Which Segment of Pharmaceutical Company will Bring Good Fortune?

- May 10, 2020

Important Segments to track growth for Pharma Companies

Shuchi.P.Nahar

Investments in the global pharmaceuticals sector to increase to over $1,400 billion over the next three years, driven by a number of new medicines. With healthy R&D spending going forward, the Contract Research and Manufacturing (CRAMS) segment offers growth opportunities to Indian companies. Change in regulations around generic approvals will help Indian companies to increase penetration in Chinese markets, which will improve margin expansion.

What are CRAMS ?

CRAMS is defined as the process of outsourcing research services/ product manufacturing activities to organizations which can provide the service at a low cost. CRAMS basically consists of the following two activities: contract research and contract manufacturing. CRAMS is mainly used in the Pharmaceutical and Biotechnology sectors that require extensive R&D and large-scale manufacturing facilities. It is expected that the demand for contract research and contract manufacturing is expected to increase in India in the future.

Future for Pharmaceutical Companies

Developing countries such as India, China, Mexico, and Brazil are witnessing significant improvements in their healthcare infrastructure and technological innovations in their drug development processes. As a result, several pharmaceutical companies from developed countries are outsourcing the research and manufacturing operations to the vendors in such countries. The availability of labor at a comparatively lower price is one of the critical reasons for the growing popularity of outsourcing these processes.

Moreover, the rising number of US FDA-approved manufacturing plants in developing countries also encourages outsourcing. These factors will augment the growth of the pharmaceutical CRAM market during the forecast period.

Rising demand for generic formulations, increased investments in pharmaceutical Research & Development and advanced manufacturing technologies by contract development and manufacturing organization (CDMO’s) are key factors contributing to the high CAGR of Pharmaceutical Contract Manufacturing market during the forecast period.

Market Size – USD 82430.9 Million in 2018, Market Growth – CAGR of 7.2 %, Market Trends – Increasing outsourcing of clinical trials, increasing CDMO’s manufacturing footprint in Asia

The pharmaceutical industry uses outsourcing services from providers in the form of contract research organizations (CROs) and contract manufacturing organizations (CMOs). Comprehensive single-source provider from drug development through commercial manufacture has emerged in recent years.

It is known as contract research and manufacturing services (CRAMS), or contract development and manufacturing organizations (CDMO). Pharmaceutical Contract Manufacturing organizations are a response to the competitive international nature of the pharmaceutical market as well as the increasing demand for outsourced services.

Owing to a wide ranging product mix consisting of high-end research services, biologics, and complex technology services, all offered at a low cost, contract manufacture and research services (CRAMS) industry has witnessed tremendous growth in the Indian subcontinent.

With externalization of research to emerging markets, India presents a strong case for outsourcing research and manufacturing.

Picture Credit: RedNewswire

PHARMACEUTICAL CONTRACT MANUFACTURING MARKET TO REACH USD 144958.8 MILLION BY 2026 GROWING AT A CAGR OF 7.2%

The pharmaceutical industry has undergone significant changes over the years, in terms of technology for R&D of drugs. One of these significant advances include the use of analytics for identifying various essential aspects of research. The use of analytical tools for clinical data synthesis helps companies to quicken the drug development process.

Big data helps to avoid the high cost of adverse events. It also allows companies to keep a record of patients for long durations, which enables regular monitoring after treatment. The advent of big data will benefit CROs as it makes the process more efficient.

With lower cost manufacturers capturing a major portion of the market, India is in a pole position in the area of dosage form and end-to-end efficiency in outsourcing.

Industry experts find a tectonic shift across the contract research organisation landscape with several key pharma players now outsourcing their early drug development activities covering pre-clinical and early phase research to some of the leading CRO players in the market which was earlier handled by pharma companies themselves.

With externalization of research to emerging markets, India presents a strong case for outsourcing research and manufacturing. Whilst contract manufacturing is expected to garner a larger share of revenues in the range of over 50-60 per cent, the country is also witnessing a simultaneous contribution from the contract research services capturing rest of the CRAMS services and over 20 per cent of the APAC CRO market.

The Indian government policies to encourage exports and support the growing R&D through several tax benefits and have allowed the country to be on the forefront of contract research and manufacturing services.

India is amongst the preferred destinations for outsourcing of research as well as manufacturing activities. New age CRAMS providers are able to cater to not just the pharmaceutical clients, but also biotech, agrochemicals, nutrition, animal health, consumer goods and others. This has opened up wider growth opportunities for the sector. At present, there is very less innovator manufacturing happening out of India as contract manufacturing

Indian CRAMS companies hold a competitive edge across the global pharmaceutical industry in being the most preferred partners for drug development and manufacturing. Owing to a wide ranging product mix consisting of high-end research services, biologics, and complex technology services, all offered at a low cost, CRAMS industry has witnessed tremendous growth in the Indian subcontinent.

Global CRAMS market is highly fragmented with over 1000 players with SEA countries such as India, China, Japan, Singapore, Malaysia etc. expected to show a robust double digit growth. In most cases, process development and clinical research are the majorly opted services from CRAMS players. According to the Indian Government, by 2020, India would be one of the top five pharmaceutical innovation hubs with one out of every five to 10 drugs discovered in India. Despite positioning as the Go To market, China stands strong as a key contender especially in the field of generics manufacturing.

For example, in June 2019, China’s National Health Commission published their first list of 34 drugs which are off patent or nearing patent expiration and have no generic drug counterpart. This in turn is encouraging local pharma companies to make generic drugs, under the drug regulator’s priority review pathway, which until now has mostly been handed to innovative drugs. Hence, we expect Asia Pacific to stay at the forefront of the CRAMS industry with India and China leading the charts.

Conclusion:

Global Pharmatech said that contract manufacturing for the Indian market is a challenging space. Margins are low or non-existent. This is particularly true for products under price control. Manufacturers who have large -scale operations which are run efficiently may make a profit but it is probably still below reasonable return on investment.

Contract manufacturing for the US and other regulated markets is relatively more attractive but this requires investment in facilities, people and systems to maintain regulatory approvals. Companies which maintain their compliance status can continue to earn good returns even as pure CDMO.

Sources :Pharmabizz
Data and reports
Rednews Letters
Pharma research Report

SHUCHI.P.NAHAR