manufacturers
The top pharmaceutical contract manufacturers need to fulfil certain criteria to deliver the best of needs of patients and consumers following good manufacturing practices, maintaining the manufacturing capabilities and operational excellence. The pharmaceutical contract manufacturers need to keep themselves abreast of the information to win the development and manufacturing of new pharmaceutical drugs from around the world. The drug manufacturing sector is compounded with several highly sophisticated factors such as highly engineered drug delivery devices along with primary and secondary packaging to increase the value and effectiveness of the therapy. This factor is as important as the API itself. The packaging, on the other hand, has its importance for providing the security and safety of the pharmaceutical products. This makes the sector more complex and critical.
The pharmaceutical contract manufacturers also need to keep themselves up to date of the strategies of providing their customers with effective drugs in the most cost-effective way. Other factors that pharmaceutical contract manufacturers should consider are regulatory approvals, experience and technical expertise, quality and consistency of the supply and cost-effectiveness. The pharmaceutical contract manufacturers with proven production facilities and a well-trained workforce can bring you the distinguishing factor of competitive advantage.
However, to find the best manufacturer for your needs you should consider the following:
- The capacity of your potential CMO is a critical point to be considered. You need to know whether your CMO has the capability and experience required for manufacturing your product. You may not like it as a trial run for your CMO and hence you need to know whether it has the right equipment.
- You need to know whether your CMO has a sustainable track record with the Federal Drug Regulatory Authority (FDA). Whether they are willing to share their recent inspection report with you along with the record of any recall at their part. It is imperative to know whether your potential CMO understands the importance of compliance of regulations and maintaining quality throughout the process.
- The responsiveness of your potential CMO is an indication of the interest of the other party to engage you in the business. Remember, responsiveness goes down as they get orders. Beware of the fact that business development department is performing its duties. It is you which has to read between the lines.
- After the responsiveness, communication is the second most important factor. You would like to know whether CMO has an open communication channel available to answer your queries.
- You need to know whether your demand corresponds to the manufacturing scale of contract manufacturing. Find out who else has partnered with your CMO and whether your potential partner would not ignore you in the presence of a big fish. Select your CMO according to your capability and capacity. If you are a new entrant you need to be more careful.
- Before going into documentation you must check for the certifications that your potential CMO has including GMPs. Don’t fall prey to the misconception that compliance is the responsibility of your CMO. Make sure that you have the right workforce to audit the compliance and quality regime of your potential contract manufacturer. Frequent visits are another method of verifying that the right processes and equipment is being used by the manufacturer. Annual contract reviewing is advisable. Lack of quality may lead you to look for another partner.
- No healthy relationship can foster without honesty and transparency. In the wake of any inevitable conflict, both parties must be honest and transparent to each other. It would help you to resolve the conflict and come to a conclusion beneficial for both of you.
- Start your search from your vicinity. Local is the best location. Just send your quality control team to visit the facility and you save a lot on costs and headache.
We have a ready to consult a list of top pharmaceutical contract manufacturers for you in our manufacturer list.