Overview of the Biopharma Industry
Biotechnology finds application in segments such as pharmaceuticals, downstream chemical processing, bio services, and agriculture among others. The biopharma sector mainly comprises of products such as vaccines, monoclonal antibodies, insulin, generic and branded drugs. The global biopharma market is primarily driven by the regulatory support provided by governments of various countries, technological advances that help combat fatal diseases, depleting natural resources, and increasing demand for food. However, certain factors like long lead times from research to commercialization and the perception of consumers towards biopharma products is restricting the growth of the pharmaceutical companies. Some of the factors include:
- The complexity of biopharma supply chain and operations: As the number of products increases and new process technologies such as continuous manufacturing are introduced, the complexity of biopharma operations and the biopharma supply chain will increase. This challenge is only expected to increase as sites move from the current “one line, one product” setup toward nimble and flexible multiple-product operations and are required to manage both current and future technologies under one roof.
- Demand for affordability and improved access: Governments in emerging markets understand the critical role that biopharma will play in boosting healthcare outcomes – and are aggressively supporting alternative ways to fulfill the demand for these products.
Many such factors are compelling players in the biopharma industry space to leverage the use of supplier profiling solutions.
The Business Challenge and Journey
The client, one of the key pharmaceutical companies specializing in offering biopharma products, wanted to leverage the use of supplier profiling solutions to decrease excess inventory and procurement costs and deliver high-quality products and services while improving their ability to identify economic opportunities. Additionally, the client wanted to identify the most profitable pharmaceutical companies and the risks involved while procuring biopharma products from a pool of suppliers. The principal objective of the client was to seek ways to engage with the best suppliers and compare their offerings with that of the competitors.
SpendEdge’s supplier profiling experts followed a scrupulous research methodology and carried out discussions with prominent stakeholders in the biopharma industry space to help the client address the rising concerns and reduce supply costs. The experts also compiled information across a wide array of proprietary sources such as paid industry databases, company presentations, and industry forums of pharmaceutical companies to help the client profile the potential suppliers.
During the course of the supplier profiling engagement, the biopharma industry client was able to identify the potential bottlenecks in the supply chain. The client also profiled the suppliers based on their efficiency and performance and gained better visibility into the supply chain process. This helped them improve cross-functional collaboration to sustain better partnerships with key pharmaceutical companies.
Key questions answered in this supplier profiling engagement
The supplier profiling solution from SpendEdge helped the industry client identify ways to segregate the suppliers based on the quality of products offered and their categories. The engagement also helped the client to measure the supplier’s performance in terms of the risk management, cost management, and operational improvements.
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The rising cost of drug development process has urged pharmaceutical companies to look out for ways to reduce the overall cost and time. The pharma industry turns towards highly specialized contract research organizations (CROs) who depict expertise in drug discovery assistance, regulatory compliance, lead identification, clinical data management, consultation, clinical trials, and project management. Pharmaceutical analytical testing is one of the research support services rendered by CROs and contract laboratories to pharmaceutical manufacturers. These organizations use various processes to analyze the intermediate drug ingredients and final drugs, so that the quality of the medication can be ensured. Toxicological risk assessments, environmental monitoring, clinical and non-clinical bioanalysis, stability testing, method validation, preclinical research, and biological assay development are some of the services under pharmaceutical analytical testing. The procurement market intelligence report predicts a healthy growth rate of 7.71% for the pharmaceutical testing market.
Capability Enhancement Toward Analytical Testing of Biosimilars
Numerous drugs in the pharma industry are nearing the end of their patent lifetime. This has led pharmaceutical companies to divert their attention to biosimilars from biologics. Such move has motivated pharmaceutical testing companies to enhance their capabilities in the analytical testing of biosimilars. Compatibility studies for biosimilars, stability testing, product release testing, and protein analysis of biosimilars are some of the capabilities suppliers have been focusing. Consequently, enhancement of such capabilities reduces the risks associated with drug development.
Rising Demand from Nutraceuticals Industry
Traditionally, the pharmaceutical testing services were availed mainly by the pharmaceutical companies. However, today that trend looks to be slowly changing as nutraceuticals industry is also emerging as an active consumer of these services. This surge in demand can be attributed to increasing regulations for nutraceutical manufacturing companies demanding them to get their raw materials tested for quality and conduct release testing for their products.
Adoption of FTE-based Contracts
Since a long time, pharmaceutical testing service providers have been charging their clients on a per contract or per sample basis. Such pricing strategy is slowly changing as suppliers are looking to charge their clients on FTE-based contracts irrespective of workload, compound, or analytical technique used. The supplier allocates a dedicated team during the tenure of the project and manages the project resources along with the client. Such contracts ensure that the dedicated team members acquire a strong knowledge of the procedures and requirements of the project leading to fewer errors and higher consistency in the output.
Technological Advancements in Analytical Testing Equipment
The pharma industry is pressurizing pharmaceutical testing companies to reduce the testing time for drug ingredients forcing the suppliers to use advanced equipments and processes. For the same reason, the majority of the suppliers are now using HRAM instruments that allow users to identify the target molecule confidently. Additionally, several suppliers are now actively using morphologically-directed Raman spectroscopy, which is based on a combination of Ramana spectroscopy and automated imaging. Use of advanced equipment eliminates the need to perform multiple trials and subsequently increases the reliability and accuracy of pharmaceutical testing.
Read more about the trends in the pharmaceutical testing market along with sourcing strategies, pricing insights, top pharmaceutical analytical testing service providers, procurement challenges, and pricing models in SpendEdge’s upcoming report on the global pharmaceutical analytical testing services market.
Typically, the cost of developing a drug costs pharmaceutical companies millions of dollars and sometimes even touching the billion dollar market. The development process goes through multiple stages which can last about 10-12 years. In the changing economy, pharmaceutical companies have to look for ways to control such costs and ensure compliance against stringent regulations. As a result, the pharma industry is looking to outsource the drug development process to Contract Research Organization (CRO) companies. CRO companies partner with various drug companies and thereby gather vast experiences in conducting clinical trials and testing out the efficacy of the new drug. CRO service providers offer services including drug discovery assistance, clinical data management, consultation, regulatory compliance, lead identification, clinical trials, and project management. The recent procurement market intelligence report on global pharmaceutical drug development services market estimates the market to grow at a rate of 7.35% during the forecast period.
IQVIA, formerly known as Quintiles IMS Holdings, is one of the leading CRO companies involved in the field of biopharmaceutical development and outsourcing services alongside depicting expertise in healthcare database and analytical services. The company is the world’s largest contract research organization and specializes in phase II-IV trials. The company was formed as a result of the merger between Quintiles Transnational and IMS Health in 2016. It is also the world’s largest CRO company based on market revenue with the company posting revenues of US$6.87 billion in 2016.
LabCorp is an American company and one of the leading CRO companies in the world. Currently, with close to 40 clinical laboratories in the US, it has one of the largest networks of clinical labs in the world. With more than 50,000 employees serving more than 220,000 clients across 60 countries, the company generated revenues of US$9.43 billion in 2016. The company is the pioneer in the field of using polymerase chain technology for genomic technology and also exhibits expertise in oncology trials, HIV genotyping, and phenotyping.
PAREXEL is a world-renowned life sciences consulting firm that helps pharma companies develop approximately 95% of the 200 top-selling biopharmaceuticals on the market. Leading pharma companies such as Catalent Inc, Merck & Co. Inc., Pfizer Inc., ICON plc, and GlaxoSmithKline plc all depend on PARAXEL for new drug development. In June 2017, the company announced that it is set to be acquired by Pamplona Capital for US$5 billion.
ICON is a global provider of outsourced drug development services depicting expertise in the field of late phase services. In fact, it is the world’s second-largest player in the field of late phase services in terms of market share. Their services range from clinical, consulting, and commercial services, which incorporate trial design and full study execution. The company is renowned for its exceptional quality management system subjected to more than 1,700 successful audits by buyers, regulatory bodies, and ISO. They also offer knowledge, software, and systems for adaptive trials.
INC Research is one of the leading CRO companies known for ‘The Trusted Process,’ a proprietary trial management methodology developed by the company. The company recently merged its operations with inVentive Health to expand the global scale and add capabilities. Their key services include early phase trials, phase II and III trials, late phase trials, consulting, and clinical monitoring.
Read more about the top CRO companies along with CRO services, clinical trials, drug development, pricing strategy, procurement challenges, and supplier evaluation criteria in SpendEdge’s upcoming report on the global pharmaceutical drug development services market.
If you were to ever glance on the packaging of medicines, it would enlist the chemicals and composition used to manufacture that drug. However, chemicals are not the only raw material used in the pharmaceutical manufacturing process. Pharmaceutical raw materials also include natural raw materials like leaves, flowers, fruits, fungi, and seeds, in addition to synthetic materials and biologics. Pharmaceutical raw materials are classified into three groups namely active pharmaceutical ingredients (APIs), intermediaries, and additives. The pharmaceutical industry relies heavily on chemical suppliers and biologics manufacturers for their pharmaceutical supplies. The pharmaceutical industry has been witnessing stable growth with higher growth prospects in emerging regions such as the APAC, which is expected to grow at a CAGR of nearly 9%-10% by 2021. (SpendEdge Procurement Market Intelligence Report – Bulk Drug Raw Materials Market) Although the growth prospects look promising for the pharmaceutical industry, suppliers of pharmaceutical raw materials have been facing tough challenges that affect their growth.
Top Challenges in the Pharmaceutical Raw Materials Market
Threat from Counterfeit Products
Falsified medicines or counterfeit drug products can easily enter the pharma supply chain across the world. Counterfeit drugs, usually contain low-quality APIs, wrong ingredient, or even the incorrect dosages. Such counterfeit products are then fraudulently mislabeled without compliance with intellectual property rights and can cause side-effects and other complexities when consumed. Pharmaceutical raw materials manufacturers will be negatively affected by such acts. As a result, medicine surveillance services and fake -identification technologies such as mass spectrometry (MS), infra-red (FTIR) spectroscopy, nuclear magnetic resonance (NMR) spectroscopy, Raman spectroscopy, and gas chromatography-mass spectrometry (GC-MS) are gaining prominence.
Increase in Trade Taxes
Manufacturing hubs of the final drug products are located in the primary markets such as the US and Europe. However, these companies procure pharmaceutical raw materials from emerging countries like Brazil, China, India, and Israel. The problem arises when drug manufacturers have to incur additional expenses in the form of trade taxes and customs expenses. To promote “Made in America” movement, the Trump administration has slapped a double-digit tariff for companies outsourcing drug manufacturing activities. Such regulations will discourage drug manufacturers to obtain pharmaceutical raw materials at a lower cost.
Increase in Regulatory Delays
Drugs and medicines being a sensitive matter regarding public health, are heavily regulated by governments and medical associations. Pharmaceutical raw materials suppliers, therefore, must obtain approval from regulatory bodies such as FDA and EMA to bring the final products to the market. Delays in the approval process can slow down the time-to-market, and risk expiry of patent validity along with other operational issues. Such delays severely affect the drug manufacturers profitability, thereby hindering the overall growth of the market.
Read more about the top challenges in the pharmaceutical raw materials market along with competitive landscape analysis, contract and SLA terms, pricing strategies, sourcing strategy, and procurement market intelligence in SpendEdge’s upcoming report on the global beef market.
It is very characteristic of a pharma company to invest millions of dollars in new drug development with very little success rate. They then face pressure from governments and consumers to keep the prices of such medicines low for it to be accessible to everyone. Consequently, pharma companies are looking for new ways to increase their revenue stream and improve efficiency in every aspect of their business. Innovations in pharma procurement along with advancements in technology can significantly boost profitability in the pharma industry and provide them a competitive advantage.
Current Trends in Pharmaceutical Industry
Reinvesting in R&D Process
For a very long time, big pharma players in this industry were relying on old techniques and technology for drug discovery. Since companies started using big data analytics, they have significantly improved their success rates for drug discovery. Additionally, using real-world evidence has equipped them to speed up the drug discovery process, decrease R&D costs, and improve time-to-market.
Resource Reallocation in the Emerging Markets
The pharma industry has been shifting its focus from developed nations to emerging markets as the growth curve in the developed parts of the world continues to flatten. The emerging markets which are relatively underserved have a vast growth potential for key suppliers in the pharma industry. The suppliers are exploring ways to increase the efficiency of the pharmaceutical supply chain by identifying potential locations for developing and manufacturing medicines. For instance, the developed parts of the world are looking at the Asian and Latin American region to outsource the process of clinical research.
New Modes of Healthcare Delivery
Hospitals and healthcare specialists are driving up the overall cost of healthcare. Companies are looking for ways to cut down costs and improve outcomes by trying to reduce reliance on hospitals and specialists. The recent advancements in medicines along with technological advancements such as fitness tracker and health monitoring devices has made self-medication and telemedicine possible. Such disruption in the pharmaceutical supply chain could significantly improve the costs, efficiency, and profitability of the pharma industry.
Increasing Emphasis on Outcomes
The increasing emphasis on outcomes is the most prominent pharma trend currently. Majority of the players in the pharma industry are modifying their existing models such as a fee for service models in favor of outcome-based models. Such measures help reduce wastages and fraud mostly in the healthcare reimbursement sector. The pharmaceutical supply chain needs to be highly active by closely supervising and monitoring the value delivery process to the patients in order to improve outcomes.
For more information on how optimization of pharmaceutical supply chain, pharma trends, pharma manufacturing, and pharmaceutical procurement:
Over the years, the biopharmaceutical industry has been facing increased pressure from the end-user segments to develop medicines to prevent and cure diseases effectively. Additionally, establishments across the biopharmaceutical industry have been forced to bridge the demand-supply gap owing to the rise in customer demands and expectations. Through a robust supply chain risk analysis, leading firms in the biopharmaceutical industry can reduce supply disruptions and longer lead times. Also, firms operating in this industry space can gain better visibility into their supply chain processes and increase their performance.
Moreover, SpendEdge’s supply chain risk analysis help leading procurement establishments in the biopharmaceutical space to comprehensively collect, analyze, and manage supplier information.
The Procurement Pain Point and Insights Offered
A global biopharmaceutical industry client was facing predicaments in understanding the supply structure and the typical risks associated with them. As a result, they wanted to understand the risks that are likely to impact the profitability of the business, supply trends, and forecasts across the supply chain. Additionally, the client wanted to ensure robust production and delivery competencies and cut down issues related to sales losses.
With years of proficiency in offering a wide range of procurement and sourcing solutions, SpendEdge’s supply chain analysts carried out a blended research methodology, which included primary and secondary research coupled with quantitative and qualitative data collection methodologies to address the client’s business issue.
During the course of this supply chain risk management study, the biopharmaceutical industry client was able to categorize and mitigate risks associated with supply chain functions. Furthermore, the client was able to comprehensively collect, analyze, and manage supplier information and gain insights into the potential financial issues in the industry space.
Fundamental questions answered in this supply chain risk analysis study include
The supply chain risk engagement helped the client identify potential threats and devise effective strategies to gain better visibility into the contract, spend, and compliance management. Additionally, the client was given real-time strategic insights into the risk factors affecting their growth.
Want to know more about our supply chain risk analysis solutions for the biopharmaceutical industry?
Pharmaceutical packaging is a matter of serious concern for both the drug manufacturers and consumers. The primary objective of pharmaceutical packaging is to protect the medicine from external factors such as heat, moisture, oxygen, and contamination to ensure drug efficacy, patient safety, and extended shelf life. Since pharmaceuticals are sensitive to fluctuations in environmental conditions and contaminations, suppliers must comply with government rules and regulations regarding the packaging of medicines. Here are some of the regulatory frameworks that pharmaceutical packaging suppliers must comply by:
Drug tampering cases like Tylenol tampering with potassium cyanide in the past have resulted in deaths. After the Tylenol case, the FDA issued the Federal Anti-Tampering Act, requiring OTC drug manufacturers to create tamper resistant packaging. FDA rules for OTC drugs are relatively simple as well. For instance, two-piece hard gelatin capsules need a minimum of two tamper resistant packaging features, whereas one feature is sufficient for everything else. Shrink wrap, blister wrap, bubble packs, HIS liners, sealed metal tubes, and aerosol containers are some of the options available for manufacturers to develop tamper resistant packaging.
The pharmaceutical packaging industry is highly regulated in terms of labeling requirements. Key players in the pharmaceutical packaging industry must adhere to the Fair Packaging and Labeling Act (1967) in the US, which mandates the label to include product identity, manufacturer and supplier address, contents, net quantity, and prescription information.
Pharmaceutical packaging suppliers must comply with the global pharmacopeia standards set by WHO to ensure product quality. For instance, water used in packaging processes should be EP grade as it ensures high purity of water and meets worldwide specifications. Although WHO standards are globally accepted, countries can modify the standards to suit their own needs; thus, forming standards such as European Pharmacopoeia – 5.12 and British Pharmacopoeia chemical reference substances (BPCRS).
Read more about the rules and regulations in the pharmaceutical packaging market along with supply market landscape, pricing, and procurement insights in SpendEdge’s upcoming procurement report on the pharmaceutical packaging market.
The global pharmaceutical packaging industry is rapidly growing due to the use of biodegradable materials as it adds to the sustainability of the packaging through all the stages of the pharmaceutical supplies lifecycle. However, the unpredictability in the price of the raw materials used in this industry may pose a significant challenge to the key market stakeholders.
The Procurement Pain Point and Insights Offered
A global pharmaceutical products company wanted to cut down the costs of the goods associated with pharmaceutical supplies. Furthermore, they also wanted to incorporate the best practices and consolidate their procurement strategies with suppliers from different countries. The client also wanted to streamline their existing procurement process for pharmaceutical supplies and identify potential cost saving opportunities.
SpendEdge carried out an in-depth research process consisting of primary and secondary research methodologies coupled with qualitative and quantitative data collection methods to cater to the specific category requirements of the client. Furthermore, the suppliers were also graded based on the standards and allotted weights. The final supplier selection was carried out on parameters including geographic coverage, qualitative assessment scores, previous experience with the vendors, and product development and tooling costs. Moreover, we collaborated our research with a huge database of exclusive resources such as industry journals and reports, white papers, and news articles. The best practices study on the sourcing of pharmaceutical supplies also helped gain a better understanding of the procurement best practices for pharmaceutical supplies and the vital service offerings of the medical suppliers.
This best practices study on the sourcing of pharmaceutical supplies helped the client identify and reduce the list of the major suppliers offering pharmaceutical packing solutions. This list offered by SpendEdge also helped the client achieve better high-cost savings compared to the current spend. Additionally, material cost indexing and steady conversion costs were also negotiated.
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The latest procurement market intelligence study by SpendEdge on the supply market of legal services providers helps companies in the biopharmaceutical industry to gain comprehensive insights on the supply landscape for legal services and amend their ability to benchmark current services and pricing.
Legal services – market at a glance
Legal services firms are offering advisory and technical assistance or representational services pertaining for all legal disciplines in the healthcare industry. The stringency of new healthcare regulations, reimbursement policies, and shift towards value-based systems is fueling the requirement for regular legal services. Technological advances, patent registration or renewals, and mergers and acquisitions are few areas in the healthcare industry that requires legal services. The continuous development of new products and changes in the legal framework will boost the demand for expertise in the field. Pharma and drug companies, start-ups, and universities are the primary end-users of legal services in the global market. Supply market intelligence offered by SpendEdge helps pharmaceutical giants to identify key suppliers of legal services in the targeted region, insights on procurement best practices, and category management.
The increasing popularity of legal process outsourcing (LPO), also called legal outsourcing is helping companies source talented resources from various regions. LPO models are gaining predominance across many industries as these are viable options for cost reduction. These organizations offer legal services of lawyers, attorneys, and counsels from offshore locations. These systems provide access to talented employees at reduced cost and require a minimal focus on tactical work.
Emergence of e-health and new biosimilars
The growth of e-health and access to clinical data has given rise to regulatory and cybersecurity challenges, instigating pharmaceutical companies to tighten their legal services. The clinical development and market authorization of biosimilars require more approvals by different regulatory bodies. Licensing is the most requested legal service in the global market, and the continuous development of new age products will boost the growth of this service.
Big Data analytics in legal services
Big Data analytics helps companies assess visibility on legal spend, offers insight-based support for decision making, and provides effective demand forecasting and management. Many suppliers in the market are adopting Big Data analytics tools to streamline operations and improve the decision-making process. By using data analytics, law firms are optimizing their spend, identifying cost saving opportunities, and enhancing the efficacy of demand forecasting.
What solutions SpendEdge offer
The supply market intelligence experts at SpendEdge helped a leading pharmaceutical company gain insights on the key suppliers of legal services in North America and many other solutions, some of which are listed below:
- Identify and acquire information from various reliable sources who have expertise in the legal services category
- Develop category-specific insights that helped the client’s procurement teams with category planning and category management
- Analyze information on the various aspects of the major suppliers in the industry including their positioning matrix, operational capabilities, financials, and their major customers
- Assess the industry trends and market drivers, and enhance their ability to benchmark current services and pricing
- Offer overview of the various pricing models and their benefits and assess the merits of the various pricing models
Read our complete case study titled – Assessment of the Supply Market of Legal Services Providers for a Leading Biopharmaceutical Company
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- SpendEdge’s Tail-spend Assessment Helps a Leading Pharmaceutical Company Identify Opportunities to Save Millions
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